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JOSE CERDA
Box 5:
Rohy Pnol
Bratton NYC Police Commissioner
Methamphetamine
Mutli-Cultural Programs
Immigration - Fraternal Order of Police Firearm related juvenile use of drugs
OVERSIZE ATTACHMENTS 16957
ENCLOSURES FILED
NANA 14148
ROHYPNOL: THE DATE RAPE DRUG
BACKGROUND
Rohypnol, also known as "Roofies", is the brand name of the drug
flunitrazepam. It is used in some countries to treat insomnia or anxiety but is illegal
to produce or prescribe in the United States. Referred to as the "date rape drug",
Rohypnol-- tasteless, odorless and easily dissolved in alcohol-- has increasingly
been used by rapists to incapacitate their victims. Its use is also growing in
popularity among young people.
WHAT THE CLINTON ADMINISTRATION HAS DONE:
1. Customs Crackdown at the Ports of Entry
On March 5, 1996, Secretary Rubin and Customs Commissioner Weise
directed the U.S Department of Customs to seize all Rohypnol coming across the
border. The Customs Service is now confiscating any amount of Rohypnol brought
into the country by travelers, commercial shipments, or through the mail.
2. President Clinton's Anti-Gang and Youth Violence Act of 1996
In May of this year, President Clinton submitted legislation to Congress to
further fight the scourge of Rohypnol. Among the other provisions to keep kids
drug-free, the bill would give the Attorney General emergency authority to
reclassify certain emerging drugs such as Rohypnol on the list of controlled
substances-- thereby stiffening the penalties for their use.
3. President Clinton's Commitment to Sign H.R. 4137 Into Law
President Clinton will sign into law H.R. 4137, the Drug-Induced Rape
Prevention and Punishment Act of 1996. The bill will criminalize the use of
Rohypnol-- or any illegal drug-- used with the intent to facilitate a violent crime.
Enactment of the legislation will mean tougher penalties for such crimes, with
criminals who use Rohypnol on their victims particularly targeted. The bill will
also commission a six-month Drug Enforcement Agency study to determine
whether Rohypnol should be reclassified.
JAN-23-96 TUE 11:55
P.02
Rophynol (row-hip-nole)
(flunitrazepam)
I
Known as "quaalude of "90s" in some parts of the country.
Background
benzodiazepine sedative (same family as Valium, Xanax, Halcion); manufactured by
Roche Pharmaceuticals
not legally available in U.S.; approved medicine in most other parts of the world
prescribed as sedative (short-term treatment of insomnia & sleep disorders)
Names: "rophies" "ropies" "roaches" "R2" "getting roached"
Oral or pills crushed and put in joints
Effects
10 times more potent than Valium; sedative/disinhibition effects are amplified in
combination with alcohol
2mg tablet = drunken-like feelings, euphoria, disinhibidon, muscle relaxation, slowed
1
coordination, hangover. High doses = stupor. Unique property is its ability to cause
amnesia (memory loss), particularly in combination with alcohol. This is a characteristic
of many benzodiazepines. Late 1980s, cases of Halcion causing memory loss as long as
48 hours after use.
Onset 20-30 minutes; lasts about 8 hours
Risks: like all benzodiazepines, can produce dependence, rebound insomnia, withdrawal
after extended use. Long-half life (slow elimination from body) 11 residual effects that
can be dangerous if users take additional doses. Generally low OD potential, but high
doses/drinking can cause significant respiratory & cardio depression.
National Trends
fastest growing drug problem among adolescents in south Florida; "epidemic" began over
summer of 1993
Other "hotspots": southern Texas
Users: club drug (young adults); alcohol extender (teenagers); ease comedown from
crack/speed (street population in treatment)
implicated in "date rape" cases in Florida
JAN-23-96 TUE 11:56
P.03
Arizona
First reports to CEWG in April 1995 of coming in over the border; Tucson, Yuma;
mainly adolescents/teenagers taking it in combination with alcohol
4 ERs in Yuma reported during September 1995; all kids
41 DEA actions through November 1995
CEWG: no current reports of availability outside southern Arizona; use appears centered
among high school students, so would expect eventual spread north
1
1
JAN 23 '96 11:57 E
602 844 8449
TO:
P01
INTERVENTION SPECIALISTS
EAST VALLEY ALCOHOLISM COUNCIL, INC.
554 S. Bellview
Mess, Arizona 85204
Administrative Services (602) 962-7922
Clinical Services (602) 962-7711
OFFICERS:
President
FAX TRANSMISSION
Rub Evans
Vice President
DATE:
1-23-96
TIME: 12:45
Larry Chesley
AGENCY/CO. NAME:
Secretary/Treasurer
Patricia Miller
ATTENTION:
Dwight Vick
Immediate Past President
David 12. W. Shumway
FAX NUMBER:
202-456-7028
TRANSMISSION CONSISTS OF 3 PAGES INCLUDING COVER.
MEMBERS:
William Benedict
PROBLEMS? CALL 602-962-7922
Suzanne Dester
EVAC'S FAX NUMBER IS 602-844-8449
Kerry Dunne
Helen Enloe
MESSAGE: Duright Per our
R.R. Evans
Conversation, here is the info
Chris Fickas
Pat Gilbert
Falk to you soon
Hon. R. Wayne Johnson
Lars Jarvie
John Hohman
Kenneth Levine. D.O.
Program Director
John McKindles
Lee Ann Schultz
One Shill. M.D.
EVAC
Robert Soca
1
EXECUTIVE DIRECTOR:
Rulph Hobe. M.A.
People who attended the meeting:
Ross Deck
Edward Jurith
Representatives from HHS
Roche legal council
member - Robert T. Angarola - Carter Drug Czar
Don Kaiser - lawyer from Swiss office, now in
Washington
Rohypnol is produced by the Switzerland-based company,
Roche. It is an international company with more than 80
production plants around the world. Two of their companies
produce the drug, Rohypnol. They are located in Mexico City,
Mexico and Bogota, Columbia.
Kaiser presented the information. The Roche company heard
of the drug's presence in late 1994. Hospital emergency rooms,
treatment centers, and detoxification centers in Florida were
admitting people with this drug in their blood stream or on their
person. At first the company was not concerned. As these calls
increased, the company began to worry as well. They did not know
how it entered the country. Several options were explored.
At first, Roche thought the people using the drug had
obtained the drug through legal means. Kaiser mentioned the FDA
and Customs agents allow someone to fill a prescription in
another country as long as they do not have more than a 90-day
supply. Foreign travelers use the drug as a sleep aid when
travelling abroad and drank too much. Since this drug is legal
by prescription in 62 foreign countries, this was of no major
concern to Roche.
The drug entered the U.S. through Florida with Caribbean-
and Northeastern-based construction companies. Arriving to help
PHOTOCOPY
PRESERVATION
rebuild Miami after Hurrican Andrew, the construction workers
were working long hours and needed a drug to help them sleep
heavily. They brought and took Rohypnol as prescribed.
Eventually, the drug was mixed with alcohol to double the effects
of the drugs. It became popular in bars and entered the street
scene. However, Rohypnol was not the only drug to be abused in
the area. Emergency rooms, detoxification centers and drug
treatment facilities overflowed with people who were depressed
and/or overworked after the hurricane.
Roche is auditing its Mexican and Columbian plants
internally for leaks. This is a strong possibility since the
pills appear in bubble wrapping. Their audits show that no
employee or groups of employees are removing the supplies or
products outside of their facilities.
Roche hired a drug research organization from Haight-Asbury
in San Francisco to interview users in South Texas. Their
findings showed that three types of people are more likely to
take Rohypnol: opiate addicts, habitual users, first-time
users. Opiate addicts use the drug to detoxify from all opiates.
Basically, it stops most withdrawal symptoms. It is also a
bridge drug. They use it until they can obtain more opiates. If
used more than two weeks, the addict has simply switched
addictions - from opiates to Rohypnol. Habitual users will use
anything to get a "fix", including Rohypnol. The most
predominate user is the first-time, naive user. They are usually
kids who are rebelling against their parents. Roche stated their
studies show most of the kids could not pick out Rohypnol from
the pill charts they were shown.
The company expects to use the Haight Asbury to conduct
research in the South Florida area. However they expect some
drug connection. There will be few similarities between the
Florida and Texas epidemics.
The company has agreed to limit access to pharmacies in or
near Mexican border towns. In South Texas, the Haight Asbury
study determined there is no major syndicate involvement in the
distribution of Rohypnol. The users go to a Mexican physician
located near a pharmacy and obtain a prescription. They take it
to the nearest full-service pharmacist and get the pills. Most
orders are not over 100 pills and are easily hidden from Customs
agents (who would not be concerned about a prescription drug from
Mexico in the first place). The company states they do not
conclusively know how it is currently entering the Florida
region.
Roche is negotiating with Mexican officials in an effort to
regulate the Rophynol market. Their biggest concern is their
lack of understanding the Mexican laws. The company fears any
serious involvement with the Columbian government. They do no
want their employees or investigators to die.
My Thoughts on Rhynopol
Roche used this as a meeting to prevent any further media
damage or government action this drug.
They are scared that Roche will be associated with the
production of a "date-rape drug". I think they are willing to
regulate themselves so they can prevent damage control and
government intervention. There were two cases in South Texas and
Florida where the woman was raped after being exposed the
Rohypnol. The kids call this violent activity, and getting high
off the drug, as "roaching". The word Roche is printed on the
tablet and the people mispronounce it.
I have some serious misgivings about the validity and
reliability of their research. First, they brought outsiders
into South Texas to interview kids and users on the amount of the
drug they used. Students are not generally honest about their
use. They will lie to "look tough" or to cover up real usage
amounts. While they did hire former users to interview them,
these former users are outsiders to the South Texas. The
interviewers are not familiar with the lifestyles and people.
The interviewees will see them as "suckers" so they are more
likely to lie than if it were someone they could identify with at
the time.
I asked the Roche representatives what were the other pills
the users were shown. They all responded that various types were
shown. Since generic forms of Rohypnol are just as easily
available in Mexico as the Roche pill itself, I asked if they
were pictured. There were no definitive answers. Furthermore,
they stated they did not know if these users were taking the
generic forms; yet, their findings in South Texas were
conclusive. They did not know who the producers of the generic
Rophynol market. Their only response was that 50 percent of men
and 15 percent of the women could pick out the Roche pill. This
made no sense to me and it was obvious I would get no further
answers at this session.
They were constantly referring to the drug as an oral drug.
I asked them if their research showed that Rohypnol was smoked.
Their studies did not show this occurrence at all. They stated
the drug has no effect on the body once it is heated above 110
degrees. I stated the kids are still doing it and its use is
increasing. When I called my friends in Phoenix, I learned some
people crush the pill and mix it with marijuana. This is the
second most common method of ingestion.
The drug is not fatal unless the person ingests large
amounts of alcohol and Rohypnol at the same time over a long
period of time. Several people believe it is a loss leader by
the black markets. They are attempting to gain more customers
and they are targeting the three groups mentioned above.
The Roche representatives stated they were the first company
in American history to offer self-regulation to the government.
They will work with the Mexican government to control the drug in
border towns and foreign governments to prevent any leaks. They
are also working with the Columbian government to prevent
possible leaks from their country. The representatives agreed
this would be difficult since the Columbian government is under
siege. I agree. There was a brief mention of the product being
shipped from other Central American or South American countries.
No substantive investigations into this possibility were
mentioned.
This issue has become a race issue. Throughout 20th Century
America, drug use has been a race issue. Opiate smoking was
regulated in California because it was a Chinese tradition. The
Chinese experienced racism throughout the region. No other
opiate use was controlled. Marijuana and cocaine were regulated
by state and local governments in an effort to control Hispanic
and black populations. Once these problems involved white,
middle-class Americans, federal involvement was demanded. When
this was a South Florida/Caribbean problem, it was not a problem.
When the drug entered Floridian, middle-class white American kids
and young adults at dance bars, it became a problem.
At this point in time, national citizen forces are not
strongly aligned on this issue. Their influence at this time is
not a factor in the policy making process. With media attention,
this will grow without question.
One salient, yet silent, factor in drug policy formulation
is the alcohol and pharmaceutical industries. Tighter controls
on these industries mean more money will be spent on drugs in the
black market. Roche's meeting today falls along those lines.
The only anomaly is Roche's advocating a mostly self-regulation
measure. Roche is courting the Federal government in an effort
to gain control of the situation without governmental action.
In my opinion, it boils down to this - the Roche Company is
afraid the American public will perceive this as the crack
cocaine of the 1990s and the date rape pill. They gathered these
groups of government employees together to encourage them to
implement the company's wishes.
My Recommendations
-
Take no legislative action at this time. If the WH attempts
to control Rohypnol, it must look at controlling other
benzodiazepines like valium. After the Maxine Water's
arguments on crack cocaine VS. cocaine sentencing, it would
renew old arguments.
-
All action should originate from the Executive Branch.
-
Publicity should be avoided. Children watch television. If
the media portrays this as the "crack of the 1990s", demand
will increase. Many people will want to see what it is like
and will try it. This could result in higher Rohypnol
addiction rates than we are currently experiencing.
-
The President should instruct the Secretary of State to
contact his counterpart within the Mexican government.
Since most of the South Texas business appears to be "mom-
and-pop" store purchases in Mexico, the U.S. should
encourage them to place stricter controls on the Rohypnol
and its generic products in or near border towns.
-
The President should instruct the Secretary of the Treasury
to notify Customs agents of the increased use of this drug
and it is made accessible through their ports of entry.
Roach Pharmaceutical cited several instances where they
asked people to purchase the drug and smuggle it over the
border. Others were asked to declare it. In all cases, no
action was taken by Customs.
-
The President should instruct the Secretary of Health and
Human Services to prepare a pamphlet for immediate
distribution to all teachers, school administrators,
treatment facilities, and emergency room personnel on this
drug, its increased use among youth, and subsequent
symptoms. Its use among habitual addicts should be
mentioned as well. These groups are more likely to report
is presence because of his involvement. Presidential
attention to this issue will provide more reliable data
available for study.
Roche should be encouraged to apply for a patent on the
drug. The only reason Rohpynol is not available on the
American market today is due to its direct competition with
valium. If they applied and received the rights to market
the drug in the U.S., Roche could increase their profits on
the drug by selling at a higher price in the United States
than they would receive for Rohypnol in Mexico. The drug
would be less alluring and the government could control its
purity. The Federal government will monitor the drug.
Rohypnol is not a drug like cocaine or heroin;
therefore, it does not require a Schedule 1 rating. This
will free the law enforcement agencies to monitor the influx
of more serious drugs, like heroin and cocaine.
If this becomes the "Crack of the 1990s", executive action
will prove to the American people during an election year
that President Clinton has made every attempt to control
this problem without media attention. Media attention could
attract children to the drug, making all actions
counterproductive.
If these policies are implemented, I think it will be a win-win
situation for all involved. I would like to discuss these
options with you.
Thank you for the excellent oppotunity. I want to
participate in any and all of these opportunities that occur.
People who attended the meeting:
Ross Deck
Edward Jurith
Representatives from HHS
Roche legal council
member - Robert T. Angarola - Carter Drug Czar
Don Kaiser - lawyer from Swiss office, now in
Washington
Rohypnol is produced by the Switzerland-based company,
Roche. It is an international company with more than 80
production plants around the world. Two of their companies
produce the drug, Rohypnol. They are located in Mexico City,
Mexico and Bogota, Columbia.
Kaiser presented the information. The Roche company heard
of the drug's presence in late 1994. Hospital emergency rooms,
treatment centers, and detoxification centers in Florida were
admitting people with this drug in their blood stream or on their
person. At first the company was not concerned. As these calls
increased, the company began to worry as well. They did not know
how it entered the country. Several options were explored.
At first, Roche thought the people using the drug had
obtained the drug through legal means. Kaiser mentioned the FDA
and Customs agents allow someone to fill a prescription in
another country as long as they do not have more than a 90-day
supply. Foreign travelers use the drug as a sleep aid when
travelling abroad and drank too much. Since this drug is legal
by prescription in 62 foreign countries, this was of no major
concern to Roche.
The drug entered the U.S. through Florida with Caribbean-
and Northeastern-based construction companies. Arriving to help
rebuild Miami after Hurricane Andrew, the construction workers
were working long hours and needed a drug to help them sleep
heavily. They brought and took Rohypnol as prescribed.
Eventually, the drug was mixed with alcohol to double the effects
of the drugs. It became popular in bars and entered the street
scene. However, Rohypnol was not the only drug to be abused in
the area. Emergency rooms, detoxification centers and drug
treatment facilities overflowed with people who were depressed
and/or overworked after the hurricane.
Roche is auditing its Mexican and Columbian plants
internally for leaks. This is a strong possibility since the
pills appear in bubble wrapping. Their audits show that no
employee or groups of employees are removing the supplies or
products outside of their facilities.
Roche hired a drug research organization from Haight-Asbury
in San Francisco to interview users in South Texas. Their
findings showed that three types of people are more likely to
take Rohypnol: opiate addicts, habitual users, first-time
users. Opiate addicts use the drug to detoxify from all opiates.
Basically, it stops most withdrawal symptoms. It is also a
bridge drug. They use it until they can obtain more opiates. If
used more than two weeks, the addict has simply switched
addictions - from opiates to Rohypnol. Habitual users will use
anything to get a "fix", including Rohypnol. The most
predominate user is the first-time, naive user. They are usually
kids who are rebelling against their parents. Roche stated their
studies show most of the kids could not pick out Rohypnol from
the pill charts they were shown.
The company expects to use the Haight Asbury to conduct
research in the South Florida area. However they expect some
drug connection. There will be few similarities between the
Florida and Texas epidemics.
The company has agreed to limit access to pharmacies in or
near Mexican border towns. In South Texas, the Haight Asbury
study determined there is no major syndicate involvement in the
distribution of Rohypnol. The users go to a Mexican physician
located near a pharmacy and obtain a prescription. They take it
to the nearest full-service pharmacist and get the pills. Most
orders are not over 100 pills and are easily hidden from Customs
agents (who would not be concerned about a prescription drug from
Mexico in the first place). The company states they do not
conclusively know how it is currently entering the Florida
region.
Roche is negotiating with Mexican officials in an effort to
regulate the Rophynol market. Their biggest concern is their
lack of understanding the Mexican laws. The company fears any
serious involvement with the Columbian government. They do no
want their employees or investigators to die.
My Thoughts on Rhynopol
Roche used this as a meeting to prevent any further media
damage or government action this drug.
They are scared that Roche will be associated with the
production of a "date-rape drug". I think they are willing to
regulate themselves SO they can prevent damage control and
government intervention. There were two cases in South Texas and
Florida where the woman was raped after being exposed the
Rohypnol. The kids call this violent activity, and getting high
off the drug, as "roaching". The word Roche is printed on the
tablet and the people mispronounce it.
I have some serious misgivings about the validity and
reliability of their research. First, they brought outsiders
into South Texas to interview kids and users on the amount of the
drug they used. Students are not generally honest about their
use. They will lie to "look tough" or to cover up real usage
amounts. While they did hire former users to interview them,
these former users are outsiders to the South Texas. The
interviewers are not familiar with the lifestyles and people.
The interviewees will see them as "suckers" so they are more
likely to lie than if it were someone they could identify with at
the time.
I asked the Roche representatives what were the other pills
the users were shown. They all responded that various types were
shown. Since generic forms of Rohypnol are just as easily
available in Mexico as the Roche pill itself, I asked if they
were pictured. There were no definitive answers. Furthermore,
they stated they did not know if these users were taking the
generic forms; yet, their findings in South Texas were
conclusive. They did not know who the producers of the generic
Rophynol market. Their only response was that 50 percent of men
and 15 percent of the women could pick out the Roche pill. This
made no sense to me and it was obvious I would get no further
answers at this session.
They were constantly referring to the drug as an oral drug.
I asked them if their research showed that Rohypnol was smoked.
Their studies did not show this occurrence at all. They stated
the drug has no effect on the body once it is heated above 110
degrees. I stated the kids are still doing it and its use is
increasing. When I called my friends in Phoenix, I learned some
people crush the pill and mix it with marijuana. This is the
second most common method of ingestion.
The drug is not fatal unless the person ingests large
amounts of alcohol and Rohypnol at the same time over a long
period of time. Several people believe it is a loss leader by
the black markets. They are attempting to gain more customers
and they are targeting the three groups mentioned above.
The Roche representatives stated they were the first company
in American history to offer self-regulation to the government.
They will work with the Mexican government to control the drug in
border towns and foreign governments to prevent any leaks. They
are also working with the Columbian government to prevent
possible leaks from their country. The representatives agreed
this would be difficult since the Columbian government is under
siege. I agree. There was a brief mention of the product being
shipped from other Central American or South American countries.
No substantive investigations into this possibility were
mentioned.
This issue has become a race issue. Throughout 20th Century
America, drug use has been a race issue. Opiate smoking was
regulated in California because it was a Chinese tradition. The
Chinese experienced racism throughout the region. No other
opiate use was controlled. Marijuana and cocaine were regulated
by state and local governments in an effort to control Hispanic
and black populations. Once these problems involved white,
middle-class Americans, federal involvement was demanded. When
this was a South Florida/Caribbean problem, it was not a problem.
When the drug entered Floridian, middle-class white American kids
and young adults at dance bars, it became a problem.
At this point in time, national citizen forces are not
strongly aligned on this issue. Their influence at this time is
not a factor in the policy making process. With media attention,
this will grow without question.
One salient, yet silent, factor in drug policy formulation
is the alcohol and pharmaceutical industries. Tighter controls
on these industries mean more money will be spent on drugs in the
black market. Roche's meeting today falls along those lines.
The only anomaly is Roche's advocating a mostly self-regulation
measure. Roche is courting the Federal government in an effort
to gain control of the situation without governmental action.
In my opinion, it boils down to this - the Roche Company is
afraid the American public will perceive this as the crack
cocaine of the 1990s and the date rape pill. They gathered these
groups of government employees together to encourage them to
implement the company's wishes.
My Recommendations
Take no legislative action at this time. If the WH attempts
to control Rohypnol, it must look at controlling other
benzodiazepines like valium. After the Maxine Water's
arguments on crack cocaine vs. cocaine sentencing, it would
renew old arguments i.e., white middle-class VS. poor urban
blacks, etc
After further consideration, Senator Biden is more correct
that I initially thought him to be. I still think a low-key
approach to the problem is the Administration's best
alternative. Media attention will increases youth demand
for the drug. The country's best method to deter use is to
deter youth attention while gaining the attention of
community leaders such as school teachers, law enforcement
agencies, and treatment facilities.
If legislative means are necessary, Rohypnol should be
given a Schedule 1 rating if treatment and educational
funding is provided. I think this could resurrect Cong.
Waters' arguments on cocaine and crack cocaine. If the
Administration supports her statements, they can rely on a
1991 Minnesota case where the legal distinction between the
two drugs and jail time was addressed.
If no treatment funding is provided, the Federal
government should list it as a Schedule 2 drug. Therefore,
Federal, state and local governments could tax the drug and
use the revenues for treatment and education initiatives.
Used this way, Rohypnol could be the country's first
controlled drug that viewes addiction as a public health
problem rather than as a law enforcement one. Most
opponents to this will cite this is a European measure and
drugs are still prevelant in those countries. The argument
can be counterattacked by stating the U.S. has the highest
estimated addiction rates among all industrialized nations
in the world. Furthermore, we have established this
precedence in America with drug-addicted pregnant women.
This statement will shut up the opposition. No one wants to
publicly oppose children, particularly in an election year.
The supply-siders, like Roche and William Bennett, will
encourage punishment for possession of the drug. This may
be a good offer. Unfortunately, these groups want to lock
them up and throw away the key. The drug sellers serve one-
third of their time and are released, due to jail
overcrowding. This is a downside to listed Rohypnol as a
Schedule 1 drug. Intensive treatment and educational
funding must be provided to prevent the spread of this now
"fad" drug.
There is no mention in the Biden Report or with the ONDCP
meeting of treatment funding for these addicted children.
There is no mention of cooperation of cooperative efforts
between state and local governments on this issue.
-
All action should originate from the Executive Branch.
-
Publicity should be avoided. Children watch television. If
the media portrays this as the "crack of the 1990s", demand
will increase. Many people will want to see what it is like
and will try it. This could result in higher Rohypnol
addiction rates than we are currently experiencing.
The President should instruct the Secretary of State to
contact his counterpart within the Mexican government.
Since most of the South Texas business appears to be "mom-
and-pop" store purchases in Mexico, the U.S. should
encourage them to place stricter controls on the Rohypnol
and its generic products in or near border towns.
The President should instruct the Secretary of the Treasury
to notify Customs agents of the increased use of this drug
and it is made accessible through their ports of entry.
Roach Pharmaceutical cited several instances where they
asked people to purchase the drug and smuggle it over the
border. Others were asked to declare it. In all cases, no
action was taken by Customs.
The President should instruct the Secretary of Health and
Human Services to prepare a pamphlet for immediate
distribution to all teachers, school administrators,
treatment facilities, and emergency room personnel on this
drug, its increased use among youth, and subsequent
symptoms. Its use among habitual addicts should be
mentioned as well. These groups are more likely to report
is presence because of his involvement. Presidential
attention to this issue will provide more reliable data
available for study.
Like the Secretary of State and HHS, the Attorney General
should contact the appropriate agencies within her
jurisdiction to control the spread of Rohypnol.
Roche should be encouraged to apply for a patent on the
drug. The only reason Rohpynol is not available on the
American market today is due to its direct competition with
valium. If they applied and received the rights to market
the drug in the U.S., Roche could increase their profits on
the drug by selling at a higher price in the United States
than they would receive for Rohypnol in Mexico. The drug
would be less alluring and the government could control its
purity. The Federal government will monitor the drug.
Rohypnol is not a drug like cocaine or heroin;
therefore, it does not require a Schedule 1 rating. This
will free the law enforcement agencies to monitor the influx
of more serious drugs, like heroin and cocaine.
-
If this becomes the "Crack of the 1990s", executive action
will prove to the American people during an election year
that President Clinton has made every attempt to control
this problem without media attention. Media attention could
attract children to the drug, making all actions
counterproductive.
Thank you for the excellent opportunity. I want to
participate in any and all of these opportunities that occur.
Page 35
LEVEL 1 - 16 OF 29 STORIES
Copyright 1995 The Tribune Co. Publishes The Tampa Tribune
The Tampa Tribune
September 12, 1995, Tuesday, FINAL EDITION
SECTION: NATION/WORLD, Pg. 8
LENGTH: 508 words
HEADLINE: What are kids doing out at 4 a.m.?
BODY:
It's 4 o' clock Sunday morning. Do you know where your kids are?
That's the wake-up call that the parents of 2,500 mostly teenagers should
have gotten this weekend when police and sheriff's deputies busted up a "rave"
party in downtown Tampa.
"Rave" clubs are the latest youth fad, drawing young people after bar closing
hours to while away the morning dancing, lounging and generally having "fun."
Within minutes of the bust at the Parthenon club, 13 people had been arrested
- seven for possessing illegal drugs. Hundreds more appeared to be under the
influence of something other than loud music.
The smell of cigarettes, marijuana and alcohol hung in the air. Police
confiscated LSD, marijuana, ecstasy and Rohypnol.
LSD, as nearly everyone knows, is a hallucinogenic drug popular during the
'60s and currently experiencing a revival. Ecstasy is a powerful and very
addictive drug that has been available for years.
And, Rohypnol is one of the newer drugs on the underground market. A sedative
similar to Halcion and Valium, it mimics alcohol intoxication. Nicknamed
"roofies," the pills sell for $ 3 to $ 5 each and are growing in popularity.
Rohypnol is the drug Broward County prosecutors say a rapist used earlier this
year to sedate women he met in bars and later attacked.
No responsible parent would want a son or daughter trying these dangerous
drugs. But one has to wonder how many of these kids have responsible parents.
Among those arrested were 17-year-olds from Tampa, Pinellas Park and St.
Petersburg. Police suspect others in the crowd were 16, 15 and possibly even 14.
Party-goers interviewed by The Tampa Tribune said they've seen children as young
as 12 at some "rave" parties.
Hellooooo. Is an adult present at these kids' homes?
Tampa has a curfew that was supposed to put an end to such shenanigans, but
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The Tampa Tribune, September 12, 1995
everyone knows it is largely ignored. City officials say they are sitting
helplessly on their hands until some high court somewhere says curfews are
legal. So much for bold leadership.
Courts haven't stopped cities like Phoenix, Washington, D.C., Atlanta,
Boston, Buffalo, Dallas, Denver, New Orleans, Newark and Orlando from adopting
and enforcing curfews. Indeed, those cities have seen a significant drop in
juvenile crimes such as auto thefts ever since the kids were forced to stay off
the streets in the middle of the night.
Parents who can't see to it that their kids get home by midnight or shortly
after don't get a lot of sympathy here. Certainly parenting is hard work. Saying
no, being firm, taking away the car keys isn't easy. But it has to be done to
assure the kids' survival.
As for the dance clubs that put on the "raves," the police are well within
their jurisdiction to do just what they did at Parthenon over the weekend: shut
them down. Police cited faulty wiring and unsafe conditions in order to close
the place. They can also go a step further and declare them a public nuisance.
This community doesn't need a business that entices kids to stay out all night.
TYPE: EDITORIAL; EDITORIALS
LOAD-DATE: September 14, 1995
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LEVEL 1 - 17 OF 29 STORIES
Copyright 1995 TEXAS MONTHLY, INC.
TEXAS MONTHLY
September, 1995
SECTION: STATE WIDE REPORTER; Pg. 88
LENGTH: 839 words
HEADLINE: A New Low
BYLINE: HELEN THORPE; Edited by David McCormick
HIGHLIGHT:
Across the state, kids are getting seriously messed up on a dirt-cheap downer
from Mexico.
BODY:
ROB IS A JITTERY NINE-teen-year-old bean pole who lives in Houston. He
doesn't work or go to school, but he spends a lot of time in the city's
nightclubs, where he frequently buys a potent sedative called Rohypnol. A
single two-milligram pill has more intoxicating power than a six-pack of beer.
"I was at Numbers, a club down the street," says Rob, sitting in front of a
youth center on Westheimer. "I took two Rohypnol and I was like he rolls
his eyes, tilts his head, and lets his tongue hang out of his mouth. "I went
outside and there were these two cops in the parking lot. I said, 'Excuse me,
Mr. Beers, I haven't had any officers tonight.
Although Rohypnol is illegal in the United States, it is available by
prescription in Mexico, and importing it is no trouble at all: Lately the drug
has become a fad among teenagers around the state. Rohypnol is manufactured by
the Swiss pharmaceutical giant Hoffman-La Roche and was introduced in the
seventies in Europe and South America, where it is prescribed as a means to
relax patients before surgery and as a treatment for insomnia. Beginning in the
eighties, hard-core drug users in Europe started using it to come down from
cocaine or metham-phetamine highs. Now thrill-seeking teenagers in Texas,
Florida, and other parts of the South have discovered the drug. To them, it's
ideal because it makes them feel drunk but doesn't make them throw up, doesn't
show up in the most common urine tests, and is dirt cheap. One pill can cost
anywhere from $ 1 to $ 5. But the pills are far from harmless; early last year,
the late grunge rock star Kurt Cobain slipped into a coma after taking
Rohypnol and drinking champagne while on tour in Italy, though he was revived
after his stomach was pumped.
So many teenagers have been taking it that the Texas Commission on Alcohol
and Drug Abuse (TCADA) issued a warning to drug treatment centers about the
pills in May. On the street the drug has many nicknames; teenagers know it as
rope, ribs, or roaches. Law-enforcement authorities call it Mexican Valium
because of its similarities to that drug, but Rohypnol is estimated to be ten
times stronger and has some novel attributes. Another of its many names is "the
forget pill,' because Rohypnol typically causes complete short-term amnesia. It
also reduces inhibitions. Rob says, "You take it -- you black out. The next day
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TEXAS MONTHLY September, 1995
people tell you what you did, and you're like, 'Wha-a-a-a-t?"" In rare cases
Rohypnol can also induce aggression, rages, hallucinations, or psychoses. Many
teenagers take it while drinking, which greatly increases the impairment of
their motor abilities. Statewide, there have been two suspected fatal
overdoses.
Rohypnol first became popular in border towns. According to figures compiled
by the TCADA, law enforcement along the border reported 31 cases involving the
drug in 1991. Last year there were 197 cases. Nilda Gomez, a drug abuse
counselor who works with teenagers in Brownsville, says Rohypnol is everywhere
she turns. "What's so surprising is that it used to be fifteen-year-olds who
were doing drugs, but now it's thirteen-, twelve- and even eleven-year-olds,' "
says Gomez.
The use of Rohypnol gradually spread north, and today drug counselors in
Houston, San Antonio, Dallas, and Austin know of people who have taken
Rohypnol. The drug is said to have a moderate to high risk of addiction. Eight
months ago Annette, a self-possessed sixteen-year-old, was buying Rohypnol
regularly in clubs along Sixth Street in Austin. (Her name has been changed to
protect her privacy.) She now lives in Odyssey House, a residential treatment
facility in Houston for teenagers. As she sits on a sofa there, wearing a white
T-shirt and white cotton pants, her honey-colored hair twisted into a bun,
Annette looks like an extra in Beverly Hills 90210. but she recites a family
history of abuse and chemical dependency. "I'm the kind of person who wouldn't
take one or two," she says of her experiences with Rohypnol. "I would take
three or four and drink at the same time. We used to call them
'run-trip-and-falls. Sometime last year Annette took enough Rohypnol to
obliterate four full days. She came to at her boyfriend's house, with a
hospital band around her wrist. "A friend of mine from San Antonio had run
away, and she wanted to do some because she'd never tried them. We got a lot.
The last thing I remember is my friend turning to me and saying, 'Annette, we
need to go. And then it just goes black.
"Four days later I woke up well, not really woke up, because I hadn't been
asleep. I had gone to another friend's apartment, and I had had sex with
somebody this is what they told me and I had had a tampon in, and it had
gotten stuck up inside me, so I had to go to the emergency room. I lost track
of my friend, and she didn't know anybody in Austin.'
Clearly, playing drugstore cowboy is no game. Rohypnol is more than an easy
way to get wasted it's an easy way to waste a life.
GRAPHIC: Picture, Known as "the forgot pill, "-Rohypnol reduces inhibitions and
causes short-term amnesia. ANDREW YATES
LANGUAGE: ENGLISH
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LEVEL 1 - 18 OF 29 STORIES
Copyright 1995 The Tribune Co. Publishes The Tampa Tribune
The Tampa Tribune
June 23, 1995, Friday, FINAL EDITION
SECTION: FLORIDA/METRO, Pg. 6
LENGTH: 359 words
HEADLINE: Radio host blamed for drug mishap
BYLINE: WILLIAM YELVERTON; Tribune Staff Writer
DATELINE: CLEARWATER
BODY:
Prosecutors are holding radio personality Ron Bennington of "Ron and Ron"
fame responsible for leaving an illegal drug where his young daughter could find
it.
The 10-year-old girl was hospitalized overnight in March. She fell asleep and
couldn't be roused after taking medicine from a box marked "children's Tylenol."
An investigation determined the child had taken an undetermined amount of
Rohypnol - a powerful narcotic similar to Valium - that was in the Tylenol
container.
Pinellas sheriff's spokeswoman Marianne Pasha said Bennington told a deputy
someone in Miami had given him the Rohypnol a year ago. His daughter was taken
to All Children's Hospital in St. Petersburg for observation but was home the
next day, Pasha said.
"Ron felt very bad about the whole situation," Pasha said.
Bennington, 36, who with Ron Diaz has a popular show on WSUN, was charged
earlier this month with culpable negligence in the March 6 incident at his
Seminole home. He has filed a written plea of not guilty.
Bennington agreed to enter a pretrial intervention program, said Rebecca
Graham, assistant county court director for Pinellas State Attorney Bernie
McCabe.
The program is a form of probation for first-time, nonviolent offenders. If
participants complete the program and stay out of trouble, charges are dropped.
Bennington could not be reached for comment Thursday.
His daughter, Gail, was taken to a Seminole hospital the night of March 6
after her mother couldn't rouse her, Pasha said.
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The Tampa Tribune, June 23, 1995
Julie Bennington told a deputy who was called to the hospital that she feared
the girl was having an allergic reaction to children's Tylenol. The mother had
told the girl to take the Tylenol earlier that night when she wasn't feeling
well.
At the request of emergency workers at the hospital, Julie Bennington
telephoned her husband and told him to bring in the box and package, Pasha said.
Ron Bennington was charged June 8. He was not arrested. Instead he was issued
a summons. His wife was not charged.
Although Rohypnol, also known as "roofies," "rufies" and Roche, is illegal,
Bennington was not charged with a drug offense.
GRAPHIC: PHOTO,
Ron Bennington
TYPE: FOCUS ON FLORIDA
LOAD-DATE: July 3, 1995
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LEVEL 1 - 19 OF 29 STORIES
Copyright 1995 The Dallas Morning News
THE DALLAS MORNING NEWS
June 15, 1995, Thursday, HOME FINAL EDITION
SECTION: NEWS; Pg. 1A
LENGTH: 1065 words
HEADLINE: Dangerous sedative being smuggled across border Mind-altering drug
reduces inhibitions, can cause amnesia
BYLINE: Rebecca Howland, Staff Writer of The Dallas Morning News
BODY:
Law enforcement officials say they are alarmed at the growing popularity of a
dangerous and potent sedative being smuggled across the Mexican border and now
making its way north through the state.
Rohypnol - commonly called Roach, Rophie or the Forget Pill on the street -
is a hypnotic or mind-altering drug that reduces users' inhibitions and can
cause amnesia, especially when taken with alcohol.
The drug reportedly has been used in gang initiations and date-rape cases in
which the woman can't remember the next day what happened, say drug treatment
and law enforcement officials.
The drug - which officials say is about 10 times stronger than Valium - is
illegal in the United States. But in other countries anyone can get Rohypnol
with a doctor's approval, and in some, including Mexico and Colombia, it is
often sold over the counter.
The drug is most often seen among males ages 13 to 18 and is
frequently used in gang initiations, officials in South Texas say.
Law enforcement officials and medical experts say use of the drug in South
Texas is skyrocketing, and there is increasing incidence of it in Austin,
Houston and Dallas. The drug is often sold on the street for 50 cents to $ 3 a
pill, officials said.
Use of the drug has also increased dramatically in southern Florida,
especially in Miami, since 1992. Officials there said it is streaming into the
United States from Colombia.
Hoffmann-LaRoche, a Switzerland-based pharmaceutical company that
manufactures the drug, produces Rohypnol in plants in Colombia and Mexico.
Although selling Rohypnol over the counter is technically illegal worldwide,
it happens frequently in the two countries, which do not effectively enforce
regulations, officials from the World Health Organization said.
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THE DALLAS MORNING NEWS, June 15, 1995
The drug is used as a sleeping aid to combat severe insomnia or to sedate
psychotic patients, said Al Wasilewski, director of public policy and
communications for Hoffmann-LaRoche. It is also prescribed to patients about
to undergo surgery and who are not going to receive full anesthesia. After
taking the drug, the patient would not remember the uncomfortable procedure.
Mr. Wasilewski declined to comment about whether or not Hoffmann-LaRoche
would consider discontinuing its production of the drug, although he said the
company is "very concerned" about the abuse.
Rohypnol "happens to have that attraction to a certain subset of the
population that will abuse anything
It is an unbelievable thing to hear
that these drugs which have a good therapeutic use are being abused in this
way, If Mr. Wasilewski said.
Hoffmann-LaRoche never sought approval from the Food and Drug Administration
to distribute Rohypnol in the United States, he said.
"There was already a significant number of similar sedative hypnotics" in the
United States, he said. "There was no need to add another one to the pie."
Steve Mithos, the director of program services for the Palmer Drug Abuse
treatment center in McAllen, said more than half of the teenagers he sees are
"getting roached."
"It's pretty widespread, and in the last six months, it's really grown, " he
said. "Now, about 15 percent of the kids I see list it as their primary drug of
choice, not just something they take once in a while."
Sean, a 19-year-old in treatment for drug abuse in Dallas and who asked not
to be identified by his last name, said Rohypnol began "hitting it big" on
Dallas' club and party scene last year.
Sean estimated that half of his friends had experimented with the drug or
were using it regularly. "It's everywhere," he said.
"If you just go down and see a doctor in Mexico and get a prescription, you
can carry five boxes across the border, no problem, " he said. "Each box has 50
or 100 pills in it." "
Sean estimated he'd taken the pills 10 or 11 times.
"It's real mellow. I just felt like I didn't want to move, " he said.
Although Sean described feeling "under control" while on the drug, he
recounted experiencing amnesia after mixing the drug with alcohol, and described
several "incidents" in which men "took advantage of women sexually because the
women didn't know what they were doing." "
The drug can also trigger belligerent and aggressive behavior, Mr. Mithos
said.
One of Mr. Mithos' patients is on probation for manslaughter, he said.
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THE DALLAS MORNING NEWS, June 15, 1995
"The guy doesn't even remember shooting anyone. He's neat, a real nice guy.
You wouldn't think he would do something like that, but he was loaded on
Roaches. If
In Austin and Houston, law enforcement officials say the drug is rapidly
growing in popularity and is most often seen in conjunction with "heavier" drugs
such as heroin or crack cocaine.
"We're seeing (Rohypnol) all over the place," " said Tony Arnold, a forensic
chemist for the Austin Police Department.
"People are using the hyperactive drugs, and when they finally burn out, then
they use the Rohypnol to go to sleep, Mr. Arnold said, estimating that one out
of every five cases he sees involves the drug.
A few months ago, nobody had heard of the drug, Mr. Arnold said.
"At first, most of the cops thought they were 2-milligram Valiums, he said.
Hoffmann-LaRoche also produces Valium, a small, blue pill stamped with the
number "10" in a circle. Rohypnol differs in color - it is white - and is
marked by "2" instead of "10." The numbers refer to the dosage of the active
ingredient in milligrams.
Many law enforcement officials in Dallas said that while they had encountered
the small white pills several times during the past year, they were not overly
concerned that it was getting out of control.
But Martin Pracht, who works for the Drug Enforcement Administration in
Dallas, said officials are underestimating the drug's spread.
"Rophies are much more dangerous and potent than what people are giving them
credit for, Mr. Pracht said. "You'd be crazy to say this will not be a
problem" in Dallas.
"It's just taking a while to get up here and increase in popularity. But it
will," he said.
Because the drug has never been legal in the United States, detecting it is
difficult, Mr. Pracht said. The drug is not listed in the commonly-used
Physician's Desk Reference, and police and medical officers do not know what
symptoms to look for.
Customs officials on the border said it is difficult to stop such smuggling
because officers search for materials that look like contraband.
GRAPHIC: CHART (S) (DMN) Rohypnol.
LANGUAGE: ENGLISH
LOAD-DATE: July 13, 1995
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LEVEL 1 - 21 OF 29 STORIES
Copyright 1994 The Atlanta Constitution
The Atlanta Journal and Constitution
November 29, 1994
SECTION: NATIONAL NEWS; Section D; Page 17
LENGTH: 256 words
HEADLINE: 'Roofies' give Florida teens a cheap high Popular drug makes its users
feel drunk
BYLINE: By Donna Pazdera FORT LAUDERDALE SUN-SENTINEL
BODY:
Fort Lauderdale, Fla. - It's just a $ 5 hit. But wash it down with a beer and
you might do something embarrassing - or downright scary.
You might crumple to the ground. Or urinate on yourself.
Or stop breathing.
Technically, the drug is called Rohypnol. Those more familiar with the little
white pills call them "roofies."
If you haven't heard of them yet, you will, drug abuse specialists and police
say.
"It will be as popular as crack because it is so cheap," said Dave Marcus,
case manager at Spectrum Program Inc., a drug treatment center for adolescents
in Pompano Beach, Fla.
High schoolers are particularly fond of roofies because they are cheap and
because they make them feel very, very drunk, Marcus said.
The pills sell for $ 3 to $ 5 apiece. Teenagers generally buy the drug
off-campus and take it at weekend parties. Sometimes they pop one in the morning
before school, making them incoherent all day.
"It's like the poor man's Quaalude, " Marcus said, referring to a sedative
drug that was popular in the 1970s.
It's not known how many people are abusing Rohypnol, but in Broward County,
Fla., nearly one in five clients at two drug treatment centers for adolescents
have used them.
In Palm Beach County, Fla., officials say roofies are slowly becoming popular
with teenagers and young adults.
Rohypnol, manufactured by Roche, a U.S. pharmaceutical company, is not legal
in the United States. It is used in Central and South America to sedate patients
for surgery, said Al Wazaluski, a Roche spokesman.
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1994 The Atlanta Journal and Constitution, November 29, 1994
LANGUAGE: ENGLISH
LOAD-DATE: December 1, 1994
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LEVEL 1 - 21 OF 29 STORIES
Copyright 1994 The Atlanta Constitution
The Atlanta Journal and Constitution
November 29, 1994
SECTION: NATIONAL NEWS; Section D; Page 17
LENGTH: 256 words
HEADLINE: 'Roofies' give Florida teens a cheap high Popular drug makes its users
feel drunk
BYLINE: By Donna Pazdera FORT LAUDERDALE SUN-SENTINEL
BODY:
Fort Lauderdale, Fla. - It's just a $ 5 hit. But wash it down with a beer and
you might do something embarrassing - or downright scary.
You might crumple to the ground. Or urinate on yourself.
Or stop breathing.
Technically, the drug is called Rohypnol. Those more familiar with the little
white pills call them "roofies. "
If you haven't heard of them yet, you will, drug abuse specialists and police
say.
"It will be as popular as crack because it is so cheap," said Dave Marcus,
case manager at Spectrum Program Inc., a drug treatment center for adolescents
in Pompano Beach, Fla.
High schoolers are particularly fond of roofies because they are cheap and
because they make them feel very, very drunk, Marcus said.
The pills sell for $ 3 to $ 5 apiece. Teenagers generally buy the drug
off-campus and take it at weekend parties. Sometimes they pop one in the morning
before school, making them incoherent all day.
"It's like the poor man's Quaalude,' Marcus said, referring to a sedative
drug that was popular in the 1970s.
It's not known how many people are abusing Rohypnol, but in Broward County,
Fla., nearly one in five clients at two drug treatment centers for adolescents
have used them.
In Palm Beach County, Fla., officials say roofies are slowly becoming popular
with teenagers and young adults.
Rohypnol, manufactured by Roche, a U.S. pharmaceutical company, is not legal
in the United States. It is used in Central and South America to sedate patients
for surgery, said Al Wazaluski, a Roche spokesman.
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1994 The Atlanta Journal and Constitution, November 29, 1994
LANGUAGE: ENGLISH
LOAD-DATE: December 1, 1994
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LEVEL 1 - 22 OF 29 STORIES
Times Publishing Company
St. Petersburg Times
November 29, 1994, Tuesday, Tampa Edition
SECTION: TAMPA TODAY; TAMPA BAY & STATE; Pg. 5B
DISTRIBUTION: TAMPA TODAY; TAMPA BAY AND STATE
LENGTH: 511 words
HEADLINE: Tranquilizer hooks teens, drug users
BYLINE: SUSAN CLARY
BODY:
It's just a few dollars a hit. But wash it down with a beer and you might do
something embarrassing - or downright scary.
You might crumple to the ground. Or urinate on yourself.
Or stop breathing.
Technically, the drug is called Rohypnol. Those more familiar with the
little, white pills call them "Roofies."
If you haven't heard of them yet, you will, drug abuse specialists and
police say.
"They have become the Quaaludes of the '90s," said Dr. Sven Norman,
referring to a sedative that was popular in the 1970s. "One of the reasons
they are abusing it is they get the desired effect. It causes drowsiness and a
pretty significant intoxication."
Norman, director of the Florida Poison Information Center at Tampa General
Hospital, said the center first heard of the drug earlier this year.
Experts say it is popular with three groups. Teenagers use it to intensify
the effects of alcohol. Heroin users like it because it enhances the sedating
effects of lower-purity heroin. Cocaine abusers use it to parachute down from
a binge.
"It is extremely dangerous," Norman said. "When combined with alcohol, it
can be life-threatening."
The tranquilizer is a small, white tablet imprinted with the letters RH.
Experts say the drug is several times more powerful than Valium. Users call
the pills "roofies," "ruffies" or "Roche," (pronounced Ro-shay) after the
company that makes them.
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St. Petersburg Times, November 29, 1994
The drug's side effects include hallucinations, respiratory problems, sleep
disturbances and anxiety.
While the drug is widely used in South Florida, law enforcement officials in
the Tampa Bay area said they have yet to see any cases.
"I'm not saying it doesn't exist around here, but it's not a problem. Not
yet," said Lt. Bob Guidara, commander of the Tampa Police Department QUAD
Squad.
St. Petersburg police spokesman Bill Doniel said the same is true in his
city but noted that new drugs in South Florida often migrate here.
Roofies have become especially popular with high schoolers because they are
inexpensive - 50 cents to $ 8 each. When taken alone, they make users feel very
sleepy. The effect is intensified when combined with alcohol.
Rohypnol is manufactured by Roche, a U.S. pharmaceutical company, but is not
legal here. It is used in Central and South America to sedate patients for
surgery, said Al Wazaluski, a Roche spokesman.
- Information from the Associated Press was used in this report.
TEEN DRUG
NAME: Rohypnol (Roofies)
WHAT IT LOOKS LIKE: Little white pills.
PRICE: Inexpensive - $ 3 to $ 5 each.
WHAT IT DOES: Used alone, roofies make users feel very sleepy. Combined with
alcohol, the effect intensifies. Described as 10 times stronger than Valium.
Side effects include hallucinations, respiratory problems, sleep disturbances,
anxiety and possible addiction.
MANUFACTURER: Rohypnol is manufactured by Roche, a U.S. company, but is not
legal here. Authorities think the drug is being brought in from South America.
LANGUAGE: ENGLISH
LOAD-DATE: November 30, 1994
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LEVEL 1 - 23 OF 29 STORIES
Copyright 1994 Phoenix Newspapers, Inc.
THE PHOENIX GAZETTE
November 29, 1994 Tuesday, Final
SECTION: FRONT; Pg. A2
LENGTH: 351 words
HEADLINE: NEW, CHEAP DRUG CATCHING ON WITH TEENS
DATELINE: FORT LAUDERDALE
BODY:
It's just a $5 hit. But wash it down with a beer and you might do something
embarrassing or downright scary.
You might crumple to the ground. Or urinate on yourself.
Or stop breathing.
Technically, the drug is called Rohypnol. Those more familiar with the little
white pills call them roofies.
If you haven't heard of them yet, you will, drug abuse specialists and police
say.
"It will be as popular as crack because it is so cheap," said Dave Marcus,
case manager at Spectrum Program Inc., a drug treatment center for adolescents
in Pompano Beach, Fla.
In Arizona, however, the drug is unknown, police said.
"We've never even heard of it, but if it gets popular in other areas of the
country, it will get here sooner or later,' said Lt. Rick Knight, a state
Department of Corrections narcotics detective.
High schoolers are particularly fond of roofies because they are cheap and
because they make users feel very, very drunk, Marcus said.
The pills sell for $3 to $5 apiece. Teenagers generally buy the drug
off-campus and take it at weekend parties. Sometimes they pop one in the morning
before school, making them incoherent all day.
"It's like the poor man's Quaalude," Marcus said, referring to a sedative
drug that was popular in the '70s.
It's not known how many people are abusing Rohypnol, but in Broward County,
Fla., nearly one in five clients at two drug treatment centers for adolescents
have used them.
Rohypnol is manufactured by Roche, a U.S. pharmaceutical company. The drug is
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THE PHOENIX GAZETTE, November 29, 1994
not legal in the United States. It is used in Central and South America to
sedate patients for surgery, Al Wazaluski, a Roche spokesman, said.
School officials say many teenagers get the drug at parties, where it is
given away by a dealer who is looking for customers.
The drug, sold in tablet form, has been described as 10 times stronger than
Valium. Used alone, roofies make users feel very sleepy. Combined with beer, the
effect is intensified.
The drug also is crushed and snorted to cushion the crash from a cocaine or
crack high, said Hollywood Police Sgt. Mark May.
LANGUAGE: ENGLISH
LOAD-DATE: December 13, 1994
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LEVEL 1 - 13 OF 29 STORIES
Copyright 1995 Star Tribune
Star Tribune
October 24, 1995, Metro Edition
SECTION: Variety; Pg. 1E
LENGTH: 538 words
HEADLINE: FYI;
Kissing Keanu and telling
BODY:
Noting that after 25 takes of a kissing scene with Keanu Reeves for "Bram
Stoker's Dracula, " Winona Ryder "reportedly left the set in tears, II YM (Young
and Modern) magazine has harvested the following smooching critiques:
"Keanu's so sure of himself, but I was back there spraying Binaca and hoping
that I wouldn't offend him. " - Sandra Bullock, costar in "Speed."
"He was pretty scruffy
but he had a sexy smell. " - Ione Skye, costar
in "River's Edge. "
"Kissing scenes are pretty complicated, but we tried to enjoy them. " -
Aitana Sanchez-Gijon, costar in "A Walk in the Clouds. "
"He's a very good kisser.
He's definitely blessed. II - Lori Petty,
costar in "Point Break. "
- San Francisco Chronicle
'Spanish fly' becomes real
Rohypnol, an illicit sedative-hypnotic drug most commonly abused in Florida
and Texas, has made its way to Minnesota. It is used for medicinal purposes in
other parts of the world, but not approved in the United States. Primary users
are adolescents who combine it with alcohol and other drugs. Because of its
amnesialike effects, it is also being used as a "date rape" drug, according to a
drug alert issued by Carol Falkowski, research coordinator for the Chemical
Dependency Division of the Minnesota Department of Human Services.
In southern Minnesota, abuse of the drug has been suspected in several cases
in which a drug was placed in alcoholic beverages of young females who are
subsequently exploited sexually, said Falkowski. Victims have no recall of
events following sedation. Rohypnol has a bitter taste when added to a beverage
and is about 10 times more potent than Valium. For more information on
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Star Tribune, October 24, 1995
Rohypnol, call the Minnesota Prevention Resource Center at (800) 247-1303.
- Hazelden Foundation
Today Costumed guides will lead visitors by candlelight through Historic Fort
Snelling. The living-history players will be preparing for winter.
When: 7 to 9 p.m. today
Where: Historic Fort Snelling, Hwy. 5 and 55, near the Minneapolis-St. Paul
International Airport.
Admission: Adults, $ 6; seniors, $ 5; ages 6 to 15, $ 4.
Call: 725-2413
Same space, whole new place
The old Rupert's in Golden Valley has been remodeled and reincarnated as the
Metropolitan, an elegant room to rent for events and concerts. The Metropolitan,
on Interstate Hwy. 394, is owned by upscale Twin Cities restaurateurs, the
D'Amico Brothers. The space underwent a $ 1 million renovation. It seats 730
people for concerts at tables on various tiers.
A site for wedding and bar mitzvah parties, it also will be open to the
public for the "Live at the Met" concert series in the next few weeks. October
Project, an arty pop band featuring poetic singer Mary Fahl, will kick off the
series tonight. Lowen & Navarro, an adult-pop duo, will do the Met Nov. 21, and
jazz vocalist Dee Dee Bridgewater will sing there Nov. 26.
What: October Project.
When: 8 p.m. today.
Where: The Metropolitan, 5418 Wayzata, Blvd., Golden Valley.
Admission: $ 14 to $ 20.
Call: 989-5151. -
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Star Tribune, October 24, 1995
GRAPHIC: Photograph
LANGUAGE: ENGLISH
LOAD-DATE: October 25, 1995
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LEVEL 1 - 14 OF 29 STORIES
Copyright 1995 Sentinel Communications Co.
THE ORLANDO SENTINEL
October 3, 1995 Tuesday, METRO
SECTION: LOCAL & STATE; Pg. C5
LENGTH: 494 words
HEADLINE: ST. CLOUD MAN DIES FROM ILLEGAL DRUG;
POLICE SAID THE 20-YEAR-OLD OVERDOSED ON THE ILLEGAL SEDATIVE SMUGGLED FROM
SOUTH AMERICA.
BYLINE: By Henry Pierson Curtis of The Sentinel Staff
DATELINE: KISSIMMEE
BODY:
A St. Cloud man may be one of the first victims in Florida to die from an
overdose of an illegal sedative smuggled from South America.
Stacy McCormack died sometime Sunday after swallowing more than a dozen
tablets of Rohypnol, a drug commonly called "roofies," Kissimmee police said.
The sedative is 10 times more powerful than Valium and is becoming known as
the "Quaalude of the '90s," a reference to the drug widely abused in the 1970s.
Rohypnol has become increasingly popular in the past few years among high school
students mixing it with beer for a cheap high, drug abuse authorities said
Monday.
Spokesmen for the Florida Poison Information Centers said Monday that no
Rohypnol-related deaths had been reported previously to offices in Miami, Tampa
and Jacksonville. It's possible that previous fatalities have not been reported
by medical examiners to the statewide network, they said.
"We've just been lucky that kids who take it are just slumped over their
desks in school and not driving. It's just a matter of time (until) we're going
to have a couple, " said Dr. Susan Sandbeck, deputy director of the Florida
Poison Information Center in Miami. "It's fast acting; it's intense. It's a
great buzz
but all you have to do is get a kid who vomits or get a kid who
is driving a car and it's deadly."
McCormack, 20, was found dead about 10:30 p.m. Sunday on a couch in a
friend's apartment on Central Avenue in Kissimmee. He had gone to sleep about 7
a.m. after taking "roofies" and watching movies, Kissimmee police Detective
Warren Shepard said.
McCormack, who worked construction and had been in robust health, apparently
choked on his own vomit after falling asleep, police reported. Several of his
friends told police that McCormack began taking Rohypnol several months ago and
had taken as many as 14 tablets at one time.
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Orlando Sentinel Tribune, October 3, 1995
The Orange-Osceola Medical Examiner's Office said the cause of McCormack's
death will not be known for several weeks - until toxicology tests are
completed. The office is investigating a second possible Rohypnol-related
death, a spokeswoman said.
The victim of that overdose was a Brevard County woman who died last week in
an Orlando-area motel room. Additional information about the death could not be
obtained Monday from the Orange County Sheriff's Office.
Rohypnol is the brand name of flunitrazepan, a sedative sold in Europe, South
America and Asia by Roche, a Swiss pharmaceutical company. Its sedation lasts
about an hour and it is used to calm patients for minor surgery in physicians'
offices, pharmacists said.
In interviews Monday, several people said Rohypnol sells for $5 a tablet in
Orlando-area nightclubs. Authorities said it began appearing in mid-1989 in
South Florida and that most shipments appear to come from Colombia.
Rohypnol abuse can cause hallucinations, slowed reflexes and altered depth
perception. Overdoses can cause respiratory arrest or death from aspirating
vomit.
LANGUAGE: ENGLISH
LOAD-DATE: October 4, 1995
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LEVEL 1 - 26 OF 29 STORIES
Copyright 1994 South China Morning Post Ltd.
South China Morning Post
June 3, 1994
SECTION: NEWS; Pg. 7
LENGTH: 1120 words
HEADLINE: Doctor in the clear over drug accusation
BYLINE: By STEVE BALL
BODY:
A DOCTOR who, after a barely two-minute consultation, sold an addictive drug
demanded by a patient he had never seen before was last night cleared of
professional misconduct by the Medical Council.
Dr Yu Hon-biu supplied 10 tablets of the tranquilliser Rohypnol to an
undercover policewoman on July 27, 1990, almost without question, the Medical
Council heard.
But the council decided the evidence against Dr Yu was not sufficient to
prove a charge of misconduct in supplying the drug.
Dr Yu said may have been slightly negligent'', but that was not the same
as misconduct.
Rohypnol, chemical name Flunitrazepam, is a commonly abused drug and, since
October 7, 1990, has been listed as a dangerous drug.
But Dr Yu denied the drug was addictive. ''It is not a drug of dependency,
he told the council.
Dr Yu based his knowledge mainly on a book written before Rohypnol was
invented. He came to the council with his copy of the third edition of Goodman
and Gilman's Pharmacological Basis of Therapeutics, published in 1965, while Dr
Yu was at medical school.
Council chairman Professor Rosie Young Tse-tse pointed out that the book was
almost 30 years old. Dr Yu said: 'But what was written there was facts.
In 1965, Professor Young said.
'Still facts, replied Dr Yu, who graduated in 1968.
In his final submission to the council, Dr Yu put his hand on his Goodman
and Gilman's and said: ''If you say that is not the authority then I don't have
any more to submit.
Professor Young pointed to a passage in the Eighth edition of Goodman and
Gilman's, published in 1990, which warned that tranquillisers were potentially
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South China Morning Post, June 3, 1994
addictive with unpleasant and sometimes dangerous side effects.
The council heard that at around 4 pm on July 27, 1990, police constable
Yeung Miu-hung went to Dr Yu's surgery in Ferry Street, Kowloon, and said: ''I
want Rohypnol .
It was Ms Yeung's first visit to the clinic, but Dr Yu did not ask her about
her previous medical history.
Instead, he simply asked her 'Insomnia?' Ms Yeung replied ''Yes'', and
she told the council Dr Yu then stared at her in such a way as if to suggest:
'How many tablets would you like?'
She asked for 10 and Dr Yu charged her $ 4 for each tablet. There was no
charge for the consultation.
Dr Yu did not tell Ms Yeung how the tablets should be taken. He did not
write out a prescription and the tablets were supplied separately by the clinic
nurse, who was not a registered nurse, based on Dr Yu's patient notes.
Cross-examining, Senior Crown Counsel Lynda Shine said: ''As a professional
doctor you did not know anything about this patient's medical history. '
Dr Yu agreed, but objected when Ms Shine said his conduct had been 'cursory
and unprofessional' and the drug prescription had not been bona fide.
Dr Yu said he did not need to ask any more questions. 'She said she was an
insomniac, that was enough.
Council member Dr David Fang then asked Dr Yu if there could have been any
other reason for lack of sleep other than insomnia. Dr Fang said: For
instance, she might have had a brain tumour. 1
Dr Yu did not answer that question, but later said: did not know of any
organic cause of insomnia.
During the hearing, Dr Yu frequently referred to the drug manufacturers'
leaflet on Rohypnol as evidence of the drug's effectiveness for all types of
insomnia.
The leaflet said that it was not advisable to prescribe the drug for someone
who was in the first stages of pregnancy. Dr Yu admitted that he did not ask Ms
Yeung whether she was pregnant.
LANGUAGE: ENGLISH
LOAD-DATE: June 15, 1994
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LEVEL 1 - 12 OF 29 STORIES
Copyright 1995 The Scotsman Publications Ltd.
The Scotsman
November 14, 1995, Tuesday
SECTION: Pg. 2
LENGTH: 1960 words
HEADLINE: Fresh drug menace surfaces
BYLINE: Severin Carrell Home Affairs Correspondent
BODY:
FEARS are growing that a potent sleeping tablet blamed for drug deaths in
Europe and the United States may be replacing temazepam among users and addicts
in Scotland.
Drugs agencies and police have received reports that heroin addicts and
regular drugs users in Greenock, Glasgow, Dundee and Stirling have begun abusing
Rohypnol, a strong sedative used mainly for insomnia, in conjunction with other
substances and alcohol.
Batches of the drug, known to users as Wallbangers or Roofies, have been
seized by Strathclyde police for the first time.
About 2000 have been impounded in two recent hauls.
One English force has also begun investigating counterfeit Rohypnol imports.
Rohypnol has caused controversy in the Netherlands, Germany, and the US over
drugs deaths, illness due to breathing problems and acts of violence by users
who had taken the stronger, two-milligramme tablet which is sold in Europe.
One of the world's largest pharmaceutical firms, Roche, has voluntarily
stopped making the stronger tablet and replaced it with much lower dosage, one-
milligramme pills similar to those sold in the United Kingdom.
Dr Donald Uges, a specialist in forensic toxicology and drug analysis from
Groningen in Holland, said the drug became popular among Dutch football
hooligans as it promoted aggression and among drug addict prostitutes as it
sedated them before sex.
Heroin addicts take it to boost the effects of poor quality heroin, and
cocaine users use it to smooth out withdrawal.
He added doctors and drug addicts had stopped using or dispensing the drug
recently because it was SO dangerous if taken with other drugs or alcohol.
"You won't be happy when Rohypnol is in your country, II Dr Uges told The
Scotsman yesterday.
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The Scotsman, November 14, 1995
"Rohypnol is even worse and more dangerous than temazepam."
The drug was withdrawn from National Health Service lists in 1985 after the
Government began its "selected list" of the cheapest generic drugs. But its use
in private prescriptions has remained high, with boxes of 30 costing pharmacists
£ 4.08.
Rusty Murray, chair of a voluntary drug users group in Dundee, said he knew
of about 20 to 30 addicts and users in the city who took Rohypnol regularly,
plus others in areas of Glasgow.
They acquired purple, diamond-scored, one-milligramme pills from doctors by
buying them on private prescription, took them personally or sold them off to
other users or dancers at raves for £ 3 or £ 4 each - securing a substantial
profit.
Despite fears the tablets would be ground down and injected, like temazepam
tablets, most swallowed them in quantities of up to 10 or 15 at a time.
Illegally imported European- strength pills sold for up to double that
price.
He said: "Once people get the feeling for them, they will just take off. You
will find they will become more and more known because doctors won't be
prescribing temazepam."
The Scottish Drugs Forum has learnt that drugs workers in Inverclyde had
found the different strengths on sale in the area, selling for as little as 50p
each. They came on sale early this year, and had begun showing up in Stirling.
Dave Liddell, the agency's director, said it was too soon to predict if
Rohypnol would replace temazepam after the clampdown on its availability and ban
on gel-filled capsules by ministers in October.
But he added: "It's something we view with concern. In some senses, there's
an inevitability about something replacing temazepam. There is no surprise in
relation to this, unless we get to grips with reducing the overall demand for
drugs. "
LANGUAGE: ENGLISH
LOAD-DATE: November 14, 1995
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LEVEL 1 - 9 OF 29 STORIES
Copyright 1995 The Tribune Co. Publishes The Tampa Tribune
The Tampa Tribune
December 2, 1995, Saturday, FINAL EDITION
SECTION: NATION/WORLD, Pg. 14
LENGTH: 500 words
HEADLINE: Menace of the "date rape drug'
BODY:
It is hard to fathom how the drug scene in America could degenerate any
further. Recently a Detroit woman was reported to have sold her 15-year-old son
to a drug dealer in exchange for crack cocaine. Police say the boy spent six
months as a sex slave and drug runner before being rescued.
That little horror is just one more in an endless series of degradations
involving crack. But a new drug is making the rounds now, with its own peculiar
brand of evil. Rohypnol, known on the street as "roofies," is not just a drug of
the slums, although it is used there by gang members. It is also traded in bars,
dance parties and other gatherings of young people. Police in California call it
"the date rape drug."
Rohypnol, the brand name for flunitrazepam, is used in other countries to
treat anxiety and insomnia and to sedate surgery patients. It is illegal to
possess it in the United States without a foreign prescription. In a story in
the Orange County Register, a spokesman for the Swiss manufacturer, the F.
Hoffmann-La Roche & Co. pharmaceutical firm, said the drug must be getting into
the United States through the mail or across the border from Mexican pharmacies.
Local police also report the drug's appearance in our area. Pinellas County
sheriff's investigators recently arrested three men in Seminole who had 38 of
the tablets, along with other drugs, guns and $ 22,000 in cash. "We're starting
to see it hand over fist," said Lt. Michael Platt of the Pinellas
narcotics-intelligence unit.
The drug is diabolically well-suited for rape, because it can be slipped into
someone's drink at a bar, and within 15 to 30 minutes that person slips into a
state of amnesia lasting up to eight hours. "It's like, "I think I got raped,
but I don't remember, " Platt said.
The victim is in danger of more than sexual assault, though. When combined
with alcohol, the drug can be fatal.
If being young weren't cruel and complicated enough these days, now young
women have to worry about whether some creep is slipping a knock-out pill into
her drink at a party. Counselors advise people to refuse a drink offered by a
stranger, and never to leave one's drink unattended.
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The Tampa Tribune, December 2, 1995
This is a law enforcement problem, of course, but it is more than that. Here
the women's rights movement and the most ardent social and religious
conservatives ought to find common ground. The level of decadence and disregard
for human worth required to drug and rape a young woman ought to arouse the
wrath of every rational person.
It would be simple if the manufacturer could just stop making the drug, but
that seems unlikely. Washington ought to press researchers to consider other
ways of accomplishing the same medicinal results, perhaps altering the formula
or form of the drug. Shipping and dispensation should be more rigorously
controlled too.
Still, the problem is not so much with the manufacturer. America's drug
problem is just one more symptom of the moral breakdown of much of society.
TYPE: EDITORIAL; EDITORIALS
LOAD-DATE: December 4, 1995
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LEVEL 1 - 11 OF 29 STORIES
Copyright 1995 Chicago Tribune Company
Chicago Tribune
November 27, 1995 Monday, EVENING UPDATE EDITION
SECTION: NEWS; Pg. 2; ZONE: C; EVENING. People.
LENGTH: 347 words
HEADLINE: NEW DRUG FINDS WAY INTO DATE-RAPE SCENARIO
BODY:
A drug used in date rapes is knocking on the nation's door, according to
narcotics experts in the U.S.
The drug, Rohypnol, is described by law enforcement as a sedative 10 times
more powerful than Valium and is manufactured by the F. Hoffmann-La Roche & Co.
pharmaceutical firm, based in Basel, Switzerland. Not approved for use in the
United States, it has been a legal prescription drug for several years in most
of the world and is available in Europe and Latin America.
On the street, users call the small, white pills "roofies" and "Roche. " The
substance has also been referred to as "the date-rape drug" and "the Quaalude of
the '90s," after another oft-abused sedative. Rohypnol is drawing the attention
of narcotics experts across the country.
It is being smuggled into the United States, usually in its original
wrapping, through Colombia and Mexico, according to Bob Nichols, an assistant
state prosecutor in Ft. Lauderdale, where illegal use of roofies in this country
first became noticed.
Nichols has been involved in five sexual-battery cases connected to roofies
in the last five months.
"The pattern with the rapes is that high school and college kids and gang
members are slipping it into drinks at nightclubs and pickup joints, " Nichols
said.
Police in South Florida and Southern California report an increase in the
number of women filing complaints that they felt drugged after drinking just a
drink or two, and then waking up to find they had been raped.
Drug counselors and law-enforcement officers are bracing for the arrival of
roofies, which typically cost $1 to $5 for a single, 2-milligram pill. The pill
is also taken by cocaine users who want to parachute down less harshly from a
cocaine high.
Reports of Rohypnol abuse have surfaced in Florida, Texas and other parts of
the Southwest.
Jennifer Trenshaw, health educator at the University of Southern California
Health Center, had a word of advice for people, especially women:
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Chicago Tribune, November 27, 1995
Don't leave your drink unattended, and don't accept a drink from a stranger.
LANGUAGE: ENGLISH
LOAD-DATE: January 15, 1996
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LEVEL 1 - 7 OF 29 STORIES
Copyright 1995 The New York Times Company
The New York Times
December 9, 1995, Saturday, Late Edition - Final
SECTION: Section 1; Page 6; Column 1; National Desk
LENGTH: 1313 words
HEADLINE: In South, Drug Abusers Turn to a Smuggled Sedative
BYLINE: By MIREYA NAVARRO
DATELINE: MIAMI, Dec. 8
BODY:
A prescription drug sold abroad is becoming the fastest-growing abused drug
among young people in Florida and one that has found its way to a dozen other
states, law-enforcement officials say.
Manufactured by Hoffmann-La Roche, the Swiss pharmaceutical company, and sold
by prescription in about 60 countries as Rohypnol, the pills are not made or
approved for use in the United States. But Drug Enforcement Administration
officials say the police in Florida, Texas and other Southern states are
reporting an increase in smuggled shipments from Colombia, a Hoffmann-La Roche
distribution site for other Latin American countries, and from Mexico, where
some pharmacies sell Rohypnol over the counter.
The Federal Drug Enforcement Agency has reported Rohypnol seizures in at
least 13 states but says its distribution and abuse has been concentrated in
Texas and Florida, where some law enforcement officials say the pills threaten
to become "the Quaaludes of the '90s."
Lee P. Brown, the White House drug policy director, said today that
Rohypnol was an emerging drug that his office was tracking closely but that "it
has by no means become a national problem."
But in Florida, drug counselors say Rohypnol has found a thriving market
among teen-agers who have made it the latest addition to the drug scene at
nightclubs and in schools. School officials in South Florida say Rohypnol,
considered a bargain at $5 or less a pill, has become almost as widely used as
marijuana and LSD among students.
Officials in Dade County, where the sedative first surfaced in 1989, have
become concerned enough that they have begun routine testing for Rohypnol in
cases where the driver appears drunk but registers low alcohol levels. The
medical examiner's office will soon begin to test for Rohypnol in cases in which
women say they might have been raped but do not remember.
In Texas, where Hoffman-La Roche is financing an epidemiological study to
examine why Rohypnol is being abused, researchers say it is mostly taken by
users of other drugs who find it more potent than other sedatives. Cocaine
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The New York Times, December 9, 1995
addicts say Rohypnol helps them come down more smoothly from their high; heroin
users say it offsets their withdrawal symptoms.
Known among American users as "roofies,' from the mispronunciation of the
brand name, and sometimes as "roach" or "rope," Rohypnol is a benzodiazepine, a
class of sedatives that includes Valium. Marketed in 1- or 2-milligram dosages,
it induces muscle relaxation, short-term amnesia and sleep. Its effect, felt
within 15 to 20 minutes and lasting eight hours or more, is similar to that of
alcohol in that it helps loosen inhibitions before sedation takes hold.
Frequent users can develop tolerance and get addicted, requiring treatment.
In Miami, officials at the Up Front Drug Information Center said its hot line
had received calls from teen-age girls who said they had grown dependent on
Rohypnol and wanted help.
When combined with alcohol or other drugs, drug experts say, it can cause
respiratory depression and death. Kurt Cobain, the grunge rock singer, collapsed
and slipped into a brief coma a month before his suicide last year after
ingesting Rohypnol with champagne in a hotel room in Rome.
While in Europe and Latin America Rohypnol is mainly known as a sleeping aid
and pre-surgery anesthetic (although it is also abused), many here learned of
its existence in startling ways. Drug information hotlines started to hear from
parents wondering about the pills they had just found in their child's pocket.
Teachers called paramedics because a student had passed out.
At Miami Palmetto Senior High School, the school newspaper reported, a junior
was taken to the hospital when a friend noticed she missed her mouth while
eating nachos.
Now, 20 percent of the patients at the adolescent drug abuse program at
Jackson Memorial Hospital say they have taken Rohypnol, doctors there said. In
Dade County schools, 21 cases of Rohypnol possession or use have been reported
to police since they began tracking the drug five months ago.
In Broward County, north of here, prosecutors say they handled two rape cases
recently and are investigating two others where men gave the drug to women and
then sexually assaulted them. In one case, the pill was slipped into the woman's
drink while she visited the defendant. The man then bragged he had done the same
to a dozen other women.
"When they wake up, they're completely naked and the defendant is sitting
next to them in his underwear,' said Assistant State Attorney Bob Nichols,
adding that both defendants pleaded guilty and went to prison. "These girls are
all in therapy because they can only imagine what happened.
Since Dade County began testing drunk drivers for Rohypnol, 35 drivers have
tested positive for the drug, making roofies the most popular among caught
drivers after marijuana and cocaine, said Dr. Lee Hearn, director of the
toxicology laboratory at the county's medical examiner's office.
"Police are reporting that they stop them for driving really badly and when
they open the door, they fall out,' he said.
Its low price and harmless look, bubble-wrapped like so much medicine, may
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The New York Times, December 9, 1995
explain some of the drug's popularity, drug counselors and police said. At Miami
Palmetto High, Rene C., a 16-year-old junior, said he liked it because "it gets
you drunk. " Maria B., an 18-year-old senior, said she only took roofies on
special occasions to feel relaxed.
"You don't hear anything bad about it, like heroin or crack, where people die
or anything," she said.
They were able to obtain Rohypnol from both classmates and friends, the
students said. In Florida, Rohypnol is mainly smuggled through the mail and
delivery packages or in luggage, DEA officials say. In Texas, the drug comes in
through border crossings, often legally. A recent survey by the University of
Texas College of Pharmacy in Austin found that 43 percent of those declaring
prescription drugs in customs forms at the border brought Rohypnol. Only Valium
was declared more frequently.
The Food and Drug Administration generally allows people to bring drugs sold
abroad but not approved here but only for their personal use, defined as a
three-month supply. But once in, the drug is considered illegal by law
enforcement officials. They said Rohypnol was a controlled substance and its
possession punishable by both fines and prison.
D.E.A. officials have reported seizures of more than 50,000 pills at a time
in both Texas and Louisiana, and they say they are concerned about the
involvement of cocaine and marijuana traffickers in Rohypnol's distribution. So
are drug counselors, who say they worry that it may be used by dealers to hook
children on other drugs.
"We feel South Florida is a test market for this drug," said James Hall, of
Up Front Drug Center here.
Alfred J. Wasilewsky, a spokesman for Hoffmann-La Roche's affiliate in the
United States, said the company was working on altering Rohypnol's dosage to try
to make it less attractive. He said the presence of similar products in the
market dissuaded the company from seeking approval to sell the drug in the
United States.
In South Florida, school officials have added roofies to their group
counseling and classroom discussions. In Texas, the state's Commission on
Alcohol and Drug Abuse is about to send out 10,000 fliers on the drug to school
nurses and has added a question about Rohypnol to its survey of 100,000 4th to
12th-graders about drug use, which is given every other year.
But the Miami Palmetto Senior High School principal, Leonard Glazer, noted
that alcohol, not roofies, remained the biggest problem in schools.
"I think we tend to overlook that in the high school scene, alcohol is the
introducer,' he said. "Once your inhibitions have been lowered by alcohol,
you're more likely to experiment."
GRAPHIC: Photo: The fastest-growing abused drug in Florida is the Rohypnol pill,
made by Hoffmann-La Roche.
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The New York Times, December 9, 1995
Map: "A CLOSER LOOK: Abusing a Sedative"
Siezures by law-enforcement agencies of the prescription sleeping pill
Rohypnol, which is not approved for sale in the United States, have risen
sharply in certain states. Map of continental U.S. shows states where the
greatest quantities of Rohypnol have been siezed, along with other states where
the drug has been siezed. (Source: Drug Enforcement Administration)
LANGUAGE: ENGLISH
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LEVEL 1 - 6 OF 29 STORIES
Copyright 1995 Denver Publishing Company
Rocky Mountain News
December 10, 1995, Sunday
SECTION: NEWS/NATIONAL/INTERNATIONAL; Ed. B; Pg. 2A
LENGTH: 400 words
HEADLINE: New drug threatens U.S. youth
Florida, Texas report rising use of Rohypnol, prescription sedative sold
abroad, illegal in U.S.
BYLINE: Mireya Navarro; The New York Times
DATELINE: MIAMI
BODY:
A prescription drug sold abroad is becoming the fastest- growing abused drug
among young people in Florida and one that has found its way to a dozen other
states, law-enforcement officials say.
Manufactured by Hoffmann-La Roche, the Swiss pharmaceutical company, and sold
by prescription in about 60 countries as Rohypnol, the pills are not made or
approved for use in the United States.
But federal Drug Enforcement Agency officials say the police in Florida,
Texas and other Southern states are reporting an increase in smuggled shipments
from Colombia, a Hoffmann-La Roche distribution site for other Latin American
countries, and from Mexico, where some pharmacies sell Rohypnol over the
counter.
The DEA has reported Rohypnol seizures in at least 13 states but says its
distribution and abuse has been concentrated in Texas and Florida, where some
law enforcement officials say the pills threaten to become ''the Quaaludes of
the '90s.
Lee P. Brown, the White House drug-policy director, said Friday that
Rohypnol is an emerging drug that his office is tracking closely but that ''it
has, by no means, become a national problem.
But in Florida, drug counselors say Rohypnol has found a thriving market
among teen-agers who have made it the latest addition to the drug scene at
nightclubs and in schools.
School officials say Rohypnol has become almost as widely used as marijuana
and LSD.
In Texas, where Hoffman-La Roche is financing an epidemiological study to
examine why Rohypnol is being abused, researchers say it is taken mostly by
users of other drugs who find it more potent than other sedatives.
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Rocky Mountain News, December 10, 1995
Known among American users as ''roofies, from the mispronunciation of the
brand name, and sometimes as ''roach'' or ''rope, Rohypnol is a
benzodiazepine, a class of sedatives that includes Valium. The drug induces
muscle relaxation, short-term amnesia and sleep.
LANGUAGE: English
LOAD-DATE: December 13, 1995
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LEVEL 1 - 5 OF 29 STORIES
Copyright 1995 Denver Publishing Company
Rocky Mountain News
December 10, 1995, Sunday
SECTION: NEWS/NATIONAL/INTERNATIONAL Ed. F; Pg. 95A
LENGTH: 374 words
HEADLINE: New drug takes hold among teens
Florida, Texas report surging use of Rohypnol, sold legally in 60 countries
but not U.S.
BYLINE: Mireya Navarro; The New York Times
DATELINE: MIAMI
BODY:
A prescription drug sold abroad is becoming the fastest- growing abused drug
among young people in Florida and has found its way to a dozen other states,
law-enforcement officials say.
Manufactured by Hoffmann-La Roche, the Swiss pharmaceutical company, and sold
by prescription in about 60 countries as Rohypnol, the pills are not made or
approved for use in the United States.
Federal Drug Enforcement Agency officials say police in Florida, Texas and
other southern states are reporting an increase in smuggled shipments from
Colombia, a Hoffmann-La Roche distribution site for other Latin American
countries, and from Mexico, where some pharmacies sell Rohypnol over the
counter.
The DEA has reported Rohypnol seizures in at least 13 states but says its
distribution and abuse has been concentrated in Texas and Florida, where some
law enforcement officials say the pills threaten to become ''the Quaaludes of
the '90s.
Lee P. Brown, the White House drug-policy director, said Friday that
Rohypnol is an emerging drug that his office is tracking closely but that ''it
has, by no means, become a national problem.
In Florida, drug counselors say Rohypnol has found a thriving market among
teen-agers who have made it the latest addition to the drug scene at nightclubs
and in schools.
School officials say Rohypnol has become almost as widely used as marijuana
and LSD.
In Texas, where Hoffman-La Roche is financing an epidemiological study to
examine why Rohypnol is being abused, researchers say it is taken mostly by
people who find it more potent than other sedatives.
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Rocky Mountain News, December 10, 1995
Rohypnol is a benzodiazepine, a class of sedatives that includes Valium. The
drug induces muscle relaxation, short-term amnesia and sleep.
LANGUAGE: English
LOAD-DATE: December 12, 1995
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LEVEL 1 - 4 OF 29 STORIES
Copyright 1995 The Dallas Morning News
THE DALLAS MORNING NEWS
December 17, 1995, Sunday, BULLDOG EDITION
SECTION: NEWS; Pg. 40A
LENGTH: 1655 words
HEADLINE: Police suspect illegal sedative used in date rapes
BYLINE: Julio Laboy, Orange County Register
DATELINE: SANTA ANA, Calif.
BODY:
SANTA ANA, Calif. - It started out as a casual get-together for a 25-year-old
student but ended in rape, humiliation and the harrowing revelation that a drug
used in date rapes is knocking on the nation's door.
The drug, Rohypnol, is described by law enforcement as a sedative 10 times
more powerful than Valium and is manufactured by the F. Hoffmann-La Roche & Co.
pharmaceutical firm, based in Basel, Switzerland. Not approved for use in the
United States, it has been a legal prescription drug for several years in most
of the world and is available in Europe and Latin America.
The sale and introduction of the drug into interstate commerce in the United
States is illegal; virtually the only people who can possess it legally in this
country are those who have prescriptions written in other countries.
On the street, users call the small, white pills "roofies" and "Roche." The
substance has also been referred to as "the date rape drug" and "the Quaalude of
the '90s," after another oft-abused sedative. Rohypnol is drawing the attention
of narcotics experts across the country.
It is being smuggled into the United States, usually in its original
wrapping, through Colombia and Mexico, according to Bob Nichols, an assistant
state prosecutor in Fort Lauderdale, Fla., where illegal use of roofies in this
country first was noticed.
Mr. Nichols has been involved in five sexual-battery cases connected to
roofies in the last five months.
"I don't know why it's suddenly on the scene. It's been around awhile,' " Mr.
Nichols said. "The pattern with the rapes is that high school and college kids
and gang members are slipping it into drinks at nightclubs and pick-up joints."
That is what one Orange County, Calif., woman, an English major at the
University of California, San Diego, thinks happened to her Sept. 29.
The student attended a concert that night with a male friend.
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THE DALLAS MORNING NEWS, December 17, 1995
The two were not romantically involved, she said.
She had three glasses of wine that night. At least one glass of wine was
consumed in the parking lot of the San Diego theater where the concert was
taking place.
That's when the student started feeling strange. She doesn't remember the
concert. She doesn't remember how she got home. She doesn't remember getting
into bed. The last thing she does recall is waking up the next morning naked
and in a pool of vomit.
"I was so sick when I woke up," she said. "I could hardly hold my head up.
I couldn't remember anything. I noticed there was vomit on the bed and stuck on
my hair. I was lying in it. I could have choked on it and died. He was naked
and I was naked. He said we made love. "
The woman was crushed. Their relationship had never been an intimate one,
she said. The Orange County Register , which generally doesn't publish the
names of sexual-abuse victims, is withholding her name from publication.
The woman, who works as a part-time language teacher and as a waitress,
thinks that her companion slipped a roofie into her wine that night and that it
erased her memory, an effect described by pharmacologists and in medical
reports.
Struggling to overcome the nightmare, the woman is seeing a therapist and is
taking a vacation out of the country to escape the everyday reminders of that
ill-fated night. She agreed to share her story because, she said, "I didn't do
anything wrong. "
She wants to turn a negative experience into a positive one. She wants to
warn other young women about roofies.
"My friends had no clue about this drug, " she said. "This stuff is scary.
You can't be cautious enough. "
She called a rape hotline after spending two lonely days knee-deep in guilt
and self-doubt. She then went to a therapist at Kaiser Permanente in San Diego.
"Some people were saying I got drunk. But I didn't. I just had wine, the
student said. "I was telling the therapist that I couldn't believe it. I was
crying. I was confused. As I started telling her my story she said, Hold on.
I know what this is. II
The student learned from the therapist that her situation resembled a
drugging and that an epidemic of similar cases had arisen in the past six
months.
"She said they all were feeling sluggish and drunk on dates that ended in
rape, If the student said.
That's when the student first heard about roofies.
"We have seen many date-rape cases,' 11 Kaiser Permanente spokesman Jim McBride
said. "Many of those patients report being drugged. Our therapists believe
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THE DALLAS MORNING NEWS, December 17, 1995
these stories are credible. It's real. It's happening."
The woman then notified the San Diego Police Department.
Investigators are looking into the matter.
Police Sgt. Joanne Archambault of the sex-crimes unit said she cannot comment
on rape cases because of privacy reasons, but she confirmed that the student's
report had been taken.
"Recently, lots of girls have been coming in saying they were drugged or
passed out after having one or two drinks,' Sgt. Archambault said. "We even
talked to the Poison Control Center about it. "
Orange County drug counselors and law-enforcement officers are bracing for
the arrival of roofies, which typically cost $ 1 to $ 5 for a single,
2-milligram pill.
"I would assume that because of the movement of things in the San Diego-Los
Angeles-Orange County corridor, that yes, it may be here," said Bill Edelman,
division manager in charge of alcohol and drug programs at the Orange County
Health Care Agency. Reports of Rohypnol abuse have surfaced in Florida, Texas
and other parts of the Southwest, he said.
Jennifer Trenshaw, health educator at the University of Southern California
Health Center, sai she advised people, especially women, not to leave their
drinks unattended and not to to accept drinks from strangers.
The UCSD student who says she was raped remembers going to the bathroom twice
during the concert. She left her drink with her date.
The student described all the classic circumstances and side effects of a
roofie mixed with alcohol, Mr. Edelman said.
"It's a sedative. It's a drug that can be enhanced when it is combined with
alcohol or opiates,' Mr. Edelman said.
Rohypnol, the brand name for Flunitrazepam, is used in other countries to
treat anxiety and insomnia and to sedate surgery patients, according to
pharmacologists and drug-information centers.
Patients on the drug appear drunk. When it's combined with alcohol, the
effects can be deadly.
"These guys using this to get girls are like those people who like to do
things with dead bodies, " Mr. Edelman said. "It's sick.
Maybe we need to think about a campaign about how this drug is used in bars. "
Al Wasilewski, a spokesman for the pharmaceutical company's U.S. division,
said the drug is being illegally mailed into the United States. He also said
that some Mexican pharmacies near the U.S. border are illegally selling the drug
over the counter. He said Hoffmann-La Roche has never sought approval to market
the drug in the United States.
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THE DALLAS MORNING NEWS, December 17, 1995
"It's a legitimate product sold for legitimate use in those countries where
it's registered, " Mr. Wasilewski said. He disagreed with law-enforcement
officials who have described the drug as being 10 times more powerful than
Valium but acknowledged that taken in equal doses, Rohypnol will act more
quickly and more powerfully than Valium.
"They are two different drugs designed to do two different things, If Mr.
Wasilewski added. "It was about a year ago when we began to see just more than
sporadic abuse of Rohypnol."
Hoffmann-La Roche has initiated studies to learn more about how the drug is
being abused, where it's coming into the United States, and where in the country
it is most likely to be found. The company is trying to track its movement
throughout the country and recently helped set up a task force with members
drawn from federal and local law-enforcement agencies, academics and
drug-counseling centers, Mr. Wasilewski said. The company has also disseminated
alerts to the health-care industry and police departments.
Hoffmann-La Roche has divisions in Mexico City and Bogota, Colombia, where
Rohypnol is manufactured for the Latin American market.
"We're doing everything that is possible for Roche to get this product off
the streets, " Mr. Wasilewski said. "We're confident that the diversion of
Rohypnol is not occurring internally from our sites in Mexico and Colombia."
Dr. Jim Adams, associate professor of molecular pharmacology and toxicology
at USC's School of Pharmacy, said Flunitrazepam can make someone lose control of
motor and neurological functions.
Respiration is also affected. When it's mixed with alcohol, he said, a coma
can easily follow. Vomiting also can occur, and if a victim is unconscious, he
or she runs the risk of drowning in the discharge.
The drug reacts with brain cells to quickly diminish nervous system
operations, said Dr. Edward Newton, a consultant to the Los Angeles Regional
Poison Control Center. The area the center serves includes Orange County.
"It depresses neurological activity in the brain," Dr. Newton said. "People
do die if they take too much."
It is difficult to determine a lethal dose of Rohypnol because reactions to
sedatives differ among individuals, and when taken alone it is not difficult to
manage, according to the Up Front Drug Information and Education Center in
Miami. An overdose is more likely when Rohypnol is mixed with alcohol or other
drugs. The speed with which the overdose will take place depends on how much
alcohol a person has consumed.
A roofie will sedate its user quickly. Sedation occurs 15 to 30 minutes
after ingestion and lasts about eight hours, USC's Ms. Trenshaw said. If an
overdose occurs, the need for medical care is urgent.
An added problem with Rohypnol is that it causes amnesia for most of the
sedation period, especially during a patient's first consumption. That makes
prosecution of abuse cases difficult, Ms. Trenshaw said.
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THE DALLAS MORNING NEWS, December 17, 1995
LANGUAGE: ENGLISH
LOAD-DATE: December 18, 1995
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LEVEL 1 - 1 OF 29 STORIES
Copyright 1996 Star Tribune
Star Tribune
January 16, 1996, Metro Edition
SECTION: Variety; Pg. 1E
LENGTH: 654 words
HEADLINE: FYI;
'Date-rape' drug
BYLINE: Dave Matheny; Staff Writer
BODY:
Rohypnol, a potent sedative-hypnotic drug, has made its way to Minnesota.
Rohypnol is a sleeping pill used in Mexico but not approved for use in the
United States. It has been abused primarily by young people who combine the drug
with alcohol. Because of its amnesialike effects it also is being used as a
date rape drug, according to a drug alert issued by the Minnesota Department of
Human Services.
In southern Minnesota, abuse of the drug has been suspected in several cases
in which some is placed in alcoholic beverages of young women who are
subsequently exploited sexually. Victims have no recall of the events following
sedation. Rohypnol has a bitter taste when added to a beverage and is about 10
times more potent than Valium. For more information on this drug, call the
Minnesota Prevention Resource Center at 427-5310 (metro) or (800) 247-1303.
- Hazelden Foundation
Saddam happens
Five years ago today, the Gulf War suddenly became real, as Allied jets
swept into Iraq. We're indebted to "War Slang" by Paul Dickson (Pocket Books
hardcover; $ 25) for the following information. There is something appealing
about slang that grows up around particular pursuits or disciplines, especially
hazardous ones: It reflects how we adapt to hardship and even to the possibility
of being killed.
Dickson includes sections on specialized slang from the Civil War up through
the present. Here are a few from the Gulf War:
- Diver: CNN reporter Charles Jaco, known for diving off camera during Scud
alerts.
- Homer: A member of the Iraqi army (based on bumbling Homer Simpson).
- Little Hollywood: Area near the swimming pool of the Dharhran hotel, from
which TV correspondents frequently delivered their live reports, often wearing
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Star Tribune, January 16, 1996
helmets, flak jackets and goggles, while the camera crews wore T-shirts.
Mysterious blue domes seen in the background actually were pool cabanas and
storage sheds.
- Poor man's defense: The Iraqi tactic of filling the sky with randomly
aimed gunfire, as was seen over Baghdad almost nightly.
- Saddam Happens: Bumper sticker seen on the back of a tank.
- Speed bumps: At first, the handful of U.S. troops on the Saudi Arabian
side of the border, facing the massed Iraqi forces on the other side; if the
Iraqis had attacked, the Americans saw themselves as little more than speed
bumps. Later the term was applied to Iraqi soldiers. (By the time the war ended,
Iraqi troops had been killed by Allied forces at a ratio of about 1,000 to one.
In fact, the Pentagon later said that more Americans would have died if the
troops had remained stateside during the same period, largely from road
accidents.)
- W.T.O.: The Washington Theater of Operations - an ironic reference.
In a subsection titled "Murphy's Laws for Grunts,' Dickson includes a list
of 29 laws. A sampling:
- When in doubt, empty your magazine.
- If the enemy is in range, so are you.
- Tracers work both ways.
- The easy way is always mined.
- Dave Matheny
This week
Thinking about the warm
One way to take the edge off of winter is to go to a big indoor place where
they pretend it's some other season - summer, for example. Actually, the annual
Minnesota Sportsmen's Boat, Camping and Vacation Show isn't just for
warm-weather activities, but that's what comes to mind for most folks: Boats,
RVs, hunting and fishing stuff is what it's about. As usual there are displays
and demonstrations, including a live trout pond and stage shows.
- What: 1996 Minnesota Sportsmen's Boat, Camping and Vacation Show
- When: Today, 5 to 10:30 p.m.; noon to 10:30 p.m. tomorrow through Friday;
10 a.m. to 10:30 p.m. Saturday; 10 a.m. to 6:30 p.m. Sunday.
- Where: St. Paul Civic Center, St. Paul.
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Star Tribune, January 16, 1996
- Admission: $ 6 adults, $ 2 children under 12; preschoolers free.
GRAPHIC: Illustration
LANGUAGE: ENGLISH
LOAD-DATE: January 17, 1996
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CFR Index
code of
and Finding Aids
PRNS
LIBRARY
Reem
Washington, DC 20800
federal regulations
Revised as of January 1, 1995
EXECUTIVE OFFICE
OF THE PRESIDENT
MAY JU 1995
LAW
NATION AND RECORDS
1985
R Index
Authorities
R
21 U.S.C.-Continued
CFR
21 U.S.C.-Continued
CFR
21 U.S.C.-Continued
CFR
1,
53, 56, 72. 73, 75-79, 85, 91, 160-162
334
21 Part 800
206, 207, 211, 225, 226, 299, 329, 429,
98
120
7 Part 1
336
21 Parts 58,
432, 433, 607, 640, 803, 804, 895, 1040.
0,
9 Parts 49, 70, 82. 93, 99
109, 130, 250, 509
1050
01
122-123
9 Parts 49, 70
337
21 Part 100
353
21 Parts 310, 312, 329, 500
60
122
7 Part 1
341-343
21 Parts 70,
355-360a
21 Part 514
60
9 Part 93, 99
73, 74, 156
355-358
21 Part 201
34
123-126
9 Parts 56,
341
21 Parts 71,
355-357
21 Part 3.
11
72, 73, 75, 76, 78, 79, 82, 85
103-105, 130, 131, 133, 135-137, 139,
50, 56, 58, 71, 170, 171, 202, 207, 211.
0
125-127
9 Parts 49, 70
145, 146, 150, 152, 155, 156, 158, 160,
312, 314, 320, 361, 430, 505, 510, 570.
0
125
9 Parts 50, 51. 160-162
161, 163-166, 168-176, 178, 300, 556,
571, 700, 800, 812, 813, 1003
7
127
7 Part 1
564, 571, 573, 584
355-356
21 Part 200
10
134-134h
9 Part 75
342-343
21 Parts 100,
355
21 Parts 1. 2.
0
134a
9 Parts 82, 93
179, 501, 505, 514, 801
12, 60, 73, 74. 206, 250, 290, 291, 299.
36
134a-134h
9 Parts 54, 56
342
21 Parts 58,
300, 310, 330-333, 336, 338, 340, 341.
15
134a-134d
9 Parts 92, 98
7
108-110, 113, 114, 122, 129, 170, 172,
344, 347-349, 357, 433, 500, 501, 600,
134a-134c
9 Part 94
8
134b-134c
181, 182, 184, 186, 189, 250, 500, 507-
601, 606, 607, 610. 620, 630, 640, 801,
9 Parts 49, 70, 93, 99
7
134b
9 Parts 50, 51,
509, 570, 589
809
343
8
53, 71-73, 76-80, 82, 85, 91, 99, 160,
21 Parts 1,
356-357
21 Parts 369, 429
8
161, 162
101-105, 107, 130, 131, 133, 135, 136,
356
21 Part 310
134d
9 Part 93
139, 145. 160, 161, 163, 164, 166, 168,
357-358
21 Part 200
2
134e-134f
169. 502, 564
357
21 Parts 2,
5
7 Part 1
2
9 Parts 49, 70, 93, 99
344
21 Parts 108, 508
60, 206, 300, 320, 430-433, 436, 440-
2
134f
9 Parts 71-73,
345
21 Part 561
444, 446, 448-450, 452, 453, 455, 460,
7
76-80, 82, 85, 91, 92. 94, 98, 99, 160-
346-346a
21 Parts 50,
500, 501, 544, 801, 809
358
21 Part 299
2
162
56, 58, 71, 109, 170, 171, 193, 320, 361,
360-360 note
135-135a
430, 431, 514, 570, 571, 812, 813, 1003,
21 Parts 606, 610
9 Parts 93, 99
360
21 Parts 3.
4
135
9 Part 92
1010
135a
7 Parts 1, 319
40 Parts 2, 180
20, 50, 56, 58, 71, 170. 171, 180, 201,
0
136-136a
7 Parts 320,
346
21 Parts 175,
207, 225, 310, 320, 330, 332, 333, 336,
338, 340, 341, 344, 347, 348, 349, 357,
330, 352, 354
176, 178, 250, 509, 561
5
9 Parts 91, 92, 95, 96, 130
21 Part 2
361, 430, 510, 511, 520, 571, 600, 607,
346a
7
640, 803, 804, 809, 812-814, 821, 862,
9
136a
7 Part 319
40 Parts 9, 23,
864, 866, 868, 870, 872, 874, 876. 878,
9 Part 156
160, 163, 178, 179, 185
8
880, 882, 884, 886, 888, 890, 892, 1010,
141-149
21 Parts 5, 10, 12-16
346c
21 Part 561
1
1030, 1040, 1050
151-159
9 Parts 101-109, 116-118
347
21 Parts 1, 166
2
360b-360f
21 Parts 58,
21 Part 112
40 Part 180
8
71, 170, 171, 180, 314, 430, 431, 511,
2
151-158
9 Parts 113, 114, 122, 123
348
21 Parts 50,
570, 571. 812, 1003, 1010
32 Part 627
56, 58, 60, 70, 71. 73, 100, 101, 103,
360b-360c
21 Part 12
154
7 Part 1
105, 109, 129. 131, 133, 135-137. 139,
360b
21 Parts 1, 2.
159
9 Part 113
145. 146, 150, 156, 161, 163, 164, 166,
70, 201, 207, 225, 226, 250, 299, 300,
262
21 Part 56
168-173, 175-182, 184, 186, 189, 320,
453, 505, 514, 520, 522, 524, 526, 529,
271
21 Parts 500, 505
361, 430, 500, 501, 509, 570, 571, 573,
556, 558, 801, 809
301 note
21 Part 101
579, 582, 584. 589, 700, 801, 813, 1003
360c-360j
21 Part 814
321 et seq
21 Parts 10, 13, 514
40 Parts 9, 23,
360c-360f
21 Parts 3,
7
321-394
21 Part 5
160, 177-180, 185, 186
50, 56, 310, 320, 361, 510, 813
321-393
21 Parts 7,
348a
21 Part 156
360c-360e
21 Parts 20, 860
10, 12-16, 20, 25
350
21 Part 105
360c-360d
21 Parts 809, 861
321-371
21 Part 14
350a
21 Parts 7. 106, 107
360c
21 Part 807,
321
21 Parts 1-3,
351-353
21 Parts 3,
862, 864, 866, 868, 870, 872, 874, 876,
50, 56, 70, 71, 73, 74, 100-107, 109, 130,
56, 71, 170. 171, 180, 200, 201, 205, 312,
878, 880, 882, 884, 886, 888, 890, 892
131, 133, 135, 137, 145, 156, 160, 161,
314, 320, 330-333, 336, 338, 340, 341,
360e-360j
21 Parts 1010,
163, 164, 166, 168-179, 181, 182, 184,
344, 347, 348, 349, 357, 430, 431, 506,
1020, 1030, 1040, 1050
186, 189, 200-202, 206, 207, 211, 250,
510, 511, 514. 570, 571, 600, 616, 620,
360e
21 Parts 60, 200,
310, 312, 314, 330-333, 336, 338, 340,
630, 640, 812-814, 1003, 1010
800, 820, 821, 862, 864, 866, 868, 870,
341, 344, 347-349, 357, 361, 369, 430-
351-352
21 Parts 2,
872, 874, 876, 878, 880, 882, 884, 886,
432, 500-502, 505, 510, 511, 570, 573,
20, 299, 300, 500, 501, 600, 606, 700,
888, 890, 892
579, 582, 584, 589, 600, 606, 607, 610,
800, 801, 807, 809, 820, 821, 861
360f
21 Part 895
640, 700, 710, 730, 740, 800, 801, 1020
351
21 Parts 70, 73,
360h-360j
21 Parts 3,
331
21 Parts 2,
210, 211, 225, 226, 310, 351, 505, 607,
50, 56, 58, 71, 171, 180, 320, 361, 430,
20, 100, 201, 206, 299, 300, 500, 501,
862, 864, 866, 868, 870, 872, 874, 876,
431, 809, 812, 813, 820, 1003, 1010
505, 510, 730, 807, 809, 812, 813, 821
878, 880, 882, 884, 886, 888, 890, 892,
360h-3601
21 Parts 170, 571, 821, 895
40 Part 177
1010, 1020, 1030, 1040, 1050
3601-360j
21 Parts 20, 801, 860
331j
40 Part 9
352-353
21 Parts 50,
3601
21 Parts 800,
332-334
21 Part 110
58, 202, 250, 290, 310, 361, 369
803, 804, 862, 874, 900
333
21 Part 7
352
21 Parts 1, 73,
3601
21 Parts 60, 606,
786
787
UNITED STATES CODE
ANNOTATED
Title 21
Food and Drugs
§§ 1 to 800
1995
Supplementary Pamphlet
Covering Years 1973 to 1994
Replacing 1994 pocket part in back of 1972 bound volume
Includes the Laws of the
103rd CONGRESS, SECOND SESSION (1994)
For close of Notes of Decisions
See page III
For Later Laws and Cases
Consult
USCA
Interim Pamplet Service
1993
NEW
Please detach the perforated card-from inside the
front cover and place it in the pocket part slot of
the corresponding main volume as a reminder to
refer to this supplementary pamphlet.
WEST PUBLISHING CO.
ST. PAUL, MINN.
21 § 353
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 7
tiality for harmful effects through excessive use
Morse V. Riverside Hospital, 1974, 339 N.E.2d
to the merely average man and even to those
the Secretary as a part of the application (A) full reports of investigations which have
846, 44 Ohio App.2d 422.
below the average. National Nutritional Foods
been made to show whether or not such drug is safe for use and whether such drug is
Ass'n V. Weinberger, D.C.N.Y.1978, 866 F.Supp.
18.
- Weight and sufficiency
effective in use; (B) a full list of the articles used as components of such drug; (C) a full
1841, affirmed 491 F.2d 845.
Public promotion of high dosage quantities of
statement of the composition of such drug; (D) a full description of the methods used in,
Commissioner is not required to set over-the-
vitamins A and D for the cure, mitigation, treat-
and the facilities and controls used for, the manufacture, processing, and packing of such
counter limit beyond which drug may be ob-
ment, and prevention of a variety of ailments,
drug; (E) such samples of such drug and of the articles used as components thereof as
tained only by prescription, at maximum which
when coupled with the fact that there exists
the Secretary may require; and (F) specimens of the labeling proposed to be used for
consumer might withstand; substantial margin
little, if any, evidence of known nutritional re-
such drug. The applicant shall file with the application the patent number and the
of safety may be used. National Nutritional
quirements above the levels of 10,000 IU per
Foods Ass'n V. Weinberger, D.C.N.Y.1973, 366
expiration date of any patent which claims the drug for which the applicant submitted
dosage unit of vitamin A and 400 IU per dosage
F.Supp. 1341, affirmed 491 F.2d 845.
the application or which claims a method of using such drug and with respect to which a
unit of vitamin D was sufficient to demonstrate
11. Elements of offense
that Food and Drug Administration require-
claim of patent infringement could reasonably be asserted if a person not licensed by the
ments that preparations of vitamins A and D
owner engaged in the manufacture, use, or sale of the drug. If an application is filed
Where federal law prohibits dispensing of a
above those levels be restricted to prescription
under this subsection for a drug and a patent which claims such drug or a method of
drug without a prescription, propriety of secur-
sale and be labeled accordingly was not arbi-
using such drug is issued after the filing date but before approval of the application, the
ing and adjusting that drug without a prescrip-
trary or capricious. National Nutritional Foods
tion does not depend upon user's knowledge of
applicant shall amend the application to include the information required by the
the particular dangers involved. Lindsay V. Or-
Ass'n V. Mathews, D.C.N.Y.1976, 418 F.Supp.
preceding sentence. Upon approval of the application, the Secretary shall publish
394.
the Pharmaceutical Corp., C.A.N.Y.1980, 637
information submitted under the two preceding sentences.
F.2d 87.
Although evidence sufficient to support find-
ing that high potency preparations of certain
(2) An application submitted under paragraph (1) for a drug for which the investiga-
12. Jurisdiction
vitamins had no demonstrated usage as a food,
tions described in clause (A) of such paragraph and relied upon by the applicant for
Reason Food and Drug Administration has
at least for all but an extremely small percent-
approval of the application were not conducted by or for the applicant and for which the
primary jurisdiction to determine whether drug
age of the population, above levels established in
applicant has not obtained a right of reference or use from the person by or for whom
sought to be marketed constitutes "new drug"
Food and Drug Administration regulations re-
the investigations were conducted shall also include-
subject to this chapter is expertise of Federal
quiring that high potency preparations be avail-
(A) a certification, in the opinion of the applicant and to the best of his
Drug Administration in resolving technical and
able for sale only by prescription and be labeled
scientific questions. Biotics Research Corp. V.
accordingly, might not, standing alone, be suffi-
knowledge, with respect to each patent which claims the drug for which such
Heckler, C.A.Nev.1988, 710 F.2d 1375.
cient to sustain the regulations, it was a relevant
investigations were conducted or which claims a use for such drug for which the
18. Persons liable
and important data in favor of the regulations.
applicant is seeking approval under this subsection and for which information is
National Nutritional Foods Ass'n V. Mathews,
required to be filed under paragraph (1) or subsection (c) of this section-
Under "bulk supplier doctrine," bulk supplier
D.C.N.Y.1976, 418 F.Supp. 894.
of polytetrafluoroethylene (PTFE) to manufac-
(i) that such patent information has not been filed,
turer of jaw joint implant, which was regulated
19a. Witnesses
(ii) that such patent has expired,
by the Food and Drug Administration (FDA),
Commissioner of food and drugs would not be
(iii) of the date on which such patent will expire, or
did not have any duty to warn of possible dan-
called at "Overton-type" hearing, which was be-
gers of PTFE in implant, and thus, patients
(iv) that such patent is invalid or will not be infringed by the manufacture
ing held to determine whether the Food and
could not recover from supplier for injuries al-
Drug Administration acted rationally in requir-
use, or sale of the new drug for which the application is submitted; and
legedly received as result of implant, on breach
ing that preparations of vitamins A and D in
(B) if with respect to the drug for which investigations described in paragraph
of duty to warn theory; FDA approved PTFE
excess of specified dosages be restricted to pre-
(1)(A) were conducted information was filed under paragraph (1) or subsection (c) of
as appropriate medical device for use in a medi-
scription sale and be labeled accordingly, for
cal implant, and before filling the order, supplier
this section for a method of use patent which does not claim a use for which the
informed manufacturer of its lack of knowledge
cross-examination by those opposing the actions
applicant is seeking approval under this subsection, a statement that the method of
taken by the Food and Drug Administration.
of whether use of device in implants was appro-
use patent does not claim such a use.
priatc. Veil V. Vitek, Inc., D.N.D.1992, 803
National Nutritional Foods Ass'n V. Mathews,
F.Supp. 229.
D.C.N.Y.1976, 418 F.Supp. 394.
(3)(A) An applicant who makes a certification described in paragraph (2)(A)(iv) shall
R.C. Ohio §§ 8715.01(A) (5) (a), (A) (6) (a), (B)
21. State regulation or control
include in the application a statement that the applicant will give the notice required by
subparagraph (B) to-
(2) do not apply to the administration of a drug
Lethal injection statute was not preempted by
or device by a licensed member of the medical
Federal Drug Abuse Prevention and Control Act
(i) each owner of the patent which is the subject of the certification or the
profession. Morse V. Riverside Hospital, 1974,
(DAPCA) or Federal Food, Drug and Cosmetic
representative of such owner designated to receive such notice, and
839 N.E.2d 846, 44 Ohio App.2d 422.
Act (FDCA); Statute's single goal was merely to
(ii) the holder of the approved application under subsection (b) of this section for
Complaint brought by patient who contracted
effect execution of lawfully condemned inmates,
the drug which is claimed by the patent or a use of which is claimed by the patent
hepatitis during a blood transfusion did not state
in contrast to the federal Acts' concerns over
or the representative of such holder designated to receive such notice.
a valid claim for relief against hospital and blood
deleterious effects of unregulated usage of con-
bank based upon negligence by reason of a
trolled substances by individual citizens, and
(B) The notice referred to in subparagraph (A) shall state that an application has
violation of R.C. Ohio § 3715.01(A) (5) (a), (A) (6)
statute could not violate federal law, inasmuch
been submitted under this subsection for the drug with respect to which the certification
(a), (B) (2), inasmuch as provisions thereof did
as federal government utilized lethal injection
is made to obtain approval to engage in the commercial manufacture, use, or sale of the
not apply to administration of a drug or device
method of execution. State V. Deputy, Del.Su-
by a licensed member of medical profession.
drug before the expiration of the patent referred to in the certification. Such notice
per.1994, 644 A.2d 411.
shall include a detailed statement of the factual and legal basis of the applicant's opinion
§ 355. New drugs
that the patent is not valid or will not be infringed.
(C) If an application is amended to include a certification described in paragraph
(a) Necessity of effective approval of application
(2)(A)(iv), the notice required by subparagraph (B) shall be given when the amended
No person shall introduce or deliver for introduction into interstate commerce any
application is submitted.
new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of
this section is effective with respect to such drug.
(c) Period for approval of application; period for, notice, and expedition of hear-
ing; period for issuance of order
(b) Filing application; contents
(1) Within one hundred and eighty days after the filing of an application under
(1) Any person may file with the Secretary an application with respect to any drug
subject to the provisions of subsection (a) of this section. Such person shall submit to
subsection (b) of this section, or such additional period as may be agreed upon by the
Secretary and the applicant, the Secretary shall either-
186
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
(A) Approve the application if he then finds that none of the grounds for denying
approval specified in subsection (d) of this section applies, or
28 for a declaratory judgment with respect to the patent. Any action brought
(B) Give the applicant notice of an opportunity for a hearing before the Secre-
under such section 2201 shall be brought in the judicial district where the defendant
tary under subsection (d) of this section on the question whether such application is
has its principal place of business or a regular and established place of business.
approvable. If the applicant elects to accept the opportunity for hearing by written
(D)(i) If an application (other than an abbreviated new drug application) submit-
request within thirty days after such notice, such hearing shall commence not more
ted under subsection (b) of this section for a drug, no active ingredient (including
than ninety days after the expiration of such thirty days unless the Secretary and
any ester or salt of the active ingredient) of which has been approved in any other
the applicant otherwise agree. Any such hearing shall thereafter be conducted on
application under subsection (b) of this section, was approved during the period
an expedited basis and the Secretary's order thereon shall be issued within ninety
beginning January 1, 1982, and ending on September 24, 1984, the Secretary may
days after the date fixed by the Secretary for filing final briefs.
not make the approval of another application for a drug for which the investigations
(2) If the patent information described in subsection (b) of this section could not be
described in clause (A) of subsection (b)(1) of this section and relied upon by the
filed with the submission of an application under subsection (b) of this section because
applicant for approval of the application were not conducted by or for the applicant
the application was filed before the patent information was required under subsection (b)
and for which the applicant has not obtained a right of reference or use from the
of this section or a patent was issued after the application was approved under such
person by or for whom the investigations were conducted effective before the
subsection, the holder of an approved application shall file with the Secretary the patent
expiration of ten years from the date of the approval of the application previously
number and the expiration date of any patent which claims the drug for which the
approved under subsection (b) of this section.
application was submitted or which claims a method of using such drug and with respect
to which a claim of patent infringement could reasonably be asserted if a person not
(ii) If an application submitted under subsection (b) of this section for a drug, no
licensed by the owner engaged in the manufacture, use, or sale of the drug. If the
active ingredient (including any ester or salt of the active ingredient) of which has
holder of an approved application could not file patent information under subsection (b)
been approved in any other application under subsection (b) of this section, is
of this section because it was not required at the time the application was approved, the
approved after September 24, 1984, no application which refers to the drug for
holder shall file such information under this subsection not later than thirty days after
which the subsection (b) application was submitted and for which the investigations
September 24, 1984, and if the holder of an approved application could not file patent
described in clause (A) of subsection (b)(1) of this section and relied upon by the
information under subsection (b) of this section because no patent had been issued when
applicant for approval of the application were not conducted by or for the applicant
an application was filed or approved, the holder shall file such information under this
and for which the applicant has not obtained a right of reference or use from the
subsection not later than thirty days after the date the patent involved is issued. Upon
person by or for whom the investigations were conducted may be submitted under
the submission of patent information under this subsection, the Secretary shall publish
subsection (b) of this section before the expiration of five years from the date of the
it.
approval of the application under subsection (b) of this section, except that such an
(3) The approval of an application filed under subsection (b) of this section which
application may be submitted under subsection (b) of this section after the expira-
tion of four years from the date of the approval of the subsection (b) application if it
contains a certification required by paragraph (2) of such subsection shall be made
contains a certification of patent invalidity or noninfringement described in clause
effective on the last applicable date determined under the following:
(iv) of subsection (b)(2)(A) of this section. The approval of such an application shall
(A) If the applicant only made a certification described in clause (i) or (ii) of
be made effective in accordance with this paragraph except that, if an action for
subsection (b)(2)(A) of this section or in both such clauses, the approval may be
patent infringement is commenced during the one-year period beginning forty-eight
made effective immediately.
months after the date of the approval of the subsection (b) application, the thirty-
(B) If the applicant made a certification described in clause (iii) of subsection
month period referred to in subparagraph (C) shall be extended by such amount of
(b)(2)(A) of this section, the approval may be made effective on the date certified
time (if any) which is required for seven and one-half years to have elapsed from
under clause (iii).
the date of approval of the subsection (b) application.
(C) If the applicant made a certification described in clause (iv) of subsection
(iii) If an application submitted under subsection (b) of this section for a drug,
(b)(2)(A) of this section, the approval shall be made effective immediately unless an
which includes an active ingredient (including any ester or salt of the active
action is brought for infringement of a patent which is the subject of the certifica-
ingredient) that has been approved in another application approved under subsec-
tion before the expiration of forty-five days from the date the notice provided under
tion (b) of this section, is approved after September 24, 1984, and if such application
paragraph (3)(B) is received. If such an action is brought before the expiration of
contains reports of new clinical investigations (other than bioavailability studies)
such days, the approval may be made effective upon the expiration of the thirty-
essential to the approval of the application and conducted or sponsored by the
month period beginning on the date of the receipt of the notice provided under
applicant, the Secretary may not make the approval of an application submitted
paragraph (3)(B) or such shorter or longer period as the court may order because
under subsection (b) of this section for the conditions of approval of such drug in the
either party to the action failed to reasonably cooperate in expediting the action,
except that-
approved subsection (b) application effective before the expiration of three years
from the date of the approval of the application under subsection (b) of this section
(i) if before the expiration of such period the court decides that such patent
if the investigations described in clause (A) of subsection (b)(1) of this section and
is invalid or not infringed, the approval may be made effective on the date of
relied upon by the applicant for approval of the application were not conducted by
the court decision,
or for the applicant and if the applicant has not obtained a right of reference or use
(ii) if before the expiration of such period the court decides that such patent
from the person by or for whom the investigations were conducted.
has been infringed, the approval may be made effective on such date as the
(iv) If a supplement to an application approved under subsection (b) of this
court orders under section 271(e)(4)(A) of Title 35, or
section is approved after September 24, 1984, and the supplement contains reports
(iii) if before the expiration of such period the court grants a preliminary
of new clinical investigations (other than bioavailability studies) essential to the
injunction prohibiting the applicant from engaging in the commercial manufac-
approval of the supplement and conducted or sponsored by the person submitting
ture or sale of the drug until the court decides the issues of patent validity and
the supplement, the Secretary may not make the approval of an application
infringement and if the court decides that such patent is invalid or not
submitted under subsection (b) of this section for a change approved in the
infringed, the approval shall be made effective on the date of such court
supplement effective before the expiration of three years from the date of the
decision.
approval of the supplement under subsection (b) of this section if the investigations
In such an action, each of the parties shall reasonably cooperate in expediting the
described in clause (A) of subsection (b)(1) of this section and relied upon by the
action. Until the expiration of forty-five days from the date the notice made under
applicant for approval of the application were not conducted by or for the applicant
paragraph (3)(B) is received, no action may be brought under section 2201 of Title
and if the applicant has not obtained a right of reference or use from the person by
188
or for whom the investigations were conducted.
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21
§
355
(v) If an application (or supplement to an application) submitted under subsection
tion; or (5) that the at the application contains any untrue statement of a material fact:
(b) of this section for a drug, which includes an active ingredient (including any
Provided, That if the Secretary (or in his absence the officer acting as Secretary) finds
ester or salt of the active ingredient) that has been approved in another application
that there is an imminent hazard to the public health, he may suspend the approval of
under subsection (b) of this section, was approved during the period beginning
such application immediately, and give the applicant prompt notice of his action and
January 1, 1982, and ending on September 24, 1984, the Secretary may not make
afford the applicant the opportunity for an expedited hearing under this subsection; but
the approval of an application submitted under this subsection and for which the
the authority conferred by this proviso to suspend the approval of an application shall
investigations described in clause (A) of subsection (b)(1) of this section and relied
not be delegated. The Secretary may also, after due notice and opportunity for hearing
upon by the applicant for approval of the application were not conducted by or for
to the applicant, withdraw the approval of an application submitted under subsection (b)
the applicant and for which the applicant has not obtained a right of reference or
or (j) of this section with respect to any drug under this section if the Secretary finds (1)
use from the person by or for whom the investigations were conducted and which
that the applicant has failed to establish a system for maintaining required records, or
refers to the drug for which the subsection (b) application was submitted effective
has repeatedly or deliberately failed to maintain such records or to make required
before the expiration of two years from September 24, 1984.
reports, in accordance with a regulation or order under subsection (k) of this section or
to comply with the notice requirements of section 360(k)(2) of this title, or the applicant
(d) Grounds for refusing application; approval of application; "substantial evi-
has refused to permit access to, or copying or verification of, such records as required by
dence" defined
paragraph (2) of such subsection; or (2) that on the basis of new information before him,
If the Secretary finds, after due notice to the applicant in accordance with subsection
evaluated together with the evidence before him when the application was approved, the
(c) of this section and giving him an opportunity for a hearing, in accordance with said
methods used in, or the facilities and controls used for, the manufacture, processing, and
subsection, that (1) the investigations, reports of which are required to be submitted to
packing of such drug are inadequate to assure and preserve its identity, strength,
the Secretary pursuant to subsection (b) of this section, do not include adequate tests by
quality, and purity and were not made adequate within a reasonable time after receipt of
all methods reasonably applicable to show whether or not such drug is safe for use
written notice from the Secretary specifying the matter complained of; or (3) that on the
under the conditions prescribed, recommended, or suggested in the proposed labeling
basis of new information before him, evaluated together with the evidence before him
thereof; (2) the results of such tests show that such drug is unsafe for use under such
when the application was approved, the labeling of such drug, based on a fair evaluation
conditions or do not show that such drug is safe for use under such conditions; (3) the
of all material facts, is false or misleading in any particular and was not corrected within
methods used in, and the facilities and controls used for, the manufacture, processing,
a reasonable time after receipt of written notice from the Secretary specifying the
and packing of such drug are inadequate to preserve its identity, strength, quality, and
matter complained of. Any order under this subsection shall state the findings upon
purity; (4) upon the basis of the information submitted to him as part of the application,
which it is based.
or upon the basis of any other information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe for use under such
[See main volume for text of (f) to (i)]
conditions; or (5) evaluated on the basis of the information submitted to him as part of
(j) Abbreviated new drug applications
the application and any other information before him with respect to such drug, there is
a lack of substantial evidence that the drug will have the effect it purports or is
(1) Any person may file with the Secretary an abbreviated application for the
represented to have under the conditions of use prescribed, recommended, or suggested
approval of a new drug.
in the proposed labeling thereof; or (6) the application failed to contain the patent
(2)(A) An abbreviated application for a new drug shall contain-
information prescribed by subsection (b) of this section; or (7) based on a fair evaluation
(i) information to show that the conditions of use prescribed, recommended, or
of all material facts, such labeling is false or misleading in any particular; he shall issue
suggested in the labeling proposed for the new drug have been previously approved
an order refusing to approve the application. If, after such notice and opportunity for
for a drug listed under paragraph (6) (hereinafter in this subsection referred to as a
hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall issue an
"listed drug");
order approving the application. As used in this subsection and subsection (e) of this
section, the term "substantial evidence" means evidence consisting of adequate and well-
(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient,
controlled investigations, including clinical investigations, by experts qualified by scienti-
information to show that the active ingredient of the new drug is the same as that of
the listed drug;
fic training and experience to evaluate the effectiveness of the drug involved, on the
basis of which it could fairly and responsibly be concluded by such experts that the drug
(II) if the listed drug referred to in clause (i) has more than one active
will have the effect it purports or is represented to have under the conditions of use
ingredient, information to show that the active ingredients of the new drug are the
prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i) has more than one active
(e) Withdrawal of approval; grounds; immediate suspension upon finding immi-
ingredient and if one of the active ingredients of the new drug is different and the
nent hazard to public health
application is filed pursuant to the approval of a petition filed under subparagraph
The Secretary shall, after due notice and opportunity for hearing to the applicant,
(C), information to show that the other active ingredients of the new drug are the
withdraw approval of an application with respect to any drug under this section if the
same as the active ingredients of the listed drug, information to show that the
Secretary finds (1) that clinical or other experience, tests, or other scientific data show
different active ingredient is an active ingredient of a listed drug or of a drug which
that such drug is unsafe for use under the conditions of use upon the basis of which the
does not meet the requirements of section 321(p) of this title, and such other
application was approved; (2) that new evidence of clinical experience, not contained in
information respecting the different active ingredient with respect to which the
such application or not available to the Secretary until after such application was
petition was filed as the Secretary may require;
approved, or tests by new methods, or tests by methods not deemed reasonably
(iii) information to show that the route of administration, the dosage form, and
applicable when such application was approved, evaluated together with the evidence
the strength of the new drug are the same as those of the listed drug referred to in
available to the Secretary when the application was approved, shows that such drug is
clause (i) or, if the route of administration, the dosage form, or the strength of the
not shown to be safe for use under the conditions of use upon the basis of which the
new drug is different and the application is filed pursuant to the approval of a
application was approved; or (3) on the basis of new information before him with respect
petition filed under subparagraph (C), such information respecting the route of
to such drug, evaluated together with the evidence available to him when the application
administration, dosage form, or strength with respect to which the petition was filed
was approved, that there is a lack of substantial evidence that the drug will have the
as the Secretary may require;
effect it purports or is represented to have under the conditions of use prescribed,
(iv) information to show that the new drug is bioequivalent to the listed drug
recommended, or suggested in the labeling thereof; or (4) the patent information
referred to in clause (i), except that if the application is filed pursuant to the
prescribed by subsection (c) of this section was not filed within thirty days after the
approval of a petition filed under subparagraph (C), information to show that the
receipt of written notice from the Secretary specifying the failure to file such informa-
active ingredients of the new drug are of the same pharmacological or therapeutic
190
21 $ 355
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21 § 355
class as those of the listed drug referred to in clause (i) and the new drug can be
expected to have the same therapeutic effect as the listed drug when administered
(A) the methods used in, or the facilities and controls used for, the manufacture,
to patients for a condition of use referred to in clause (i);
processing, and packing of the drug are inadequate to assure and preserve its
(v) information to show that the labeling proposed for the new drug is the same
identity, strength, quality, and purity;
as the labeling approved for the listed drug referred to in clause (i) except for
(B) information submitted with the application is insufficient to show that each of
changes required because of differences approved under a petition filed under
the proposed conditions of use have been previously approved for the listed drug
subparagraph (C) or because the new drug and the listed drug are produced or
referred to in the application;
distributed by different manufacturers;
(C)(i) if the listed drug has only one active ingredient, information submitted
(vi) the items specified in clauses (B) through (F) of subsection (b)(1) of this
with the application is insufficient to show that the active ingredient is the same as
section;
that of the listed drug;
(vii) a certification, in the opinion of the applicant and to the best of his
(ii) if the listed drug has more than one active ingredient, information submitted
knowledge, with respect to each patent which claims the listed drug referred to in
with the application is insufficient to show that the active ingredients are the same
clause (i) or which claims a use for such listed drug for which the applicant is
as the active ingredients of the listed drug, or
seeking approval under this subsection and for which information is required to be
(iii) if the listed drug has more than one active ingredient and if the application
filed under subsection (b) or (c) of this section-
is for a drug which has an active ingredient different from the listed drug,
(I) that such patent information has not been filed,
information submitted with the application is insufficient to show-
(II) that such patent has expired,
(I) that the other active ingredients are the same as the active ingredients of
the listed drug, or
(III) of the date on which such patent will expire, or
(II) that the different active ingredient is an active ingredient of a listed
(IV) that such patent is invalid or will not be infringed by the manufacture,
drug or a drug which does not meet the requirements of section 321(p) of this
use, or sale of the new drug for which the application is submitted; and
title,
(viii) if with respect to the listed drug referred to in clause (i) information was
or no petition to file an application for the drug with the different ingredient
filed under subsection (b) or (c) of this section for a method of use patent which
was approved under paragraph (2)(C);
does not claim a use for which the applicant is seeking approval under this
subsection, a statement that the method of use patent does not claim such a use.
(D)(i) if the application is for a drug whose route of administration, dosage form,
or strength of the drug is the same as the route of administration, dosage form, or
The Secretary may not require that an abbreviated application contain information in
strength of the listed drug referred to in the application, information submitted in
addition to that required by clauses (i) through (viii).
the application is insufficient to show that the route of administration, dosage form,
(B)(i) An applicant who makes a certification described in subparagraph (A)(vii)(IV)
or strength is the same as that of the listed drug, or
shall include in the application a statement that the applicant will give the notice
(ii) if the application is for a drug whose route of administration, dosage form, or
required by clause (ii) to-
strength of the drug is different from that of the listed drug referred to in the
(I) each owner of the patent which is the subject of the certification or the
application, no petition to file an application for the drug with the different route of
representative of such owner designated to receive such notice, and
administration, dosage form, or strength was approved under paragraph (2)(C);
(II) the holder of the approved application under subsection (b) of this section for
(E) if the application was filed pursuant to the approval of a petition under
the drug which is claimed by the patent or a use of which is claimed by the patent
paragraph (2)(C), the application did not contain the information required by the
or the representative of such holder designated to receive such notice.
Secretary respecting the active ingredient, route of administration, dosage form, or
(ii) The notice referred to in clause (i) shall state that an application, which contains
strength which is not the same;
data from bioavailability or bioequivalence studies, has been submitted under this
(F) information submitted in the application is insufficient to show that the drug
subsection for the drug with respect to which the certification is made to obtain approval
is bioequivalent to the listed drug referred to in the application or, if the application
to engage in the commercial manufacture, use, or sale of such drug before the expiration
was filed pursuant to a petition approved under paragraph (2)(C), information
of the patent referred to in the certification. Such notice shall include a detailed
submitted in the application is insufficient to show that the active ingredients of the
statement of the factual and legal basis of the applicant's opinion that the patent is not
new drug are of the same pharmacological or therapeutic class as those of the listed
valid or will not be infringed.
drug referred to in paragraph (2)(A)(i) and that the new drug can be expected to
have the same therapeutic effect as the listed drug when administered to patients
(iii) If an application is amended to include a certification described in subparagraph
(A)(vii)(IV), the notice required by clause (ii) shall be given when the amended
for a condition of use referred to in such paragraph;
application is submitted.
(G) information submitted in the application is insufficient to show that the
labeling proposed for the drug is the same as the labeling approved for the listed
(C) If a person wants to submit an abbreviated application for a new drug which has
drug referred to in the application except for changes required because of differ-
a different active ingredient or whose route of administration, dosage form, or strength
ences approved under a petition filed under paragraph (2)(C) or because the drug
differ from that of a listed drug, such person shall submit a petition to the Secretary
and the listed drug are produced or distributed by different manufacturers;
seeking permission to file such an application. The Secretary shall approve or disap-
(H) information submitted in the application or any other information available to
prove a petition submitted under this subparagraph within ninety days of the date the
the Secretary shows that (i) the inactive ingredients of the drug are unsafe for use
finds- petition is submitted. The Secretary shall approve such a petition unless the Secretary
under the conditions prescribed, recommended, or suggested in the labeling pro-
posed for the drug, or (ii) the composition of the drug is unsafe under such
(i) that investigations must be conducted to show the safety and effectiveness of
conditions because of the type or quantity of inactive ingredients included or the
the drug or of any of its active ingredients, the route of administration, the dosage
manner in which the inactive ingredients are included;
form, or strength which differ from the listed drug; or
(I) the approval under subsection (c) of this section of the listed drug referred to
(ii) that any drug with a different active ingredient may not be adequately
in the application under this subsection has been withdrawn or suspended for
evaluated for approval as safe and effective on the basis of the information required
grounds described in the first sentence of subsection (e) of this section, the
to be submitted in an abbreviated application.
Secretary has published a notice of opportunity for hearing to withdraw approval of
(3) Subject to paragraph (4), the Secretary shall approve an application for a drug
the listed drug under subsection (c) of this section for grounds described in the first
unless the Secretary finds—
sentence of subsection (e) of this section, the approval under this subsection of the
192
listed drug referred to in the application under this subsection has been withdrawn
193
21
§
355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
or suspended under paragraph (5), or the Secretary has determined that the listed
Secretary and the applicant otherwise agree. Any such hearing shall thereafter be
drug has been withdrawn from sale for safety or effectiveness reasons;
conducted on an expedited basis and the Secretary's order thereon shall be issued within
(J) the application does not meet any other requirement of paragraph (2)(A); or
ninety days after the date fixed by the Secretary for filing final briefs.
(K) the application contains an untrue statement of material fact.
(D)(i) If an application (other than an abbreviated new drug application) submitted
(4)(A) Within one hundred and eighty days of the initial receipt of an application
under subsection (b) of this section for a drug, no active ingredient (including any ester
under paragraph (2) or within such additional period as may be agreed upon by the
or salt of the active ingredient) of which has been approved in any other application
Secretary and the applicant, the Secretary shall approve or disapprove the application.
under subsection (b) of this section, was approved during the period beginning January
1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of
(B) The approval of an application submitted under paragraph (2) shall be. made
an application submitted under this subsection which refers to the drug for which the
effective on the last applicable date determined under the following:
subsection (b) application was submitted effective before the expiration of ten years from
(i) If the applicant only made a certification described in subclause (I) or (II) of
the date of the approval of the application under subsection (b) of this section.
paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective
(ii) If an application submitted under subsection (b) of this section for a drug, no
immediately.
active ingredient (including any ester or salt of the active ingredient) of which has been
(ii) If the applicant made a certification described in subclause (III) of paragraph
approved in any other application under subsection (b) of this section, is approved after
(2)(A)(vii), the approval may be made effective on the date certified under subclause
September 24, 1984, no application may be submitted under this subsection which refers
(III).
to the drug for which the subsection (b) application was submitted before the expiration
(iii) If the applicant made a certification described in subclause (IV) of para-
of five years from the date of the approval of the application under subsection (b) of this
graph (2)(A)(vii), the approval shall be made effective immediately unless an action
section, except that such an application may be submitted under this subsection after the
is brought for infringement of a patent which is the subject of the certification
expiration of four years from the date of the approval of the subsection (b) application if
before the expiration of forty-five days from the date the notice provided under
it contains a certification of patent invalidity or noninfringement described in subclause
paragraph (2)(B)(i) is received. If such an action is brought before the expiration of
(IV) of paragraph (2)(A)(vii). The approval of such an application shall be made
such days, the approval shall be made effective upon the expiration of the thirty-
effective in accordance with subparagraph (B) except that, if an action for patent
month period beginning on the date of the receipt of the notice provided under
infringement is commenced during the one-year period beginning forty-eight months
paragraph (2)(B)(i) or such shorter or longer period as the court may order because
after the date of the approval of the subsection (b) application, the thirty-month period
either party to the action failed to reasonably cooperate in expediting the action,
referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any)
except that-
which is required for seven and one-half years to have elapsed from the date of approval
(I) if before the expiration of such period the court decides that such patent
of the subsection (b) application.
is invalid or not infringed, the approval shall be made effective on the date of
(iii) If an application submitted under subsection (b) of this section for a drug, which
the court decision,
includes an active ingredient (including any ester or salt of the active ingredient) that
(II) if before the expiration of such period the court decides that such patent
has been approved in another application approved under subsection (b) of this section,
has been infringed, the approval shall be made effective on such date as the
is approved after September 24, 1984, and if such application contains reports of new
court orders under section 271(e)(4)(A) of Title 35 or
clinical investigations (other than bioavailability studies) essential to the approval of the
(III) if before the expiration of such period the court grants a preliminary
application and conducted or sponsored by the applicant, the Secretary may not make
injunction prohibiting the applicant from engaging in the commercial manufac-
the approval of an application submitted under this subsection for the conditions of
ture or sale of the drug until the court decides the issues of patent validity and
approval of such drug in the subsection (b) application effective before the expiration of
infringement and if the court decides that such patent is invalid or not
three years from the date of the approval of the application under subsection (b) of this
infringed, the approval shall be made effective on the date of such court
section for such drug.
decision.
(iv) If a supplement to an application approved under subsection (b) of this section is
In such an action, each of the parties shall reasonably cooperate in expediting
approved after September 24, 1984, and the supplement contains reports of new clinical
the action. Until the expiration of forty-five days from the date the notice
investigations (other than bioavailability studies) essential to the approval of the
made under paragraph (2)(B)(i) is received, no action may be brought under
supplement and conducted or sponsored by the person submitting the supplement, the
section 2201 of Title 28 for a declaratory judgment with respect to the patent.
Secretary may not make the approval of an application submitted under this subsection
Any action brought under section 2201 shall be brought in the judicial district
for a change approved in the supplement effective before the expiration of three years
where the defendant has its principal place of business or a regular and
from the date of the approval of the supplement under subsection (b) of this section.
established place of business.
(v) If an application (or supplement to an application) submitted under subsection (b)
(iv) If the application contains a certification described in subclause (IV) of
of this section for a drug, which includes an active ingredient (including any ester or salt
paragraph (2)(A)(vii) and is for a drug for which a previous application has been
of the active ingredient) that has been approved in another application under subsection
submitted under this subsection continuing such a certification, the application shall
(b) of this section, was approved during the period beginning January 1, 1982, and
be made effective not earlier than one hundred and eighty days after-
ending. on September 24, 1984, the Secretary may not make the approval of an
(I) the date the Secretary receives notice from the applicant under the
application submitted under this subsection which refers to the drug for which the
previous application of the first commercial marketing of the drug under the
subsection (b) application was submitted or which refers to a change approved in a
previous application, or
supplement to the subsection (b) application effective before the expiration of two years
(II) the date of a decision of a court in an action described in clause (iii)
from September 24, 1984.
holding the patent which is the subject of the certification to be invalid or not
(5) If a drug approved under this subsection refers in its approved application to a
infringed,
drug the approval of which was withdrawn or suspended for grounds described in the
whichever is earlier.
first sentence of subsection (e) of this section or was withdrawn or suspended under this
(C) If the Secretary decides to disapprove an application, the Secretary shall give the
paragraph or which, as determined by the Secretary, has been withdrawn from sale for
applicant notice of an opportunity for a hearing before the Secretary on the question of
safety or effectiveness reasons, the approval of the drug under this subsection shall J be
whether such application is approvable. If the applicant elects to accept the opportunity
withdrawn or suspended-
for hearing by written request within thirty days after such notice, such hearing shall
(A) for the same period as the withdrawal or suspension under subsection
ed
commence not more than ninety days after the expiration of such thirty days unless the
this section or this paragraph, or
194
195
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
(B) if the listed drug has been withdrawn from sale, for the period of withdrawal
(C) the name of each person to whom the review of the chemistry of the
from sale or, if earlier, the period ending on the date the Secretary determines that
application was assigned and the date of such assignment, and
the withdrawal from sale is not for safety or effectiveness reasons.
(D) the name of each person to whom the bioequivalence review for such
(6)(A)(i) Within sixty days of September 24, 1984, the Secretary shall publish and
application was assigned and the date of such assignment.
make available to the public-
The information the Secretary is required to maintain under this paragraph with respect
(I) a list in alphabetical order of the official and proprietary name of each drug
to an application submitted under this subsection shall be made available to the public
which has been approved for safety and effectiveness under subsection (c) of this
after the approval of such application.
section before September 24, 1984;
(II) the date of approval if the drug is approved after 1981 and the number of the
(k) Records and reports; required information; regulations and orders; access to
application which was approved; and
records
(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are
(1) In the case of any drug for which an approval of an application filed under
required for applications filed under this subsection which will refer to the drug
subsection (b) or (j) of this section is in effect, the applicant shall establish and maintain
published.
such records, and make such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise obtained by such
(ii) Every thirty days after the publication of the first list under clause (i) the
applicant with respect to such drug, as the Secretary may by general regulation, or by
Secretary shall revise the list to include each drug which has been approved for safety
order with respect to such application, prescribe on the basis of a finding that such
and effectiveness under subsection (c) of this section or approved under this subsection
records and reports are necessary in order to enable the Secretary to determine, or
during the thirty-day period.
facilitate a determination, whether there is or may be ground for invoking subsection (e)
(iii) When patent information submitted under subsection (b) or (c) of this section
of this section. Regulations and orders issued under this subsection and under
respecting a drug included on the list is to be published by the Secretary, the Secretary
subsection (i) of this section shall have due regard for the professional ethics of the
shall, in revisions made under clause (ii), include such information for such drug.
medical profession and the interests of patients and shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request, by the persons to whom
(B) A drug approved for safety and effectiveness under subsection (c) of this section
such regulations or orders are applicable, of similar information received or otherwise
or approved under this subsection shall, for purposes of this subsection, be considered to
obtained by the Secretary.
have been published under subparagraph (A) on the date of its approval or September
24, 1984, whichever is later.
(2) Every person required under this section to maintain records, and every person in
charge or custody thereof, shall, upon request of an officer or employee designated by
(C) If the approval of a drug was withdrawn or suspended for grounds described in
the Secretary, permit such officer or employee at all reasonable times to have access to
the first sentence of subsection (e) of this section or was withdrawn or suspended under
and copy and verify such records.
paragraph (5) or if the Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in the list under subpara-
(I) Public disclosure of safety and effectiveness data
graph (A) or, if the withdrawal or suspension occurred after its publication in such list, it
shall be immediately removed from such list—
Safety and effectiveness data and information which has been submitted in an
application under subsection (b) of this section for a drug and which has not previously
(i) for the same period as the withdrawal or suspension under subsection (e) of
been disclosed to the public shall be made available to the public, upon request, unless
this section or paragraph (5), or
extraordinary circumstances are shown-
(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal
(1) if no work is being or will be undertaken to have the application approved,
from sale or, if earlier, the period ending on the date the Secretary determines that
the withdrawal from sale is not for safety or effectiveness reasons.
(2) if the Secretary has determined that the application is not approvable and all
legal appeals have been exhausted,
A notice of the removal shall be published in the Federal Register.
(3) if approval of the application under subsection (c) of this section is withdrawn
(7) For purposes of this subsection:
and all legal appeals have been exhausted,
(A) The term "bioavailability" means the rate and extent to which the active
(4) if the Secretary has determined that such drug is not a new drug, or
ingredient or therapeutic ingredient is absorbed from a drug and becomes available
(5) upon the effective date of the approval of the first application under subsec-
at the site of drug action.
tion (j) of this section which refers to such drug or upon the date upon which the
(B) A drug shall be considered to be bioequivalent to a listed drug if-
approval of an application under subsection (j) of this section which refers to such
(i) the rate and extent of absorption of the drug do not show a significant
drug could be made effective if such an application had been submitted.
difference from the rate and extent of absorption of the listed drug when
(m) "Patent" defined
administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple doses; or
For purposes of this section, the term "patent" means a patent issued by the Patent
(ii) the extent of absorption of the drug does not show a significant
and Trademark Office of the Department of Commerce.
difference from the extent of absorption of the listed drug when administered
(As amended Aug. 16, 1972, Pub.L. 92-387, § 4(d), 86 Stat. 562; Sept. 24, 1984, Pub.L. 98-417, Title
at the same molar dose of the therapeutic ingredient under similar experimen-
I, §§ 101, 102(a)-(b)(5), 103, 104, 98 Stat. 1585, 1592, 1593, 1597; May 13, 1992, Pub.L. 102-282, § 5,
tal conditions in either a single dose or multiple doses and the difference from
106 Stat. 161; Aug. 13, 1993, Pub.L. 103-80, $ 3(n), 107 Stat. 777.)
the listed drug in the rate of absorption of the drug is intentional, is reflected in
its proposed labeling, is not essential to the attainment of effective body drug
HISTORICAL AND STATUTORY NOTES
concentrations on chronic use, and is considered medically insignificant for the
1993 Amendments
Subsec. (k)(1). Pub.L. 103-80, $ 3(n)(2),
drug.
Subsec.
(j)(6)(A)(ii).
Pub.L.
103-80,
struck out ": Provided, however, That regula-
§ 3(n)(1)(A), corrected a typographical error in
tions" and inserted in lieu thereof a period and
(8) The Secretary shall, with respect to each application submitted under this
the original by substituting "Secretary" for
"Regulations".
subsection, maintain a record of-
"Secretry".
1992 Amendments
(A) the name of the applicant,
Subsec.
(j)(6)(A)(iii).
Pub.L.
103-80,
§ 3(n)(1)(B), inserted a comma after "published
Subsec. (j)(8). Pub.L. 102-282, $ 5, added
(B) the name of the drug covered by the application,
by the Secretary".
par. (8).
196
197
21 8 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
1984 Amendment
of this section or to comply with the notice
Subsec. (a). Pub.L. 98-417, $ 102(b)(1), add-
requirements of section 360(j)(2) of this title".
for any drug which has been approved for safety
16, 1972, see section 5 of Pub.L. 92-387, set out
ed "or (j)" following "pursuant to subsection
Subsec. (j). Pub.L. 98-417, § 101, added sub-
and effectiveness under section 505(c) of the
as a note under section 360 of this title.
(b)".
sec. (j). Former subsec. (j) was redesignated
Federal Food, Drug, and Cosmetic Act [subsec.
Subsec. (b)(1). Pub.L. 98-417, $ 103(a), des-
(k).
(c) of this section] before the date of the enact-
Federal Policy Regarding the Export of
ment of this Act [Sept. 24, 1984]. If any such
Banned or Significantly Restricted Sub-
ignated the existing provisions of subsec. (b) as
Subsec. (k). Pub.L. 98-417, $ 101, redesig-
nated former subsec. (j) as (k).
provision is inconsistent with the requirements
stances
par. (1) thereof and redesignated existing cls. (1)
through (6) of par. (1) as 60 redesignated as cls.
of section 505(j) of the Federal Food, Drug, and
For provisions relating to the applicability of
(A) through (F) thereof, respectively.
Subsec. (k)(1). Pub.L. 98-417, 1 102(b)(5),
Cosmetic Act [subsec. (j) of this section], the
the term "banned or significantly restricted sub-
substituted "under subsection (b) or (j) of this
Pub.L. 98-417, $ 102(a)(1), added requirement
Secretary shall consider the application under
stance", as defined, and the Federal policy re-
section" for "pursuant to this section".
that the applicant file with the application the
the applicable requirements of such section.
garding the export of banned or significantly
patent number and the expiration date of any
Subsecs. (l), (m). Pub.L. 98-417, $ 104, add-
The Secretary of Health and Human Services
restricted substances, see section 1-101 of Ex.
ed subsecs. (l) and (m).
patent which claims the drug for which the
may not approve such an abbreviated new drug
Ord. No. 12264, Jan. 15, 1981, 46 F.R. 4659, set
applicant submitted the application or which
application which is filed for a drug which is
out as a note under section 2403 of Title 50,
1972 Amendment
described in sections 505(c)(3)(D) and
claims a method of using such drug and with
Appendix, War and National Defense.
Subsec. (e). Pub.L. 92-387 inserted "or to
respect to which a claim of patent infringement
505(j)(4)(D) of the Federal Food, Drug, and
comply with the notice requirements of section
could reasonably be asserted if a person not
Cosmetic Act [subsecs. (c)(8)(D) and (j)(4)(D) of
Legislative History
360(j) (2)' in clause (1) of the second sentence
licensed by the owner engaged in the manufac-
this section], except in accordance with such
For legislative history and purpose of Pub.L.
relating to the maintenance of records.
ture, use, or sale of the drug, that the applicant
section."
92-387, see 1972 U.S. Code Cong. and Adm.
amend the application to include such informa-
Change of Name
News, p. 2963. See, also, Pub.L. 98-417, 1984
Effective Date of 1972 Amendment
tion if an application is filed under this subsec-
The Department of Health, Education, and
U.S. Code Cong. and Adm. News, p. 2647;
tion for a drug and a patent which claims such
Welfare was redesignated the Department of
Amendment by Pub.L. 92-887 effective on the
Pub.L. 102-282, 1992 U.S. Code Cong. and Adm.
drug or a method of using such drug is issued
Health and Human Services, and the Secretary
first day of the sixth month beginning after Aug.
News, p. 103.
after the filing date but before approval of the
of Health, Education, and Welfare or any other
application, and that, upon approval of the appli-
CROSS REFERENCES
official of the Department of Health, Education
cation, the Secretary, publish the information
submitted.
and Welfare was redesignated the Secretary or
Patents, extension of patent term, see 35
official, as appropriate, of Health and Human
USCA $ 156.
Subsec. (b)(2), (3). Pub.L. 98-417, § 103(a),
Services, with any reference to the Department
added pars. (2) and (8).
of Health, Education, and Welfare, the Secre-
FEDERAL PRACTICE AND PROCEDURE
Subsec. (c)(1): Pub.L. 98-417, § 102(a)(2),
tary of Health, Education, and Welfare, or any
Review of administrative decisions in courts of
designated the existing provisions of subsec. (c)
official of the Department of Health, Education,
appeals, see Wright, Miller, Cooper & Gress-
as par. (1) thereof and in par. (1) as 80 designat-
and Welfare, in any law, rule, regulation, certifi-
man: Jurisdiction $ 3941.
ed redesignated former pars. (1) and (2) as
cate, directive, instruction, or other official pa-
subpars. (A) and (B), respectively.
per in force on the effective date of Pub.L.
WESTS FEDERAL PRACTICE MANUAL
Pub.L. 98-417, $ 102(b)(2), substituted "sub-
96-88, as prescribed by section 601 of Pub.L.
96-88, Title VI, Oct. 17, 1979, 93 Stat. 696, set
Application for use of new drug, see $ 3638.
section (b) of this section" for "this subsection".
Subsec. (c)(2). Pub.L. 98-417, $ 102(a)(2),
out as a note under section 3401 of Title 20,
added par. (2).
Education, deemed to refer and apply to the
CODE OF FEDERAL REGULATIONS
Department of Health and Human Services or
Formal evidentiary public hearing, see 21
New animal feed drugs, see 21 CFR 558.3.
Subsec. (c)(3). Pub.L. 98-417, § 103(b), add-
the Secretary of Health and Human Services,
CFR 12.1 et seq.
New drugs for human use, see 21 CFR
ed par. (8).
respectively, except to the extent such reference
New animal drugs, see 21 CFR 510.3.
310.100 et seq.
Subsec. (d)(6). Pub.L. 98-417, § 102(a)(3)(A),
is to a function or office transferred to the
added cl. (6) relating to the failure of the appli-
Secretary of Education or the Department of
LAW REVIEW COMMENTARIES
cation to contain the patent information pre-
Education under Pub.L. 96-88, Title III, §§ 301
A survey of law regarding the liability of
Getting new drugs to people with AIDS: A
scribed by subsec. (b) of this section. Former
to 307, Oct. 17 1979, 93 Stat. 677 to 681. See
cl. (6) was redesignated (7).
section 3441 to 3447 and 3508 of Title 20.
manufacturers and sellers of drug products and
public policy response to Lansdale. Marsha N.
medical devices. Bryan J. Maedgen and Sheree
Cohen, 18 Hastings Const.L.Q. 471 (1991).
Subsec. (d)(7). Pub.L. 98-417, $ 102(a)(3)(A),
Effective Date of 1984 Amendment
Lynn McCall, 18 St. Mary's L.J. 395 (1986).
redesignated former cl. (6) as (7).
Long-range planning in environmental and
Section 105 of Pub.L. 98-417 provided that:
Subsec. (e). Pub.L. 98-417, $ 102(a)(3)(B),
Brother can you spare a drug: Should the
health regulatory agencies. Richard N.L. An-
added, in the first sentence covering the
"(a) The Secretary of Health and Human
experimental drug distribution standards be
drews, 20 Ecology L.Q. 515 (1993).
grounds for withdrawal of approval by the Sec-
Services shall promulgate, in accordance with
modified in response to the needs of persons
retary, a new cl. (4) relating to the failure to file
the notice and comment requirements of section
More gold and more fleece: Improving the
with Aids? 19 Hofstra L.Rev. 191 (1990).
553 of title 5, United States Code [section 553 of
legal sanctions against medical research fraud.
the patent information prescribed by subsec. (c)
of this section within 30 days after the receipt of
Title 5, Government Organization and Employ-
Developing, testing, and marketing an AIDS
James T. O'Reilly, 42 Admin.L.Rev. 393 (1990).
written notice from the Secretary specifying the
ees], such regulations as may be necessary for
vaccine: Legal concerns for manufacturers.
OMB involvement in FDA drug regulations:
failure to file such information, and redesignated
the administration of section 505 of the Federal
Alison Joy Arnold, 139 U.Pa.L.Rev. 1077 (1991).
Regulating the regulators. Comment, 38 Catho-
the former cl. (4) as (5).
Food, Drug, and Cosmetic Act [this section], as
amended by sections 101, 102, and 103 of this
Drug Price Competition and Patent Term
lic U.L.Rev. 175 (1988).
Pub.L. 98-417, § 102(b)(3), inserted, in the
Act [enacting subsec. (j) of this section and
Restoration Act of 1984: Is it a healthy long
Right of privacy in choosing medical treat-
provisions of the second sentence preceding cl.
amending subsecs. (a) to (e) and (k)(1) of this
term solution? Note, 21 Rutgers L.J. 147
ment: Should terminally ill persons have access
(1) of the enumeration of clauses covering the
section and section 360cc(a) and (b) of this title],
(1989).
to drugs not yet approved by the Food and
grounds for withdrawal of approval by the Sec-
within one year of the date of enactment of this
From dog food to prescription drug advertis-
Drug Administration? 20 John Marshall L.Rev.
retary, the phrase "submitted under subsection
Act [Sept. 24, 1984].
ing: Litigating false scientific establishment
696 (1987).
(b) or (j) of this section" after "withdraw the
"(b) During the period beginning sixty days
claims under the Lanham Act. Charles J.
approval of an application".
The Drug Price Competition and Patent Term
after the date of the enactment of this Act [Sept.
Walsh and Marc S. Klein, 22 Seton Hall L.Rev.
Restoration Act of 1984. James J. Wheaton, 35
Pub.L. 98-417, § 102(b)(4), substituted, in cl.
24, 1984], and ending on the date regulations
389 (1992).
Catholic U.L.Rev. 433 (1986).
(1) of the second sentence covering the grounds
promulgated under subsection (a) take effect,
for withdrawal of approval by the Secretary, the
phrase "under subsection (k) of this section or to
abbreviated new drug applications may be sub-
LIBRARY REFERENCES
mitted in accordance with the provisions of sec-
comply with the notice requirements of section
tion 314.2 of title 21 of the Code of Federal
Regulation of drugs and pharmacists general-
Regulation of drugs and pharmacists general-
360(k)(2) of this title" for "under subsection (j)
Regulations and shall be considered as suitable
ly, see Drugs and Narcotics
&
1,
11,
et
seq.
ly, see C.J.S. Drugs and Narcotics $ 27 et
198
seq.
100
21 8 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 4a
NOTES OF DECISIONS
Generally 5a
be read with provision of this section requiring a
4a. Retroactive effect
2. Construction
Active ingredient 9c
new drug application to contain a full description
Even if a substance is also a food, it may be
of methods used in, and facilities and controls
Drug, with respect to which a new drug appli-
Admissibility of evidence 22a
Application, cancellation of 6a
subjected to requirements of this chapter if it is
used for, manufacture, processing, and packing
cation had been filed under this chapter as
Approval of drug
used in the diagnosis, cure, mitigation, treat-
of drug and, as 80 read, should be construed as
originally enacted which permitted evaluation of
Timeliness 15a
ment or prevention of diseases in man or other
requiring premarketing approval for a new drug
a new drug solely on grounds of unsafety, was
Authority of Secretary 5c
animals; intended use is an important aspect in
product of any manufacturer even if product
not exempt from 1962 amendments to this chap-
Breast implants 13b
determining whether the substance is a drug.
purports to be a generic or "me-too" copy of a
ter, which directs the Food and Drug Adminis-
Clinical studies 13a
Rutherford V. U.S., C.A.Okl.1976, 542 F.2d 1137,
recognized drug. Pharmadyne Laboratories,
tration to withdraw any prior approval if sub-
Components 9a
on remand 424 F.Supp. 105.
Inc. V. Kennedy, D.C.N.J.1979, 466 Supp. 100,
stantial evidence that the drug is effective for its
Declaratory judgment 29
A consistent construction of this chapter by
affirmed 596 F.2d 568.
intended use is lacking, by virtue of "grandfa-
Issues which were presented in complaint
ther clause" of 1962 amendments to this chapter,
Defenses 7b
the Food and Drug Administration for 30 years
Discretion of court 18a
and a construction which accords with the literal
challenging Food and Drug Administration's ad-
notwithstanding contention that when drug be-
came generally recognized as safe and was no
Drugs administered by physicians 31
language of this chapter may only be changed
ministering of this section and section 357 of this
longer a "new drug," its new drug application
Exclusive marketing period 9b
by Congress itself. USV Pharmaceutical Corp.
title, governing withdrawal of approval of antibi-
ceased to be effective. Weinberger V. Hynson,
Exemptions 7a
V. Richardson, C.A.Va.1972, 461 F.2d 223, af-
otic and nonantibiotic drugs upon finding of lack
Westcott and Dunning, Inc., Va.1973, 93 S.Ct.
Exhaustion of remedies 6b
firmed 93 S.Ct. 2498, 412 U.S. 655, 87 L.Ed.2d
of substantial evidence that the drugs have ef-
2469, 412 U.S. 609, 37 L.Ed.2d 207.
Insurance 16a
244.
fect they are represented to have under condi-
Investigatory drugs 35
New drug provisions must be construed
tions of use prescribed, recommended or sug-
This section contemplates that drugs whose
Jurisdiction 17a
broadly to meet congressional purpose to keep
gested in labeling, and which did not deal with
new drug applications became effective prior to
Labeling information 36
inadequately tested medical and related prod-
agency discretion were subject to review under
adoption thereof will be on basis of adequate and
Notes of approval 32
ucts which might cause widespread danger to
the Administrative Procedure Act, sections 551
well-controlled investigations; withdrawal pro-
Offenses within section 5b
human life out of interstate commerce. U.S. V.
et seq. and 701 et seq. of Title 5. American
ceedings cannot be thwarted by a showing of
Opinion letters 32a
General Nutrition, Inc., W.D.N.Y.1986, 638
Public Health Ass'n V. Veneman, D.C.D.C.1972,
general recognition of effectiveness based mere-
Prescription drugs 30
F.Supp. 556.
349 F.Supp. 1811.
ly on expert testimony and reports with respect
Reapplication 6c
to investigations and clinical observations re-
Definition of "new drug," within meaning of
4. Purpose
Remand 34
gardless of the controls used. Weinberger V.
Remedy 33
this section, which provided that such drugs
In enacting 1962 amendments to this chapter
Hynson, Westcott and Dunning, Inc., Va.1973,
could not be marketed prior to approval by Food
Retroactive effect 4a
which direct Food and Drug Administration to
98 S.Ct. 2469, 412 U.S. 609, 87 L.Ed.2d 207.
Review 28
and Drug Administration of either new drug
refuse approval for a new drug application and
Standards of review 28a
application or abbreviated new drug application,
to withdraw any prior approval if substantial
Efficacy requirements of this section were not
must be liberally construed in order to effectu-
Summary judgment 27
evidence that drug is effective for its intended
designed to be prospective only. Weinberger V.
ate policy of this chapter, which is protection of
use is lacking, Congress intended test for estab-
Hynson, Westcott and Dunning, Inc., Va.1973,
Timeliness, approval of drug 15a
public health and safety. U.S. V. Articles of
lishing efficacy to be a rigorous one; Congress
93 S.Ct. 2469, 412 U.S. 609, 37 L.Ed.2d 207.
Drug
HORMONIN, D.C.N.J.1980, 498
intended that clinical impressions of practicing
If, on October 9, 1962, laetrile was marketed
F.Supp. 424, affirmed 672 F.2d 902, 904.
1. Constitutionality
physicians and poorly controlled experiments
for exactly the same uses for which it is present-
3.
With other laws
would not constitute an adequate basis for es-
ly being sold and was generally recognized by
A single administrative proceeding in which
Reach of scientific inquiry under subsec. (d) of
tablishing efficacy. Weinberger V. Hynson,
qualified experts as safe for those uses, it is
each manufacturer of drug challenged on ground
of efficacy may be heard is constitutionally per-
this section defining general contours of "sub-
Westcott and Dunning, Inc., Va.1978, 93 S.Ct.
exempt, under grandfather clause contained in
2469, 412 U.S. 609, 37 L.Ed.2d 207.
1962 amendment to this chapter [set out as a
missible measured by requirements of procedur-
stantial evidence" respecting efficacy of drug for
al due process. Weinberger V. Hynson, West-
purposes of refusal or approval of a new drug
Drug Price Competition and Patent Term
note under section 321 of this title], from the
cott and Dunning, Inc., Va.1973, 98 S.Ct. 2469,
application, and under section 321 of this title
Restoration Act has the general purposes of
test of general recognition by experts as being
412 U.S. 609, 87 L.Ed.2d 207.
increasing the availability of low-cost drugs by
safe and effective for its claimed uses. Ruther-
defining a "new drug," subject to provisions of
Defendant could be indicted for violations of
this chapter, as a drug not generally recognized
expanding the generic drug approval procedure
ford V. U.S., C.A.Okl.1976, 542 F.2d 1137, on
among experts as effective as well as safe for its
and of encouraging new drug research by re-
remand 424 F.Supp. 105.
recordkeeping regulations promulgated by Food
intended uses, is precisely the same. Wein-
storing some of the patent term lost while drug
Where new drug application had been ap-
and Drug Administration (FDA) for new drug
berger V. Bentex Pharmaceuticals, Inc., S.C.
products undergo testing and await FDA pre-
proved and no proceedings had been commenced
investigations, as FDA had authority to create
1973, 93 S.Ct. 2488, 412 U.S. 645, 37 L.Ed.2d
market approval. Glaxo Operations UK Ltd. V.
by the Secretary to withdraw approval, drug
regulations and delegation of that authority to
235.
Quigg, C.A.Fed. (Va.) 1990, 894 F.2d 392.
FDA satisfied constitutional concerns of non-
manufacturer's purported withdrawal prior to
delegation doctrine. U.S. V. Garfinkel, C.A.8
Court would presume that Congress was
This chapter and underlying regulations gov-
day immediately preceding effective date of 1962
(Minn.) 1994, 29 F.3d 451.
aware that this chapter would effect the earning
erning approval of marketing of new drugs were
effectiveness amendment [set out as a note un-
potentiality of 8 drug patentee and chose to
not intended to provide patent-like protection
der section 321 of this title] to this chapter was
This section requiring new drug approval does
permit that effect when it tightened require-
for a seller who has gained approval of a pioneer
ineffective for purpose of determining whether
not deny equal protection to person suffering
ments for obtaining approval for new drugs.
new drug application. Upjohn Mfg. Co. V.
drugs qualified for permanent "grandfather
from Down's Syndrome or their parents and
Roche Products, Inc. V. Bolar Pharmaceutical
Schweiker, C.A.Mich.1982, 681 F.2d 480.
clause" exemption from enlarged definition of a
custodians. Duncan V. U.S., D.C.Okl.1984, 590
Co., Inc., C.A.Fed.1984, 733 F.2d 858, certiorari
Purpose of this section relating to new drugs
"new drug" included in amendments. USV
F.Supp. 39.
denied 106 S.Ct. 183, 469 U.S. 856, 83 L.Ed.2d
is to protect public against danger to human life
Pharmaceutical Corp. V. Richardson, C.A.Va.
This chapter's statutory scheme for gaining
117.
arising from use of unsafe and ineffective drugs
1972, 461 F.2d 223, affirmed 93 S.Ct. 2498, 412
approval for new drug applications in order to
Orders which do not deny or withdraw a new-
by assuring that, before any drug is marketed, it
U.S. 655, 37 L.Ed.2d 244.
permit introduction into interstate commerce of
drug application are reviewable under Adminis-
will have been carefully reviewed by Food and
Manufacturer, whose marketing approval for
such new drug does not require Food and Drug
trative Procedure Act, sections 551 et seq. and
Drug Administration experts, and Congress' ex-
its drug was outstanding and had not been
Administration to approve or disapprove any
701 et seq. of Title 5, if they declare a "new
clusion of generally recognized drug products
legally withdrawn on date of 1962 amendment to
new drug in absence of application and is consti-
drug" status. North American Pharmacal, Inc.
from definition of "new drug" is very narrow
this chapter was not entitled to claimed benefit
tutional as exercise of Congress's power to set
V. Department of Health, Ed. and Welfare,
one, which is not intended to permit pharmaceu-
of section 107 of Pub.L. 87-781, set out as a note
standards in order to protect public from unsafe
C.A.8, 1973, 491 F.2d 546.
tical manufacturer to substitute its opinion re-
under section 321 of this title, applicable to
drugs, even though drug application may involve
Provision of section 321 of this title defining a
garding safety or effectiveness of a drug for that
drugs not covered by an effective marketing
costs which are so substantial as to cause per-
sons appropriately situated to forego compliance
"new drug" as any drug not generally recog-
of the Food and Drug Administration or to
order on day immediately before enacting date
nized among qualified experts as safe and effec-
require court to develop its own body of scienti-
of amendments. Hynson, Westcott & Dunning,
with this chapter. Gadler V. U.S., D.C.Minn.
1977, 425 F.Supp. 244.
tive for use under conditions prescribed, recom-
fic knowledge in substitution for that of the
Inc. V. Richardson, C.A.4, 1972, 461 F.2d 215,
mended, or suggested in labeling thereof should
FDA. Premo Pharmaceutical Laboratories, Inc.
modified on other grounds 93 S.Ct. 2469, 412
V. U.S., C.A.N.Y.1980, 629 F.2d 795.
200
U.S. 609, 37 L.Ed.2d 207.
201
41 8 300
FOOD AND DRUGS
Note 5a
FOOD AND DRUGS
21 § 355
5a. Generally
6. Rules and regulations
Note 6b
While this chapter provides the Food and
Strict and demanding standards in regulations
In rejecting evidence submitted in support of
counter drug market were unlawful to the ex-
Drug Administration with sanctions, such as civil
issued under this subchapter, which standards
new drug application, Food and Drug Adminis-
tent that they affirmatively sanctioned continued
injunction proceedings, criminal penalties, and in
bar anecdotal evidence indicating that doctors
tration should make its criticisms express and
marketing of Category III drugs in the absence
rem seizure and condemnation, to enforce prohi-
"believe" in efficacy of a drug, are amply justi-
detailed and cite pertinent regulations and evi-
of an administrative determination that the
bition against sale in commerce of any article
fied by legislative history of its provisions.
dentiary flaws. Cooper Laboratories, Inc. V.
products were generally recognized by experts
without an effective new drug application, this
Weinberger V. Hynson, Westcott and Dunning,
Commissioners, Federal Food and Drug Admin-
as safe and effective. Cutler V. Kennedy,
chapter does not create a dual system, one
Inc., Va.1973, 93 S.Ct. 2469, 412 U.S. 609, 37
istration, 1974, 501 F2d 772, 163 U.S.App.D.C.
D.C.D.C.1979, 475 F.Supp. 888.
administrative and the other judicial. CIBA
L.Ed.2d 207.
212.
While Food and Drug Administration is to be
Corp. V. Weinberger, N.J.1978, 93 S.Ct. 2495,
Food and Drug Administration (FDA) may
Under regulation pursuant to this section, as
given administrative flexibility to make regula-
412 U.S. 640, 87 L.Ed.2d 230.
impose regulations on development of drugs but
it existed prior to 1960 a drug company had the
tions and determine new drug status of individu-
Food and Drug Administration was not com-
authorized regulations must be for purpose of
option of filing a supplemental application for a
al drugs or classes of drugs, argument that Food
pelled to pursue new drug procedure in the
proposed change in the conditions under which
conditioning investigational drug exemptions
and Drug Administration lacks administrative
laetrile situation in the absence of an application.
which will apply only to drugs intended for use
such drug is to be used instead of a new drug
resources to insurer compliance with this sec-
Rutherford V. U.S., C.A.Okl.1976, 542 F.2d 1137,
by qualified experts investigating the safety and
application when a new drug application has
tion, cannot be permitted to postpone to some
on remand 424 F.Supp. 105.
already been approved, thereby eliminating the
effectiveness of the drug, but regulations may
indefinite future date implementation of re-
need to duplicate parts of the application previ-
Where it was well-known that liver damage
not require clinical investigators to submit inves-
quired preclearance approval of new drug appli-
ously approved, rather than mere option of filing
was among adverse effects on humans from
tigational reports directly to FDA. U.S. V. Gar-
cations. Hoffmann-LaRoche, Inc. V. Wein-
a supplemental application or not. Hoffman V.
prolonged use of drug, drug manufacturer,
finkel, C.A.8 (Minn.) 1994, 29 F.3d 451.
berger, D.C.D.C.1975, 425 F.Supp. 890.
Sterling Drug, Inc., C.A.Pa.1973, 485 F.2d 182,
The Food and Drug Administration does not
which was neither sponsor nor promoter of
Amendment to Food and Drug Administra-
on remand 874 F.Supp. 850.
drug, was not liable for death of user from liver
have unbridled discretion to do what it pleases
tion's over-the-counter drug review regulations,
Regulations whereby new drug application
damage on theory that drug had not been prop-
in determining whether product is a "new drug"
creating 12-month period for comment on tem-
would not be accepted for filing if incomplete on
erly tested for dangerous and harmful side ef-
since its procedures must satisfy the rudiments
porary final monographs, which consumers al-
its face by omission of required material and
fects it would produce. Brick V. Barnes-Hines
of fair play. National Ethical Pharmaceutical
leged served only to delay implementation of
which called for notice to the applicant and, in
Pharmaceutical Co., Inc., D.C.D.C.1977, 428
Food, Drug, and Cosmetic Act's safety and effi-
Ass'n V. Weinberger, D.C.S.C.1978, 865 F.Supp.
later regulation, provided for requested filing
F.Supp. 496.
785, affirmed 508 F.2d 1051.
cacy requirements by further postporting publi-
over protest were reasonable and valid. Duro-
cation of final monographs, was consistent with
vic V. Richardson, C.A.III.1978, 479 F.2d 242,
6a. Application, cancellation of
5b. Offenses within section
Act, and was designed to facilitate gathering of
certiorari denied 94 S.Ct. 232, 414 U.S. 944, 38
Where new drug application applicant fails to
Cancer patient's purchase of Laetrile in Mexi-
supplemental information to promote efficiency,
L.Ed.2d 168, rehearing denied 94 S.Ct. 611, 414
produce adequate and well-controlled studies
co and subsequent transportation of that drug to
and thus was not arbitrary, capricious or other-
U.S. 1088, 38 L.Ed.2d 494.
showing efficacy, summary disposition of appli-
Minnesota for his personal use constituted intro-
wise improper. Cutler V. Hayes, 1987, 818 F.2d
Food and Drug Administration's (FDA) regu-
cation is authorized. Cooper Laboratories, Inc.
duction of Laetrile into interstate commerce and
879, 260 U.S.App.D.C. 230.
lation concerning waiver of in vivo bioequiva-
V. Commissioner, Federal Food and Drug Ad-
was prohibited by this section prohibiting intro-
Authority granted by subsec. (i) of this section
lence testing for approval of generic drugs in
ministration, 1974, 501 F.2d 772, 163 U.S.App.
duction or delivery for introduction into inter-
allowing the Secretary of Health and Human
certain circumstances did not exceed FDA's au-
D.C. 212.
state commerce any new drug, unless approval
Services to establish "other conditions relating
thority under Hatch-Waxman Amendments
While an applicant for approval to market a
of application by Food and Drug Administration
to the protection of public health" with respect
which govern FDA's approval of applications for
new drug may withdraw his application during
is effective with respect to such drug; this sec-
to maintaining accurate drug records is insuffi-
generic versions of pioneer drugs, where FDA
pendency thereof, he has no such right after
tion does not purport to apply only to manufac-
cient legislative guidance for the issuance of
regulation did not attempt to waive bioequiva-
approval of the application by the Secretary; at
turers or distributors, but plainly states that "no
regulations which, if violated, would furnish the
lence determinations but, rather, regulation per-
that point only the Secretary can withdraw the
person shall introduce or deliver for introduction
basis for criminal liability. U.S. V. Smith,
mitted waiver of discrete, specific form of in vivo
approval USV Pharmaceutical Corp. V. Rich-
into interstate commerce any new drug." Ga-
C.A.Cal.1984, 740 F.2d 784.
testing for those categories of drugs where in
ardson, C.A.Va.1972, 461 F.2d 223, affirmed 93
dler V. U.S., D.C.Minn.1977, 425 F.Supp. 244.
vivo bioavailability or bioequivalence of drug
The fact-finding procedures employed by
S.Ct. 2498, 412 U.S. 655, 87 L.Ed.2d 244.
product could be considered self-evident based
5c. Authority of Secretary
Food and Drug Administration in approving
on other data Federal Food, Drug, and Cosmet-
Criteria which were used by Secretary of
British drug manufacturer's new drug applica-
ic Act, § 505(j)(7)(B), as amended, 21 U.S.C.A.
Health, Education, and Welfare in deciding to
Although this section requiring Secretary of
tion and rejecting American drug manufactur-
$ 355(j)(7)(B). Fisons Corp. V. Shalala, D.D.C.
suspend new drug applications for phenformin
Health, Education and Welfare (now Secretary
er's petition urging denial of the application was
1994, 860 F.Supp. 859.
hydrochloride on ground that drug posed an
of Health and Human Services] to disapprove a
adequate, since Administration followed applica-
"imminent hazard" did not improperly reflect
new drug application if he or she finds that
ble statutory and regulatory criteria for approv-
It is not a crime for protocol investigators to
intent of Congress nor were they at substantial
proposed labeling is false or misleading reflects
ing the application, and engaged in informal
fail to maintain adequate and accurate records;
Congress' continuing concern that drug labeling
fact-finding procedures to gather evidence con-
although statute expressly authorizes promul-
variance with Food and Drug Administration
regulation. Forsham V. Califano, D.C.D.C.1977,
should be both truthful and complete, it cannot
cerning the safety and effectiveness of the drug.
gation of regulations requiring drug manufactur-
Upjohn Mfg. Co. V. Schweiker, C.A.Mich.1982,
ers or sponsors of clinical investigations to main-
442 F.Supp. 203.
fairly be read to encompass authority for requir-
ing the delivery of written material to patient at
681 F.2d 480.
tain and submit reports setting forth the results
Under this section authorizing Secretary of
of clinical tests involving experimental drugs to
Health, Education, and Welfare to suspend new
time of dispensing and these provisions, as con-
trasted with mislabeling provisions of this chap-
Where drug manufacturer failed to comply
Food and Drug Administration (FDA), statute's
drug application for a drug which poses an
ter, apply only at moment of shipment in inter-
with this chapter and regulations governing the
general regulatory authority is insufficient legis-
"imminent hazard," meaning of "imminent haz-
state commerce and not to action subsequent to
manufacturing, sampling and labeling of pro-
lative guidance for issuance of regulations which,
ard" is not to be restricted to a concept of crisis.
shipment in interstate commerce. Pharmaceuti-
posed new drug, new drug application could not
If violated, would furnish basis for criminal lia-
Forsham V. Califano, D.C.D.C.1977, 442 F.Supp.
cal Mfrs. Ass'n V. Food and Drug Administra-
be approved. Edison Pharmaceutical Co., Inc.
bility. U.S. V. Garfinkel, D.Minn.1993, 822
203.
tion, D.C.Del.1980, 484 F.Supp. 1179.
V. Food and Drug Admin., Dept. of Health, Ed.
F.Supp. 1457.
6b. Exhaustion of remedies
and Welfare, 1979, 600 F.2d 831, 195 U.S.App.
In deciding that phenformin hydrochloride
D.C. 17.
Regulation promulgated by the Food and
Failure of consumers of over-the-counter
Drug Administration (FDA), which interpreted
posed an imminent hazard, Secretary was autho-
drugs to exhaust their administrative remedies
Only those studies of effectiveness of drug
"feasibility" exception to statutory prohibition
rized to create within suspension order volun-
before challenging Food and Drug Administra-
that meet the standards particularized in 21
against administration of unapproved drugs to
tary system of limited distribution to those small
tion's regulations implementing Food, Drug and
C.F.R. 130.14 pertaining to adequate and well-
permit administration of such drugs in specific
number of patients for whom it might be deter-
Cosmetic Act program concerning new over-the-
mined that drug's benefits outweighed its risks
controlled studies are acceptable in determining
combat circumstances, was not arbitrary, capri-
counter drugs did not require dismissal of action
whether there is substantial evidence to support
cious, or manifestly contrary to statute. Doe V.
and was also authorized to delay implementation
in view of Food and Drug Administration's waiv-
the claims of effectiveness for any drug. Ster-
Sullivan, D.D.C.1991, 756 F.Supp. 12, affirmed
of order for 90 days. Forsham V. Califano,
er of issue by failing to raise objection and
D.C.D.C.1977, 442 F.Supp. 203.
ling Drug Inc. V. Weinberger, C.A.2, 1974, 503
938 F.2d 1370, 291 U.S.App.D.C. 111.
futility of pursuing administrative remedies.
F.2d 675.
Regulations adopted by the Food and Drug
Cutler V. Hayes, 1987, 818 F.2d 879, 260
202
Administration for policing the nation's over-the-
U.S.App.D.C. 230.
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 6b
Note 7b
When Food and Drug Administration has pri-
6c. Reapplication
Options available to Food and Drug Adminis-
drugs, and those exemptions must be condi-
mary jurisdiction to determine status of product,
one seeking to contest agency's determination
Unless pharmaceutical manufacturer can show
tration such as good manufacturing practice reg-
tioned on imposition of informed-consent provi-
that its drug product is generally recognized,
ulations and section 351 of this title did not
sions on manufacturers or sponsors. U.S. V.
must exhaust all administrative remedies before
seeking judicial review. Biotics Research Corp.
among experts qualified by scientific training
adequately protect the public so as to obviate
Garfinkel, C.A.8 (Minn.) 1994, 29 F.3d 451.
V. Heckler, C.A.Nev.1983, 710 F.2d 1875.
and experience to evaluate safety and effective-
need for preclearance, as "new drugs", generic
As an exemption to a comprehensive regulato-
ness of drugs, as safe and effective for use under
drugs having the same active ingredients and in
ry statute concerned with public safety, grandfa-
Food and Drug Administration and California
conditions prescribed and that, being 80 recog-
some cases the same inactive ingredients as in
ther clause of 1962 amendments to this subchap-
State Department of Health Services had pri-
nized, it has been used to material extent or for
their FDA-approved pioneer counterparts. U.S.
ter is to be strictly construed, and party seeking
mary jurisdiction to determine whether persons
material time under such conditions, manufac-
V. Premo Pharmaceutical Laboratories, Inc.,
to grandfather in pre-1962 drug bears burden of
could traffic in new drug; thus, if plaintiff
turer must file with Food and Drug Administra-
wished to obtain Laetrile to use in the nutrition-
D.C.N.J.1981, 511 F.Supp. 958.
proof as to each condition. U.S. V. Articles of
tion a new drug application and establish by
Drug Consisting of following: 5,906 Boxes,
al program for prevention of cancer, he had to
substantial evidence to satisfaction of Food and
Food and Drug Administration's policy of per-
C.A.Puerto Rico 1984, 745 F2d 105, certiorari
exhaust his administrative remedies prior to
Drug Administration that drug is safe and effec-
mitting new drugs that were chemically equiva-
denied 105 S.Ct. 1358, 470 U.S. 1004, 84 L.Ed.2d
seeking judicial relief. Carnohan V. U.S.,
tive for its intended uses. Premo Pharmaceuti-
lent to pioneer drug for which full new drug
379.
C.A.Cal.1980, 616 F.2d 1120.
cal Laboratories, Inc. V. U.S., C.A.N.Y.1980, 629
application was in effect to be marketed without
F.2d 795.
Grandfather clause exempting certain drugs
Alleged statements by Food and Drug Admin-
approved new drug application contravened
from requirement under this chapter of provid-
istration (FDA) employees that they intended to
Food and Drug Administration acted reason-
clear statutory requirement of preclearance, was
ing effectiveness makes no distinction between
waive bioequivalence testing for certain abbrevi-
ably in interpreting term "drug" as used in
not within intendment of 1962 amendments to
pioneer and "me-too" drugs but exempts only
ated new drug applications and that they intend-
provisions of Federal Food, Drug and Cosmetic
this section and legislative scheme they embody,
that generic class of drugs which on October 9,
ed to treat impurity analysis for generic drugs
Act requiring information to be filed on "any
and, by permitting marketing of large classes of
1962, were not covered by an effective new drug
differently were not final agency actions and,
patent which claims the drug for which the
applicant submitted the application," to mean
such drugs, violated its own regulations. Hoff-
application. Smithkline Corp. V. Food and Drug
therefore, could not be challenged under Admin-
mann-La Roche, Inc. V. Weinberger, D.C.D.C.
Administration, 1978, 587 F.2d 1107, 190
istrative Procedure Act. Fisons Corp. V. Shala-
"drug product" for which new drug application
1975, 425 F.Supp. 890.
U.S.App.D.C. 210.
la, D.D.C.1994, 860 F.Supp. 859.
was filed. Pfizer, Inc. V. Food and Drug Ad-
min, D.Md.1990, 758 F.Supp. 171.
Where there was similarity in formula be-
Manufacturer of drug called "PAX," which
Soap manufacturer was required to exhaust
tween drug marketer's citrus bioflavonoid drugs
his administrative remedies with Food and Drug
7. Necessity of approval
was a "new drug" within the meaning of this
subject to new drug applications and its "me-
Administration regarding to determination of
section, would be preliminarily enjoined from
Durovic V. Richardson, 327 F.Supp. 386, [main
too" drugs, both the NDA'd and the "me-too"
whether soap was "safe and effective" for partic-
volume] affirmed 479 F.2d 242, certiorari denied
introducing and delivering such drug into inter-
drugs would be treated alike and neither could
ular purpose for which it had already been
94 S.Ct. 232, 414 U.S. 944, 38 L.Ed.2d 168,
state commerce from foreign trade zone unless
qualify for exemption under the "grandfather
marketed, and whether it was therefore not
rehearing denied 94 S.Ct. 611, 414 U.S. 1088, 88
and until approval of an application filed pursu-
clause" from 1962 effectiveness amendment [set
subject to new drug hearings. Farquhar V.
L.Ed.2d 494.
ant to this section was effective with respect to
out as a note under section 321 of this title] to
Food and Drug Admin., D.C.D.C.1985, 616
Drug that had same active ingredient as Food
such drug. U.S. V. Yaron Laboratories, Inc.,
this chapter. USV Pharmaceutical Corp. V.
F.Supp. 190.
D.C.Cal.1972, 865 F.Supp. 917.
Richardson, C.A.Va.1972, 461 F.2d 223, affirmed
and Drug Administration-approved drug prod-
93 S.Ct. 2498, 412 U.S. 655, 37 L.Ed.2d 244.
Drug manufacturer which marketed drug un-
uct, which had been marketed for many years,
der trademark and which filed pioneer new drug
but which had different inactive ingredients,
7a. Exemptions
In light of health risks associated with estro-
application for that drug could maintain action
could not be marketed without obtaining approv-
Phrase "any drug," in "grandfather clause" of
genic drug products, drug product which was
challenging Food and Drug Administration's ap-
al of new drug application from Food and Drug
fixed combination of three unconjugated estro-
Drug Amendments of 1962, set out as a note
proval of new drug application to British manu-
Administration, where it was not generally rec-
gens was not apt subject for exemption from
ognized among qualified experts as safe and
under section 321 of this title, which exempts
facturer and distributor of drug called "ibupro-
requirement that expert consensus as to general
effective for use under conditions stated in label-
from effectiveness requirements any drug which
fen," even though manufacturer had not ex-
recognition of the product's safety and effective-
hausted its administrative remedies where, to
ing, there was no published scientific literature
on date preceding enactment was commercially
ness be founded upon substantial evidence in
obtain withdrawal of British manufacturer's ap-
as to drug to enable qualified experts to make
used or sold in the United States, was not a
order for the product to transcend "new drug"
plication, manufacturer would have to show that
necessary determination, experts had sharp dif-
"new drug" as defined in this chapter as origi-
status. U.S. V. Articles of Drug
HORMO-
drug was not safe or not effective and that
ferences of opinion, both as to methods used and
nally enacted, and was not covered by an effec-
NIN, D.C.N.J.1980, 498 F.Supp. 424, affirmed
avenue would have been fruitless. Upjohn Mfg.
results claimed, and, although manufacturer had
tive application for a new drug under this chap-
672 F.2d 902, 904.
Co. V. Schweiker, D.C.Mich.1981, 520 F.Supp.
sold 16,500,000 tablets there was no evidence
ter as originally enacted, is used in the generic
Practice of pharmacy exemption from sanc-
58, affirmed 681 F.2d 480.
that drug had been used to material extent or
sense, 80 that "me-toos," those drugs similar or
tions of this chapter was not applicable where
for any substantial period of time. Premo Phar-
Where substantive questions as refined in
identical to drugs with effective new drug appli-
corporation disseminated information to solicit
maceutical Laboratories, Inc. V. U.S., C.A.N.Y.
cations, whether products of same or different
applications for membership in its organization
proceedings required decision as to whether
1980, 629 F.2d 795.
Finkel memorandum to effect that Food and
manufacturers "covered" by an effective new
and, as a result of such memberships, prescrip-
Drug Administration would approve post-1962
Constitutional rights of privacy and personal
drug application, are not exempt from efficacy
tions for its products were referred to single
liberty do not give individuals the right to obtain
requirements. USV Pharmaceutical Corp. V.
pharmacy that specialized in compounding the
duplicate new drug applications in reliance on
published reports without fresh clinical investi-
Laetrile free of lawful exercise of government
Weinberger, Va.1973, 93 S.Ct. 2498, 412 U.S.
drug. U.S. V. Sene X Eleemosynary Corp., Inc.,
gations or available raw data should be issued as
police power. Carnohan V. U.S., C.A.Cal.1980,
640, 37 L.Ed.2d 230.
D.C.Fla.1979, 479 F.Supp. 970.
616 F.2d 1120.
a rule or as a general statement of policy, ex-
Where there had been no completed tests or
Regional compounding centers which per-
Exemption under the "grandfather clause" of
empt from notice and comment requirement,
investigations to determine either the efficacy or
questions should have been confronted squarely
formed same function that doctors would other-
the Drug Amendments of 1962, set out as a note
safety of animal drugs, they were never general-
and decided by the Food and Drug Administra-
wise have performed by taking chemotherapeu-
under section 321 of this title, is afforded only
ly recognized as safe and effective for the uses
tion before judicial review was sought and, thus,
tic drugs approved by the FDA and diluting and
for drugs that never had been subject to new
intended, and thus "grandfather clause" exemp-
case would be dismissed for failure to exhaust
repackaging them into single-dosage units ready
drug regulation. Weinberger V. Hynson, West-
tion from the effectiveness requirement of this
administrative remedies. Hoffmann-La Roche,
to be used by patients did not fall within the
cott and Dunning, Inc., Va.1973, 93 S.Ct. 2469,
section was not applicable. U.S. V. 14 Cases
Inc. V. Harris, D.C.D.C.1979, 484 F.Supp. 58.
"repackaging" or "bioequivalent product" excep-
412 U.S. 609, 37 L.Ed.2d 207.
More or Less, "Naremco Medi-Matic Free
tions to federal premarketing approval require-
Choice Poultry Formula", D.C.Mo.1974, 374
District court's assertion of jurisdiction over
ments. U.S. V. Baxter Healthcare Corp.,
Food and Drug Administration (FDA) is re-
F.Supp. 922.
action for determination as to whether drug was
N.D.Ill.1989, 712 F.Supp. 1352.
quired to promulgate regulations allowing for
a "new drug" would be premature prior to refus-
New drug approval requirement applies to
exemptions from operation of new drug applica-
7b. Defenses
al of Food and Drug Administration to issue
patients or users of a new drug as well as to
tion process which will apply only to drugs
Producer and distributor of nutritional, per-
declaratory order Carolina Brown, Inc. V. Wein-
berger, D.C.S.C.1973, 365 F.Supp. 310.
manufacturers of it. Duncan V. U.S., D.C.Okl.
intended solely for investigational use, by ex-
sonal care and related products, and its officers
1984, 590 F.Supp. 39.
perts to investigate safety and effectiveness of
and employees, all of whom were prosecuted for
204
205
21 8 355
FOOD AND DRUGS
Note 7b
FOOD AND DRUGS
21 § 355
allegedly "misbranding" drug could not complain
Va.1973, 93 S.Ct. 2498, 412 U.S. 640, 37 L.Ed.2d
Note 9
that drug was improperly classified as prescrip-
230.
therefore, for the Government to perform bioa-
tion drug where they did not avail themselves of
944, 38 L.Ed.2d 168, rehearing denied 94 S.Ct.
Parties cannot confer jurisdiction to deter-
vailability, bioequivalence, and other qualified
procedures to make its arguments before appro-
611, 414 U.S. 1088, 38 L.Ed.2d 494.
mine "new drug" status of a drug; only Con-
controlled tests to establish safety and efficacy.
priate agency and waited until they had been
Where drug was offered for use in the man-
prosecuted to make arguments in district court.
gress can do 80. Weinberger V. Bentex Phar-
U.S. V. Articles of Drug, C.A.Pa.1978, 585 F.2d
575.
agement of malignant tumors, "grandfather
U.S. V. General Nutrition, Inc., W.D.N.Y.1986,
maceuticals, Inc., S.C.1973, 93 S.Ct. 2488, 412
clause" in the Drug Amendments of 1962, set
U.S. 645, 37 L.Ed.2d 235.
638 F.Supp. 556.
Acceptance by the Federal Trade Commission
out as note under section 321 of this title, had no
Whether a particular drug is a "new drug," 80
of the Food and Drug Administration determi-
Cancer patient's right to privacy would not
effect on it, in determining whether a new drug
as to require an effective new drug application
nation that drug used by weight reducing clinic
application was required. Durovic V. Richard-
protect his importation for personal use of new
before it may be introduced into commerce,
was a new drug when used for the treatment of
son, C.A.III.1973, 479 F.2d 242, certiorari denied
drug Laetrile in violation of this section prohibit-
ing introduction into interstate commerce of any
depends in part on expert knowledge and expe-
obesity, and thus that the fact should be dis-
94 S.Ct. 232, 414 U.S. 944, 38 L.Ed.2d 168,
rience of scientists based on controlled clinical
closed to consumers, was supported by substan-
rehearing denied 94 S.Ct. 611, 414 U.S. 1088, 38
new drug unless approval of application by Food
experimentation and backed by substantial sup-
tial evidence and was reasonable. Simeon Man-
L.Ed.2d 494.
and Drug Administration is effective with re-
port in scientific literature. Weinberger V. Ben-
agement Corp. V. F.T.C., C.A.9, 1978, 579 F.2d
spect to such drug. Gadler V. U.S., D.C.Minn.
Drug is a "new drug," and thus is subject to
tex Pharmaceuticals, Inc., S.C.1973, 93 S.Ct.
1137.
1977, 425 F.Supp. 244.
seizure if shipped in interstate commerce with-
2488, 412 U.S. 645, 37 L.Ed.2d 235.
Although substantial evidence of effectiveness
out prior approval of a new drug application,
8. Interstate commerce
Issue whether drugs were generally recog-
for the labeled use is required for a drug to be
unless it is presently regarded by qualified ex-
In order for a court properly to condemn a
nized as safe and effective and thus not "new
generally recognized as effective, such substan-
perts as both safe and effective for its intended
drug item, a nexus must be shown between drug
drugs" within this chapter and whether the
tial evidence may exist long before the drug is
use or unless it was generally regarded by quali-
item and commerce 80 as to invoke federal
drugs were exempt from new effectiveness re-
generally recognized as effective for that use;
fied experts on the October 9, 1962, effective
jurisdiction; on the one hand, in a case in which
quirements by reason of grandfather clause in
approval of a new drug application does not,
date of the "grandfather clause" exemption as
a drug is found to be misbranded, it may be
the Drug Amendments of 1962, set out as a note
alone, remove the approved drug from new drug
safe for intended use. U.S. V. An Article of
condemned when introduced into or while in
under section 321 of this title, were kinds of
status. Simeon Management Corp. V. F.T.C.,
Drug "Bentex Ulcerine", C.A.Tex.1972,
interstate commerce or while held for sale after
issues peculiarly suited to initial determination
C.A.9, 1978, 579 F.2d 1187.
469 F.2d 875, certiorari denied 93 S.Ct. 2772,
shipment in interstate commerce; on the other
by the Food and Drug Administration with its
In the absence of evidence as to how laetrile
412 U.S. 938, 37 L.Ed.2d 397.
hand, if a drug is confiscated because it is an
specialized competence and expertise, and dis-
was marketed before passage of 1962 amend-
Fact that pre-1962 new drug application drugs
trict court's referral of these issues to the Ad-
unapproved "new drug," it must be shown to
ministration was appropriate. Weinberger V.
ment to this chapter requiring drugs to be rec-
became generally recognized as safe on or be-
have been introduced or delivered for introduc-
Bentex Pharmaceuticals, Inc, S.C.1978, 93 S.Ct.
ognized as effective, court could not determine
fore effective date of 1962 effectiveness amend-
tion in interstate commerce before it may be
whether drug was subject to the new require-
ments [set out as a note under section 321 of
2488, 412 U.S. 645, 37 L.Ed.2d 235.
condemned. U.S. V. Articles of Drug, C.A.Pa.
ment or was grandfathered in. Rutherford V.
this title] to this chapter did not establish that
1978, 585 F.2d 575.
Food and Drug Administration has jurisdic-
U.S., C.A.Okl.1976, 542 F.2d 1137, on remand
such drugs were no longer covered by an effec-
tion to determine jurisdictional question whether
A drug is "in interstate commerce" for pur-
424 F.Supp. 105.
tive new drug application and, thus, exempt,
a particular drug is a "new drug" 80 as to
acquire an effective new drug application before
"New drug" for purposes of this section is a
under the permanent "grandfather clause", from
poses of this section, if one of its components
previously traveled in interstate commerce, and
drug may be introduced into commerce. Wein-
substance which is generally recognized by sci-
the amendment. USV Pharmaceutical Corp. V.
entific experts as safe and effective for use
Richardson, C.A.Va.1972, 461 F.2d 223, affirmed
if finished drug itself is destined in ordinary
berger V. Hynson, Westcott and Dunning, Inc.,
93 S.Ct. 2498, 412 U.S. 655, 37 L.Ed.2d 244.
course of business for interstate distribution;
Va.1973, 93 S.Ct. 2469, 412 U.S. 609, 87 L.Ed.2d
under the conditions prescribed or suggested in
therefore, since ingredients of drugs seized from
207.
the labeling thereof unless, prior to 1962, it was
Hair care products which were intended to
pharmaceutical laboratory traveled in interstate
subject to the requirements of the Food and
prevent or cure baldness or thinning hair and
commerce, were manufactured in usual course of
Toothpaste manufacturer failed to show by
laboratory's business, and were intended for in-
substantial evidence that potassium nitrate
Drugs Act of 1906, Act June 30, 1906, Ch. 3915,
which had not been generally recognized as safe
34 Stat. 768. Rutherford V. U.S., C.A.Okl.1976,
and effective for their intended use were "new
terstate distribution, there was sufficient nexus
made contribution to claimed effect of treating
542 F.2d 1137, on remand 424 F.Supp. 105.
drugs" and, as such, were subject to regulation
with interstate commerce to justify their seizure.
dentin hypersensitivity and could not rely solely
by Food and Drug Administration (FDA). U.S.
U.S. V. Articles of Drug
upon laboratory testing profiles for toothpastes
Fact that label contained a contraindication of
V. Kasz Enterprises, Inc., D.R.I.1994, 855
WANS, D.C.
with single active ingredient of sodium MFP to
use in cases of "known or suspected malignan-
Puerto Rico 1981, 526 F.Supp. 703.
F.Supp. 534.
prove anticaries effectiveness; therefore, tooth-
cies" did not preclude consideration of danger of
Within subsec. (a) of this section, "into inter-
activation of latent cancer of prostate in deter-
Before a product can be exempted from statu-
paste combining sodium MFP and potassium
state commerce" necessarily encompasses intro-
nitrate was "new drug" for which application
mining whether drug marketed by claimant was
tory new drug preclearance procedures it must
duction of items into flow of shipments and
a new drug within this subchapter especially in
be generally recognized by qualified experts as
had to be filed and approved before marketing.
transportation within United States, even if the
U.S. V. Articles of Drug, C.A.7 (III.) 1987, 826
light of evidence that in four out of five cases a
safe and effective for its intended use, and "gen-
final destination of the drug is not within the
F.2d 564.
patient may have latent cancer of the prostate
eral recognition" requirement does not involve
United States. U.S. V. An Article of Drug Con-
though not known or suspected. U.S. V.
actual safety or effectiveness of product, rather
sisting of 197 Boxes, More or Less, each Con-
Food and Drug Administration memorandum,
1,048,000 Capsules, More or Less, "Afrodex,"
it is product's reputation in scientific community
concerning approval of new drug applications for
467. taining 150 Capsules, D.C.Tex.1981, 520 F.Supp.
generic versions of drugs first marketed after
C.A.Tex.1974, 494 F.2d 1158.
that is relevant. U.S. V. 225 Cartons, More or
Less, of an Article of Drug, D.N.J.1988, 687
1962 that are based on reports in the scientific
The newness of a drug within meaning of
F.Supp. 946.
9. New drug, determination of status as
literature to establish the drug's safety and ef-
provision of this section relating to introduction
fectiveness, was consistent with published regu-
into interstate commerce of any "new drug" may
Drug manufacturer's application for approval
Although drug marketer in 1961 had stated in
arise by reason of a new or different recom-
of oral dosage of injectable calcium product,
lations of the Administration; the memo did not
a letter to director of new drug branch of bureau
of medicine in the Food and Drug Administra-
conflict with regulation requiring an applicant to
mended use for the drug even though the same
even if properly termed "paper" new drug appli-
submit reports of all clinical tests sponsored or
drug may not be a "new drug" when used for
cation or abbreviated new drug application, was
tion that a certain class of products were no
not subject to competing manufacturer's exclu-
received by the applicant, nor did it conflict with
another disease. Hoffman V. Sterling Drug,
longer considered to be new drugs, and market-
Inc., C.A.Pa.1973, 485 F.2d 132, on remand 374
sivity rights where former's application did not
regulation stating that certain summaries of
er in 1961 had stopped filing supplemental infor-
safety and effectiveness data do not constitute
F.Supp. 850.
refer to latter's oral product or to any investiga-
mation as required by regulation with regard to
tions which were conducted by or for the latter;
full reports of investigations. Burroughs Well-
products for which new drug applications had
Affidavits in declaratory judgment action es-
hence, effective date of approval of former's
come Co. V. Schweiker, C.A.N.C.1981, 649 F.2d
become effective, marketer's new drug applica-
tablished that drug intended for use in manage-
application was not delayed by 1984 amend-
221.
tions had not been withdrawn prior to 1962 80
ment of malignant tumors had not, either before
ments to Federal Food, Drug, and Cosmetic Act.
that its products were no longer covered by an
Requirements of "new drug" section of this
or after the Drug Amendments of 1962, set out
Burroughs Wellcome Co. V. Bowen, E.D.N.C.
effective application for purposes of "grandfa-
chapter, namely, general safety and effective-
as note under section 321 of this title, achieved
1986, 630 F.Supp. 787.
ther clause" in Drug Amendments of 1962, set
ness recognition, were met once the Government
general recognition among qualified experts as
Government can prove lack of "general recog-
out as a note under section 321 of this title.
admitted that all of manufacturer's drugs were
safe and effective for such use, 80 as to be
nition" of drug as safe and effective for recom-
USV Pharmaceutical Corp. V. Weinberger,
the same generically as a drug already approved
exempt from requirement of new drug applica-
mended uses SQ as to require filing of new drug
as safe and effective and it was not necessary,
tion. Durovic V. Richardson, C.A.III.1973, 479
application by proving absence of material fact
206
F.2d 242, certiorari denied 94 S.Ct. 232, 414 U.S.
as to any of following issues: general recogni-
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 9
Note 12
tion in fact among nation's experts that seized
fair grounds for litigation. Rizzo V. U.S.,
Bristol-Myers Co. V. F.T.C., C.A.2, 1984, 738
exclusivity depending primarily on pharmaceuti-
drugs are safe and effective for intended use,
D.C.N.Y.1977, 432 Supp. 356.
F.2d 554, certiorari denied 105 S.Ct. 960, 469
cal novelty, the phrase "active ingredient (in-
existence of adequate and well-controlled studies
Food and Drug Administration does not have
U.S. 1189, 83 L.Ed.2d 966.
cluding any ester or salt of the active ingredi-
which constitute substantial evidence of safety
unbridled discretion to do what it pleases in
Before two or more drugs may be recombined
ent)" was ambiguous, as the phrase could refer
and effectiveness required for approval of new
determining whether a product is a new drug,
in single product, manufacturer must demon-
to either the active ingredient of the original
drug application, and generally available scienti-
and its procedures must satisfy rudiments of fair
strate by adequate and well-controlled investiga-
approved drug or to the active ingredient in the
fic literature substantiating expert consensus of
play. Rutherford V. U.S., D.C.Okl.1977, 429
tions that each additional component provides
new drug. Abbott Laboratories V. Young, 1990,
safety and effectiveness. U.S. V. Articles of
F.Supp. 506.
specific benefit to patient that warrants in-
920 F.2d 984, 287 U.S.App.D.C. 190, certiorari
Drug, N.D.IIL1985, 624 F.Supp. 776, affirmed
826 F2d 564.
Where shelf life of drug had been exceeded
creased risk. U.S. V. 225 Cartons, More or
denied 112 S.Ct. 76, 116 L.Ed.2d 49.
and, beyond the Food and Drug Administration
Less, of an Article of Drug, D.N.J.1988, 687
Food and Drug Administration Compliance
F.Supp. 946.
12. Submission of investigative reports
approved shelf life, it was a drug of unknown
Policy Guide did not bar enforcement action
effectiveness, it was, in effect, a "new drug"
With respect to combination drug, it must be
Claimant failed to demonstrate that the Food
against manufacturer of toothpaste grounded on
without Administration approval and had to be
demonstrated that the combination of ingredi-
and Drug Administration committed a clear er-
its introduction into interstate commerce with-
presumed dangerous. Blanton V. U.S., D.C.D.C.
ents is generally recognized as safe and effective
ror of judgment or acted arbitrarily and capri-
out approved new drug application where lan-
1977, 428 F.Supp. 860.
in order for the drug to transcend "new drug"
ciously in denying claimant's request for relabel-
guage of Guide at issue was not statement of
Food and Drug Administration has complete
status. U.S. V. Articles of Drug
HORMO-
ing of medical device known as "Diapulse" de-
policy or interpretation constituting advisory
authority to determine which drugs are "new"
NIN, D.C.N.J.1980, 498 F.Supp. 424, affirmed
vice, in light of the FDA's thorough examination
opinion and where Guide discussed action to be
and require an approved new drug application in
672 F.2d 902, 904.
of claimant's supporting documents and charac-
taken by Food and Drug Administration person-
order to be sold to the public. U.S. V. Marcen
Although each of the components of a drug
terization of studies as either concerning basic
nel only and did not purport to address behavior
Laboratories, Inc., D.C.N.Y.1976, 416 F.Supp.
may be generally recognized as safe and effec-
biological phenomena which offered little more
by anyone outside Administration. U.S. V. Arti-
453, affirmed 556 '2d 562.
tive, a new drug is created when they are com-
than encouragement for follow-up studies, stud-
cles of Drug Promise Toothpaste for Sensi-
designed for use for performing in home,
bined together in a new and different formula-
ies with animals which were only indicative as to
tive Teeth, D.C.III.1984, 594 F.Supp. 211.
"preliminary screening test" by which human
tion. U.S. V. An Article of Drug Labeled "En-
efficacy of device, studies in humans concerning
Generic drugs manufactured without submis-
trol-C Medicated," D.C.Cal.1973, 362 F.Supp.
medical conditions differing from those proposed
female may obtain indication of probability that
sion to and approval by Food and Drug Admin-
she is or is not pregnant was not "drug" within
424, affirmed 513 F.2d 1127.
by claimant, and studies conducted with devices
istration of a new-drug application or abbreviat-
meaning of this section requiring that "new
substantially different from "Diapulse." U.S. V.
ed new-drug application were "new drugs" for
9b. Exclusive marketing period
An
Article
of
Device
drug" may be marketed in interstate commerce
Diapulse, C.A.7 (III)
purpose of application requirement where al-
without first filing "new drug application." U.S.
A new drug developer's interpretation of the
1985, 768 F.2d 826.
though active ingredients and in some cases
V. Article of Drug-OVA II, D.C.N.J.1975, 414
phrase "active ingredient (including any ester or
For purpose of determining whether a new
inactive ingredients as well were the same as
F.Supp. 660, affirmed, 585 F.2d 1248.
salt of the active ingredient)" as permitting a
drug is effective, substantial evidence consisting
those in FDA-approved, pioneer counterparts
The actual safety or efficacy of a drug is
drug company to obtain an extended period of
of well-controlled scientific testing is required
there was expert testimony that such drugs
irrelevant as to whether its safety and efficacy is
market exclusivity for the new drug by applying
and isolated case reports, random experience
were not generally recognized among qualified
generally recognized among qualified experts,
for an approval of the acid first, followed by the
and reports lacking details needed to permit
experts as safe and effective and even assuming
and an announcement by the Food and Drug
salt, but not under the reverse sequence, was
scientific evaluation are not to be considered.
identity of ingredients quantitatively and quali-
Administration or any other person as to the
not a reasonable interpretation of the statute
Edison Pharmaceutical Co., Inc. V. Food and
tatively, there were potentially significant differ-
actual effectiveness of a drug is not determina-
giving developers of new drugs a specified peri-
Drug Admin., Dept. of Health, Ed. and Welfare,
ences in manufacturing processes between the
tive, and is irrelevant, to the ultimate issue of
od of market exclusivity. Abbott Laboratories
1979, 600 F.2d 831, 195 U.S.App.D.C. 17.
generic and pioneer products. U.S. V. Premo
whether a drug is a "new drug." National
V. Young, 1990, 920 F.2d 984, 287 U.S.App.D.C.
190, certiorari denied 112 S.Ct. 76, 116 L.Ed.2d
Substantial evidence supported finding of the
Pharmaceutical Laboratories, Inc., D.C.N.J.
Ethical Pharmaceutical Ass'n V. Weinberger,
1981, 511 F.Supp. 958.
D.C.S.C.1973, 365 F.Supp. 735, affirmed 503
49.
Commissioner, made in connection with refusal
to approve new drug application, that studies
Pharmaceutical manufacturer is not permitted
F.2d 1051.
Generic manufacturer of drug products con-
submitted by drug manufacturer to prove the
to substitute its judgment as to whether drug
In determining whether a drug is "new drug"
taining controlled released propranolol IIC1,
efficacy of new drug were replete with inaccura-
product is "new drug" for that of Food and Drug
there must be determination of whether drug
which had filed abbreviated new drug applica-
cies and ambiguities and lacked protocol and
Administration, nor is the court required to
has mustered the requisite scientifically reliable
tion, was entitled to 180 days of exclusivity from
statistical analysis and that, therefore, the stud-
develop its own body of scientific knowledge in
evidence of safety and effectiveness before they
date of first commercial marketing of manufac-
ies were not "adequate and well controlled"
substitution for the Administration. U.S. V. Ar-
are in position to drop out of active regulation
turer's product, even though relevant patent
within the meaning of this section and did not
ticles of Drug
HORMONIN, D.C.N.J.
by ceasing to be "new drug." National Ethical
holder chose not to sue manufacturer for patent
establish the efficacy of the new drug. Edison
1980, 498 F.Supp. 424, affirmed 672 F.2d 902,
Pharmaceutical Ass'n V. Weinberger, D.C.S.C.
infringement. Inwood Laboratories, Inc. V.
Pharmaceutical Co., Inc. V. Food and Drug Ad-
904.
1973, 365 F.Supp. 735, affirmed 503 F.2d 1051.
Young, D.D.C.1989, 723 F.Supp. 1523.
min., Dept. of Health, Ed. and Welfare, 1979,
Decision as to whether drug X-Otag Plus
Where drug which consisted of 14 mgs. of
Federal Food, Drug, and Cosmetic Act,
600 F.2d 831, 195 U.S.App.D.C. 17.
shipped by defendants in interstate commerce
chemical ingredient 9-aminoacridine hydrochlo-
$ 505(j)(4)(D)(ii), as amended, 21 U.S.C.A.
Studies conducted on manufacturer's old for-
was a "new drug" and subject to requisite ap-
ride and binder of 14 mgs. of polyvinylpyrroli-
§ 355(j)(4)(D)(ii), establishing five-year exclusive
mulation of Fiorinal with Codeine were not well-
proval before being held for sale in interstate
done and which was marketed as prescription
marketing period following approval of new drug
controlled clinical investigations of products us-
market was to be made by Food and Drug
drug for alleviation of various vaginal infections
application for nonantibiotic drug in which no
ing manufacturer's new formulation in which
Administration, as agency entrusted by Con-
had much larger dosage than used in other
abbreviated new drug application may be filed to
gress with necessary expertise to make well-
aminoacridine medication for vaginal infections,
market generic version of such drug did not
phenacetin was replaced with increased dosages
of aspirin, and thus extrapolation of data derived
informed decisions on issue, and was not a deci-
was in tampon form rather than gel tablet and
apply to provide manufacturer of new antibiotic
from studies of old formulation could not be
sion which was within jurisdiction of district
cream form, and had binder, drug was "new
drug with exclusive marketing period during
drug" and not exempt from seizure based on
used to obviate need for new drug application
court in enforcement and injunction proceedings
which Food and Drug Administration could not
for new formulation; manufacturer did not sub-
brought against defendants by United States.
claim of misbranding. U.S. V. Article of Drug
approve competitor's generic version of pioneer
U.S. V. X-Otag Plus Tablets, D.C.Colo.1977, 441
"Mykocert", D.C.IIL.1972, 845 F.Supp. 571.
antibiotic drug, particularly where Congress had
mit any data to indicate bioequivalence of new
formulation with old formulation. U.S. V. 225
F.Supp. 105, affirmed in part, remanded in part
9a. Components
refused to amend language of provision pertain-
Cartons, More or Less, of an Article of Drug,
on other grounds 602 F.2d 1387.
ing to approval of antibiotic drugs [Federal
Federal Trade Commission order purporting
Food, Drug, and Cosmetic Act, § 507, as amend-
D.N.J.1988, 687 F.Supp. 946.
Plaintiff who was dying from cancer of the
to remedy wrongs which Commission has found
ed, 21 U.S.C.A. § 357] to create similar exclusiv-
In determining validity of approval of dupli-
pancreas and who sought to enjoin the Food and
not to have been committed should be set aside,
ity period. Glaxo, Inc. V. Heckler, D.C.N.C.
cate new drug application, law does not require
Drug Administration from preventing importa-
but portion of its order applying to "unusual or
1985, 623 F.Supp. 69.
any single study, viewed in isolation, to provide
tion or interstate transportation of Laetrile for
special ingredient representations" for all of
total support for Food and Drug Administra-
purposes of his own consumption raised statuto-
plaintiffs over-the-counter drugs was reasonably
9c. Active ingredient
tion's action, but rather, record must be viewed
ry questions as to classification of Laetrile as a
related to violation made by misrepresenting
In the context of a statute that gave develop-
as whole, taking into account cumulative and
"new drug" sufficiently serious to make them
that plaintiffs analgesics did not contain aspirin.
ers of new drugs a specified period of market
reinforcing nature of evidence. Upjohn Mfg.
208
209
21 § 355
FOOD AND DRUGS
Note 12
FOOD AND DRUGS
21 § 355
Co. v. Schweiker, D.C.Mich.1981, 520 F.Supp.
Note 14
Regulation promulgated by Food and Drug
58, affirmed 681 F.2d 480.
Administration with respect to "new drugs" indi-
fects of drug. George V. Parke-Davis, 1987, 738
Trial court's order that drug manufacturer
In determining whether allegedly misbranded
cates that newness is a function of the novelty of
P.2d 507, 107 Wash.2d 584.
provide drug free of charge to participants in
drug came under grandfather clause exemption
a particular formulation, including the novel
double-blind study of drug for 12 months after
13a. Clinical studies
from requirement of "effectiveness," court could
composition, combination, dosage, or administra-
study was completed as agreed to in contract did
properly consider reprints of professional medi-
tion and, though regulation extends 80 far as to
Food and Drug Administration bulletin, which
not violate doctrine of primary jurisdiction by
cal studies of the drug published by doctors in
encompass new uses for a drug or new methods
provided that physician may, as part of practice
taking decision away from Food and Drug Ad-
medical journals, and "dear doctor" letters
of application, it does not encompass a scope 80
of medicine, prescribe different dosage for pa-
ministration (FDA) with respect effectiveness of
printed by claimant which were distributed to
broad as to require bioavailability and bioequiva-
tient without obtaining approval of the FDA,
drug; FDA's determination of efficacy did not
physicians in promoting the sale of the drug.
lence tests once a drug is established as being
related to drugs which already had received
have to precede injunction requiring one year of
U.S. V. 1,048,000 Capsules, More or Less, "Afro-
the same generically as a drug already approved
FDA approval, and did not support contention of
drug be provided free of charge to participants
dex", D.C.Tex.1972, 847 F.Supp. 768, affirmed
safe and effective. U.S. V. Articles of Drug,
claimant, who sought relabeling of medical de-
who subjected themselves to double-blind study.
494 F.2d 1158.
C.A.Pa.1978, 585 F.2d 575.
vice known as "Diapulse" device, that differing
Dahl V. HEM Pharmaceuticals Corp., C.A.9
Even if reliance on a single well-known active
conditions of use between studies and relabeling
(Nev.) 1993, 7 F.3d 1899.
13. Testing of drugs
Commissioner of Food and Drug Administra-
ingredient like gentian violet lowered test for
proposal were irrelevant, in light of statutory
Determination that new drug application was
tion did not err in requiring drug manufacturers
general recognition of efficacy and safety, ani-
criteria contained in Federal Food, Drug, and
"approved" in December of 1981 when manufac-
mal drugs and food additive, which government
Cosmetic Act, [§§ 505(d), 513(a)(3)(B)(i, ii)] as
turer was informed of approval, even though the
to show that their oral proteolytic enzymes were
amended, 21 U.S.C.A. $$ 355(d), 360c(a)(3)(B)(i,
therapeutically effective in order to satisfy re-
sought to condemn, could not be properly
approval was granted with the understanding
quirement for FDA approval that drugs be ef-
deemed to be generally recognized as safe or
ii)], which provides that scientific studies must
that remaining issues concerning final printed
effective, in absence of any adequate, well con-
be such that it could fairly and responsibly be
labeling be resolved, was not arbitrary and ca-
fective by showing of clinical, rather than merely
statistical, significance. Warner-Lambert Co. V.
trolled, completed test of safety or efficacy of
concluded that drug or device will have effect it
pricious, 80 that drug was not entitled to period
these combinations. U.S. V. Articles of Food
purports or is represented to have under condi-
of nonpatent exclusivity under the Hatch-Wax-
Heckler, C.A.8, 1986, 787 F.2d 147.
and Drug Consisting of Coli-Trol 80, F4C-60
tions of use prescribed, recommended or sug-
man Amendments. Mead Johnson Pharmaceu-
Dismissal without prejudice of post-office pro-
Feed Grade, Entrol-S Medicated, Entrol-P,
gested in labeling or proposed labeling thereof.
tical Group, Mead Johnson & Co. V. Bowen,
ceeding against manufacturer of hair and scalp
C.A.Ga.1975, 518 F.2d 743.
U.S. V. An Article of Device Diapulse, C.A.7
1988, 838 F.2d 1332, 267 U.S.App.D.C. 882.
products did not collaterally estop Food and
(III.) 1985, 768 F2d 826.
Drug Administration from denying efficacy of
That pain is difficult, or even impossible, to
Position of Food and Drug Administration
that it could approve new drug application prior
the treatment, since issue in post-office case
measure quantitatively does not entail infessibil-
Food and Drug Administration had estab-
lished that published clinical studies on Florinal
to submission of final labeling was reasonable
concerned accuracy of advertising while issue
ity of controlled tests for determining drug's
efficacy 80 as to establish grounds for waiver of
with Codeine Nos. 1 and 2 did not establish
interpretation of statute where statute only re-
before Food and Drug Administration was
requisite recognition of product or contribution
quired submission of proposed labeling and FDA
whether data submitted constituted adequate
regulations requiring efficacy of drug to be es-
tablished by controlled investigation. Cooper
of its components 80 as to obviate need for new
regulation stated that approval would ordinarily
and well-controlled studies, and since dismissals
Laboratories, Inc. V. Commissioner, Federal
drug application with respect to drugs; manu-
follow submission of final labeling. Norwich
without prejudice do not constitute a final deter-
facturer submitted no studies with respect to
Eaton Pharmaceuticals, Inc. V. Bowen, C.A.6
mination. Brandenfels V. Heckler, C.A.9, 1988,
Food and Drug Administration, 1974, 501 F.2d
Fiorinal with Codeine No. 1, most studies sub-
(Ohio) 1987, 808 F.2d 486, certiorari denied 108
716 F2d 558.
772, 163 U.S.App.D.C. 212.
mitted were conducted with old formulation of
S.Ct. 68, 484 U.S. 816, 98 L.Ed.2d 32.
Under this chapter, before a new drug intend-
Where drug manufacturer's submission did
Fiorinal with Codeine Nos. 2 and 3, and studies
In determining effectiveness of drugs, Com-
ed for human use can be marketed in interstate
not set forth clearly and concisely the specific
failed to measure efficaciousness of certain com-
missioner of Food and Drug Administration is
commerce, the drug must be clinically tested to
provision or provisions in regulations which
ponents of drugs. U.S. V. 225 Cartons, More or
not required to defer to conclusions of experts
establish that it is both safe and effective. Edi-
were inapplicable to research dealing with
Less, of an Article of Drug, D.N.J.1988, 687
that studies submitted by drug companies are
son Pharmaceutical Co., Inc. V. Food and Drug
drug's efficacy and did not specify or define
F.Supp. 946.
adequate and well-controlled and prove effec-
Administration, Dept. of Health, Ed., and Wel-
alternative procedures which should be used to
tiveness of drugs under consideration; both va-
fare, 1979, 600 F.2d 881, 195 U.S.App.D.C. 17.
test drug's efficacy, neither Food and Drug Ad-
13b. Breast implants
lidity of methodology used in particular studies
In proceeding on new drug application, sub-
ministration nor court could waive regulations
Food and Drug Administration (FDA) report
and ultimate question of effectiveness are issues
stantial evidence supported conclusion of the
requiring that efficacy of drug be established by
on risks of silicone gel breast implants was
for Commissioner to determine. Warner-Lam-
Commissioner that, though it might be unethical
controlled investigation. Cooper Laboratories,
sufficiently reliable to be admissible hearsay as
bert Co. V. Heckler, C.A.3, 1986, 787 F.2d 147.
to conduct such 8 study comparing two groups
Inc. V. Commissioner, Federal Food and Drug
product of factual investigation conducted by
With respect to application for clearance to
of cardiac patients, double-blind controlled test-
Administration, 1974, 501 F.2d 772, 168
FDA pursuant to its statutory authority. Toole
U.S.App.D.C. 212.
market a new animal drug, when Food and Drug
ings of the new drug and one of its components
V. McClintock, M.D.Ala.1991, 778 F.Supp. 1543.
Administration proceeds by way of ad hoc artic-
could ethically be performed on noncardiac pa-
That causal connection between chloroquine
ulation of safety standards, it is incumbent upon
tients and that such testing was necessary be-
phosphate and chloroquine retinopathy was not
14. Approval of drug-Administrative agen-
it to give applicant notice of those standards and
fore the drug could be administered to cardiac
even suspected in the long term use by humans
cy
of manner in which the data before it failed to
patients. Edison Pharmaceutical Co., Inc. V.
of the drug at the time manufacturers tested the
Food and Drug Administration has jurisdic-
meet them and that notice must be given in
Food and Drug Administration, Dept. of Health,
drug would not relieve them of negligence in
tion to decide with administrative finality, sub-
timely fashion to put manufacturer in position to
Ed., and Welfare, 1979, 600 F.2d 831, 195
failing to conduct animal studies to show the
ject to types of judicial review provided, the
dispute Administration's interpretation of the
U.S.App.D.C. 17.
connection between the drug and the disease.
"new drug" status of individual drugs or classes
safety criteria, object to Administration's cri-
That multiinvestigator clinical trials testing
Hoffman V. Sterling Drug, Inc., C.A.Pa.1973, 485
of drugs. Weinberger V. Bentex Pharmaceuti-
tique of submitted studies, and conduct and
effectiveness of combination drug which con-
F.2d 132, on remand 374 F.Supp. 850.
cals, Inc., S.C.1973, 98 S.Ct. 2488, 412 U.S. 645,
proffer new studies meeting newly articulated
tained Dexedrine and amobarbital and which
The safety and efficacy of combination drug
37 L.Ed.2d 235.
requirements, and, should applicant then identi-
was labelled for use with obese patients involved
involved in misbranding action cannot be equat-
Even though a drug manufacturer does not
fy a material issue of fact, Administration must
subjects who were anxious, obese patients so
ed with the safety of the components separately
have any new drug application in effect and is
hold hearing. American Cyanamid Co. V. Food
that trials provided no assurance that Dexe-
or in combination with different ingredients; the
not seeking approval of any drugs, the Food and
and Drug Administration, 1979, 606 F2d 1307,
drine, in amounts contained in drug, produced in
fact that one individual component of combina-
Drug Administration may make a declaratory
196 U.S.App.D.C. 400.
nonanxious, obese patients aide effects capable
tion drug may be generally recognized as safe
order that a drug is a "new drug" 80 as to
Recommendations of the National Academy of
of being remedied by amobarbital did not render
and effective is not relevant to the issue whether
acquire an effective new drug application before
Sciences-National Research Council as to effec-
trials deficient under Food and Drug regulation
the combination itself is 80 recognized. U.S. V.
drug may be introduced into commerce; power
tiveness of a new drug are advisory in nature.
requiring suitability of subjects 80 as to autho-
1,048,000 Capsules, More or Less, D.C.Tex.1972,
of the Administration to decide threshold juris-
Holland Rantos Co., Inc. V. U.S. Dept. of Health,
rize summary, denial of new drug application in
347 F.Supp. 768, affirmed 494 F.2d 1158.
dictional question whether the drug is a "new
Ed. and Welfare, 1978, 587 F.2d 1173, 190
that present labeling of drug could be altered to
Raw manufacturer of DES could not be verti-
drug" is not only an incident to its power to
U.S.App.D.C. 276.
recommend use with anxious, obese patients.
cally liable for distribution of DES tablets where
approve or withdraw approval of a new drug
Food and Drug Administration's disregard,
Smithkline Corp. V. Food and Drug Administra-
tablet manufacturer bore responsibility of con-
application. Weinberger V. Hynson, Westcott
without reasons, of recommendation of study
tion, 1978, 587 F.2d 1107, 190 U.S.App.D.C. 210.
ducting separate test to determine adverse ef-
and Dunning, Inc., Va.1973, 93 S.Ct. 2469, 412
group of the National Academy of Sciences-
210
U.S. 609, 37 L.Ed.2d 207.
National Research Council that new drug be
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 14
Note 16
considered effective for treatment of vaginitis
Health, Ed. and Welfare, 1972, 466 F.2d 455, 151
sue whether drug product is a "new drug" sub-
did not constitute sufficient ground to set aside
light suggesting that the drug has become un-
U.S.App.D.C. 284.
ject to provisions of this chapter district court
final order denying new drug application where
safe, whether or not the drug was generally
Commissioner of Food and Drugs has juris-
might well stay its hand, awaiting appropriate
refusal to accept panel's rating of effectiveness
recognized as safe in the interim, a new drug
diction, in proceeding to determine whether lack
administrative determination of this threshold
application remains effective unless it is sus-
was essentially judgment that applicant had not
yet offered substantial evidence of drug's effec-
of effectiveness as claimed makes a drug unmar-
jurisdictional question; however, where there is
pended. Weinberger V. Hynson, Westcott and
tiveness and should be put to its proof and
ketable, to decide the threshold question wheth-
an administrative determination, whether it be
Dunning, Inc., Va.1978, 98 S.Ct. 2469, 412 U.S.
er the product in controversy is a "new drug,"
explicit or implicit in the withdrawal of a new
609, 87 LEd2d 207.
where subsequent events vindicated such judg-
ment in that application was unable to produce
and if the administrative agency takes jurisdic-
drug application, the tactic of "reserving" the
Substantial evidence supported determination
necessary adequate and well-controlled studies
tion, the same jurisdictional issue is present for
threshold jurisdictional question for later judi-
of Commissioner of Food and Drug Administra-
of drug's effectiveness. Holland Rantos Co.,
judicial review on direct appeal from the admin-
cial determination is not tolerable. CIBA Corp.
tion that use of concomitant medication flawed
Inc. V. U.S. Dept. of Health, Ed. and Welfare,
istrative decision. Ciba Corp. V. Richardson,
V. Weinberger, N.J.1978, 98 S.Ct. 2495, 412 U.S.
clinical study of oral proteolytic enzymes and
C.A.N.J.1972, 463 F2d 225, affirmed 93 S.Ct.
640, 87 L.Ed.2d 280.
1978, 587 F.2d 1178, 190 U.S.App.D.C. 276.
that other studies were in violation of regulatory
2495, 412 U.S. 640, 87 L.Ed.2d 230.
Action of Federal Trade Commission in order-
Action by pharmaceutical trade association
criteria such that withdrawal of approval was
ing operations of weight loss clinics to state in
In light of Food and Drug Administration's
and one of its member companies seeking judi-
appropriate. Warner-Lambert Co. V. Heckler,
their advertisements that one of the drugs being
function of protecting public health and safety,
cial review of Food and Drug Administration's
C.A.8, 1986, 787 F.2d 147.
used was a new drug which had not been deter-
"paper new drug application policy" which al-
regulation of certain drugs which were treated
Manufacturer was not prejudiced by nine-year
mined to be effective for obesity did not imper-
lows approval of duplicate new drug application
as "new drugs," and seeking a judgment declar-
delay between request for hearing before Food
missibly encroach upon the confidential relation-
without examination of raw data when verifica-
ing that those drugs were not "new drugs," was
and Drug Administration on hair and scalp
ship between a physician and a patient; the
tion of prior studies has been accomplished
properly dismissed on the ground that the mat-
products and Food and Drug Administration's
FTC order did not affect the right of a physician
through scrutiny of scientific community and
ter lay within the primary jurisdiction of the
withdrawal of approval, where the delay enabled
to prescribe or administer the drug for his or
which is supported by argument that likelihood
Food and Drug Administration, that judicial re-
him to continue marketing the products and
her patients but merely prevented the weight
of fraud or bias existing after years of published
view was available only after a formal adminis-
where the deaths of doctors who conducted stud-
loss clinics from advertising their clinics and
studies subject to verification through scrutiny
trative ruling, and that, in respect to the prayer
les did not prejudice defendant in that the truth
weight reduction program in a way which failed
of publishing journals and general scientific
for declaratory relief, a sound exercise of discre-
of their views was not the issue but whether the
to disclose that the Food and Drug Administra-
community, potential for testing and duplication,
tion required the court to refuse to take jurisdic-
studies on their face complied with Food and
tion had not approved the drug for such use.
and experience of drug's performance once it
tion. National Ethical Pharmaceutical Ass'n V.
Drug Administration guidelines. Brandenfels V.
Simeon Management Corp. V. F.T.C., C.A.9,
has been on market, becomes vastly diminished,
Weinberger, C.A.S.C.1974, 503 F.2d 1061.
Heckler, C.A.9, 1983, 716 F.2d 553.
1978, 579 F.2d 1187.
is valid. Upjohn Mfg. Co. V. Schweiker,
D.C.Mich.1981, 520 F.Supp. 58, affirmed 681
Determination of Court of Appeals reviewing
Manufacturers of drug were entitled to notice
A new drug may not be introduced into inter-
F.2d 480.
decision of Commissioner of Food and Drugs
of specific grounds on which the Food and Drug
state commerce unless an application has been
that a drug is a "new drug" within meaning of
Administration proposed to withdraw approval
filed with and approved by the Food and Drug
Determination of actual safety and effective-
this section providing for exclusion of new drugs
of the drug's new drug application and to an
Administration; the FDA may not approve a
ness of drug product is committed to Food and
from market unless proven effective as claimed
opportunity to submit evidence which would en-
new drug application unless it finds that there is
Drug Administration due to its superior access
is reviewable by the Supreme Court, and it is
title them to a hearing before an order of with-
substantial evidence that the drug is effective
to technical expertise. U.S. V. Articles of Drug
not appropriate that a district court entertain a
drawal could be validly issued. Sterling Drug
for the labeled use. Simeon Management Corp.
HORMONIN, D.C.N.J.1980, 498 F.Supp.
separate suit by the loser in the administrative
Inc. V. Weinberger, C.A.2, 1974, 503 F.2d 675.
V. F.T.C., C.A.9, 1978, 579 F.2d 1137.
424, affirmed 672 F.2d 902, 904.
proceeding for a redetermination of the same
If court finds that Food and Drug Administra-
Under this subchapter, ultimate determination
Determination of whether product constituted
question. Ciba Corp. V. Richardson, C.A.N.J.
tion's order withdrawing drug from market
of safety of a drug is not a matter given to the
a "new drug" requiring filing and approval of a
1972, 463 F.2d 225, affirmed 93 S.Ct. 2495, 412
identified defects which conclusively rendered
courts, but one to be determined by the Food
new drug application was within the primary
U.S. 640, 37 L.Ed.2d 230.
each piece of evidence submitted in support of
and Drug Administration upon submission of a
jurisdiction of the Food and Drug Administra-
The Food and Drug Administration had pri-
drug's efficacy as being inadequate or uncon-
new drug application. U.S. V. 1,048,000 Cap-
tion, precluding district court review until final
mary jurisdiction to determine whether each
trolled in light of permit regulations, court must
sules, More or Less, "Afrodex", C.A.Tex.1974,
agency action and exhaustion of administrative
drug named in applicants' complaint was "new
affirm order. Cooper Laboratories, Inc. V.
494 F.2d 1158.
remedies. IMS Ltd. V. Califano, D.C.Cal.1977,
drug" and, following such administrative deter-
Commissioner, Federal Food and Drug Admin-
453 F.Supp. 157.
Order of Commissioner of Food and Drugs
mination, applicants would then be entitled to
istration, 1974, 501 F.2d 772, 163 U.S.App.D.C.
Since the Federal Drug Administration has
212.
withdrawing approval of line of drugs for inter-
seek judicial review. National Ethical Pharma-
state marketing was not supported by adequate
failed to act in contemplation of what Congress
ceutical Ass'n V. Weinberger, D.C.S.C.1978, 365
Standard of review to be applied to order of
findings and conclusions, where order merely
intended in this section, the Administration and
F.Supp. 735, affirmed 503 F.2d 1051.
the Food and Drug Administration denying an
tracked language of this section, stating in con-
Department of Health, Education and Welfare
Determination by Food and Drug Administra-
evidentiary hearing on effectiveness of drug pre-
clusory terms that there was lack of substantial
would be found to have in fact disapproved the
tion that a product is "new drug" or a "me-too"
vioualy approved for marketing solely on demon-
evidence that the drugs were effective, and did
use of laetrile for treating cancer, and the dis-
drug is reviewable. National Ethical Pharma-
stration that it was safe for its intended use is
not disclose evidence upon which the Commis-
trict court, for want of action on the part of the
ceutical Ass'n V. Weinberger, D.C.S.C.1978, 365
whether deficiencies found in the studies submit-
aioner based his judgment. USV Pharmaceuti-
agencies, had jurisdiction of class action brought
F.Supp. 735, affirmed 503 F.2d 1051.
ted by manufacturer of the drug conclusively
cal Corp. V. Secretary of Health, Ed. and Wel-
by cancer victims and their spouses seeking an
render the studies inadequate. E. R. Squibb &
fare, 1972, 466 F.2d 455, 151 U.S.App.D.C. 284.
order directing the Administration to desist
15a.
Timeliness
Sons, Inc. V. Weinberger, C.A.3, 1973, 483 F.2d
from precluding the administration of laetrile to
Where Commissioner of Food and Drugs had
Writ of mandamus would not issue to compel
1382.
failed to name hearing examiner in response to
patients in the United States suffering from
Food and Drug Administration to expedite pro-
Satisfactory adjudication of appeal from denial
drug manufacturer's demand and delayed more
cancer. Rutherford V. U.S., D.C.Okl1975, 399
cessing of application for approval of generic
by the Food and Drug Administration of eviden-
F.Supp. 1208, affirmed and remanded on other
than two months in responding to manufactur-
drug, following expiration of statutory period
tiary hearing on effectiveness of drug which had
er's request, filed two years later, for a stay
grounds 542 F.2d 1137, on remand 424 F.Supp.
during which decision was to be made; while
been previously approved on the basis of safety
105.
pending decision in manufacturer's action for
judicial intervention might benefit applicant,
only mandated that a meaningful comparison be
declaratory judgment that its drugs were not
Whether drugs are "new" or "old" requires
there would be corresponding harm to other
made by the FDA between the study submitted
new drugs, Commissioner's precipitous sum-
determination by the Food and Drug Adminis-
applicants whose processing would be further
in the instant case and study held sufficient by
mary withdrawal of approval of previously
tration as to whether they are generally recog-
delayed. In re Barr Laboratories, Inc., 1991,
the Supreme Court, and also mandated amplifi-
granted new drug applications were arbitrary.
nized, among qualified experts, as safe and ef-
930 F.2d 72, 289 U.S.App.D.C. 187, certiorari
cation and clarification in light of highly esoteric
USV Pharmaceutical Corp. V. Secretary of
fective for their intended use. National Ethical
denied 112 S.Ct. 297, 298, 116 L.Ed.2d 241.
and scientific terms employed in the information
Health, Ed. and Welfare, 1972, 466 F.2d 455, 151
Pharmaceutical Ass'n V. Weinberger, D.C.S.C.
before the court. E. R. Squibb & Sons, Inc. V.
U.S.App.D.C. 284.
1973, 365 F.Supp. 785, affirmed 503 F.2d 1051.
16. Withdrawal of approval
Weinberger, C.A.S, 1973, 483 F.2d 1382.
Under this chapter as originally enacted,
Issue of whether drug is actually safe and
15. Judicial
Action of Food and Drug Administration
which empowers the Food and Drug Adminis-
effective is for the Food and Drug Administra-
(FDA) in rescinding its approval of manufactur-
In cases where there has been no formal
tion. USV Pharmaceutical Corp. V. Secretary of
tration to withdraw approval of a new drug
er's application to make and sell new drug, on
administrative determination of jurisdictional is-
application whenever new evidence comes to
ground that approval had been issued through
212
213
21 8 355
FOOD AND DRUGS
FOOD AND DRUGS
Note 16
21 § 355
Note 17a
inadvertent mistake, was not so clearly ultra
tion because of lack of substantial evidence of
vires as to justify disregard of exclusive jurisdic-
appropriate to require Commissioner, as an ex-
efficacy of drug when it is apparent at threshold
issue of fact which would justify a hearing.
tion of Court of Appeals and intervention by
ception to usual case, whichever way he decides
that applicant has not tendered any evidence
U.S.V. V. Pharmaceutical Corp. V. Secretary of
district court; even if right vested, manufactur-
threshold issue, to hold a full evidentiary hear-
which on its face meets statutory standards as
Health, Ed. and Welfare, 1972, 466 F.2d 455, 151
er was not deprived of factual hearing to prove
ing on "all" relevant issues relating to approva-
particularized by regulations, appropriate.
U.S.App.D.C. 284.
its qualifications to make and sell drug, and
bility of new drug application, where drug manu-
Weinberger V. Hynson, Westcott and Dunning,
In circumstance in which the Food and Drug
postdenial hearing met due process require-
Inc., Va.1978, 98 S.Ct. 2469, 412 U.S. 609, 37
facturer had first filed new drug application over
Administration publishes in Federal Register
ments. American Therapeutics, Inc. V. Sullivan,
L.Ed.2d 207.
six years prior thereto and in the interim its
the required notice to drug manufacturers of
D.D.C.1990, 755 F.Supp. 1.
application had been denied on three separate
Due process does not demand a hearing on
opportunity for hearing and proposed withdraw-
occasions without an opportunity for hearing
Proposed withdrawal of approval of new drug
proposed withdrawal of an effective new drug
al of drugs from market and manufacturers then
despite direction to contrary from court. Edi-
applications in effect for drug is not a final order
application because of lack of substantial evi-
fail to avail themselves of opportunity for the
son Pharmaceutical Co., Inc. V. Food and Drug
and is not ordinarily reviewable in district court.
dence of efficacy of drug when it appears conclu-
hearing within required 30 days, withdrawal of
Administration, Dept. of Health, Ed. and Wel-
Sterling Drug, Inc. V. Weinberger, D.C.N.Y.
sively from applicant's pleadings that it cannot
drugs from market is required by this section
fare, 1975, 513 F.2d 1068, 16 U.S.App.D.C. 273,
1974, 384 F.Supp. 557, affirmed 509 F.2d 1236.
succeed. Weinberger V. Hynson, Westcott and
governing withdrawal of drugs and is purely a
rehearing denied 517 F.2d 164, 170 U.S.App.
Secretary of Health, Education, and Welfare
Dunning, Inc., Va.1973, 93 S.Ct. 2469, 412 U.S.
ministerial duty, and failure to withdraw consti-
D.C. 350.
609, 37 L.Ed.2d 207.
tutes agency action unlawfully withheld. Ameri-
must, under this section and section 357 of this
The Food and Drug Administration may with-
can Public Health Ass'n. V. Veneman, D.C.D.C.
title governing withdrawal of antibiotic and no-
Food and Drug Administration's denial of ad-
draw a drug from the market without a hearing
1972, 349 F.Supp. 1311.
nantibiotic drugs, upon finding of lack of sub-
judicatory hearing on application for clearance
when, and only when, it appears conclusively
stantial evidence that the drugs have effect they
to market a new animal drug will be upheld if
from the applicants "pleadings" that the new
Hearing on withdrawal of a new drug applica-
are represented to have under conditions of use
Administration identifies at least one conclusive
tion is to be scheduled as soon as practicable
drug application cannot succeed. Sterling Drug
prescribed, recommended or suggested in label-
deficiency in each of tests proffered, but if stud-
after request by drug manufacturers for such a
Inc. V. Weinberger, C.A.2, 1974, 508 F.2d 675.
ing, begin procedures to withdraw a drug when
ies adopting all reasonably applicable methods of
hearing; and, while some agency discretion is
he concludes that there is no substantial evi-
Word "applicant" or "respondent" in subsec.
showing drug's safety have not been conclusively
conferred in scheduling the hearing, intermina-
(g) of this section refers only to holders of new-
dence of efficacy rather than thereafter granting
demonstrated to be inadequate, Administration
ble delay is not contemplated. American Public
drug applications; thus, said subsection did not
manufacturers time to bolster record regarding
must hold a hearing. American Cyanamid Co.
Health Ass'n. V. Veneman, D.C.D.C.1972, 349
V. Food and Drug Administration, 1979, 606
require Secretary personally to notify drug man-
the drug's effectiveness. American Public
F.Supp. 1811.
Health Ass'n V. Veneman, D.C.D.C.1972, 849
F.2d 1307, 196 U.S.App.D.C. 400.
ufacturers which produced anorectic drugs con-
taining amphetamines and which did not hold
17a. Jurisdiction
F.Supp. 1811.
Food and Drug Administration would have
new-drug applications covering combination am-
Jurisdictional question whether a drug prod-
Invocation of emergency procedure to imme-
valid ground for denying hearing on application
phetamine products of hearing regarding Secre-
uct is a "new drug," which is defined in section
diately suspend drugs which present an immi-
for clearance to market a new animal drug if
tary's withdrawal of approval of such applica-
321 of this title as a drug not generally recog-
nent hazard to the public health is matter which
Administration's interpretation and application
tions. North American Pharmacal, Inc. V. De-
nized among experts is effective as well as safe
is peculiarly one of judgment. American Public
of statutory safety standards are unimpeachable.
partment of Health, Ed. and Welfare, C.A.8,
for its intended uses, involves a determination of
Health Ass'n V. Veneman, D.C.D.C.1972, 349
American Cyanamid Co. V. Food and Drug Ad-
1973, 491 F2d 546.
technical and scientific questions by experts, and
F.Supp. 1811.
ministration, 1979, 606 F.2d 1307, 196 U.S.App.
Publication in Federal Register of notice of
agency is therefore appropriately the arm of
D.C. 400.
16a. Insurance
hearing regarding the withdrawal of approval of
government to make threshold determination of
Only if drug manufacturer has had fair oppor-
new-drug applications covering combination am-
issue of coverage. CIBA Corp. V. Weinberger,
Notwithstanding provisions in health insur-
tunity to dispute newly articulated safety stan-
phetamine products gave manufacturers, which
N.J.1973, 93 S.Ct. 2495, 412 U.S. 640, 37
ance policy providing that policy was to be inter-
dards of Food and Drug Administration and to
produced anorectic drugs containing amphet-
L.Ed.2d 230.
preted in accordance with laws of District of
resubmit compliant tests, or if original tests
amines and which did not hold new-drug applica-
Food and Drug Administration has jurisdic-
Columbia where laetrile was illegal, insured,
conclusively failed to meet general statutory
tions covering combination amphetamine prod-
tion in an administrative proceeding on proposed
who was terminally ill, who received laetrile
prerequisites, may Food and Drug Administra-
ucts, sufficient opportunity to be heard; and
withdrawal of an effective new drug application
treatments in Oklahoma under specific authority
tion deny hearing on basis of methodology of
failure personally to notify each manufacturer of
because of lack of substantial evidence of effica-
under an order of United States district court
research relied upon by manufacturer. Ameri-
hearing did not deprive them of due process.
cy to determine jurisdictional question whether
and who complied with policy's requirements
can Cyanamid Co. V. Food and Drug Adminis-
North American Pharmacal, Inc. V. Department
a drug product is a "new drug" within this
with regard to establishing her claim, was enti-
tration, 1979, 606 F.2d 1307, 196 U.S.App.D.C.
of Health, Ed. and Welfare, C.A.8, 1973, 491
chapter which defines a new drug as a drug not
tled to have laetrile treatments paid for by
400.
F.2d 546.
generally recognized among experts as effective
insurer as covered medical expenses. Wilson V.
Under this chapter, it is contemplated that a
Travelers Ins. Co., Okl.1980, 605 P.2d 1327.
Petitioner was not entitled to hearing before
as well as safe for its intended uses. CIBA
new drug will be approved or disapproved on
Commissioner on question of whether or not its
Corp. V. Weinberger, N.J.1973, 98 S.Ct. 2495,
17. Hearing
the basis of scientific tests contained in the new
product constituted new animal drug within
412 U.S. 640, 37 L.Ed.2d 230.
Food and Drug Administration's so-called ad-
drug application; the hearing offers an opportu-
meaning of this section. Agri-Tech, Inc. V. Rich-
Food and Drug Administration has jurisdic-
nity to test the strength and credibility of this
ministrative summary judgment procedure,
ardson, C.A.8, 1973, 482 F.2d 1148.
tion to decide "new drug" status of product and
material. Edison Pharmaceutical Co., Inc. V.
whereby it will not provide a formal hearing on
Opportunity to be heard administratively is
district court may refer new drug issue to Food
Food and Drug Admin., Dept. of Health, Ed.
not prerequisite to prosecution for introduction
and Drug Administration for resolution, but
proposed withdrawal of an effective new drug
and Welfare, 1979, 600 F.2d 831, 195 U.S.App.
application because of lack of substantial evi-
D.C. 17.
of a "new drug" into interstate commerce with-
court may exercise its concurrent jurisdiction to
adjudicate status of product. Premo Pharma-
dence of efficacy of drug when it is apparent at
out approval of a new drug application. Durovic
threshold that applicant has not tendered any
Though a new drug applicant may present
V. Richardson, C.A.T11.1973, 479 F.2d 242, certio-
ceutical Laboratories, Inc. V. U.S., C.A.N.Y.1980,
evidence which on its face meets statutory stan-
testimony or evidence at the hearing to show
rari denied 94 S.Ct. 232, 414 U.S. 944, 38
629 F.2d 795.
dards as particularized by regulations, is valid.
that the studies and data submitted with the
L.Ed.2d 168, rehearing denied 94 S.Ct. 611, 414
Limited "new drug" issue was sufficiently
Weinberger V. Hynson, Westcott and Dunning,
new drug application in fact constitute the ade-
U.S. 1088, 38 L.Ed.2d 494.
clear to warrant district court's exercise of its
Inc., Va.1973, 98 S.Ct. 2469, 412 U.S. 609, 37
quate tests and substantial evidence necessary
for new drug approval, the applicant cannot
Where drug manufacturer's applications for
subject-matter jurisdiction, especially where to
L.Ed.2d 207.
marketing a line of drugs had been approved
refer issue to Food and Drug Administration at
submit new studies at the hearing to be consid-
ered in the first instance by the administrative
pursuant to prior law but Commissioner of Food
the late date would be wasteful and duplicative.
This section and regulations issued thereun-
der, which express well-established principles of
law judge; to do 80 would effectively shield an
and Drugs proposed, without a hearing, to with-
Premo Pharmaceutical Laboratories, Inc. V.
draw that approval on basis of a new standard
U.S., C.A.N.Y.1980, 629 F.2d 795.
scientific investigation, in their reduction of
applicant's data from the initial scrutiny of staff
"substantial evidence" standard to detailed
and new information, together with evidence
Decision of Commissioner that Laetrile is a
experts. Edison Pharmaceutical Co., Inc. V.
guidelines for protection of public, make Food
Food and Drug Admin., Dept. of Health, Ed.
available when approval was originally granted,
"new drug" subject to premarketing approval
and Drug Administration's so-called administra-
and Welfare, 1979, 600 F.2d 831, 195 U.S.App.
it was incumbent upon Commissioner, before
under this chapter was properly within Food
tive summary judgment procedure, whereby the
D.C. 17.
calling upon manufacturer for additional evi-
and Drug Administration's primary jurisdiction.
FDA will not provide a formal hearing on pro-
On hearing to determine threshold issue of
dence establishing a right to a hearing, to state
Carnohan V. U.S., C.A.Cal.1980, 616 F.2d 1120.
posed withdrawal of effective new drug applica-
safety of double-blind tests for new drug, it was
facts and reasons showing at least prima facie
Initial determination of whether drug is new
that the evidence before him raised no material
animal drug is within jurisdiction of Commis-
214
215
21 8 355
FOOD AND DRUGS
Note 17a
FOOD AND DRUGS
21 § 355
Note 22
sioner, and he may summarily deny hearing on
D.C.Mich.1981, 520 F.Supp. 58, affirmed 681
issue whether drug is generally "recognized"
F.2d 480.
suit brought by individual against drug compa-
Food and Drug Administration could not ban
and therefore exempt from withdrawal provi-
ny, on behalf of himself and other purchasers of
use of laetrile under grandfather clause if in fact
Threat of injury to plaintiffs, whose claim was
sions if he finds there is no "substantial evi-
allegedly ineffective drugs to recover money
laetrile had been used prior to the cutoff date in
not that they would in fact consume unsafe or
dence" raising issue of fact. Agri-Tech, Inc. V.
spent in purchase of such drugs and to obtain
treatment of cancer and without ill effect, It was
ineffective drugs, but that they were being sub-
Richardson, C.A.8, 1978, 482 F.2d 1148.
punitive damages. Consumer Federation of
not necessary that the drug be shown to have
jected to risk to their health on account of
America V. Upjohn Co., D.C.App.1975, 846 A.2d
been effective in treatment of cancer. Ruther-
Since Congress has created primary jurisdic-
marketing of Category III drugs, was both real
725.
tion in Food and Drug Administration to deter-
ford V. U.S., D.C.Okl.1977, 429 F.Supp. 506.
and immediate and, hence, was sufficient to give
mine in first instance safety and efficacy of new
plaintiffs standing in suit for declaratory and
19. Res judicata
21. Burden of proof
drug with such administrative determinations
injunctive relief against regulations of Food and
Doctrine of res judicata did not preclude Fed-
Proponents of laetrile did not conduct the
subject to review in appropriate court of ap-
Drug Administration governing the over-the-
eral Food and Drug Administration from pro-
research and laboratory testing required under
peals, as a jurisdictional matter district courts
counter drug market. Cutler V. Kennedy,
ceeding to withdraw approval of drug on theory
prevailing agency procedures and by this chap-
have no role to play in determining whether a
D.C.D.C.1979, 475 F.Supp. 838.
that drug had not been proved effective as sin-
ter, thus, they did not meet their burden to
new drug should be approved by Food and Drug
Action wherein plaintiff consumers challenged
gle active component drug, though administra-
fulfill premarketing requirements. Rutherford
Administration. Hanson V. U.S., D.C.Minn.1976,
regulations adopted by Food and Drug Adminis-
tion had previously determined that drug had
V. U.S., C.A.Okl.1980, 616 F.2d 455, certiorari
417 F.Supp. 30, affirmed 540 F.2d 947.
tration for policing the nation's over-the-counter
not been shown to be effective as fixed combina-
denied 101 S.Ct. 836, 449 U.S. 987, 66 L.Ed.2d
Under section 1337 of Title 28 giving the
drug market met the ripeness requirement in
tion drug. Sterling Drug Inc. V. Weinberger,
160.
district courts original jurisdiction of any civil
that the issue whether the regulations were
C.A.N.Y.1975, 509 F.2d 1236.
Where Federal Trade Commission sought an
action or proceeding arising under any act of
consistent with the statutory scheme pursuant
20. Estoppel
order requiring weight loss clinics to disclose in
Congress regulating commerce, the district
to which they were promulgated was fit for
their advertisements the fact that one of the
court had jurisdiction of class action brought
judicial resolution and both litigants would suf-
Drug manufacturer could be collaterally es-
drugs being used in the program was a new
against the United States and the Secretary of
fer a hardship from further delay in resolving
topped from litigating, in seizure proceeding,
drug which had not been determined by the
Health, Education and Welfare by cancer vic-
that issue. Cutler V. Kennedy, D.C.D.C.1979,
whether Fiorinal with codeine was "new drug"
Food and Drug Administration to be effective
time, and their spouses, seeking an order direct-
475 F.Supp. 838.
that could not be marketed without Food and
for obesity, FTC did not have the burden of
ing the Federal Drug Administration to desist
Where individual and corporate defendant had
Drug Administration (FDA) approval, in view of
proving that the weight loss clinics' program
from precluding the administration of laetrile to
actual notice that Food and Drug Administra-
determination in prior seizure proceeding con-
was unsafe or ineffective. Simeon Management
patients in the United States suffering from
tion considered subject drugs "new drugs" and
cerning related drugs that differed only in
Corp. V. F.T.C., C.A.9, 1978, 579 F.2d 1137.
cancer, as the prohibiting language of this sec-
knew that there was no effective new drug
amount of codeine they contained; amounts of
application permitting sale of subject drugs, de-
codeine in drugs was immaterial to new drug
Those who seek to market a drug or food
tion stems from and has to do with commerce
powers of the United States, and as plaintiffs
fendants were not entitled to claim that this
determination, factual and legal issues in pro-
additive in interstate commerce have some bur-
section prohibiting sale of new drugs without
ceedings were almost identical, findings of other
den of proving the safety and, for drugs, the
were being precluded from transporting laetrile
in commerce. Rutherford V. U.S., D.C.Okl.1975,
approval of new drug application by FDA was
court were necessary to outcome of prior pro-
effectiveness of their product. U.S. V. Articles
399 F.Supp. 1208, affirmed and remanded on
unconstitutionally vague and could not support a
ceeding, and manufacturer had full and fair op-
of Food and Drug Consisting of Coli-Trol 80,
conviction. U.S. V. Marcen Laboratories, Inc.,
portunity to litigate in other proceeding. U.S. V.
F4C-60 Feed Grade, Entrol-S Medicated, En-
other grounds 542 F.2d 1137, on remand 424
D.C.N.Y.1976, 416 F.Supp. 453, affirmed 556
Sandoz Pharmaceuticals Corp., C.A.6 (Ohio)
trol-P, C.A.Ga.1975, 518 F.2d 743.
F.Supp. 105.
F.2d 562.
1990, 894 F.2d 825, certiorari denied 111 S.Ct.
Those who seek to market a drug or food
18. Persons entitled to bring suit
45, 498 U.S. 810, 112 L.Ed.2d 21.
additive in interstate commerce have some bur-
Drug company met "zone of interests" test for
As the named plaintiff, a cancer victim, and
those similarly situated were wholly without
Prior litigation between consumers of over-
den of proving the safety and, for drugs, the
prudential standing to bring action to prevent
the-counter drugs and Food and Drug Adminis-
effectiveness of their product. U.S. V. Articles
Food and Drug Administration (FDA) from ap-
means or resources to comply with provisions of
tration in which it was determined that consum-
of Food and Drug Consisting of Coli-Trol 80,
proving generic versions of Intal Nebulizer Solu-
this section pertaining to filing an application
tion (eromolyn) without requiring specific test-
with the Secretary of Health, Education and
ers had standing to challenge Food and Drug
F4C-60 Feed Grade, Entrol-S Medicated, En-
Welfare for approval to introduce a new drug
Administration's regulations, which went unap-
trol-P, C.A.Ga.1975, 518 F.2d 743.
ing, as Congress intended Hatch-Waxman
into interstate commerce, the named plaintiff
pealed by Food and Drug Administration, pre-
Burden is on sponsor of new drug to demon-
Amendments which govern FDA's approval of
cluded Food and Drug Administration from at-
strate its safety and effectiveness. Edison
applications for generic versions of pioneer
and those similarly situated, in being thus de-
tempting to assert that consumers had no stand-
Pharmaceutical Co., Inc. V. Food and Drug Ad-
drugs to benefit pioneer drug manufacturers.
nied freedom of choice for treatment by the
ing to challenge rule implementing Food, Drug,
ministration, Dept. of Health, Ed. and Welfare,
Fisons Corp. V. Shalala, D.D.C.1994, 860 F.Supp.
drug laetrile to alleviate or cure their cancer,
and Cosmetic Act, under doctrine of collateral
1975, 518 F.2d 1063, 168 U.S.App.D.C. 273, re-
859.
were deprived of life, liberty or property without
estoppel, in absence of evidence of change in
due process of law. Rutherford V. U.S.,
hearing denied 517 F.2d 164, 170 U.S.App.D.C.
Claim of AIDS (Acquired Immunodeficiency
controlling facts sufficient to justify exception to
350.
D.C.Okl.1975, 899 F.Supp. 1208, affirmed and
Syndrome) sufferer that drug manufacturer and
collateral estoppel principles. Cutler V. Hayes,
remanded on other grounds 542 F.2d 1187, on
Drug manufacturers must carry burden of
university acted illegally when they terminated
1987, 818 F.2d 879, 260 U.S.App.D.C. 230.
remand 424 F.Supp. 105.
showing by substantial evidence the claimed effi-
investigation into use of drug Ampligen as treat-
Since Food and Drug Administration had no
Consumer organizations were without stand-
cacy and safety of drugs. North American
ment for the disease and ceased providing him
authority to approve marketing of drug product
Pharmacal, Inc. V. Department of Health, Ed.
with the drug as part of their clinical studies did
ing to institute suit against drug companies on
without new drug application, Government was
and Welfare, C.A.8, 1973, 491 F.2d 546.
not arise under the Federal Food, Drug, and
behalf of themselves, their members and all
not estopped from asserting that that drug
other purchasers of certain allegedly ineffective
Physicians and patients challenging, by way of
Coametic Act 80 as to give court jurisdiction
product and related product were "new drugs"
drugs to recover money spent by purchasers of
petition for preliminary injunction, decision of
over his claim as the civil action arising under an
under section 321 of this title. U.S. V. Articles
act of Congress regulating commerce. DeVito
such drugs and to obtain punitive damages
Secretary suspending new drug applications for
of
Drug
HORMONIN, D.C.N.J.1980, 498
V. HEM, Inc., M.D.Pa.1988, 705 F.Supp. 1076.
where such organizations had not purchased any
phenformin hydrochloride on ground that drug
F.Supp. 424, affirmed 672 F.2d 902, 904.
of drugs involved and had not themselves been
posed an "imminent hazard" had burden of dem-
Drug manufacturer which marketed drug un-
injured in fact, and where individualized proof
United States was not estopped from bringing
onstrating substantial likelihood that decision
der trademark and which filed pioneer new drug
would be necessary to establish each particular
an enforcement proceeding to prevent further
was a clear error of judgment and that he failed
application for that drug had standing to file
purchase and resulting damages incurred by
shipment of drug X-Otag Plus in interstate
to articulate any rational connection between
action challenging Food and Drug Administra-
each member and individual damage claims
commerce without first obtaining an approved
facts submitted to him and choice he made.
tion's approval of new drug application to Brit-
would be governed by common law of each state
new drug application or abbreviated new drug
Forsham V. Califano, D.C.D.C.1977, 442 F.Supp.
ish manufacturer and distributor of drug called
in which drug sales took place. Consumer Fed-
application despite claim that, because of refusal
203.
"ibuprofen" on its claim of competitive market
eration of America V. Upjohn Co., D.C.App.1975,
of Food and Drug Administration to follow its
position and its claim that trade secret data and
346 A.2d 725.
own regulations, abbreviated new drug applica-
22. Evidence
information contained in its pioneer new drug
tion submitted by manufacturer for X-Otag
"Substantial evidence," as used in this section,
application was made subject to public disclo-
18a. Discretion of court
Plus was rejected. U.S. V. X-Otag Plus Tab-
which directs the Food and Drug Administration
sure due to approval of challenged new drug
Trial court did not abuse its discretion in
lets, D.C.Colo.1977, 441 F.Supp. 105, affirmed in
to refuse approval of a new drug application or
application. Upjohn Mfg. Co. V. Schweiker,
diamissing, on forum non conveniens grounds,
part, remanded in part, on other grounds 602
to withdraw any prior approval if substantial
F.2d 1387.
216
evidence that the drug is effective for its intend-
917
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 22
Note 25
ed use is lacking, means adequate and well-
Substantial evidence of effectiveness is a nec-
adequate and well-controlled studies of product
controlled investigations from which experts
Health, Ed. and Welfare, 1979, 600 F.2d 831, 195
essary but not a sufficient condition for approval
itself or by adequate and well-controlled studies
may conclude that the drug will have the
U.S.App.D.C. 17.
of a new drug application. Edison Pharmaceuti-
which concern another drug with same active
claimed effect. CIBA Corp. V. Weinberger, N.J.
cal Co., Inc. V. Food and Drug Administration,
ingredients and which demonstrate bioequiva-
At hearing on new drug application, adminis-
1973, 98 S.Ct. 2495, 412 U.S. 640, 37 L.Ed.2d
1975, 517 F.2d 164, 170 U.S.App.D.C. 850.
lence of product and other drug. U.S. V. Unde-
trative law judge correctly excluded evidence of
280.
termined Quantities of an Article of Drug
tests that were not submitted with the new drug
Meaning of label is relevant to general recog-
Phrase "lack of substantial evidence," in this
nition of safety of alleged new drug. U.S. V.
(Anucort HC Suppositories), D.N.J.1987, 709
application where the drug manufacturer had
section which directs Food and Drug Adminis-
F.Supp. 511, affirmed 857 F.2d 1464, 1466, cer-
failed to invoke the regulation which provides a
1,048,000 Capsules, More of Less, "Afrodex,"
tration to refuse approval of a new drug applica-
C.A.Tex.1974, 494 F.2d 1158.
tiorari denied 109 S.Ct. 864, 488 U.S. 1040, 102
procedure for filing new studies. Edison Phar-
tion and to withdraw any prior approval if sub-
Evidence supported order of Food and Drug
L.Ed.2d 988.
maceutical Co., Inc. V. Food and Drug Admin.,
Dept. of Health, Ed. and Welfare, 1979, 600 F.2d
stantial evidence that drug is effective for its
Administration withdrawing approval of new-
Even if substantial evidence to support gener-
831, 195 U.S.App.D.C. 17.
intended use is lacking, is not applicable only to
drug applications covering combination amphet-
al recognition of safety and effectiveness of a
proof of actual effectiveness of drugs that fall
amine products. North American Pharmacal,
combination drug exists concerning the individu-
At hearing on new drug application, adminis-
within definition of a new drug; hurdle of "gen-
al components of the drug, there must also be
trative law judge properly excluded as irrelevant
Inc. V. Department of Health, Ed. and Welfare,
eral recognition" of effectiveness requires at
substantial evidence of the safety and efficacy of
evidence concerning different treatment which
C.A.8, 1978, 491 F.2d 546.
least substantial evidence of effectiveness for
approval of a new drug application. Weinberger
Evidence warranted submission to jury of is-
the combination of the generally recognized
the Administration allegedly gave to another
drug. Edison Pharmaceutical Co., Inc. V. Food
components in order for the combination drug to
V. Hynson, Westcott and Dunning, Inc., Va.1973,
sue of whether "Aralen" (chloroquine phosphate)
was sold for use in the treatment of lupus
transcend "new drug" status. U.S. V. Articles of
and Drug Admin., Dept. of Health, Ed. and
98 S.Ct. 2469, 412 U.S. 609, 37 L.Ed.2d 207.
erythematosus without adequate testing to de-
Drugs HORMONIN, D.C.N.J.1980, 498
Welfare, 1979, 600 F2d 831, 195 U.S.App.D.C.
17.
Evidence submitted by drug manufacturer
termine possible harmful side effects. Hoffman
F.Supp. 424, affirmed 672 F2d 902, 904.
with respect to efficacy of drug for use in treat-
V. Sterling Drug, Inc., C.A.Pa.1973, 485 F.2d
Plaintiffs, who sought to establish their stand-
24. Questions of fact
ment of premature labor and habitual abortion,
132, on remand 874 F.Supp. 850.
ing as consumers to challenge regulations
Factual question as to whether double-blind
including a list of literature references, a copy of
an unpublished study, and a representative sam-
The "substantial evidence" standard as set out
adopted by the Food and Drug Administration
tests for new drug were too dangerous to per-
ple testimonial letter on behalf of the drug, was
in this section and regulation with respect to
with respect to policing the nation's over-the-
form was a sufficiently material fact in dispute
showing required by manufacturers of drugs is
counter drug market, were not required,
to require an evidentiary hearing on drug manu-
sufficient to warrant a hearing on proposed
through independent research, to monitor the
facturer's new drug application before Commis-
withdrawal of effective new drug application be-
directed only to question of efficacy, and a dif-
cause of lack of substantial evidence of efficacy
ferent standard applies where question of safety
Federal Register or similar means to keep
aioner could issue a final order. Edison Phar-
arises, and such different standard should be
abreast of precisely which of the thousands of
maceutical Co. Inc. V. Food and Drug Adminis-
of the drug. Weinberger V. Hynson, Westcott
and Dunning, Inc., Va.1973, 93 S.Ct. 2469, 412
articulated by the Food and Drug Administra-
the over-the-counter drug products contained
tration, Dept. of Health, Ed. and Welfare, 1975,
tion. E. R. Squibb & Sons, Inc. V. Weinberger,
conditions classifying Category III since such
513 F.2d 1063, 168 U.S.App.D.C. 273, rehearing
U.S. 609, 87 L.Ed.2d 207.
C.A.3, 1973, 483 F.2d 1382.
efforts would not alleviate the injury to their
denied 517 F.2d 164, 170 U.S.App.D.C. 350.
To prevail at a Food and Drug Administration
statutory interests any more than would decision
hearing on proposed withdrawal of an effective
Evidence that drug was, prior to Oct. 9, 1962,
Whether Federal Food and Drug Administra-
to forgo the use of the drugs altogether. Cutler
new drug application because of lack of substan-
effective date of amendments to provisions of
tion had new information which would justify
V. Kennedy, D.C.D.C.1979, 475 F.Supp. 838.
tial evidence of efficacy, applicant must furnish
this chapter, prescribed and enthusiastically en-
withdrawal of approval of new drug application
Fact that much of the raw data used by
in effect for prescription drug was factual deter-
evidence stemming from adequate and well-con-
dorsed by a few physicians in one city and sold
trolled investigations. Weinberger V. Hynson,
to no more than 150 to 200 doctors in two or
Bureau of Drugs in arriving at its conclusion
mination to be made first by the Administration.
three neighboring states was insufficient to es-
that drug posed an imminent hazard had been
Sterling Drug Inc. V. Weinberger, C.A.N.Y.1975,
Westcott and Dunning, Inc., Va.1978, 93 S.Ct.
available for some length of time did not pre-
509 F.2d 1236.
2469, 412 U.S. 609, 37 L.Ed.2d 207.
tablish that the drug was generally recognized
as safe on the date in question, and thus drug
clude use of data in finding imminent hazard
Affidavits stating that particular disease that
Drug manufacturer's attempt to replace evi-
was not entitled to "grandfather clause" exemp-
where magnitude of drug's risk was determined
drug was marketed as treatment for was hard to
dence of controlled investigation with testimony
tion from present requirement of this chapter
only after extensive reevaluation of data follow-
diagnose. ran variable course, and caused pain
relating to personal experiences or clinical im-
that drug not be shipped in interstate commerce
ing hearing. Forsham V. Califano, D.C.D.C.
did not create factual question requiring Food
pressions arising from use of proposed new drug
without prior approval of a new drug application
1977, 442 F.Supp. 203.
and Drug Administration to conduct hearing as
was inconsistent with this chapter as well as
unless it is generally recognized as both safe and
Even though testimony of general practition-
to whether testimonials of experienced physi-
with accompanying regulations and explicit Su-
effective. U.S. V. An Article of Drug
ers as to safety or efficacy of drugs may be less
cians, rather than controlled studies, should be
preme Court precedent. Edison Pharmaceutical
"Bentex Ulcerine", C.A.Tex.1972, 469 F.2d 875,
than compelling, court will not reject all clinical
recognized as substantial evidence of drug's effi-
Co., Inc. V. Food and Drug Admin., Dept. of
certiorari denied 93 S.Ct. 2772, 412 U.S. 938, 37
impressions by general practitioners in suit to
cacy. Cooper Laboratories, Inc. V. Commission-
Health, Ed. and Welfare, 1979, 600 F.2d 831, 195
L.Ed.2d 397.
condemn misbranded drug. U.S. V. 1,048,000
er, Federal Food and Drug Administration,
U.S.App.D.C. 17.
Decision of Commissioner of Food and Drugs
Capsules, More or Less, D.C.Tex.1972, 347
1974, 501 F.2d 772, 163 U.S.App.D.C. 212.
Substantial evidence including the testimony
relating to marketing order entered after a
F.Supp. 768, affirmed 494 F.2d 1158.
Whether drug manufacturers violated this
of three expert witnesses supported decision of
hearing will be upheld and sustained by any
Evidence in suit to condemn allegedly mis-
section by not submitting new drug application
the Commissioner that both animal studies and
substantial evidence, but in determining whether
branded drugs was insufficient to meet claim-
to Food and Drug Administration for "Aralen,"
clinical testing offered by drug manufacturer in
Commissioner acted within limits of discretion
ant's burden of proving, as bearing on right to
their trade name for chloroquine phosphate,
support of new drug application were insuffi-
on procedural question of whether hearing is to
benefit of grandfather clause exemption from
when the drug was offered for use in the treat-
cient and failed to demonstrate the safety of the
be allowed, test is whether there is any genuine
showing of effectiveness, that on October 9, 1962
ment of lupus erythematosus was question for
new drug. Edison Pharmaceutical Co., Inc. V.
and substantial evidence that supports position
the drug was generally recognized among quali-
jury in user's action against manufacturers for
Food and Drug Admin., Dept. of Health, Ed.
of applicant. Hynson, Westcott & Dunning, Inc.
fied experts as safe for use under the conditions
loss of vision as result of using the drug. Hoff-
and Welfare, 1979, 600 F.2d 831, 195 U.S.App.
V. Richardson, C.A.4 1972, 461 F.2d 215, modi-
prescribed, recommended or suggested in the
man V. Sterling Drug, Inc., C.A.Pa.1973, 485
D.C. 17.
fied on other grounds 93 S.Ct. 2469, 412 U.S.
labeling as of that date. U.S. V. 1,048,000 Cap-
F.2d 132, on remand 374 F.Supp. 850.
A drug can be generally recognized as effec-
609, 37 L.Ed.2d 207.
sules, More or Less, D.C.Tex.1972, 847 F.Supp.
Whether manufacturers' alleged violation of
tive only if the expert consensus is based upon
Evidence in proceeding to withdraw approval
768, affirmed 494 F.2d 1158.
this section in the introduction of "Aralen" (chlo-
substantial evidence that the drug is effective
of drug supported finding that manufacturer's
22a. Admissibility of evidence
roquine phosphate) without new drug statement
for the labeled use; anecdotal evidence, such as
studies of effect of drug, which was designed to
for use in the treatment of lupus erythematosus
testimonials by satisfied patients or statements
reduce incidence of certain attacks of vertigo,
At hearing on new drug application, adminis-
was proximate cause of the user's loss of vision
by doctors that, based on their experience, they
were not sufficiently adequate and well con-
trative law judge properly excluded testimonial
from use of the drug was question for the jury.
believe the drug is effective do not constitute
trolled as to constitute substantial evidence of
evidence which the drug manufacturer offered to
Hoffman V. Sterling Drug, Inc., C.A.Pa.1973, 485
adequate and well-controlled investigations and
claims for efficacy. Unimed, Inc. V. Richardson,
demonstrate the efficacy of the new drug; per-
F.2d 132, on remand 374 Supp. 850.
cannot provide substantial evidence of effective-
1972, 458 F.2d 787, 147 U.S.App.D.C. 368.
sonal testimonials simply did not meet the exact-
ness. Simeon Management Corp. V. F.T.C.,
ing standard of evidence required by this chap-
25. Injunction
C.A.9, 1978, 579 F.2d 1187.
Substantial evidence of safety and effective-
ter and regulations. Edison Pharmaceutical
ness of alleged new drug can be shown only by
Corporation which acquired title to new drug
Co., Inc. V. Food and Drug Admin., Dept. of
application was not in contempt of order enjoin-
218
910
21 8 355
FOOD AND DRUGS
Note 25
ing previous holder of application from infring-
FOOD AND DRUGS
21 § 355
ing plaintiff's drug patents; plaintiff failed to
antibiotic drug. manufacturer was not entitled to
show that corporation, which acquired title to
preliminary injunction to compel Food and Drug
Note 27
application and which was not a party to patent
Administration to withhold approval of competi-
Administration developed proper administrative
Pharmaceutical Manufacturers V. Department of
tor's application to market generic version of
record to support its claim that laetrile was a
infringement case, was an instrumentality of
Health and Human Services, D.C.N.Y.1984, 586
manufacturer's new antibiotic drug; public in-
new drug. Rutherford V. U.S., D.C.Okl.1977,
F.Supp. 740.
previous holder designed to evade injunction or
acted in concert or in participation with original
terest was best served by allowing agency to
429 F.Supp. 506.
Record was inadequate to support finding that
defendants in patent infringement action, and
interpret its own regulations and to operate
In cancer patient's action for preliminary in-
Food and Drug Administration abused its dis-
new drug application was not equivalent to prod-
unimpeded by courts in such matter. Glaxo,
junction to restrain government or its agents
cretion by failing to exercise authority to imme-
uct addressed and did not authorize anyone to
Inc. V. Heckler, D.C.N.C.1985, 623 F.Supp. 69.
from barring patient's importation of Laetrile
diately suspend drugs which present an immi-
make, use or sell drug. EH Lilly and Co. V.
Even if placement of an over-the-counter drug
solely for his personal use, plaintiff failed to
nent hazard to the public health. American
Premo Pharmaceutical Laboratories, Inc.,
in Category III, absent grandfather status or
demonstrate substantial probability of success
Public Health Ass'n. V. Veneman, D.C.D.C.1972,
C.A.Fed. (N.J.) 1988, 843 F.2d 1378.
coverage by a new drug application, was tanta-
with respect to his claim that Laetrile was not
349 F.Supp. 1311.
Where court's recall order did not address
mount to a finding of illegality under this chap-
"new drug" within meaning of this section pro-
ter, it was not necessary to issue an injunction
hibiting importation of such drug until approval
27. Summary judgment
particular violation of this chapter from which
injury might be presumed, an independent
requiring the commissioner to take the drugs off
of new drug application by Food and Drug
Study which compared new drug's efficacy
showing of irreparable harm was required to
the over-the-counter market, but only necessary
Administration. Gadler V. U.S., D.C.Minn.1977,
against that of drug known to be effective and
to issue an injunction prohibiting the commis-
425 F.Supp. 244.
which observed that rate of remission for known
warrant issuance of such order. U.S. V. Spectro
Foods Corp., C.A.N.J.1976, 544 F.2d 1175.
sioner from implementing the offensive aspects
Proper procedure for manufacturers and dis-
drug was 56.5% and that for new drug was
of the subject regulations. Cutler V. Kennedy,
Questions as to whether laetrile was marketed
tributors of prescription drug involved in pro-
27.6% and thus did not show new drug to be as
D.C.D.C.1979, 475 F.Supp. 838.
on October 9, 1962, as a cancer drug and was
ceeding to withdraw approval of new drug appli-
effective as active control did not produce evi-
then generally recognized as safe, or whether it
Litigation by Food and Drug Administration
cations was to raise defense of res judicata in
dence of new drug's efficacy and thus did not
was recognized or used as a cancer drug under
of new drug status of two products manufac-
the administrative proceedings and then have
meet Food and Drug Administration's regulato-
the same conditions of present use during the
tured by plaintiff in pending condemnation ac-
the agency determination on that issue, should it
ry standards for adequate and well-controlled
period when the Food and Drugs Act of 1906
tions would not be preliminarily enjoined given
be contrary to their claim, reviewed on appeal to
investigations 80 as to preclude summary judg-
[Act June 30, 1906, Ch. 8915, 84 Stat. 768] was in
serious question as to correctness of dictum in
court of appeals from whatever adverse final
ment order denying new drug application. Hol-
effect, and thus question of whether laetrile is
Lannett decision permitting a generic or "me-
decision the FDA might make with respect to
land-Rantos Co., Inc. V. U.S. Dept. of Health,
exempt as a new drug under this section were
too" drug to be marketed without premarketing
withdrawal proceedings and manufacturers and
Ed. and Welfare, 1978, 587 F.2d 1173, 190
U.S.App.D.C. 276.
sufficiently substantial, difficult and doubtful to
approval if its therapeutically active ingredients
distributors were not entitled to circumvent the
support grant of preliminary injunction against
are identical to a recognized drug both chemical-
administrative channels by seeking to enjoin the
Food and Drug Administration's endorsement
interference with cancer patient's personal use
ly and quantitatively. Pharmadyne Laborato-
proceeding. Sterling Drug, Inc. V. Weinberger,
of Dexedrine as effective for short term manage-
of the drug. Rutherford V. U.S., C.A.OkL1976,
ries, Inc. V. Kennedy, D.C.N.J.1979, 466 F.Supp.
D.C.N.Y.1974, 384 F.Supp. 557, affirmed 509
ment of obesity provided prima facie support for
100, affirmed 596 F.2d 568.
542 F.2d 1137, on remand 424 F.Supp. 105.
F.2d 1236.
drug manufacturer's use of Dexedrine as active
District court did not abuse its discretion in
Plaintiff who was dying from cancer of the
control in testing efficacy of new drug to be used
26. Record
pancreas and who sought to enjoin the Food and
in the control of obesity, precluding summary
refusing to enjoin United States authorities from
interfering with distribution of specified vitamin
Drug Administration from interfering with im-
Food and Drug Administration must produce
judgment order denying new drug application on
portation or interstate transportation of Laetrile
an administrative record to support its determi-
ground that clinical trials testing drug's efficacy
which had not been approved for distribution by
for purposes of his own consumption raised right
nation that laetrile is a new drug; FDA must
were deficient under FDA regulation requiring
the Food and Drug Administration, in absence
of privacy issue sufficiently serious to be fair
present substantial evidence to support the
that study provide comparison of results of
of showing by distributors that there was sub-
grounds for litigation, warranting preliminary
proposition that laetrile is not generally recog-
treatment or diagnosis with a control in such a
stantial probability of success with respect to
their claim that such vitamin was not a sub-
injunction. Rizzo V. U.S., D.C.N.Y.1977, 432
nized among qualified experts as safe and effec-
fashion as to permit quantitative evaluation.
F.Supp. 356.
tive and that its use is not grandfathered in.
Smithkline Corp. V. Food and Drug Administra-
stance subject to control within meaning of this
Plaintiff who was dying from cancer and who
Rutherford V. U.S., C.A.Okl.1976, 542 F.2d 1137,
tion, 1978, 587 F.2d 1107, 190 U.S.App.D.C. 210.
chapter. Hanson V. U.S., C.A.Minn.1976, 540
F.2d 947.
sought to enjoin Food and Drug Administration
on remand 424 F.Supp. 105.
This section granting applicant's right to due
Pharmaceutical company was not entitled to
from preventing importation or interstate trans-
Record established that studies whereby 50
notice and opportunity for hearing prior to with-
portation of Laetrile for purposes of his own
patients with herpes zoster were treated with
drawal of approval to market new drugs in
injunctive relief prohibiting Food and Drug Ad-
consumption raised due process question in re-
drug while six received a placebo but without
interstate commerce does not preclude use of
ministration from granting approval of generic
gard to requirement of filing and prosecution of
method of selecting patients to insure that sub-
summary judgment procedure by Food and
copies of drug product Desyrel, trazadone HCL
within ten-year period of nonpatent marketing
a "new drug" application of sufficient serious-
jects were suitable for purposes of study, with-
Drug Administration in appropriate circum-
exclusivity provided by 1984 amendments to the
ness to make it fair grounds for litigation, war-
out subjects being designed in such way as to
stances, but it does restrict application of that
Federal Food, Drug, and Cosmetic Act; there
ranting preliminary injunction. Rizzo V. U.S.,
minimize bias, and without comparability of per-
procedure to cases in which no material factual
D.C.N.Y.1977, 432 F.Supp. 356.
tinent variables being assured, and study where-
issue is presented and a hearing would be a
was no substantial likelihood that pharmaceuti-
cal company could demonstrate that letter of
Balance of equities tipped decidedly in favor
by 34 patients with herpes zoster were treated
hollow formality. USV Pharmaceutical Corp. V.
December 24, 1981, which stated that drug "is
of granting temporary injunction to plaintiff, a
with drug and ten with injections of Vitamin B₁₂
Secretary of Health, Ed. and Welfare, 1972, 466
approved" and which approval would except
cancer patient, who sought to enjoin Food and
were not "well-controlled" and were properly
F.2d 455, 151 U.S.App.D.C. 284.
drug from ten-year period of nonpatent market-
Drug Administration from preventing importa-
rejected by Food and Drug Administration as
Manufacturer of hemorrhoidal suppositories
ing exclusivity, was not approval letter, pharma-
tion or interstate transportation of Laetrile for
proof of efficacy of drug. Cooper Laboratories,
with hydrocortisone acetate was not entitled to
ceutical company did not demonstrate existence
purposes of his own consumption and plaintiff
Inc. V. Commissioner, Federal Food and Drug
discovery of specific instances in which Food
of imminent injury in connection with disclosure
sufficiently demonstrated possibility of irrepara-
Administration, 1974, 501 F.2d 772, 168
and Drug Administration approved drug based
of safety and effectiveness data, and pharmaceu-
ble injury by death. Rizzo V. U.S., D.C.N.Y.
U.S.App.D.C. 212.
on extrapolation, in that studies of approved
tical company failed to demonstrate that grant-
1977, 432 F.Supp. 356.
Exclusion from administrative record of docu-
drug could not be extrapolated to newly market-
ing of injunctive relief would not significantly
Since plaintiff class, all terminally ill cancer
ments generated in course of Food and Drug
ed product simply on basis that new product
harm other interested parties. Mead Johnson
patients, was in danger of suffering irreparable
Administration's compliance and enforcement
contained same active ingredient as approved
Pharmaceutical Group V. Bowen, D.D.C.1986,
injury if relief in form of allowing such patients
activities did not preclude meaningful public
drug. U.S. V. Undetermined Quantities of an
655 F.Supp. 53, affirmed 838 F.2d. 1332, 267
who wished to import laetrile for use was post-
comment on or judicial review of Administra-
Article
of
Drug
(Anucort HC Suppositories),
U.S.App.D.C. 382.
poned or denied and the potential loss to the
tion's "current good manufacturing practice"
D.N.J.1987, 709 F.Supp. 511, affirmed 857 F.2d
Absent showing that probable injury to drug
Food and Drug Administration from granting of
regulations in view of their general, nontechnical
1464, 1466, certiorari denied 109 S.Ct. 864, 488
nanufacturer without preliminary injunction
relief was slight and record disclosed indications
nature, especially as administrative record did
U.S. 1040, 102 L.Ed.2d 988.
outweighed harm to Food and Drug Administra-
that laetrile was exempt from new drug classifi-
include descriptive summaries of the Adminis-
In action brought against Secretary by physi-
ion and competitor with preliminary injunction
cation under grandfather clause, court would
tration's enforcement activities and most of the
cians and patients who sought to preliminarily
or showing of likelihood of success on merits,
grant temporary injunction to permit class to
actual documents were available for public in-
enjoin Secretary from implementing order sus-
import and use laetrile while the Food and Drug
spection either in the Administration's files or
pending new drug applications for phenformin
220
through requests under Freedom of Information
hydrochloride on ground that drug posed an
Act
559
5
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
Note 27
Note 33
Secretary was precluded by existence of issues
of material fact. Forsham V. Califano, D.C.D.C.
muco-evacuant drug "Alevaire," the court of ap-
made and it became clear on what specific infor-
trative determination, the district court, in exer-
peals would deny manufacturers' motion to re-
mation FDA relied for its conclusion, could court
1977, 442 F.Supp. 208.
cise of its sound discretion under Declaratory
quire the Administration to remove a listing of
determine whether data used constituted new
Judgment Act, section 2201 et seq. of Title 28,
28. Review
"Alevaire" as "ineffective" from the Administra-
information. Sterling Drug, Inc. V. Weinberger,
would refuse to take jurisdiction of action for
While a Food and Drug Administration order
tion's Interim Index. Sterling Drug Inc. V.
D.C.N.Y.1974, 884 F.Supp. 557, affirmed 509
declaration that particular drugs were not "new
denying a new drug application or withdrawing
Weinberger, C.A.2, 1974, 508 F2d 675.
F.2d 1236.
drug." National Ethical Pharmaceutical Ass'n
one is reviewable by the Court of Appeals under
Issue of whether anorectic drugs containing
Complaint seeking determination as to wheth-
V. Weinberger, D.C.S.C.1978, 365 F.Supp. 785,
this section, an order declaring a "new drug"
amphetamines were "grandfathered" by 1962
er drug was 8 "new drug" was an inappropriate
affirmed 503 F.2d 1051.
status is reviewable under the Administrative
amendments to this chapter was initially a mat-
vehicle to determine issues of case as, if plain-
ter for determination of the Food and Drug
30. Prescription drugs
Procedure Act, sections 551 et seq. and 701 et
tiffs were to seek judicial review of any Food
seq. of Title 5, by the district court. Wein-
Administration, subject to review in district
and Drug Administration order, complaint would
Prescription drugs on market are subject to
berger V. Bentex Pharmaceuticals, Inc., S.C.
court pursuant to the Administrative Procedure
have to be withdrawn and petition for review
efficacy requirements of this chapter. USV
1978, 98 S.Ct. 2488, 412 U.S. 645, 87 L.Ed.2d
Act, sections 551 et seq. and 701 et seq. of Title
substituted. Carolina Brown, Inc. V. Wein-
Pharmaceutical Corp. V. Weinberger, Va.1973,
285.
5, and could not be determined by the Court of
berger, D.C.S.C.1973, 365 F.Supp. 310.
93 S.Ct. 2498, 412 U.S. 640, 37 L.Ed.2d 230.
Declaratory order of Food and Drug Adminis-
Appeals in action by manufacturers of such
Manufacturer of pioneer antibiotic drug was
drugs to set aside order of Administration with-
28a. Standards of review
tration that a drug is a "new drug" so as to
not entitled to protection of amendment to Fed-
require an effective new drug application before
drawing approval of new-drug applications cov-
The Food and Drug Administration's denial of
eral Food, Drug and Cosmetic Act preventing
drug may be introduced into commerce is not
ering combination amphetamine products.
claimant's request for relabeling of medical de-
any manufacturer of prescription pharmaceutical
reviewable in the Court of Appeals under sub-
North American Pharmacal, Inc. V. Department
vice was an informal adjudicatory process, as to
drugs from marketing generic version of drug
sec, (h) of this section, but is reviewable by the
of Health, Ed. and Welfare, C.A.8, 1973, 491
which Administration was not required to con-
for five years from date of pioneer drug's ap-
F.2d 546.
district court under Administrative Procedure
duct an "on the record" hearing to produce
proval, where drug had not been submitted and
Act, sections 551 et seq. and 701 et seq. of Title
Court of Appeals did not lack jurisdiction to
record that was basis of action, the basic re-
approved pursuant to referenced section and
5. Weinberger V. Hynson, Westcott and Dun-
review merits of petition by manufacturers of
quirement for substantial evidence review, and
had been approved pursuant to another section
ning, Inc., Va.1978, 98 S.Ct. 2469, 412 U.S. 609,
anorectic drugs containing amphetamines to set
thus, decision to deny relabeling was subject to
and only thereafter exempted and subsequently
37 L.Ed.2d 285.
aside order of Food and Drug Administration
review under the arbitrary and capricious stan-
regulated under governing statute. Glaxo, Inc.
In reviewing an order of the Commissioner
withdrawing approval of new-drug applications
dard contained in 5 U.S.C.A. $ 706(2)(A). U.S.
V. Bowen, E.D.N.C.1986, 640 F.Supp. 933.
denying a hearing on proposed withdrawal of an
covering combination amphetamine products be-
V. An Article of Device
Diapulse, C.A.7 (III)
effective new drug application because of lack of
cause manufacturers were not holders of such
1985, 768 F.2d 826.
31. Drugs administered by physicians
substantial evidence of efficacy of the drug, a
applications but manufactured drugs which were
Whether or not endocrine drug was a "new
Court of Appeals must determine whether the
identical, similar or related to drugs covered by
29. Declaratory judgment
drug," operators of weight reduction clinics were
Commissioner's findings accurately reflect study:
another manufacturer's new drug application.
Where order of Commissioner on Food and
not required to seek Food and Drug Administra-
in question and if they do, whether the deficien-
North American Pharmacal, Inc. V. Department
Drugs withdrawing drug manufacturer's new
tion approval for use of the drug in treatments
cies he finds conclusively render the study inad-
of Health, Ed. and Welfare, C.A.8, 1978, 491
drug applications had not become final prior to
administered by licensed physicians. F.T.C. V.
F.2d 546.
equate or uncontrolled in light of the pertinent
district court assuming jurisdiction of manufac-
Simeon Management Corp., D.C.Cal.1975, 391
regulations. Weinberger V. Hynson, Westcott
In suit for damages and injunctive relief based
turer's suit for declaratory judgment that its
F.Supp. 697, affirmed 582 F.2d 708.
and Dunning, Inc., Va.1973, 93 S.Ct. 2469, 412
on alleged conspiracy by defendants to keep
drugs were exempt from efficacy requirements,
The Food and Drug Administration does not
U.S. 609, 37 L.Ed.2d 235.
plaintiffs' drug off interstate market by influenc-
and in fact the Court of Appeals had reversed
have jurisdiction to regulate the administration
Deference owed to political branches in mill-
ing the Administration to deny fair consideration
the Commissioner's decision and proceedings on
of a drug by a physician. F.T.C. V. Simeon
tary matters did not preclude judicial review of
of new drug applications, district court should
remand were pending before the Commission,
Management Corp., D.C.Cal.1975, 391 F.Supp.
Food and Drug Administration (FDA) regula-
not be inhibited from considering conclusions
manufacturer was not barred from proceeding in
697, affirmed 532 F2d 708.
tion permitting Defense Department to use
reached by the Administration with respect to
the district court. USV Pharmaceutical Corp. V.
unapproved, investigational drugs on military
safety and efficacy of drug for interstate sale in
Weinberger, Va.1978, 93 S.Ct. 2498, 412 U.S.
32. Notes of approval
personnel, without service member's informed
light of whatever showing plaintiffs make of the
640, 37 L.Ed.2d 230.
Where Food and Drug Administration had
consent, in certain combat-related situations.
existence of a conspiracy, unfairness, or conflict
Drug manufacturer, who had opportunity to
issued and published in the Federal Register a
Doe V. Sullivan, C.A.D.C.1991, 938 F.2d 1870.
of interests on part of defendants. Israel V.
litigate jurisdictional question whether drug
new "Notice of Opportunity for Hearing" on
Baxter Laboratories, Inc., 1972, 466 F.2d 272,
product was a "new drug" before Food and
proposal withdrawing approval of New Drug
District court could not reconsider the issue of
151 U.S.App.D.C. 101.
drug's lack of effectiveness for alleviation of
Drug Administration and to raise issue on ap-
Applications for "Alevaire," a muco-evacuant
pain, and had no jurisdiction to reopen the case,
District court's review of decision of Secretary
peal to a court of appeals to review withdrawal
drug, and the notice made specific reference to
to suspend phenformin hydrochloride as an im-
where Court of Appeals had previously affirmed
order, could not relitigate the issue in a separate
Court of Appeals decision which permitted the
minently hazardous drug was limited to determi-
district court's affirmance of finding by the Food
proceeding for a declaratory judgment. CIBA
notice, the Administration would not be required
nation of whether Secretary's decision was arbi-
Corp. V. Weinberger, N.J.1978, 93 S.Ct. 2495,
to publish notice of reinstatement of approval of
and Drug Administration with respect to the
drug's lack of effectiveness. Rutherford V. U.S.,
trary and capricious, an abuse of discretion, or
412 U.S. 640, 37 L.Ed.2d 230.
the new drug applications in the Federal Regis-
C.A.10 (Okl.) 1986, 806 F.2d 1455.
otherwise not in accordance with the law. Fors-
Plaintiffs who were in commercial business of
ter. Sterling Drug Inc. V. Weinberger, C.A.2,
ham V. Califano, D.C.D.C.1977, 442 F.Supp. 203.
1974, 503 F.2d 675.
Action of Food and Drug Administration in
selling laetrile, who did not need drug, and who
withdrawing new drug application for muco-eva-
Any error made by Food and Drug Adminis-
did not allege that they were unable to afford
32a. Opinion letters
cuant "Alevaire" on ground that it was not effec-
tration in its consideration of a new drug appli-
new drug application procedures, were not enti-
tive as a "fixed combination drug" was arbitrary
cation or an abbreviated new drug application
tled to relief in their action for declaratory
Issuance of opinion letter stating that particu-
and invalid where there was no mention of that
for drug X-Otag Plus manufactured by defen-
judgment that laetrile is a food and is not a new
lar drug product would not require clearance
dant was not for consideration of district court
under "new drug" procedure was beyond statu-
theory as ground for proposed withdrawal in the
drug and for order decreeing that no agency of
in enforcement proceeding brought by United
notice of opportunity for hearing and the manu-
United States has right to interfere with impor-
tory authority of Food and Drug Administration,
States, but was for consideration of court of
tation and distribution of laetrile on theory that
which had no legal authority to permit market-
facturers were never given a meaningful oppor-
appeals after a final agency determination on
ing of the product without new drug application
tunity to submit studies or data to contravene
it is unconstitutional to deny consumer of lae-
status of drug. U.S. V. X-Otag Plus Tablets,
approved for safety and efficacy. U.S. V. Arti-
that theory. Sterling Drug Inc. V. Weinberger,
trile opportunity to obtain it because consumer
D.C.Colo.1977, 441 F.Supp. 105, affirmed in
cles of Drug
HORMONIN, D.C.N.J.1980,
C.A.2, 1974, 503 F.2d 675.
cannot afford costly procedures required for
part, remanded in part on other grounds 602
new drug application. Hanson V. U.S.,
498 F.Supp. 424, affirmed 672 F.2d 902, 904.
Where the nature of the Food and Drug
F.2d 1387.
D.C.Minn.1976, 417 F.Supp. 30, affirmed 540
33. Remedy
Administration Interim Index and the basis on
Whether FDA had "new information" justify-
F.2d 947.
which listings thereon are made were not before
This section which provides that court may
the court of appeals and were not explored on
ing withdrawal of approval of new drug applica-
Where issue of whether drug is "new drug"
order additional evidence to be taken and to be
appeal from Administration's orders which with-
tion in effect for prescription drug was factual
was matter within the primary jurisdiction of
adduced upon hearing in such manner and upon
drew approval of new drug applications for
determination which should first be made by
the Food and Drug Administration and judicial
such terms as to court may seem proper and
FDA and, only after that determination was
review would be available following the adminis-
that Commissioner may modify findings as to
222
000
21 § 355
FOOD AND DRUGS
Note 33
FOOD AND DRUGS
21 § 357
facts by reason of additional evidence gives
If Food and Drug Administration has not
court broad authority to fashion a remedy capa-
developed adequate administrative record to
1 and Pub.L. 96-88 and Pub.L. 102-300, the
96-88, Title VI, Oct. 17, 1979, 93 Stat. 696, set
ble of balancing fairness to new drug applicant
permit determination whether laetrile is proper-
amendment resulted in no change in text.
out as a note under section 3401 of Title 20,
against public's right to expeditious enforcement
of this chapter. Smithkline Corp V. Food and
ly classified as a new drug, appropriate proce-
1992 Amendments
Education, deemed to refer and apply to the
dure for district court is to remand the case to
Department of Health and Human Services or
Drug Administration, 1978, 587 F.2d 1107, 190
the FDA for proceedings adequate to develop
Subsec. (a). Pub.L. 102-300, $ 6(b)(2), struck
the Secretary of Health and Human Services,
U.S.App.D.C. 210.
the record; such proceedings should give lae-
out "of Health, Education, and Welfare" follow-
respectively, except to the extent such reference
trile proponents an opportunity to express their
ing "The Secretary".
Creation of federal common-law damages
is to a function or office transferred to the
remedy under this chapter was not necessary to
views. Rutherford V. U.S., C.A.Okl.1976, 542
Change of Name
Secretary of Education or the Department of
enforcement of claims asserted in individual's
F.2d 1187, on remand 424 F.Supp. 105.
The Department of Health, Education, and
Education under Pub.L. 96-88, Title III, §§ 301
suit against drug companies to recover damages
35. Investigatory drugs
Welfare was redesignated the Department of
to 307, Oct. 17, 1979, 93 Stat. 677 to 681. See
arising out of purchase of allegedly ineffective
section 3441 to 3447 and 8508 of Title 20.
drugs, since cause of action in question was of
Food and Drug Administration (FDA) had
Health and Human Services, and the Secretary
kind traditionally governed by state law. Con-
authority, under statute regulating new drug
of Health, Education, and Welfare or any other
investigations, to impose recordkeeping require-
official of the Department of Health, Education
Federal Policy Regarding the Export of
sumer Federation of America V. Upjohn Co.,
and Welfare was redesignated the Secretary or
Banned or Significantly Restricted Sub-
D.C.App.1975, 846 A.2d 725.
ments on clinical investigators of new drugs, in
light of dangers incumbent in receipt of false
official, as appropriate, of Health and Human
stances
data. U.S. V. Garfinkel, C.A.8 (Minn.) 1994, 29
Services, with any reference to the Department
For provisions relating to the applicability of
34. Remand
F.8d 451.
of Health, Education, and Welfare, the Secre-
the term "banned or significantly restricted sub-
Where trial before district court should not
Food and Drug Administration (FDA) regula-
tary of Health, Education, and Welfare, or any
stance", as defined, and the Federal policy re-
have occurred, and its record was part of admin-
tion permitting Defense Department to use
official of the Department of Health, Education,
garding the export of banned or significantly
istrative record on remand solely for information
unapproved, investigational drugs on military
and Welfare, in any law, rule, regulation, certifi-
restricted substances, see section 1-101 of Ex.
it contained and as a matter of administrative
personnel, without service member's informed
cate, directive, instruction, or other official pa-
Ord. No. 12264, Jan. 15, 1981, 46 F.R. 4659, set
convenience, the Food and Drug Administration,
consent, in certain combat-related situations,
per in force on the effective date of Pub.L.
out as a note under section 2403 of Title 50,
in proceeding on claimant's request for relabel-
was within FDA's rule-making authority under
96-88, as prescribed by section 601 of Pub.L.
Appendix, War and National Defense.
ing of medical devices, was not bound by find-
Food, Drug, and Cosmetic Act, which provided
ings of the district court, and fact that trial
for use of unimproved investigational drugs only
CODE OF FEDERAL REGULATIONS
procedure took place did not transform the Ad-
on the informed consent of human subjects af-
Drugs composed wholly or partly of insulin,
ministration's decision-making process into adju-
fected "except where [the experts administering
see 21 CFR 429.3.
dicatory hearing. U.S. V. An Article of Device
the drug] deem [the human subject's consent]
Diapulse, C.A.7 (III.) 1985, 768 F.2d 826.
not feasible." Doe V. Sullivan, C.A.D.C.1991,
988 F.2d 1370.
§ 357. Certification of drugs containing penicillin, streptomycin, chlortetracy-
There was no error in refusing to remand to
cline, chloramphenicol, bacitracin or any other antibiotic drug
the Food and Drug Administration for develop-
36. Labeling information
ment of an administrative record in support of
Plaintiffs could not recover from name brand
(a) Regulations prescribed by Secretary; release prior to certification; "antibiotic
Food and Drug Administration's contention that
manufacturer for death of their daughter who
drug" defined
drug was a new drug requiring approval of a
new drug application, where the Administration
died as result of ingesting generic equivalent of
The Secretary, pursuant to regulations promulgated by him, shall provide for the
had only instituted condemnation proceedings
drug on theory that negligent misrepresenta-
tions on generic drug's label were merely copied,
certification of batches of drugs (except drugs for use in animals other than man)
against a certain quantity of the drug and in-
as permitted by federal law, from name brand
composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline,
junction proceedings against a single drug man-
ufacturer, 80 that its action was not in the
manufacturer's label; manufacturer of generic
chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof. A
drug was responsible for accuracy of labels
batch of any such drug shall be certified if such drug has such characteristics of identity
nature of a declaratory order, and where deter-
placed on its products and name brand manufac-
and such batch has such characteristics of strength, quality, and purity, as the Secretary
mination that the drug was a "new drug" for
turer's statements regarding its drug could not
purposes of condemnation and injunction pro-
prescribes in such regulations as necessary to adequately insure safety and efficacy of
ceedings was made by the district court follow-
serve as basis for liability for injuries caused by
use, but shall not otherwise be certified. Prior to the effective date of such regulations
ing trial. U.S. V. X-Otag Plus Tablets,
another manufacturer's drug. Foster V. Ameri-
the Secretary, in lieu of certification, shall issue a release for any batch which, in his
C.A.Colo.1979, 602 F.2d 1387.
can Home Products Corp., C.A.4 (Md.) 1994, 29
F.3d 165.
judgment, may be released without risk as to the safety and efficacy of its use. Such
release shall prescribe the date of its expiration and other conditions under which it shall
§ 356. Certification of drugs containing insulin
cease to be effective as to such batch and as to portions thereof. For purposes of this
section and of section 352(I) of this title, the term "antibiotic drug" means any drug
(a) The Secretary, pursuant to regulations promulgated by him, shall provide for the
intended for use by man containing any quantity of any chemical substance which is
certification of batches of drugs composed wholly or partly of insulin. A batch of any
produced by a microorganism and which has the capacity to inhibit or destroy microor-
such drug shall be certified if such drug has such characteristics of identity and such
ganisms in dilute solution (including the chemically synthesized equivalent of any such
batch has such characteristics of strength, quality, and purity, as the Secretary
substance).
prescribes in such regulations as necessary to adequately insure safety and efficacy of
use, but shall not otherwise be certified. Prior to the effective date of such regulations
[See main volume for text of (b) to (d)]
the Secretary, in lieu of certification, shall issue a release for any batch which, in his
judgment, may be released without risk as to the safety and efficacy of its use. Such
(e) Exempted new drugs subject to section 355 of this title; request for certifica-
release shall prescribe the date of its expiration and other conditions under which it shall
tion of exempted drug; determination of compliance with sections 351(b) and
352(g) of this title
cease to be effective as to such batch and as to portions thereof.
No drug which is subject to this section shall be deemed to be subject to any provision
[See main volume for text of (b) and (c)]
of section 355 of this title except a new drug exempted from the requirements of this
(As amended June 16, 1992, Pub.L. 102-300, $ 6(b)(2), 106 Stat. 240; Aug. 13, 1993, Pub.L. 103-80,
section and of section 352(I) of this title pursuant to regulations promulgated by the
$ 3(o), 107 Stat. 777.)
Secretary. For purposes of section 355 of this title, the initial request for certification,
as thereafter duly amended, pursuant to this section, of a new drug so exempted shall be
HISTORICAL AND STATUTORY NOTES
considered a part of the application filed pursuant to section 355(b) of this title with
Ch. 13
Ch. 13
DRUG ABUSE PREVENTION AND CONTROL
21 § 811
), 84 Stat. 1242, and is popularly
960 and 961 of this title] shall take effect 120 days after the
§
803.
Repealed. Pub.L. 95-137, § 1(b), Oct. 18,
Substances Act". For complete
enactment of this Act [Nov. 18, 1988]."
1977, 91 Stat. 1169.
e Code, see Short Title note set
Change of Name. "Secretary of Health and Human
this title and Tables volume.
Services" was substituted for "Secretary of Health, Edu-
PART B-AUTHORITY TO CONTROL: STANDARDS AND SCHEDULES
pter", referred to in text, was in
cation, and Welfare" on authority of Pub.L. 96-88, Title V,
ning Title III of Pub.L. 91-513,
§ 509, Oct. 17, 1979, 93 Stat. 695, which is classified to
§
811. Authority and criteria for classification
Part A of Title III comprises
section 3508 of Title 20, U.S.C.A., Education.
of substances
'1'. For classification of Part B,
Regulations by Attorney General. Section 1903 of
Rules and regulations of Attorney
to 1105 of Title III, see Tables
Pub.L. 101-647 provided that:
General; hearing
"(a) Abuse potential.-The Attorney General, upon the
and Cosmetic Act, referred to in
recommendation of the Secretary of Health and Human
(a) The Attorney General shall apply the provi-
25, 1938, c. 675, 52 Stat. 1040, as
Services, may, by regulation, exempt any compound, mix-
sions of this subchapter to the controlled substances
generally to chapter 9 (§ 301 et
ture, or preparation containing a substance in paragraph
listed in the schedules established by section 812 of
olete classification of this Act to
(41) of section 102 of the Controlled Substances Act [par.
this title and to any other drug or other substance
of this title and Tables volume.
(41) of this section] (as added by section 2 of this Act [sic])
added to such schedules under this subchapter. Ex-
Revenue Code of 1986, referred
from the application of all or any part of the Controlled
cept as provided in subsections (d) and (e) of this
section 5001 et seq. of Title 26,
Substances Act [21 U.S.C.A. § 801 et seq.] if, because of its
section, the Attorney General may by rule-
Code.
concentration, preparation, mixture or delivery system, it
has no significant potential for abuse.
(1) add to such a schedule or transfer between
to in par. (32)(A), are set out in
such schedules any drug or other substance if he-
"(b) Drugs for treatment of rare diseases.-If the At-
torney General finds that a drug listed in paragraph (41) of
(A) finds that such drug or other substance
ent by section 83 of Pub.L.
section 102 of the Controlled Substances Act (as added by
has a potential for abuse, and
not executed in view of prior
section 2 of this Act [sic]) is-
(B) makes with respect to such drug or other
Pub.L. 99-570 making identical
"(1) approved by the Food and Drug Administration as
substance the findings prescribed by subsection
an accepted treatment for a rare disease or condition, as
(b) of section 812 of this title for the schedule in
1954 in any law, etc., to include
defined in section 526 of the Federal Food, Drug, and
which such drug is to be placed; or
nue Code of 1986, except when
Cosmetic Act (21 U.S.C. 360bb) [21 U.S.C.A. $ 360bb];
(2) remove any drug or other substance from the
9-514, § 2, Oct. 22, 1986, 100
and
schedules if he finds that the drug or other sub-
"(2) does not have a significant potential for abuse, the
stance does not meet the requirements for inclu-
)1(a) of Pub.L. 98-509, Oct. 19,
Attorney General may exempt such drug from any pro-
sion in any schedule.
.r. (28) which substituted "one
duction regulations otherwise issued under the Controlled
venty-one" was executed to par.
Rules of the Attorney General under this subsection
Substances Act [21 U.S.C.A. $ 801 et seq.] as may be
'8) prior to its redesignation by
necessary to ensure adequate supplies of such drug for
shall be made on the record after opportunity for a
507(a), Oct. 12, 1984, 98 Stat.
medical purposes.
hearing pursuant to the rulemaking procedures pre-
of Congress.
scribed by subchapter II of chapter 5 of Title 5.
"(c) Date of issuance of regulations.-The Attorney
mendments. Section 330024(f)
General shall issue regulations implementing this section not
Proceedings for the issuance, amendment, or repeal
that: "The amendments made
later than 45 days after the date of enactment of this Act
of such rules may be initiated by the Attorney Gener-
is section and sections 824, 960,
[Nov. 29, 1990], except that the regulations required under
al (1) on his own motion, (2) at the request of the
ake effect as of the date that is
section 3(a) [sic] shall be issued not later than 180 days after
Secretary, or (3) on the petition of any interested
of enactment of the Domestic
the date of enactment of this Act [Nov. 29, 1990]."
party.
I Act of 1993 [Dec. 17, 1993].
Promulgation of Regulations for Administration of
Amendments. Section 11 of
Evaluation of drugs and other substances
Amendment by Alcohol Abuse, Drug Abuse, and Mental
at: "This Act and the amend-
Health Amendments of 1984; Inclusion of Findings in
(b) The Attorney General shall, before initiating
nacting section 814 of this title,
Report. Section 301(b) of Pub.L. 98-509, Oct. 19, 1984, 98
proceedings under subsection (a) of this section to
sections 821, 822, 823, 824, 830,
Stat. 2364, provided that: "The Secretary of Health and
control a drug or other substance or to remove a
I 971 of this title and enacting
Human Services shall, within ninety days of the date of the
drug or other substance entirely from the schedules,
under this section and section
enactment of this Act [Oct. 19, 1984], promulgate regulations
and after gathering the necessary data, request from
fect on the date that is 120 days
for the administration of section 102(28) of the Controlled
it of this Act [Dec. 17, 1993].
the Secretary a scientific and medical evaluation, and
Substances Act as amended by subsection (a) [probably par.
his recommendations, as to whether such drug or
mendment. Section 1902(d)
29 of this section] and shall include in the first report
other substance should be so controlled or removed
it: "This section and the amend-
submitted under section 505(b) of the Public Health Service
enacting par. (41) of this section,
Act [section 290aa-4 of Title 42, The Public Health and
as a controlled substance. In making such evaluation
S title, and enacting a provision
Welfare] after the expiration of such ninety days the find-
and recommendations, the Secretary shall consider
tion 829 of this title] shall
ings of the Secretary with respect to the effect of the
the factors listed in paragraphs (2), (3), (6), (7), and
of enactment of this Act [No
amendment made by subsection (a) [amending par. (29) of
(8) of subsection (c) of this section and any scientific
this section]."
or medical considerations involved in paragraphs (1),
it: Amendment. "Except as otherwise provide
Section
6061
(4), and (5) of such subsection. The recommenda-
Code of Federal Regulations
tions of the Secretary shall include recommendations
itle [enacting section 972 of
Controlled drugs, warnings, see 21 CFR 290.5 et seq.
with respect to the appropriate schedule, if any,
830, 841, 842, 843, 872, 876, 8814
Treatment of narcotic addicts, see 21 CFR 291.501 et seq.
under which such drug or other substance should be
Complete Annotation Materials, see Title 21, U.S.C.A.
1043
21 § 811
FOOD AND DRUGS
Ch.
13
Ch.
13
listed. The evaluation and the recommendations of
(2)(A) Whenever the Secretary of State receives
drug or substance and th.
the Secretary shall be made in writing and submitted
notification from the Secretary-General of the United
Federal Food, Drug, and
to the Attorney General within a reasonable time.
Nations that information has been transmitted by or
requirements of the sched\
The recommendations of the Secretary to the Attor-
to the World Health Organization, pursuant to article
tion or schedule notice at
ney General shall be binding on the Attorney General
2 of the Convention on Psychotropic Substances,
action:
as to such scientific and medical matters, and if the
which may justify adding a drug or other substance
(A) If such requireme
Secretary recommends that a drug or other sub-
to one of the schedules of the Convention, transfer-
ing controls but the Se
stance not be controlled, the Attorney General shall
ring a drug or substance from one schedule to anoth-
man Services nonethele
not control the drug or other substance. If the
er, or deleting it from the schedules, the Secretary of
gent controls should t
Attorney General determines that these facts and all
State shall immediately transmit the notice to the
substance, the Secretar
other relevant data constitute substantial evidence of
Secretary of Health and Human Services who shall
Attorney General that
potential for abuse such as to warrant control or
publish it in the Federal Register and provide oppor-
scheduling the drug or
substantial evidence that the drug or other substance
tunity to interested persons to submit to him com-
sections (a) and (b) of t
should be removed entirely from the schedules, he
ments respecting the scientific and medical evalua-
controls.
shall initiate proceedings for control or removal, as
tions which he is to prepare respecting such drug or
(B) If such requirer
the case may be, under subsection (a) of this section.
substance. The Secretary of Health and Human
existing controls and t
Services shall prepare for transmission through the
Human Services concur
Factors determinative of control
Secretary of State to the World Health Organization
or schedule notice trai
or removal from schedules
such medical and scientific evaluations as may be
the Secretary shall re
(c) In making any finding under subsection (a) of
appropriate regarding the possible action that could
General that he initiate
this section or under subsection (b) of section 812 of
be proposed by the World Health Organization re-
the drug or substance
this title, the Attorney General shall consider the
specting the drug or substance with respect to which
ule pursuant to subs-
following factors with respect to each drug or other
a notice was transmitted under this subparagraph.
section.
substance proposed to be controlled or removed from
(B) Whenever the Secretary of State receives in-
(C) If such require!
the schedules:
formation that the Commission on Narcotic Drugs of
existing controls and 1
(1) Its actual or relative potential for abuse.
the United Nations proposes to decide whether to
Human Services does
add a drug or other substance to one of the schedules
(2) Scientific evidence of its pharmacological ef-
decision or schedule no
of the Convention, transfer a drug or substance from
fect, if known.
fication, the Secretary
one schedule to another, or delete it from the sched-
(3) The state of current scientific knowledge re-
ules, the Secretary of State shall transmit timely
(i) if he deems
garding the drug or other substance.
notice to the Secretary of Health and Human Ser-
necessary to protect
(4) Its history and current pattern of abuse.
vices of such information who shall publish a sum-
recommended to th
(5) The scope, duration, and significance of
mary of such information in the Federal Register and
initiate proceedings
provide opportunity to interested persons to submit
substance pursuant
abuse.
to him comments respecting the recommendation
this section, to ap!
(6) What, if any, risk there is to the public
which he is to furnish, pursuant to this subparagraph,
(ii) request the S
health.
respecting such proposal. The Secretary of Health
a notice of qualified
and Human Services shall evaluate the proposal and
specified in the C,
(7) Its psychic or physiological dependence lia-
furnish a recommendation to the Secretary of State
graph 7 of article
bility.
which shall be binding on the representative of the
Secretary-General
(8) Whether the substance is an immediate pre-
United States in discussions and negotiations relating
(iii) request the
cursor of a substance already controlled under this
to the proposal.
a notice of qualifie-
subchapter.
(3) When the United States receives notification of
clause (ii) and requ
a scheduling decision pursuant to article 2 of the
ask for a review
International treaties, conventions, and protocols
Council of the U:
requiring control; procedures respecting
Convention on Psychotropic Substances that a drug
changes in drug schedules of Convention on
or other substance has been added or transferred to
with paragraph 8
of the scheduling
Psychotropic Substances
a schedule specified in the notification or receives
(iv) in the case
(d)(1) If control is required by United States obli-
notification (referred to in this subsection as a
gations under international treaties, conventions, or
"schedule notice") that existing legal controls applica-
the Secretary of S
protocols in effect on October 27, 1970, the Attorney
ble under this subchapter to a drug or substance and
under the Conven
General shall issue an order controlling such drug
the controls required by the Federal Food, Drug, and
remove the drug
Cosmetic Act do not meet the requirements of the
ules under the (
under the schedule he deems most appropriate to
schedule of the Convention in which such drug or
drug or substance
carry out such obligations, without regard to the
substance has been placed, the Secretary of Health
vention different
findings required by subsection (a) of this section or
section 812(b) of this title and without regard to the
and Human Services, after consultation with the At-
schedule notice.
procedures prescribed by subsections (a) and (b) of
torney General, shall first determine whether existing
(4)(A) If the Attori
this section.
legal controls under this subchapter applicable to the
consultation with the S
Complete Annotation Materials, see Title 21, U.S.C.A.
1044
Ch. 13
DRUG ABUSE PREVENTION AND CONTROL
21
§
811
Ch. 13
of State receives
drug or substance and the controls required by the
Services, that proceedings initiated under recommen-
neral of the United
Federal Food, Drug, and Cosmetic Act, meet the
dations made under paragraph (B) or (C)(i) of para-
1 transmitted by or
requirements of the schedule specified in the notifica-
graph (3) will not be completed within the time period
pursuant to article
tion or schedule notice and shall take the following
required by paragraph 7 of article 2 of the Conven-
tropic Substances,
action:
tion, the Attorney General, after consultation with the
or other substance
(A) If such requirements are met by such exist-
Secretary and after providing interested persons op-
onvention, transfer-
ing controls but the Secretary of Health and Hu-
portunity to submit comments respecting the require-
schedule to anoth-
man Services nonetheless believes that more strin-
ments of the temporary order to be issued under this
es, the Secretary of
gent controls should be applied to the drug or
sentence, shall issue a temporary order controlling
the notice to the
substance, the Secretary shall recommend to the
the drug or substance under schedule IV or V, which-
Services who shall
Attorney General that he initiate proceedings for
ever is most appropriate to carry out the minimum
and provide oppor-
scheduling the drug or substance, pursuant to sub-
United States obligations under paragraph 7 of arti-
cle 2 of the Convention. As a part of such order, the
ubmit to him com-
sections (a) and (b) of this section, to apply to such
and medical evalua-
controls.
Attorney General shall, after consultation with the
ecting such drug or
Secretary, except such drug or substance from the
(B) If such requirements are not met by such
Health and Human
application of any provision of part C of this subchap-
existing controls and the Secretary of Health and
nission through the
ter which he finds is not required to carry out the
Human Services concurs in the scheduling decision
Health Organization
United States obligations under paragraph 7 of arti-
or schedule notice transmitted by the notification,
uations as may be
cle 2 of the Convention. In the case of proceedings
the Secretary shall recommend to the Attorney
le action that could
initiated under subparagraph (B) of paragraph (3),
General that he initiate proceedings for scheduling
th Organization re-
the Attorney General, concurrently with the issuance
the drug or substance under the appropriate sched-
ith respect to which
of such order, shall request the Secretary of State to
ule pursuant to subsections (a) and (b) of this
this subparagraph.
transmit a notice of qualified acceptance to the Secre-
section.
tary-General of the United Nations pursuant to para-
of State receives in-
(C) If such requirements are not met by such
graph 7 of article 2 of the Convention. A temporary
n Narcotic Drugs of
existing controls and the Secretary of Health and
order issued under this subparagraph controlling a
decide whether to
Human Services does not concur in the scheduling
drug or other substance subject to proceedings initi-
one of the schedules
decision or schedule notice transmitted by the noti-
ated under subsections (a) and (b) of this section shall
g or substance from
fication, the Secretary shall-
e it from the sched-
expire upon the effective date of the application to
all transmit timely
(i) if he deems that additional controls are
the drug or substance of the controls resulting from
th and Human Ser-
necessary to protect the public health and safety,
such proceedings.
recommended to the Attorney General that he
hall publish a sum-
(B) After a notice of qualified acceptance of a
'ederal Register and
initiate proceedings for scheduling the drug or
scheduling decision with respect to a drug or other
d persons to submit
substance pursuant to subsections (a) and (b) of
substance is transmitted to the Secretary-General of
he recommendation
this section, to apply such additional controls;
the United Nations in accordance with clause (ii) or
o this subparagraph,
(ii) request the Secretary of State to transmit
(iii) of paragraph (3)(C) or after a request has been
Secretary of Health
a notice of qualified acceptance, within the period
made under clause (iv) of such paragraph with re-
ate the proposal and
specified in the Convention, pursuant to para-
spect to a drug or substance described in a schedule
Secretary of State
graph 7 of article 2 of the Convention, to the
notice, the Attorney General, after consultation with
epresentative of the
Secretary-General of the United Nations;
the Secretary of Health and Human Services and
negotiations relating
(iii) request the Secretary of State to transmit
after providing interested persons opportunity to sub-
a notice of qualified acceptance as prescribed in
mit comments respecting the requirements of the
ceives notification of
clause (ii) and request the Secretary of State to
order to be issued under this sentence, shall issue an
to article 2 of the
ask for a review by the Economic and Social
order controlling the drug or substance under sched-
Council of the United Nations, in accordance
stances that a drug
ule IV or V, whichever is most appropriate to carry
led or transferred to
with paragraph 8 of article 2 of the Convention,
out the minimum United States obligations under
tification or receives
of the scheduling decision; or
paragraph 7 of article 2 of the Convention in the case
(iv) in the case of a schedule notice, request
is subsection as a
of a drug or substance for which a notice of qualified
egal controls applica-
the Secretary of State to take appropriate action
acceptance was transmitted or whichever the Attor-
rug or substance and
under the Convention to initiate proceedings to
ney General determines is appropriate in the case of
eral Food, Drug, and
remove the drug or substance from the sched-
a drug or substance described in a schedule notice.
ules under the Convention or to transfer the
requirements of the
As a part of such order, the Attorney General shall,
which such drug or
drug or substance to a schedule under the Con-
after consultation with the Secretary, except such
Secretary of Health
vention different from the one specified in the
drug or substance from the application of any provi-
ultation with the At-
schedule notice.
sion of part C of this subchapter which he finds is not
nine whether existing
(4)(A) If the Attorney General determines, after
required to carry out the United States obligations
pter applicable to the
consultation with the Secretary of Health and Human
under paragraph 7 of article 2 of the Convention. If,
Complete Annotation Materials, see Title 21, U.S.C.A.
1045
FOOD AND DRUGS
Ch. 13
Ch.
21 § 811
as a result of a review under paragraph 8 of article 2
Abuse potential
of the Convention of the scheduling decision with
(f) If, at the time a new-drug application is submit-
Ge
ted to the Secretary for any drug having a stimulant,
int-
respect to which a notice of qualified acceptance was
depressant, or hallucinogenic effect on the central
wh
transmitted in accordance with clause (ii) or (iii) of
paragraph (3)(C)-
nervous system, it appears that such drug has an
(
abuse potential, such information shall be forwarded
ted
(i) the decision is reversed, and
by the Secretary to the Attorney General.
(2)
(ii) the drug or substance subject to such deci-
Non-narcotic substances sold over the counter
sectio
sion is not required to be controlled under schedule
without prescription; dextromethorphan
date
IV or V to carry out the minimum United States
subst:
obligations under paragraph 7 of article 2 of the
(g)(1) The Attorney General shall by regulation
durin;
exclude any non-narcotic substance from a schedule if
Convention,
(a)(1)
such substance may, under the Federal Food, Drug,
exten-
the order issued under this subparagraph with re-
and Cosmetic Act, be lawfully sold over the counter
mont]
spect to such drug or substance shall expire upon
without a prescription.
(3)
receipt by the United States of the review decision.
(2) Dextromethorphan shall not be deemed to be
the A
If, as a result of action taken pursuant to action
included in any schedule by reason of enactment of
with I
initiated under a request transmitted under clause
this subchapter unless controlled after October 27,
the p
(iv) of paragraph (3)(C), the drug or substance with
1970 pursuant to the foregoing provisions of this
parag!
respect to which such action was taken is not re-
section.
section
quired to be controlled under schedule IV or V, the
(3) The Attorney General may, by regulation, ex-
mate
order issued under this paragraph with respect to
empt any compound, mixture, or preparation contain-
ture,
such drug or substance shall expire upon receipt by
ing a controlled substance from the application of all
(4)
the United States of a notice of the action taken with
or any part of this subchapter if he finds such com-
an orc
respect to such drug or substance under the Conven-
pound, mixture, or preparation meets the require-
to the
tion.
ments of one of the following categories:
issuing
(C) An order issued under subparagraph (A) or (B)
(A) A mixture, or preparation containing a non-
Gener
may be issued without regard to the findings re-
narcotic controlled substance, which mixture or
submit
quired by subsection (a) of this section or by section
preparation is approved for prescription use, and
transm
812(b) of this title and without regard to the proce-
which contains one or more other active ingredi-
(5)
dures prescribed by subsection (a) or (b) of this
ents which are not listed in any schedule and which
spect t
are included therein in such combinations, quantity,
section.
sion of
proportion, or concentration as to vitiate the poten-
under
(5) Nothing in the amendments made by the Psy-
tial for abuse.
such St
chotropic Substances Act of 1978 or the regulations
or orders promulgated thereunder shall be construed
(B) A compound, mixture, or preparation which
(6)
to preclude requests by the Secretary of Health and
contains any controlled substance, which is not for
subject
administration to a human being or animal, and
Human Services or the Attorney General through the
(Pub.L.
which is packaged in such form or concentration, or
Pub.L. ?
Secretary of State, pursuant to article 2 or other
with adulterants or denaturants, so that as pack-
Pub.L.
applicable provisions of the Convention, for review of
aged it does not present any significant potential
Pub.L.
scheduling decisions under such Convention, based on
Stat 20⁻
for abuse.
new or additional information.
Temporary scheduling to avoid imminent
Immediate precursors
hazards to public safety
Refere
(e) The Attorney General may, without regard to
(h)(1) If the Attorney General finds that the sched-
metic A
June 25
the findings required by subsection (a) of this section
uling of a substance in schedule I on a temporary
basis is necessary to avoid an imminent hazard to the
classified
or section 812(b) of this title and without regard to
21, U.S.O.
the procedures prescribed by subsections (a) and (b)
public safety, he may, by order and without regard to
Sched.
of this section, place an immediate precursor in the
the requirements of subsection (b) of this section
are set
same schedule in which the controlled substance of
relating to the Secretary of Health and Human Ser
The P:
which it is an immediate precursor is placed or in any
vices, schedule such substance in schedule I if the
subsec. (
substance is not listed in any other schedule in seq
which e
other schedule with a higher numerical designation.
tion 812 of this title or if no exemption or approval:
U.S.C.A.
If the Attorney General designates a substance as an
immediate precursor and places it in a schedule,
in effect for the substance under section 355 of this
tions 852
title. Such an order may not be issued before
and 965
other substances shall not be placed in a schedule
The Pub'
solely because they are its precursors.
expiration of thirty days from-
Complete Annotation Materials, see Title 21, U.S.C.A.
1046
Ch. 13
Ch. 13
DRUG ABUSE PREVENTION AND CONTROL
21
§
812
(A) the date of the publication by the Attorney
out as notes under sections 801, 801a, 812, and 830 of Title
tential
General of a notice in the Federal Register of the
21.
trug application is submit-
intention to issue such order and the grounds upon
Change of Name. "Secretary of Health and Human
y drug having a stimulant,
which such order is to be issued, and
Services" was substituted for "Secretary of Health, Edu-
nic effect on the central
cation, and Welfare" on authority of Pub.L. 96-88, Title V,
S that such drug has an
(B) the date the Attorney General has transmit-
§ 509, Oct. 17, 1979, 93 Stat. 695, which is classified to
mation shall be forwarded
ted the notice required by paragraph (4).
section 3508 of Title 20, U.S.C.A., Education.
torney General.
(2) The scheduling of a substance under this sub-
Code of Federal Regulations
section shall expire at the end of one year from the
Administrative functions, practices, and procedures, see
S sold over the counter
date of the issuance of the order scheduling such
21 CFR 1316.01 et seq.
dextromethorphan
substance, except that the Attorney General may,
Debarment and suspension, drug-free workplace, grants,
neral shall by regulation
during the pendency of proceedings under subsection
see 21 CFR 1404.100 et seq.
ibstance from a schedule if
(a)(1) of this section with respect to the substance,
Drug abuse prevention, audiovisual education, see 34 CFR
the Federal Food, Drug,
extend the temporary scheduling for up to six
763.1 et seq.
fully sold over the counter
months.
Drug-free schools and campuses, see 34 CFR 86.1 et seq.
(3) When issuing an order under paragraph (1),
Mandatory declassification review program, see 21 CFR
hall not be deemed to be
the Attorney General shall be required to consider,
1402.1 et seq.
y reason of enactment of
with respect to the finding of an imminent hazard to
Schedules, see 21 CFR 1308.01 et seq. and Table.
ntrolled after October 27,
the public safety, only those factors set forth in
Uniform administrative requirements, grants and cooper-
regoing provisions of this
paragraphs (4), (5), and (6) of subsection (c) of this
ative agreements, see 21 CFR 1403.1 et seq.
section, including actual abuse, diversion from legiti-
al may, by regulation, ex-
mate channels, and clandestine importation, manufac-
§
812.
Schedules of controlled substances
ire, or preparation contain-
ture, or distribution.
Establishment
from the application of all
(4) The Attorney General shall transmit notice of
(a) There are established five schedules of con-
apter if he finds such com-
an order proposed to be issued under paragraph (1)
ration meets the require-
trolled substances, to be known as schedules I, II,
to the Secretary of Health and Human Services. In
III, IV, and V. Such schedules shall initially consist
ing categories:
issuing an order under paragraph (1), the Attorney
of the substances listed in this section. The sched-
eparation containing a non-
General shall take into consideration any comments
ules established by this section shall be updated and
stance, which mixture or
submitted by the Secretary in response to a notice
republished on a semiannual basis during the two-
1 for prescription use, and
transmitted pursuant to this paragraph.
year period beginning one year after October 27,
more other active ingredi-
(5) An order issued under paragraph (1) with re-
1970 and shall be updated and republished on an
1 in any schedule and which
spect to a substance shall be vacated upon the conclu-
annual basis thereafter.
such combinations, quantity,
sion of a subsequent rulemaking proceeding initiated
ation as to vitiate the poten-
under subsection (a) of this section with respect to
Placement on schedules; findings required
such substance.
(b) Except where control is required by United
ture, or preparation which
(6) An order issued under paragraph (1) is not
States obligations under an international treaty, con-
substance, which is not for
subject to judicial review.
vention, or protocol, in effect on October 27, 1970, and
man being or animal, and
(Pub.L. 91-513, Title II, § 201, Oct. 27, 1970, 84 Stat. 1245;
except in the case of an immediate precursor, a drug
ch form or concentration, or
Pub.L. 95-633, Title I, § 102(a), Nov. 10, 1978, 92 Stat. 3769;
or other substance may not be placed in any schedule
naturants, so that as pack-
Pub.L. 96-88, Title V, § 509, Oct. 17, 1979, 93 Stat. 695;
unless the findings required for such schedule are
nt any significant potential
Pub.L. 98-473, Title II, §§ 508, 509(a), Oct. 12, 1984, 98
made with respect to such drug or other substance.
Stat. 2071, 2072.)
The findings required for each of the schedules are as
follows:
ng to avoid imminent
EDITORIAL NOTES
(1) Schedule I.—
public safety
References in Text. The Federal Food, Drug, and Cos-
General finds that the sched
metic Act, referred to in subsecs. (d)(3) and (g)(1), is Act
(A) The drug or other substance has a high
schedule I on a temporary
June 25, 1938, c. 675, 52 Stat. 1040, as amended, which is
potential for abuse.
d an imminent hazard to the
classified generally to chapter 9 (section 301 et seq.) of Title
21, U.S.C.A., Food and Drugs.
(B) The drug or other substance has no current-
order and without regard
Schedules IV and V, referred to in subsec. (d)(4)(A), (B),
ly accepted medical use in treatment in the United
osection (b) of this section
States.
are set out in section 812(c) of this title.
of Health and Human Ser
The Psychotropic Substances Act of 1978, referred to in
(C) There is a lack of accepted safety for use of
stance in schedule I if the
subsec. (d)(5), is Pub.L. 95-633, Nov. 11, 1978, 92 Stat. 3768,
the drug or other substance under medical supervi-
1 any other schedule in ser
which enacted sections 801a, 830, and 852 of Title 21,
sion.
no exemption or approvali
U.S.C.A., Food and Drugs, amended this section and sec-
ce under section 355 of this
tions 352, 802, 812, 823, 827, 841 to 843, 872, 881, 952, 953,
(2) Schedule II.-
ay not be issued before
and 965 of Title 21 and section 242a of Title 42, U.S.C.A.,
(A) The drug or other substance has a high
The Public Health and Welfare, and enacted provisions set
potential for abuse.
from-
Complete Annotation Materials, see Title 21, U.S.C.A.
1047
6< A
Rohypnol
Q What 15 this drug ?
6
the where IS if made?
G How IS it getting In the
Country?
G What does Schedule IV
mean ?
6 How can a drug's Schedule
be Changed ?
OFFICE THE NATIONAL PRESIDENT SIATES CONTRA MUNITED
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF NATIONAL DRUG CONTROL POLICY
Washington, D.C. 20503
January 23, 1996
MEMORANDUM TO ELENA KAGAN
DENNIS BURKE
FROM:
EDWARD H. JURITH EH)
RE:
ROHYPNOL
I have further reviewed the law and legislative history
surrounding 21 USC 811(h)(1) and the specific argument that the
disjunctive nature of the statute would permit the Attorney
General to place flunitrazepam (rohypnol) in Schedule 1 on an
emergency basis. I ask that you consider the following case law
and interpretations in deciding whether we can recommend using
the emergency authority in this instance.
First, a plain reading of the statute yields the conclusion that
the AG could not temporarily schedule a substance if it was
already in Schedules II-V or if it was subject to an IND or NDA
under section 355 granted by FDA. Moreover the statute in issue
talks in terms of the "scheduling" of a drug. What is being
proposed is a "rescheduling" of an previously scheduled drug.
Using 811 in this manner would do disruption to the entire CSA
scheduling scheme.
Second, can the AG temporarily place a drug in schedule I if it
is not subject to a pending IND or NDA, even though it is listed
in schedule IV? If that is correct, the converse would also be
true -- the AG could place an FDA approved drug in schedule 1 if
it is not already scheduled. I believe case law. logic, and the
legislative history of the statute argue against this conclusion.
In Grinspoon V. DEA, 828 F.2d 881 (lst Cir, 1987), the court in
reviewing the provisions of the emergency scheduling authority
noted:
"This provision allows the Attorney General
to place certain substances into schedule I
on a temporary basis without regard to the
regular scheduling criteria and procedures if
such emergency scheduling is 'necessary to
avoid an imminent hazard to public safety.'
21 USC 811(h)(1). This amendment to the CSA,
however, expressly states that the Attorney
2.
General's authority to schedule substances in
this expedited manner does not apply where an
"exemption or approval is in effect for the
substances under section 355 of this title",
i.e., where the FDA has permitted the
substances to be marketed in interstate
commerce."
Substances listed in schedules II-V in Section 812 all share the
criteria of having a currently accepted medical use in treatment.
Grinspoon specifically rejected the notion that a substance must
have FDA approval or exemption to have a currently accepted
medical use. Thereafter, DEA adopted a five criteria test which
would allow it to conclude a medically useful drug not marketed
in the United States has a "currently accepted medical use" under
the Controlled Substances Act. The test is as follows; the
drug's chemistry must be known and reproducible; there must be
adequate safety studies, there must be adequate and well
controlled studies proving efficacy, acceptance by qualified
experts is required, and the scientific evidence must be widely
available.
This five criteria test is set forth at 57 Fed. Reg, 10499-10508,
March 26, 1992. In this notice DEA, specifically reference the
fact that when the Controlled Substances Act was enacted, drugs
with medical uses but without approved NDA's, were placed by
Congress in Schedules II, III, IV and V. Citing Grinspoon, the
notice states that "NDA approval is not the only method by which
drugs can achieve Federal recognition as having medical uses" (at
page 10504).
Thus, under Grinspoon, if a substance is listed in schedule II -
V under section 812 (regardless of whether it has an exemption or
approval under section 355) it has an accepted medical use, or if
a substance is subject to an approval or exemption under section
355, the AG may not list the substance in schedule I on an
emergency basis.
Legislative History
Addressing concerns of medical treatment House Report 98-835
states:
The Subcommittee believed that these concerns
raised significant questions about the impact
an emergency scheduling authority would have
on the manufacture and distribution of drugs
that are currently used in medical treatment.
In examining the particular substance for
which the scheduling action was most
necessary, the Subcommittee concluded that
limiting the authority only to substances
that have no currently accepted medical use
in treatment addressed both the legitimate
3.
concerns of those in the health care industry
and the principal danger to the public
health.
The stated congressional intent was to limit the effect of 811 (h)
to substances that have no currently accepted medical use in
treatment.
In essence, being listed in schedules II-V, indicates that a
substance has an accepted medical use, as do drugs having an FDA
approval or exemption under section 355. Congress did not intend
that medically useful drugs be subject to emergency scheduling in
schedule I -- which the CSA reserves for substances that have
no currently accepted medical uses.
Practical Application
Moreover, the practical use of the emergency authority has been
limited to drugs which fall outside the current schedules or lack
NDA or IND status under section 355. As the attached list
illustrates, it has been directed at fentanyl and other "designer
drug" analogs which have a high potential for abuse. This is not
the case with medications that have been approved for medical use
and otherwise scheduled.
Conclusion
Based on the above analysis, I do not believe we can utilize the
emergency scheduling authority to "reschedule" rohypnol in
Schedule I
I suggest we explore the following alternatives:
1. Formal rescheduling of rohypnol to schedule II or III. This
will ensure tighter controls over the drug from an administrative
point of view.
2. Propose legislation that enhances Federal penalties for use
of a controlled substance in connection with a sexual assault.
OD AND DRUGS
FOOD AND DRUGS
21 § 355
ing held to determine whether the Food and
cross-examination by those opposing the actions
Drug Administration acted rationally in requir-
rug Administration has
taken by the Food and Drug Administration.
ing that preparations of vitamins A and D in
National Nutritional Foods Ass'n V. Mathews,
determine whether drug
excess of specified dosages be restricted to pre-
constitutes "new drug"
D.C.N.Y.1976, 418 F.Supp. 394.
scription sale and be labeled accordingly, for
is expertise of Federal
resolving technical and
otics Research Corp. V.
§ 355. New drugs
710 F.2d 1375.
(a) Necessity of effective approval of application
doctrine," bulk supplier
No person shall introduce or deliver for introduction into interstate commerce any
ne (PTFE) to manufac-
new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of
nt, which was regulated
this section is effective with respect to such drug.
Administration (FDA),
0 warn of possible dan-
(b) Filing application; contents
ant, and thus, patients
(1) Any person may file with the Secretary an application with respect to any drug
supplier for injuries al-
It of implant, on breach
subject to the provisions of subsection (a) of this section. Such person shall submit to
FDA approved PTFE
the Secretary as a part of the application (A) full reports of investigations which have
levice for use in a medi-
been made to show whether or not such drug is safe for use and whether such drug is
illing the order, supplier
effective in use; (B) a full list of the articles used as components of such drug; (C) a full
of its lack of knowledge
statement of the composition of such drug; (D) a full description of the methods used in,
in implants was appro-
and the facilities and controls used for, the manufacture, processing, and packing of such
Inc., D.N.D.1992, 803
drug; (E) such samples of such drug and of the articles used as components thereof as
the Secretary may require; and (F) specimens of the labeling proposed to be used for
A) (5) (a), (A) (6) (a), (B)
such drug. The applicant shall file with the application the patent number and the
dministration of a drug
expiration date of any patent which claims the drug for which the applicant submitted
member of the medical
iverside Hospital, 1974,
the application or which claims a method of using such drug and with respect to which a
App.2d 422.
claim of patent infringement could reasonably be asserted if a person not licensed by the
patient who contracted
owner engaged in the manufacture, use, or sale of the drug. If an application is filed
transfusion did not state
under this subsection for a drug and a patent which claims such drug or a method of
rainst hospital and blood
using such drug is issued after the filing date but before approval of the application, the
gence by reason of a
applicant shall amend the application to include the information required by the
3715.01(A) (5) (a), (A) (6)
preceding sentence. Upon approval of the application, the Secretary shall publish
provisions thereof did
information submitted under the two preceding sentences.
ion of a drug or device
medical profession. Id.
(2) An application submitted under paragraph (1) for a drug for which the investiga-
tions described in clause (A) of such paragraph and relied upon by the applicant for
sufficiency
approval of the application were not conducted by or for the applicant and for which the
gh dosage quantities of
applicant has not obtained a right of reference or use from the person by or for whom
cure, mitigation, treat-
the investigations were conducted shall also include-
a variety of ailments,
fact that there exists
(A) a certification, in the opinion of the applicant and to the best of his
f known nutritional re-
knowledge, with respect to each patent which claims the drug for which such
evels of 10,000 IU per
investigations were conducted or which claims a use for such drug for which the
and 400 IU per dosage
applicant is seeking approval under this subsection and for which information is
afficient to demonstrate
required to be filed under paragraph (1) or subsection (c) of this section-
Administration require-
of vitamins A and D
(i) that such patent information has not been filed,
stricted to prescription
(ii) that such patent has expired,
ordingly was not arbi-
(iii) of the date on which such patent will expire, or
tional Nutritional Foods
N.Y.1976, 418 F.Supp.
(iv) that such patent is invalid or will not be infringed by the manufacture
use, or sale of the new drug for which the application is submitted; and
fficient to support find-
(B) if with respect to the drug for which investigations described in paragraph
preparations of certain
(1)(A) were conducted information was filed under paragraph (1) or subsection (c) of
trated usage as a food,
this section for a method of use patent which does not claim a use for which the
xtremely small percent-
ove levels established in
applicant is seeking approval under this subsection, a statement that the method of
stration regulations re-
use patent does not claim such a use.
y preparations be avail-
(3)(A) An applicant who makes a certification described in paragraph (2)(A)(iv) shall
scription and be labeled
include in the application a statement that the applicant will give the notice required by
standing alone, be suffi-
lations, it was a relevant
subparagraph (B) to-
avor of the regulations.
(i) each owner of the patent which is the subject of the certification or the
representative of such owner designated to receive such notice, and
(ii) the holder of the approved application under subsection (b) of this section for
and drugs would not be
the drug which is claimed by the patent or a use of which is claimed by the patent
hearing, which was be-
or the representative of such holder designated to receive such notice.
175
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
(B) The notice referred to in subparagraph (A) shall state that an application has
(i) if before the expiration of such period the cour
been submitted under this subsection for the drug with respect to which the certification
is invalid or not infringed, the approval may be ma
is made to obtain approval to engage in the commercial manufacture, use, or sale of the
the court decision,
drug before the expiration of the patent referred to in the certification. Such notice
(ii) if before the expiration of such period the cour
shall include a detailed statement of the factual and legal basis of the applicant's opinion
has been infringed, the approval may be made effe
that the patent is not valid or will not be infringed.
court orders under section 271(e)(4)(A) of Title 35,
(C) If an application is amended to include a certification described in paragraph
(iii) if before the expiration of such period the c
(2)(A)(iv), the notice required by subparagraph (B) shall be given when the amended
injunction prohibiting the applicant from engaging in
application is submitted.
ture or sale of the drug until the court decides the is
infringement and if the court decides that such
(c) Period for approval of application; period for, notice, and expedition of hearing; period for
infringed, the approval shall be made effective or
issuance of order
decision.
(1) Within one hundred and eighty days after the filing of an application under
In such an action, each of the parties shall reasonably C(
subsection (b) of this section, or such additional period as may be agreed upon by the
action. Until the expiration of forty-five days from the d
Secretary and the applicant, the Secretary shall either-
paragraph (3)(B) is received, no action may be brought 1
(A) Approve the application if he then finds that none of the grounds for denying
28 for a declaratory judgment with respect to the pat
approval specified in subsection (d) of this section applies, or
under such section 2201 shall be brought in the judicial di
(B) Give the applicant notice of an opportunity for a hearing before the Secre-
has its principal place of business or a regular and esta
tary under subsection (d) of this section on the question whether such application is
(D)(i) If an application (other than an abbreviated new
approvable. If the applicant elects to accept the opportunity for hearing by written
ted under subsection (b) of this section for a drug, no a
request within thirty days after such notice, such hearing shall commence not more
any ester or salt of the active ingredient) of which has be
than ninety days after the expiration of such thirty days unless the Secretary and
application under subsection (b) of this section, was ap
the applicant otherwise agree. Any such hearing shall thereafter be conducted on
beginning January 1, 1982, and ending on September 24
an expedited basis and the Secretary's order thereon shall be issued within ninety
not make the approval of another application for a drug f
days after the date fixed by the Secretary for filing final briefs.
described in clause (A) of subsection (b)(1) of this sectic
(2) If the patent information described in subsection (b) of this section could not be
applicant for approval of the application were not conduct
filed with the submission of an application under subsection (b) of this section because
and for which the applicant has not obtained a right of
person by or for whom the investigations were condu
the application was filed before the patent information was required under subsection (b)
expiration of ten years from the date of the approval of
of this section or a patent was issued after the application was approved under such
approved under subsection (b) of this section.
subsection, the holder of an approved application shall file with the Secretary the patent
number and the expiration date of any patent which claims the drug for which the
(ii) If an application submitted under subsection (b) of
application was submitted or which claims a method of using such drug and with respect
active ingredient (including any ester or salt of the active
to which a claim of patent infringement could reasonably be asserted if a person not
been approved in any other application under subsect:
licensed by the owner engaged in the manufacture, use, or sale of the drug. If the
approved after September 24, 1984, no application whi
holder of an approved application could not file patent information under subsection (b)
which the subsection (b) application was submitted and fc
of this section because it was not required at the time the application was approved, the
described in clause (A) of subsection (b)(1) of this sectic
holder shall file such information under this subsection not later than thirty days after
applicant for approval of the application were not conduct
September 24, 1984, and if the holder of an approved application could not file patent
and for which the applicant has not obtained a right of
information under subsection (b) of this section because no patent had been issued when
person by or for whom the investigations were conducte
an application was filed or approved, the holder shall file such information under this
subsection (b) of this section before the expiration of five
subsection not later than thirty days after the date the patent involved is issued. Upon
approval of the application under subsection (b) of this BE
the submission of patent information under this subsection, the Secretary shall publish
application may be submitted under subsection (b) of thi
it.
tion of four years from the date of the approval of the sub
contains a certification of patent invalidity or noninfring
(3) The approval of an application filed under subsection (b) of this section which
(iv) of subsection (b)(2)(A) of this section. The approval C
contains a certification required by paragraph (2) of such subsection shall be made
be made effective in accordance with this paragraph ex
effective on the last applicable date determined under the following:
patent infringement is commenced during the one-year pe
(A) If the applicant only made a certification described in clause (i) or (ii) of
months after the date of the approval of the subsection
subsection (b)(2)(A) of this section or in both such clauses, the approval may be
month period referred to in subparagraph (C) shall be ex
made effective immediately.
time (if any) which is required for seven and one-half ye
(B) If the applicant made a certification described in clause (iii) of subsection
the date of approval of the subsection (b) application.
(b)(2)(A) of this section, the approval may be made effective on the date certified
(iii) If an application submitted under subsection (b)
under clause (iii).
which includes an active ingredient (including any est
(C) If the applicant made a certification described in clause (iv) of subsection
ingredient) that has been approved in another applicatio
(b)(2)(A) of this section, the approval shall be made effective immediately unless an
tion (b) of this section, is approved after September 24, 19
action is brought for infringement of a patent which is the subject of the certifica-
contains reports of new clinical investigations (other th
tion before the expiration of forty-five days from the date the notice provided under
essential to the approval of the application and conduc
paragraph (3)(B) is received. If such an action is brought before the expiration of
applicant, the Secretary may not make the approval of
such days, the approval may be made effective upon the expiration of the thirty-
under subsection (b) of this section for the conditions of ap
month period beginning on the date of the receipt of the notice provided under
approved subsection (b) application effective before the
paragraph (3)(B) or such shorter or longer period as the court may order because
from the date of the approval of the application under sur
either party to the action failed to reasonably cooperate in expediting the action,
if the investigations described in clause (A) of subsection
except that-
relied upon by the applicant for approval of the applicati
176
177
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
in subparagraph (A) shall state that an application has
(i) if before the expiration of such period the court decides that such patent
ection for the drug with respect to which the certification
is invalid or not infringed, the approval may be made effective on the date of
ngage in the commercial manufacture, use, or sale of the
the court decision,
the patent referred to in the certification. Such notice
(ii) if before the expiration of such period the court decides that such patent
nt of the factual and legal basis of the applicant's opinion
has been infringed, the approval may be made effective on such date as the
will not be infringed.
court orders under section 271(e)(4)(A) of Title 35, or
ended to include a certification described in paragraph
(iii) if before the expiration of such period the court grants a preliminary
by subparagraph (B) shall be given when the amended
injunction prohibiting the applicant from engaging in the commercial manufac-
ture or sale of the drug until the court decides the issues of patent validity and
infringement and if the court decides that such patent is invalid or not
tion; period for, notice, and expedition of hearing; period for
infringed, the approval shall be made effective on the date of such court
decision.
d eighty days after the filing of an application under
In such an action, each of the parties shall reasonably cooperate in expediting the
or such additional period as may be agreed upon by the
action. Until the expiration of forty-five days from the date the notice made under
ne Secretary shall either-
paragraph (3)(B) is received, no action may be brought under section 2201 of Title
tion if he then finds that none of the grounds for denying
28 for a declaratory judgment with respect to the patent. Any action brought
ection (d) of this section applies, or
under such section 2201 shall be brought in the judicial district where the defendant
notice of an opportunity for a hearing before the Secre-
has its principal place of business or a regular and established place of business.
of this section on the question whether such application is
(D)(i) If an application (other than an abbreviated new drug application) submit-
nt elects to accept the opportunity for hearing by written
ted under subsection (b) of this section for a drug, no active ingredient (including
after such notice, such hearing shall commence not more
any ester or salt of the active ingredient) of which has been approved in any other
expiration of such thirty days unless the Secretary and
application under subsection (b) of this section, was approved during the period
ree. Any such hearing shall thereafter be conducted on
beginning January 1, 1982, and ending on September 24, 1984, the Secretary may
e Secretary's order thereon shall be issued within ninety
not make the approval of another application for a drug for which the investigations
by the Secretary for filing final briefs.
described in clause (A) of subsection (b)(1) of this section and relied upon by the
n described in subsection (b) of this section could not be
applicant for approval of the application were not conducted by or for the applicant
and for which the applicant has not obtained a right of reference or use from the
1 application under subsection (b) of this section because
person by or for whom the investigations were conducted effective before the
the patent information was required under subsection (b)
expiration of ten years from the date of the approval of the application previously
S issued after the application was approved under such
approved under subsection (b) of this section.
proved application shall file with the Secretary the patent
ite of any patent which claims the drug for which the
(ii) If an application submitted under subsection (b) of this section for a drug, no
hich claims a method of using such drug and with respect
active ingredient (including any ester or salt of the active ingredient) of which has
ringement could reasonably be asserted if a person not
been approved in any other application under subsection (b) of this section, is
d in the manufacture, use. or sale of the drug. If the
approved after September 24, 1984, no application which refers to the drug for
ion could not file patent information under subsection (b)
which the subsection (b) application was submitted and for which the investigations
described in clause (A) of subsection (b)(1) of this section and relied upon by the
:ot required at the time the application was approved. the
ion under this subsection not later than thirty days after
applicant for approval of the application were not conducted by or for the applicant
e holder of an approved application could not file patent
and for which the applicant has not obtained a right of reference or use from the
5) of this section because no patent had been issued when
person by or for whom the investigations were conducted may be submitted under
subsection (b) of this section before the expiration of five years from the date of the
proved. the holder shall file such information under this
days after the date the patent involved is issued. Upon
approval of the application under subsection (b) of this section, except that such an
mation under this subsection, the Secretary shall publish
application may be submitted under subsection (b) of this section after the expira-
tion of four years from the date of the approval of the subsection (b) application if it
contains a certification of patent invalidity or noninfringement described in clause
lication filed under subsection (b) of this section which
(iv) of subsection (b)(2)(A) of this section. The approval of such an application shall
ed by paragraph (2) of such subsection shall be made
be made effective in accordance with this paragraph except that, if an action for
date determined under the following:
patent infringement is commenced during the one-year period beginning forty-eight
ily made a certification described in clause (i) or (ii) of
months after the date of the approval of the subsection (b) application, the thirty-
is section or in both such clauses. the approval may be
month period referred to in subparagraph (C) shall be extended by such amount of
ly.
time (if any) which is required for seven and one-half years to have elapsed from
ade a certification described in clause (iii) of subsection
the date of approval of the subsection (b) application.
he approval may be made effective on the date certified
(iii) If an application submitted under subsection (b) of this section for a drug,
which includes an active ingredient (including any ester or salt of the active
ade a certification described in clause (iv) of subsection
ingredient) that has been approved in another application approved under subsec-
he approval shall be made effective immediately unless an
tion (b) of this section, is approved after September 24, 1984, and if such application
ngement of a patent which is the subject of the certifica-
contains reports of new clinical investigations (other than bioavailability studies)
of forty-five days from the date the notice provided under
essential to the approval of the application and conducted or sponsored by the
ed. If such an action is brought before the expiration of
applicant, the Secretary may not make the approval of an application submitted
may be made effective upon the expiration of the thirty-
under subsection (b) of this section for the conditions of approval of such drug in the
on the date of the receipt of the notice provided under
approved subsection (b) application effective before the expiration of three years
shorter or longer period as the court may order because
from the date of the approval of the application under subsection (b) of this section
1 failed to reasonably cooperate in expediting the action.
if the investigations described in clause (A) of subsection (b)(1) of this section and
relied upon by the applicant for approval of the application were not conducted by
176
177
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
or for the applicant and if the applicant has not obtained a right of reference or use
application was approved; (2) that new evider
from the person by or for whom the investigations were conducted.
such application or not available to the Se
(iv) If a supplement to an application approved under subsection (b) of this
approved. or tests by new methods, or te
section is approved after September 24, 1984, and the supplement contains reports
applicable when such application was approv
of new clinical investigations (other than bioavailability studies) essential to the
available to the Secretary when the applicatio
approval of the supplement and conducted or sponsored by the person submitting
not shown to be safe for use under the cond
the supplement, the Secretary may not make the approval of an application
application was approved; or (3) on the basis 0:
submitted under subsection (b) of this section for a change approved in the
to such drug, evaluated together with the evide
supplement effective before the expiration of three years from the date of the
was approved, that there is a lack of substan:
approval of the supplement under subsection (b) of this section if the investigations
effect it purports or is represented to have
described in clause (A) of subsection (b)(1) of this section and relied upon by the
recommended, or suggested in the labeling
applicant for approval of the application were not conducted by or for the applicant
prescribed by subsection (c) of this section W
and if the applicant has not obtained a right of reference or use from the person by
receipt of written notice from the Secretary S]
or for whom the investigations were conducted.
tion; or (5) that the at the application contains
(v) If an application (or supplement to an application) submitted under subsection
Provided, That if the Secretary (or in his abse
(b) of this section for a drug, which includes an active ingredient (including any
that there is an imminent hazard to the public
ester or salt of the active ingredient) that has been approved in another application
such application immediately, and give the a]
under subsection (b) of this section, was approved during the period beginning
afford the applicant the opportunity for an exp.
January 1, 1982, and ending on September 24, 1984, the Secretary may not make
the authority conferred by this proviso to sus
the approval of an application submitted under this subsection and for which the
not be delegated. The Secretary may also, aft.
investigations described in clause (A) of subsection (b)(1) of this section and relied
to the applicant, withdraw the approval of an a.
upon by the applicant for approval of the application were not conducted by or for
or (j) of this section with respect to any drug u:
the applicant and for which the applicant has not obtained a right of reference or
that the applicant has failed to establish a sys
use from the person by or for whom the investigations were conducted and which
has repeatedly or deliberately failed to main
refers to the drug for which the subsection (b) application was submitted effective
reports, in accordance with a regulation or ord
before the expiration of two years from September 24, 1984.
to comply with the notice requirements of secti
has refused to permit access to, or copying or V
(d) Grounds for refusing application; approval of application; "substantial evidence" defined
paragraph (2) of such subsection; or (2) that on
If the Secretary finds, after due notice to the applicant in accordance with subsection
evaluated together with the evidence before hin
(c) of this section and giving him an opportunity for a hearing, in accordance with said
methods used in, or the facilities and controls u:
subsection, that (1) the investigations, reports of which are required to be submitted to
packing of such drug are inadequate to assu
the Secretary pursuant to subsection (b) of this section, do not include adequate tests by
quality. and purity and were not made adequate
all methods reasonably applicable to show whether or not such drug is safe for use
written notice from the Secretary specifying the
under the conditions prescribed, recommended, or suggested in the proposed labeling
basis of new information before him, evaluated
thereof; (2) the results of such tests show that such drug is unsafe for use under such
when the application was approved, the labeling
conditions or do not show that such drug is safe for use under such conditions; (3) the
of all material facts, is false or misleading in any
methods used in, and the facilities and controls used for, the manufacture, processing,
a reasonable time after receipt of written no
and packing of such drug are inadequate to preserve its identity, strength, quality, and
matter complained of. Any order under this
purity; (4) upon the basis of the information submitted to him as part of the application,
which it is based.
or upon the basis of any other information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe for use under such
[See main volume for
conditions; or (5) evaluated on the basis of the information submitted to him as part of
(j) Abbreviated new drug applications
the application and any other information before him with respect to such drug, there is
a lack of substantial evidence that the drug will have the effect it purports or is
(1) Any person may file with the Secreta
represented to have under the conditions of use prescribed, recommended, or suggested
approval of a new drug.
in the proposed labeling thereof; or (6) the application failed to contain the patent
(2)(A) An abbreviated application for a new
information prescribed by subsection (b) of this section; or (7) based on a fair evaluation
(i) information to show that the conditic
of all material facts, such labeling is false or misleading in any particular; he shall issue
suggested in the labeling proposed for the n
an order refusing to approve the application. If, after such notice and opportunity for
for a drug listed under paragraph (6) (hereir
hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall issue an
"listed drug");
order approving the application. As used in this subsection and subsection (e) of this
(ii)(I) if the listed drug referred to in ci
section, the term "substantial evidence" means evidence consisting of adequate and well-
controlled investigations, including clinical investigations, by experts qualified by scienti-
information to show that the active ingredier
the listed drug;
fic training and experience to evaluate the effectiveness of the drug involved, on the
basis of which it could fairly and responsibly be concluded by such experts that the drug
(II) if the listed drug referred to in
will have the effect it purports or is represented to have under the conditions of use
ingredient, information to show that the act
prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
same as those of the listed drug, or
(III) if the listed drug referred to in
(e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to
ingredient and if one of the active ingredier
public health
application is filed pursuant to the approval
The Secretary shall, after due notice and opportunity for hearing to the applicant,
(C), information to show that the other acti-
withdraw approval of an application with respect to any drug under this section if the
same as the active ingredients of the liste
Secretary finds (1) that clinical or other experience, tests, or other scientific data show
different active ingredient is an active ingred
that such drug is unsafe for use under the conditions of use upon the basis of which the
does not meet the requirements of sectio.
178
179
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
icant has not obtained a right of reference or use
application was approved; (2) that new evidence of clinical experience, not contained in
he investigations were conducted.
such application or not available to the Secretary until after such application was
plication approved under subsection (b) of this
approved. or tests by new methods, or tests by methods not deemed reasonably
er 24, 1984. and the supplement contains reports
applicable when such application was approved, evaluated together with the evidence
er than bioavailability studies) essential to the
available to the Secretary when the application was approved, shows that such drug is
onducted or sponsored by the person submitting
not shown to be safe for use under the conditions of use upon the basis of which the
may not make the approval of an application
application was approved; or (3) on the basis of new information before him with respect
of this section for a change approved in the
to such drug, evaluated together with the evidence available to him when the application
expiration of three years from the date of the
was approved, that there is a lack of substantial evidence that the drug will have the
subsection (b) of this section if the investigations
effect it purports or is represented to have under the conditions of use prescribed,
tion (b)(1) of this section and relied upon by the
recommended, or suggested in the labeling thereof; or (4) the patent information
cation were not conducted by or for the applicant
prescribed by subsection (c) of this section was not filed within thirty days after the
ed a right of reference or use from the person by
receipt of written notice from the Secretary specifying the failure to file such informa-
ere conducted.
tion; or (5) that the at the application contains any untrue statement of a material fact:
nent to an application) submitted under subsection
Provided, That if the Secretary (or in his absence the officer acting as Secretary) finds
hich includes an active ingredient (including any
that there is an imminent hazard to the public health, he may suspend the approval of
ent) that has been approved in another application
such application immediately, and give the applicant prompt notice of his action and
tion, was approved during the period beginning
afford the applicant the opportunity for an expedited hearing under this subsection; but
September 24, 1984, the Secretary may not make
the authority conferred by this proviso to suspend the approval of an application shall
abmitted under this subsection and for which the
not be delegated. The Secretary may also, after due notice and opportunity for hearing
(A) of subsection (b)(1) of this section and relied
to the applicant. withdraw the approval of an application submitted under subsection (b)
al of the application were not conducted by or for
or (j) of this section with respect to any drug under this section if the Secretary finds (1)
applicant has not obtained a right of reference or
that the applicant has failed to establish a system for maintaining required records, or
hom the investigations were conducted and which
has repeatedly or deliberately failed to maintain such records or to make required
subsection (b) application was submitted effective
reports. in accordance with a regulation or order under subsection (k) of this section or
rs from September 24, 1984.
to comply with the notice requirements of section 360(k)(2) of this title, or the applicant
has refused to permit access to, or copying or verification of, such records as required by
pproval of application; "substantial evidence" defined
paragraph (2) of such subsection; or (2) that on the basis of new information before him,
tice to the applicant in accordance with subsection
evaluated together with the evidence before him when the application was approved, the
opportunity for a hearing, in accordance with said
methods used in, or the facilities and controls used for, the manufacture, processing, and
; reports of which are required to be submitted to
packing of such drug are inadequate to assure and preserve its identity, strength,
(b) of this section, do not include adequate tests by
quality, and purity and were not made adequate within a reasonable time after receipt of
) show whether or not such drug is safe for use
written notice from the Secretary specifying the matter complained of; or (3) that on the
ommended. or suggested in the proposed labeling
basis of new information before him, evaluated together with the evidence before him
show that such drug is unsafe for use under such
when the application was approved, the labeling of such drug, based on a fair evaluation
drug is safe for use under such conditions; (3) the
of all material facts, is false or misleading in any particular and was not corrected within
nd controls used for, the manufacture. processing,
a reasonable time after receipt of written notice from the Secretary specifying the
uate to preserve its identity, strength, quality, and
matter complained of. Any order under this subsection shall state the findings upon
rmation submitted to him as part of the application.
which it is based.
nation before him with respect to such drug, he has
[See main volume for text of (f) to (i)]
e whether such drug is safe for use under such
asis of the information submitted to him as part of
(j) Abbreviated new drug applications
ation before him with respect to such drug, there is
: the drug will have the effect it purports or is
(1) Any person may file with the Secretary an abbreviated application for the
tions of use prescribed, recommended, or suggested
approval of a new drug.
or (6) the application failed to contain the patent
(2)(A) An abbreviated application for a new drug shall contain-
n (b) of this section; or (7) based on a fair evaluation
(i) information to show that the conditions of use prescribed, recommended, or
false or misleading in any particular: he shall issue
suggested in the labeling proposed for the new drug have been previously approved
oplication. If. after such notice and opportunity for
for a drug listed under paragraph (6) (hereinafter in this subsection referred to as a
auses (1) through (6) do not apply, he shall issue an
"listed drug");
is used in this subsection and subsection (e) of this
(ii)(I) if the listed drug referred to in clause (i) has only one active ingredient,
ice" means evidence consisting of adequate and well-
information to show that the active ingredient of the new drug is the same as that of
linical investigations, by experts qualified by scienti-
the listed drug;
uate the effectiveness of the drug involved, on the
sponsibly be concluded by such experts that the drug
(II) if the listed drug referred to in clause (i) has more than one active
is represented to have under the conditions of use
ingredient, information to show that the active ingredients of the new drug are the
rested in the labeling or proposed labeling thereof.
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i) has more than one active
immediate suspension upon finding imminent hazard to
ingredient and if one of the active ingredients of the new drug is different and the
application is filed pursuant to the approval of a petition filed under subparagraph
notice and opportunity for hearing to the applicant.
(C), information to show that the other active ingredients of the new drug are the
in with respect to any drug under this section if the
same as the active ingredients of the listed drug, information to show that the
other experience. tests, or other scientific data show
different active ingredient is an active ingredient of a listed drug or of a drug which
der the conditions of use upon the basis of which the
does not meet the requirements of section 321(p) of this title, and such other
178
179
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
information respecting the different active ingredient with respect to which the
petition was filed as the Secretary may require;
seeking permission to file such an application.
prove a petition submitted under this subparagr.
(iii) information to show that the route of administration, the dosage form, and
petition is submitted. The Secretary shall appro
the strength of the new drug are the same as those of the listed drug referred to in
finds-
clause (i) or, if the route of administration, the dosage form, or the strength of the
new drug is different and the application is filed pursuant to the approval of a
(i) that investigations must be conducted
petition filed under subparagraph (C), such information respecting the route of
the drug or of any of its active ingredients, 1
administration, dosage form, or strength with respect to which the petition was filed
form, or strength which differ from the liste
as the Secretary may require;
(ii) that any drug with a different activ
(iv) information to show that the new drug is bioequivalent to the listed drug
evaluated for approval as safe and effective 0
referred to in clause (i), except that if the application is filed pursuant to the
to be submitted in an abbreviated application
approval of a petition filed under subparagraph (C), information to show that the
(3) Subject to paragraph (4), the Secretary st
active ingredients of the new drug are of the same pharmacological or therapeutic
unless the Secretary finds-
class as those of the listed drug referred to in clause (i) and the new drug can be
(A) the methods used in, or the facilities a
expected to have the same therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in clause (i);
processing, and packing of the drug are is
identity, strength, quality, and purity;
(v) information to show that the labeling proposed for the new drug is the same
as the labeling approved for the listed drug referred to in clause (i) except for
(B) information submitted with the applica
changes required because of differences approved under a petition filed under
the proposed conditions of use have been p:
subparagraph (C) or because the new drug and the listed drug are produced or
referred to in the application;
distributed by different manufacturers;
(C)(i) if the listed drug has only one ac:
(vi) the items specified in clauses (B) through (F) of subsection (b)(1) of this
with the application is insufficient to show th
section;
that of the listed drug;
(vii) a certification, in the opinion of the applicant and to the best of his
(ii) if the listed drug has more than one a
knowledge, with respect to each patent which claims the listed drug referred to in
with the application is insufficient to show th
clause (i) or which claims a use for such listed drug for which the applicant is
as the active ingredients of the listed drug,
seeking approval under this subsection and for which information is required to be
(iii) if the listed drug has more than one
filed under subsection (b) or (c) of this section-
is for a drug which has an active ingre
(I) that such patent information has not been filed,
information submitted with the application is
(II) that such patent has expired,
(I) that the other active ingredients ar
the listed drug, or
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the manufacture,
(II) that the different active ingredie
drug or 8 drug which does not meet the
use, or sale of the new drug for which the application is submitted; and
title,
(viii) if with respect to the listed drug referred to in clause (i) information was
filed under subsection (b) or (c) of this section for a method of use patent which
or no petition to file an application for
does not claim a use for which the applicant is seeking approval under this
was approved under paragraph (2)(C);
subsection. a statement that the method of use patent does not claim such a use.
(D)(i) if the application is for a drug whos-
or strength of the drug is the same as the rc
The Secretary may not require that an abbreviated application contain information in
strength of the listed drug referred to in the
addition to that required by clauses (i) through (viii).
the application is insufficient to show that the
(B)(i) An applicant who makes a certification described in subparagraph (A)(vii)(IV)
or strength is the same as that of the listed
shall include in the application a statement that the applicant will give the notice
(ii) if the application is for a drug whose r
required by clause (ii) to-
strength of the drug is different from that
(I) each owner of the patent which is the subject of the certification or the
application, no petition to file an application f
representative of such owner designated to receive such notice, and
administration, dosage form, or strength W.
(II) the holder of the approved application under subsection (b) of this section for
(E) if the application was filed pursuant
the drug which is claimed by the patent or a use of which is claimed by the patent
paragraph (2)(C), the application did not con
or the representative of such holder designated to receive such notice.
Secretary respecting the active ingredient, rc
(ii) The notice referred to in clause (i) shall state that an application, which contains
strength which is not the same;
data from bioavailability or bioequivalence studies, has been submitted under this
(F) information submitted in the applicatic
subsection for the drug with respect to which the certification is made to obtain approval
is bioequivalent to the listed drug referred to
to engage in the commercial manufacture, use, or sale of such drug before the expiration
was filed pursuant to a petition approved
of the patent referred to in the certification. Such notice shall include a detailed
submitted in the application is insufficient to
statement of the factual and legal basis of the applicant's opinion that the patent is not
new drug are of the same pharmacological or
valid or will not be infringed.
drug referred to in paragraph (2)(A)(i) and 1
(iii) If an application is amended to include a certification described in subparagraph
have the same therapeutic effect as the liste
(A)(vii)(IV), the notice required by clause (ii) shall be given when the amended
for a condition of use referred to in such pa:
application is submitted.
(G) information submitted in the applica
(C) If a person wants to submit an abbreviated application for a new drug which has
labeling proposed for the drug is the same 8
a different active ingredient or whose route of administration, dosage form. or strength
drug referred to in the application except fc
differ from that of a listed drug, such person shall submit a petition to the Secretary
ences approved under a petition filed under
and the listed drug are produced or dist
180
Bk88 USCA 1994 P.P.-7
181
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
rent active ingredient with respect to which the
seeking permission to file such an application. The Secretary shall approve or disap-
ry may require;
prove a petition submitted under this subparagraph within ninety days of the date the
the route of administration, the dosage form, and
petition is submitted. The Secretary shall approve such a petition unless the Secretary
the same as those of the listed drug referred to in
finds—
inistration, the dosage form, or the strength of the
application is filed pursuant to the approval of a
(i) that investigations must be conducted to show the safety and effectiveness of
ph (C), such information respecting the route of
the drug or of any of its active ingredients, the route of administration, the dosage
trength with respect to which the petition was filed
form, or strength which differ from the listed drug; or
(ii) that any drug with a different active ingredient may not be adequately
the new drug is bioequivalent to the listed drug
evaluated for approval as safe and effective on the basis of the information required
t that if the application is filed pursuant to the
to be submitted in an abbreviated application.
r subparagraph (C), information to show that the
(3) Subject to paragraph (4), the Secretary shall approve an application for a drug
ug are of the same pharmacological or therapeutic
unless the Secretary finds—
referred to in clause (i) and the new drug can be
(A) the methods used in, or the facilities and controls used for, the manufacture,
peutic effect as the listed drug when administered
processing, and packing of the drug are inadequate to assure and preserve its
e referred to in clause (i);
identity, strength, quality, and purity;
he labeling proposed for the new drug is the same
(B) information submitted with the application is insufficient to show that each of
e listed drug referred to in clause (i) except for
ifferences approved under a petition filed under
the proposed conditions of use have been previously approved for the listed drug
e new drug and the listed drug are produced or
referred to in the application;
turers;
(C)(i) if the listed drug has only one active ingredient, information submitted
Juses (B) through (F) of subsection (b)(1) of this
with the application is insufficient to show that the active ingredient is the same as
that of the listed drug;
pinion of the applicant and to the best of his
(ii) if the listed drug has more than one active ingredient, information submitted
patent which claims the listed drug referred to in
with the application is insufficient to show that the active ingredients are the same
e for such listed drug for which the applicant is
as the active ingredients of the listed drug, or
section and for which information is required to be
(iii) if the listed drug has more than one active ingredient and if the application
of this section-
is for a drug which has an active ingredient different from the listed drug,
mation has not been filed,
information submitted with the application is insufficient to show-
expired,
(I) that the other active ingredients are the same as the active ingredients of
the listed drug, or
h such patent will expire, or
(II) that the different active ingredient is an active ingredient of a listed
invalid or will not be infringed by the manufacture,
drug or a drug which does not meet the requirements of section 321(p) of this
rug for which the application is submitted; and
title.
sted drug referred to in clause (i) information was
or no petition to file an application for the drug with the different ingredient
of this section for a method of use patent which
was approved under paragraph (2)(C);
ch the applicant is seeking approval under this
method of use patent does not claim such a use.
(D)(i) if the application is for a drug whose route of administration. dosage form,
or strength of the drug is the same as the route of administration. dosage form, or
:
an abbreviated application contain information in
strength of the listed drug referred to in the application, information submitted in
(i) through (viii).
the application is insufficient to show that the route of administration, dosage form,
certification described in subparagraph (A)(vii)(IV)
or strength is the same as that of the listed drug, or
statement that the applicant will give the notice
(ii) if the application is for a drug whose route of administration, dosage form. or
strength of the drug is different from that of the listed drug referred to in the
t which is the subject of the certification or the
application. no petition to file an application for the drug with the different route of
esignated to receive such notice, and
administration, dosage form. or strength was approved under paragraph (2)(C);
d application under subsection (b) of this section for
(E) if the application was filed pursuant to the approval of a petition under
e patent or a use of which is claimed by the patent
paragraph (2)(C), the application did not contain the information required by the
older designated to receive such notice.
Secretary respecting the active ingredient, route of administration, dosage form. or
se (i) shall state that an application, which contains
strength which is not the same;
livalence studies, has been submitted under this
(F) information submitted in the application is insufficient to show that the drug
to which the certification is made to obtain approval
is bioequivalent to the listed drug referred to in the application or, if the application
ture, use, or sale of such drug before the expiration
was filed pursuant to a petition approved under paragraph (2)(C), information
ertification. Such notice shall include a detailed
submitted in the application is insufficient to show that the active ingredients of the
sis of the applicant's opinion that the patent is not
new drug are of the same pharmacological or therapeutic class as those of the listed
drug referred to in paragraph (2)(A)(i) and that the new drug can be expected to
to include a certification described in subparagraph
have the same therapeutic effect as the listed drug when administered to patients
y clause (ii) shall be given when the amended
for a condition of use referred to in such paragraph;
(G) information submitted in the application is insufficient to show that the
n abbreviated application for a new drug which has
labeling proposed for the drug is the same as the labeling approved for the listed
se route of administration, dosage form, or strength
drug referred to in the application except for changes required because of differ-
ich person shall submit a petition to the Secretary
ences approved under a petition filed under paragraph (2)(C) or because the drug
and the listed drug are produced or distributed by different manufacturers;
180
181
Bk88 USCA 1994 P.P.-7
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
(H) information submitted in the application or any other information available to
(I) the date the Secretary receiv
the Secretary shows that (i) the inactive ingredients of the drug are unsafe for use
previous application of the first com
under the conditions prescribed, recommended, or suggested in the labeling pro-
previous application, or
posed for the drug, or (ii) the composition of the drug is unsafe under such
(II) the date of a decision of a C
conditions because of the type or quantity of inactive ingredients included or the
holding the patent which is the subje
manner in which the inactive ingredients are included;
infringed,
(I) the approval under subsection (c) of this section of the listed drug referred to
whichever is earlier.
in the application under this subsection has been withdrawn or suspended for
grounds described in the first sentence of subsection (e) of this section, the
(C) If the Secretary decides to disapprove a
Secretary has published a notice of opportunity for hearing to withdraw approval of
applicant notice of an opportunity for a hearin
the listed drug under subsection (c) of this section for grounds described in the first
whether such application is approvable. If the
sentence of subsection (e) of this section, the approval under this subsection of the
for hearing by written request within thirty (
listed drug referred to in the application under this subsection has been withdrawn
commence not more than ninety days after the
or suspended under paragraph (5), or the Secretary has determined that the listed
Secretary and the applicant otherwise agree
drug has been withdrawn from sale for safety or effectiveness reasons;
conducted on an expedited basis and the Secre
ninety days after the date fixed by the Secret
(J) the application does not meet any other requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of material fact.
(D)(i) If an application (other than an abb
under subsection (b) of this section for a drug
(4)(A) Within one hundred and eighty days of the initial receipt of an application
or salt of the active ingredient) of which has
under paragraph (2) or within such additional period as may be agreed upon by the
under subsection (b) of this section, was appro
Secretary and the applicant, the Secretary shall approve or disapprove the application.
1, 1982. and ending on September 24, 1984, the
(B) The approval of an application submitted under paragraph (2) shall be made
an application submitted under this subsectio
effective on the last applicable date determined under the following:
subsection (b) application was submitted effect.
(i) If the applicant only made a certification described in subclause (I) or (II) of
the date of the approval of the applicatio
paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective
(ii) If an application submitted under subs
immediately.
active ingredient (including any ester or salt 0
(ii) If the applicant made a certification described in subclause (III) of paragraph
approved in any other application under subse
(2)(A)(vii), the approval may be made effective on the date certified under subclause
September 24, 1984, no application may be sub
(III).
to the drug for which the subsection (b) applic
(iii) If the applicant made a certification described in subclause (IV) of para-
of five years from the date of the approval of t
graph (2)(A)(vii), the approval shall be made effective immediately unless an action
section, except that such an application may be
is brought for infringement of a patent which is the subject of the certification
expiration of four years from the date of the at
before the expiration of forty-five days from the date the notice provided under
it contains a certification of patent invalidity 0
paragraph (2)(B)(i) is received. If such an action is brought before the expiration of
(IV) of paragraph (2)(A)(vii). The approval
such days, the approval shall be made effective upon the expiration of the thirty-
effective in accordance with subparagraph (
month period beginning on the date of the receipt of the notice provided under
infringement is commenced during the one-y
paragraph (2)(B)(i) or such shorter or longer period as the court may order because
after the date of the approval of the subsectio
either party to the action failed to reasonably cooperate in expediting the action,
referred to in subparagraph (B)(iii) shall be e
except that-
which is required for seven and one-half years
(I) if before the expiration of such period the court decides that such patent
of the subsection (b) application.
is invalid or not infringed. the approval shall be made effective on the date of
(iii) If an application submitted under subs
the court decision,
includes an active ingredient (including any e:
(II) if before the expiration of such period the court decides that such patent
has been approved in another application appr
has been infringed, the approval shall be made effective on such date as the
is approved after September 24, 1984, and if
court orders under section 271(e)(4)(A) of Title 35 or
clinical investigations (other than bioavailabilit
application and conducted or sponsored by th.
(III) if before the expiration of such period the court grants a preliminary
the approval of an application submitted unc
injunction prohibiting the applicant from engaging in the commercial manufac-
approval of such drug in the subsection (b) app
ture or sale of the drug until the court decides the issues of patent validity and
infringement and if the court decides that such patent is invalid or not
three years from the date of the approval of th
section for such drug.
infringed, the approval shall be made effective on the date of such court
decision.
(iv) If a supplement to an application appro
In such an action, each of the parties shall reasonably cooperate in expediting
approved after September 24, 1984, and the su
the action. Until the expiration of forty-five days from the date the notice
investigations (other than bioavailability stu
made under paragraph (2)(B)(i) is received, no action may be brought under
supplement and conducted or sponsored by th
section 2201 of Title 28 for a declaratory judgment with respect to the patent.
Secretary may not make the approval of an ap
Any action brought under section 2201 shall be brought in the judicial district
for a change approved in the supplement effe
where the defendant has its principal place of business or a regular and
from the date of the approval of the supplem
established place of business.
(v) If an application (or supplement to an an
(iv) If the application contains a certification described in subclause (IV) of
of this section for a drug, which includes an act
paragraph (2)(A)(vii) and is for a drug for which a previous application has been
of the active ingredient) that has been approve
submitted under this subsection continuing such a certification, the application shall
(b) of this section, was approved during the
be made effective not earlier than one hundred and eighty days after-
ending on September 24, 1984, the Secreta
182
183
FOOD AND DRUGS
FOOD AND DRUGS
21 § 355
ed in the application or any other information available to
(I) the date the Secretary receives notice from the applicant under the
i) the inactive ingredients of the drug are unsafe for use
previous application of the first commercial marketing of the drug under the
cribed, recommended, or suggested in the labeling pro-
previous application, or
i) the composition of the drug is unsafe under such
(II) the date of a decision of a court in an action described in clause (iii)
type or quantity of inactive ingredients included or the
holding the patent which is the subject of the certification to be invalid or not
ive ingredients are included;
infringed,
ubsection (c) of this section of the listed drug referred to
whichever is earlier.
this subsection has been withdrawn or suspended for
first sentence of subsection (e) of this section, the
(C) If the Secretary decides to disapprove an application, the Secretary shall give the
notice of opportunity for hearing to withdraw approval of
applicant notice of an opportunity for a hearing before the Secretary on the question of
:ction (c) of this section for grounds described in the first
whether such application is approvable. If the applicant elects to accept the opportunity
of this section, the approval under this subsection of the
for hearing by written request within thirty days after such notice, such hearing shall
he application under this subsection has been withdrawn
commence not more than ninety days after the expiration of such thirty days unless the
raph (5), or the Secretary has determined that the listed
Secretary and the applicant otherwise agree. Any such hearing shall thereafter be
from sale for safety or effectiveness reasons;
conducted on an expedited basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing final briefs.
not meet any other requirement of paragraph (2)(A); or
ains an untrue statement of material fact.
(D)(i) If an application (other than an abbreviated new drug application) submitted
under subsection (b) of this section for a drug, no active ingredient (including any ester
and eighty days of the initial receipt of an application
or salt of the active ingredient) of which has been approved in any other application
such additional period as may be agreed upon by the
under subsection (b) of this section, was approved during the period beginning January
e Secretary shall approve or disapprove the application.
1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of
lication submitted under paragraph (2) shall be made
an application submitted under this subsection which refers to the drug for which the
date determined under the following:
subsection (b) application was submitted effective before the expiration of ten years from
made a certification described in subclause (I) or (II) of
the date of the approval of the application under subsection (b) of this section.
both such subclauses, the approval may be made effective
(ii) If an application submitted under subsection (b) of this section for a drug, no
active ingredient (including any ester or salt of the active ingredient) of which has been
e a certification described in subclause (III) of paragraph
approved in any other application under subsection (b) of this section, is approved after
y be made effective on the date certified under subclause
September 24, 1984, no application may be submitted under this subsection which refers
to the drug for which the subsection (b) application was submitted before the expiration
ude a certification described in subclause (IV) of para-
of five years from the date of the approval of the application under subsection (b) of this
val shall be made effective immediately unless an action
section, except that such an application may be submitted under this subsection after the
nt of a patent which is the subject of the certification
expiration of four years from the date of the approval of the subsection (b) application if
orty-five days from the date the notice provided under
it contains a certification of patent invalidity or noninfringement described in subclause
ved. If such an action is brought before the expiration of
(IV) of paragraph (2)(A)(vii). The approval of such an application shall be made
all be made effective upon the expiration of the thirty-
effective in accordance with subparagraph (B) except that, if an action for patent
n the date of the receipt of the notice provided under
infringement is commenced during the one-year period beginning forty-eight months
shorter or longer period as the court may order because
after the date of the approval of the subsection (b) application, the thirty-month period
failed to reasonably cooperate in expediting the action.
referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any)
which is required for seven and one-half years to have elapsed from the date of approval
iration of such period the court decides that such patent
of the subsection (b) application.
ged, the approval shall be made effective on the date of
(iii) If an application submitted under subsection (b) of this section for a drug, which
includes an active ingredient (including any ester or salt of the active ingredient) that
piration of such period the court decides that such patent
has been approved in another application approved under subsection (b) of this section,
e approval shall be made effective on such date as the
is approved after September 24, 1984, and if such application contains reports of new
ction 271(e)(4)(A) of Title 35 or
clinical investigations (other than bioavailability studies) essential to the approval of the
application and conducted or sponsored by the applicant, the Secretary may not make
expiration of such period the court grants a preliminary
the approval of an application submitted under this subsection for the conditions of
the applicant from engaging in the commercial manufac-
approval of such drug in the subsection (b) application effective before the expiration of
ig until the court decides the issues of patent validity and
three years from the date of the approval of the application under subsection (b) of this
the court decides that such patent is invalid or not
al shall be made effective on the date of such court
section for such drug.
(iv) If a supplement to an application approved under subsection (b) of this section is
h of the parties shall reasonably cooperate in expediting
approved after September 24, 1984, and the supplement contains reports of new clinical
expiration of forty-five days from the date the notice
investigations (other than bioavailability studies) essential to the approval of the
h (2)(B)(i) is received, no action may be brought under
supplement and conducted or sponsored by the person submitting the supplement, the
'8 for a declaratory judgment with respect to the patent.
Secretary may not make the approval of an application submitted under this subsection
nder section 2201 shall be brought in the judicial district
for a change approved in the supplement effective before the expiration of three years
has its principal place of business or a regular and
from the date of the approval of the supplement under subsection (b) of this section.
usiness.
(v) If an application (or supplement to an application) submitted under subsection (b)
contains a certification described in subclause (IV) of
of this section for a drug, which includes an active ingredient (including any ester or salt
is for a drug for which a previous application has been
of the active ingredient) that has been approved in another application under subsection
ection continuing such a certification. the application shall
(b) of this section, was approved during the period beginning January 1, 1982, and
lier than one hundred and eighty days after-
ending on September 24, 1984, the Secretary may not make the approval of an
182
183
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
application submitted under this subsection which refers to the drug for which the
(ii) the extent of absorp:
subsection (b) application was submitted or which refers to a change approved in a
difference from the extent of
supplement to the subsection (b) application effective before the expiration of two years
at the same molar dose of the
from September 24, 1984.
tal conditions in either a sing
(5) If a drug approved under this subsection refers in its approved application to a
the listed drug in the rate of a
drug the approval of which was withdrawn or suspended for grounds described in the
its proposed labeling, is not e
first sentence of subsection (e) of this section or was withdrawn or suspended under this
concentrations on chronic use
paragraph or which, as determined by the Secretary, has been withdrawn from sale for
drug.
safety or effectiveness reasons, the approval of the drug under this subsection shall be
(8) The Secretary shall, with res:
withdrawn or suspended-
subsection, maintain a record of-
(A) for the same period as the withdrawal or suspension under subsection (e) of
this section or this paragraph, or
(A) the name of the applicant,
(B) if the listed drug has been withdrawn from sale, for the period of withdrawal
(B) the name of the drug cove:
from sale or, if earlier, the period ending on the date the Secretary determines that
(C) the name of each person
the withdrawal from sale is not for safety or effectiveness reasons.
application was assigned and the
(6)(A)(i) Within sixty days of September 24, 1984, the Secretary shall publish and
(D) the name of each person
make available to the public-
application was assigned and the
(I) a list in alphabetical order of the official and proprietary name of each drug
which has been approved for safety and effectiveness under subsection (c) of this
The information the Secretary is requir
section before September 24, 1984;
to an application submitted under this
after the approval of such application.
(II) the date of approval if the drug is approved after 1981 and the number of the
application which was approved; and
(k) Records and reports; required info:
(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are
required for applications filed under this subsection which will refer to the drug
(1) In the case of any drug for
published.
subsection (b) or (j) of this section is i:
such records, and make such report
(ii) Every thirty days after the publication of the first list under clause (i) the
experience and other data or inform
Secretary shall revise the list to include each drug which has been approved for safety
and effectiveness under subsection (c) of this section or approved under this subsection
applicant with respect to such drug, a
during the thirty-day period.
order with respect to such applicatio
records and reports are necessary in
(iii) When patent information submitted under subsection (b) or (c) of this section
facilitate a determination, whether the
respecting a drug included on the list is to be published by the Secretary, the Secretary
of this section. Regulations and 0
shall, in revisions made under clause (ii), include such information for such drug.
subsection (i) of this section shall ha
(B) A drug approved for safety and effectiveness under subsection (c) of this section
medical profession and the interests 0
or approved under this subsection shall, for purposes of this subsection. be considered to
deems it to be appropriate, for the ex.
have been published under subparagraph (A) on the date of its approval or September
such regulations or orders are applic:
24, 1984, whichever is later.
obtained by the Secretary.
(C) If the approval of a drug was withdrawn or suspended for grounds described in
(2) Every person required under th
the first sentence of subsection (e) of this section or was withdrawn or suspended under
charge or custody thereof, shall, upon
paragraph (5) or if the Secretary determines that a drug has been withdrawn from sale
the Secretary, permit such officer or E
for safety or effectiveness reasons, it may not be published in the list under subpara-
and copy and verify such records.
graph (A) or, if the withdrawal or suspension occurred after its publication in such list, it
shall be immediately removed from such list-
(1) Public disclosure of safety and effect
(i) for the same period as the withdrawal or suspension under subsection (e) of
Safety and effectiveness data anc
this section or paragraph (5), or
application under subsection (b) of thi
(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal
been disclosed to the public shall be I
from sale or, if earlier, the period ending on the date the Secretary determines that
extraordinary circumstances are show
the withdrawal from sale is not for safety or effectiveness reasons.
(1) if no work is being or will
A notice of the removal shall be published in the Federal Register.
(2) if the Secretary has determ
(7) For purposes of this subsection:
legal appeals have been exhauste
(A) The term "bioavailability" means the rate and extent to which the active
ingredient or therapeutic ingredient is absorbed from a drug and becomes available
(3) if approval of the applicatio:
at the site of drug action.
and all legal appeals have been e
(B) A drug shall be considered to be bioequivalent to a listed drug if
(4) if the Secretary has dete.
(i) the rate and extent of absorption of the drug do not show a significant
(5) upon the effective date of t
difference from the rate and extent of absorption of the listed drug when
tion (j) of this section which refe:
administered at the same molar dose of the therapeutic ingredient under
approval of an application under
similar experimental conditions in either a single dose or multiple doses: or
drug could be made effective if S
184
FOOD AND DRUGS
FOOD AND DRUGS
21 $ 355
section which refers to the drug for which the
(ii) the extent of absorption of the drug does not show a significant
itted or which refers to a change approved in a
difference from the extent of absorption of the listed drug when administered
lication effective before the expiration of two years
at the same molar dose of the therapeutic ingredient under similar experimen-
tal conditions in either a single dose or multiple doses and the difference from
subsection refers in its approved application to a
the listed drug in the rate of absorption of the drug is intentional, is reflected in
drawn or suspended for grounds described in the
its proposed labeling, is not essential to the attainment of effective body drug
section or was withdrawn or suspended under this
concentrations on chronic use, and is considered medically insignificant for the
y the Secretary, has been withdrawn from sale for
drug.
pproval of the drug under this subsection shall be
(8) The Secretary shall, with respect to each application submitted under this
subsection, maintain a record of-
withdrawal or suspension under subsection (e) of
(A) the name of the applicant,
r
1 withdrawn from sale, for the period of withdrawal
(B) the name of the drug covered by the application,
1 ending on the date the Secretary determines that
(C) the name of each person to whom the review of the chemistry of the
for safety or effectiveness reasons.
application was assigned and the date of such assignment, and
tember 24. 1984, the Secretary shall publish and
(D) the name of each person to whom the bioequivalence review for such
application was assigned and the date of such assignment.
of the official and proprietary name of each drug
fety and effectiveness under subsection (c) of this
The information the Secretary is required to maintain under this paragraph with respect
to an application submitted under this subsection shall be made available to the public
84;
after the approval of such application.
: drug is approved after 1981 and the number of the
and
(k) Records and reports; required information; regulations and orders; access to records
vo bioequivalence studies, or both such studies, are
inder this subsection which will refer to the drug
(1) In the case of any drug for which an approval of an application filed under
subsection (b) or (j) of this section is in effect, the applicant shall establish and maintain
such records. and make such reports to the Secretary, of data relating to clinical
publication of the first list under clause (i) the
experience and other data or information, received or otherwise obtained by such
lude each drug which has been approved for safety
applicant with respect to such drug, as the Secretary may by general regulation, or by
c) of this section or approved under this subsection
order with respect to such application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the Secretary to determine, or
bmitted under subsection (b) or (c) of this section
facilitate a determination, whether there is or may be ground for invoking subsection (e)
-t is to be published by the Secretary, the Secretary
of this section. Regulations and orders issued under this subsection and under
use (ii), include such information for such drug.
subsection (i) of this section shall have due regard for the professional ethics of the
nd effectiveness under subsection (c) of this section
medical profession and the interests of patients and shall provide, where the Secretary
all, for purposes of this subsection. be considered to
deems it to be appropriate, for the examination, upon request, by the persons to whom
graph (A) on the date of its approval or September
such regulations or orders are applicable, of similar information received or otherwise
obtained by the Secretary.
S withdrawn or suspended for grounds described in
(2) Every person required under this section to maintain records, and every person in
of this section or was withdrawn or suspended under
charge or custody thereof, shall, upon request of an officer or employee designated by
termines that a drug has been withdrawn from sale
the Secretary, permit such officer or employee at all reasonable times to have access to
it may not be published in the list under subpara-
and copy and verify such records.
aspension occurred after its publication in such list, it
1 such list-
(I) Public disclosure of safety and effectiveness data
he withdrawal or suspension under subsection (e) of
Safety and effectiveness data and information which has been submitted in an
or
application under subsection (b) of this section for a drug and which has not previously
en withdrawn from sale, for the period of withdrawal
been disclosed to the public shall be made available to the public, upon request, unless
od ending on the date the Secretary determines that
extraordinary circumstances are shown-
it for safety or effectiveness reasons.
(1) if no work is being or will be undertaken to have the application approved,
iblished in the Federal Register.
(2) if the Secretary has determined that the application is not approvable and all
ion:
legal appeais have been exhausted,
ty" means the rate and extent to which the active
dient is absorbed from a drug and becomes available
(3) if approval of the application under subsection (c) of this section is withdrawn
and all legal appeals have been exhausted,
ered to be bioequivalent to a listed drug if-
(4) if the Secretary has determined that such drug is not a new drug, or
: of absorption of the drug do not show a significant
(5) upon the effective date of the approval of the first application under subsec-
and extent of absorption of the listed drug when
tion (j) of this section which refers to such drug or upon the date upon which the
ne molar dose of the therapeutic ingredient under
approval of an application under subsection (j) of this section which refers to such
ditions in either a single dose or multiple doses; or
drug could be made effective if such an application had been submitted.
184
185
21 § 355
FOOD AND DRUGS
FOOD AND DRUGS
(m) "Patent" defined
96-88, Title VI, Oct. 17, 1979, 93 Stat. 696
For purposes of this section, the term "patent" means a patent issued by the Patent
out as a note under section 3401 of Titl
and Trademark Office of the Department of Commerce.
Education, deemed to refer and apply to
Department of Health and Human Service
(As amended Aug. 16, 1972. Pub.L. 92-387, $ 4(d), 86 Stat. 562; Sept. 24, 1984. Pub.L. 98-417, Title
the Secretary of Health and Human Serv
I, §§ 101, 102(a)-(b)(5). 103, 104. 98 Stat. 1585. 1592, 1593, 1597; May 13, 1992, Pub.L. 102-282, § 5,
respectively, except to the extent such refer-
106 Stat. 161; Aug. 13, 1993. Pub.L. 103-80, § 3(n), 107 Stat. 777.)
is to a function or office transferred to
Secretary of Education or the Departmer
HISTORICAL AND STATUTORY NOTES
Education under Pub.L. 96-88, Title III, §§
1993 Amendments
to 307, Oct. 17 1979, 93 Stat. 677 to 681.
scribed by subsec. (b) of this section. Former
section 3441 to 3447 and 3508 of Title 20.
Subsec.
(j)(6)(A)(ii).
Pub.L.
103-80,
cl. (6) was redesignated (7).
§ 3(n)(1)(A), corrected a typographical error in
Subsec. (d)(7). Pub.L. 98-417, § 102(a)(3)(A),
Effective Date of 1984 Amendment
the original by substituting "Secretary" for
redesignated former cl. (6) as (7).
"Secretry".
Section 105 of Pub.L. 98-417 provided
Subsec. (e). Pub.L. 98-417, $ 102(a)(3)(B),
Subsec.
(j)(6)(A)(iii).
Pub.L.
103-80.
added, in the first sentence covering the
"(a) The Secretary of Health and Hu
§ 3(n)(1)(B). inserted a comma after "published
grounds for withdrawal of approval by the Sec-
Services shall promulgate, in accordance
by the Secretary".
retary, a new cl. (4) relating to the failure to file
the notice and comment requirements of se
Subsec. (k)(1). Pub.L. 103-80, § 3(n)(2),
the patent information prescribed by subsec. (c)
553 of title 5, United States Code [section 5
struck out *: Provided, however. That regula-
of this section within 30 days after the receipt of
Title 5, Government Organization and Emp
tions" and inserted in lieu thereof a period and
written notice from the Secretary specifying the
ees), such regulations as may be necessary
"Regulations".
failure to file such information, and redesignated
the administration of section 505 of the Fec
the former cl. (4) as (5).
Food, Drug, and Cosmetic Act [this section
1992 Amendments
Pub.L. 98-417, § 102(b)(3). inserted. in the
amended by sections 101, 102, and 103 of
Subsec. (j)(8). Pub.L. 102-282. § 5, added
Act [enacting subsec. (j) of this section
provisions of the second sentence preceding cl.
par. (8).
amending subsecs. (a) to (e) and (k)(1) of
(1) of the enumeration of clauses covering the
section and section 360cc(a) and (b) of this t
1984 Amendment
grounds for withdrawal of approval by the Sec-
within one year of the date of enactment of
retary. the phrase "submitted under subsection
Subsec. (a). Pub.L. 98-417, § 102(b)(1), add-
(b) or (j) of this section" after "withdraw the
Act [Sept. 24, 1984].
ed "or (j)" following "pursuant to subsection
approval of an application".
"(b) During the period beginning sixty
(b)".
Pub.L. 98-417, § 102(b)(4), substituted, in cl.
after the date of the enactment of this Act [S
Subsec. (b)(1). Pub.L. 98-417. § 103(a), des-
(1) of the second sentence covering the grounds
24, 1984], and ending on the date regulat
ignated the existing provisions of subsec. (b) as
for withdrawal of approval by the Secretary, the
promulgated under subsection (a) take ef
par. (1) thereof and redesignated existing cls. (1)
phrase "under subsection (k) of this section or to
abbreviated new drug applications may be
through (6) of par. (1) as so redesignated as cls.
comply with the notice requirements of section
mitted in accordance with the provisions of
(A) through (F) thereof, respectively.
360(k)(2) of this title" for "under subsection (j)
tion 314.2 of title 21 of the Code of Fed
Pub.L. 98-417, $ 102(a)(1), added requirement
of this section or to comply with the notice
Regulations and shall be considered as suit
that the applicant file with the application the
requirements of section 360(j)(2) of this title".
for any drug which has been approved for BE
patent number and the expiration date of any
Subsec. (j). Pub.L. 98-417. § 101, added sub-
and effectiveness under section 505(c) of
patent which claims the drug for which the
Federal Food, Drug, and Cosmetic Act [sui
sec. (j). Former subsec. (j) was redesignated
applicant submitted the application or which
(k).
(c) of this section) before the date of the en
claims a method of using such drug and with
respect to which a claim of patent infringement
Subsec. (k). Pub.L. 98-417, § 101, redesig-
CROS:
could reasonably be asserted if a person not
nated former subsec. (j) as (k).
Patents. extension of patent term, see sec
licensed by the owner engaged in the manufac-
Subsec. (k)(1). Pub.L. 98-417, § 102(b)(5),
156 of Title 35, Patents.
ture. use. or sale of the drug. that the applicant
substituted "under subsection (b) or (j) of this
amend the application to include such informa-
section" for "pursuant to this section".
FEDERAL PRA
tion if an application is filed under this subsec-
Subsecs. (l), (m). Pub.L. 98-417, § 104, add-
tion for a drug and a patent which claims such
ed subsecs. (l) and (m).
Review of administrative decisions in court
drug or a method of using such drug is issued
appeals, see Wright, Miller, Cooper & Gr
after the filing date but before approval of the
1972 Amendment
man: Jurisdiction § 3941.
application. and that, upon approval of the appli-
Subsec. (e). Pub.L. 92-387 inserted "or to
cation, the Secretary publish the information
comply with the notice requirements of section
WESTS FEDE]
submitted.
360(j) (2)" in clause (1) of the second sentence
Application for use of new drug, see § 3
Subsec. (b)(2), (3). Pub.L. 98-417, § 103(a),
relating to the maintenance of records.
added pars. (2) and (3).
Change of Name
CODE OF FE
Subsec. (c)(1). Pub.L. 98-417, § 102(a)(2),
The Department of Health, Education, and
Formal evidentiary public hearing, see
designated the existing provisions of subsec. (c)
Welfare was redesignated the Department of
CFR 12.1 et seq.
as par. (1) thereof and in par. (1) as 80 designat-
Health and Human Services, and the Secretary
New animal drugs, see 21 CFR 510.3.
ed redesignated former pars. (1) and (2) as
of Health, Education. and Welfare or any other
subpars. (A) and (B), respectively.
official of the Department of Health, Education
LAW REVII
Pub.L. 98-417, § 102(b)(2), substituted "sub-
and Welfare was redesignated the Secretary or
A survey of law regarding the liability
section (b) of this section" for "this subsection".
official. as appropriate, of Health and Human
manufacturers and sellers of drug products
Subsec. (c)(2). Pub.L. 98-417, § 102(a)(2).
Services, with any reference to the Department
of Health. Education. and Welfare, the Secre-
medical devices. Bryan J. Maedgen and She
added par. (2).
tary of Health, Education, and Welfare, or any
Lynn McCall, 18 St. Mary's L.J. 395 (19
Subsec. (c)(3). Pub.L. 98-417, § 103(b). add-
ed par. (3).
official of the Department of Health, Education,
Brother can you spare a drug: Should
and Welfare, in any law, rule, regulation. certifi-
experimental drug distribution standards
Subsec. (d)(6). Pub.L. 98-417, § 102(a)(3)(A),
cate, directive, instruction. or other official pa-
modified in response to the needs of pers
added cl. (6) relating to the failure of the appli-
per in force on the effective date of Pub.L.
with Aids? 19 Hofstra L.Rev. 191 (1990).
cation to contain the patent information pre-
96-88, as prescribed by section 601 of Pub.L.
186
9
Ch. 9
FOOD, DRUG, AND COSMETIC ACT
21
§ 355
ilm-
cer-
tions for potentially harmful drug with- dicts is not necessary. Dugan Drug
903.
out authorization by prescribing physician
Stores. Inc. V. I'. S., C.A.Tex.1964. 326 F.
was immaterial since consistency in yer. 2d 835.
ha
tion
ith.
§ 354.
Repealed. Pub.L. 86-618, Title I, § 103(a) (2), July
12, 1960, 74 Stat. 398
tain
oxic
heir
Historical Note
S.
Section. Act June 25. 1938. C. 675. $ 504. Effective Date of Repeal. Repeal of
52 Stat. 1052. required the Secretary to
section effective. subject to the provisions
re-
promulgate regulations for the listing of
of section 203 of Pub.L. 86-618. on July
hor-
coal-tar colors for drugs and is covered
12. 1960. see section 202 of Pub.L. SG-618.
by section 376 of this title
by
set out as a note under section 376 of
ion,
this title.
the
310
§ 355.
New drugs-Necessity of effective approval of appli-
ens-
tab-
cation
rim-
sity
(a) No person shall introduce or deliver for introduction into inter-
tion
state commerce any new drug. unless an approval of an application
iven
filed pursuant to subsection (b) of this section is effective with re-
time
spect to such drug.
tent
in
ony
Filing application; contents
and
ful.
(b) Any person may file with the Secretary an application with re-
:F.
368
spect to any drug subject to the provisions of subsection (a) of this
ned
section. Such person shall submit to the Secretary as a part of the
..).
application (1) full reports of investigations which have been made to
ons-
show whether or not such drug is safe for use and whether such drug
tab-
is effective in use; (2) a full list of the articles used as components
rap-
of such drug: (3) a full statement of the composition of such drug:
"no-
(4) a full description of the methods used in, and the facilities and
tion.
controls used for, the manufacture, processing, and packing of such
the
drug; (5) such samples of such drug and of the articles used as com-
tate
.Ga.
ponents thereof as the Secretary may require; and (6) specimens of
0 S.
the labeling proposed to be used for such drug.
Period for approval of application; period for, notice, and expedition
of hearing; period for issuance of order
rap-
phe-
(c) Within one hundred and eighty days after the filing of an ap-
tion
plication under this subsection, or such additional period as may be
gton
agreed upon by the Secretary and the applicant. the Secretary shall ei-
ther—
(1) approve the application if he then finds that none of the
and
grounds for denying approval specified in subsection (d) of this
rip-
section applies, or
387
21 § 355
FOOD AND DRUGS
Ch. 9
Ch. 9
(2) give the applicant notice of an opportunity for a hearing
effect it pt
before the Secretary under subsection (d) of this section on the
prescribed.
question whether such application is approvable. If the applicant
beling the
elects to accept the opportunity for hearing by written request
within thirty days after such notice, such hearing shall commence
Withdr:
not more than ninety days after the expiration of such thirty
days unless the Secretary and the applicant otherwise agree. Any
(e) The
such hearing shall thereafter be conducted on an expedited basis
ing to the
and the Secretary's order thereon shall be issued within ninety
to any dru
days after the date fixed by the Secretary for filing final briefs.
or other e
is unsafe
Grounds for refusing application: approval of application:
the applic.
"substantial evidence" defined
rience, no:
(d) If the Secretary finds, after due notice to the applicant in ac-
tary until
cordance with subsection (c) of this section and giving him an oppor-
ods, or te
tunity for a hearing, in accordance with said subsection, that (1) the
applicatio
investigations, reports of which are required to be submitted to the
ble to the
Secretary pursuant to subsection (b) of this section, do not include ad-
such drug
equate tests by all methods reasonably applicable to show whether or
upon the
not such drug is safe for use under the conditions prescribed, recom-
basis of n
mended. or suggested in the proposed labeling thereof; (2) the results
ated toge!
of such tests show that such drug is unsafe for use under such condi-
was appr
tions or do not show that such drug is safe for use under such condi-
drug will
tions; (3) the methods used in, and the facilities and controls used
the condit
for, the manufacture, processing, and packing of such drug are inade-
beling the
quate to preserve its identity, strength. quality, and purity; (4) upon
ment of a
the basis of the information submitted to him as part of the applica-
sence the
tion, or upon the basis of any other information before him with re-
hazard to
spect to such drug, he has insufficient information to determine
plication
whether such drug is safe for use under such conditions; or (5) eval-
tion and
uated on the basis of the information submitted to him as part of the
ing under
application and any other information before him with respect to such
to susper.
drug, there is a lack of substantial evidence that the drug will have the
Secretary
effect it purports or is represented to have under the conditions of use
the appli
prescribed. recommended, or suggested in the proposed labeling there-
any drug
of or (6) based on a fair evaluation of all material facts, such label-
cant has
ing is false or misleading in any particular; he shall issue an order
or has re
refusing to approve the application. If, after such notice and opportu-
make req
nity for hearing, the Secretary finds that clauses (1) through (6) do
subsectio:
not apply, he shall issue an order approving the application. As used
access to
in this subsection and subsection (e) of this section, the term "sub-
paragrap
stantial evidence" means evidence consisting of adequate and well-con-
formation
trolled investigations, including clinical investigations, by experts
when the
qualified by scientific training and experience to evaluate the effec-
ties and
tiveness of the drug involved, on the basis of which it could fairly and
such dru
responsibly be concluded by such experts that the drug will have the
quality.
:
388
Ch. 9
Ch. 9
FOOD. DRUG. AND COSMETIC ACT 21 § 355
for a hearing
effect it purports or is represented to have under the conditions of use
section on the
prescribed. recommended. or suggested in the labeling or proposed la-
f the applicant
beling thereof.
ritten request
hall commence
Withdrawal of approval: grounds: immediate suspension upon finding
of such thirty
imminent hazard to public health
se agree. Any
(e) The Secretary shall. after due notice and opportunity for hear-
xpedited basis
ing to the applicant. withdraw approval of an application with respect
within ninety
to any drug under this section if the Secretary finds (1) that clinical
g final briefs.
or other experience. tests. or other scientific data show that such drug
is unsafe for use under the conditions of use upon the basis of which
ation:
the application was approved; (2) that new evidence of clinical expe-
rience, not contained in such application or not available to the Secre-
plicant in ac-
tary until after such application was approved, or tests by new meth-
him an oppor-
ods. or tests by methods not deemed reasonably applicable when such
that (1) the
application was approved. evaluated together with the evidence availa-
mitted to the
ble to the Secretary when the application was approved. shows that
not include ad-
such drug is not shown to be safe for use under the conditions of use
W whether or
upon the basis of which the application was approved; or (3) on the
cribed, recom-
basis of new information before him with respect to such drug, evalu-
2) the results
ated together with the evidence available to him when the application
er such condi-
was approved. that there is a lack of substantial evidence that the
r such condi-
drug will have the effect it purports or is represented to have under
controls used
the conditions of use prescribed. recommended. or suggested in the la-
ug are inade-
beling thereof: or (4) that the application contains any untrue state-
:ty; (4) upon
ment of a material fact: Provided, That if the Secretary (or in his ab-
f the applica-
sence the officer acting as Secretary) finds that there is an imminent
him with re-
hazard to the public health. he may suspend the approval of such ap-
to determine
plication immediately. and give the applicant prompt notice of his ac-
or (5) eval-
tion and afford the applicant the opportunity for an expedited hear-
:S part of the
ing under this subsection: but the authority conferred by this proviso
spect to such
to suspend the approval of an application shall not be delegated. The
will have the
Secretary may also. after due notice and opportunity for hearing to
litions of use
the applicant, withdraw the approval of an application with respect to
beling there-
any drug under this section if the Secretary finds (1) that the appli-
S, such label-
cant has failed to establish a system for maintaining required records,
sue an order
or has repeatedly or deliberately failed to maintain such records or to
and opportu-
make required reports. in accordance with a regulation or order under
rough (6) do
subsection (j) of this section, or the applicant has refused to permit
on. As used
access to, or copying or verification of. such records as required by
: term "sub-
paragraph (2) of such subsection; or (2) that on the basis of new in-
and well-con-
formation before him, evaluated together with the evidence before him
by experts
when the application was approved, the methods used in. or the facili-
t.e the effec-
ties and controls used for. the manufacture. processing, and packing of
Id fairly and
such drug are inadequate to assure and preserve its identity, strength,
vill have the
quality. and purity and were not made adequate within a reasonable
389
21 § 355
FOOD AND DRUGS
Ch. 9
Ch.
time after receipt of written notice from the Secretary specifying the
addu
matter complained of ; or (3) that on the basis of new information be-
court
fore him, evaluated together with the evidence before him when the
reaso
application was approved, the labeling of such drug, based on a fair
ing t
evaluation of all material facts, is false or misleading in any particu-
to be
lar and was not corrected within a reasonable time after receipt of
in su
written notice from the Secretary specifying the matter complained of.
may
Any order under this subsection shall state the findings upon which it
facts
is based.
with
tial
Revocation of order refusing, withdrawing or suspending
the S
approval of application
firm:
(f) Whenever the Secretary finds that the facts so require, he shall
subje
revoke any previous order under subsection (d) or (e) of this section
tiora
refusing, withdrawing, or suspending approval of an application and
comr
shall approve such application or reinstate such approval, as may be
speci
appropriate.
the
Service of orders
(g) Orders of the Secretary issued under this section shall be
served (1) in person by any officer or employee of the Department
(i)
designated by the Secretary or (2) by mailing the order by registered
the
mail or by certified mail addressed to the applicant or respondent at
tend
his last-known address in the records of the Secretary.
train
drug.
Appeal from order
amor
(h) An appeal may be taken by the applicant from an order of the
provi
Secretary refusing or withdrawing approval of an application under
this section. Such appeal shall be taken by filing in the United States
court of appeals for the circuit wherein such applicant resides or has
his principal place of business, or in the United States Court of Ap-
peals for the District of Columbia Circuit, within sixty days after the
entry of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be forthwith
transmitted by the clerk of the court to the Secretary, or any officer
designated by him for that purpose, and thereupon the Secretary shall
certify and file in the court the record upon which the order com-
plained of was entered, as provided in section 2112 of Title 28. Upon
the filing of such petition such court shall have exclusive jurisdiction
to affirm or set aside such order, except that until the filing of the
record the Secretary may modify or set aside his order. No objection
to the order of the Secretary shall be considered by the court unless
such objection shall have been urged before the Secretary or unless
there were reasonable grounds for failure SO to do. The finding of
the Secretary as to the facts, if supported by substantial evidence,
shall be conclusive. If any person shall apply to the court for leave to
390
Ch. 9
Ch. 9
FOOD, DRUG, AND COSMETIC ACT
21 § 355
etary specifying the
adduce additional evidence, and shall show to the satisfaction of the
new information be-
court that such additional evidence is material and that there were
efore him when the
reasonable grounds for failure to adduce such evidence in the proceed-
rug, based on a fair
ing before the Secretary, the court may order such additional evidence
ding in any particu-
to be taken before the Secretary and to be adduced upon the hearing
ime after receipt of
in such manner and upon such terms and conditions as to the court
hatter complained of.
may seem proper. The Secretary may modify his findings as to the
ndings upon which it
facts by reason of the additional evidence so taken, and he shall file
with the court such modified findings which, if supported by substan-
tial evidence, shall be conclusive, and his recommendation, if any, for
suspending
the setting aside of the original order. The judgment of the court af-
firming or setting aside any such order of the Secretary shall be final,
S so require, he shall
subject to review by the Supreme Court of the United States upon cer-
r (e) of this section
tiorari or certification as provided in section 1254 of Title 28. The
f an application and
commencement of proceedings under this subsection shall not, unless
approval, as may be
specifically ordered by the court to the contrary, operate as a stay of
the Secretary's order.
his section shall be
Exemptions of drugs for research: discretionary and mandatory
conditions: direct reports to Secretary
e of the Department
(i) The Secretary shall promulgate regulations for exempting from
e order by registered
the operation of the foregoing subsections of this section drugs in-
ant or respondent at
tended solely for investigational use by experts qualified by scientific
tary.
training and experience to investigate the safety and effectiveness of
drugs. Such regulations may, within the discretion of the Secretary,
among other conditions relating to the protection of the public health,
from an order of the
provide for conditioning such exemption upon-
an application under
(1) the submission to the Secretary, before any clinical testing
in the United States
of a new drug is undertaken, of reports. by the manufacturer or
licant resides or has
the sponsor of the investigation of such drug, of preclinical tests
States Court of Ap-
(including tests on animals) of such drug adequate to justify the
1 sixty days after the
proposed clinical testing;
that the order of the
in shall be forthwith
(2) the manufacturer or the sponsor of the investigation of a
retary, or any officer
new drug proposed to be distributed to investigators for clinical
on the Secretary shall
testing obtaining a signed agreement from each of such investiga-
which the order com-
tors that patients to whom the drug is administered will be under
12 of Title 28. Upon
his personal supervision. or under the supervision of investigators
exclusive jurisdiction
responsible to him. and that he will not supply such drug to any
intil the filing of the
other investigator. or to clinics, for administration to human
order. No objection
beings; and
d by the court unless
(3) the establishment and maintenance of such records, and the
Secretary or unless
making of such reports to the Secretary, by the manufacturer or
do. The finding of
the sponsor of the investigation of such drug, of data (including
substantial evidence.
but not limited to analytical reports by investigators) obtained as
the court for leave to
the result of such investigational use of such drug, as the Secre-
391
21 § 355
FOOD AND DRUGS
Ch. 9
Ch. 9
F
tary finds will enable him to evaluate the safety and effectiveness
631; June 11.
of such drug in the event of the filing of an application pursuant
1962, Pub.L. 8
to subsection (b) of this section.
(2), 76 Stat. 78
Such regulations shall provide that such exemption shall be condi-
tioned upon the manufacturer, or the sponsor of the investigation, re-
quiring that experts using such drugs for investigational purposes
1962 Amendment
87-781, § 104(a).
certify to such manufacturer or sponsor that they will inform any
of" preceding "A
human beings to whom such drugs, or any controls used in connec-
Subsec. (b). l'
tion therewith, are being administered, or their representatives, that
inserted "and wh
such drugs are being used for investigational purposes and will ob-
fective in use"
use."
tain the consent of such human beings or their representatives, ex-
cept where they deem it not feasible or, in their professional judg-
Subsec. (c). P
substituted provis
ment, contrary to the best interests of such human beings. Nothing
retary, within 18
in this subsection shall be construed to require any clinical investi-
application, or su
gator to submit directly to the Secretary reports on the investiga-
the Secretary an
upon, to either :
tional use of drugs.
if meeting the T
(d) of this sectio
portunity for h.
Records and reports; required Information: regulations and orders:
whether such AP
acceKa 10 records
and providing th
(j) (1) In the case of any drug for which an approval of an appli-
hearing in writi:
hearing shall beL
cation filed pursuant to this section is in effect. the applicant shall es-
expiration of sa
tablish and maintain such records, and make such reports to the Secre-
Secretary and ap
that such heari
tary, of data relating to clinical experience and other data or informa-
and that the Se
tion, received or otherwise obtained by such applicant with respect to
issued within 90
such drug. as the Secretary may by general regulation. or by order
final briefs, for
with respect to such application, prescribe on the basis of a finding
application bee
sixtieth day aft.
that such records and reports are necessary in order to enable the Sec-
prior thereto 11
retary to determine. or facilitate a determination. whether there is or
the date by writ
but not more th
may be ground for invoking subsection (e) of this section: Provided,
as the Secretar:
however, That regulations and orders issued under this subsection and
study and inves
under subsection (i) of this section shall have due regard for the pro-
Subsec. (d).
fessional ethics of the medical profession and the interests of patients
inserted referenc-
and shall provide. where the Secretary deems it to be appropriate. for
cls. (5) and (6).
the examination. upon request, by the persons to whom such regula-
notice and oppo:
Secretary finds
tions or orders are applicable, of similar information received or oth-
apply, he shall
erwise obtained by the Secretary.
and defined "s'
used in this sui
(2) Every person required under this section to maintain records,
of this section.
and every person in charge or custody thereof, shall, upon request of
Subsec. (e).
an officer or employee designated by the Secretary, permit such offi-
amended subsect
other changes. d
cer or employee at all reasonable times to have access to and copy and
withdraw approv
verify such records.
by tests. other
ence, or new evi
June 25. 1938, c. 675, § 505, 52 Stat. 1052: 1940 Reorg. Plan No. IV, §
ence not contain-
12, eff. June 30, 1940, 5 F.R. 2422. 54 Stat. 1237 June 25, 1948, c.
available at the
drug is shown
646, § 32(b), 62 Stat. 991; May 24, 1949, c. 139, § 127, 63 Stat. 107;
basis of new inf
1953 Reorg. Plan No. 1, § 5, eff. Apr. 11. 1953, 18 F.R. 2053, 67 Stat.
a lack of subst.
392
T. 21 U.S.C.A.
UGS
Ch. 9
Ch. 9
FOOD, DRUG, AND COSMETIC ACT
21 § 355
the safety and effectiveness
631; June 11, 1960, Pub.L. 86-507, § 1(18), 74 Stat. 201; Oct. 10,
g of an application pursuant
1962, Pub.L. 87-781. Title I. §§ 102(b)-(d), 103(a), (b), 104(a)-(d)
(2), 76 Stat. 781-783, 784. 785.
h exemption shall be condi-
nsor of the investigation, re-
Historical Note
for investigational purposes
1962 Amendment. Subsec. (a). Pub.L.
drug has the effect it is represented to
r that they will inform any
87-781. § 104(a). inserted "an approval
have. and provided that if the Secretary.
of" preceding "nn application."
or acting Secretary. finds there is an im-
my controls used in connec-
minent hazard to public health, he may
Subsec. (b). Pub.L. 87-781. § 102(b).
or their representatives, that
suspend approval immediately. notify the
Inserted "and whether such drug is ef-
applicant. and give him opportunity for
tional purposes and will ob-
fective in use" following "is safe for
an expedited hearing. that the Secretary
or their representatives. ex-
use."
may withdraw approval if the applicant
; in their professional judg-
Subsec. (e). Pub.L. 87-781. § 104(b).
fails to establish a system for maintain-
uch human beings. Nothing
substituted provisions requiring the Sec-
ing required records. or has repeatedly
retary, within 180 days after filing an
or deliberately failed to maintain rec-
require any clinical investi-
application. or such additional period as
ords and make reports, or has re-
ry reports on the investiga-
the Secretary and the applicant agree
fused access to. or copying or verifica-
tion of such records, or if the Secretary
upon, to either approve the application,
finds on new evidence that the methods.
if meeting the requirements of subsec.
facilities and controls in the manufac-
(d) of this section, or give notice of op-
turing. processing. and packing are in-
portunity for hearing on question of
on: regulations and orders:
whether such application is approvable.
adequate to assure and preserve the
de
drugs' identity, strength. quality and
and providing that if applicant requests
hearing in writing within 30 days. the
purity, and were not made adequate
hich an approval of an appli-
hearing shall begin within 90 days after
within a reasonable time after receipt
effect. the applicant shall es-
of written notice thereof. or finds on
expiration of said 30 days. unless the
ake such reports to the Secre-
Secretary and applicant agree otherwise.
new evidence, that the labeling is false
or musleading and was not corrected
ce and other data or informa-
that such hearing shall be expedited.
within a reasonable time after receipt
and that the Secretary's order shall be
uch applicant with respect to
of written notice thereof.
issued within 90 days after date for filing
neral regulation. or by order
final briefs, for provisions which had an
Subsec. (f). Pub.L. ST-781. $ 104(c).
be on the basis of a finding
application become effective on the
substituted provisions requiring the
sixtieth day after filing thereof unless
ary in order to enable the Sec-
Secretary to revoke any previous order
prior thereto the Secretary postponed
under subsees, (1) or (e) of this section
mination. whether there is or
the date by written notice to such time,
refusing. withdrawing. or suspending ap-
e) of this section: Provided,
but not more than 180 days after filing.
proval of an application and to approve
as the Secretary deemed necessary to
ued under this subsection and
such application or reinstate such ap-
study and investigate the application.
proval. for provisions which required
have due regard for the pro-
him to revoke an order refusing effective-
Subsec. (d). Pub.L. ST-781. $ 102(c).
and the interests of patients
ness to an application.
inserted references to subsec. (e). added
eems it to be appropriate. for
cls. (5) and (6), provided that if after
Subsec. (h). Pub.L. ST-781. $ 104(d)
ersons to whom such regula-
notice and opportunity for hearing, the
(1), (2). inserted "as provided in section
Secretary finds that cls. (1)-(6) do not
: information received or oth-
2112 of Title 28". and "except that until
apply. he shall approve the application.
the filing of the record the Secretary may
and defined "substantial evidence" as
modify or set aside his order". substi-
used in this subsection and subsee. (e)
futed "or withdrawing approval of an
S section to maintain records.
of this section.
application under this section" for "to
thereof, shall. upon request of
Subsec. (e). Pub.L. 87-781, $ 102(d)
permit the application to become effec-
e Secretary, permit such offi-
amended subsection generally. and among
tive, or suspending the effectiveness of
0 have access to and copy and
other changes. directed the Secretary to
the application". "United States court
withdraw approval of an application if
of appeals for the circuit" for "district
by tests. other scientific data or experi-
court of the United States within any
ence. or new evidence of clinical experi-
district". "Court of Appeals for the Dis-
12: 1940 Reorg. Plan No. IV, §
ence not contained in the application or
trict of Columbia Circuit" for "District
Stat. 1237; June 25, 1948, c.
available at the time of its approval, the
Court for the District of Columbia",
drug is shown to be unsafe. or on the
"transmitted by the clerk of the court
19, c. 139, § 127, 63 Stat. 107:
basis of new information. there is shown
to" for "served upon". and "by the Su-
1. 1953, 18 F.R. 2053, 67 Stat.
a lack of substantial evidence that the
preme Court of the United States upon
T. 21 U.S.C.A. §§ 1-800-14
393
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
881
880
Cite as 828 F.2d 881 (1st Clr. 1987)
take its meaning from the statute that is
a balance between efforts to protect exist-
likely condition when a pension fund seeks
being amended-ERISA. And ERISA, for
ing pension plan beneficiaries through a
to recover against officers or shareholders
Lester GRINSPOON, M.D., Petitioner,
whatever reason, defines the word "em-
short term strategy of imposing burdens
personally, the corporation will enter into
V.
ployer" only for subchapter I.¹ Defining
on current employer contributors and
bankruptcy proceedings, thereby losing
DRUG ENFORCEMENT
its meaning for subchapter III is up to the
through a long term strategy of encourag-
control over which creditors receive pay-
ADMINISTRATION,
courts. Cf. Robinson v. C.I.R., 805 F.2d
ing new employers to contribute to multi-
ments.
Respondent.
38, 40 (1st Cir.1986).²
employer pension funds. See H.R. No. 96-
Given the control corporations have over
869, 96th Cong., 2d Sess., reprinted in
No. 86-2007.
(3) This conclusion brings us back to
payroll taxes and wages, personal liability
1980 U.S.Code Cong. & Admin.News at
what the Trustee is really asking us to do:
for those debts should rarely have actually
United States Court of Appeals,
2918, 2919-20, 2935. Imposing personal
to define the word "employer" to include
assessed. The threat of personal liability
First Circuit.
liability for withdrawal payments would
controlling shareholders and officers. We
should be enough to induce the individuals
hurt that long term strategy by discourag-
who control corporations to prefer the IRS
Heard March 3, 1987.
decline, for the following reasons.
ing controlling individuals from directing
and employee creditors over other creditors
Decided Sept. 18, 1987.
First, as mentioned before, the principle
their corporations to participate in multi-
in times of financial difficulty. If not, the
of limited liability for corporate debts is
employer pension funds.
individuals controlling the corporation ac-
longstanding enough and important enough
Withdrawal liability under the MPPAA is
cept a known risk. Personal liability for
Administrative Drug Enforcement Ad-
to be considered a background norm,
quite different than payroll taxes under the
withdrawal payments, on the other hand,
ministration issued final rule placing 3, 4-
against which Congress may act of course,
Social Security Act and minimum wage
cannot be similarly avoided. This personal
methylenedioxymethamphetamine into
but which is controlling in the absence of
Schedule I of Controlled Substances Act.
payments under the Fair Labor Standards
liability may well force corporations to
such action. See Connors v. P & M Coal
Act, two corporate debts for which control-
more extreme efforts to avoid bankruptcy,
Researcher on therapeutic use of substance
Co., 801 F.2d at 1376. In deciding whether
ling shareholders and officers can be held
but any benefit is likely to be marginal,
petitioned for review. The Court of Ap-
Congress has acted to expand liability "fed-
liable. See Donovan v. Agnew, 712 F.2d at
since controlling shareholders can be ex-
peals, Coffin, Circuit Judge, held that: (1)
eral courts will look closely at the purpose
1511; United States v. McMullen, 516 F.2d
pected to attempt to avoid bankruptcy gen-
absence of FDA interstate marketing ap-
of the federal statute to determine whether
917, 920 (7th Cir.1975) (26 U.S.C. § 7512
erally, in the hope of obtaining some return
proval was not conclusive evidence that
the statute places importance on the corpo-
imposes liability for payroll taxes on person
on their investment. Rather than a rarely
substance had no currently accepted medi-
rate form Town of Brookline v.
with control over corporations affairs).
exercised threat that induces a desired be-
cal use or lacked accepted safety for use
Gorsuch, 667 F.2d 215, 221 (1st Cir.1981)
Payroll taxes and minimum wage payments
havior, personal liability for withdrawal
under medical supervision; (2) there was
(citations omitted). The MPPAA does not
are liabilities which a corporation can
payments would be a routine accompani-
sufficient evidence to support finding that
on its face indicate any intention to treat
choose to pay or not pay. A decision to
ment to corporate bankruptcy proceedings.
substance had high potential for abuse;
corporate debts for withdrawal liability dif-
forgo paying payroll taxes or wages is a
This personal liability would discourage
and (3) administrator was not required to
ferent from any other corporate debts.
conscious decision to prefer some creditors
controlling shareholders and officers from
consider evidence that placement of sub-
The way that one could have expected Con-
over the government or the corporation's
directing their corporations to contribute to
stance into Schedule I would strongly dis-
gress to make such an intention felt was
employees. Corporations do not have the
multi-employer pension plans, thereby mak-
courage medical research on substance.
through a definition of the word "employ-
same control over withdrawal liability pay-
ing it less likely that their employees will
Rule vacated and remanded.
er." Yet Congress did not define the word
ments, especially in the context in which
receive pension benefits. In the long run,
in the MPPAA. Nor did Congress provide
shareholder and officer liability is most
personal liability would hurt even those
an applicable definition in ERISA.
likely to be relevant: bankruptcy. With-
employees who are already beneficiaries of
1. Drugs and Narcotics -46
Furthermore, the purposes of the
drawal liability is not assessed until an
multi-employer pension plans, because the
Absence of interstate marketing ap-
MPPAA, as described in the legislative his-
employer "withdraws" from the pension
vitality of those plans depends on new em-
proval of substance by Federal Drug Ad-
tory of that act, would not be served by an
plan, by ceasing to do business for in-
ministration is not conclusive evidence that
ployers contributing to them. See House
extension of personal liability for corporate
stance. If the liabilities of the employer
Report, 1980 U.S.Code Cong. & Admin.
substance has no currently accepted medi-
withdrawal payments. The Act represents
corporation exceed its assets, which is the
News at 2919-20, 2935.
cal use and lacks accepted safety for use
under medical supervision for purposes of
1. In Nachman Corp. V. Pension Benefit Guar.
cers or shareholders, a question which has occa-
The decision of the district court is af-
determining whether substance should be
Corp., 446 U.S. 359, 370 n. 14, 100 S.C. 1723,
sioned considerable litigation, and difference of
opinion. Compare, e.g., Solomon V. Klein, 770
firmed.
1731 n. 14, 64 L.Ed.2d 354 (1980), the Supreme
placed in Schedule I under Controlled Sub-
Court noted that Congress made some Title I
F.2d 352, 354 (3d 1985) (controlling share.
stances Act. Comprehensive Drug Abuse
(subchapter I in the Code) definitions applicable
holder and officer not an "employer") with, e.g.,
Prevention and Control Act of 1970,
to Title IV (part of subchapter III in the Code),
Mass. State Carpenters Pension Fund V. Atlantic
see, e.g., 29 U.S.C. § 1321(a)(1). "This specific
§ 202(b)(1), as amended, 21 U.S.C.A.
Diving Co., Inc., 635 F.Supp. 9, 13-14 (D.Mass.
KEY NUMBER SYSTEM
incorporation suggests that Title I definitions do
1984) (controlling shareholder or officer may be
§ 812(b)(1).
not apply elsewhere in the Act of their own
"employer"). We reserve this question for a
force
Id.
case in which it makes a difference in the out-
2. Drugs and Narcotics -46
2. We do not reach the question whether the
come.
Finding that 3, 4-methylenedioxymeth-
subchapter I definition includes controlling offi-
amphetamine had "high" potential for
882
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
883
Cite as 828 F.2d 881 (1st Clr. 1987)
Drug Section, Dennis F. Hoffman, Chief
for "accepted safety for use
under
Schedule I criteria listed in section 812(b)(1)
abuse was not arbitrary and capricious,
where administrator of Drug Enforcement
Counsel, Drug Enforcement Admin., Ste-
medical supervision" in 21 U.S.C.
and concluded that (1) MDMA has a high
Administration considered close structural
phen E. Stone, Associate Chief Counsel,
§ 812(b)(1). The other three reasons con-
potential for abuse; (2) MDMA has no
and pharmacological similarity between
Drug Enforcement Admin., Washington,
tained in Dr. Grinspoon's petition challenge
known legitimate medical use for treat-
substance and other substances which had
D.C., and Charlotte A. Johnson, were on
the scheduling determination as arbitrary
ment in the United States; and (3) there is
already been found to have high potential
brief, for respondent.
and capricious because (a) the Administra-
a lack of accepted safety for the use of
tor's determination that MDMA had a
for abuse and placed in Schedule I, as well
MDMA under medical supervision. Based
as studies which suggested that substance
Before COFFIN and TORRUELLA,
"high" potential for abuse was flawed by
upon these findings, the DEA recom-
Circuit Judges, and PETTINE,' Senior
his failure to articulate a legal standard
was related in its effect to Schedule I and
mended that MDMA be placed into Sched-
District Judge.
and his reliance on insufficient record evi-
ule I of the CSA.
II substances. Comprehensive Drug
dence; (b) the Administrator failed to give
Abuse Prevention and Control Act of 1970,
adequate weight to the evidence showing
In March of 1984, pursuant to the proce-
§ 202(b)(1), as amended, 21 U.S.C.A.
COFFIN, Circuit Judge.
that placing MDMA into Schedule I would
dures set out in the CSA, 28 U.S.C. 811(b),'
§ 812(b)(1).
On November 13, 1986, the Administra-
the Administrator submitted the DEA's
create a barrier to medical research on the
tor of the Drug Enforcement Administra-
control recommendation to the Assistant
3. Drugs and Narcotics -46
drug; and (c) the rule is based upon incom-
Alleged failure of administrator of
tion ("DEA") issued a final rule placing the
plete and arbitrary recommendations from
Secretary for Health of the Department of
Drug Enforcement Administration to con-
substance 3,4-methylenedioxymethamphe
the Secretary of Health and Human Servic-
Health and Human Services ("HHS") for
sider impact of determination to place sub-
tamine ("MDMA") into Schedule I of the
es. Petitioner urges this court to remand
scientific and medical evaluation and for an
stance on Schedule I upon legitimate scien-
Controlled Substances Act ("CSA"), 21
the case to the DEA with instructions to
HHS recommendation as to whether
tific research was not improper. Compre-
U.S.C. §§ 811, 812 (1987).¹ 51 Fed.Reg.
place the substance MDMA into Schedule
MDMA should be controlled. The HHS
hensive Drug Abuse Prevention and Con-
36,552 (1986). In reaching this decision,
III.
evaluation was conducted by Dr. Charles
the Administrator found that MDMA met
Tocus, Chief of the Drug Abuse Staff of
trol Act of 1970, § 202(b)(1), as amended,
Although we are satisfied that these fi-
all three of the statutory requirements for
the Food and Drug Administration
21 U.S.C.A. § 812(b)(1).
nal three claims do not require us to over-
classification as a Schedule I substance,
turn the rule, we believe that Dr. Grin-
("FDA"). Dr. Tocus stated in his affidavit
4. Administrative Law and Procedure
namely,
that he searched the FDA files and found
spoon's first claim has considerable merit
364
(A) The drug or other substance has a
no reference to MDMA. Based upon this
and requires us to remand the scheduling
Drugs and Narcotics -46
high potential for abuse.
absence of information in the FDA files
determination for reconsideration by the
Department of Health and Human Ser-
(B) The drug or other substance has no
and a review of the information contained
Administrator. After describing the ad-
vices' adoption of analysis already per-
currently accepted medical use in treat-
in the DEA control recommendation carried
ministrative history of the rule, we shall
formed by Drug Enforcement Administra-
ment in the United States.
consider each of petitioner's claims in turn.
out by Dr. Tocus, HHS responded by mak-
tion that substance should have been classi-
(C) There is a lack of accepted safety for
ing minor (typographical) corrections in the
fied in Schedule I without consulting any
use of the drug or other substance under
I. Administrative History.
DEA's eight-factor analysis and concur-
organization medical professionals or its
medical supervision.
ring in the recommendation that MDMA be
In January of 1984, the DEA prepared a
own panel of experts was harmless error,
document entitled "Schedule I Control Rec-
placed into Schedule I.
and did not require rescheduling of sub-
21 U.S.C. § 812(b)(1).
Dr. Lester Grinspoon, a psychiatrist and
ommendation Under the CSA for 3,4-Me-
Upon receiving the HHS evaluation and
stance, where there was substantial evi-
faculty member of the Harvard Medical
thylenedioxymethamphetamine (MDMA)."
recommendation, the Administrator issued
dence to support classification. Compre-
School, petitions this court to review the
The control recommendation, which was
a Notice of Proposed Rulemaking with re-
hensive Drug Abuse Prevention and Con-
final rule. Dr. Grinspoon seeks to conduct
based upon information compiled from vari-
gard to placing MDMA into Schedule I of
trol Act of 1970, § 201(b, c), as amended,
21 U.S.C.A. § 811(b, c).
research on the therapeutic use of MDMA
ous DEA data sources and scientific and
the CSA. 49 Fed.Reg. 30,210 (1984). La-
and believes that the imposition of Sched-
medical literature, considered all three
ter, following the receipt of several com-
ule I controls will effectively foreclose such
2. 21 U.S.C. § 811(b) provides that
(2) Scientific evidence of its pharmacological
Richard Cotton, Washington, D.C., for
research. He cites four reasons for vacat-
The Attorney General shall, before initiating
effect, if known.
petitioner.
ing the Administrator's scheduling determi-
proceedings under subsection (a) of this sec-
(3) The state of current scientific knowledge
Harry S. Harbin, Washington, D.C., with
tion to control a drug or other substance
regarding the drug or other substance.
nation. The first reason advanced is that
the Administrator applied the wrong legal
and after gathering the necessary data, re-
(4) Its history and current pattern of abuse.
whom William F. Weld, Asst. Atty. Gen.,
quest from the Secretary a scientific and
(5) The scope, duration, and significance of
Criminal Div., Boston, Mass., Charles S.
standards for "currently accepted medical
medical evaluation, and his recommenda-
abuse.
Sapho, Chief, Narcotic and Dangerous
use in treatment in the United States" and
tions, as to whether such drug or other sub-
(6) What, if any, risk there is to the public
stance should be so controlled.
health.
Of the District of Rhode Island, sitting by desig.
U.S.C. § 811. These listings are subject to
(7) Its psychic or physiological dependence
amendments and additions pursuant to 21
3. Section 811(c) requires the Administrator to
liability.
nation.
U.S.C. § 811. Substances placed into Schedule I
consider the following eight factors for each
(8) Whether the substance is an immediate
1. The Act established five categories of sub-
are subject to the most severe controls and
drug proposed to be controlled under the CSA:
precursor of a substance already controlled
stances whose manufacture and distribution are
penalties imposed by the Act.
(1) [The drug's) actual or relative potential
under this subchapter.
subject to federal control. The Act's initial
for abuse.
21 U.S.C. § 811(c).
scheduling of substances can be found in 21
884
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
885
Cite as 828 F.2d 881 (lst Clr. 1987)
ments and requests for a hearing, the Ad-
medical supervision. Finally, the Adminis-
If
the court determines Congress has
[1] The Administrator contends that
ministrator referred the matter to an Ad-
trator found that the DEA had sustained
not directly addressed the precise ques-
congressional intent favoring his interpre-
ministrative Law Judge ("ALJ") with in-
its burden of proving that MDMA has a
tion at issue, the court does not simply
tation of the CSA can be gleaned from the
structions to "conduct a hearing for the
high potential for abuse. The Administra-
impose its own construction on the stat-
language of the statute, its legislative his-
purpose of receiving factual evidence and
tor's final rule, effective November 13,
ute, as would be necessary in the ab-
tory, and the language and history of sub-
expert opinion regarding the proposed
1986, placed MDMA into Schedule I. Dr.
sence of an administrative interpretation.
sequent legislative enactments designed to
scheduling of MDMA." 51 Fed.Reg. 36,-
Grinspoon appeals from this final rule un-
Rather, if the statute is silent or ambigu-
enhance the regulatory system established
552 (1986). During the course of the hear-
der the CSA, 21 U.S.C. § 877.
ous with respect to the specific issue, the
by the CSA in 1970. In the alternative, he
ing, the ALJ heard 33 witnesses and re-
question for the court is whether the
argues that if the intent of Congress is
ceived 95 exhibits into evidence.⁴ On May
II. Accepted Medical Use And Safety
agency's answer is based on a permissi-
ambiguous, then his construction of the
22, 1986, the ALJ issued a comprehensive
Under The CSA.
ble construction of the statute.
statute is permissible in view of the statu-
opinion finding that MDMA fit none of the
Id. at 843, 104 S.Ct. at 2781-82 (footnote
tory scheme.5 Our review of the sources
three criteria prerequisite to placement in
We turn first to petitioner's claim that
omitted; emphasis supplied).
identified by the litigants convinces us that
Schedule I. Relying on the hearing testi-
the Administrator erred in interpreting the
phrases "accepted medical use in treatment
It is undisputed that Congress has not
Congress neither expressed nor implied an
mony of experts in the health care commu-
in the United States" and "accepted safety
directly spoken to the question at issue
affirmative intent regarding how the sec-
nity, the ALJ concluded that MDMA had an
for use
here, namely, the proper means of inter-
ond and third Schedule I criteria should be
accepted medical use for treatment in the
under medical supervision" in
section 812(b)(1) to mean, in essence, "ap-
preting the second and third criteria of
interpreted. Nevertheless, these same
United States, 21 U.S.C. § 812(b)(1)(B), and
proved for interstate marketing by the
section 812(b)(1). The absence of express
sources-the language and structure of the
an accepted safety for use under medical
intent, however, does not compel us to pro-
CSA and FDCA, the legislative history of
supervision, 21 U.S.C. § 812(b)(1)(C). The
FDA under the FDCA." Before embark-
ceed to the deferential second step of the
the CSA, and the subsequent handiwork of
ALJ also found that the record did not
ing on an analysis of that issue, however,
Chevron scheme. As the Supreme Court
Congress in the area of controlled sub-
establish that MDMA had a "high" poten-
we begin by explaining the appropriate
indicated in a footnote to its Chevron opin-
stance regulation-lead us to conclude that
tial for abuse. 21 U.S.C. § 812(b)(1)(A).
standard of review in a case, such as this,
where a court must assess an agency's
ion, "[i]f a court, employing traditional
the Administrator's construction of subsec-
The ALJ therefore recommended that
tools of statutory construction, ascertains
tions (B) and (C) of 21 U.S.C. § 812(b)(1) is
MDMA be placed into Schedule III of the
interpretation of a statute it administers.
that Congress had an intention on the pre-
contrary to congressional intent.6
CSA.
cise question at issue, that intention is law
The Administrator, however, declined to
A. Standard of Review.
and must be given effect." Id. at 843 n. 9,
B. Statutory Language and Structure.
accept the reasoning and scheduling recom-
The Administrator argues correctly that
104 S.Ct. at 2781 n. 9. Recently the Su-
The Administrator begins by arguing
mendation of the ALJ. In his October 13,
we must review his interpretation of the
preme Court has reaffirmed this proposi-
that the language of the CSA itself is evi-
1986, decision, the Administrator held that
CSA in light of the guidelines set forth by
tion, holding in INS v. Cardoza-Fonseca,
dence of congressional intent favoring his
the phrases "currently accepted medical
the Supreme Court in Chevron U.S.A., Inc.
U.S. 107 S.Ct. 1207, 94 L.Ed.2d
construction of the statute. His argument
use in treatment in the United States" and
v. Natural Resources Defense Council,
434 (1987), that a court faced with a "pure
is based on the definitions of terms chosen
"accepted
safety
for
use
under
medical
Inc., 467 U.S. 837, 104 S.Ct. 2778, 81
question of statutory interpretation"
by Congress in drafting the relevant provi-
supervision" as used in the CSA, 21 U.S.C.
L.Ed.2d 694 (1984). In Chevron the Court
should rely upon traditional methods of
sions of the CSA. He first cites the defini-
§ 812(b)(1), both mean that the FDA has
explained that a reviewing court must em-
statutory construction in an attempt to de-
tion of the term "United States" as used in
evaluated the substance for safety and ap-
ploy a two-step analysis that focuses initial-
termine the intent of Congress. Id. 107
"accepted medical use in treatment in the
proved it for interstate marketing in the
ly on the intentions of Congress:
S.Ct. at 1221; International Union, UAW
United States." 21 U.S.C. § 812(b)(1)(B).
United States pursuant to the Federal
v. Brook, 816 F.2d 761, 764-65 (D.C.Cir.
This term is the only portion of the Sched-
Food, Drug, and Cosmetic Act of 1938
First, always, is the question whether
1987) (applying "traditional tools" of statu-
ule I criteria that Congress has expressly
("FDCA"), 21 U.S.C. § 355. From these
Congress had directly spoken to the pre-
tory construction to invalidate agency's in-
defined in the CSA, providing that "[t]he
premises, the Administrator reasoned that
cise question at issue. If the intent of
Congress is clear, that is the end of the
terpretation of statutory language as con-
term 'United States,' when used in a geo-
because the FDA has not approved a new
matter; for the court, as well as the
flicting with intent of Congress).
graphic sense, means all places
subject
drug application ("NDA") or investigation-
al new drug application ("IND") authoriz-
agency, must give effect to the unambig-
5. Contrary to the assertions of the Administra-
§ 811(a)(1)(B) (emphasis supplied). This ex-
uously expressed intent of Congress.
tor, this is not a situation in which Congress has
plicit delegation of authority to apply prescribed
ing interstate marketing of MDMA under
expressly vested the Administrator with authori-
statutory criteria is not equivalent to an explicit
the FDCA, MDMA cannot be lawfully mar-
Id. at 842-43, 104 S.Ct. at 2781 (emphasis
ty to define general statutory criteria by issuing
delegation of authority to define those criteria.
keted and has neither a currently accepted
supplied). In the absence of congressional
regulations. Were this such a case, such regula-
medical use in treatment in the United
intent, however, the court must proceed to
tions would be controlling unless they were
6. Our review of the legislative sources below
"arbitrary, capricious, or manifestly contrary to
also convinces us that the Administrator's inter-
States nor an accepted safety for use under
a second inquiry:
the statute." Chevron, 467 U.S. at 843-44, 104
pretation is unreasonable and would be invalid
S.Ct. at 2782. Here, the CSA expressly delegates
4. On July 1. 1985, while the hearing was pro-
sions of the Act, 21 U.S.C. § 811(h)(1). 50 Fed.
even under the second prong of the Chevron
to the Attorney General only the authority to
Reg. 23,118 (1985). The Administrator deter-
test. See International Union, UAW v. Brock,
ceeding, the Administrator placed MDMA into
make "the findings prescribed by subsection (b)
Schedule I of the Controlled Substances Act
mined that this action was necessary to avoid an
816 F.2d at 765 n. 6.
of section 812 of this title for the schedule in
pursuant to the emergency scheduling provi-
imminent hazard to the public safety. Id
which (a) drug is to be placed." 21 U.S.C.
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
886
828 FEDERAL REPORTER, 2d SERIES
887
Cite as 828 F.2d 881 (1st Clr. 1987)
to the jurisdiction of the United States."
(emphasis supplied). We find this lan-
this argument appears to have considerable
marketing approval (or exemption) for any
21 U.S.C. § 802(28) (emphasis supplied).
guage to be further evidence that the Con-
merit. The Uniform CSA, like its federal
of seven specific reasons. 21 U.S.C.
Coupling this statutory definition of "Unit-
gress did not intend "accepted medical use
counterpart, creates five schedules of con-
§ 355(d)(1)-(7). Although approval may be
in treatment in the United States" to re-
trolled substances and, indeed, was mod-
withheld because the substance lacks both
ed States" with the dictionary definition of
"accepted"-which means "generally ap-
quire a finding of recognized medical use in
eled on the federal CSA. 9 U.L.A. 187, 188
"safety", 21 U.S.C. § 355(d)(2), and "effica-
proved" or "generally agreed upon"-the
every state or, as the Administrator con-
(1979).' But, while we agree that the Uni-
cy" for a particular use, 21 U.S.C.
tends, approval for interstate marketing of
form CSA offers an interesting compari-
Administrator argues that the phrase "ac-
§ 355(d)(5), it is equally possible for a sub-
the substance.
son, we fail to see how the interpretation of
cepted medical use in treatment in the
stance to be disapproved for interstate
the Uniform CSA offered by the Commis-
United States," 21 U.S.C. § 812(b)(1)(B),
Nor does the dictionary definition of "ac-
marketing because it lacks only one of
sioners has any bearing at all on the intent
must contemplate an administrative deter-
cepted" offered by the Administrator con-
these attributes, or because the application
mination that the substance has been "gen-
vince us that Congress intended FDA ap-
of Congress, which enacted the federal
fails to contain relevant patent information,
erally approved" for use in treatment in
proval to be the equivalent of the second
CSA prior to the creation of the Uniform
21 U.S.C. § 355(d)(6), or even because the
CSA. We can only conclude, therefore,
"all places" subject to United States juris-
and third Schedule I criteria. Use of the
labeling proposed for the drug "is false or
diction. In other words, FDA interstate
term "accepted" in sections 812(b)(1)(B) and
that this argument, despite its facial ap-
misleading in any particular." 21 U.S.C.
marketing approval is necessary to satisfy
812(b)(1)(C) may indicate that Congress in-
peal, has no bearing on the claim that the
§ 355(d)(7). Thus, we find no necessary
this criterion because, otherwise, the sub-
tended the medical use or safety of the
language of the federal CSA evidences con-
linkage between failure to obtain FDA in-
stance could not be deemed to be "general-
substance to be "generally agreed upon,"
gressional intent to adopt the construction
terstate marketing approval and a determi-
but this alone does not inform us as to who
of the statute favored by the Administra-
ly approved". everywhere in the United
nation that the substance in question is
tor.
States.¹
must generally be in agreement. The Ad-
unsafe and has no medical use. Indeed,
We find this argument to be strained and
ministrator reads "accepted" to mean that
While the Administrator's arguments fail
the FDCA does not even mention the term
the FDA must have approved the drug for
to persuade us that Congress affirmatively
unpersuasive. The CSA's definition of
"medical use." In short, it is plainly possi-
interstate marketing. Dr. Grinspoon, on
intended his construction of the CSA, we
"United States" plainly does not require
ble that a substance may fail to obtain
the other hand, prefers to interpret "ac-
believe nevertheless that the language and
the conclusion asserted by the Administra-
interstate marketing approval even if it has
cepted" as meaning that the medical com-
structure of the two relevant statutes, the
tor simply because section 802(28) defines
an accepted medical use.
munity generally agrees that the drug in
CSA and the FDCA, are helpful in deter-
"United States" as "all places subject to
mining whether the Administrator's inter-
Another possible reason for failure to
the jurisdiction of the United States." 21
question has a medical use and can be used
U.S.C. § 802(28) (emphasis supplied). Con-
safely under medical supervision. Our con-
pretation squares with congressional in-
obtain FDA new drug approval is that the
tent. Although, as the District of Colum-
manufacture, distribution, and use of a
gress surely intended the reference to "all
clusion is that the term "accepted" does
places" in section 802(28) to delineate the
not cure the statute's ambiguity. We are
bia Circuit has stated, "[t]he interrelation-
substance might not involve interstate mar-
simply unable to extrapolate from the
ship between the two Acts [CSA and
keting.¹⁰ Unlike the CSA scheduling re-
broad jurisdictional scope of the CSA and
drafters' choice of the word "accepted" and
FDCA] is far from clear," National Orga-
strictions, the FDCA interstate marketing
to clarify that the CSA regulates conduct
occurring any place, as opposed to every
thereby ascertain a general congressional
nization for Reform of Marijuana Laws
provisions do not apply to drugs manufac-
place, within the United States. As peti-
intention favoring the interpretation ad-
(NORML) v. DEA, 559 F.2d 735, 750 (D.C.
tured and marketed wholly intrastate.
vanced by the Administrator.
Cir.1977), we are persuaded that this in-
Compare 21 U.S.C. § 801(5) with 21 U.S.C.
tioner aptly notes, a defendant charged
In another argument focusing upon the
terrelationship precludes the Administra-
$ 321(b), 331, 355(a). Thus, it is possible
with violating the CSA by selling controlled
tor's reliance on the absence of FDA ap-
that a substance may have both an accept-
substances in only two states would not
language of the statute, the Administrator
urges us to adopt his interpretation of the
proval as a substitute for the second and
ed medical use and safety for use under
have a defense based on section 802(28) if
third Schedule I criteria under the CSA.
CSA because it is entirely consistent with
medical supervision, even though no one
he contended that his activity had not OC-
curred in "all places" subject to United
The CSA clearly provides that a sub-
has deemed it necessary to seek approval
the interpretation of the phrase "accepted
States jurisdiction. We add, moreover,
medical use in treatment in the United
stance may not be placed in Schedule I
for interstate marketing. Indeed, as Dr.
that the Administrator's clever argument
States" employed in the Commissioners'
unless it lacks both a "currently accepted
Grinspoon argues, there is no economic or
Notes to the Uniform Controlled Sub-
medical use in treatment in the United
other incentive to seek interstate market-
conveniently omits any reference to the
fact that the pertinent phrase in section
stances Act, §§ 203-12, 9 U.L.A. 221-35
States" and "accepted safety for use
ing approval for a drug like MDMA be-
812(b)(1)(B) reads "in the United States,"
(1979) ("Uniform CSA").8 At first glance,
under medical supervision." The FDCA,
cause it cannot be patented and exploited
on the other hand, provides that a sub-
commercially. The prospect of commercial
7. The Administrator does not confine this argu-
Experimental substances found to have a po.
stance may fail to obtain FDA interstate
development, of course, is irrelevant to one
ment to section 812(b)(1)(B), but also states that
tential for abuse in early testing will also be
"accepted safety for use under medical su-
included in Schedule 1. When those sub-
the criteria set out in Sections 205, 207, 209,
lands have adopted the Uniform CSA. 9 U.L.A.
pervision, 21 U.S.C. § 812(b)(1)(C), is equivalent
stances are accepted by the Federal Food and
and 211.
Supp. 123-24 (1986).
to FDA approval because. otherwise, the safety
Drug Administration as being safe and effec-
9 U.L.A. at 221.
of the substance could never be "generally
tive, they will then be considered to have an
10. Indeed, Dr. Grinspoon argues that MDMA is
agreed upon."
accepted medical use for treatment in the
9. The Uniform CSA was approved for adoption
a drug that has been legally manufactured and
United States, and thus, will be eligible to be
by the states in 1970. To date, 48 states, the
used only within a particular state. Petitioner's
8. The Commissioners' Notes provide:
shifted to an appropriate schedule based upon
District of Columbia, Guam, and the Virgin Is-
brief at 20.
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
889
888
Cite as 828 F.2d 881 (1st Clr. 1987)
who, like Grinspoon, seeks only to do re-
'safety and efficacy' of narcotic and dan-
D. Subsequent Legislation.
use expedited procedures and rely upon the
search.
gerous drugs (e.g., whether such drugs are
The Administrator has cited three subse-
absence of FDA interstate marketing ap-
These considerations tend to indicate that
acceptable for medical use and safe for
quent legislative enactments as support for
proval, rather than the usual Schedule I
the absence of FDA approval for interstate
such use) be determined by [HHS] under
his position that Congress has approved his
criteria, only in temporary emergency situ-
commerce does not foreclose the possibility
the [FDCA]." Respondent's Brief at 17-18
construction of the second and third crite-
ations suggests to us that these shorthand
that a substance might still possess an
(emphasis deleted). The Administrator's
ria for Schedule I substances. Our review
methods are not appropriate in routine (i.e.,
accepted medical use or even be considered
conclusion is objectionable, however, be-
of these legislative enactments, however,
nonemergency) situations such as the one
safe for use under medical supervision. It
cause his parenthetical comment-equating
leads us to find that the subsequent legisla-
before us in the instant case. We do not
appears, instead, that blind reliance on the
a finding of "safety and efficacy" by the
tion tends to weaken, not strengthen, the
interpret the explicit reference to FDA ap-
lack of FDA interstate marketing approval
FDA with a finding of "accepted medical
position espoused by the Administrator in
proval in the "emergency scheduling" pro-
could cause a substance to be placed in
un-
this litigation. We can only conclude, de-
vision to mean, as the Administrator would
use" and "accepted safety for use
Schedule I, even though one or two of the
spite the Administrator's claim that Con-
have us believe, that Congress sought to
der medical supervision"-is totally unsup-
three requirements prescribed by Congress
ported by the quoted passage from the
gress has repeatedly approved his con-
permit blind reliance on FDA standards as
struction of the CSA, that Congress has
a legitimate shortcut in the general run of
for placement of a drug in Schedule I have
House Committee Report. Nowhere does
cases.
not been proven. Based solely on the lan-
Congress equate "safety and efficacy" un-
never expressly or implicitly approved an
der the FDCA with the second and third
interpretation of section 812(b)(1) that
Second, Congress amended the CSA
guage of the CSA and the FDCA, there-
Schedule I criteria contained in section
would direct findings of "no currently ac-
again in 1986 when it enacted the Con-
fore, we find it unlikely that substituting
the lack of FDA interstate marketing ap-
812(b)(1). This, indeed, is the point at issue
cepted medical use" and "lack of accepted
trolled Substance Analogue Enforcement
proval for the statutory requirements that
in this litigation, and we are loath to accept
safety for use under medical supervi-
Act, Pub.L. No. 99-570, §§ 1201-04, 100
sion" whenever a substance lacked FDA
Stat. 3207 (codified at 21 U.S.C.
a substance lack both an "accepted medical
such a disingenuous argument.
un-
Second, the Administrator looks to the
interstate marketing approval. Rather, we
§§ 802(32)(A), 813). This amendment de-
use" and "accepted safety for use
history underlying the legislative schedul-
are persuaded to the contrary that the sub-
fines a "controlled substance analogue" as
der medical supervision" is consistent with
sequent enactments by Congress buttress
a substance having a chemical structure
the intent of Congress in enacting the CSA.
ing of the drug alphacetylmethadol in
our conclusion that the Administrator's
and effect on the central nervous system
We turn now to consider whether the legis-
Schedule I for support. With regard to the
construction of the CSA conflicts with con-
substantially similar to that of a Schedule I
lative history of the CSA confirms or re-
scheduling of this substance, there is evi-
or II controlled drug. 21 U.S.C.
buts this tentative conclusion.
dence that the Director of the Bureau of
gressional intent. To demonstrate why
this is so, we shall review each of the three
§ 802(32)(A). It provides that analogues of
Narcotics and Dangerous Drugs represent-
Schedule I and II controlled substances
pieces of subsequently enacted legislation
C. Legislative History.
ed to Congress that the FDA had not is-
relevant to the current dispute in the para-
shall, to the extent intended for human
The Administrator purports to have iden-
sued an NDA or an IND for alphacetylme-
graphs that follow.
consumption, be subject to the same con-
tified portions of the CSA's legislative his-
thadol, and claimed that this lack of FDA
trols and penalties as the controlled sub-
tory that support his construction of the
approval settled the issue whether alphace-
First, in 1984, Congress amended the
stances themselves. 21 U.S.C. § 813. As
statutory language. First, he cites a pas-
tylmethadol had a "currently accepted
CSA to include an "emergency scheduling"
the Administrator points out, the provision
sage from the House Committee Report
medical use." Because Congress eventual-
provision. See 21 U.S.C. § 811(h). This
expressly excludes from its definition of
ly did schedule alphacetylmethadol in
provision allows the Attorney General to
that states:
"controlled substance analogue," and hence
Schedule I of the CSA, see 21 U.S.C. § 812,
place certain substances into Schedule I on
Under Reorganization Plan No. 1 of 1968
from the scope of the amendment's sub-
Schedule I(a)(3), the Administrator con-
a temporary basis without regard to the
[reprinted in 1968 U.S.Code Cong. &
stantive controls pending final scheduling,
tends that it directly approved the statu-
regular scheduling criteria and procedures
Ad.News 4734] a Bureau of Narcotics
any substance for which there is an ap-
and Dangerous Drugs has been estab-
tory interpretation he advances today. We
if such emergency scheduling is "necessary
proved new drug application or an exemp-
are unpersuaded, however, that this isolat-
to avoid an imminent hazard to the public
lished in the Department of Justice to
tion for investigational use under section
ed instance-with no indication of express
safety." 21 U.S.C. § 811(h)(1). This
355 of the FDCA. 21 U.S.C.
regulate all these drugs (including legit-
congressional approval or even tacit re-
amendment to the CSA, however, expressly
imate importation, exportation, manufac-
§ 802(32)(B)(ii), (iii). Again, however, we
ture, and distribution) to prevent diver-
liance on the-Director's statement-is rea-
states that the Attorney General's authori-
are unpersuaded by the Administrator's ar-
son enough to defer to the Administrator's
ty to schedule substances in this expedited
sion from legitimate channels. Safety
gument that explicit permission to rely on
construction of the statute. Indeed, the
manner does not apply where an "exemp-
FDA standards in the case of analogues
and efficacy will continue to be regulated
under the Federal Food, Drug, and Cos-
impermissibility of substituting FDCA
tion or approval is in effect for the sub-
evidences congressional approval of his use
metic Act by [HHS].
standards for CSA scheduling criteria be-
stance under section 355 of this title," 11
of this shorthand method in all scheduling
comes even more apparent when we com-
i.e., where the FDA has permitted the sub-
determinations. We believe instead that
H.R.Rep. No. 1444, 91st Cong., 2d Sess.
stance to be marketed in interstate com-
the authorization to impose Schedule I con-
(1970), reprinted in 1970 U.S.Code Cong.
pare the dearth of support in the legislative
history for such an interpretation with the
merce. Id. The fact that Congress ex-
trols based on the lack of FDA approval,
& Ad.News 4566, 4584 (hereinafter cited as
language and history of several subsequent
pressly authorized the Attorney General to
rather than satisfaction of the scheduling
"House Committee Report"). From this,
the Administrator draws the proposition
legislative enactments in the controlled
11. 21 U.S.C. § 355 is the section of the FDCA
FDA interstate marketing approvals and exemp-
that "Congress clearly intended that the
substance field.
describing the standards and procedures for
tions.
828 2d-21
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
891
890
Cite as 828 F.2d 881 (1st Clr. 1987)
criteria set out in section 812(b)(1), in the
do not find the methaqualone legislation to
three requirements for scheduling a sub-
weight on the absence of FDA interstate
unique situation of analogues intended for
be persuasive authority for the proposition
stance in Schedule I. We believe instead
marketing approval, it has also determined
human consumption constitutes a special,
that the Administrator's interpretation of
that, for the hearing opportunity to be a
that a hearing procedure is unwarranted.
and justifiable, exception to the general
section 812(b)(1) is consistent with congres-
significant one on these issues, the agency
Clearly, this is not the case in the general
procedure mandated by section 812(b)(1).
sional intent.
must remain flexible enough to weigh and
administrative scheduling proceedings and
consider claims raised at the administrative
We believe, however, that in other cases
the hearing requirement should be given
involving nonanalogues, or analogues in-
E. Need For A Meaningful Hearing.
hearing to the effect that a substance has
full effect rather than being shortcircuited
tended for uses other than human con-
an accepted use and is accepted as safe
by blind reliance on the absence of FDA
We believe there is yet one additional
sumption, absolute reliance on the absence
even though it is not approved for distribu-
approval.
policy reason, no doubt related to some of
tion in interstate commerce.
of FDA approval would be inappropriate
the other factors already discussed, for re-
and, indeed, contrary to the intent of Con-
jecting the construction of the CSA ad-
The importance of a meaningful hearing
F. Conclusion.
gress in enacting the CSA.
vanced by the Administrator as contrary to
prior to scheduling can best be appreciated
For the reasons listed above, we conclude
when one considers those situations for
Third, in 1984, Congress legislatively
congressional intent. Under the statutory
that the Administrator erroneously applied
placed the drug methaqualone in Schedule
which Congress has permitted the Adminis-
scheme set up by Congress, the Attorney
an interpretation of the "accepted medical
I. Despite its reputation as a widely
trator to regulate substances in the ab-
General may not schedule a substance un-
use in treatment in the United States" and
abused substance, methaqualone was uni-
sence of a hearing. Neither the emergency
der the CSA without first obtaining the
"accepted safety for use under
medical
versally acknowledged to have an accepted
scheduling provision, 21 U.S.C. § 811(h),
recommendation of the FDA, through its
supervision" criteria of section 812(b)(1)
medical use and had been approved for
nor the provision for treatment of con-
parent agency, HHS, 21 U.S.C. § 811(b),
that directly conflicts with congressional
interstate marketing by the FDA. The
trolled substance analogues, 21 U.S.C.
and providing an "opportunity for a hear-
intent. We therefore vacate the Adminis-
House Committee Report concerning the
§ 813, requires the Administrator to hold a
ing pursuant to the rulemaking procedures
trator's determination that MDMA should
scheduling of methaqualone stated:
hearing prior to taking regulatory action.
prescribed by [the Administrative Proce-
be placed in Schedule I of the CSA and
the [DEA] does not have authority to
Congress crafted both of these sections to
dure Act]." 21 U.S.C. § 811(a). It is plain,
remand the rule for further consideration
impose Schedule I controls on a drug
serve as stop-gap measures to be employed
therefore, that while Congress intended the
by the DEA. On remand, the Administra-
which has been approved by the [FDA]
pending a final scheduling determination
recommendation of HHS to have signifi-
tor will not be permitted to treat the ab-
for medical use. The statutory findings
by the DEA, following a full evidentiary
cant weight in the decisionmaking process,
sence of FDA interstate marketing approv-
required for agency scheduling decisions
hearing, for the substance in question.
it also intended that there be an opportuni-
al as conclusive evidence that MDMA has
clearly state that the agency may not, in
Significantly, it is only in these provisions
ty for a meaningful hearing after receipt of
no currently accepted medical use and
the absence of Congressional action, sub-
for temporary controls pending final
the HHS report. It would surely be ano-
lacks accepted safety for use under medical
ject drugs with a currently accepted
scheduling that Congress has emphasized
malous if the FDA's recommendation,
supervision.
medical use in the United States to
the absence of FDA interstate marketing
based solely on the absence of approval for
Schedule I controls.
approval, 21 U.S.C. § 811(h)(1) (emergency
Petitioner Grinspoon has offered his own
interstate marketing, sufficed to determine
scheduling provision); 21 U.S.C.
theory concerning the type of inquiry the
H.R.Rep. No. 534, 98th Cong., 2d Sess. 4
the ultimate conclusion prior to the hear-
§ 802(32)(B)(ii), (iii) (controlled substance
Administrator must make under the stat-
(1984), reprinted in 1984 U.S.Code Cong.
ing.
analogue act). In the case of emergency
ute. He urges us to adopt a standard for
& Ad.News 540, 543. The Administrator
If we were to accept the Administrator's
scheduling, it appears that Congress has
the second and third criteria that is based
cites this passage in yet another attempt to
construction of section 812(b)(1) in this
already done the balancing and determined
upon the opinion of members of the medical
demonstrate congressional approval of his
case, the opportunity for a meaningful
that the risk of ongoing abuse amounting
community. He contends that Congress
position that a substance cannot have an
hearing would be lost, and satisfaction of
to an "imminent hazard to the public safe-
drafted the CSA with this type of standard
accepted medical use unless the FDA has
already approved it for interstate market-
the "accepted medical use" and "accepted
ty" justifies temporary scheduling without
in mind. To support this contention, Grin-
ing. In fact, however, the actions of Con-
safety" criteria would turn solely on the
a hearing in the absence of FDA approval.
spoon cites the testimony of two represent-
gress with respect to methaqualone demon-
existence of FDA approval for interstate
Likewise in the latter case, Congress has
atives of the Bureau of Narcotics and Dan-
strate at most the converse of this proposi-
marketing. A hearing on issues of the sort
responded to the need for expedited investi-
gerous Drugs ("BNDD"), DEA's predeces-
tion: that FDA approval precludes schedul-
required by the statute-Does the sub-
gation and prosecution of "clandestine
sor agency, during legislative consideration
stance have an accepted medical use in
chemists who develop subtle chemical vari-
of Pub.L. No. 91-513, the Comprehensive
ing of a substance in Schedule I., In other
treatment in the United States? Is the
ations of controlled substances (called ana-
Drug Abuse Prevention and Control Act of
words, the methaqualone legislation dem-
onstrates Congress' belief that FDA ap-
substance safe for use under medical su-
logues or "designer drugs') for illicit distri-
1970. Michael R. Sonnenreich, Deputy
bution and use," H.R.Rep. No. 848, 99th
Chief Counsel of the BNDD, testified that
proval is sufficient to establish the exist-
pervision?-would be reduced to an empty
ence of an accepted medical use, but not
formality and, for participants like Dr.
Cong., 2d Sess., pt. 1, 2 (1986), and permit-
drugs in Schedule I would "have no medi-
Grinspoon, would amount to an exercise in
ted Schedule I controls to take effect with-
cal use as determined by the medical com-
that the lack of FDA approval-the issue in
this case-necessarily negates the possibili-
futility. We hesitate to interpret the CSA
out first requiring a hearing so long as
munity," and that "the medical communi-
in a manner that would cause its important
FDA approval is lacking. Thus, in both
ty" would decide "whether or not the drug
ty that the substance in question has an
provision requiring a administrative hear-
"emergency" situations for which Con-
has [a] medical use
Hearings on
accepted medical use and is safe for use
under medical supervision. We therefore
ing to be meaningless as to two of the
gress has seen fit to place particular
Drug Abuse Control Amendments Before
892
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
893
Cite as 828 F.2d 881 (1st Clr. 1987)
the Subcomm. on Public Health and Wel-
found nothing to indicate how Congress
1. Legal Standard.
there is "a substantial potential for the
fare of the House Comm. on Interstate and
affirmatively intended these two ambigu-
The CSA provides no definition of the
occurrence of significant diversions from
Foreign Commerce, 91st Cong., 2d Sess.
ous statutory phrases to be construed and
phrase "high potential for abuse," but both
legitimate channels, significant use by indi-
696, 718 (1970) ("House Hearings"). Like-
applied. It appears to us that Congress
parties agree that the legislative history of
viduals contrary to professional advice, or
wise, John Ingersoll, Director of the
has implicitly delegated to the Administra-
the statute provides guidance in this re-
substantial capability of creating hazards
BNDD, testified that substances placed in
tor the authority to interpret these portions
gard. Specifically, the report of the House
to the health of the user or the safety of
Schedule I would be those drugs that "the
of the CSA, and we must therefore refrain
Committee on Interstate and Foreign Com-
the community." House Committee Re-
medical profession has already determined
from imposing our own statutory interpre-
merce accompanying the bill that eventual-
port, supra, at 4602.
to have no legitimate medical use in the
tation upon the agency. Chevron, 467 U.S.
ly became the CSA sets forth four alterna-
The Administrator argues that he applied
United States." House Hearings at 678.
at 843, 104 S.Ct. at 2781. Hence, to avoid
tive legal standards for determining when
the standards expressly approved by Con-
While we acknowledge that the state-
unduly infringing upon the Administrator's
a substance possesses a "potential for
gress, but Dr. Grinspoon complains that
ments by the BNDD witnesses before the
legitimate discretion to develop a legally
abuse." Borrowing from regulations
the Administrator articulated no standard
House Subcommittee tend to support Dr.
acceptable standard-i.e., one that does not
promulgated under the FDCA, the House
for showing that MDMA had a relative
Grinspoon's position, we do not believe
conflict with the intentions of Congress,
Committee Report provides that the Admin-
potential for abuse sufficient to warrant
they are entitled to much weight as indicia
and makes sense in light of the statutory
istrator may determine a substance has
placement in Schedule I. As Grinspoon
of congressional intent in fashioning the
language, the legislative history, and the
potential for abuse if:
notes, the passage from the legislative his-
"accepted medical use" and "accepted safe-
purposes of the entire legislative scheme-
(1) There is evidence that individuals are
tory quoted above provides guidance only
ty for use
under medical supervision"
we remand the rule to the Administrator
taking the drug or drugs containing such
as to the minimum needed to show any
criteria. See McCaughn v. Hershey Choc-
for reconsideration and for further pro-
a substance in amounts sufficient to cre-
potential for abuse, in other words, enough
olate Co., 283 U.S. 488, 493-94, 51 S.Ct.
ceedings not inconsistent with this opinion.
ate a hazard to their health or to the
to justify a level of CSA control as low as
510, 512, 75 L.Ed. 1183 (1931) ("statements
safety of other individuals or of the com-
placement in Schedule V. It offers no
made to committees of Congress
munity; or
guidance for assessing whether a sub-
are without weight in the interpretation of
III. Challenges Based on "Arbitrary
(2) There is significant diversion of the
stance should be subject to Schedule I con-
a statute"). This is especially true where,
and Capricious" Standard.
drug or drugs containing such a sub-
trols, the strictest imposed under the CSA,
as here, there is no indication whatsoever
Although a remand is necessary due to
stance from legitimate drug channels; or
which require a "high" potential for abuse.
in either the legislative history or the histo-
our above holding, we nonetheless feel
(3) Individuals are taking the drug or
For this, argues Grinspoon, the Administra-
ry of any subsequent amendments that
compelled to address the other issues
drugs containing such a substance on
tor must prove that MDMA has a high
Congress concurred with the views ex-
raised in Dr. Grinspoon's petition because
their own initiative rather than on the
potential for abuse relative to other sched-
pressed by the witnesses. In short, we do
they are likely to arise again when the
basis of medical advice from a practition-
uled substances and must base its proof on
not find Grinspoon's evidence to be per-
Administrator reconsiders the rule.
er licensed by law to administer such
existing levels of actual abuse "on the
suasive on the issue of affirmative congres-
drugs in the course of his professional
streets."
sional intent to have certain members of
the medical community determine whether
A. "High" Potential For Abuse.
practice; or
[2] While we acknowledge that the Ad-
(4) The drug or drugs containing such a
ministrator's final rule is silent with re-
a substance has an "accepted medical use
In addition to the "accepted medical use"
substance are new drugs so related in
spect to the legal standard required for a
in treatment in the United States" or "ac-
and "accepted safety" criteria discussed
their action to a drug or drugs already
finding of "high" potential for abuse, we
cepted safety for use
under medical
above, the CSA also requires substances
listed as having a potential for abuse to
do not find the Administrator's action to be
supervision.".
identified for placement in Schedule I to
make it likely that the drug will have the
arbitrary and capricious. The fourth stan-
The nature of our review further con-
have a "high potential for abuse." 21
same potentiality for abuse as such
dard contained in the segment of the Com-
strains us from requiring the Administra-
U.S.C. § 812(b)(1)(A). Dr. Grinspoon con-
drugs, thus making it reasonable to as-
mittee Report quoted above makes it quite
tor to adopt Dr. Grinspoon's proposed con-
tends that the Administrator's placement
sume that there may be significant diver-
clear that the Administrator can permissi-
struction of section 812(b)(1). Although we
of MDMA in Schedule I is arbitrary and
sions from legitimate channels, signifi-
bly reach a conclusion regarding a sub-
find that the Administrator's present inter-
capricious because the Administrator failed
cant use contrary to or without medical
stance's level of potential for abuse by
pretation of the second and third Schedule
to articulate a legal standard for assessing
advice, or that it has a substantial capa-
comparing the substance to drugs already
I criteria contravenes congressional intent,
MDMA's potential for abuse and because
bility of creating hazards to the health of
scheduled under the CSA. Here the Ad-
we are unable to ascertain with any cer-
the evidence in the record is insufficient to
the user or to the safety of the communi-
ministrator has done just that, offering
tainty what Congress intended to be the
support a finding that MDMA has a "high"
ty.
several findings concerning the evidence of
proper interpretation of subsections (B) and
potential for abuse. While conceding that
MDMA has some potential for abuse, and
House Committee Report, supra, at 4601.
close structural and pharmacological sim-
(C). In other words, while we are satisfied
therefore should be scheduled under the
The Committee Report goes on to state
ilarity between MDMA and other sub-
that Congress intended to preclude reliance
CSA, Dr. Grinspoon insists that the Admin-
that "potential for abuse" exists only when
stances, such as MDA." which already
on the absence of FDA approval in assess-
ing whether a substance has an "accepted
istrator has not proved, as he must for a
12. "MDA" is 3,4-methylenedioxyamphetamine
narrowly defined, phenylisopropylamines or
medical use" and "accepted safety for use
Schedule I substance, that MDMA's poten-
and, like MDMA, belongs to a class of com-
amphetamines.
under medical supervision," we have
tial for abuse is high.
pounds known as phenethylamines or, more
GRINSPOON V. DRUG ENFORCEMENT ADMIN.
895
894
828 FEDERAL REPORTER, 2d SERIES
Cite as 828 F.2d 881 (1st Clr. 1987)
er words, "[e]ven if reasonable minds could
and rats trained to recognize MDA also
have been found to have a high potential
2. Substantial Evidence.
also go the other way, we must uphold the
recognized MDMA; (7) based on recent
for abuse and have been placed in Schedule
In reviewing the Administrator's conclu-
[agency] if its ultimate finding is supported
tests involving human subjects, MDMA can
I or II. 51 Fed.Reg. 36,555-57 (1986). The
sion regarding MDMA's potential for
by substantial evidence in the record as a
be described as maintaining the same po-
Administrator also cited animal studies, hu-
abuse, we must determine whether it is
whole." NLRB v. J.K. Electronics, Inc.,
tency as MDA, but exhibiting subtle differ-
man behavioral studies, and a survey of
based on "substantial evidence," a term the
592 F.2d 5, 7 (1st Cir.1979).
ences in the qualitative nature of the intoxi-
MDMA users which suggest that MDMA is
Supreme Court has defined as 'such rele-
The question before us, therefore, is
cation.
related in its effects to Schedule I and II
vant evidence as a reasonable mind might
whether there is substantial evidence in the
Dr. Grinspoon, in an item-by-item analy-
substances such as LSD, cocaine, mesca-
accept as adequate to support a conclu-
administrative record to support the Ad-
sis contained in the proposed findings of
line, and MDA." We believe this approach
sion.'' American Textile Manufacturers
ministrator's determination that MDMA is
fact and conclusions of law he submitted to
to ascertaining MDMA's potential for
Institute, Inc. v. Donovan, 452 U.S. 490,
"so related in [its] action to a drug or
the DEA, calls into question many of the
abuse is entirely consistent with the statu-
522-23, 101 S.Ct. 2478, 2497, 69 L.Ed.2d
drugs already listed as having a [high]
Administrator's findings concerning
tory scheme developed by Congress and
185 (1981) (quoting Universal Camera
potential for abuse" that it is likely MDMA
MDMA's similarity to other drugs with a
therefore hold that the Administrator's
Corp. v. NLRB, 340 U.S. 474, 477, 71 S.Ct.
high potential for abuse. For instance,
456, 459, 95 L.Ed. 456 (1951)). The Court
"will have the same potentiality for abuse
method is not arbitrary and capricious.¹⁴
as such drugs." House Committee Report,
Grinspoon agrees that MDMA is a member
has further explained this lenient standard
The question remains, of course, whether
of review, stating that 'the possibility of
supra, at 4601. In support of his conclu-
of a family of psychoactive drugs, but dis-
the evidence collected by the Administrator
sion, the Administrator made 46 numbered
putes the validity of the inference drawn
drawing two inconsistent conclusions from
is sufficient to justify his conclusion that
the evidence does not prevent an adminis-
findings related to MDMA's similarity to
from the similarity by the Administrator.
MDMA has a high potential for abuse.
trative agency's findings from being sup-
other drugs with a high potential for
According to Grinspoon, "chemical similari-
ported by substantial evidence." Id.
abuse. These findings were based on sci-
ty is not necessarily a good guide to the
Since Dr. Grinspoon has also challenged
(quoting Consolo v. Federal Maritime
entific evidence concerning the chemical
actual effects of a compound in the human
this aspect of the scheduling determination
as arbitrary and capricious, we turn next to
Commission, 383 U.S. 607, 620, 86 S.Ct.
structural similarity between MDMA and
body." Petitioner's Brief at 37. Grinspoon
1018, 1026, 16 L.Ed.2d 131 (1966)). In oth-
other Schedule I and II drugs; the similar
notes that of the 28 known phenethyla-
a discussion of this issue.
pharmacological effects of MDMA and
mines, 17 were not scheduled under the
13. The Administrator also considered that the
ceives as the current low level of MDMA abuse
these other drugs; animal drug discrimina-
CSA as late as December 1983. Even a
United Nations Commission on Narcotic Drugs
"on the streets." For example, Grinspoon notes
tion studies; animal self-administration
subsequent review of these 17 substances
has placed MDMA in Schedule I of the Conven-
in his brief that the statistics above concerning
the 41 evidentiary exhibits identified as MDMA
studies; and recent studies of the neuro-
by the World Health Organization's Expert
tion on Psychotropic Substances and that
MDMA occupies the same schedule in the Cana-
toxic effects of MDMA and related drugs
Committee on Drug Dependence resulted in
during the period 1972-1985 are insignificant
dian Food and Drug Act as MDA and LSD. 51
when one considers that MDMA accounted for
on rats. Based on this evidence, the Ad-
a recommendation that only nine of the
Fed.Reg. 36,559 (1986).
only one ten-thousandth of all DEA exhibits
ministrator found, among other things,
substances be scheduled by member na-
14. In addition to the evidence comparing
compiled during this period. Likewise, the five
that (1) MDMA is the N-methyl analogue of
tions. Eight were thought harmless
MDMA to other substances with a high potential
laboratories with the potential to manufacture
for abuse, the Administrator also considered
MDMA account for only a minute fraction of
MDA and retains the psychomimetic prop-
enough to remain unscheduled.¹⁵ Also, re-
evidence related to the "actual" abuse of MDMA
the 2400 laboratories seized by the DEA from
erties of MDA; (2) MDMA produces phar-
ferring to the Administrator's finding that
and made several findings in this regard. See
1972-1983. Furthermore, Grinspoon challenges
macological effects in common with both
MDMA, like MDA and amphetamine, is a
51 Fed.Reg. 36,557-36,558 (1986). These find-
the finding that MDMA has been associated with
ings reveal, among other things, that: (1) be-
overdose deaths as "seriously suspect."
central nervous system ("CNS") stimulants
central nervous system stimulant, Grin-
tween 1972 and April 1985, DEA laboratories
While we appreciate Dr. Grinspoon's point
like amphetamine and hallucinogens like
spoon asserts that this evidence of pharma-
identified 41 exhibits of MDMA, consisting of
that MDMA abuse is low relative to other drugs
MDA in animals; (3) MDMA and MDA
cological similarity proves nothing. Sever-
60,000 dosage units; (2) from July 1985, when
that seem to be more popular "on the street," we
MDMA was temporarily placed in Schedule I
produce the same spectrum of pharmaco-
al other substances also fit this description,
do not believe that this fact precludes the Ad-
ministrator from finding that MDMA has a high
logical effects in mice, dogs, and monkeys
including caffeine and six of the eight
pursuant to the Administrator's emergency
scheduling powers, up to the time that the final
when observed during toxicity studies; (4)
phenethylamines that are neither currently
potential for abuse. Grinspoon's argument
rule was promulgated, 14 MDMA exhibits, con-
overlooks the importance of the term "poten-
MDMA, like MDA, amphetamine, and
controlled nor recommended for control by
sisting of 35,000 dosage units, had been identi-
tial" in section 812(b)(1)(A) and runs contrary
fied by DEA laboratories; (3) DEA has encoun-
methamphetamine, produces neurotoxic ef-
WHO. Based on this, Grinspoon concludes
tered five laboratories capable of clandestinely
to the explicit intent of Congress that the Ad-
fects when administered to animals; (5)
that the mere fact that a substance is a
producing kilogram quantities of MDMA; (4)
ministrator "not be required to wait until a
the estimate of one DEA witness Is that street
number of lives have been destroyed or substan-
MDMA and MDA may both produce the
CNS stimulant does not necessarily imply
distribution of MDMA has increased from 10,-
tial problems have already arisen before desig-
same neurotoxic effects to serotonergic
that it has a high potential for abuse.
000 dosage units in 1978 to 30,000 dosage units
nating a drug as subject to the controls of the
nerves in humans; (6) in drug discrimina-
In addition, Dr. Grinspoon (1) attacks the
per month in 1985; (5) according to Dr. Grin-
bill." House Committee Report, supra, at 4602.
tion tests, rats trained to recognize amphet-
Administrator's other findings concerning
spoon himself, MDMA is being taken by a grow.
So long as the Administrator can marshal sub-
ing number of people, particularly students and
stantial evidence to demonstrate that MDMA is
amine also recognized MDA and MDMA,
MDMA's LD-50 rating 16 as being irrele-
young professionals, in a casual and recreation-
sufficiently similar to scheduled drugs with a
al manner; and (6) MDMA is reported to have
"high potential for abuse," we will sustain his
15. These eight are clobenzorex, fenbutrazate,
16. "LD-50" signifies the dose of a given drug
been associated with two overdose deaths.
determination regardless of existing levels of
furfenorex, morazone, para-oxyamphetamine,
that will kill 50% of the animals treated with
4-bromo-2,5-dimethoxyphenethylamine. N.N-
that dose.
Dr. Grinspoon attacks these findings of actual
actual abuse.
dimethylamphetamine, and N-ethyl-3,4-methy-
abuse, focusing on the need to assess the relative
lenedioxyamphetamine.
level of actual abuse and stressing what he per-
896
828 FEDERAL REPORTER, 2d SERIES
GRINSPOON v. DRUG ENFORCEMENT ADMIN.
897
Cite as 828 F.2d 881 (1st Clr. 1987)
vant to the "potential for abuse" inquiry;
the impact of a scheduling decision on legit-
MDMA have available avenues by which to
section 811(b) request for a scientific and
(2) discounts the importance of findings
imate research amounts to arbitrary and
pursue such research." Id.
medical evaluation; neglected to consult
that MDMA is neurotoxic when adminis-
capricious action on the part of the Admin-
Second, and more importantly, Dr. Grin-
any organization of medical professionals
tered to rats; (3) questions the relevancy of
istrator because he did not weigh all rele-
spoon has identified nothing in the CSA, its
or even the FDA's own panel of experts,
the findings related to animal drug discrim-
vant factors in making his decision. Motor
legislative history, or its implementing reg-
the Drug Abuse Advisory Committee; and
ination studies; and (4) asserts that the
Vehicle Manufacturers Association v.
ulations that can be read to require the
simply rubber-stamped the Administrator's
Administrator has incorrectly interpreted
State Farm Mutual Insurance Co., 463
Administrator to consider the impact of a
conclusion by adopting the section 811(c)
the results of two animal self-administra-
U.S. 29, 42-43, 103 S.Ct. 2856, 2866, 77
scheduling determination upon legitimate
eight-factor analysis already performed by
tion studies. We have reviewed Dr. Grin-
L.Ed.2d 443 (1983). To buttress his conten-
scientific research. From our review of
the DEA. There is also evidence that FDA
spoon's item-by-item analysis closely, but
tion, Grinspoon recites a litany of legal,
the CSA, we can only conclude that Con-
analysts failed to forward a letter received
administrative, and practical obstacles that
gress has already weighed the costs and
from the National Institute of Drug Abuse,
find no basis sufficient to overturn the
hinder researchers seeking to conduct ex-
benefits of legitimate research on danger-
which stated that the evidence cited by the
Administrator's decision. Grinspoon's rein-
DEA did not support the existence of abuse
terpretation of the scientific evidence be-
periments with Schedule I drugs. These
ous drugs and has determined, in a cate-
obstacles include mandatory FDA approval
gorical manner, that if the three Schedule I
potential in animals, to either the FDA
fore the agency surely demonstrates that
the available evidence does not inexorably
of research involving Schedule I sub-
criteria are satisfied, see 21 U.S.C.
Commissioner or the Assistant Secretary of
stances, 21 C.F.R. § 1301.42(a)-(c); manda-
§ 812(b)(1), then the substance should be
HHS prior to the issuance of the HHS
lead to a conclusion that MDMA is similar
to drugs possessing a high potential for
tory special registration with the DEA, 21
subject to Schedule I controls even if this
recommendation to the Administrator."
abuse. But, faced with such uncertainty,
C.F.R. §§ 1301.33, 1301.42; mandatory re-
action will create administrative and other
[4] Despite these alleged procedural
we must defer to the conclusion reached by
porting and security procedures beyond
burdens for researchers. Here there is no
shortcomings, we fail to see how the proce-
the Administrator, even if we may have
those required for drugs placed in Sched-
dispute that the Administrator considered
dure followed by HHS tainted the Adminis-
favored Dr. Grinspoon's approach had we
ules II through V; unavoidable bureaucrat-
all of the section 812(b)(1) criteria in arriv-
trator's determination. The CSA does not
studied the evidence in a de novo fashion.
ic delays; and other adverse impacts due to
ing at his final rule, so we are left with a
specify the steps to be taken by HHS; it
In reaching this conclusion, we follow the
the grave concern caused by a substance's
situation in which there can be no com-
simply requires the Administrator to re-
well-established maxim that "[w]here the
placement in Schedule I, such as difficulty
plaint that the Administrator failed to con-
quest from the Secretary of HHS a scien-
agency presents scientifically respectable
sider any relevant factor.
tific and medical evaluation. 21 U.S.C.
in obtaining volunteers for clinical studies
evidence which the petitioner can contin-
and, for academic researchers, difficulty in
§ 811(b). Moreover, the HHS recommen-
ually dispute with rival, and we will as-
C. Reliance Upon HHS Evaluation And
dation to schedule a substance is not bind-
securing approval from institutional review
sume, equally respectable evidence, the
Recommendation.
boards.
ing 18 and, indeed, serves to trigger an ad-
court must not second-guess the particular
Dr. Grinspoon's final dissatisfaction with
ministrative hearing at which interested
way the agency chooses to weigh the con-
[3] Again, we do not doubt that Dr.
the final rule is the Administrator's alleged
persons may introduce evidence to rebut
flicting evidence or resolve the dispute."
Grinspoon has correctly identified several
reliance on the conclusions recommended
the Secretary's scheduling recommenda-
Asarco, Inc. v. OSHA, 746 F.2d 483, 490
ways in which the placement of MDMA in
by HHS on the criteria enumerated in sec-
tion. Ultimately, of course, responsibility
(9th Cir.1984) (quoting United Steelwork-
Schedule I will impede his research and the
tion 812(b)(1). Grinspoon argues that the
rests with the Administrator, not HHS, to
ers of America v. Marshall, 647 F.2d 1189,
efforts of other researchers interested in
determination by the Secretary of HHS
ensure that the final rule rests on permissi-
1263 (D.C.Cir.1980), cert. denied, 453 U.S.
exploring the possibility of clinical uses for
was arbitrary and capricious and not in
ble legal standards and substantial evi-
913, 101 S.Ct. 3148, 69 L.Ed.2d 997 (1981)).
MDMA. We must conclude, nevertheless,
accordance with law, and that all relevant
dence. It is true that the Administrator
We find this maxim to have particular
that the existence of such hurdles does not
scientific and medical evidence was not be-
twice mentioned the HHS recommendation
force in a case such as this because, as one
render the Administrator's scheduling deci-
fore the Secretary at the time of the deter-
in his final rule, once in relation to the
court has explained, "[a]ppellate courts
sion arbitrary and capricious. First, it is
mination. The record, in fact, reveals that
"accepted medical use" criterion and once
have neither the expertise nor the re-
simply untrue that the Administrator failed
HHS performed in a less than admirable
in relation to the "high potential for abuse"
sources to evaluate complex scientific
to consider the impact on medical research
fashion in making its recommendation to
criterion. With regard to the first mention,
claims." Thompson Medical Co. v. FTC,
that would be caused by a decision to place
the Administrator. The record indicates
however, we have already determined that
791 F.2d 189, 196 (D.C.Cir.1986), cert. de-
MDMA in Schedule I. In the final rule, the
that HHS failed to look beyond its own
this aspect of the case must be remanded
nied, - U.S. 107 S.Ct. 1289, 94
Administrator states explicitly that he
files upon receiving the Administrator's
and reconsidered because the Administra-
L.Ed.2d 146 (1987).
"read with interest the comments from var-
17. Dr. Grinspoon also complains that the Acting
18. According to section 811(b), the HHS recom-
ious parties in the record concerning the
Assistant Secretary of Health concluded errone-
mendation is binding as to "scientific and medi-
B. Impact Of Scheduling On Research.
effect placement of MDMA into Schedule I
ously that MDMA had a "high" potential for
cal" matters, but not with respect to the appro-
Dr. Grinspoon also takes issue with the
would have on legitimate research into the
abuse because the recommendation of FDA's
priate schedule in which to place a particular
Administrator's alleged failure to consider
substance." 51 Fed.Reg. 36,559 (1986).
Deputy Commissioner described MDMA's poten-
substance. The exception to this rule is that, "if
tial for abuse as "significant," rather than
the Secretary recommends that a drug or other
evidence tending to show that placement of
After several paragraphs discussing the
"high." In light of the fact that the FDA Deputy
substance not be controlled. the Attorney Gener-
MDMA in Schedule I would strongly dis-
contours of the additional Schedule I con-
Commissioner recommended placement of
al shall not control the drug or other sub-
courage medical research on the drug.
trols, the Administrator concludes that
MDMA in Schedule I, we attribute no signifi-
stance." 21 U.S.C. § 812(b) (emphasis sup-
cance to this semantic argument.
plied).
Grinspoon contends that failure to consider
"those who wish to conduct research with
898
828 FEDERAL REPORTER, 2d SERIES
FURMAN V. CIRRITO
899
Cite as 828 F.2d 898 (2nd Clr. 1987)
tor interpreted the statutory language in a
owners of partnership pursuant to RICO
ate" purchase of partnership at higher
Before VAN GRAAFEILAND,
manner that is contrary to the intent of
statute. The United States District Court
price was inadequate to establish that oth-
NEWMAN and PRATT, Circuit Judges.
Congress. Because, on remand, the Ad-
for the Southern District of New York,
er firm made offer to purchase. 18 U.S.
ministrator will not be able to rely on lack
Irving Ben Cooper, J., 578 F.Supp. 1535,
C.A. §§ 1961-1968.
VAN GRAAFEILAND, Circuit Judge:
of FDA approval to demonstrate the ab-
dismissed action for failure to state claim,
3. Commerce =82.72
This is an appeal from an order of the
sence of an accepted medical use, we need
and appeal was taken. The Court of Ap-
Allegations by minority partners that
United States District Court for the South-
not discuss any possible reliance on the
peals, 741 F.2d 524, affirmed. On petition
their signatures on written contract for
ern District of New York (Cooper, J.)
HHS recommendation regarding the ab-
for writ of certiorari, the United States
sale of partnership assets were coerced by
granting appellees' motion under Fed.R.
sence of an accepted medical use. With
Supreme Court, 105 S.Ct. 3550, vacated.
criminal conduct on part of majority part-
Civ.P. 12(b)(1) and (6) to dismiss appellants'
regard to the second mention, we believe
that the Administrator's conclusion that
Following vacation, 779 F.2d 36, and on
ners and that minority partners were
complaint, and from the judgment entered
MDMA has a high potential for abuse is
remand, the district court concluded that
"forced to accept employment" on unfavor-
pursuant thereto. For the reasons that
amply supported by a substantial amount
complaint failed to allege any continuity of
able terms was too conclusory to support
follow, we affirm.
of independent evidence. Because we be-
activity and dismissed RICO cause of ac-
charge of criminal wrongdoing in order to
lieve that the Administrator's finding with
tion, and appeal was again taken. The
maintain action under RICO statute; each
Appellants' complaint states three causes
of action, two that are state law claims of
regard to MDMA's potential for abuse is
Court of Appeals, Van Graafeiland, Circuit
partner had right to negotiate on his or her
justified even in the absence of the HHS
Judge, held that: (1) sale of partnership
behalf whether, and on what terms, he or
partnership fraud and breach of fiduciary
recommendation to place MDMA in Sched-
assets did not constitute wrongdoing to
she was willing to become associated with
duty and a third grounded on the Racke-
support RICO action; (2) majority partners
purchasing partnership, and even if minori-
teer Influenced and Corrupt Organizations
ule I, we hold that any reliance on the HHS
were not guilty of any criminal conduct
ty partners lacked sufficient sophistication
Act (RICO), 18 U.S.C. §§ 1961-68. It twice
evaluation by the Administrator consti-
tutes, at most, harmless error.
based on alleged failure to promptly inform
to know that they could not be bonded over
has been dismissed by the district court.
For the foregoing reasons, the rule is
to purchasing partnership without their
The first dismissal was based on appel-
minority partners that they would be re-
vacated and remanded to the Adminis-
consent, they made no allegation of any-
lants' failure to allege a separate, distinct
quired to sign written contract with pur-
trator for further proceedings consistent
thing that prevented them from refusing to
racketeering enterprise injury. 578
chasing partnership; and (3) even if minori-
sign contract unless they received more
F.Supp. 1535 (S.D.N.Y.1984). This Court's
with this opinion.
ty partners spelled out some form of crimi-
favorable treatment. 18 U.S.C.A. §§ 1961-
affirmance of that decision, 741 F.2d 524,
nal fraud on part of majority partners, they
was vacated by the Supreme Court, 473
1968.
KEY NUMBER SYSTEM
failed to allege pattern of racketeering ac-
U.S. 922, 105 S.Ct. 3550, 87 L.Ed.2d 672
tivity conducted in affairs of "enterprise."
4. Commerce =82.72
(1985), on the basis of its holdings in Sedi-
Assuming that minority general part-
ma, S.P.R.L. v. Imrex Co., 473 U.S. 479,
Affirmed.
ners' complaint spelled out some form of
105 S.Ct. 3275, 87 L.Ed.2d 346 (1985), and
George C. Pratt, Circuit Judge, filed
criminal fraud on part of majority partners
American Nat'l Bank & Trust Co. v. Har-
Aaron J. FURMAN, Martin J. Joel, Jr.,
dissenting opinion.
in selling partnership assets, complaint
oco, Inc., 473 U.S. 606, 105 S.Ct. 3291, 87
Alvin Katz, Francis P. Maglio, Harvey
failed to allege pattern of racketeering ac-
L.Ed.2d 437 (1985) (per curiam). Following
Sheid, Everard M.C. Stamm and Robert
tivity conducted in affairs of "enterprise"
remand to the district court, appellees
C. Stamm, Plaintiffs,
to enable minority partners to maintain
1. Partnership 70, 97
moved to dismiss for failure to allege a
Martin J. Joel, Jr., Harvey Sheld,
RICO action; at time allegedly wrongful
Rights and obligations of partners, as
"pattern of racketeering activity", 18
Everard M.C. Stamm and Robert
acts occurred, majority partners were not
between themselves, are fixed by terms of
U.S.C. § 1962(c), or, in the alternative, to
C. Stamm, Plaintiffs-Appellants,
functioning as continuing unit in ongoing
partnership agreement; even terms which
compel arbitration pursuant to the Federal
organization, as they were acting solely on
V.
permit self-dealing by partner will be en-
Arbitration Act, 9 U.S.C. 1-14. Relying
their own to prevent alleged enterprise
John CIRRITO, Harold S. Coleman, John
forced.
on Sedima, supra, 473 U.S. at 496 n. 14,
from being ongoing, continuing unit
A. Miller, Francis G. Rea, Peter M. Toc-
105 S.Ct. at 3285 n. 14; id. at 527-28, 105
through sale of partnership. 18 U.S.C.A.
zek and A.J. Yorke, Defendants-Appel-
2. Commerce -82.72
S.Ct. at 3289-90 (Powell, J., dissenting),
§§ 1961-1968.
lees.
Allegations by minority shareholders
and cases that followed, the district court
No. 18, Docket 86-7283.
of partnership to effect that majority mem-
held that racketeering activity must be con-
bers committed mail fraud in selling assets
Seymour Shainswit, New York City (Coo-
tinuous and related in order to constitute a
United States Court of Appeals,
Second Circuit.
of partnership was frivolous, and thus
per Cohen Singer Ecker & Shainswit and
pattern and must be ongoing or occur in
could not support action brought pursuant
Steven E. Levitsky, New York City, of
more than one criminal episode. Although
Argued Oct. 20, 1986.
to RICO statute; partnership agreement
counsel), for plaintiffs-appellants.
the district court felt that appellees' al-
Decided Sept. 1, 1987.
gave absolute and sole discretion to majori-
Max Gitter, New York City (Paul, Weiss,
leged acts were related, it concluded that
ty members to sell partnership assets, and
Rifkind, Wharton & Garrison and Dorothy
the complaint failed to allege any continui-
further, allegation that principal of another
E. Roberts, New York City, of counsel), for
ty of activity, and dismissed the RICO
Minority general partners of partner-
ship brought civil claim against majority
brokerage firm was "prepared to negoti-
defendants-appellees.
cause of action. The district court held
Federal Register / Vol. 57. No. 59 / Thursdav. March 26. 1992 / Notices
1049
Tanif Act of 1930. On February 4. 1992.
FOR FURTHER INFORMATION CONTACT:
DEA's interpretation of the term
the Commission scheduled a public
Joseph H. Detimar. (202) 927-5660. (TDD
"currently accepted medical use in
hearing in connection therewith for
for hearing impaired: (202) 927-5712.
treatment in the United States."
March 26. 1992. On March 17. 1992. the
SUPPLEMENTARY INFORMATION:
Alliance for Cannabis Therapeutics V.
Commission received notice of
Additional information is contained in
DEA. 930 F.2d 936.
withdrawal from the only scheduled
the Commission's decision. To purchase
Following a review of the entire
witness for the hearing scheduled for
a copy of the fuil decision. write to. call.
record in this matter. and a
March 26. 1992. Therefore. the public
or pick up in person from: Dynamic
comprebensive re-examination of the
hearing in connection with this
Concepts. Inc.. room 2229. Interstate
relevant statutory standard. I conclude
investigation (scheduled to be held
Commerce Commission Building.
that marijuana has no currently
beginning at 9:30 a.m. on March 26. 1992.
Washington. DC 20423. Telephone: (202)
accepted medical use and must remain
at the U.S. International Trade
289-4357/4359. (Assistance for the
in Schedule I. Further hearings are
Commission Building. 500 E Street. SW..
hearing impaired is available through
unnecessary since the record is
Washington DC). is cancelled.
TDD services (202) 927-5721.)
extraordinarily complete. all parties h
EFFECTIVE DATE: March 20. 1992.
Decided March 11. 1992.
ample opportunity and wide latitude 1
FOR FURTHER INFORMATION CONTACT:
By the Commission. Chairman Philbin. Vice
present evidence and to brief all
Edward Carroll (202-205-1819). Office of
Chairman McDonaid. Commissioners
relevant issues. and the narrow questi
Public Affairs. U.S. International Trade
Simmons. Phillips. and Emmett.
on remand centers exclusively on this
Commission. Hearing impaired persons
Sidney L Strickland. r.,
Agency's legal interpretation of a
can obtain information on this study bv
Secretary.
statutorily-created standard.
contacting the Commission's TDD
!FR Doc. 92-7017 Filed 3-25-92: 045 ami
Summary of the Decision
terminal on (202-205-1810).
BILLING CODE 7035-01-
By order of the Commission
Does the marijuana plant have any
currently accepted medical use in
Dated: March 24. 1992.
treatment in the United States. within
Kenneth R. Mason.
DEPARTMENT OF JUSTICE
the meaning of the Federal Controlle
Secretary.
Drug Enforcement Administration
Substances Act. 21 U.S.C. 801. et seq.
FR Duc 92-7160 Filed 3-25-92. 8.45 and
Put simply. is marijuana good medici:
BILLING CODE 7020-02-M
[Docket No. 86-221
for illnesses we all fear. such as mult.
sclerosis (MS). glaucoma and cancer?
Marijuana Scheduling Petition: Denial
The answer might seem obvious
INTERSTATE COMMERCE
of Petition; Remand
based simply on common sense.
COMMISSION
AGENCY: Drug Enforcement
Smoking causes lung cancer and othe
(Finance Docket No. 32016|
Administration. Justice.
deadly diseases. Americans take the
ACTION: Final order.
medicines in pills. solutions. sprays.
Sioux & Western Railroad Co.-
shots. drops. creams and sometimes
Construction Exemption-Charles
SUMMARY: This is a final order of the
suppositories. but never by smoking.
County, Mo; Notice
Administrator of the Drug Enforcement
medicine prescribed for us today is
Administration (DEA) concluding the
smoked.
AGENCY: Interstate Commerce
plant material marijuana has no
With a little homework. one can le
Commission.
currently accepted medical use and
that marijuana has been rejected as
ACTION: Notice of exemption.
denying the petition of the National
medicine by the American Medical
SUMMARY: Pursuant to 49 U.S.C. 10505.
Organization for Reform of Marijuana
Association. the National Multiple
the Interstate Commerce Commission
Laws (NORML) to reschedule marijuana
Sclerosis Society. the American
conditionally exempts from the prior
from Schedule I to Schedule il of the
Claucoma Society. the American
Controlled Substances Act.
approval requirements of 49 U.S.C. 10901
Academy of Ophthalmology the
the construction by the Sioux & Western
EFFECTIVE DATE: March 26. 1992.
American Cancer Society. Not one
Railroad Company of approximately 2
FOR FURTHER INFORMATION CONTACT:
American health association accepts
miles of rail line between the Sioux
Office of Congressional and Public
marijuana as medicine.
Plant and a Union Pacific Railroad
Affairs. 202-307-7363.
For the last half century. drug
Company line in Charles County. MO.
evaluation experts at the United Sta:
SUPPLEMENTARY INFORMATION:
DATES: The exemption will not become
Food and Drug Administration (FDA
Background
have been responsible for protecting
effective until the environmental process
:s completed. At that time. the
On December 21. 1989. the former
Americans from unsafe and ineffect
Commission will issue a further decision
Administrator of DEA. following
new medicines. Relying on the same
addressing the environmental matters
rulemaking on the record. which
scientific standards used to judge al.
and establishing an effective date for
included a hearing before an
other drugs. FDA experts repeatedly
the exemption. if appropriate. Petitions
administrative law judge. issued a final
have rejected marijuana for-medical
in reopen must be filed by April 15. 1992.
order concluding the plant material
Yet claims persist that marijuana
ADDRESSES: Send pleadings referring to
marijuana has no currently accepted
medical value. Are these claims true
medical use. and denying the petition of
What are the facts?
Finance Docket No. 32016 to:
NORML to reschedule marijuana from
Between 1987 and 1988. DEA and
:1 Office of the Secretary. Case Control
Schedule 1 to Schedule II of the
NORML under the guidance of an
Branch. Interstate Commerce Cummission.
Controlled Substances Act. 54 FR 63767.
administrative law judge. collected
Washington. DC 20423.
'I Petitioner S representative: John R. Moim.
On April 26. 1991. the United States
relevant information on this subject
Esquire. Troutman. Sanders. Lockerman
Court of Appeals for the District of
Stacked together it stands nearly fiv
and Ashmore. 1400 Candler Building. 127
Columbia Circuit remanded the matter
feet high. is there reliable scientific
Peachtree Street. NE.. Atlanta. GA 30303.
to the Administrator for clarification of
evidence that marijuana is medicall
10500
Federal Register / Vol. 57. No. 59 / Thursday. March 26. 1992 / Notices
effective. If it has medical value. do its
blood pressure if they experiment with
"Randamized Double Blind Comparis
benefits outweight its risks? What do
marijuana. For MS and glancoma
of Delta-9-Tetrahydrocannabinol (TH)
America's top medical and scientific
patients who must take medications for
and Marijuana As Chemotherapy
experts say? Would they prescribe it for
the rest of their lives, experimenting
Antiemetics," (Meeting Abstract) 3
their patients. their families. their
with marijuana poses the additional
Proceedings of the Annual Meeting of
friends?
risks of lung cancer. emphysema.
the American Society of Clinical
As the current Administrator of Drug
bladder cancer and leukemia.
Oncology 91 (1984).
Enforcement. and as a former United
Many risks remain unknown.
During the 1970's and 1980's. a num
States District Judge. I have made a
Marijuana contains over 400 separately
of states set up research programs to
detailed review of the evidence in this
identified chemicals. No one knows all
record to find the answers.
give marijoana to cancer and glaucom
the effects of burning these chemicals
There are significant short-term side
patients. on the chance it might help.
together and inhaling the burnt mix. Are
effects and long-term risks linked to
Some people point to these programs
these risks outweighed by medical
proof of marijuana's usefulness.
smoking marijuana. Marijuana is likely
benefits?
to be more cancer-causing than tobacco:
Unfortunately. all research is not
There are scientific studies showing
damages brain cells: causes lung
necessarily good scientific research.
pure THIC (Delta-9-
problems. such as bronchitis and
These state programs failed to follow
Tetrahydrocannabinol). one of the many
responsible scientific methods. Patier
emphysema: may weaken the body's
chemicals found in marijuana. has some
antibacterial defenses in the lungs:
took marijuana together with their
effect in controlling nausea and
lowers overall blood pressure. which
regular medicines. so it is impossible
vomiting. Pure THC is pharmaceutically
could adversely affect the supply of
say whether marijuana helped them.
made in a clean capsule form. called
Observations or results were not
blood to the head: causes sudden drops
Marmol. and is evailable for use by the
in blood pressure (orthostatic
scientifically measured. Procedures
medical community. More information
hypotension). rapid heart beat
were so poor that much critical resea
on Marimol can be found in the
data were lost or never recorded.
(tachycardia). and heart palpitations:
"Physicians" Desk Reference. available
suppresses futeinizing bormone
in most libraries.
Although these programs were well-
secretion in women. which affects the
Since marijuana contains THC. you
intentioned. they are not scientific pr
production of progesterone. an
might think marijuana also would be
of anything.
important female hormone: causes
effective. However. the effect of taking a
Some people refer to a study by
anxiety and panic in some users
drug in combination with other
Doctor Thomas Ungerleider as proof
because of its mind-altering effects:
chemicals is seldom the same as taking
marijuana reduced nausea in bone
produces dizziness. trouble with
just the pure drug. As already noted.
marrow transplant patients.
thinking. trougle with concentrating.
marijuana contains over 400 other
Unfortunately. Doctor Ungerleider
fatigue. and sleepiness: and impairs
chemicals. not just THC. There are no
neglected to follow responsible
motor skills.
reliable scientific studies that show
scientific methods in his study. Like
As a plant. marijuana can contain
marijuana to be significantly effective in
state programs. it proves nothing. Dc
bacteria capable of causing serious
controlling nausea and vomiting. People
Ungerleider chose not to publish his
infections in humans. such as
refer to the Sallan study as proving
study evidently because of its seriou
salmonella enteritidis. Klebsiella
marijuana's effectiveness. They are
weaknesses. He admitted as much "
pneumoniae. group D Streptoccoccus
mistaken. The study involved
questioned under oath.
and pathogenic aspergillus.
pure THC not marijuana. People refer to
Those who say there are reliable
Several of these risk stand out. The
the Chang study to support marijuana's
scientific studies showing marijuana
immune systems of cancer patients are
effectiveness. They also are mistaken.
an effective drug for teating nausea
weakened by radiation and
Doctor Chang tested the combination of
vomiting are wrong. No such studies
chemotherapy. leaving them susceptible
pure THC and marijuana to treat nausea
exist.
in infection. If they experiment with
and vomiting. The preliminary results he
Our nation's top cancer experts re
marijuana to control nausea. they risk
got were probably due to the THC. not
marijuana for medical use. Doctor D
weakening their immune systems further
the marijuana. Because he tested the
S. Ertinger. a professor of oncology
and exposing themselves to the
combination. we cannot tell just what
the Johns Hopkins University Schoo
infection-causing bacteria in the plant. It
effects can be attributed to marijuana
Medicine. an author of over 100
IS estimated. for example. that at
alone. People cite a third study. done by
scholarly articles on cancer treatme:
Memorial Sloan-Kettering Cancer
Doctor Levitt. as proof marijuana is
and a nationally respected cancer
Center 60 patients die each year from
effective. They are mistaken. Doctor
expert. testified:
pathogenic aspergilhus infections.
Levitt compared marijuana to THC in
Glaucoma patients face possible
There is no indication that marijuana
controlling nausea and vomiting. and he
blindness caused by very high fluid
concluded that THC was the more
effective in treating nausea and vomiting
pressures within their eyes. If they
resulting from radiation treatment or oth
effective drug.
causes. No legitimate studies have been
experiment with marijuana to lower
A librarian can help locate copies of
conducted which make such conclusions
their eye fluid pressure. it can cause
thes studies should you want to see
dramatic drops in their blood pressure
them for yourself. Sallan. et al..
Doctor Richard J. Gralla. a profes'
and reduce the blood supply to their
"Antiemetic Effect of Delta-9-
of medicine at Cornell University
heads. Glaucoma experts testified this
Tetrahydrocannibinol in Patients
Medical College. an associate atten
reduced the blood supply to the optic
Receiving Cancer Chemotherapy." 293
physician at the Memorial Sloan-
nerves and could speed up. rather than
New England Journal of Medicine 795-
Kettering Cancer Center. and an ex.
slow down. their loss of eyesight.
797 (1975): Chang. et al_ "Delta-9-
in cancer research. testified:
MS. glaucoma and cancer patients
Tetrahydrocannabinol as an Antiemetic
Most experts would say. and our stud
who have undiagnosed heart problems
in Cancer Patients Receiving High-Dose
support. that the cannabinoide in genera
risk heart palpitations. very rapid heart
Methotrexate," 91 Annais of Internal
not very effective against the major caur
beats and sudden dramatic drops in
Medicine 819-824 (1979): Levill et ai.
nausea and vomiting.
Federal Register / Vol. 57, No. 59 / Thursdav. March 26. 1992 / Notices
10:
Doctor Gralla added:
Glaucoma." 87 Ophthalmology 222-228
Doctor George Spaeth is the Direct
I have found that because of the negative
(1980)
of the Glaucoma Service at Wills Eye
side effects and problems associated with
Unusally large doses or marijuana
Hospital in Philadelphia. the largest
marijuana
most medical oncoiogists
were needed in these three studies to
service in the United States devoted
and researchers have little interest in
achieve the desired effect. Heavy
researching and treating glaucoma a:
manyuana for the treatment of nausea and
marijuana use produces dizziness.
to teaching other doctors about this
vomiting in their patients.
trouble with thinking. impaired motor
disease. Doctor Spaeth is President C
Doctor John Laszlo. Vice President of
skills. fatigue and sleepiness. The 1976
the American Glaucoma Society. He
Research for the American Cancer
study by Doctors Hepler. Frank and
professor of ophthalmology. the edito
Society. an expert who has spent 37
Petrus emphasized "Our subjects were
a scholarly eye journal (Ophthalmic
years researching cancer treatments.
sometimes too sleepy to permit
Surgery). and the author of over 200
and who has written a leading textbook
measurement of intraocular pressures
research articles on glaucoma. He
on the subject. "Antiemetics and Cancer
3 hours after intoxication." If a
testified:
Chemotherapy." testified there is not
glaucoma patient were to smoke
I have not found any documentary
enough scientific evidence to justify
marijuana 8 to 10 times every day for
evidence which indicates that a single pa
using marijuana to treat nausea and
the rest of his life. would he be alert and
has had his or her natural history of the
vomiting. Not one nationally-recognized
energetic enough to live a relatively
disease altered by smoking marijuana.
cancer expert could be found to testify
normal life? Would he develop other
on marijuana's behalf.
diseases? No scientific studies exist to
Amputees and victims of MS can
To be an effective treatment for
answer these questions. Robert Randall
suffer from extreme muscle spasms.
glaucoma. a drug must: (i) Lower the
claims to have saved his sight by
claimed marijuana is useful in treati
pressure within the eye (intraocular
smoking 8 to 10 marijuana cigarettes
spasticity. Three unusually small.
pressure). (ii) for prolonged periods of
every day. Under oath he admits he
inconclusive studies have tried using
time. and (iii) actually preserve sight
stars at home most days. follows no
pure THC. not marijuana. to treat
Ivisual fields). Five scientific studies are
daily schedule or routine. and has not
spasticity. D.J. Petro and C. Ellenber
cited as evidence marijuana IS an
held a regular job in over 15 years. He
"Treatment of Human Spasticity wit
effective glaucoma treatment. Those
also has avoided having a
Delta-9-Tetrahydro-cannabinol. 21
who cite these studies are mistaken
comprehensive medical examination
Journal of Clinical Pharmacology 41:
These studies tested pure THC. not
since 1975.
416S (1981) (included only nine
marijuana. W.D. Purnell and J.M. Cregg.
patients). Two of the studies are me:
No scientific studies have shown
"Delta-9-Tetrahydorcannabinol.
abstracts. or short digests. without r
marijuana can reduce eye pressure over
Euphoria and Intraocular Pressure in
detail. Hanigan. Destee & Troung Al
long periods of time.
Man." 7 Annals of Ophthalmology 921-
B45. Clin. Pharmacol. Ther. 198 (198
No scientific studies have shown
923 (1975): M. Perez-Reyes. D. Wagner.
(included only five patients). and
M.E. Wall. and K.H. Davis. "Intravenous
marijuana can save eyesight.
Sandyk. Cannoe. Stern and Snider
Administration of Cannabinoids on
America's top glaucoma experts reject
Abstr. PP 331. 36 Neurology 342 (198
Intraocular Pressure." The
marijuana as medicine. Doctor Keith
(included only three patients).
Pharmacology of Marijuana 829-832
Green is a professor of Ophthalmology
No scientific studies exist which 1
(M.C. Braude and S. Szara eds. 1976):
who serves. or has served. on the
marijuana to relieve spasticity.
J.C. Merritt. S.M. McKinnon. J.R.
editorial boards of eight prestigious eye
National experts on MS reject
Armstrong. G. Hatem. and L.A. Reid.
journals (Ophthalmic Research. Oftalmo
marijuana as medicine. Doctor Ken:
"Oral Delta-9-Tetrahydrocannabinol in
Abstracto. Current Eye Research.
P. Johnson is Chariman of the
Hyperogeneous Glaucomas." 12 Annals
Experimental Eye Research.
Department of Neurology at the
of Ophthalmology 947 (1980): K. Green
Investigative Opthalmology. American
University of Maryland School of
and M. Roth. "Ocular Effects of Topical
Journal of Ophthalmology. Archives of
Medicine. He manages that Marylar
Administration of Delta-9-
Ophthalmology. and Survey of
Center for MS. one of the most activ
Tetrahydrocannabinol in Man." 100
Ophthalmology). Doctor Green has
MS research and treatment centers
conducted extensive basic and clinical
Archives of Ophthalmology 265-267
the United States. He sits on the
(1982): and WM. Jay and K. Green.
research using marijuana and THC to
editiorial boards of noted medical
Multiple-Drop Study of Topically
treat glaucoma patients. He has
journals related to MS (Neurology a
Applied 1% Delta-9-
authored over 200 books or research
Journal of Neuroimmunology). He is
Tetrahydrocannabinol in Human Eyes."
articles in ophthalmology and is a highly
author of over 100 scientific and me
101 Archives of Ophthalmology 591-593
respected expert on this subject. Doctor
articles on MS. Doctor Johnson has
Green testified:
(1983).
spent most of his long career
Threee studies show very heavy doses
There is no scientific evidence
that
researching MS and has diagnosed
of marijuana. taken for short periods of
indicates that marijuana is effective in
treated more than 6.000 patients wir
time. can reduce eye pressure. R.S.
regulating the progression of symptoms
MS. Doctor Johnson testified:
Hepler. I.M. Frank. and T.J. Ungerleider.
associated with glaucoma.
It is clear
At this time. I am not aware of
"Pupillary Constriction After Marijuana
that there is no evidence that marijuana use
legtimate medical research in which
Smoking. 74 American Journal of
prevents the progression of visual loss in
marijuana was used to treat the sympto
Ophthalmology 1185-1190 (1972): R.S.
glaucoma.
The quantities of the drug
multiple sclerosis.
To conclude th.
Hepier. I.M. Frank. and R. Petrus.
required to reduce intraocular pressure in
marijuana IS therapeutically effective W
"Ocular Effects of Marijuana Smoking."
glaucoma sufferers are large. and would
conducting rigorous testing would be
require the inhalation of at least six
The Pharmacology of Marijuana 815-824
professionally irresponsible.
marijuana cigarettes each day.
(1976): and J.C. Merritt. W.J. Crawford.
Smoking is not a desirable form of treatment
Doctor Stephen Reingold is Assis
P.C. Alexander. A.L. Anduze and S.S.
for many reasons
[M]arijuana
has
Vice President of Research for the
Gelbart. "Effect of Marijuana on
little potential future as a glaucoma
National Multiple Sclerosis Society
Intraocular and Blood Pressure in
medication.
which spends over $7 million each
10502
Federal Register / VoL 57. No. 59 / Thursday. March 26. 1992 / Notices
on MS research. Only the Federal
sight yet be has taken standard
testing. Weinberger V. Hynson. Etc.
Government spends more. Doctor
glaucoma drugs continuously since 1972
U.S. 609. 639:
Reingold testified:
There is DO objective way to tell from
[Mapressions or beliefs of physicians.
I could find no actual published research
these stories whether it is marijuana
matter how fervently held. are treachere
which has used marijuana
la the
that is helpful. or the proven. traditional
existing research using THC. the results were
medicines. Even these users can never
Nearly half the doctors who testif
inconclusive
In the absence of any
know for sure
for NORML are psychiatrists. They
well-designed. well-controlled research
Third. any mind-altering drug that
not specialize in treating or research
the National Multiple Sclerosis Society
produces euphoria can make a sick
cancer. glaucoma or MS. One is a
does not endorse or advocate its
use
person think he feels better. Stories from
general practitioner who works as a
patients who claim marijuana helps
wellness counselor at a health spa.
Doctor Donald H. Silberberg is
them may be the result of the mind-
Under oath he admits to using every
Chairman of the Department of
altering effects of the drug. not the
illegal. mind-altering drug he has ev
Neurology at the University of
results of improvements in their
studied. and he prides himself on
Pennsylvania School of Medicine and
conditions.
recommending drugs that would ne'
Chief of the Neurology Service at the
Fourth. long-time abusers of
be recommended by medical school
Hospital of Pennsylvania. Doctor
marijuana are not immune to illness.
reputable physicians. Another is a
Silberberg is on the editorial board of
Many eventually get cancer. glaucoma.
general practitioner who quit practi
Annals of Neurology and is President of
MS and other diseases. People who
in 1974. He admits he has not kept 1
the National Medical Advisory Board
become dependent on mind-altering
new medical and scientific informa.
for the National Multiple Sclerosis
drugs tend to rationalize their behavior.
about marijuana for 18 years.
Society. He has been actively
They invent excuses. which they can
Only one of the doctors called by
researching and treating MS for most of
come to believe. to justify their drug
NORML is a nationally-recognized
his career. has written over 130 medical
dependence. Stories of marijuana's
expert. Doctor John C. Merritt is a
articles on MS and is Co-Director of a
benefits from sick people with a prior
board-certified ophthalmologist an
large MS research center at the
history of marijuana abuse may be
researcher who has authored articl
University of Pennsylvania. Doctor
based on rationalizations caused by
the use of marijuana and cannabine
Silberberg testified:
drug dependence. not on any medical
to reduce eye pressure. He is in pri-
I have not found any legitimate medical or
benefits caused by the drug. Robert
practice and sees mostly children
scientific works which snow that marijuana
Randail. for example. admits under oath
suffer from glaucoma. Doctor Mem
is medically effective LD treating
to becoming a regular user in 1968. four
testified. "[M]arijuana is a highly
multiple sclerosis or spasticity.
The
years before he showed the first signs
effective IOP-lowering drug which
long-term treatment of the symptoms of
of. and was diagnosed as having.
multiple scierosis through the use of
be of critical value to some glaucar
glaucoma. Since then he has smoked
marijuana could be devastating.
[T]he
patients who. without marijuana. P
use of (marysana). especially for long-term
marijuana 8 to 10 times every day.
progressively go blind." The last
treatment
would be worse than the
A century ago many Americans relied
scientific study using marijuana in
original disease itself.
on stories to pick their medicines.
glaucoma patients. published by D
especially from snake oil salesmen.
The only favorable evidence that
Mernal in 1979. concluded:
Thanks to scientific advances and to the
could be found by NORML and DEA
passage of the Federal Food. Drug and
It IS because of the frequency end Be
consists of stories by marijuana users
with which the untoward events OCCURT
Cosmetic Act (FDCA) in 1906. 21 U.S.C.
who claim to have been helped by the
that marijuana inhalation is not an idea
301 et seq.. we now rely on rigorous
drug. Scientists call these stories
therapeutic modality for glaucoma pati
scientific proof to assure the safety and
anecdotes. They do not accept them as
effectiveness of new drugs. Mere stories
One year later. in 1980. Doctor N
reliable proofs. The FDA's regulations.
are not considered an acceptable way 10
gave the following testimony. unde
for exampie. provide that in deciding
judge whether dangerous drugs should
oath. before the United States Con
whether a new drug is a safe and
be used as medicines
House Select Committee on Name:
effective medicine. "isolated case
There are doctors willing 10 testify
Abuse and Control:
reports
will not be considered." 21
that marijuana has medical uses
For me to sit here and say that the to
CFR 314.126(e). Why do scientists
NORML found over a dozen to tesufy in
pressure effects occurred repeatedly. d
consider stories from patients and their
this case. We have a natural tendency to
and day out I have no data. and neithe
doctors to be unreliable?
believe doctors. We assume their
anyone else. and that IS the real crux σ
First. sick people are not objective
opinions are entitled to respect But
natter. When we are talking about tree
scientific observers. especially when If
what if a docto' is giving an opinion
disease like glaucoma. which LS a chron
comes to their own health We all have
beyond his professional competence?
disease. the real issue IS. does the man
heard of the placebo effect. Patients
Evaluating the safety and effectiveness
repearediv lower the intraocular prease
have a tendency to respond to drugs as
have shown you no
studies. and
of drugs is a specialized area Does the
they believe is expected of them.
knowledge there is no data to that effe
doctor have this specialized expertise?
Imagine how magnified this placebo
Is he familiar with all the published
Doctor Merritt was unable to ex
effect can be when a suffering person
scientific studies? Or is he improperly
under oath. the contradictory posi
experiments on himself. praying for
basing his opinion on mere stories or
he has taken on this subject.
some relief. Many stories no doubt are
anecdotal evidence? Does be really
Each of NORML's doctors testifi
due to the placebo effect. not to any real
know what he is talking about? Does he
opinion is based on the published
medical effects of manjuana.
have a personal motive to exaggerate as
scientific studies. With one except
Second. most of the stories come from
lie? Questions like these led the United
none of them could identify under
people who took marijuana at the same
States Supreme Court. in 1973. to warn
the scientific studies they swore th
time they took prescription drugs for
about the opinions of doctors concerning
relied on Only one had enough
their symptoms. For example, Robert
the value of drugs as medicine. when
knowledge to discuss the scientific
Randall claims marijuana has saved his
not supported by rigorous scientific
technicalities involved. Eventually
Federal Register / Vol. 57. No. 59 / Thursday. March 26. 1992 / Notices
1050
one admitted he was basing his opinion
began away from anecdotal evidence to
"grandfathered" drugs. They need not
on anecdotal evidence, on stories he
objectively conducted scientific
meet modern standards for safety and
heard from patients. and on his
research. away from uninformed
effectiveness.
impressions about the drug.
opinions of lay persons and local
A fifth group of drugs was accepted
Sadiy. Doctor Ivan Silverberg. an
doctors to expert opinions of specialists
for research use only. not for use in
oncologist from San Francisco,
trained to evaluate the safety and
treatment of patients. 21 U.S.C. 355(i)
exaggerated while on the witness stand.
effectiveness of drugs. and away from
(so-called "IND or approved
At first he swore "there is voluminous
totally democratic decision-making to
investigational new drugs")
medical research which shows
oversight by the Federal Government.
Drugs intended for medical use and
marijuana is effective in easing nausea
By 1969. Congress had developed
shipped interstate are subject to Feder
and vomiting." Pushed on cross-
detailed Federal statutory criteria under
seizure under the FDCA if they do not
examination to identify this voluminous
the FDCA to determine whether drugs
within one of the above accepted sets
research. Doctor Silverberg replied.
are acceptable for medical use. Those
groupings. It seems fair to say that
"Well
I'm going to have to back
deemed acceptable can be marketed
seizable drugs were rejected by
off a little bit from that." How far would
nationally. Those deemed unacceptable
Congress for medical uses.
Doctor Silverberg back off? Was he
are subject to Federal seizure if
in enacting the Controlled Substanc
aware. at least, of the approximate
marketed interstate. The FDCA is a very
Act in 1970. could Congress have
number of scientific studies that have
complex regulatory scheme not easily
intended to create a totally new Feder
been done using marijuana to treat
summarized. However, it is fair to say
standard for determining whether dru:
nausea? Under oath. he replied. "I would
that drugs falling into one of four FDCA
have accepted medical uses? Or did
doubt very few. But. no. I'm not."
categories were accepted by Congress
Beyond doubt. the claims that
Congress intend to rely on standards
for medical use.
had developed over the prior 64 years
marijuana is medicine are false,
First. Congress accepted new drugs
dangerous and cruei.
under the FDCA? There is nothing in
which have been approved by FDA's
Controlled Substances Act. its
Sick men. women and children can be
experts as safe and effective for use in
fooled by these claims and experiment
legislative history. or its purposes tha
treatment. based on substantial
with the drug. Instead of being helped.
would indicate Congress intended to
scientific evidence. 21 U.S.C. 321(p) and
they risk serious side effects. If they
depart radically from existing Federa
355 (so-called "NDA-approved drugs").
law.
neglect their regular medicines while
Second. Congress accepted those
trying marijuana, the damage could be
drugs "generally recognized, among
Indeed. it seems likely that the core
irreversible. It is a cruel hoax to offer
experts qualified by scientific training
standards developed under the FDCA
false hope to desperately ill people.
and experience to evaluate the safety
represent a long-term consensus of
Those who insist marijuana has
and effectiveness of drugs. as safe and
expert medical and scientific opinion
medical uses would serve society better
effective," based on substantial
conterning when a drug should be
by promoting or sponsoring more
scientific evidence. 21 U.S.C. 321(p) and
accepted by anyone as safe and
legitimate scientific research. rather
effective for medical use.
355: Weinberger V. Bentex
than throwing their time. money and
Pharmaceuticals, Inc.. 412 U.S. 645
Fortunately. there is a way to
rhetoric into lobbying. public relations
(1973). An acronym for this category is
corroborate what Congress intended.
campaigns and perennial litigation.
"human GRASE drugs" (Generally
Congress did more than just announc
Clarification of Currently Accepted
Recognized As Safe and Effective).
criteria for scheduling drugs of abuse
under the Controlled Substances Act.
Medical Use
These drugs achieve acceptance through
rigorous scientific proof. through a past
Congress applied those criteria to an
The Controlled Substances Act of
history of widespread use in treatment
initial listing of drugs that it placed in
1970 divides the universe of all durgs of
in the United States. and through
the original five schedules of the Act
abuse into five sets or schedules. Drugs
recognition by a consensus of drug
NDA-approved drugs were placed
in Schedule I are subject to the most
experts outside the FDA.
Congress into Schedules II. III. IV an
severe controis, because they have a
Third. Congress accepted for use in
of the Act. For example, pethidine (a
high potential for abuse and no currently
veterinary medicine those drugs
known as meperidine) received New
accepted medical use in treatment in the
"generally recognized. among experts
Drug Application (NDA) approval in
United States. 21 U.S.C. 812 (b)(1). Drugs
qualified by scientific training and
1942 Congress put it into Schedule
of abuse which have currently accepted
experience to evaluate the safety and
II(b)(14). Methamphetamine had an
medical use in treatment in the United
effectiveness of animal drugs. as safe
approved NDA. Congress put it into
States are placed in Schedules II. III. IV
and effective." based on substantial
Schedule III(a)(3). I am not aware of
and V. Regrettably. the Controlled
scientific evidence. 21 U.S.C. 321(w) and
drug with an approved NDA that
Substances Act does not speak directly
355. An acronym for these is "animal
Congress originally put into Schedule
to what is meant by "currently accepted
GRASE drugs." They achieve
Drugs with medical uses, but with
medical use."
acceptance through rigorous scientific
approved NDA's also were placed by
A century before the Controlled
evidence and through recognition by a
Congress into Schedules II. III. IV an
Substances Act was enacted. the
consensus of drug experts outside the
For example. cocaine was put into
determination of what drugs to accept
FDA. Unlike human GRASE drugs.
Schedule ll(a)(4). Codeine combinati
as medicine was totally democratic and
animal GRASE drugs need not have a
were put into Schedules III(d)(1) and
totally standardless. Each patient and
past history of widespread use.
Morphine combinations were put int
each physician was free to decide for
Finally. Congress accepted those
Schedule III(d)(8). Phenobarbital wa
himself. often based on no more than
drugs marketed prior to 1938 which had
put into Schedule IV(11). Barbiturate
anecdotal evidence. This state of affairs
been subject to the 1906 provisions of
were put into Schedule III(b)(1).
became unsatisfactory to a majority of
the FDCA. provided these very old drugs
Amphetamines were put into Sched
the American people. in 1906. Congress
retain their exact formulations and are
III(a)(1).
intervened with the passage of the Food.
never promoted for new uses. 21 U.S.C.
The Court of Appeals for the First
Drug and Cosmetic Act (FDCA). A shift
321(p) and (w). These are politically
Circuit was correct when it decided
10504
Federal Register / Vol. 57, No. 59 / Thursday. March 26. 1992 / Notices
Grinspoon V. DEA. 828 F.2d 881 (1987)
8. Recognition and use of the substance by
risks. there must be adequate stuc
that NDA approval is not the only
a substantial segment of the medical
all methods reasonably applicable
method by which drugs can achieve
practitioners in the United States.
show the pharmacological and
Federal recognition as having medical
Some uncertainty remains over the
toxicological effects of the drug. 2
uses. Congress put both GRASE drugs
precise meaning and application of parts
314.125(b)(2). This includes anima
and pre-1938-grandfathered drugs into
of this test. Therefore. the Court of
studies and clinical trials in large
Schedules II. III. IV and V of the CSA.
Appeals for the District of Columbia
numbers of humans. 21 CFR 312.21
Drugs recognized under the FDCA for
Circuit remanded these proceedings for
studies need not be well-controlle
research use only. not for use in
a further explanation. In addition to
they must be adequate. Edison
treatment. such as alphacetylmethadol
addressing those parts of the test that
Pharmaceuticals Co. V. FDA. 600
and marijuana. were placed by Congress
concerned the Court of Appeals. it
837 (D.C. Cir. 1979). Short term (ac
into Schedule 1.
would be useful to clarify the entire test.
studies of a drug intended to treat
Unfortunately, Federal records are not
pinpoint its origins. and identify which
term (chronic) illnesses. such as
complete enough to do a comprehensive
elements are both necessary and
glaucoma or MS. are clearly inade
mathematical mapping. tracing every
sufficient to establish a prima facie case
United States V. Naremco. Inc.. 55
drug in the initial Controlled Substances
of currently accepted medical use. This
1138. 1143 (8th Cir. 1977). The seco
Act schedules back to its legal status
is not an effort to change the substantive
element of our eight-point test. na
under the FDCA. Nevertheless.
law. The statutory meaning of currently
"the toxicology and pharmacolog
determining legislative intent does not
accepted medical use remains the same
substance in animals." should be
require mathematical certainty.
as enacted by Congress in 1970. My
clarified as follows:
Probability based on circumstantial
purpose simply is to clarify this
evidence, on samplings. and on
Agency's understanding of the law.
There must be adequate pharmacoi
and toxicological studies. done by all
inductive reasoning can suffice.
A The Drug's Chemistry Must Be
methods reasonably applicable. on th
especially when there is nowhere else to
Known and Reproducible
of which it could fairly and responsib
turn.
concluded. by experts qualified by SC
The pattern of initial scheduling of
The ability to recreate a drug in
training and experience to evaluate 1:
drugs in the Controlled Substance Act.
standardized dosages is fundamental to
and effectiveness of drugs. that the st
viewed in light of the prior legal status
testing that drug and to using it as a
is safe for treating a specific. recogni:
of these drugs under the FDCA.
medicine. Knowing the composition.
disorder.
properties. methods of production. and
convinces me that Congress equated the
It must be emphasized that wh
term "currently accepted medical use in
methods of analysis of a drug is
existence of adequate safety test
essential to reproducing it in
treatment in the United States" as used
separate analytical question. the
in the Controlled Substances Act with
standardized dosages. To be GRASE or
ultimate determination of wheth
the core FDCA standards for acceptance
to receive NDA approval. a drug's
drug is safe for a specific use is Γ.
of drugs for medical use.
chemistry must be known and
distinct issue. Safety and effectiv
reproducible. See e.q.. 21 CFR
This is not to say that every FDCA
are inextricably linked in a risks
314.50(d)(1) and 314.126(b)(7)(d): Dorovic
requirement for GRASE status. or for
benefits calculation. A determina
V. Richardson. 749 F.2d 242. 251 (7th Cir.
NDA approval. is pertinent to
that a drug is ineffective is tantar
1973). The listing of a drug in a current
scheduling determinations under the
to a determination that it is unsa
edition of one of the official compendia
Controlled Substances Act. There are
United States V. Rutherford. 442
normally satisfies this requirement. 21
differences. But the core FDCA criteria
(1970).
U.S.C. 321(j): 21 CFR 314.50(d)(1).
appear to have guided the Congress in
The first element of our eight-point
The scheduling criteria of the
the decisions it made concerning the
test. namely. "scientifically determined
Controlled Substances Act appe
initial scheduling of drugs in the Act.
treat the lack of medical use and
and acccepted knowledge of its
These same core FDCA criteria served
chemistry." should be clarified to read:
safety as separate consideration:
as the basis for an eight-point test used
rulings of this Agency purported
The substance's chemistry must be
by my predecessor as Administrator to
safety as a distinct factor. 53 FR
scientifically established to permit it to be
describe drugs with currently accepted
(February 22. 1988). In retrospect
reproduced into dosages which can be
medical uses. 54 FR 53783 (December 29.
inconsistent with scientific realit
standardized. The listing of the substance in
1989):
a current edition of one of the official
Safety cannot be treated as a sep
compendia. as defined by section 201(i) of the
analytical question.
1. Scientifically determined and accepted
Food. Drug and Cosmetic Act. 21 U.S.C.
knowledge of its chemistry:
321(j). is sufficient generally to meet this
C There Must Be Adequate and
2 The toxicology and pharmacology of the
requirement.
Controlled Studies Proving Effice
substance in animals:
3. Establishment of its effectiveness in
Acceptance of this knowledge will be
Since 1962. Congress has prohi
humans through scientifically designed
discussed elsewhere.
the FDA to approve an NDA unle
clinical trials:
applicant submits adequate. well
B. There Must Be Adequate Safety
4. General availability of the substance and
contolled. well-designed. well-
Studies
information regarding the substance and its
conducted. and well-documentec
use:
No drug can be considered safe in the
studies. performed by qualified
5. Recognition of its clinical use in
abstract. Safety has meaning only when
investigators. which prove the ef
generally accepted pharmacopeia. medical
judged against the intended use of the
of a drug for its intended use. 21
references. jounals or textbooks:
drug. its known effectiveness. its known
355(d): 21 CFR 314.126. Similarly.
6. Specific indications for the treatment of
and potential risks. the severity of the
cannot be considered GRASE un
recognized disorders:
illness to be treated. and the availability
is supported by this same quanti
7. Recognition of the use of the substance
of alternative therapies. Hess & Clark
quality of scienfitic proof. 21 CFI
by organizations or associations of
Division of Rhodia. Inc. V. FDA. 495 F.2d
314.200(e)(i): Weinberger V. Hyns
physicians: and
975. 993 (D.C. Cir. 1974). To know the
Etc.. 412 U.S. 609. 629 (1973).
Federal Register / Vol. 57, No. 59 1. Thursday, March 26. 1992 ! Notices
105
Studies involving related. but not
requirements in the FDCA since 1938.
the Controlled Substances Act does no
identical. drugs are irrelevant. United
the only body of opinion that counts is
authorize the Attorney General. nor b
States v. Articles of Food & Drug. 518
that of experts qualified by scientific
delegation the DEA Administrator. to
F.2d 743. 747 (5th Cir. 1975). Studies
training and experience to evaluate the
make the ultimate medical and policy
involving the same drug combined with
safety and effectiveness of drugs. 21
decision as to whether a drug should !
other drugs are irrelevant. United States
U.S.C. 321 (p) and (w).
used as medicine. Instead. he is limite
V. Articles of Drug Promise
From this. one would conclude that
to determing whether others accept a
Toothpaste. 626 F.2d 564. 570 (7th Cir.
expert acceptance of a drug as safe and
drug for medical use. Any other
1987). Incomplete studies are
effective for its intended use is essential
construction would have the efect of
insufficient. United States V. Articles of
to a drug having a currently accepted
reading the word "accepted" out of th
Food & Drug. supra. Uncontrolled
medical use under the CSA. How
statutory standard. Since Congress
studies are insufficient. 21 U.S.C. 355(d):
widespread must this expert acceptance
recognized NDA-approved drugs as
Cooper Labs V. FDA. 501 F.2d 772, 778
be?
having currently accepted medical use
(D.C. Cir. 1974). Statistically
To be GRASE. a drug must be
without any need for a national
insignificant studies are insufficient. 21
"generally recognized" among experts
consensus of experts. FDA acceptanc
CFR 312.21. 314.50(d)(6) and
as safe and effective for its intended
of a drug through the NDA process
314.126(b)(7). Poorly designed studies
use. The drug must be known or familiar
would seem to satisfy the Controlled
are insufficient. 21 CFR 314.126(b)(2).
to the national community of relevant
Substances Act. And. since Congress
Poorly conducted studies are
experts. United States V. Articies of
recognized GRASE drugs as having
insufficient. 21 CFR part 58-Good
Drug* "Furestrol Vaginal
currently accepted medical uses.
Laboratory Practices. Poorly
Suppositories. 294 F. Supp. 1307, 1309
without the need for NDA approval.
documented studies are insufficient. 21
(N.D. Ca. 1968) off'd. 415 F.2d 390 (5th
acceptance of a drug by a national
CFR 312.58 and 314.200(e)(4). Studies by
Cir. 1969). To determine if a drug is
consensus of experts also would seer
investigators who are not qualified. both
known to the community of experts.
satisfy the Act.
to conduct and to evaluate them are
courts have looked to whether there is
widely available scientific literature
When a drug lacks NDA approval
insufficient. 21 U.S.C. 355(d). Moreover.
about the drug. Premo Pharmaceutical
is not accepted by a consensus of
since scientific reliability requires a
double examination with similar results.
Laboratories. Inc. V. United States. 629
experts outside FDA. it cannot be fou
one valid study is insufficient. There
F.2d 795. 803 (2d Cir. 1980), whether it is
by the Attorney General or his delega
must be two or more valid studies which
widely taught in medical schools.
to have a currently accepted medical
corroborate each other. See 1].
Lemmon Pharmaceuticals Co. V.
use. To do so would require the
O'Reilley "Food and Drug
Richardson. 319 F. Sup. 375, 378 (E.D. Pa.
Attorney Genral to resolve complex
1970). and whether it is widely
scientific and medical disputes amon
Administration" 13-55 n.12 (1985).
discussed by experts. United States V.
experts. to decide the ultimate medic
Lay testimonials. impressions of
policy question. rather than merely
physicians. isolated case studies.
Bentex Ulcerine. 469 F. 2d 875. 880 (5th
random clinical experience. reports 80
Cir. 1972).
determine whether the drug is accept
lacking in details they cannot be
The recognition of a drug as GRASE
by others.
scientifically evaluated. and all other
need not be universal. General
Because the recognition of a drug 1
forms of anecdotal proof are entirely
recognition is sufficient. United States V.
non-experts is irrelevant to GRASE
irrelevant. 21 CFR 314.126(e):
41 Cartons* *Ferro-Lac. 420 F.2d 1126.
status. to NDA approval. and to
Weingerger V. Hynson. Etc.. 412 U.S.
1132 (5th Cir. 1970). The Supreme Court
currently accepted medical use unde
609. 630 (1973).
has interpreted this to mean a consensus
the Controlled Substances Act. point
Element three of our eight-point test.
of experts is familiar with and accepts a
seven and eight of our eight-point tes
drug as safe and effective. Weinberger
should be combined and restated as
namely. "establishment of its
effectiveness in humans through
V. Hynson. Etc.. 412 U.S. 609. 629 (1973).
follows:
scientifically designed clinical trials."
However. if there is a serious dispute
The drug has a New Drug Application
should be restated as:
among the experts. a drug cannot be
(NDA) approved by the Food and Drug
considered GRASE. United States V. An
Administration pursuant to the Food. Dru
There must be adequate. well-controlled.
Article of Food Coco Rico. 752 F.2d
and Cosmetic Act. 21 U.S.C. 355. Or. a
well-designed. well-conducted and well-
11. 15 (1st Cir. 1985): Merrit Corp. V.
consensus of the national community of
documented studies. including clinical
Folsom. 165 F. Supp. 418. 421 (D.D.C.
experts. qualified by scientific training ar
investigations. by experts qualified by
1958).
experience to evaluate the safety and
scientific training and experience to evaluate
the safety and effectiveness of drugs. on the
During the NDA process. the FDA
effectiveness of drugs. accepts the safety
effectiveness of the substance for use in
basis of which it could fairly and responsibly
may reach out to the expert community
treating a specific. recognized disorder. i.
be concluded by such experts that the
for its views. 21 CFR 314.103(c)(3). The
material conflict of opinion among exper:
substance will have the intended effect in
FDA need not determine that a drug is
preciudes a finding of consensus.
treating a specific. recognized disorder.
generally known and accepted by the
D. Acceptance by Qualified Experts Is
expert community. Nor must the FDA
This restatement also incorporates
Required
develop a consensus of opinion among
component of part one of our eight-p
outside experts. The FDA has both the
test concerning "accepted knowledg
The opinions of lay persons are totally
experts and the statutory mandate to
its chemistry."
irreievant to whether a drug is GRASE
resolve conflicts over the safety and
or meets NDA requirements. The
E. The Scientific Evidence Must Be
efficacy of new drugs. Weinberger V.
observations and opinions of medical
Widely Available
Bentex Pharmaceuticals. Inc.. 412 U.S.C
practioners who are not experts in
638. 653 (1973).
Nothing in the FDCA. nor in FDA
evaluating drugs also are irrelevant to
In drafting the Controlled Substances
regulations. requires that scientific
whether a drug IS GRASE or meets NDA
Act. Congress appears to have
evidence supporting an NDA be
requirements. Weinberger V. Hynson.
accommodated. rather than chosen from
published. This stems from the fact I
Etc.. 412 U.S. 609. 619 (1973). By explicit
these different FDCA standards. Clearly,
a consensus of experts outside FDA
10506
Federal Register / Vol. 57. No. 59 / Thursday. March 26. 1992 / Notices
not required for NDA approval. In
As the Court of Appeals points out.
compendia. as defined by section 201
contrast. most courts have held that a
requiring a material history of past use
Food. Drug and Cosmetic Act. 21 U.S
drug cannot be considered GRASE
in treatment before recognizing a drug
321(i). is sufficient generally to meet
unless the supporting scientific evidence
as having a currently accepted medical
requirement.
appears in the published scientific and
use. would permanently freeze all
(ii) There Must Be Adequate Safety
medical literature. Without published
Schedule I drugs LETER Schedule I. 930
studies. it would be difficult for the
There must be adequate pharmacc
F.2d at 940. Clearly. Congress did not
community of experts outside FDA to
and toxicological studies done by ali
intend this result Moreover. the use of
reasonably applicable on the basis 0
develop an informed acceptance of a
the word "currently" before the term
it couid fairly and responsibly be con
drug for medical use. Cooper Labs Inc. v.
"accepted medical use" would indicate
by experts qualified by scientific trai
FDA. 501 F.2d 772. 786 (D.C. Cir. 1974).
Congress rejected the human GRASE
experience to evaluate the safety an
Point four of the eight-point test
requirement of past material use in
effectiveness of drugs. that the subst
focuses. in part. on the "general
treatment. I conclude that the general
safe for treating a specific. recognize
disorder.
availability of information regarding the
availability of a drug is irrelevant to
substance and its use." This should be
whether it has a currently accepted
(iii) There Must Be Adequate and W.
clarified to read:
medical use in treatment within the
Controlled Studies Proving Efficacy
In the absence of NDA approval.
meaning of the Controlled Substances
There must be adequate. well-con:
information concerning the chemistry.
Act.
well-designed. well-conducted and V
pharmacology. toxicology and effectiveness
documented studies. including clinic
G. Recognition in Generally Accepted
of the substance must be reported. published.
investigations. by experts qualified t
Texts Is Irreievant
scientific training and experience to
or otherwise widely available. in sufficient
Point five of the eight-point test deals
the safety and effectiveness of drugs
detail to permit experts. qualified by
scientific training and experience to evaluate
with "recognition of its clinical use in
basis of which it could fairly and res
be concluded by such experts. that 1
the safety and effectiveness of drugs. to fairly
generally accepted pharmacopeia.
substance will have its intended eff
and responsibly conclude the substance IS
medical references, journals or
treating a specific. recognized disoro
sate and effective for use in treating a
textbooks.' The fisting of a drug in an
specific. recognized disorder.
official compendium is sufficient to
(iv) The Drug Must Be Accepted by
Experts
F. General Availability 0' a Drug Is
show Its chemistry is scientifically
Irrelevant
established. This appears in my
The drug must have a New Drug
clarification to point one. The
Application (NDA) approved by the
Drug Administration. pursuant to the
The second component of point four of
requirement that information concerning
Drug and Cosmetic Act. 21 U.S.C. 35
the eight-point test involves the
the chemistry. pharmacology. toxicology
consensus of the national communit
"general availability of the substance"
and effectiveness of the substance be
experts. qualified by scientific train
for use in treatment. The second
reported. published or otherwise widely
experience to evaluate the safety an
component of point eight focuses on
available. is explained adequately in
effectivenss of drugs. must accept it
"use of the substance by a substantial
revised point four. To the extent the
and effectiveness of the substance o
segment of the medical practitioners in
scheduling of a drug directly influences
treating a specific. recognized disoro
the United States." These elements
its recognition in publications. this
material conflict of opinion among e
justifiably concerned the Court of
precludes a finding of consensus.
element is subject to the same criticism
Appeals. leading to the remand in this
identified by the Court of Appeals
(v) The Scientific Evidence Must Be
Available
case.
concerning point four. Therefore. this
Under the FDCA. a human GRASE
should not be treated as a distinct
In the absence of NDA approval.
drug must have a material history of
requirement.
information concerning the chemistr
pharmacology. toxicology and effect
past use in treatment in the United
H. Specific Recounized Disorders Are
of the substance must be reported. F
States. 21 U.S.C. 321(p)(2) (which has
the Referent
or otherwise widely available in sul
otherwise than in such
detail to permit experts. qualified by
investigations. been used to a material
II is impossible to judge the safety and
scientific training and experience to
extent or a material time): Weinberger
effectiveness of a drug except in relation
the safety and effectiveness of drug:
1. Hynson. Etc.. 412 U.S. 609. 631 (1973).
to a specific intended use. A drug cannot
and responsibly conclude the substa
Rigorous scientific proofs and current
obtain NDA approval or GRASE status
safe and effective for use in treating
enanimous acceptance by the medical
except in relation to the treatment of a
specific. recognized disorder.
and scientific community are not enough
specific. recognized disorder. This is an
Together these five elements
for a human drug to be GRASE. Tri-Bio
essential aspect of whether a drug has
constitute prima facie evidence
Labs. Inc. V. United States. 836 F.2d 135.
currently accepted medical use. Rather
drug has currently accepted me
142 n.8 (3d Cir. 1987). The general
than standing alone. this requirement
in treatment in the United States
availability of a drug for use in
will be more clearly understood by
interest of total clarity. let me en
treatment is a factor courts have
incorporating it into the other critical
those proofs that are irrelevant
considered to determine if a human drug
elements.
determination of currently accep
is GRASE.
To summarize. the five necessary
medical use. and that will not be
In contrast. a drug can achieve current
elements of a drug with currently
considered by the Administrato.
acceptance for human medical use
accepted medical use in treatment in the
United States are:
(i) Isolated case reports:
through the NDA process without a past
(ii) Clinical impressions of practit.
history of use in treatment. Also. animal
(i) The Drug's Chemistry Must Be Known and
drugs can become accepted as CRASE
Reproducible
(iii) Opinions of persons not quali
scientific training and experience to
without any past historv of medical use.
The substance's chemistry must be
the safetv and effectiveness of the 5
Given this conflict in FDCA standards.
scientifically established to permit it to be
at issue:
which did Congress choose when
reproduced into dosages which can be
(iv) Studies or reports so lacking 1.
drafting the CSA?
standardized. The being of the substance in
as to preciude responsible scientific
a current edition of one of the official
evaluation:
Federal Register / Vol. 57. No. 59 1 Thursday. March 26. 1992 / Notices
1
(v) Studies or reports involving drug
effectiveness. and the limited data
how smoking or burning the plant
substances other than the precise substance
available on its risks. as reflected in the
at issue:
material affects the composition of
(vi) Studies or reports involving the
published scientific studies. He also
these chemicals. It is not possible 1
substance at issue combined with other drug
emphasized the importance of this data
reproduce the drug in dosages which
substances:
to the conclusions reached by experts
can be considered standardized by
(vii) Studies conducted by persons not
concerning the drze 54 FR 53783. I take
currently accepted scientific criter
qualified by scientific training and experience
this to mean that under initial factor
Marijuana is not recognized in any
to evaluate the safety and effectivness of the
(4)(b). he believed the information
substance at issue:
current edition of the official compt
available to experts is insufficient for
(viii) Opinions of experts based entirely on
21 U.S.C. 321(j).
unrevealed or unspecified information:
them responsibly and fairly to conclude
Second. adequate safety studies
(1x) Opinions of experts based entirely on
the marijuana is safe and effective for
not been done. All reasonably
theoretical evaluations of safety or
use as medicine.
applicable pharmacological and
effectiveness.
Marijuana is not recognized as
toxicological studies have not been
medicine in generally accepted
Bad Medicine By Any Standard
carried out. Most of the chronic an:
pharmacopeia. medical references and
studies have been conducted with
My predecessor as DEA Adminstrator
textbooks. as noted by my predecessor.
or intravenous THC. not with mari
developed and relied upon an eight-
54 FR 53784. I take this to mean. under
Pharmacological data on marijuan:
point test to determine whether
initial factor (5). that he determined that
bioavailability. metabolic pathway
marijuana has accepted medical uses. 54
marijuana's chemistry is neither known.
pharmacokinetics in inadequate. S
FR 53783 (December 29. 1989):
nor reproducible. as evidenced by its
in humans are too small and too fe
1. Scientifically determined and accepted
absence from the official pharmacopeia.
Sophisticated epidemiological stud
knowledge of its chemistry:
Finally. my predecessor concluded.
marijuana use in large populations
! the toxicology and pharmacology of the
under initial factor (8)(a). that the vast
required. similar to those done for
substance in animals:
majority of physicians does not accept
3 Establishment of its effectiveness in
tobacco use. Far too many questio
marijuana as having medical use. 54 FR
humans through scientifically designed
remain unknown for experts fairly
53784. Along the way. he found that
clinical trials:
responsibly to conclude marijuana
highly respected oncologists and
4. General availability of the substance and
safe for any use.
information regarding the substance and i!s
antiemetic researchers reject marijuana
for use in controlling nausea and
Third. there are no adequate. Wt
use:
5. Recognition of its clincial use in
vomiting. 54 FR 53777. that experts
controlled scientific studies provin
generally accepted pharmacopeia. medical
experienced in researching glaucoma
marijuana is effective for anything
references. journals or textbooks:
medications reject marijuana for use in
Fourth. marijuana is not accepte
6. Specific indications for the treatment of
treating glaucoma. 54 FR 53779. and that
medical use in treatment by even
recognized disorders:
noted neurologists who specialize in
respectable minority, much less a
7. Recognition of the use of the substance
treating and conducting research in
consenus. of experts trained to ev:
by organizations or associations of
spasticity reject marijuana for use by
drugs. The FDA's expert drug eval
physicians: and
8. Recognition and use of the substance by
MS patients, 54 FR 53780. I take this to
have rejected marijuana for medic
mean my predecessor found no national
No NDA has been approved by FT
d substantial segment of the medical
consensus of qualified experts accepts
marijuana. The testimony of natio:
practitioners in the United States.
The Court of Appeals remanded the
marijuana's value as medicine.
recognized experts overwhelmingi
decision of my predecessor for
Certainly I cannot know my
rejects marijuana as medicine.
predecessor's unstated reasoning.
compared to the scientifically emp
clarification of what role factors (4). (5)
However. I have reviewed the entire
testimony of the psychiatrists. a
end (8) of the initial eight-point test
record de novo. and I am convinced that
wellness counselor and general
played in his reasoning. For ease of
discussion. these factors can be divided
his application of the initial eight-point
practitioners presented by NORM
as follows:
test to this record correctly resulted in
Fifth. given my conclusions on F
the conclusion that marijuana has no
one. two and three. it follows that
(4)(a) General availability of the
currently accepted medical use in
published scientific evidence is nc
substance
treatment in the United States.
adequate to permit experts to fairi
(4)(b) General availability of
Therefore. I adopt in their entirety the
responsibly conclude that marijua
information regarding the substance and its
findings of facts and conclusions of law
safe and effective for use in huma:
use:
reached by the former Administrator in
A failure to meet just one of the
(5) Recegnition of its clinical use in
generally accepted pharmacopeia. medical
his final order of December 21. 1989. 54
points precludes a drug from havir
references. journals or textbooks:
FR 53767.
currently accepted medical use.
(8)(a) Recognition
of the substance
Pursuant to the remand of the Court of
Marijuana fails all five points of th
by a substantial segment of the medical
Appeais. I have condensed and clarified
NORML has argued. unsuccessi
practitioners in the United States: and
the initial standard into a five-point test.
that the legal standard for current
(8)(b) [U]use of the substance by a
substantial segment of the medical
My application of the refined. five-point
accepted medical use should be W
test to this record is set out briefly
a respectable minority of physicia
practitioners in the United States.
below.
accepts the drug. The key to this
I have found no evidence indicating
First. marijuana's chemistry is neither
medical malpractice defense is th:
nitial factors (4)(a) or (8)(b) played any
fully known. nor reproducible. Thus far.
minority opinion must be recogniz
role in my predecessor's decision. In
over 400 different chemicals have been
respectable. as competent. by mer
light of my understanding of the legal
identified in the plant. The proportions
of the profession.
standard involved. these factors are
and concentrations differ from plant to
In the absence of reliable evide:
irrelevant to whether marijuana has a
plant. depending on growing conditions.
adequately establishing marijuana
currently accepted medical use.
age of the plant. harvesting and storage
chemistry. pharmacology. toxicolo
My predecessor emphasized the lack
factors. THC levels can vary from less
and effectiveness. no responsible
of scientific evidence of marijuana's
than 0.2% to over 10%. It is not known
physician could conclude that ma:
10508
Federal Register / Vol. 57. No. 59 / Thursday. March 26. 1992 ! Notices
is safe and effective for medical use. To
may also participate in a public meeting
Waste Management and
quote Doctor Kenneth P. Johnson.
being derb to solicit oral comments on
Decommissioning. Office of Nuclear
Chairman of the Department of
the proposed guidance document.
Material Safety and Safeguards. U.S.
Neurology at the University of
Interested individuals will be given an
Nuclear Regulatory Commission.
Maryland. and the author of over 100
oppentunity to speak for fifteen minutes
Washington. DC 20555. telephone (36
scientific and medical articles on MS:
at this meeting. This time allowance
504-2568 or. Reid Rosnick. Mixed W.
"To conclude that marijuana is
may be extended. on request for good
Coordinator. Permits and State
therapeutically effective without
cause. if the schedule of speakers
Programs Division. Office of Solid
conducting rigorous testing would be
permits this extension.
Waste. U.S. Environmental Protectio
professionally irresponsible."
DATES: The agencies will accept written
Agency. 401 M Street SW.. Washingt
By any modern scientific standard.
comments until May 26. 1992.
DC 20460. telephone (202) 260-4755.
marijuana is no medicine.
Individuals submitting comments after
Under the authority vested in the
Dated at Rockville. MD this 19th day 0:
this date cannot be assured that the
March. 1992.
Attorney General by section 201(a) of
agencies will be able to afford their
the Controlled Substances Act. 21 U.S.C.
For the U.S. Nuclear Regnlatory
comments full consideration in any
Commission
811(a). and delegated to the
revisions that may be made to the
Administrator of the Drug Enforcement
Robert M. Bernero.
proposed guidance document.
Administration by regulations of the
The public meeting to solicit oral
Director. Office of Nuciear Material Safe
Department of justice. 28 CFR 0.100tb).
and Sojeguards.
comments on the proposed guidance
the Administrator hereby orders that
document will be held on April 14. 1992.
For the U.S. Environmental Protection
marijuana remain in Schedule 1 as listed
from 8:30 a.m. until 4:30 p.m. at the
Agency.
in 21 CFR 1308.11(d)(14).
MayBower/Stouffer Hotel. New York
Sylvia K. Lowrance.
Dated: March 18. 1992.
Room 1127 Connecticut Avenue NW_
Director. Office of Solid Waste.
Robert C. Bonner.
Washington. DC 20036. telephone (202)
(FR Doc. 92-7031 Filed 3-25-92 8:45 am(
Administrator.
347-3000.
BILLING CODE 7590-01-M
(FR Doc. 92-6714 Filed 3-25-92: e 45 ami
ADDRESSES: Copies of the proposed
BILLING CODE 4410-09-M
guidance document may be obtained by
contacting Dominick A. Orlando. NRC
OFFICE OF MANAGEMENT AND
Mixed Waste Project Manager. Division
BUDGET
NUCLEAR REGULATORY
of Low-Level Waste Management and
COMMISSION
Decommissioning. Office of Nuclear
Circular No. A-76: Performance of
ENVIRONMENTAL PROTECTION
Material Safety and Safeguards. U.S.
Commercial Activities; Amendmen
AGENCY
Nuclear Regulatory Commission.
Washington. DC 20555. telephone (301)
AGENCY: Office of Management and
Proposed Guidance Document on the
504-2566.
Budget.
Testing of Mixed Radioactive and
Written comments on the proposed
ACTION: Issuance of Transmittal
Hazardous Waste
guidance document should be directed
Memorandum No. 11. amending OM
AGENCIES: Nuclear Regulatory
to David L Meyer. Chief. Regulatory
Circular No. A-76. "Performance of
Commission. Environmental Protection
Publications Branch. Division of
Commercial Activities."
Agency.
Freedom of Information and
ACTION: Notice of availability and
Publications Service. Office of
SUMMARY: This notice contains
request for public comment
Administration. U.S. Nuclear Regulatory
Transmittal No. 11. dated February
Commission. Washington. DC 20555 or
1992. to OMB Circular No. i
SUMMARY: The Nuclear Regulatory
hand delivered to the Commission's
Performance of Commercial
Commission (NRC) and the
offices at 7920 Norfolk Avenue.
Activities."
Environmental Protection Agency (EPA)
Bethesda. MD between the hours of 7:45
This Transmittal Memorandum
are jointly issuing a proposed guidance
a.m. and 4:14 p.m. on Federal workdays.
updates the Federal pay raise
document on the testing of mixed
Requests to speak at the public
assumptions and inflation factors u
radioactive and hazardous waste (mixed
meeting should be submitted. in writing.
for computing the Government's in-
waste). This guidance document was
to EPA. The written request should be
house personnel and non-pay cost
developed to assist mixed waste
addressed to Reid Rosnick. Mixed
increases for Fiscal Years 1992 thro
generators in identifying and performing
Waste Coordinator. Permits and State
1997. The Federal pay raise assump
the testing required under the Federal
Programs Branch. Office of Solid Waste
and the non-pay category rates are
regulations that implement the Resource
(OS-342). U.S. Environmental Protection
contained in the President's Budget
Conservation and Recovery Act Subtitle
Agency. 401 M Street SW.. Washington.
Fiscal Year 1993. The factors contal
C hazardous waste program and to
DC 20460. Interested speakers should
in OMB Circular No. A-76. Transm
ensure that employee radiation
include in the written request a
Memorandum No. 10. dated Februa
exposures are maintained As Low As
statement identifying the topics to be
1991. are outdated.
Reasonably Achievable (ALARA). The
addressed in their presentations. the
The revision does not require an:
agencies are soliciting comments from
names and affiliations of the
agency to (1) create or maintain a
interested members of the regulated
individual(s) that will speak. and the
duplicate control/monitoring/repor
community. the States. and the public.
amount of time the speaker(s) will
system OF (2) adopt any additional
Interested individuals may provide
require. A transcript of the oral
controls. not presently in complian
the agencies with their comments on the
proceedings will be included in the
with Federal Acquisition Regulatio
proposed guidance document by
record for this action.
(FAR).
forwarding their written comments to
FOR FURTHER INFORMATION CONTACT:
FOR FURTHER INFORMATION CONTAC
the NRC at the address listed in the
Dominick A. Orlando. Mixed Waste
Mr. David Childs. Federal Services
"ADDRESSES" section. Interested parties
Project Manager. Division of Low-Level
Branch. General Management Divis
JAN. -23 96(TUE) 16:16
P. 002
rederal Register / Vol. 49, No. 195 / Friday. October 5. 1984 1 Rules and Regulations
38307
ACTION Finale rule.
(A) and (C) of the CSA. This allows for
DEPARTMENT OF JUSTICE
the Issuance of a temporary order
SUMMARY: This final rule is issued by
Drug Enforcement Administration
controlling a substance in Schedule IV
the Administrator of the Drug
or V. depending upon whichever is most
21 CFR Part 1308
Enforcement Administration to
appropriate to carry out the minimum
temporarily place twenty-one (21)
United States obligations. within the
Schedules of Controlled Substances;
benzodiazepine substances into
Temporary Placement of
Schedule IV of the Controlled
time period required by paragraph 7 of
article 2 of the Convention, that is.
Bromazepam, Camazepam, Clobazam,
Substances Act (CSA) (21 U.S.A. 801 et
within 180 days after the date of the
Clotiazepam, Cloxazolam,
seq.). The 21 benzodiazepine substances
CND communication. The findings
Delorazepam, Estazolam, Ethyl
are bromazepam. camazepam.
pursuant to sections 261 (a). (b) and
Lofiasepate, Fludiazepam,
clobazam. clotiezepam. cloxezolam.
Flunitrazepam, Haloxazolam,
delorasepam. estaxolam. ethyl
202(b) which concern an assessment of
Kelazolam, Loprazolam,
loflazepate. fludiazepam. Dunitrazepam,
the abuse potential for each of the 21
haloxezolem. ketezolam. loprazolam.
benzodiazepines are neither established
Lormetazepam, Medazapam,
Nimetazepam, Nitrazepara,
formetazepam. medazepam.
nor required for this temporary
nimetezepam. nitrazepam. nordiazepam.
scheduling order.
Nordiazepam, Oxazolam, Pinazepam,
and Tetrazepam Into Schedule IV
oxazolam, pinezepam. and tetraxepam.
On Wednesday. August 1. 1984, a
This temporary scheduling action is
notice was published in the Federal
AGENCY: Thrug Enforcement
required in order for the United States to
Register (40 FR 30748-9) proposing to
Administration Justice.
discharge its obligations under the
temporarily place the 21
Convention on Psychotropic Substances.
benzodiazepines into Schedule IV of the
1971. The effects of this rale will be to
CSA. By this action. the United States
require that the manufacture.
would be in compliance with the drug
distribution. dispensing security.
control treaty, the Convention on
registration, record keeping. reporting.
Psychotropic Substances, 1871. All
inventory. exportation and importation
Interested persons were given until
of each of the 21 benzodiazapines are
August 31. 1984 to submit any comments
subject to controls for Schedule IV
or objections regarding the proposal. No
substances. The temporary scheduling
comments or objections were received
order for each substance shall remain in
in response to the proposal nor were
effect unill the process of permanent
there any requests for a hearing.
scheduling. pursuant to sections 201 (a)
Therefore, under the authority vested
and [b] (21 U.S.C. 811 (a) and (b)) of the
in the Attorney General by section
CSA, is completed.
201(d)(4) (A) and (C) of the CSA (21
EFFECTIVE DATE: November 5. 1964.
U.S.C. 811(d)(4) (A) and (C)) and
delegated to the Administrator of the
FOR FURTHER INFORMATION CONTACT:
Drug Enforcement Administration by
Howard McClain. Jr.. Chief. Drug
regulations of the Department of Justice
Control Section, Drug Enforcement
(28 CFR Part 0.100). the Administrator
Administration, Washington. DC 20537.
hereby orders that paragraph (c) of
Telephone: (202) 633-1366.
I 1308.14 be amended by revising the list
SUPPLEMENTARY INFORMATION
of controlled substances to read as
List of Subjects in 21 CFR Part 1300
follows:
Administrative practice and
procedure. Drug traffic control
4 1308.14 Scheckde IV.
Narcotics, Prescription drugs.
By notice of March 29, 1984. the
(c)
Secretary-General of the United Nations
(1) Alprazolam
2882
advised the Secretary of State of the
(2) Barbital
2145
United States that the Commission on
(3) Promezepam
2748
Narcotic Drugs (CND) has decided that
(4) Camazepam
2749
the above 21 benzodiazepine substances
(5) Chloral betaine
2480
be added to Schedule IV of the
(8) Chloral hydrate
2465
(7) Chlordiaxepaxide
2744
Convention on Psychotropic Substances,
(8) Clobazam
2751
1971.
(9) Clonezepam
2737
In e letter dated May 1. 1984. the
(10) Clorazepate
2758
Assistant Secretary for Health. on
(11) Clotiazepam
2732
behalf of the Secretary of the
(12) Cloxaxwism
2753
Department of Health and Human
(13) Delorazapam
2754
Services (DHHS). advised the
(14) Diszepam
2785
Administrator of the Drug Enforcement
(15) Estazolam
US
Administration that the 21
(16) Ethchlorvynel
2540
(17) Ethinamete
2545
benzodiezepines be controlled in CSA
[18] Ethyl loflazepate
2758
Schedule IV, using authority provided
(19) Fludiazepam
2759
by sections 201(d)(3)(B) and 201(d)(4)
(20) Flunitrazepam
2783
JAN. -23' 96 (TUE) 16:17
P. 003
(21) Flurazepam
2767
since none have attained accepted
(22) Halaxepam
2782
medical use in treatment status in the
(23) Haloxasolam
2071
United States. as would be indicated by
(24) Ketazolam
3772
(25) Loprazolam
2773
approvel of a new drug application by
(26) Lorazepam
2885
the Foods and Drug Administration.
(27) Lormetezepem
2774
7. Importation and Exportations. All
(28) Mebutamate
2000
importation and exportation of each of
(28) Medazapam
2836
the 21 benzodiazepines shall be in
(30) Meprobamate
2820
compliance with Part 1312 of Title 21 of
(32) Methohexital
2284
the Code of Federal Regulations.
(32) Mathylphenobarbitsl
(mephobarbital)
8. Criminal Liability. The
2250
(33) Niruetazepam
2837
Administrator, Drug Enforcement
(34) Nitrazepam
2834
Administration. hereby orders that any
(35) Nordiazepen
2838
activity with respect to each of the 21
(36) Oxazepam
2835
benzodiezepines not authorized by. or in
(37) Oxazolam
2839
violation of. the Controlled Substances
(38) Paraidehyde
2585
Act or the Controlled Substances Import
(39) Petrichloral
2591
(40) Phenoberbital
2285
and Export Act. conducted after
(43) Pinazepam
2883
(November 5. 1984) shall be unlawful.
(42) Prazepam
2764
except that any person who is not now
(43) Temazepam
2925
registered to handles each
(44) Telrazepam
2688
benzodiazepine but who is entitled to
(45) Triazolam
2887
registration under such Acts may
continue to conduct normal business or
Effective Dates for applicable
professional practice with any of the 21
regulations:
benzodiazepines between the date on
All regulations applicable to each of
which this rule is published and the date
the 21 benzodiazepines as temporarily
which the person obtains or is denied
controlled substances in Schedule IV of
the CSA are effective on November 5.
registration provided that the
application for such registration is
1984, except " otherwise provided
submitted on or before November 5.
below:
1. Registration Any person who
1984.
manufactures. distributes. imports or
Pursuant to 5 U.S.C. 605(b). the
exports any of the 21 benzodiazepines
Administrator certifies that the
or who engages in research or conducts
placement of the 21 benzodiazepines
Instructional activities, must apply for
into Schedule IV of the CSA will have
registration by November 5. 1984. to
no impact upon small businesses or
conduct such activities in accordance
other entities whose interests must be
with Parts 1301 end 1311 of Title 21 of
considered under the Regulatory
the Code of Federal Regulations.
Flexibility Act (Pub. L 96-354). This
2. Security. Each of the 21
action involves the initial control of
benzodiazepines must be manufactured.
substances with no legitimate medical
distributed and stored in accordance
use in the United States and must be
with " 1301.71-1301.76 of Title 21 of the
carried out in order to fulfill United
Code of Federal Regulations.
States international treaty obligations.
3. Labeling and Packaging All labels
in any event.
and labeling for commercial containers
of each of the 21 benzodiazepines must
In accordance with the provisions of
comply with the requirements of
21 U.S.C. 811(d), this scheduling action is
" 1302.03-1302.05 and 1302.06 of Title
a formal rulemaking that is required by
21 of the Code of Federal Regulations by
United States obligations under
February 4, 1985.
international convention. that 16. the
4. Inventory. Every registrant required
Convention on Psychotropic Substances.
to keep records who possesses any
1971. Such formal proceedings are
quantity of any of the 21
conducted pursuant to the provisions of
benzediazepines must lake inventories
5 U.S.C. 556 and 557, and as such. have
pursuant to = 1304.11-1304.19 of Title
been exempted from the consultation
21 of the Code of Federal Regulations, of
requirements of Executive Order 12991
all stocks of these substances on hand.
(46 FR 13193).
5. Records and Reports. All
Dated: October 1. 1984.
registrants required to keep records and
submit reports pursuant to Part 1304 of
Francis M. Mullen. fre
Title 21 of the Code of Federal
Administrator. Drug Enforcement
Regulations shall do so regarding each
Administration
of the 21 benzodiazepines.
a. Prescriptions. None of the 21
IFR Dec 04-28360 Filed 19-4-04: as am)
benzodiatepines can be prescribed
BILLING CODE 4410-00-18
98TH CONGRESS
REPT. 98-835
2d Session
HOUSE OF REPRESENTATIVES
Part 1
DANGEROUS DRUG DIVERSION CONTROL ACT OF 1984
JUNE 12, 1984.-Ordered to be printed
-
Mr. HUGHES, from the Committee on the Judiciary,
submitted the following
REPORT
[To accompany H.R. 5656 which on May 15, 1984, was referred jointly to the
Committee on the Judiciary and the Committee on Energy and Commerce]
[Including cost estimate of the Congressional Budget Office]
The Committee on the Judiciary, to whom was referred the bill
(H.R. 5656) to amend the Controlled Substances Act to strengthen
the authority to prevent diversion of controlled substances, and for
other purposes, having considered the same, report favorably there-
on with an amendment and recommend that the bill as amended
do pass.
The amendment is as follows:
Strike out all after the enacting clause and insert in lieu thereof
the following:
That (a) this Act may be cited as the "Dangerous Drug Diversion Control Act of
1984".
(b) Whenever in sections 2 through 14 an amendment or repeal is expressed in
terms of an amendment to, or repeal of, a section or other provision, the reference
shall be considered to be made to a section or other provision of the Controlled Sub-
stances Act, and whenever in sections 15 through 21 an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a section or other provision, the
reference shall be considered to be made to a section or other provision of the Con-
trolled Substances Import and Export Act.
SEC. 2. (a) Section 102 (21 U.S.C. 802) is amended by redesignating paragraphs (14)
through (29) as paragraphs (15) through (30), respectively, and by adding after para-
graph (13) the following:
"(14) The term 'isomer' means the optical isomer, except as used in schedule I(c)
and schedule II(a)(4). As used in schedule I(c), the term 'isomer' means the optical,
positional, or geometric isomer. As used in schedule II(a)(4), the term 'isomer' means
the optical or geometric isomer."
(b) Paragraph (17) (as so redesignated) of section 102 is amended to read as fol-
lows:
"(17) The term 'narcotic drug' means any of the following whether produced di-
rectly or indirectly by extraction from substances of vegetable origin, or independ-
31-006 o
10
The Subcommittee felt that these concerns were meritorious and
narrowed the scope fo the factor to apply to "such other conduct
which may threaten the public health and safety." This change sat-
isfactorily responds to those concerns.
Seizing drugs of an out-of-business registrant
The American Pharmaceutical Association and the American
Veterinary Medical Association expressed concern that a minimum
90-day period before the Attorney General could destroy the con-
trolled substances sealed or seized from an out-of-business regis-
trant provided for in H.R. 4698 was too short. The Subcommittee
took these meritorious concerns into consideration in revising sec-
tion 8 by lengthening the period of time and adding certain protec-
tive procedures.
Emergency scheduling
The proposal for emergency scheduling was subject to extensive
comment and concern by the American Medical Association, the
American Pharmaceutical Association, the American Veterinary
Medical Association and the Pharmaceutical Manufacturers Asso-
ciation. All of these concerns were based on a perception that drugs
currently used in medical treatment might be subject to temporary
control by the Attorney General who would take into consideration
principally law enforcement issues. Consequently, several witnesses
urged that the bill permit emergency scheduling only if there were
affirmative concurrence of the Secretary of Health and Human
Services. Indeed, it appeared that the Administration had this un-
derstanding of its proposal in view of the testimony of the Depart-
ment of Health and Human Services.
The Subcommittee believed that these concerns raised significant
questions about the impact an emergency scheduling authority
would have on the manufacture and distribution of drugs that are
currently used in medical treatment. In examining the particular
substances for which the scheduling action was most necessary, the
Subcommittee concluded that limiting the authority only to sub-
stances that have no currently accepted medical use in treatment
addressed both the legitimate concerns of those in the health care
industry and the principal danger to the public health.
Registration of importers and exporters
The original version to these amendments (H.R. 4698) included
two sections (sections 19 and 21) that were designed to eliminate
the cross-references from the Controlled Substances Import and
Export Act (section 1008 (a) and (c)) (21 U.S.C. 958 (a) and (c)) to the
Controlled Substances Act (section 303(a) and (d) (21 U.S.C. 823 (a)
and (d)) with respect to the registration criteria for importers and
exporters.
At full Committee markup of the Subcommittee's reported bill,
those sections were deleted because by eliminating language that
related to the manufacture of drugs, they created the appearance
of a change in policy although no policy change was intended.
The current law is settled, and does not need to be revised to re-
solve any ambiguity. The Administration and the affected parties
11
urged that the current law be retained. The Committee agreed and
struck out those two sections.
Hearing on application for registration to import Schedule I and II
substances
The Administration had urged that section 1008(h) (21 U.S.C.
958(h)) be amended to eliminate a right for registered bulk manu-
facturers to intervene in the application of a party to become an
importer of Schedule I or II substances. A recent proceeding under
this section lasted for several years and involved a commitment of
several thousand hours of DEA staff time. The Administration sug-
gested that the hearing did not substantially contribute to the de-
termination of the legal and factual issues involved.
The Committee believes that the opportunity for public hearings
in these matters are important and should be retained. The ques-
tions of additional registration often involves economic questions
concerning the adequacy of competitive conditions for which expert
testimony can be valuable. Therefore, the Committee deleted that
portion of section 22 of the Subcommittee's reported bill which
would have eliminated the right to a public hearing. This action re-
tains current law.
The Committee, however, wants to express its concern that these
hearings not be permitted to be used for purposes of unreasonable
delay in the consideration of meritorious applications for registra-
tion. The Committee urges that these matters be resolved expedi-
tiously.
SECTION-BY-SECTION ANALYSIS
Section 1. Short Title: The Dangerous Drug Diversion Control
Act of 1984.
Section 2. (a) The term "isomer" is defined to eliminate the po-
tential ambiguity regarding different types of isomers used in the
definitions of various controlled substances.
(b) ine term "marrin tring" in for added clarity with
respect to the derivatives of opium and opiates and Newly the included derivatives in
of coca leaves, including cocaine and ecgomme.
the term are "poppy straw", and "concentrate of poppy straw",
major narcotic raw materials that are imported into the United
States.
(c) Schedule II(A)(4) is amended to explicitly include as a deriva-
tive of coca leaves cocaine and ecgonine and their salts, isomers,
derivatives and salts of isomers and derivatives. Coupled with the
definition of the term "isomer", as used in this paragraph of Sched-
ule II. defenses to prosecutions under the Act with respect to co-
caine will be precluded from raising what has been called the
"isomer defense."
Section 3. This section creates a new procedure for scheduling
substances on an expedited and temporary basis which have no
currently accepted medical use in treatment in the United States
when they are found by the Attorney General to pose an imminent
hazard to the public health.
This new procedure is intended by the Committee to apply to
what has been called "designer drugs", new chemical analogs or
12
variations of existing controlled substances, or other new sub-
stances, which have a psychedelic, stimulant or depressant effect,
and have a high potential for abuse.
Examples of such drugs include PCE and PHP which have been
clandestinely developed and manufactured to imitate the effects of
the controlled psychedelic drug, PCP. Other substances, fentanyl
analogs, have been developed and marketed illicitly as "synthetic
heroin". In other cases, substances which have been known to
chemists for some time, are "discovered" by illicit drug researchers
to have psychedelic effects. The substance, MPPP, is an example,
which is similar to the schedule II drug, meperidine (Demerol). In
1982, illicitly manufactured MPPP was sold in California. It was
contaminated in the course of its improper manufacture with a re-
lated toxic chemical, MPTP, which caused Parkinson's disease-like
symptoms in the users. Over 140 cases of MPTP induced Parkin-
son's Disease symptoms have been confirmed. The MPPP/MPTP
incident appears to have been single incident. However, the ability
to establish controls on MPPP, if its production for drug abuse
were to be encountered more often, would be important to protect
the public health and to prosecute those who wantonly risk the
public health.
Section 3 of the bill adds a new subsection (h) to the section re-
lating to scheduling.
Paragraph (1) provides that the Attorney General by order may
schedule a substance in Schedule I without regard to the require-
ment of 21 U.S.C 811(b) relating to the Secretary of Health and
Human Services if the scheduling is necessary to avoid an immi-
nent hazard to the public safety.
The order may only be issued after 30 days have elapsed from
the date of publication of a notice of intention to issue such a order
in the Federal Register along with the grounds upon which such an
order is to be issued. The order may only be issued after 30 days
have elapsed from the date the Attorney General transmits notice
of the proposed order to the Secretary of Health and Human Serv-
ices. The two 30-days periods may be concurrent.
Paragraph (2) provides that the scheduling shall expire at the
end of 1 year from the issuance of the order. However, if a rule-
making proceeding to schedule the substance has been initiated
pursuant to section 201(a)(1) (21 U.S.C. 811(a)(1)), the Attorney Gen-
eral may extend the temporary scheduling for up to 6 months.
Paragraph (3) provides that the Attorney General in finding that
a substance poses an imminent hazard to the public safety shall
consider three factors in paragraphs (4), (5) and (6) of section 201(c):
The substance's "history and current pattern of abuse"; "The
scope, duration and significance of abuse"; "What, if any, risk
there is to the public health"; and include in the consideration
actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution.
Paragraph (4) provides that the Attorney General transmit to the
Secretary of Health and Human Services notice of the order to
schedule a substance that he proposes to issue. The Attorney Gen-
eral is directed to take into consideration any comments submitted
by the Secretary in response to the transmitted notice. The Attor-
ney General's authority to issue a temporary scheduling order is
List of Substances placed in "Temporary Scheduling to Avoid
Imminent Hazards to Public Safety" Pursuant to 21 U.S.C. 811 (h)
Methcathinone
Sch :
Aminorex
Scn I
Alpha-Ethyltryptamine
Sch I
4-bromo-2,5-dimethoxyphenethylamine
Sch I
Thenylfentanyl
Sch I
Benzylfentanyl
Sch I
N,N-Dimethylamphetamine
Sch I
4-Methylaminorex
Sch I
Beta-Hydroxy-3-methylfentanyl
Sch I
Acetyl-alpha-methylfentanyl
Sch =
Alpha-methylthiofentanyl
Sch I
Beta-hydroxyfentanyl
Sch I
3-methylthiofentanyl
Sch I
Thiofentanyl
Sch I
3,4-methylenedioxy-N-ethylamphetamine
Sch I
N-hydroxy-3,4-methylenedioxyampetamine
Sch I
Para-fluorofentanyl
Sch I
N-ethyl MDA
Sch I
N-hydroxy MDA
Sch I
3,4-methylenedioxymethamphetamine
Sch I
3-methylfentanyl
Sch I
1-methyl-4-pheny1-4-propionoxypiperidine (MPPP)
Sch I
1-(2-phenethyl)-4-pheny1-4-acetoxypiperidi (PEPAP)
Sch - :
Rohypnol Talking Points
-
Chemical name
-
flunitrazepam
-
The drug is a benzodiazepine, the same class as
valium
-
The pill is 10 times strong than valium
-
The pill is round, flat, and the size of an
antacid. The word "roche" (pronunced "RO-
shay") with an encircled 2 are embosed on the
tablet.
-
given as sleep aid or for the sedation of psychotics;
in Latin American countries, it is used as a sediation
for patients undergoing surgery
-
Slang terms
-
"roofies, "poor man's Quaalude, "ruffies", "roach",
"forget pill", "Mexican valium", "Date rape drug"
-
Side effects
-
hallucinations
-
respiratory problems
-
sleep disturbances
-
anexity
-
amensia
-
reduces inhibitions
-
combined with alcohol, the pills have an added
depressant effect
-
Some men have been known to give this drug to
women in an alcoholic drink so he can sexually
dominate her after the pill takes effect and she
will not recall the incident
-
Dangerous pill since October, 1990
I
Always classified as illegal in US
-
Produced in US by Roche, an American-Swiss
pharmaceuticals company
-
Shipped to oversees markets
-
Usually re-enters US through traditional heorin
and cocaine routes
-
Who uses the pill
-
teenagers
-
very cheap
-
price ranges from $.50 to $3 per pill
-
does not cause nausea or easily detectable in
UAs
-
Kids get drunk quickly and it lasts longer
-
Easily available in all-night dance clubs,
schools
-
gangs
-
used as part of initiation rites
-
used in gang rapings, which can also be part of an
initiation rite
-
heroin addicts
-
enhances sedating effects of lower-purity heroin
-
cocaine addicts
-
use it ot parachute down from a binge
-
these two substances were found in grunge singer
body, Curt Corbain, blood samples after a suicide
attempt in Europe
-
Substance has caused two deaths in Texas
-
used primarily in the South
January 10, 1996
Presidential Memorandum on the drug, Rohypnol
Proposed Action
President signs a Memorandum to the Attorney General to schedule Rohypnol as a
Schedule I substance (subjecting it to the strongest possible restrictions under the law) under
the Drug Abuse and Prevention Control Act.
Purpose
This drug is widely used by adolescents, the one age segment in which drug use is
increasing. Senator Biden recently wrote a report on youth drug use, which addresses the
use of this drug and he is proposing legislation to increase the restrictions on this drug. This
Presidential Memorandum will show action and leadership -- that he is willing to address the
growing youth drug use problem head-on, do all within his power to curb its use, and not
wait for the legislative process to accomplish a goal that he can implement immediately.
Background
Rohypnol is a drug that has recently hit the youth scene and has quickly become
popular. It was first documented in the U.S. in June 1993 by the National Institute on Drug
Abuse. Its use incredibly pervasive in South Florida and its use by teenager has now been
reported in 30 States.
Rohypnol is classified as a depressant, and as such, it can be fatal if combined with
alcohol. Although it is marketed legally in many countries around the world, it has no legal
use in the United States. Where Rohypnol is available legally, it is primarily used as
sedative/hypnotic to treat insomnia and for some anastethetic procedures.
Rohypnol has been widely reported as used for date rape. In fact, in many areas and
in a number of newspaper accounts, Rohypnol has been referred to as a "date rapte drug."
The most famous example of Rohypnol overdose made the news when Kurt Cobain,
lead singer of the rock band Nirvana, attempted suicide with a near fatal mixture of
champagne and Rohypnol (Cobain was more successful the next time when he used a
shotgun).
Biden -- what does his bill actually say?
What does changing to Schedule I really mean?
Do we the authority to only do it temporarily?
What are the steps that need to occur to schedule it "temporarily"?
Who manufactures this drug and where?
How many DEA busts have occurred in Florida and other States w/ regards to this drug?
DRAFT
ROHYPNOL - STATEMENT OF THE PROBLEM
The abuse of Rohypnol (flunitrazepam), a Schedule IV controlled
substance, was first documented in June 1993. At that time,
Rohypnol was only seen in South Florida; since then, according to
DEA reports, use of the drug has spread throughout the South and
investigative cases have now been reported in 32 states and
Puerto Rico. It is a drug that is often abused by our nation's
youth and is often associated with date rape.
Rohypnol has been described as 10 times as potent as diazepam
(Valium) on a weight basis. Rohypnol slows psychomotor
performance and induces amnesia, muscle relaxation and sleep. Its
use may lead to the development of physical and psychic
dependence.
Rohypnol is marketed extensively worldwide but is not
manufactured or available for medical use in the United States.
DEA reports that Rohypnol is being publicized on the Internet
with advice being given how to import into the U.S.
The importation of Rohypnol as well as other prescription
medication, is generally allowed regardless of citizenship or
residency. The Code of Federal Regulations, 21 CFR 1311.27
allows an individual to import prescription drugs in his
possession which he has lawfully obtained for his personal
medical use or for administration to an animal accompanying him,
providing the following conditions are met:
(a) The controlled substance is in the original container in
which it was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate
official of the U.S. Customs Service stating:
(1) That the controlled substance is possessed for his
personal use, or for an animal accompanying him; and
(2) The trade or chemical name and the symbol designating
the schedule of the controlled substance if it appears on the
container label, or, if such name does not appear on the label,
the name and address of the pharmacy or practitioner who
dispensed the substance and the prescription number, if any.
U.S. Customs allows individuals to enter the drug at ports of
entry when crossing into the U.S. when proper documentation, per
1311.27, is presented. FDA regulations permit individuals a 3
month supply for "personal use". DEA reports that many
individuals are abusing this regulation by acquiring a three
month supply daily in Mexico and then stock pile the drug in the
United States.
P.02/12
82:61 9661-22-833
DRAFT
-2-
The Rohypnol problem is further enhanced in that a traveller may
properly declare at the port, but if later stopped in the U.S.,
the drugs may be seized by state authorities and the violator is
subject to arrest. This is occurring in the State of Texas.
For a prescription to be valid in the State of Texas it must have
been issued by a doctor licensed and registered in Texas, or in
another state if the doctor has a current Drug Enforcement
Administration registration number and can legally prescribe
controlled substances in that state. A prescription issued for a
controlled substance by a doctor in Mexico is NOT VALID in Texas
unless the doctor meets the above criteria. U.S. Customs does
not enforce this state law.
U.S. Customs has seized over the past
quantities of the drug Rohypnol at U.S. Customs mail facilities.
Regulations do not allow the mailing of the drug; it must
accompany the individual when entering the United States.
In South Florida, the drug is arriving primarily from Colombia
via international mail services or commercial airlines with
overnight mail appearing to be the preferred method of
importation.
Although the previous drug czar, Mr. Lee Brown, in December 1995,
stated that this is a not a national problem, Federal, State and
Local law enforcement agencies believe it is and that abuse of
Rohypnol is likely to increase.
CUSTOMS ACTION PLAN TO ADDRESS THE ROHYPNOL PROBLEM:
OBJECTIVE: Prohibit or restrict entry of prescription drugs into
the United States. In partnership with other law enforcement
agencies and with local communities, decrease the number of
crimes related to prescription drug abuse.
SHORT TERM:
A series of enforcement initiatives and enhancements designed to
increase Customs enforcement efforts, thereby increasing the
amounts of prescription drugs voluntarily surrendered to Customs
and/or seized by local law enforcement agencies. Obtain or force
compliance by the travelling public and thereby reduce the abuse
problem.
P.00/12
19:28 9661-22-833
DRAFT
-3-
1) A letter from the President to Justice and Treasury is
anticipated advising agencies of the level of abuse of the
prescription drug Rohypnol. This letter most likely will advise
that Treasury and Justice agencies should become proactive in
addressing this problem. Customs should be proactive and write a
letter (see attached) to DEA Administrator Constantine urging
both agencies to work together to change regulations regarding
the entry of prescription drugs into the United States.
Tasking: Commissioner's office
Start Date: February 22, 1996
2) Seek cooperation with FDA. Do FDA regulations override DEA
regulations? Can they be easily changed?
Tasking: Office of Field Operations, Office of Investigations
Start Date: February 22, 1996
3) A letter should be written from U.S. Customs to Texas
Department of Public Safety (DPS) advising DPS of Customs
requirements to allow prescription drugs into the U.S, based on
21 USC 1311.27. This puts U.S. Customs on record with Texas DPS
as recognizing the problem exists and what we can and will
attempt to do about it.
Tasking: Office of Investigations, Office of Field Operations
Start Date: February 1996
4) Commissioner Weise should seek ONDCP support to recognize
this as a national problem.
Comment: In December 1995 was quoted as stating that this was
not a national problem. Dr. Brown opposed - General McCaffrey
may support
Tasking: Commissioner's office
Start Date: February 1996
2.00/12
19:29 9661-22-833
DRAFT
-4-
6) Posting of flyers (see Del Rio example) Generic poster in
English and Spanish on reverse side. This flyer would be posted
at all POE's on the Southwest border and in Customs offices
nationwide.
Tasking: Office of Field Operations, Office of Investigations
Start Date: February 1996
7) Media blitz per Port Director, Laredo suggestion. Work with
local news stations, radio and newspapers along with other law
enforcement agencies (ONDCP/State (s) /DEA/USC/FDA) to publicize
increased efforts in enforcing the importation and unlawful
distribution of prescription drugs
Question: ONDCP Funding?
Tasking: CMC (Public Affairs), Port Directors, Office of
Investigations
Start Date: February 1996
8) Seek cooperation with local law enforcement agencies in those
states where it is against that State's law to bring prescription
drugs into that state. Post a state law enforcement officer in
Customs secondary.
Question: Legal? For all prescriptions?
Tasking: Office of Field Operations, Office of Investigations,
Chief Counsel
Start Date: February 1996
9) Initiate outreach efforts with local schools and the
community. This would be a state/federal partnership.
Tasking: Office of Investigations
Start Date: March 1, 1996
P.00/12
19:29 9661-22-833
DRAFT
-5-
10) Commissioner Weise to release a statement to the press
regarding increased Customs efforts in partnership with other law
enforcement agencies
Tasking: Commissioner's office
Start Date: March 1, 1996
11) Explore changes to Customs policy/authority to enforce state
law. Can we enforce State law? Do we want to enforce State law?
Can we use discretion? (Example: Allow for the Elderly/AIDS
patient/Cancer, etc).
Tasking: Office of Field Operations, Office of Investigations,
Chief Counsel
Start Date: March 1996
LONG TERM:
Seek legislative change to the Controlled Substance Schedules for
prescription drugs and/or in regulations regarding the
importation of personal use quantities by residents/non-
residents. Obtain compliance by the American public and thereby
reduce the drug abuse problem nationally. Assist in a community
policing effort to decrease crimes related to prescription drug
abuse.
1) Support DEA's efforts to reschedule prescription drugs as a
Schedule I drug.
Comment: A change from Schedule IV to Schedule I is not likely
to happen, however, DEA has stated they will begin this process.
Tasking: Office of Investigations, Office of Field Operations
DEA
Start Date: February 13, 1996 - Continuing
219090'd
62:61 9661-22-833
DRAFT
-6-
2) Seek Congressional support (Kiki De la Garza/Kasselbaum) for
changes in law or regulations.
Comment: Kasselbaum has asked for FDA reform.
Tasking: Office of Congressional Affairs, Office of Field
Operations, Office of Investigations, DEA and FDA
Start Date: March 1, 1996 - continuing
3) Seek Change in 21 CFR 1311.27 and Customs regulations as
follows:
-
Limit quantities to a 30 day supply per declaration, instead
of the current 90 day allowance for controlled substances in
general
-
Limit the exemption for entry of controlled substances for
personal use to the standard "once in a 30 day" period which is
currently 148.36). in effect for the $400 personal exemption (19 CFR
-
requirement for a 48 hour stay abroad to be eligible for the
$400 personal exemption should be required for the exemption for
entry of controlled substances for personal use, except in
specifically defined cases (19 CFR 148.35 9a) )
-
Require a written declaration for each entry of controlled
substances for personal use (19CFR 148.13).
-
If not successful in placing prescription drugs in Schedule
I, then seek a change in regulations allowing only non-residents
to import prescription drugs for personal use. U.S. citizens
would not be allowed to import for personal use unless a
prescription can be obtained from a U.S. medical doctor.
-
In partnership with FDA enforce FDA labelling requirements
in that if prescription drugs do not contain the following
required information, entry will be denied:
21/20'd
19.29 9661-22-833
DRAFT
-7-
-
description, indications of usage, contraindications,
warnings, adverse, reactions, drug abuse and dependence, (if a
controlled substance must so indicate), overdosage, dosage and
administration. The physician's name and prescription number
must appear on the container.
Comment: Downside: AIDS/ELDERLY/Cancer/Financial considerations
Enforceable? - Would involve seeking cooperation
from other countries
Tasking: Office of Field Operations, Office of Investigations
in partnership with other agencies
Start Date: February 22, 1996 - continuing
5) Through NAFTA negotiations, require Mexico to have their
physicians log prescription dispensed and require identification
to fill all prescriptions. Require that Mexican FDA police
physicians and pharmacies to ensure that they are not allowing an
individual to acquire more than a 3 month supply over a 3 month
period.
Comment: Realistic? NAFTA issues?
Tasking: Office of Field Operations (NAFTA Task Force)
Office of Investigations, Foreign Operations
Start Date: March 1996 - continuing
6) Customs Attache to work closely with Mexican authorities to
make known the prescription drug abuse problem in the United
States and how Mexican authorities can work with the United
States in stopping the problem
Tasking: Customs Attache, Mexico
Start Date: March 1996 - continuing
21/80'd
FEB-22-1996 19:30
DRAFT
-8-
TEST
Begin February 26, 1996 media blitz, posting of flyers, outreach
and stationing of local law enforcement officers at ports of
entry in the southwest border ports of Laredo, Del Rio, McAllen,
Brownsville, El Paso. Evaluate after 90 days.
Measure effectiveness
Our effectiveness will be measured by:
1. The extent of cooperation by Mexican authorities
2. The extent of cooperation by U.S. law enforcement agencies,
federal, state and local and Congressional members
3. The extent of cooperation with the local communities
4. Subsequent changes in monitoring dispensing of prescription
drugs by Mexican authorities.
5. A change in the Controlled Substance Schedules, placing
prescription drugs in Schedule I. REALISTIC? Not likely.
6. A change in regulations which would allow a 30 day supply of
prescription drugs for non residents, NONE for U.S. residents
unless a prescription can be obtained from a U.S. doctor.
7. A change in policy which would allow Customs to enforce state
laws regarding prescription drugs
8. Changes in Customs policy - requiring a written CF 6059-B
9. Monitor seizure statistics and crime statistics. Is there a
decrease in crime related to prescription drug abuse. Are
seizures going down as the community is educated regarding abuse
of the drug Rohypnol and other prescription drugs.
21/60'd
FEB-22-1996 19:30
DEPARTMENT OF THE TREASURY
THE
U.S. CUSTOMS SERVICE
DEL RIO. TEXAS
NOTICE
EVEN THOUGH A RETURNING UNITED STATES RESIDENT DECLARES
MEDICATIONS CONTAINING CONTROLLED SUBSTANCES TO U. S. CUSTOMS AND
CUSTOMS ALLOWS THE IMPORTATION. POSSESSION OF CERTAIN CONTROLLED
SUBSTANCES IN THE STATE OF TEXAS MAY BE ILLEGAL.
UNDER TEXAS LAW FOR A PRESCRIPTION CONTAINING CERTAIN
CONTROLLED SUBSTANCES TO BE VALID IT MUST HAVE BEEN ISSUED BY A
DOCTOR LICENSED AND REGISTERED IN TEXAS, OR IN ANOTHER STATE IF THE
DOCTOR HAS A CURRENT DRUG ENFORCEMENT ADMINISTRATION NUMBER AND CAN
LEGALLY PRESCRIBE CONTROLLED SUBSTANCES IN THAT STATE. A
PRESCRIPTION ISSUED FOR A CONTROLLED SUBSTANCE BY A DOCTOR IN
MEXICO IS NOT VALID IN TEXAS UNLESS THE DOCTOR MEETS THE ABOVE
CRITERIA.
QUESTIONS SHOULD BE DIRECTED TO A TEXAS DEPARTMENT OF PUBLIC
SAFETY OFFICER.
PORT DIRECTOR OF CUSTOMS
DEL RIO, TEXAS
210) 703-2012
SEPLT TO PORT DIRECTOR -CE, BOX AM
FEB-22-1996 19:30
21/01'd
DRAFT
The Honorable Thomas A. Constantine
Administrator
Drug Enforcement Administration
Washington, D.C. 20537
Dear Mr. Constantine:
The U.S. Customs Service and the Drug Enforcement
Administration have each independently identified an issue
which must be jointly addressed by our two agencies.
Specifically, I am referring to the practice of importing,
under the guise of for "personal use", small amounts of
prescription medicines. Our respective agencies have
identified the drug "Rohypnol" as one such drug, and
others, which are being imported into the United States
(U.S.) through our various ports of entry, most notably
along the Southwest border. Rohypnol is not sold in the
U.S., and has become a drug of abuse in Florida, Texas and
in numerous other U.S. localities.
I have been informed that a joint USC/DEA meeting was held
on February 13, 1996 at your headquarters to discuss this
problem. It appears the basis for allowing "personal use"
quantities of prescription drugs into the U.S. is derived
from Chapter 21 Code of Federal Regulations, Section
1311.27. This regulation, combined with Food and Drug
Administration guidelines which define personal use as a
90 day supply, is enabling those individuals who are so
inclined to abuse the system. To make matters worse,
certain States, such as Texas, prohibit possession of
prescribed drugs which do not conform to State
regulations, which are legally imported through Customs
under 21 CFR 1311.27.
My staff is exploring alternatives within the Customs
Regulations which would enable U.S. Customs to intercept
these types of prescription drugs. However, unlike
alcohol, there are no provisions to enforce state controls
on other controlled substances. At this time, there does
not appear to be any basis within the Customs Regulations
to prevent abuses and importations utilizing this
"loophole" in the Federal regulations. I am aware that it
is no small undertaking, but it appears the only permanent
solution to preventing abuses of prescription medicines is
to rewrite 21 CFR 1311.27.
P.11/12
02:00 9661-22-333
TOTAL P.12
It is refreshing to see that our two agencies continue to
undertake joint strategies and initiatives to address
common problems.
ot
Please call upon me if I or the Customs Service can be of
assistance in helping you garner support for effecting the
on
necessary changes to the Federal Regulations. We must
continue to closely coordinate this matter, as the Customs
ou.
Service must insure that any changes to 21 CFR 1311.27 are
enforceable at our ports of entry.
-us
j
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Sincerely,
S
in
dE
il
George J. Weise
Commissioner
Me
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21
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P.12/12
19:31 9661-22-833
EXECUTIVE OFFICE OF THE PRESIDENT
22-Feb-1996 06:17pm
TO:
BURKE_D
FROM:
Mark Kleiman Crim. Just. 495
SUBJECT: Re: Conference
Dennis:
Rescheduling Rohypnol is probably only a partial solution.
You might want to talk to Susan and get her thoughts.
In any case, there's lots of prevention stuff to do,
and methamphetamine is a much bigger problem, possibly
a very big one indeed. In my previous I forgot to mention
methcathinone, which is still a third problem. BOTEC could
put together a pretty good emerging-drugs issues-and-options
paper by conference time if we got going right away; one
option would be to have CASA pay for it and BOTEC do it
as a contractor for them.
Aside from coerced-abstinence stuff (establishing coerced abstinence
as a national policy, requiring states to make
measurements and do plans as a condition of getting their
crime and drugs money, creating legislation to make it a reality
in federal probation and pretrial) I'm a little thin on legislative
ideas.
1.
Resources (people and research money) for ONDCP. This should be
easy.
2
Restore some of the CSAT (treatment) demonstration-program money,
some of the HUD drug-elimination money, some of the DoEd drug-free
schools and communities money, with a requirement that ONDCP evaluate
these programs and report to Congress in eighteen months about what's
worth doing and what isn't.
Argument: it's silly not to do something about these problems;
if the money isn't currently being used right, let ONDCP
sort it out. Maybe the Education money should be converted back
from block grants, which have been abused, to categorical grants-
in-aid, so Riley can make people spend it for the right stuff.
But I think the HUD money has been well spent.
3
Authorize/require NIDA to conduct studies on drug trafficking,
drug markets, and all aspects of drug abuse control including enforcement.
Authorize/require CSAP to mount programs on preventing dealing as well as
drug abuse.
I know all of this is boring. I'll try to come up with something
interesting.
Mark