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The White House
TIME MEET
M.D.
SEE
BER EM
DOMESTIC POLICY
FACSIMILE TRANSMISSION COVER SHEET
TO: Jenniler Boulanger
FAX NUMBER: 690-6262
TELEPHONE NUMBER:
FROM: Jun Klein
TELEPHONE NUMBER:
PAGES (INCLUDING COVER):
COMMENTS: As we discussed in meeting this week
MEMORANDUM
TO:
Carol Rasco
April 6, 1995
FR:
Chris Jennings
RE:
Today's release of FDA reg reform report
cc:
Bill, Jeremy, Jen, Paul
This morning, the Administration is releasing the attached FDA regulatory reform report. It
follows on the print shop event a few weeks ago in which the President released the EPA
report and made references to a number of the FDA reform initiatives that are included in
today's report.
The FDA report proposes numerous regulatory reforms that are estimated to save the drug
and device industries at least $500 million per year in unnecessary regulatory costs and will
also free up FDA to better target its resources toward improving and expediting market access
of new products. The recommendations are significant, not only for their substance but
because the Agency has committed to specific timetables for implementation. There will be
additional recommendations to come. The FDA has committed to the Vice President to build
on these recommendations through a bottom-up review, which will more fully include font
line FDA personnel. I anticipate additional regulatory reforms being produced from this
process by no later than June.
The report is being released in conjunction with Commissioner David Kessler's testimony
today before the Senate Labor and Human Resources Committee. The regulatory reform
review process and the product it has produced has been and will be referenced as a joint
White House/FDA effort.
Yesterday wc briefed Congressional staffs of relevant Committees, representatives of drug and
biotcch manufacturers, device manufacturers, and consumer groups. Almost universally, the
Administration is being praised for this initiative. While the industry will still push for
more, the relationships with the Administration and the FDA have improved markedly. The
report also seems to position the Administration and the FDA well for the upcoming and
inevitable debate on the need to reform but not to undermine -- the agency and its charge
to assure that the drugs and devices on the market arc safe and effective.
FYI, apparently the first AP story on this report is quite good for us. Attached for your
information is a three page summary of the report. I hope these materials are useful.
FDA
BACKGROUNDER
U.S. FOOD & DRUG ADMINISTRATION
Contact: Jim O'Hara 301-443-1130
Reinventing Drug and Medical Device Regulation
The Clinton Administration is committed to making government work better by reducing unnec-
essary regulatory burdens while maintaining the critical public health protections the American
people expect and deserve. In the case of the Food and Drug Administration, reinvention of drug
and medical device regulation will mean speeding up the review of these products.
The high standards of the FDA have given Americans access to drugs and medical devices that
are safe and that work. In addition, FDA has worked in recent years: to make new therapies
available as soon as possible, even before final approval; to accelerate the approval of life-saving
drugs; and to speed up the review and approval of all drugs with additional resources from
industry user fees.
The Clinton Administration is building on these high standards and efforts to speed up drug and
device approval with new FDA regulatory reforms. Some of these reforms will directly speed up
the review process for these products. Others will reduce unnecessary regulatory burdens on
industry. All are aimed at maintaining and protecting Americans' confidence in the safety and
effectiveness of the drugs they take and the medical devices they use.
FDA will reform drug and medical device regulation by:
Allowing manufacturers of drugs and biologics (products made from biological materi-
als) to change the way they manufacture an approved drug without FDA pre-approval if
the risk is negligible.
Impact: Industry can modernize facilities and processes more easily; FDA can shift
resources to more critical review needs.
Allowing manufacturers of biological drugs to get licenses for pilot facilities instead of
building full-scale manufacturing plants.
Impact: Manufacturers will have lower start-up costs and can more quickly begin pro-
duction of new drugs.
Permitting greater flexibility in how distributors' names appear on biological product
containers, package labels, and labeling.
(more)
HFI-40
BG 95-11 (April 5 1995)
Reinventing Drug and Medical Device Regulation
page 2
Impact: Small start-up companies, many of them biotechnology firms, may more readily
enter into manufacturing arrangements with larger companies and bring prod-
ucts to market quicker.
Eliminating special requirements for manufacturing insulin and antibiotic drugs.
Impact: Industry will no longer be burdened with outdated requirements and FDA can
regulate these products the same way it does other drugs.
Excluding drug and biologics manufacturers from requirements for most environmental
assessments.
Impact: Industry will be spared the expense of preparing assessments that FDA has
found unnecessary.
Exempting up to 125 categories of low-risk medical devices from premarket review,
adding to the 441 categories already exempted from review.
Impact: Industry will no longer have to wait for premarket review, meaning that these
devices can reach patients sooner; FDA can shift resources to more critical
review needs.
Eliminating the "reference list" and clarifying that premarket review of medical devices
can be affected only if good manufacturing practice violations are related to a specific
device.
Impact: Industry concerns that good manufacturing practice violations for one product
can slow down approval for other devices unrelated to those problems will be
alleviated, and there will be more certainty about when products can be mar-
keted.
Developing a pilot program for the review of low to moderate risk medical devices by
outside organizations.
Impact: This program will help determine if such a system can speed the review of these
devices, whether the independence of the review process can be maintained, and
if such a system will be less costly.
Speeding the marketing of medical devices by charging industry user fees to give FDA
more resources for product reviews and committing FDA to strict performance goals.
Impact: A similar program for prescription drugs has substantially reduced review times
and FDA has met all performance goals to date.
Expanding the opportunities for the export of unapproved drugs and medical devices to
industrialized countries.
Impact: Industry will have wider markets for its products and will be encouraged to
maintain operations in this country.
(more)
Reinventing Drug and Medical Device Regulation
page 3
Clarifying the effectiveness standard for new drugs.
Impact: Industry will have a better understanding of how to develop new products,
reducing the time it takes to bring a drug to FDA for review.
Harmonizing international standards for the review of drugs and medical devices.
Impact: The worldwide marketing of new products will be speeded up if there is less
need for duplicative testing to meet the standards of different countries.
Expanding and standardizing computer technologies used by FDA in the review of new
products and in the processing of imported products.
Impact: Review times for new products will be reduced as these technologies are better
utilized both by FDA and industry: imported products will be allowed into the
U.S. marketplace quicker as these systems are implemented.
###
Reinventing
DRUG & MEDICAL DEVICE
Regulations
NATIONAL
PERFORMANCE
REVIEW
PRESIDENT BILL CLINTON
VICE PRESIDENT AL GORE
APRIL 1995
REINVENTING
REGULATION OF DRUGS
AND MEDICAL DEVICES
President Bill Clinton
Vice President Al Gore
National Performance Review
April 1995
OVERVIEW
"Today, Americans don't have to worry about safety or
effectiveness when they buy [drugs and medical
devices]-from cough syrups to the latest antibiotics or
pacemakers. The Food and Drug Administration has
made American drugs and medical devices the envy of the
world and in demand all over the world. And we are going
to stick with the standards we have-the highest in the
world. But strong standards need not mean business as
usual in every area."
President Clinton - March 16, 1995
Introduction
Reforming the Federal government's regulatory processes, while maintaining critical public health
and safety standards, has been and will continue to be a top priority for the Clinton Administration.
Consistent with this commitment, President Clinton and Vice President Gore asked Health and
Human Services Secretary Donna Shalala to help them carefully examine the regulatory requirements
of the Food and Drug Administration (FDA).
As part of the Vice President's reinventing government initiative, FDA has been reviewing its
regulatory processes to determine which requirements could be reduced or eliminated without
lowering health and safety standards. This report contains recommendations resulting from the initial
phase of the review of drug and medical device regulation.
Reinventing Drug and Medical Device Regulations
1
Background
FDA is the Agency within the Department of Health and Human Services charged with ensuring that
drugs, vaccines, and medical devices are safe and effective and that foods meet basic safety standards.
In carrying out these and other responsibilities, FDA annually oversees more than $1 trillion worth of
products, which account for 25 cents of every
dollar spent by American consumers.
Drug Review Times
FDA was created in 1906 to protect
Americans from unsafe foods and drugs. In
1976, FDA's responsibilities were expanded
to include additional authority over medical
devices. During this Administration, FDA has
1992
30
taken significant initial steps to streamline the
30
regulatory process. These recent initiatives,
building on earlier reforms to ensure access
for patients to new drugs and to accelerate
1994
20
approval of treatments for life-threatening
20
illnesses, have resulted in new products being
brought to market sooner; but more can be
Months
Standard
done.
10
12
A Record of Accomplishment
Priority
6
FDA's recent regulatory improvements
1997
include:
0
New Applications
Shortening Review Times for New Drugs
and Devices
1)
FDA now uses expert review panels to expedite the review of certain biotechnology products.
(For example, a joint committee of FDA experts oversaw the licensing in record time of the
drug interferon beta 1b to treat certain patients with multiple sclerosis.)
2)
Under the Prescription Drug User Fee Act of 1992, drugs are now reviewed more quickly.
This law authorizes FDA to charge user fees for drug applications, and to use these additional
resources for the reviews of new drugs, vaccines, and biotechnology products.
2
Reinventing Drug and Medical Device Regulations
Already, review times for new chemical drugs have dropped from an average of 30 months in
1992 to 20 months in 1994.¹ By 1997, FDA will be getting these products to market in a year
or less, as fast as or faster than anywhere else in the world, with no sacrifice in review quality.
3)
Medical devices are benefiting from a number of new processes that speed up their review; for
example, devices that provide significant medical advances are now given priority review.
4)
Animal drugs are now reviewed in a more efficient manner, resulting in a record number of 38
new drugs approved in 1994.
Eliminating Unnecessary Regulatory Burdens
1)
FDA exempted 148 categories of low-risk medical devices from premarket review in
December 1994, relieving manufacturers from submitting applications to the Agency and
waiting for their approval.
2)
FDA has helped to assure safe and high-quality mammography by using existing private
sector standards to certify mammography facilities, which are mostly small businesses.
Utilizing these standards allowed FDA to implement the requirements of the 1992 law quickly
and with minimum burden on accredited and certified facilities.
3)
FDA has begun a joint program with the Customs Service to automate the entry of imported
products into the United States. The program allows an importer to notify FDA by computer
of import entries and receive prompt permission for the products to enter this country.
4)
FDA has issued a proposed regulation to permit regulated companies to use electronic records
and signatures in place of paper. This will save industry substantial costs by simplifying
record-keeping and speeding the filing of applications and other regulatory documents.
As noted in the President's State of the Union address and his recent announcement highlighting some
of the recommendations in this report, the Administration is committed to promoting results and not
rules. The reforms this report advocates will reduce paperwork, eliminate unnecessary regulation, and
thus get products to market more quickly. In so doing, they will strengthen the economy and maintain
the health and safety of Americans.
1 The 1994 median review time for all new chemical drugs was 17.5 months; (the subset of drugs reviewed in 1994 under the user fee program was
reviewed in a median time of 13.5 months).
Reinventing Drug and Medical Device Regulations
3
Principles for Reforming FDA Regulation in Carrying out this Review
In carrying out its regulatory review, the Agency carefully considered the financial burdens that its
requirements impose on industry and consumers. It looked for ways to eliminate these burdens so that
its regulatory systems would not be a bar to bringing beneficial new products to market. In reforming
its procedures and requirements, FDA followed these principles:
Using performance standards, rather than command and control regulations, whenever
possible;
Expediting product review without sacrificing the health and safety of the public;
Eliminating unnecessary requirements that may have been appropriate once but are not now
necessary to public health; and
Utilizing modern automated technology as a tool in streamlining internal Agency
management and as an aid to industry in meeting its regulatory requirements.
Regulatory Reform Recommendations
FDA is proposing a number of reforms that reinvent how FDA regulates. The reforms included in this
report are estimated to save the drug and device industries $500 million per year in unnecessary
regulatory costs. These reforms will also let FDA better target its resources toward expediting market
access of new products:
Reducing or eliminating many of the FDA requirements for companies to get approval for
changes in their manufacturing facilities or processes for manufacturing drugs, biotechnology
drugs, and other biologics;
Allowing manufacturers of biological drugs to get licenses for pilot facilities instead of
making them build full-scale plants. Manufacturers will still have to show they can meet
safety, purity, and potency standards;
Permitting greater flexibility in the appearance of distributors' names on biological product
containers, package labels, and labeling;
Eliminating outdated requirements for insulin and antibiotics and allowing a private standard-
4
Reinventing Drug and Medical Device Regulations
setting body to establish testing and quality standards (thus eliminating nearly 700 pages of
Federal regulations);
Excluding drug and biologic manufacturers from requirements for most environmental
assessments, which currently cost tens of thousands of dollars each time a new product is
developed yet provide no real benefit to the environment;
Exempting nearly 125 additional categories of low-risk medical devices from premarket
review;
Eliminating the "Reference List" by clarifying that market clearances of devices will not be
withheld unless FDA finds a reasonable relationship between the nature of current violations
and the application under review;
Developing a pilot program for review of low-risk medical devices by outside review
organizations to determine if such a system could be developed permanently;
Speeding the marketing of medical devices by seeking authority to charge industry user fees
for device reviews, and committing FDA to meet certain strict performance goals;
Expanding opportunities to export drugs and medical devices to industrialized countries;
Issuing a public statement clarifying how FDA determines the effectiveness of new drugs
and devices and that a single, multi-center study may support approval of a drug;
Harmonizing FDA's drug and device testing requirements with those of other countries, thus
expediting worldwide marketing of new products by reducing duplicative testing;
Expanding and standardizing the use of new information technologies for reviewing new
products and speeding up import entries.
Additional proposals for reforming the regulation of drugs and medical devices are being developed
and will be announced later. They will accompany recommendations related to the regulation of foods
and veterinary products.
Reinventing Drug and Medical Device Regulations
5
FDA'S PROPOSALS FOR REFORM
Drugs
New drugs must be approved by FDA prior to marketing. Under the provisions of the Federal Food,
Drug, and Cosmetic Act, they are tested first in animals, then in humans, and the data are submitted to
FDA scientists for review via a New Drug Application. Biologics include vaccines and blood
products, and drugs made using biotechnology. They are licensed under a different legal authority
from drugs, and are therefore subject to somewhat different requirements. Before marketing a new
biological product, the sponsor must submit for FDA's approval a Product License Application,
which presents safety and efficacy data. The facility making the product must submit an
Establishment License Application demonstrating that the product can be accurately and safely
manufactured.
Although full marketing of drugs must await FDA review and approval, in recent years the Agency
has established ways for patients to gain early access to treatments for life-threatening diseases.
FDA also approves such changes as substituting different ingredients by reviewing a "supplement" to
the original application for approval.
This section of the report describes reforms in the regulation of biologics and drugs. The reforms
include: permitting biologics manufacturers to demonstrate their capability to make the product
without first building a full-scale production plant; changing biologics labeling requirements to
remove an impediment to flexible manufacturing, packaging, and distribution arrangements; allowing
manufacturing changes for both drugs and biologics to be made with less FDA prior approval;
eliminating certain manufacturing requirements concerning antibiotics and insulin; and eliminating
most environmental impact assessments for both biologics and drugs.
6
Reinventing Drug and Medical Device Regulations
Drugs and Biologics: Eliminating Many Requirements
For FDA Approval of Manufacturing Changes
Background: FDA regulations governing drugs and biologics require applicants to obtain FDA
approval before implementing many manufacturing changes for those products. To obtain approval,
manufacturers submit "supplemental" applications to FDA, of which the Agency receives several
thousand each year. These changes range from the addition or subtraction of an ingredient, to the use
of a different production facility or different equipment within the same facility, to changes in
packaging. Manufacturers must often wait six to twelve months to receive FDA approval, during
which time the manufacturers are prevented from making changes to the product or production
facility that they believe are more efficient or otherwise necessary.
Proposal and Justification: FDA will reduce the number of changes that require pre-approval.
Described below are the procedures for implementing this new policy for drugs and biologics.
DRUGS
FDA's Center for Drug Evaluation and Research (CDER), the Agency component responsible for
oversight of human drug products, is developing a guidance document for drugs in tablet and capsule
form (other than those for controlled release). This document, designed to ease pre-approval
requirements for certain manufacturing changes, would distinguish changes that are unlikely to have
any detectable impact on a drug product's quality and performance from those that could have a
significant impact. Examples of changes unlikely to have an impact include the deletion of a color
from a product or changes from non-automated or non-mechanical equipment to automated or
mechanical equipment for moving ingredients. The proposed FDA guidance would ease the pre-
approval requirements for these and other manufacturing changes when the proposed manufacturing
change does not affect the drug's quality or performance.
In all instances in which prior approval would no longer be required. FDA would still receive
notification of the manufacturing changes from the drug manufacturer, either when the change takes
effect or through annual reports on the drug application.
BIOLOGICS
The Agency will create a reporting process tailored to the severity and complexity of the change. Less
Reinventing Drug and Medical Device Regulations
7
stringent reporting requirements will apply when the changes do not pose demonstrable effects on
product purity, potency, or safety - or when changes are readily amenable to on-site scrutiny during
routine inspection of the production facility. FDA will classify its oversight of manufacturing changes
for biologics as follows:
Category 1: Changes where no supplement submission will be required. The sponsor will generate
and retain all relevant data defining (and validating, if necessary) changes being made. The firm may
voluntarily notify the Agency of the changes and dates of implementation.
Examples: Changes in the supplier of components (such as stoppers, vials, seals) that meet established
specifications; changes which tighten existing specifications to provide greater assurance of product
purity and potency; relocation of equipment in appropriate areas within approved facilities.
Category II: Changes for which the sponsor submits a standard supplement; unless the Agency
objects, the sponsor can automatically implement the change in 30 days.
Examples: Expansion of existing manufacturing support systems (such as heating, ventilation, and air
conditioning); modification of an approved manufacturing area which does not adversely affect
safety, purity, or potency of product (such as adding new interior partitions or walls to increase
control over the environment or replacing or adding new surfaces to enhance cleaning); replacement
of equipment with that of similar but not identical design and operating principle that does not change
the manufacturing process.
Category III: Changes requiring Agency approval prior to implementation.
Examples: Change in processing conditions (such as process time, process temperature, or filtration
process); change in dosage form (such as a change from a liquid to a powder); extension of dating
period; use of a previously unapproved manufacturing area or facility.
Impact: These changes will benefit industry by: (1) saving resources that would have been spent on
preparing supplemental applications; (2) permitting changes to occur without waiting for prior FDA
approval; and (3) encouraging certain manufacturing improvements. Under the new procedures, the
manufacturing site changes described above for drugs could be carried out-and the new site could
begin operating-in a matter of weeks, and with significant cost savings. And the new policy will
permit a drug manufacturer to change automated equipment without prior FDA approval, an
improvement that will make newer facilities and equipment available to manufacturers much more
quickly. Similar changes for biologics manufacturers will speed their ability to make changes in
production facilities or make other manufacturing improvements.
8
Reinventing Drug and Medical Device Regulations
FDA will also benefit from these changes. The Agency estimates that this reform will eliminate its
current review of more than 800 supplemental applications for drugs and 500 for biologics annually².
Implementation and Timeline: For drugs, by the end of the year FDA will issue guidance for most
products sold in tablet form that will describe how these requirements will be relaxed. By the end of
1996, FDA will develop a similar guidance document for other dosage forms, including controlled
release drugs, liquids, and semi-solids.
For biologics, FDA will immediately issue a guidance document to implement the new three-category
plan. The document will identify the types of changes in manufacturing procedures and
establishments that may be carried out without prior approval. It will clarify which changes will not
require a supplement at all. Within nine months, in a second step, FDA will propose amending its
regulations to further reduce the instances requiring its approval before products may be marketed.
Likewise, the Agency will review its policy on lot release of some biologics (i.e., a procedure
whereby the Agency approves each batch of biologics prior to distribution), to determine how those
burdens can be minimized as well.
2 For biologics, approximately 25 percent of supplemental applications (250 a year) will fall into Category I. 25 percent (250) will fall into Category
II, and 50 percent (500) will fall into Category III.
Reinventing Drug and Medical Device Regulations
9
New Policy to Permit Use of Small-Scale and Pilot Facilities
During Development of Biologics
Background: Lack of clarity about establishment licensure requirements has led some biologics
manufacturers to make major capital investments in full-scale manufacturing facilities before
initiating the large clinical trials necessary to demonstrate the safety and efficacy of their products.
Such investments can result in significant financial losses if the product is not ultimately brought to
market.
Proposal and Justification: FDA will specifically state that manufacturers may use pilot and
small-scale facilities to demonstrate safety and effectiveness and to support approval. Under this
reform, companies may immediately submit applications for clinical studies or approval of products
manufactured in small-scale or pilot facilities.
Although the manufacture of biologics warrants a high degree of quality control and regulatory
oversight, FDA believes that licensure of pilot and small-scale facilities provides industry with the
flexibility it needs without diminishing public health protection. As a result, FDA will issue product
and establishment licenses on the basis of demonstrated safety, purity, and potency of the product
manufactured in the pilot or small-scale facility. Moving to a full-scale facility will require only a
supplement to the manufacturer's product/establishment license applications.
Impact: Of 1,500 active and pending investigational new drug applications (INDs) (the
manufacturer's application to begin testing a drug product in humans) for biologics, 100 to 500
current applicants need to decide whether to construct new facilities. Under this reform, a significant
number of these companies may choose not to construct a new full-scale manufacturing facility.
Instead, they may decide to use a pilot or small-scale facility, with potentially great cost savings. It
has been estimated to cost $25 million to construct a biologics manufacturing facility, and about $15
million a year to operate it.
Implementation and Timeline: Companies may apply immediately for licensure of small-scale and
pilot facilities and their applications will be considered. FDA will issue a guidance document to
clarify its policy on licensing small-scale and pilot facilities within the next three months.
10
Reinventing Drug and Medical Device Regulations
Revision of Labeling Requirements for Biological Products
Background: Companies that develop a product sometimes find it advantageous to have their product
manufactured by another company. Many small start-up companies, such as many biotechnology
firms, prefer this option because they do not always have the manufacturing capabilities necessary to
produce commercial quantities of a drug. However, FDA's current labeling regulations are a
disincentive to such arrangements: The manufacturer's name must be displayed on the label more
prominently than that of the developer (which can be listed only as a selling agent or distributor).
Proposal and Justification: FDA will allow the distributors' and selling agents' names to be
displayed prominently on biological product containers, package labels, and labeling. This change
will provide the biological products industry with the flexibility that it wants, and, at the same time,
maintain current label information on product manufacture and origin.
Impact: The change in labeling requirements will allow prominent display of the name of the
distributor or selling agent, thereby removing an impediment to flexible manufacturing, packaging
and distribution arrangements.
Implementation and Timeline: FDA will publish a proposal to revise its biologics labeling
regulations within six months.
Reinventing Drug and Medical Device Regulations
11
Antibiotic and Insulin Standards and Insulin Certification
Background: Section 506 of the Federal Food, Drug, and Cosmetic Act requires FDA to certify
individual batches of drugs containing insulin as meeting the standards of identity, strength, quality,
and purity that are described by FDA regulations.
Section 507 of the Act imposes similar requirements for antibiotic drugs. The regulatory
specifications for antibiotic drug products occupy almost 700 pages in the Code of Federal
Regulations.
Antibiotics and insulin are subject to more stringent requirements than those applied to other drug
products. For example, section 505 of the Act, which applies to most human drugs, does not require
FDA to certify individual batches of drug products or to issue product specifications prescribed in
regulations. Moreover, in some cases, the insulin and antibiotic regulations known as "monographs"
are outdated, reflect old technology or methodology, prescribe standards for products that are no
longer marketed, or conflict with the standards found in the United States Pharmacopeia (USP). The
USP, a compendium of standards of strength, quality, and purity for drug products, is published by the
United States Pharmacopeial Convention, a private entity. Because the FDA can change its standards
for insulin and antibiotic products only by regulation, the USP standards are often more up to date.
The existence of conflicting standards can be confusing to the industry and to FDA staff who must
determine whether a particular product meets the correct specifications.
Proposal and Justification: FDA proposes to support the repeal of the certification requirement
for insulin. Congress enacted this statutory requirement decades ago, when insulin products were new
and manufacturing and testing technology was rudimentary. Since then, the Agency and industry alike
have become much more sophisticated and experienced with insulin manufacturing, so that certifying
each batch of insulin is no longer necessary. Moreover, only two firms currently market insulin in the
United States, and in the past 8 years FDA has found no failures in more than 500 batches of insulin
that it has tested for certification purposes.
FDA also proposes to support the repeal of the statutory requirements for the FDA monographs that
are now issued for insulin and antibiotics. In the 1940's, when Congress enacted those sections of the
Federal Food, Drug, and Cosmetic Act, detailed regulations setting forth standards and tests were
thought to be necessary to ensure the quality and the safety of these products. At that time, Congress
also expressly recognized, at least with respect to antibiotics, that a time would come when
manufacturing technology would overcome the need for such detailed regulation and that the
manufacturing controls used for chemically synthesized drugs would suffice for antibiotics as well.
12
Reinventing Drug and Medical Device Regulations
FDA also supports the repeal of the statutory provisions which provide for the certification of
antibiotic drugs. The ability to control antibiotic drug quality is also well-established. For example, a
GAO study published in 1981 reported that from 1977 through 1980, less than one percent of all
antibiotic products did not comply with monograph standards. FDA therefore concludes that the
additional controls are no longer necessary to ensure the safety and efficacy of antibiotic drug
products.
The Agency therefore proposes to regulate the approval of new insulin and antibiotic drug products,
and generic antibiotic drug products, much as it
does for other human drug products. Concerning
tests and methods of assay, the USP will maintain
Antibiotic and Insulin
the standards for insulin and antibiotics in the
same way that it maintains such standards for
Standards/Certificates
other drugs.
Impact: Under this reform, insulin manufacturers
Food and Drugs
would no longer be required to submit
applications and samples to obtain batch
ations
certification. And because the insulin industry is
subject to certification fees under section 506 of
300 TO 499
of April 1993
the Act, the change would eliminate those fees.
Eliminating the statutory requirement for FDA to
issue antibiotic monographs that set forth product
federal
standards, tests, and methods of assay for
particular drugs would benefit antibiotic drug
product manufacturers. This change would
Eliminate 700 Pages
eliminate the confusion created by actual and
potential differences between FDA regulatory
standards and the USP.
Eliminating the regulations specifying insulin and antibiotic drug standards and tests will remove
nearly 700 pages from the Code of Federal Regulations.
Implementation and Timeline: The Administration will promptly propose legislation to repeal
section 506 of the Act (which pertains to insulin) and to repeal section 507 of the Act (which pertains
to antibiotic drug products). FDA would seek to have both insulin and antibiotic drug products
regulated under section 505 of the Act.
Reinventing Drug and Medical Device Regulations
13
Environmental Assessments for Human Drugs
Background: The National Environmental Policy Act (NEPA) requires all federal agencies,
including the FDA, to assess the environmental impact of their actions which may significantly affect
the quality of the human environment. A drug cannot be approved unless the manufacturer has
submitted an acceptable Environmental Assessment (EA). On the basis of FDA analysis of the EA,
the Agency can either issue a "finding of no significant impact" (FONSI), or decide that a full
environmental impact statement (EIS) must be prepared. Preparation of an EA is usually quite
expensive; yet, in virtually every case, FDA issues a FONSI.
Each year, the pharmaceutical industry submits approximately 50 to 60 full EAs and about 50
abbreviated EAs to CDER. Pharmaceutical firms also send 20 to 25 EAs annually to the Center for
Biologics Evaluation and Research (CBER), some in abbreviated form. It can take up to 6 months to
review an EA, obtain additional information from the firm to correct any deficiencies, and issue a
FONSI.
And yet, in recent years, FDA has identified only one product, Taxol, as presenting any potentially
significant environmental concerns. In the case of Taxol, the environmental impact was due to
harvesting of Pacific yew trees, an endangered species. In Taxol's case, CDER incorporated by
reference the EIS prepared by the U.S. Forest Service to address the resource question; the
manufacturing process and use were addressed through the routine EA and were found to have no
significant impact.
Proposal and Justification: FDA proposes to increase the number of categorical exclusions from
the EA and EIS requirements.
FDA proposes to reduce the number of EAs required to be submitted by industry and, consequently,
the number of FONSIs prepared by the Agency under NEPA by increasing the number of categorical
exclusions based upon little or no impact on the environment from the use of the drug. Based upon its
experience to date in reviewing environmental assessments, FDA believes that nearly all product
approvals will qualify for categorical exclusion. For example, virtually all drug approvals would
result in only minute releases of the drug into the environment as a result of human use and such
releases would not be environmentally significant. FDA procedures will provide for extraordinary
circumstances in which a normally excluded action may have a significant environmental impact-
circumstances that would require at least an EA. Taxol is an example of such an extraordinary
circumstance.
Impact: These changes will substantially benefit industry and will improve regulatory efficiency
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without having any adverse impact on public health or the environment. Industry would save from
$40,000 to $150,000 on each EA.
Implementation and Timeline: These changes will be implemented by amending FDA regulations,
in consultation with the President's Council on Environmental Quality (CEQ), to increase the number
of categorically excluded actions for which an EA or EIS is not required. New regulations will be
proposed in consultation with CEQ in six to nine months. Policy guidelines clarifying current
procedures will be published sooner.
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15
Medical Devices
There are three classes of medical devices. Class I devices, such as tongue depressors, are subject
only to general regulatory controls and receive little Agency oversight. Class II devices, such as infant
incubators, are subject to special controls, such as performance standards, to ensure their safe and
effective use. Class III devices, such as implantable pacemakers, are generally life-sustaining or life-
supporting, are implanted in the body, or present potential unreasonable risk of illness or injury.
New devices enter the market in one of two ways: (1) through a premarket notification process,
known as a "510(k)" because it is authorized under section 510(k) of the Federal Food, Drug, and
Cosmetic Act; and (2) through a more extensive premarket approval application (PMA).
Under the 510(k) process, FDA must determine whether a device is "substantially equivalent" to a
device that is already legally marketed. A manufacturer using the premarket notification process
informs FDA about the device and why any changes in its device can be made safely. (Some low-risk
devices have been exempted from premarket notification.) If FDA finds the device to be
"substantially equivalent," the manufacturer may market the device and must then comply with good
manufacturing practice (GMP) requirements to ensure that the device is properly made. More than 90
percent of all devices enter the market under the premarket notification process. The more extensive
premarket approval application is targeted toward Class III devices.
The reforms below are: additional exemptions from premarket notification; elimination of the current
reference list program, which links GMP inspections to new device approvals, and its replacement by
a process that focuses on serious GMP problems and how they may be applicable to individual
premarket notification actions; a pilot program for external review of new devices; and, a user fee
program to speed device approvals.
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Medical Device Exemptions from Premarket Notification
Background: Currently, the Federal Food, Drug, and Cosmetic Act requires that manufacturers of
most medical devices submit information to FDA and receive FDA clearance before putting a device
on the market, even if the device has an extremely low risk. Review of low-risk devices is not
necessary to protect the public health, places an unnecessary regulatory burden on device
manufacturers, and delays introduction of new devices.
FDA currently regulates about 1,700 types of medical devices. Of these, 441 categories of low-risk
devices (such as stethoscopes, hernia supports, and surgical microscopes) have already been exempted
from the requirement of premarket notification, including 148 exempted in December 1994.
Proposal and Justification: FDA will exempt up to an additional 125 medical device categories
from premarket notification requirements. As a result, about 570 categories, or one-third of all
categories of devices, will be exempt from premarket notification requirements.
Public health will not be compromised by the exemption of these devices from premarket review.
These devices will reach the market sooner and will remain subject to good manufacturing practice
requirements, which include regular factory inspections, record keeping and device problem
reporting. (Of course, continuation of an exemption is dependent upon a safe marketing history, and
exemptions can be revoked if safety problems are later identified; a review of whether these
exemptions should be continued, or others added, will be conducted in two years.)
Impact: The device industry will no longer have to prepare and submit-and the Agency will not
have to process and review-510(k) premarket notification submissions for the exempted device
categories. FDA receives about 700 submissions each year for devices in these 125 categories and
will be able to redirect the resources for the review of these products to more complex products.
Implementation and Timeline: FDA device advisory panel chairs are now reviewing the proposed
exemptions. The majority of the device categories are currently in Class II and, under the law, must be
reclassified to Class I before being exempted from FDA review. By June 1995, FDA will propose to
reclassify these devices from Class II to Class I and to exempt them from premarket notification
requirements.
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Elimination of the Reference List
Problem: Under a program known as the "Reference List," FDA tracks medical device manufacturers
found by FDA field inspections to have serious GMP violations. GMP violations are flaws in the
manufacturing process that have the potential to affect the safety or efficacy of the product. If a firm
is on the list, FDA may defer authorization for the firm to market a new product under section 510(k)
of the FD&C Act.
The basis for placing a firm on the list has been an inspectional finding of serious GMP problems. In
issuing the manufacturer a warning letter about its GMP violations, FDA has advised the
manufacturer that the Agency may not give marketing clearance to pending applications until the
violations are corrected. A company is removed from the list only after FDA has re-inspected the firm
and found that all serious GMP violations have been corrected. This process can take up to 6 months.
Industry has criticized the list as not needed to protect the public health. Industry views the list as a
"blacklist" because it feels that the Agency does not make clear which firms are placed on the
Reference List or when they are removed from it. Moreover, because it takes time to re-inspect after
violations are found, manufacturers may be delayed in marketing their products.
Proposal and Justification: FDA will eliminate the Reference List and instead focus attention on
the appropriate linkage between serious GMP deficiencies and individual pending 510(k)
applications. FDA will also clarify that market clearances of Class I and II devices will not be
deferred unless FDA finds a reasonable relationship between the nature of the current GMP violations
and the application under review. A reasonable relationship will be found only if there are GMP
violations that are directly related to the product under review or if there are systemic violations that
are generally applicable. FDA will not defer 510(k) applications if no such reasonable relationship is
found.
Second, if market clearance of a 510(k) is deferred because of GMP violations, FDA will either
reinspect the firm within 60 days after being notified that corrective actions have been taken, or
clear the 510(k) application without a reinspection.
Finally, FDA will prepare clear written policies and procedures so that companies will know if they
have an outstanding GMP violation, will understand when their 510(k) applications may be held up
due to GMP violations, and will know the procedures to follow to correct the problems and obtain
marketing clearance.
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Impact: The proposed changes benefit industry by providing assurance that no market clearance will
be deferred unless a clear linkage between GMP violations and the device under review is found. In
addition, by clarifying FDA's procedures, any industry fear of indiscriminate delay in the clearance of
a 510(k) application will be eliminated. Finally, the fixed time frame for reinspection benefits
manufacturers by removing uncertainty about when they will be able to market their products after
they correct GMP violations.
Implementation and Timeline: The Agency will implement these new policies and procedures by
publication of a notice in the Federal Register by May 1995. FDA will immediately review all
deferred applications to determine if the GMP violations are reasonably related to the pending
applications. Firms with GMP violations unrelated to the pending applications will have their
applications cleared unless there are other problems.
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19
Medical Device External Review Pilot Program
Background: Almost all medical devices enter the market by an application process in which the
manufacturer demonstrates that the device is "substantially equivalent" to a device already marketed.
The device industry contends that this process inhibits innovation and competitiveness because, due to
limited resources, FDA takes too long to review these applications. (A comprehensive assessment of
FDA's device review resource needs, conducted by FDA and audited by the device industry,
documented an annual shortfall of about $24 million and more than 200 staff positions.)
Industry recommends that FDA adopt an approach similar to that used in the European Community,
in which device firms have their device applications reviewed by a third-party scientific organization
accredited by the government. Under this approach, a manufacturer pays a third-party organization for
its review, the third-party organization notifies the government of the results of its review, the device
is marketed without government review, and the government monitors the device after it is on the
market for subsequent safety problems. This concept has not been tried in the United States, so its
applicability in this country is unknown.
Proposal and Justification: FDA proposes to create a pilot program for external reviews of
devices. This pilot program will contain several key elements of the European model to test whether
that model is appropriate for the United States. The program will have the following elements:
At least ten categories of devices, comprising at least 100-400 device applications annually,
will be identified for eligibility in the program;
Those categories of devices will have a low to moderate risk profile, clear standards for
market clearance, and no requirement for clinical data as part of their application (e.g.,
applications which principally raise engineering issues);
The outside reviewers will be accredited by FDA as capable of assessing the design,
performance, and safety of devices;
The accredited review organization will be responsible for conducting the entire review of the
device application, producing a written review document, and making a recommendation to
FDA. The review will be checked by FDA, and the final decision will be made by FDA and
communicated to the company;
The program will be funded by the manufacturer's payment to the reviewer for its services.
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Participation by manufacturers will be voluntary; and
The accredited reviewing organization will be expected to demonstrate independence from
device manufacturers for whom it will be doing reviews and adherence to conflict of interest
standards.
Impact: The pilot program will allow FDA and the device industry to determine the feasibility of
third-party reviews of devices. It will answer questions such as whether private groups can conduct a
thorough, rapid review; whether such groups exist or will need to be created; whether safeguards
against improper influence of non-government reviewers can be established; and how much groups
will charge for these services.
Implementation and Timeline: The pilot program will begin early in the next fiscal year. The pilot
program will operate for two years, and during the second year FDA will evaluate its success and
potential for expansion and permanent continuation.
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21
Device User Fees
Background: Even if the medical device external review pilot program and other streamlining efforts
detailed in this report are successful in reducing resource demands upon FDA's device program, the
Agency will still lack sufficient resources to ensure timely review of device applications. Each year,
FDA receives approximately 40 to 60 Premarket Approval Applications (PMAs), 400 PMA
supplements, and 6,000 premarket notification actions for marketing devices under section 510(k) of
the Federal Food, Drug, and Cosmetic Act. In fiscal year 1994, the average review times were about 2
years for PMAs, 1 year for PMA supplements, and 215 days for premarket notifications³. Compare
that to fiscal year 1990, when the average review times were 10 months for PMAs, 6 months for PMA
supplements, and 100 days for premarket notifications. These lengthy review times delay the
introduction of devices to the market. FDA can reduce these review times, without diminishing the
public health protections it provides, if it has adequate resources to review applications.
Proposal and Justification: FDA proposes to authorize user fees for applications. FDA will collect
fees for reviewing PMAs, PMA supplements and premarket notification actions - 510(k)s - and
dedicate them to funding premarket review and related activities. In addition, FDA will commit to
specific performance goals.
FDA will agree to performance goals of (1) eliminating the backlog of applications within 24 months;
(2) completing a comprehensive, substantive review for 90 percent of PMAs in 180 days; and (3)
taking a final action on 95 percent of 510(k)s in 90 days. These performance goals were negotiated
with the industry as part of legislation proposed last year, and major segments of the device industry
supported them.
Impact: The proposed solution will address a major complaint about federal premarket review times
for devices. The device industry will benefit from increasingly faster review and approval times, will
be able to market new and innovative products faster, and will become more competitive in foreign
markets. Consumers inside and outside the United States will benefit from easier access to new and
improved products.
Implementation and Timeline: User fees will require statutory changes to the Federal Food, Drug,
and Cosmetic Act. The Administration has proposed these changes in the budget for fiscal year 1996.
³However. premarket notifications, which have been the most controversial, were down to a median time of 98 days as of January 1995.
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Device user fees would account for $23,740,000 of the Agency's budget for the entire fiscal year, and
the funds would include associated start-up costs and the hiring of over 200 staff people over the first
two years.
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23
Cross-Cutting
Several issues confronting FDA cut across product lines and affect both the pharmaceutical and
medical device industries. Two such issues involve exports. One of them is the different mandatory
requirements that the Agency must follow in approving exports of drugs and medical devices. The
other export issue stems from the varying standards for regulated health care products in the United
States and in many of its trading partners. FDA plans to ease some of the current export restrictions.
Also, the Agency will intensify its efforts to bring into harmony international standards for health care
products, so that firms developing new products will have to deal with only one set of requirements.
Another issue raised by both the drug and device industries is whether FDA requires new products to
be shown to be superior, as opposed to equal, to products that are already on the market. An
upcoming policy statement will clarify the Agency position. FDA also proposes to take steps to
advance the development of an electronic information system to support the review processes, and to
implement the second phase of an automated system for the processing of imports.
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Drug and Device Exports
Background: Drugs and medical devices not approved for sale in the United States are now exported
under different statutory requirements.
Drugs may be exported only to the 21 developed countries listed in the statute if, among other things,
(1) the sponsor has an investigational new drug (IND) exemption in effect that permits testing in
humans, and (2) the drug is approved in the importing country.
Devices may be exported if FDA determines, based on information supplied by the exporting
company, that (1) export of the device does not harm public health and safety, and (2) the device is
approved for importation by the importing country.
Manufacturers have contended that these requirements place them at a competitive disadvantage and
that FDA review of exportation to foreign countries is both time-consuming and unnecessary.
Proposal and Justification: It is proposed to allow the export of drugs to any of the countries listed
in the statute without an IND. In addition, the Administration proposes to work with Congress on
changes in the current law based on an examination of whether to amend the present list of 21
countries, and whether to adopt other changes.
FDA proposes two new criteria for allowing devices not approved in the United States to be
exported for marketing abroad without prior FDA permission: (1) devices can be exported to
advanced industrialized countries (the list of which would be determined in consultations with
Congress) if the devices conform to the importing country's laws; (2) devices can be exported to
countries not on the above-mentioned list if the exporter has an Investigational Device Exemption
(IDE) permitting testing on humans in the United States, the importing country has given FDA a letter
providing blanket import approval for IDE-type devices, and the device is in compliance with the
importing country's laws.
This change from current procedures would significantly relax restrictions on exports to industrialized
countries, while leaving intact existing protections for countries that are not industrialized.
Impact: For drugs, companies will be able to export their products for marketing in the 21 developed
countries listed in current law, even if they do not have an IND in the United States.
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25
For devices, exports to the most significant markets-industrialized nations such as Japan and the
European Community-will be exempt from FDA's oversight. The U.S. industry will be spared the
expense of developing and submitting export requests to FDA and would not need to await FDA
review, which now averages 16 days but can take as long as 150 days. Furthermore, a firm with an
approved IDE will be able to export the unapproved device to less developed countries which have
agreed to such importation, without going through FDA review, currently averaging 10 days. The
U.S. device industry believes that these changes will encourage firms to remain in the United States
rather than moving their operations abroad. FDA could redirect the resources used for the current
export approval program to more pressing public health matters.
Implementation and Timeline: Discussions with Congress on both drug and device legislation could
begin immediately. Permitting devices with an IDE to be exported without further FDA clearance to
countries which have provided prior agreement can be accomplished administratively by FDA, and
proposed regulations will be issued within 4 to 6 months.
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Effectiveness of Drugs and Devices
Background: The pharmaceutical and medical device industries have argued that FDA requires a
new drug or Class III (highest risk) device to be shown to be more effective for its intended use than
comparable therapies that are already approved for marketing. Representatives of these industries
believe FDA's requirements for demonstrating efficacy present unreasonable difficulties in
developing new therapies and bringing them to market.
Proposal and Justification: FDA proposes to issue a public statement to respond to this concern.
The statement will make the following points:
Under the Federal Food, Drug, and Cosmetic Act, new drugs and Class III devices must be shown to
be safe and effective for their intended uses. In evaluating the safety of a new drug or Class III device,
the Agency weighs the demonstrated effectiveness of the product against its risks to determine
whether the benefits outweigh the risks. This weighing process also takes into account information
such as the seriousness and outcome of the disease, the presence and adequacy of existing treatments,
and adverse reaction data.
In evaluating effectiveness, as with safety, FDA reviews new drugs and Class III devices on their
merits. The Agency does not require new drugs and Class III devices to be more effective than
therapies for the same disease or condition that are already approved for marketing. In general, both
new drugs and Class III devices must be shown to be effective through evidence consisting of well
controlled investigations that provide a basis on which it can be concluded that the drug or Class III
device will have the effect it is represented to have.
For the majority of new drugs and Class III devices, i.e., new products intended to treat less serious
illness or provide relief from symptoms, a showing of effectiveness is usually based on a clinical trial
comparing the product to a placebo. Such a showing does not involve a comparison to any other
product.
In certain circumstances, however, it may be important to consider whether a new product is less
effective than available alternative therapies, when less effectiveness could present a danger to the
patient or to the public. For example, it is essential for public health protection that a new therapy be
as effective as alternatives that are already approved for marketing when:
1.
the disease to be treated is life-threatening or capable of causing irreversible morbidity (e.g.,
stroke or heart attack); or
Reinventing Drug and Medical Device Regulations
27
2.
the disease to be treated is a contagious illness that poses serious consequences to the health of
others (e.g., sexually transmitted disease).
It should be noted that new products are often developed for particular subpopulations who either do
not respond to or are not able to tolerate an existing approved therapy. FDA will generally approve for
use in such a subpopulation a product that is shown to have effectiveness in this group, regardless of
whether the product can be shown to be as effective in the broad target population as the alternative
therapy. This is because, in effect, there is no available alternative therapy for the subpopulation. For
example, a number of patients cannot tolerate a widely used therapy for an AIDS-related pneumonia.
FDA approved the drug atovaquone for use in these patients, even though it had been shown to be less
effective than the standard therapy when tested in a broad population.
Impact: Placing such a statement in the public record would clarify for sponsors of drugs and Class
III devices how FDA addresses and evaluates effectiveness in the context of overall review for
product approvability. This clarification should be helpful to product sponsors in the planning and
development of new products.
Implementation and Timeline: Within the next 3 months, FDA will publish a statement for
comment in the Federal Register.
Additional Effectiveness Issue:
Industry representatives also argue that the Food, Drug, and Cosmetic Act should not be read to
require multiple clinical studies when one pivotal study could suffice.
Clarification: FDA believes that a showing of effectiveness must be replicated to constitute an
adequate demonstration of effectiveness for a new product. While a second study may well be needed
to replicate results demonstrated in a first study, in some instances it is possible to replicate results
within one large, well-designed multi-center study. It should be emphasized that this approach can be
successful only when results are strong. A statistically marginal result, even in a very large study,
cannot provide convincing evidence of replication.
The biotechnology drug Pulmozyme was recently approved to treat cystic fibrosis on the basis of one
multi-center study with features that provided elements of replication. Similarly, the drug timolol was
approved to treat people after a heart attack following a demonstration of improved survival in a
single study. In that study, the favorable effect was seen in patients at several levels of severity at
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three different hospitals. A simple multi-center double-blind placebo-controlled trial led to prompt
approval of zidovudine for AIDS in 1987 when it was found that 16 deaths had occurred in the
placebo group, as opposed to one death in the group receiving the drug. FDA has also approved
vaccines, including a vaccine for hepatitis A, that have been studied for effectiveness in a single
controlled multi-center study.
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29
Harmonization of Standards
Background: Nations have differing requirements for approval of new drugs, biologics, medical
devices, and animal drugs. This results in multiple tests on animals and humans and different
applications for marketing approval. Nations also have differing standards for manufacturing practices
and regulatory inspections. There is a substantial need to harmonize standards wherever possible,
while retaining the United States' high level of public health protection.
Proposal and Justification: Seek common international standards. FDA will work with other
countries, particularly the European Community, Japan, and North American Free Trade Agreement
(NAFTA) partners, to harmonize product testing and development standards with those of the United
States. Work has already begun on drug development and should be expanded to other areas of FDA
regulation.
In addition, where appropriate, FDA will adopt international standards developed by multilateral or
private-sector standards-development bodies.
Impact: Increased harmonization offers clear benefits for U.S. public health. It increases the safety
and quality of imports into the United States. It can also improve the safety and quality of products
sold in foreign countries and may help increase the availability of new products.
Harmonization benefits industry by replacing many different standards with one international
standard that industry must meet. In the long run, this brings cost savings to industry and enhanced
opportunities for export of U.S. goods, and may lessen the time needed to bring new products to
market.
Harmonization permits FDA to make more efficient use of its resources, as other countries share the
workload of developing new standards. Harmonization also may save future FDA resources by
enabling cooperation with other countries in the assessment of new products. (However, it should be
noted that a sizable up-front investment of FDA resources is needed to reach harmonization.)
Implementation and Timeline: FDA will build on and expand efforts to achieve international
harmonization by:
1.
Launching work on new harmonization topics in the testing of human drugs, biologics, and
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devices related to clinical trials, biotechnology, medical terminology, and standards for the
electronic transfer of regulatory information. Harmonized standards will be issued as
guidelines for industry. Substantial progress on guideline development is expected within 2
years.
2.
Accelerating work on harmonizing drug Good Manufacturing Practices, Good Laboratory
Practices, and Good Clinical Practices standards and inspections. A number of proposals for
harmonized guidelines should be completed within 2 years; however, harmonization of
inspections will probably take longer.
3.
Beginning an initiative to harmonize registration requirements for animal drugs. The first
proposal for harmonized guidelines should be completed within 3 years.
4.
Initiating work towards more harmonization with our NAFTA partners. Such harmonization
efforts should become part of the work plans of existing technical working groups formed
under the Canada/U.S. Free Trade Agreement.
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31
Submission Management and Review Tracking (SMART) Program
Background: The current premarket review processes (preparation, handling, and storage of
information related to product applications) are paper intensive with limited electronic means of
accessing, sharing, or archiving product-related information within the Agency. Many applications
consist of hundreds of volumes of detailed scientific information. The regulated industry is similarly
affected by the need to generate an overwhelming amount of paper.
The Prescription Drug User Fee Act of 1992 (PDUFA) mandates significant reductions in the time
required to review new drug applications. PDUFA funds the hiring of additional review staff to
accomplish these goals. However, one of the longer term objectives is to improve the efficiency of the
review process and to begin addressing ways to improve regulated industry's data handling
efficiencies as well. FDA has begun to develop a comprehensive, standardized information
management system (SMART) to support the review processes.
Proposal and Justification: FDA proposes to proceed with the development of SMART by
pursuing a series of information systems pilot projects which will directly support FDA's meeting
the near-term PDUFA goals. The Agency is already putting in place a system to identify, evaluate,
and prioritize these pilots. A longer term SMART strategic plan has been developed that articulates
how these pilots will serve as building blocks toward integrated drug development/review information
management.
The pilots will focus on upgrading and interconnecting the hardware and software on the reviewer's
desk; establishing standards; developing applications which will directly support the receipt, review,
tracking, and archiving of industry submissions; and provide analytical tools to support the review
process. This proposed approach will provide the most immediate benefit to shortened review times
and will be funded with PDUFA fees.
Impact: The drug and biotechnology industries will continue to see progress in meeting the PDUFA
review time goals. Through information systems design, the review processes will be clarified and
managed for greater consistency, better documentation, and improved efficiencies. As standards are
developed and implemented, the regulated industry will achieve greater internal efficiencies in its
development and formatting of regulatory submissions and significant savings on paper record
generation, handling, storage, and retrieval.
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Implementation and Timeline: Over the next 12 to 24 months, FDA's drug review programs will
complete the upgrade of reviewer hardware and software and networking capability, and develop and
implement a number of automated applications (e.g., electronic Establishment Licensing
Applications, electronic lot release testing, gene therapy patient registry, pre-approval inspections,
and other pilots). The program offices will also begin selecting and implementing electronic data
interchange standards which are acceptable to the regulated industry and to regulatory authorities in
Europe and Japan.
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33
Operational and Administrative System for Import Support (OASIS)
Background: FDA is responsible for ensuring that the imported products it regulates meet the same
safety, efficacy, and quality standards as products produced domestically. Importers must have FDA
clearance for each shipment before it can enter the United States. The number of imported shipments
of FDA-related products has doubled in the 1990s to more than 2 million per year.
FDA's traditional process for clearing import shipments has required that importers prepare and
submit a prescribed form, with invoices and any other documentation attached, for each shipment.
FDA staff reviews the documentation, decides whether to admit the shipment in the country, and
sends a paper response back to the importer. This paper process often takes days to complete, and
delays in clearing shipments are a serious problem for importers. Reductions in government resources
and increasing workload make it clear that FDA's traditional paper system for clearing imports must
be improved. Automation of the process is essential.
Proposal and Justification: FDA has begun developing a phased information systems initiative to
support automation of the import clearance process. Phase I was implemented nationwide in 1994. It
operates in conjunction with the Customs Service, with which import brokers are already on line.
The new FDA system enables the import broker to enter additional FDA-specific data, which pass
through a screening process that recognizes what the product is, country of origin, producer, and
shipper. FDA has developed a set of decision criteria based on its experience with import risks and
surveillance-sampling techniques to determine whether the shipment is admissible, or whether FDA
needs to look at it more closely.
Within minutes, the broker receives a return message, advising either that FDA has cleared the
shipment or that further examination testing is needed. Shipments in which FDA has no further
interest can move immediately into commercial channels.
FDA will proceed with implementing Phase II of the Operational and Administrative System for
Import Support (OASIS). Whereas Phase I automated the initial submission and screening of import
data from import brokers, Phase II will automate FDA's internal handling of those import transactions
requiring FDA review beyond the initial screening. The Phase II system will provide automated links
between FDA laboratories and inspection and compliance units.
FDA will achieve national uniformity in tracking and enforcement of suspect products and a more
rapid final response to brokers on import disposition. In addition, full implementation of the OASIS
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system will permit electronic links with other FDA data bases that must be accessed during the import
entry review process. For example, FDA must confirm that an imported drug has an effective NDA or
an IND, that medical devices are approved and have been properly registered, and that manufacturers
of low-acid canned foods have registered.
Impact: In February 1995, 67 percent of all shipments processed in FDA's electronic system received
final clearance within minutes. Import brokers need not prepare and submit to FDA any paperwork
for these shipments that are cleared electronically. Importers' costs for holding up shipments awaiting
FDA clearance are reduced markedly. Perishable shipments no longer risk spoilage from clearance
delays.
The American consumer is the major beneficiary. The freeing up of FDA resources that would have
been required to handle and review the paperwork submitted by importers for all shipments allows the
Agency to focus its attention on those shipments that may not conform to required standards.
Implementation of the full OASIS system will speed the clearance of the one-third of shipments that
require some form of FDA detailed review. FDA can target its resources on those import shipments
that are suspected of not meeting quality requirements.
Implementation and Timeline: The full system will take several more years to complete, assuming
funding is available. FDA is seeking user fees, to be paid by the importers, to fund full development
and implementation of the OASIS system.
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35
MEMORANDUM
TO: Carol Rasco
April 6, 1995
FR:
Chris Jennings
RE:
Today's release of FDA reg reform report
cc:
Bill, Jeremy, Jen, Paul
This morning, the Administration is releasing the attached FDA regulatory reform report. It
follows on the print shop event a few weeks ago in which the President released the EPA
report and made references to a number of the FDA reform initiatives that are included in
today's report.
The FDA report proposes numerous regulatory reforms that are estimated to save the drug
and device industries at least $500 million per year in unnecessary regulatory costs and will
also free up FDA to better target its resources toward improving and expediting market access
of new products. The recommendations are significant, not only for their substance but
because the Agency has committed to specific timetables for implementation. There will be
additional recommendations to come. The FDA has committed to the Vice President to build
on these recommendations through a bottom-up review, which will more fully include font
line FDA personnel. I anticipate additional regulatory reforms being produced from this
process by no later than June.
The report is being released in conjunction with Commissioner David Kessler's testimony
today before the Senate Labor and Human Resources Committee. The regulatory reform
review process and the product it has produced has been and will be referenced as a joint
White House/FDA effort.
Yesterday we briefed Congressional staffs of relevant Committees, representatives of drug and
biotech manufacturers, device manufacturers, and consumer groups. Almost universally, the
Administration is being praised for this initiative. While the industry will still push for
more, the relationships with the Administration and the FDA have improved markedly. The
report also seems to position the Administration and the FDA well for the upcoming and
inevitable debate on the need to reform -- but not to undermine -- the agency and its charge
to assure that the drugs and devices on the market are safe and effective.
FYI, apparently the first AP story on this report is quite good for us. Attached for your
information is a three page summary of the report. I hope these materials are useful.
FDA
BACKGROUNDER
U.S. FOOD & DRUG ADMINISTRATION
Contact: Jim O'Hara 301-443-1130
Reinventing Drug and Medical Device Regulation
The Clinton Administration is committed to making government work better by reducing unnec-
essary regulatory burdens while maintaining the critical public health protections the American
people expect and deserve. In the case of the Food and Drug Administration, reinvention of drug
and medical device regulation will mean speeding up the review of these products.
The high standards of the FDA have given Americans access to drugs and medical devices that
are safe and that work. In addition, FDA has worked in recent years: to make new therapies
available as soon as possible, even before final approval; to accelerate the approval of life-saving
drugs; and to speed up the review and approval of all drugs with additional resources from
industry user fees.
The Clinton Administration is building on these high standards and efforts to speed up drug and
device approval with new FDA regulatory reforms. Some of these reforms will directly speed up
the review process for these products. Others will reduce unnecessary regulatory burdens on
industry. All are aimed at maintaining and protecting Americans' confidence in the safety and
effectiveness of the drugs they take and the medical devices they use.
FDA will reform drug and medical device regulation by:
Allowing manufacturers of drugs and biologies (products made from biological materi-
als) to change the way they manufacture an approved drug without FDA pre-approval if
the risk is negligible.
Impact: Industry can modernize facilities and processes more easily; FDA can shift
resources to more critical review needs.
Allowing manufacturers of biological drugs to get licenses for pilot facilities instead of
building full-scale manufacturing plants.
Impact: Manufacturers will have lower start-up costs and can more quickly begin pro-
duction of new drugs.
Permitting greater flexibility in how distributors' names appear on biological product
containers, package labels, and labeling.
(more)
HFI-40
BG 95-11 (April 5. 1995)
Reinventing Drug and Medical Device Regulation
page 2
Impact: Small start-up companies, many of them biotechnology firms, may more readily
enter into manufacturing arrangements with larger companies and bring prod-
ucts to market quicker.
Eliminating special requirements for manufacturing insulin and antibiotic drugs.
Impact: Industry will no longer be burdened with outdated requirements and FDA can
regulate these products the same way it does other drugs.
Excluding drug and biologics manufacturers from requirements for most environmental
assessments.
Impact: Industry will be spared the expense of preparing assessments that FDA has
found unnecessary.
Exempting up to 125 categories of low-risk medical devices from premarket review,
adding to the 441 categories already exempted from review.
Impact: Industry will no longer have to wait for premarket review, meaning that these
devices can reach patients sooner; FDA can shift resources to more critical
review needs.
Eliminating the "reference list" and clarifying that premarket review of medical devices
can be affected only if good manufacturing practice violations are related to a specific
device.
Impact: Industry concerns that good manufacturing practice violations for one product
can slow down approval for other devices unrelated to those problems will be
alleviated, and there will be more certainty about when products can be mar-
keted.
Developing a pilot program for the review of low to moderate risk medical devices by
outside organizations.
Impact: This program will help determine if such a system can speed the review of these
devices, whether the independence of the review process can be maintained, and
if such a system will be less costly.
Speeding the marketing of medical devices by charging industry user fees to give FDA
more resources for product reviews and committing FDA to strict performance goals.
Impact: A similar program for prescription drugs has substantially reduced review times
and FDA has met all performance goals to date.
Expanding the opportunities for the export of unapproved drugs and medical devices to
industrialized countries.
Impact: Industry will have wider markets for its products and will be encouraged to
maintain operations in this country.
(more)
Reinventing Drug and Medical Device Regulation
page 3
Clarifying the effectiveness standard for new drugs.
Impact: Industry will have a better understanding of how to develop new products,
reducing the time it takes to bring a drug to FDA for review.
Harmonizing international standards for the review of drugs and medical devices.
Impact: The worldwide marketing of new products will be speeded up if there is less
need for duplicative testing to meet the standards of different countries.
Expanding and standardizing computer technologies used by FDA in the review of new
products and in the processing of imported products.
Impact: Review times for new products will be reduced as these technologies are better
utilized both by FDA and industry; imported products will be allowed into the
U.S. marketplace quicker as these systems are implemented.
###
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a publication.
Publications have not been scanned in their entirety for the purpose
of digitization. To see the full publication please search online or
visit the Clinton Presidential Library's Research Room.
Reinventing
DRUG & MEDICAL DEVICE
Regulations
NATIONAL
PERFORMANCE
REVIEW
PRESIDENT BILL CLINTON
VICE PRESIDENT AL GORE
APRIL 1995
neck A w8
mailed 6/28
THE WHITE HOUSE
OFFICE OF DOMESTIC POLICY
CAROL H. RASCO
Assistant to the President for Domestic Policy
To:
JENKLEIN
Draft response for POTUS
and forward to CHR by:
Draft response for CHR by:
Please reply directly to the writer
(copy to CHR) by:
X 6/27
Please advise by:
Let's discuss:
For your information:
Reply using form code:
File:
I
Send copy to (original to CHR):
Schedule ?:
Accept
Pending
Regret
Designee to attend:
Remarks:
PLEASE respond to Assenbluse
on Dors's belaalf AND
cc: Dors. Thonks
THE WHITE HOUSE
WASHINGTON
June 28, 1995
The Honorable Paul A. Tokasz
Member of Assembly
State of New York
General Donovan State Office Building
125 Main Street
Buffalo, NY 14203
Dear Assemblyman Tokasz:
I am writing in response to your letter of June 9 to Doug
Sosnik, which outlined your concerns about the Food and Drug
Administration's (FDA) oversight of vitamins.
I am pleased to inform you that most of the issues you
raised have been addressed in recently enacted legislation. When
the President signed into law the Dietary Supplement Health and
Education Act (DSHEA), the burden of proof that a product is
unsafe was shifted to the FDA so that the FDA must demonstrate
that a product is unsafe before it can be removed from the
market. The law also gives manufacturers flexibility. For
example, statements about nutritional value may be made under
certain conditions without preclearance and without subjecting
the product to regulation as a drug. Further, materials produced
by independent sources, such as health journals, may be used
without the constraints that apply to labels, so long as certain
content and presentation conditions are met.
Thank you again for your letter. I have taken the liberty
of advising the FDA of your views. Please feel free to contact
me with any further questions or concerns.
Sincerely,
Jennifer Klein Klein
Senior Policy Analyst
CC: The Honorable Doug Sosnik
The Honorable Carol Rasco
THE WHITE HOUSE
WASHINGTON
June 15, 1995
MEMORANDUM FOR CAROL RASCO
FROM:
DOUG SOSNIK
SUBEJCT: ASSEMBLYMAN TOKASZ
Enclosed please find a letter from Assemblyman Tokasz.
As you can see he is concerned about potential FDA action
affecting vitamins.
As you can imagine, I know nothing about this issue. I told
him I forwarded the letter to your office.
Can someone please get him a response?
Thank you for your assistance
THE ASSEMBLY
STATE OF NEW YORK
ALBANY
PAUL A. TOKASZ
CHAIRMAN
Assemblyman 143rd District
Committee on Election Law
DISTRICT OFFICE:
COMMITTEES
General Donovan State Office Building
Environmental Conservation
125 Main Street
Higher Education
Buffalo, New York 14203
Local Governments
(716) 852-2791
Transportation
FAX (716) 852-2794
ALBANY OFFICE:
Room 727
Legislative Office Building
June 9, 1995
Albany, New York 12248
(518) 455-5921
FAX (518) 455-3962
Mr. Doug Sosnick
Assistant to the President for Political Affairs
Executive Office of the President, 2nd Floor, West Wing
1600 Pennsylvania Avenue, Northwest
Washington, DC 20500
Dear Mr. Sosnick:
As a Democratic elected official representing a district that
voted Republican in the last State-wide election, I am concerned
about any policy that adds to government.
The Food & Drug Administration has received a lot of publicity
recently about Dr. Kessler's anti-vitamin crusade. This is just
what we need - more regulations! Surely, There are enough life and
death matters pending to keep the FDA busy.
At a time when the United States is losing its cutting edge in
high-tech medical devices to Europe because of the lengthy approval
process required by the FDA, I would think raiding health food
stores for vitamins would be a low priority. Vitamins do not pose
a health risk.
The President should point out this obvious fact to his FDA
commissioner.
Sincerely,
Paul A. Tokasz
Member of Assembly
PAT\kab
cc: Mr. Lcon Panetta, Chief of Staff to the President
Executive Office of the President, 1st Floor, West Wing
1600 Pennsylvania Avenue, Northwest
Washington, DC 20500
Printed on recycled paper.
04/03/95 12:06
001
The White House
m.a.
2011 THE
DOMESTIC POLICY
FACSIMILE TRANSMISSION COVER SHEET
TO:
Jen Klen
FAX NUMBER: 6-2878
TELEPHONE NUMBER:
FROM: Chris
TELEPHONE NUMBER:
PAGES (INCLUDING COVER): 7
COMMENTS:
04/03/95 12:07
002
stown DI. for bornin China to Jen KYN
DRAFT - 3/30/95
send
Also WIKSAO stiff:
1
stull from Person
REINVENTING
2
REGULATION OF DRUGS
AND MEDICAL DEVICES
National Performance Review
April, 1995
04/03/95
12:07
003
OVERVIEW
"Today, Americans don't have to worry about
safety or effectiveness when they buy [drugs
and medical devices]-from cough syrups to
the latest antibiotics or pacemakers. The
Food and Drug Administration has made American
drugs and medical devices the envy of the
world and in demand all over the world. And
we should never forget that, either. And we
are going to stick with the standards we have-
the highest in the world. But strong standards
need not mean business as usual in every area."
President Clinton, March 16, 1995
Introduction
Reforming the Federal government's regulatory processes, while maintaining critical
public health and safety standards, has been and will continue to be a top priority for the
Clinton Administration. Consistent with this commitment, President Clinton and Vice-
President Gore asked Health and Human Services Secretary Donna Shalala to help them
carefully examine FDA's regulatory requirements.
As part of the Vice-President's reinventing government initiative, the FDA has been
reviewing its regulatory processes to determine which requirements could be reduced or
eliminated without lowering health and safety standards. This report contains
recommendations resulting from the initial phase of that review.
Background
The Food and Drug Administration is the Agency within the Department of Health
and Human Services charged with ensuring that drugs, vaccines, and medical devices are
safe and effective and that foods meet basic safety standards. In carrying out these and other
responsibilities, FDA oversees more than $1 trillion worth of products, which account for 25
cents of every dollar spent annually by American consumers.
2
04/03/95
12:07
004
FDA was created in 1906 to protect Americans from unsafe foods and drugs. In
1976, FDA's responsibilities were expanded to include medical devices. During this
Administration, FDA has taken significant initial steps to streamline the regulatory process.
These recent initiatives have resulted in new products being brought to market sooner; but
more can be done.
A Record of Accomplishment
FDA's recent regulatory improvements include:
0
Shortening Review Times for New Drugs and Devices
1)
FDA now uses expert review panels to expedite the review of certain
biotechnology products (for example, a joint committee of FDA experts
oversaw the licensing in record time of the drug interferon beta 1b.to treat
certain patients with multiple sclerosis).
2)
Under the Prescription Drug User Fee Act of 1992, drugs are now reviewed
more quickly. This law authorizes FDA to charge user fees for drug
applications, and to use these additional resources for the reviews of new
drugs, vaccines, and biotechnology products.
Already, review times for new chemical drugs have dropped from an average
of 30 months in 1992 to 20 months in 1994. 1 By 1997, FDA will be getting
these products to market in a year or less, as fast or faster than anywhere else
in the world, with no sacrifice in review quality. [APPROVAL CHART]
3)
Medical devices are benefiting from a number of new processes that speed up
their review; for example, devices that provide significant medical advances
are now given priority review.
4)
Animal drugs are now reviewed in a more efficient manner that resulted in a
record number of 38 new drugs approved in 1994.
o
Eliminating Unnecessary Regulatory Burden
1)
The FDA exempted 148 categories of low risk medical devices from premarket
review in December 1994, relieving manufacturers from submitting
applications to the Agency and waiting for their approval.
1
The 1994 median review time for all new chemical drugs was 17.5 months; (the subset of drugs reviewed
in 1994 under the user fee program were reviewed in a median time of 13.5 months).
3
04/03/95
12:07
005
2)
The FDA has helped to assure safe and high quality mammography by using
existing private sector standards to certify mammography facilities, which are
mostly small businesses. Utilizing these standards allowed the FDA to
implement the requirements of the 1992 law that all of these facilities be
accredited and certified.
3)
FDA has begun a joint program with the Customs Service to automate the
entry of imported products into the U.S. The program allows an importer to
notify FDA by computer of import entries and receive prompt permission to
enter this country.
4)
FDA has issued a proposed regulation to permit regulated companies to use
electronic records and signatures in place of paper. This will save industry
substantial costs by simplifying record-keeping and speeding the filing of
applications and other regulatory documents.
As noted in the President's State of the Union address and his recent announcement
highlighting some of the recommendations in this report, this Administration is committed to
promoting results and not rules. The reforms this report advocates will reduce paperwork
and eliminate necessary regulation. In so doing, they will strengthen the economy while
maintaining health and safety.
Principles for Reforming FDA Regulation in Carrying out this Review
In carrying out its regulatory review, the Agency carefully considered the financial
burdens that its requirements impose on industry and consumers and looked for ways to
allocate or eliminate these burdens. In reforming its procedures and requirements, FDA
followed these principles:
o
Using performance standards, rather than command and control regulations,
whenever possible;
o
Expediting product review, without sacrificing the health and safety of the public;
0
Eliminating unnecessary requirements that may have been appropriate once but are
not now necessary to public health; and
o
Utilizing modern automated technology as a tool in streamlining internal Agency
management and as an aid to industry in meeting their regulatory requirements.
4
04/03/95
12:08
006
Regulatory Reform Recommendations
FDA is proposing a number of reforms that reinvent how FDA regulates. The
reforms included in this report are estimated to save the drug and device industries $500
million per year in unnecessary regulatory costs. These reforms will also let FDA better
target its resources.
o
Reducing or eliminating many of the FDA requirements for companies to get
approval for changes in their manufacturing facilities or processes for manufacturing
drugs, biotech drugs, and other biologics;
Allowing manufacturers of biological drugs to get licenses for pilot facilities
instead of making them build full-scale plants. Manufacturers will still have to show
they can meet safety, purity, and potency standards;
Permitting greater flexibility in the appearance of distributors' names on
biological product containers, package labels, and labeling;
0
Eliminating outdated requirements for insulin and antibiotics and allowing a private
standard-setting body to establish testing and quality standards (thus 600 pages of
Federal regulations will be eliminated);
0
Excluding drug and biologic manufacturers from requirements for most
environmental assessments, which currently cost tens of thousands of dollars each
time a new product is developed and provide no real benefit to the environment;
O
Exempting nearly 125 additional categories of low-risk medical devices from
premarket review;
o
Eliminating the "Reference List" by clarifying that market clearances of low-risk
devices will not be withheld unless FDA finds a reasonable relationship between the
nature of current violations and the application under review;
0
Developing a pilot program for review of low-risk medical devices by outside
review organizations to determine if such a system could be developed permanently;
o
Speeding the marketing of medical devices by seeking authority to charge industry
user fees for device reviews, and committing FDA to meet certain strict performance
goals;
o
Expanding opportunities to export drugs and medical devices to industrialized
countries;
5
04/03/95
12:08
007
0
Issuing a public statement clarifying how FDA determines the effectiveness of new
drugs and devices;
0
Harmonizing FDA's drug and device approval requirements with those of other
countries, thus expediting worldwide marketing of new products by reducing
duplicative testing;
0
Expanding and standardizing the use of new information technologies for review of
new products and to speed up import entries.
Additional proposals for reforming the regulation of drugs and medical devices are
being developed and will be announced in a later report. They will accompany
recommendations related to the regulation of foods and veterinary products.
6
MEMORANDUM
To: Carol Rasco
Elaine Kamarck
Greg Simon
Sally Katzen
Jennifer Klein
Paul Weinstein
Shannah Koss
From: Chris Jennings
Date: April 18, 1995
Re:
FDA Report Clips
Attached for your information are the clips from the FDA report. I thought that you might
like to have a set.
By LAURAN NEERGAARD
Associated Press Writer
WASHINGTON (AP) - The Food and Drug Administration is preparing
to allow private organizations to review whether certain medical
devices are safe and effective enough to offer American patients,
Clinton administration documents show.
The move IS part of a package oi FDA reforms announced by Une
White House today that could save medical industries $500 million
annually in regulatory costs.
FDA critics, who say the agency takes too long to approve new
treatments, have clamored for the United States to copy Europe.
There, new medical devices from X-rays to heart valves are reviewed
by government-accredited firms that decide whether they can be
sold.
The FDA won't go that far.
In an experiment set to begin early next year. FDA will accredit
private firms to review certain low-risk medical devices such as
the cholesterol and drug-abuse tests performed in doctors'
laboratories and electronic stethoscopes for measuring heartbeats.
Those firms will decide whether the devices work properly and
are safe. The FDA retains the final say, but is expected to quickly
follow the outside reviewers' decision unless it finds evidence
that the devices shouldn't be used on patients.
The two-year pilot program will demonstrate whether critics are
right in contending that outside scientists can do the medical
testing and safety review faster than the government. If SO,
private firms might be allowed to review other FDA-regulated
products, the reform plan says.
The plan comes as the Republican-controlied Congress, prompted
by complaints from medical companies and conservative think tanks,
prepares to overhaul the FDA. Although agency approval times are
improving, it still can take two years to approve a new medicine
for sale. FDA Commissioner David kessler was addressing those
issues at a Senate hearing today.
Some critics have called for even more drastic revamping of FOA.
including having the agency only certify drugs' safety and letting
individual doctors determine whether they actually work.
The privatization plan is very cautious. resembling one put
forth earlier this week by FDA supporter Ren. Ron hyden. D-Ore.
But consumer advocates fear privatizing FDA functions will enganger
public health.
These private firms "may be making decisions based more on who
fills their pocketbook than what is best for the public health.
said Dr. Sidney Wolfe of Public Citizen, a consumer watchdog group.
He said that the program is likely to cost more in training
private firms on FDA standards. Companies that choose to
participate in the pilot program will have to pay the reviewers a
yet-to-be-determined fee.
The FDA two weeks ago took its first tentative reform steps,
including eliminating 125 very low-risk medical devices, such as
bandages, from agency review.
The reforms announced today go much further:
-Biotech firms would no longer have to build full-scale
manufacturing plants before the FDA determined whether their drugs
could be sold. This rule stemmed from biotech's earliest days, when
doctors feared drugs made from living material might turn out
differently when they moved from pilot-sized facilities to huge
plants after FDA approval. The change would save 100-500 companies
now awaiting FDA approval some $25 million apiece in construction
costs.
-Medical companies would no longer have to get special FDA
approval to export products that aren't yet approved here but are
wanted by other industrialized countries. The industry savs this
red tape has sent dozens of U.S. firms overseas.
-FDA will harmonize its requirements for new medicines with
those of other nations, so companies don't have to redo
international research in Americans before the FDA will approve a
product.
The reforms are "a significant step in the right direction.
said Alan Magazine of the Health Industry Manufacturers'
Association, who lobbied for several of the changes.
04-06 4:54p
With AM-Retooling FDA
By The Associated Press
Some reforms the Food and Drug Administration announced Thursday
to speed new therapies to market:
- A two-year pilot program to see if private companies can
determine the safety and effectiveness of certain low-risk medical
devices faster than the FDA, although the agency retains the final
decision.
-Ending a requirement that makers of genetically engineered
drugs build a full-scale factory before the drugs are approved.
-Ending FDA review before drugs and medical devices not approved
for sale in the United States can be exported to countries that
have approved them. The FDA says it has never blocked an export, so
the rule was unnecessary. But it is federal law, so Congress must
formally adopt this measure; legislation already has been
introduced.
-Exempting an additional 125 categories of very low-risk medical
devices, such as dermatology lasers and oxygen masks, from any FDA
review. The FDA already has exempted 440 categories.
-Harmonizing FDA standards with international medical standards
so the FDA can accept drugs tested abroad instead of insisting they
be rechecked in Americans.
-Accepting a single major clinical trial as evidence a drug
works, something the agency has already done on occasion.
-Reducing or eliminating requirements for companies to get FDA
approval before improving the way they manufacture products.
AP v5200 rw 3exec Retooling FDA, 540
04-06 4:46p
Clinton Reforms to Include Test of Partial FDA Privatization
With AM-FDA Reform List
By LAURAN NEERGAARD
Associated Press Writer
WASHINGTON (AP) - The Food and Drug Administration is turning
part of its job over to private companies in an attempt to speed
new medical devices to American patients, officials said Thursday.
But senators said that's not nearly enough reform.
"We need a sense of urgency, we need a commitment, we need a
passion for change, and if not, 1 think the Congress is going to
roll right over you, Sen. Barbara Mikulski, D-Md warned FDA
Commissioner David Kessler.
A package of FDA reforms announced by the White House on
Thursday would save medical industries $500 million a year in
regulatory costs.
The changes make it easier for companies to export therapies
that aren't approved for sale here and to get FDA approval for
medicines tested abroad and those given just one major trial in
people, instead of multiple testing. Also, the FDA would begin
approving genetically engineered drugs before companies build the
full-scale plants to produce them, and thousands of low-risk
medical devices could be sold without any FDA inspection.
But the biggest change is a two-year experiment to see if
private firms can do part of the FDA's job faster than the
government.
FDA critics say the agency takes too long to approve new
treatments. They have clamored for the United States to copy
Europe, where government-accredited firms decide whether new
medical devices, from X-ray equipment to heart valves, can be sold.
The FDA's pilot program won't go that far. The FDA will accredit
companies to decide whether certain low-risk medical devices, such
as laboratory cholesterol tests and electronic stethoscopes. are
safe and effective.
The FDA retains the final sav, but is expected to quickly follow
the outside reviewers' decision unless it finds evidence that the
devices shouldn't be used. If the experiment succeeds, private
companies might be allowed to review other FDA-regulated products.
Consumer advocates said the plan is dangerous.
Private firms "may be making decisions based more on who fills
their pocketbook than what is best for the public health, said
Dr. Sidney Wolfe of Public Citizen, a consumer watchdog group.
But critics said the FDA isn't going far enough.
The FDA reforms are "common-sense and, in some cases, long
overdue first steps," Sen. Nancy Kassebaum, R-Kan., told a Labor
and Human Resources Committee hearing. "More profoundly, basic
change must occur in the very way that the FDA sees its mission.
Sen. Judd Gregg, R-N.H., accused Kessler of delaying lifesaving
medicine for Americans.
"I don't know of a drug today that is an important therapeutic
advance, that could be lifesaving, that we are holding up,"
Kessler responded. But, he added. "we are also a regulatory agency
and sometimes when you're a regulatory agency, you have to say
no. the data's not there" to support a new medicine.
Gregg said Americans don't know about delays because companies
are too afraid of FDA retaliation to speak up.
Kessler said he was bewildered by such allegations. but added:
"There's no excuse for an environment or culture of
confrontation.
"
|FDA]
A26 FRIDAY, APRIL 7, 1995
THE WASHINGTON POST
FDA: Reforms That Address
Industry's Lasting Complaints
By John Schwartz
Washington Post Staff Writer
There are two points of view concerning the Food and
Drug Administration. The agency's critics say, "There's
much that could be improved-but the FDA has made
great strides in recent years."
Then there's the agency's defenders, who say, "The
FDA has made great strides in recent years-but much
could be improved."
The conflict is sometimes bitter. But the two sides ap-
pear to be heading toward common ground.
Yesterday FDA Commissioner David A. Kessler an-
nounced several reforms within his agency as part of the
Clinton administration's National Performance Review,
continuing streamlining that has been going on for more
than two years. The reforms involve nuts-and-bolts chang-
es that might make the typical consumer's eyes glaze over
but which address some long-standing industry complaints.
FDA will lift many requirements for companies making
minor changes to their manufacturing processes. It will let
biotechnology companies set up small pilot plants to prove
that they can meet standards for their new products in-
stead of requiring them to have full-scale plants in place.
The agency also proposed eliminating outdated manufac-
turing standards for insulin and some antibiotics.
Also, the FDA exempted 125 kinds of low-risk medical
devices from agency review requirements, adding to the
list of nearly 150 product categories recently exempted
from the review process. Kessler promised to develop a pi-
lot program to let outside organizations review some medi-
cal devices, and pledged to more closely align FDA and for-
eign approval procedures.
ASSOCIATED PRESS
FDA Commissioner David A. Kessler discusses proposed
But there are limits to how far reform can go without
agency streamlining on Capitol HIII. "It's not very
compromising safety, Kessler told the Senate Labor and
popular being a regulator today," he said.
Human Resources Committee. "In this country, we sit
down to dinner without even thinking about about whether
the food on the table is safe. We purchase drugs for our
children without thinking about whether they work. We of-
ten don't think twice about the new technologies being
used when we go to the emergency room.
In the end, it
is FDA's independence that gives the American people con-
fidence in the agency's decisions."
One of the FDA's strongest critics had harsh words for
the new proposals. Paul Beckner, president of Citizens for a
Sound Economy, a pro-business think tank, said, "The FDA
reforms are too few and come too late. They are a cosmetic
fix to an agency that needs a fundamental shaking."
But Alan H. Magazine, executive director of the Health
Industry Manufacturers Association, described the propos-
als as an encouraging trend. The plan and legislation spon-
sored by Rep. Ron Wyden (D-Ore.) show that Democrats
are ready to work on a bipartisan basis, he said.
"I think now that the dust is settling, cooler heads are
prevailing-and the right and left are moving to the mid-
dle," Magazine said.
When asked why the agency was under attack from so
many quarters-including a tongue-lashing yesterday from
Sen. Barbara A. Mikulski (D-Md.)-Kessler said, "It's fair
to say it's not very popular being a regulator today."
He added, "Sometimes you have to say no-and you
don't make any friends when you have to say no."
WASHINGTON
A4
FRIDAY. APRIL '. 1995
Administration
Offers Plans
O Reform FDA
Health: Proposals include
program to let outside experts
review safety and efficacy of
certain experimental medical
devices.
By MARLENE CIMONS
TIMESSIAFF WRITER
W
ASHINGTON-In an apparent
effort to head off a Republican-
driven overhaul of the Food and Drug
Administration, the White House on
Thursday proposed a series of agency
reforms, including a pilot program that
would allow outside experts to review cer-
tain experimental medical devices for
lety and efficacy.
Associated Press
The FDA. which in recent years has
FDA's David A. Kessler told senators: "It's not very popular being a regulator today."
speeded up the approval process for break-
through and life-saving drugs, has been
He added: 'My bottom line is that the
Kessler also called on Congress to
under increasing attack by GOP lawmak-
agency should be able to make decisions in
approve "user fee" legislation in connection
ers. the device industry and conservative
an environment of independence."
with medical devices, similar to what
think tanks for being overly cautious-and
already cxists for drug approvals. This
Sen. Nancy Landon Kassebaum (R-
too sluggish-ir. getting new devices onto
Kan.), who chairs the committee. called the
would require companies to pay fees that
the marketplace. Critics repeatedly have
Administration's proposals common-scnse
would be used to cover the costs of reviews.
cited the model in many European coun-
and
long overdue first steps toward
Such additional resources "are essential" in
tries. where such non-governmental
eliminating obsolete and marginally umpor-
reducing backlogs and speeding review
reviews are permitted.
tant regulatory requirements." The mea-
times. Kesaler said. Device user-fee
FDA Commissioner David A. Kessler,
sures "are a start, but [I] would look for
legislation was introduced in the last Con-
who announced the proposals in an
much greater strides if we are truly going to
gress but time ran out on the session before
address the issue." she added.
appearance before a Senate committee, in
lawmakers could act.
the past has acknowledged that the agency
And Sen. Judd Gregg (R-N.H.), in
could do better In device regulation. But he
stressing the need for changes within the
Two weeks ago. the agency announced
the elimination of 125 low-risk medical
also has pointed out that the agency has
agency. told Kessler: "We don't sense It [the
FDA) is in balance right now."
devices-such as bandages-from FDA
limited resources to meet its numerous
responsibilities. which-in addition to reg-
Kessler prodicted that the reforms could
review and Thursday proposed exempting
more than 100 additional items. such as
ulating foods, drugs. cosmetics and
save industry $500 million annually.
powered finger exercisers and certain kinds
devices-include responding to public
Alan Magazine of the Health Industry
of syringes.
emergencies, such as product tampering.
Manufacturers' Assn., which also has been
lobbying for reforms. called them "a signif-
Kessler said the agency also would end
Kessler, testifying before the Senate
icant step in the right direction."
the so-called "reference list," a program
Labor and Human Resources Committee-
that deferred agency clearance of device
which has jurisdiction over the FDA-
stressed that the agency is engaged in a
he two-year experiment with non-
applications until a company corrected
T
government experts, which will begin
manufacturing violations identified during
constant "balancing act" that must weigh
next fall. will allow the outside review of
plant inspections. Applications will be
protecting the consumer from unsafe or
low- and moderate-risk devices. such as
delayed "only where there is a relationship
ineffective products against making new
technologies available as quickly as possi-
electronic stethoscopes and cholesterol and
between the violation discovered and the
ble. The agency must never lose sight of
drug-abuse test kits used in laboratories.
pending application." he said.
that equation, he said.
These experts would then make a recom-
mendation to the agency, which would have
U
nder the new proposals. manufacturers
"People want access [to new drugs and
the ultimate say.
no longer will be required to obtain
Kessler cautionsd. however, that "there
special agency approval to export unap-
devices] but. if something goes wrong. they
want to be able to blame somebody." he
276 legitimate, serious questions as to
proved products overseas if other industrial
countries want them. Kessler said.
said. "It's not very popular being a regula-
whether such a system would work in this
tor today. You don't make any friends when
country-such as whether the capacity
Kessler said the agency also will try to
you Bay no. [But] you can't deregulate the
exists
for such reviews, whether it
work with other countries in using research
safety of food and drugs. It's just not going
would provide the same quality control and
conducted abroad so that studies might not
to work.
whether private reviewers could be
have to be duplicated in the United States
Independent."
for approval.
Friday, April 7, 1995
Los Angeles Times
"Administration Offers Plans
to Reform FDA"
Drug companies no longer will have to
construct full-acale manufacturing facilities
before their drugs are approved—
requirement that arose from past fears that
drugs made from living material could
change when they moved from smaller
plants to larger ones.
Kessler also said that except in rare
instances, the agency will no longer require
environmental impact assessments for new
drugs because "in virtually all cases, there
is no significant impact." Yet, he said, "these
evaluations costs tens of thousands of
dollars."
THE WALL STREET JOURNAL FRIDAY, APRIL 7, 1995 B3
White House Moves to Speed Up Action
At FDA as Agency Is Scolded in Senate
By LAURIE McGINLEY
staff Reporter of THE WALL STREET JOURNAL
Legislation on Exports
WASHINGTON - The Clinton adminis-
tration took steps to speed up approvals of
Easing export restrictions on unap-
drugs and medical devices, even as sena-
proved drugs and devices would require
legislation, Dr. Kessler said. Some mem-
tors scolded the Food and Drug Adminis-
tration about a "culture of confrontation"
bers of Congress recently have introduced
and urged more-sweeping changes.
legislation to ease the export rules.
Two of the biggest changes announced
Alan Magazine, president of the Health
by the White House involve creating a pilot
Industry Manufacturers Association,
which represents device makers. called the
program that would use outside experts to
review certain low-risk medical devices to
changes "important first steps toward
determine if they should be approved, and
ensuring that patients receive more timely
easing restrictions on the export of unap-
access to safe and effective medical tech-
proved drugs and devices to other industri-
nology." Sen. Nancy Kassebaum (R.,
alized countries.
Kan.), who heads the Labor and Human
The changes, which administration of-
Resources Committee, said that although
ficials claimed would save industry an
the changes announced yesterday "are
estimated $500 million annually in regula-
common sense and long overdue," more
tory-compliance costs, went beyond steps
are needed.
announced at a "reinventing government"
But the announced changes are un-
news conference held last month at the
likely to assuage conservative critics of the
White House.
agency. For example, the Competitive En-
Warning From Sen. Mikulski
terprise Institute, a Washington-based
"Congress is going to roll right over
group, has recommended that drugs and
you" if more improvements aren't forth-
devices that don't meet the FDA's stan-
coming, Sen. Barbara Mikulski (D., Md.)
dards shouldn't be banned, but should be
warned FDA Commissioner David Kessler
available under doctors' supervision with a
at a hearing of the Senate Labor and
warning of their unapproved status. Other
Human Resources Committee. Her criti-
critics say the FDA's efficacy standard
cisms were especially notable coming from
should be weakened or eliminated, allow-
a Democratic lawmaker. The FDA is lo-
ing the marketplace to decide which treat-
cated in Sen. Mikulski's state, as are
ments work.
several biotechnology companies that have
After the hearing. Dr. Kessler said,
expressed frustrations with the agency.
"We're open to thoughtful reforms, but my
Although the senators pointed to some
bottom line is making sure that the agency
specific difficulties, much of the criticism
is able to make these decisions in an
focused on such intangibles as the general
environment of independence."
attitude of FDA employees toward indus-
try. Sen. Judd Gregg (R., N.H.) said he
hears frequent complaints from constitu-
ents about a "culture of confrontation
rather than cooperation" at the agency.
The two-year pilot program announced
yesterday would allow the agency to ex-
plore a notion pushed by many of the
FDA's critics - that outside analysts can
get certain jobs done more quickly and
efficiently than FDA bureaucrats. The
agency, however, will have the final word
on whether any device is actually ap-
proved.
The pilot program also is a nod to critics
who say the U.S. should switch to a
European-style review process. In Europe,
device makers pay a third-party organiza-
tion to conduct reviews, and if the device
gets a favorable rating, it is marketed
without prior government approval; the
government monitors the device after it
goes on the market.
PAGE A6 / FRIDAY, APRIL 7, 1995
The Washington Times
FEDERA REPORT
FDA to leave firms to devices
Privatization of some functions part of agency reform
ASSOCIATED PRESS
proving genetically engineered
unless it finds evidence that the
The Food and Drug Administra-
drugs before companies build the
devices shouldn't be used. If the
tion is turning over part of its job
full-scale plants to produce them,
experiment succeeds, private
to private companies in an attempt
and thousands of low-risk medical
companies might be allowed to re-
to speed new medical devices to
devices could be sold without any
view other FDA-regulated prod-
American patients, officials said
FDA inspection.
ucts.
yesterday.
However, the biggest change is
Consumer advocates said the
But senators said that's not
a two-year experiment to see
plan is dangerous.
nearly enough reform.
whether private firms can do part
"We need a sense of urgency, we
of the FDA's job faster than the
Private firms "may be making
need a commitment, we need a
government.
decisions based more on who fills
passion for change - and if not, I
FDA critics say the agency
their pocketbook than what is best
think the Congress is going to roll
takes too long to approve new
for the public health," said Dr. Sid-
right over you," Sen. Barbara A.
treatments. They have clamored
ney Wolfe of Public Citizen, a con-
Mikulski, Maryland Democrat,
for the United States to copy Eu-
sumer watchdog group.
warned FDA Commissioner David
rope, where government-accred-
Critics said the FDA isn't going
Kessler.
ited firms decide whether new
far enough.
A package of FDA reforms an-
medical devices, from X-ray
The FDA reforms are "common-
nounced by the White House yes-
equipment to heart valves, can be
terday would save medical indus-
sold.
sense and, in some cases, long
tries $500 million a year in
The FDA's pilot program won't
overdue first steps," Sen. Nancy
go that far. The FDA will accredit
Landon Kassebaum, Kansas Re-
regulatory costs.
The changes make it easier for
companies to decide whether cer-
publican and chairman of the Sen-
ate Labor and Human Resources
companies to export therapies
tain low-risk medical devices,
that aren't approved for sale here
such as laboratory cholesterol
Committee, said during a hearing.
and to get FDA approval for medi-
tests and electronic stethoscopes,
"More profoundly, basic change
cines tested abroad and those
are safe and effective.
must occur in the very way that
the FDA sees its mission."
given just one major trial in peo-
The FDA retains the final say
ple, instead of multiple testing.
but is expected to quickly follow
Sen. Judd Gregg, New Hamp-
Also, the FDA would begin ap-
the outside reviewers' decisions
shire Republican, accused Dr.
Kessler of delaying lifesaving
medicine for Americans.
"I don't know of a drug today
that is an important therapeutic
advance, that could be lifesaving,
that we are holding up," Dr. Kess-
ler responded. "We are also a reg-
ulatory agency
and sometimes
when you're a regulatory agency,
you have to say no, the data's not
there" to support a new medicine.
Sen. Barbara A. Mukulski says
Congress is impatient with FDA.
WASHINGTON FAX™
An information and communication service
Life Science
April 7, 1995
FDA HEAD LAYS OUT SPECIFICS OF REGULATORY REFORM TO SENATE
CLAIMING PROPOSALS WILL SPEED UP DRUG AND DEVICE REVIEW PROCESS
Food and Drug Administration (FDA) Commissioner David Kessler arrived at
a Senate hearing yesterday armed with a sheaf of regulatory reforms he
claimed would get drugs and medical devices to market faster while
saving industry $500 million annually.
Kessler, under fire from Republicans--and some Democrats as well--for
running an agency whose "culture" they say has become "hostile" and
"obstructionist" in its dealings with industry, told members of the
Senate Labor and Human Resources Committee that the Clinton
administration was presenting that very day "a number of initiatives to
improve the speed and efficiency of the drug and device review process."
"These reforms, which have been developed under the leadership of Vice
President Al Gore's National Performance Review, build on what the
agency has accomplished over the last several years in speeding reviews
and expanding access to promising therapies," Kessler said in a prepared
statement. "Some of the reforms speak directly to reduced time for
review and approval. Others aim to reduce excessive regulatory burdens
that cost industry unnecessary time and money, and cost the agency
precious resources."
According to documents Kessler submitted with his testimony, the
regulatory changes announced by FDA, and published in the April 6
Federal Register, will accomplish a number of things:
They will allow companies that make drugs and biological products to
change the manufacturing process for an approved drug without first
getting clearance from FDA, if risks are shown to be negligible.
Biotech companies will be able to use "pilot" facilities instead of
large manufacturing plants to produce their products, a move FDA says
will "lower start-up costs" and hasten production.
Special requirements for manufacturing insulin and antibiotic drugs
will be eliminated.
Pharmaceutical and biotech companies will largely be excluded from
rules requiring environmental assessments.
Up to 125 categories of low-risk medical devices will be added to
those that are exempted from pre-market review.
A pilot program will be initiated to test the review of medical
devices by experts outside of FDA, and FDA will ask Congress to
approve a regimen of user fees designed to further speed medical
device review.
Industry will be given greater freedom to export unapproved drugs and
medical devices to industrialized countries.
Page 2 of 2
(LS - WASFAX 4/7/95)
FDA (Cont'd)
Sen. Nancy Kassebaum, R-KS, who chairs the Senate Labor and Human
Resources Committee, said the changes outlined by Kessler were "common
sense, and in some cases long-overdue first steps toward eliminating
obsolete and marginally important regulatory requirements." However, she
said that "more profoundly, basic changes must occur in the basic way
that the FDA sees its mission."
Though Republicans have generally been viewed as the party leading the
charge for reform at FDA--House Speaker Rep. Newt Gingrich, R-GA, is
particularly harsh in his assessment of Kessler--it was a Democrat,
Maryland Sen. Barbara Mikulski, who delivered the day's sternest
admonition.
Mikulski was unsatisfied with the response she received from Kessler
about why FDA cannot agree with industry to classify certain genetically
engineered materials as chemicals, thus reducing some of the regulatory
burden for biotech companies.
After telling Kessler that FDA needs a "21st century (regulatory)
framework and not a 1970s framework," she went on to say that "there is
enormous frustration" in the private sector about FDA's "attitude," it's
"approval" process and its "nitpicking."
"We really have to get with the program," Mikulski told Kessler. "We
need a passion change (at FDA)
or Congress is going roll right over
you."
Sen. Judd Gregg, R-NH, said Mikulski "touched on the core issue here."
"There is a view out there that the culture of FDA is stifling the
capacity of the market," Gregg said, adding that the biggest problem is
"not the regulatory structure" but what he perceived was a pervasive
anti-industry attitude at FDA.
Kessler responded that FDA is working hard to respond to the concerns of
industry, calling attention to its efforts to dramatically expedite the
approval process for potentially life-saving drugs.
"Senator, I don't know of any drug today that has important therapeutic
advances than can be life saving that we are holding up," Kessler told
Gregg. "When it comes to products that don't have important therapeutic
advances then we have to play by the rules."
Mikulski told Kessler that "no one would want FDA not to play by the
rules," but that what many Senators hear is that there is an
"adversarial environment" at FDA, that agency officials don't return
phone calls and that industry officials worry that they'll face
retaliation from FDA if they complain.
Compiled and Published by WASHINGTON FAX: AN INFORMATION SERVICE
Publisher & Editor: Bradie Metheny
Managing Editor: Shirley Haley
Marketing/Sales: R. Henry Norweb
Contributing Writer: Matthew Davis
Phone: 508-999-6097 Fax: 508-994-9366
04-06 4:46p
By LAURAN NEERGAARD
Associated Press Writer
WASHINGTON (AP) - The Food and Drug Administration is turning
part of its job over to private companies in an attempt to speed
new medical devices to American patients, officials said Thursday.
But senators said that's not nearly enough reform.
"We need a sense of urgency, we need a commitment. we need a
passion for change, and if not, I think the Congress is going to
roll right over you," Sen. Barbara Mikulski. D-Md., warned FDA
Commissioner David Kessler.
A package of FDA reforms announced bv the White House on
Thursday would save medical industries $500 million a year in
regulatory costs.
The changes make it easier for companies to export therapies
that aren't approved for sale here and to get FDA approval for
medicines tested abroad and those given just one major trial in
people, instead of multiple testing. Also, the FDA would begin
approving genetically engineered drugs before companies build the
full-scale plants to produce them, and thousands of low-risk
medical devices could be sold without any FDA inspection.
But the biggest change is a two-year experiment to see if
private firms can do part of the FDA's job faster than the
government.
FDA critics say the agency takes too long to approve new
treatments. They have clamored for the United States to copy
Europe, where government-accredited firms decide whether new
medical devices, from X-ray equipment to heart valves, can be sold.
The FDA's pilot program won't go that far. The FDA will accredit
companies to decide whether certain low-risk medical devices, such
as laboratory cholesterol tests and electronic stethoscopes, are
safe and effective.
The FDA retains the final say, but is expected to quickly follow
the outside reviewers' decision unless it finds evidence that the
devices shouldn't be used. If the experiment succeeds. private
companies might be allowed to review other FDA-regulated products.
Consumer advocates said the plan is dangerous.
Private firms "may be making decisions based more on who fills
their pocketbook than what is best for the public health, said
Dr. Sidnev Wolfe of Public Citizen, a consumer watchdog group.
But critics said the FDA isn't going far enough.
The FDA reforms are "common-sense and, in some cases, long
overdue first steps. Sen. Nancy Kassebaum. R-Kan. told a Lawor
and Human Resources Committee hearing. "More profoundly. basic
change must occur in the very way That the FHE SPFF 115. mission.
Sen. Judd Gregg. R-N.H.. accused hessier of delaying lifesaving
medicine for Americans.
"I don't know of a drug today that is an important therapeutic
advance, that could be lifesaving, that we are holding up,"
Kessler responded. But, he added, "we are also a regulatory agency
and sometimes when you're a regulatory agency, you have to say
no, the data's not there" to support a new medicine.
Gregg said Americans don't know about delays because companies
are too afraid of FDA retaliation to speak up.
Kessler said he was bewildered by such allegations, but added:
"There's no excuse for an environment or culture of
confrontation.'
FDAI
NYT A2361 uw taf-z FDA-NEW-PRODUCTS-NYT@
04-06
7:07p
BC-FDA-NEW-PRODUCTS-NYT
FDA MOVES TO HASTEN MARKETING OF NEW DEVICES
(bl)
By PHILIP J. HILTS
c.1995 N.Y. Times News Service
WASHINGTON - Hoping to head off greater changes that might De
proposed in Congress, the Clinton administration announced plans
Thursday to have the Food and Drug Administration ease the wav TO
market for some new drugs and medical devices.
Among the plans is a two-year pilot program in which review of a
number of medical devices will be turned over to private groups.
The commissioner of food and drugs, Dr. David A. Kessier,
outlined the changes at a hearing of the Senate Labor and Human
Resources Committee, saying the FDA was committed to eliminating
red tape while continuing to make sure that drugs and medical
instruments are both safe and effective.
Sen. Barbara A. Mikulski, D-Md., joined several Republican
members of the committee in warning the agency about what they
described as a confrontational attitude toward companies like the
biotechnology concerns in Senator Mikulski's own district.
"There is an enormous frustration in the private sector about
the agency's attitude. about nit-picking," she said. "We need a
passion for change at the FDA. And if not, I believe Congress is
going to roll right over you.
Kessler assured her that change had begun. "We believe many
medical devices simply don't pose a sufficient risk to be reviewed
by FDA prior to marketing," he said.
Accordingly, the two-year pilot program will enable 10
categories of medical devices - a total of 100 to 400 such
instruments that the FDA deems of low or medium risk - to be
reviewed not by the agency itseif but bv private medical groups.
These groups have not yet been chosen. or even solicited.
The manufacturers will pay for the private reviews. which are
expected to get under way in 1997.
Throughout the pilot program. the FDA will retain final
decision-making authority. That makes the program less sweeping
than the standard review procedure in some European countries that
have been approvingly cited by the American health manufacturing
industry.
Private groups accredited by the governments there have the
power to grant applications for medical devices.
Another of the changes announced Thursday will allow 125
categories of devices, which account for about 700 applications a
year, to be exempted from the need for FDA approval before going to
market. These categories include syringes, oxygen masks and simple
surgical lasers.
The agency has already exempted 441 categories of devices,
including stethoscopes and surgical microscopes. The new
exemptions, added to those earlier ones, mean that about a third of
all medical devices will now be exempt from review before
marketing.
In another change, companies will be allowed to export drugs
that are not approved for use in the United States but that do have
the approval of the countries to which they are sent.
The FDA plans to permit export to 21 countries with the best
safety records at first, and then consider expanding that number.
NYT-04-06-95 1912EDT<