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THE WHITE HOUSE WASHINGTON September 7, 1995 Dennis White Chair, Franklin County Democratic Party 279 East Livingston Avenue Columbus, Ohio 43215 Dear Mr. White: Thank you for writing to express your concerns about the Food and Drug Administration. Doug Sosnik forwarded your letter to me. The President has consistently said that the Federal government in general and the FDA in particular can regulate smarter -- with less micromanagement and intrusiveness. Working with Vice President Gore and the FDA, the President recently introduced a series of regulatory reforms designed to look at "outcomes" rather than "process" and to focus on the customers that we serve. Earlier this year, he released a report outlining specific reforms the FDA would implement to meet these goals. The President believes that more can and should be done to change the way the FDA regulates. However, he also believes that the FDA must continue to play an essential role in ensuring the safety and efficacy of drugs and devices and in maintaining the high quality of our foods. Like you, the President believes that adults are capable of making their own decisions about smoking. However, overwhelming evidence has shown that children are particularly susceptible to tobacco marketing. Some 3,000 young people take up smoking every day, and millions will ultimately lose their lives to it. That is why the President has authorized the Food and Drug Administration to initiate a broad series of steps to limit both minors' access to tobacco as well as the promotion and advertising that enhances the appeal of tobacco products to teens and children. The Administration's proposals to fight teen smoking do not constitute a ban on smoking or a threat to individual choices by adults. Instead, they are sensible steps that will help us forge a better future for our children. Dennis White September 7, 1995 Page 2 We will keep your comments in mind as the Administration moves forward in addressing these important issues. Thank you again for taking the time to write. Sincerely, Carol Caree Hasco H. Rasco Assistant to the President for Domestic Policy 6/23 CC Franklin County Democratic Party Huncox/Dous June 20, 1995 Mr. Don Fowler, Chairman Democratic National Committee 430 South Capitol Street, S.E. Washington, D.C. 20003 Dear Mr. Fowler: As chair of the Franklin County Democratic Party, I understand how critical Ohio will be to President Clinton's 1996 re-election campaign. I intend to work closely with you and others integral to next year's race to ensure that our state speaks strongly for the president. However, I am concerned about the FDA and the impact on voters that criticism of this agency may have on our re-election efforts. Voter perception of the FDA is that Commissioner Kessler follows his personal agenda above the public's agenda. Voters see the FDA as unreceptive and uncooperative, and as more interested in policing orange juice labeling than approving life-saving drugs and medical procedures like breast cancer detection pads. As a smoker, I also think the FDA may be crossing the line once too often when balancing individual choice versus health policy. This is an issue ripe for exploitation by Republicans in this state, and one that deserves greater attention from those close to the President. Perhaps the FDA should be targeted as part of your "Reinventing America" effort. It may be time for a change of leadership at the FDA. I appreciate your consideration of this letter. Sincerely, Dennis White Dennis White Chair, Franklin County Democratic Party cc: Mr. Harold Ickes, Asst. to the President and Deputy Chief of Staff for Policy and Political Affairs Executive Office of the President, 1st Floor, West Wing 1600 Pennsylvania Ave, N.W. Washington, D.C. 20500 1 Get Involved! Check "Yes" for the Ohio Political Party Fund on Your Tax Return. 279 East Livingston Avenue, Columbus, Ohio 43215 (614) 224-1193 FAX (614) 224-1196 Voice Mail (614) 224-0071 Paid for by Franklin County Democratic Party. Dennis L. White, Chair THE WHITE HOUSE gen FYI WASHINGTON for files September 7, 1995 Lynn H. Whatley, Esq. Whatley and Associates, P.C. Post Office Box 11230 Atlanta, Georgia 30310-0230 Dear Ms. Whatley: Thank you for writing to express your concerns about the Food and Drug Administration. Doug Sosnik forwarded your letter to me. The President has consistently said that the Federal government in general and the FDA in particular can regulate smarter - - with less micromanagement and intrusiveness. Working with Vice President Gore and the FDA, the President recently introduced a series of regulatory reforms designed to look at "outcomes" rather than "process" and to focus on the customers that we serve. Earlier this year, he released a report outlining specific reforms the FDA would implement to meet these goals. The President believes that more can and should be done to change the way the FDA regulates. However, he also believes that the FDA must continue to play an essential role in ensuring the safety and efficacy of drugs and devices and in maintaining the high quality of our foods. The President shares your concern for those people who earn a living in tobacco farming or related work. However, overwhelming evidence has shown that children are particularly susceptible to tobacco marketing. Some 3,000 young people take up smoking every day, and millions will ultimately lose their lives to it. Therefore, the President has authorized the Food and Drug Administration to initiate a broad series of steps to limit both minors' access to tobacco as well as the promotion and advertising that enhances the appeal of tobacco products to teens and children. These proposals do not constitute a ban on smoking, a threat to individual choices by adults, or an effort to destroy the tobacco industry. Instead, they are sensible steps that will help us forge a better future for children. Lynn H. Whatley, Esq. September 7, 1995 Page 2 We will keep your comments in mind as the Administration moves forward in addressing these important issues. Thank you again for taking the time to write. Sincerely, Carol CaroltRasco H. Rasco Assistant to the President for Domestic Policy Law Offices WHATLEY & ASSOCIATES, P.C. POST OFFICE BOX 11230 ATLANTA, GEORGIA 30310-0230 LYNN H. WHATLEY, Esq. (404) 752-8095 (404) 752-7592 FACSIMILE office June 18, 1995 Mr. Erskine Bowles, Asst. to the President and Deputy Chief of Staff Executive Office of the President, 1st Floor, West Wing 1600 Pennsylvania Avenue, N.W. Washington, D.C. 20500 Dear Mr. Bowles: As a practicing attorney who has worked very hard in my community, I have to disagree with what Dr. Kessler is doing as it relates to the FDA. Tobacco was one of our first agricultural crops and it also served as a basis for our nation's early economy. Today, thousands of people earn living in tobacco farming or related jobs. Dr. Kessler of the FDA is determined to destroy this important crop and its related industries. He wants to do this by expanding the FDA's authority. He does not care about the economic repercussions of his intended destruction of the tobacco industry. This is an outrageous and blatant example of government regulatory abuse. President Clifton cannot just sit back and allow this to happen. Fair is fair and it is definitely not fair for Dr. Kessler to use tax dollars to broaden his power base so he can destroy the way we earn those same tax dollars. I cannot stress how important I think it is for President Clinton to take action against Dr. Kessler. The President represents every American, even those who smoke. Whatley. cc: Doug Sosnick, Assistant to the President for Political Affairs THE WHITE HOUSE WASHINGTON September 18, 1995 W. David Leak, M.D. Pain Net, Inc. 1935 West Schrock Road Westerville, Ohio 43081 Dear Dr. Leak: Thank you for writing to share your thoughts on the health care system and on the Republican's plan to cut $450 billion from Medicare and Medicaid. I very much appreciate hearing from people, like you, who truly understand the impact that these cuts will have on the high quality health care that we are fortunate to have in this country. The President made his priorities clear in his balanced budget proposal. His budget showed that we can eliminate the deficit while protecting investments in health care and education and giving a targeted tax cut to middle-class Americans. He has also made it clear that he would veto the current Republican plan to sacrifice Medicare, Medicaid and education to pay for a huge and, we believe, unnecessary tax cut. The President values your efforts to share your expertise and experience as these issues continue to be debated in Congress and across the nation. As you wrote in your letter to Mr. Panetta, the American public needs to know about what the cuts currently being debated will mean for health care in this country. Sincerely, Carol Carol H. Rasco Assistant to the President for Domestic Policy CC: The Honorable Leon Panetta THE WHITE HOUSE AUG 29 1995 WASHINGTON August 9, 1995 W. David Leak, M.D. Pain Net, Inc. 1935 West Schrock Road Westerville, Ohio 43081 Dear Dr. Leak: Thank you for your letter concerning health care reform. I appreciate your kind words and your offer of assistance to the Administration. In order to give your request to discuss your health care experiences and ideas regarding reform the appropriate attention, I have forwarded your letter to Ms. Carol Rasco, Assistant to the President for Domestic Policy, and asked that she follow up with you directly. Again, thank you for writing. I hope you enjoyed your visit to Washington last month. Sincerely Lega E. Panetta Chief of Staff CC: The Honorable Carol Rasco LEP/tab PAIN NET, INC. July 12, 1995 Mr. Leon Panetta White House Chief of Staff Executive Office of the President White House Washington, D.C. Re: Clinton/Gore '96 Conference Call, Tuesday, July 12, 1995 Dear Mr. Panetta: I appreciate you taking the time out of your busy schedule to speak with the Business Outreach group concerning the Clinton/Gore '96 campaign. My areas of concern are, specifically, cuis in the area of health care and education. As you will recall, we previously discussed the significant impact that minor changes in the health care system have relative to overall outcome, i.e., the Krebs cycle ( a copy of which is enclosed ). I look forward to the meeting with the President in Washington, D.C., on July 25, 1995 at the Hay Adams Hotel. At this time, I would like to offer my assistance in the areas in which we have the most expertise to facilitate the process of dissemination of positive information. PAIN NET EDUCATION, INC. the company on the Advisory Committee for Trade Policy and Negotiations, mission is to advise the President on matters relative to trade. Our strongest area of expertise is in medicine, science and intellectual property. As an active physician practitioner in the current health care system, my experience and expertise is in the actual delivery of medical care. I am acutely aware of the day to day problems that are involved in both providing appropriate treatments and interventions, and securing them for those from whom they are medically indicated. Additionally, we have clinical experience, that relates to the inhuman outcomes and atrocities which occur, when the management of dollars takes precedence over the delivery of medically adequate, and necessary care to patients. These realities I believe need to be addressed, and if announced properly, can be used very favorably to help the issues that Mr. Clinton and Mr. Gore are promoting relative to the Administration's position. I am prepared to discuss these matters in detail, and provide examples of the horrors we currently encounter on a daily basis with our medical system. The institution of rapid monetary cuts, as proposed in the current congressional plan, will result in these occurrences escalating, and their impact becoming more abhorrent. Education with factual information delineating these dire consequences, I am convinced, will motivate the public to insist that humane solutions be developed to meet their present and future health care needs. 1935 W. Schrock Road Westerville, Ohio 43081 (614) 895-0449 FAX (614) 895-0442 page 2 July 12, 1995 Mr. Leon Panetta Again, I appreciate your time. Thank you. Sincerely, David Jaca W. David Leak, M.D. Chairman and Chief Executive, Officer Pain Net, Inc. Director, Pain Control Consultants, Inc. Diplomate, American Board of Pain Medicine WDL:bhs enclosure: copy of Krebs cycle cc: Mr. William J. Clinton, President of the United States, White House Mr. Jack Rosen, Chairman, National Finance Council, Democratic National Committee Mr. James Rubin, Director of Business Outreach, Clinton/Gore '96 Ms. A. Elizabeth Ansel, Chief Operating Officer, Pain Net, Inc. p:\pnilleaklgovernmens.I4lpaneta.712 a 13 CARBOHYDRATES McCoy TRIGLYCERIDES Collegiate Services GLYCOGEN FATTY ACIDS PENTOSE PATHWAY CITRIC ACID CYCLE 61 THE WHITE HOUSE WASHINGTON August 17, 1995 Mr. Michael Douglas Michael Douglas Youth Foundation P.O. Box 491481 College Park, GA 30349 Dear Mr. Douglas: Thank you for writing to express your concerns about the Food and Drug Administration. Doug Sosnik forwarded your letter to me. The President has consistently said that the Federal government in general and the FDA in particular can regulate smarter -- with less micromanagement and intrusiveness. Working with Vice President Gore and the FDA, the President recently introduced a series of regulatory reforms designed to look at "outcomes" rather than "process" and to focus on the customers that we serve. Earlier this year, he released a report outlining specific reforms the FDA would implement to meet these goals. The President believes that more can and should be done to change the way the FDA regulates. However, he also believes that the FDA must continue to play an essential role in ensuring the safety and efficacy of drugs and devices and in maintaining the high quality of our foods. We will keep your comments in mind as the Administration moves forward in addressing these important issues. Thank you again for taking the time to write. Sincerely, CarotHRasco Carol H. Rasco Assistant to the President for Domestic Policy M.D.Y.F. Michael Douglas Youth Foundation P.O. Box 491481 College Park, GA 30349 404/837-6719 June 16, 1995 Mr. Doug Sosnick, Assistant to the President for Political Affairs Executive Office of the President, 2nd Floor, West Wing 1600 Pennsylvania Avenue, N.W. Washington, D.C. 20500 Dear Mr. Sosnick: As a community leader and a social activist, I am very concerned about the major role that the FDA have in people lives today. At a time when the general public is clearly fed up with government regulations, I can't believe the FDA Commissioner persists in trying to broaden his personal power base through increased regulations. First, he sought to control the tobacco industry by bringing it under FDA control, then he moved onto orange juice and vitamins. Apparently, he is now concerned with seafood. President Clinton has demonstrated time again, he understands the people views on the role of government. He and his administration have worked hard to bring federal agencies in line with these views. President Clinton apparently did not get the message across to the FDA. I would like to suggest the President deliver this message now. Sincerely, Michael Douglas cc: Mickey Kantor, U.S. Trade Representative THE WHITE HOUSE WASHINGTON August 17, 1995 Mr. Lamar Allen Community Management Services, Inc. 219 Ashby Street, S.W. Atlanta, Georgia 30314 Dear Mr. Allen: Thank you for writing to express your concerns about the Food and Drug Administration. Doug Sosnik forwarded your letter to me. The President has consistently said that the Federal government in general and the FDA in particular can regulate smarter -- with less micromanagement and intrusiveness. Working with Vice President Gore and the FDA, the President recently introduced a series of regulatory reforms designed to look at "outcomes" rather than "process" and to focus on the customers that we serve. Earlier this year, he released a report outlining specific reforms the FDA would implement to meet these goals. The President believes that more can and should be done to change the way the FDA regulates. However, he also believes that the FDA must continue to play an essential role in ensuring the safety and efficacy of drugs and devices and in maintaining the high quality of our foods. We will keep your comments in mind as the Administration moves forward in addressing these important issues. Thank you again for taking the time to write. Sincerely, Carot PRasco Carol H. Rasco Assistant to the President for Domestic Policy COMMUNITY MANAGEMENT SERVICES, INC. M 219 ASHBY STREET, S.W. ATLANTA, GEORGIA 30314 (404) 758-8023 S June 18, 1995 Mr. Doug Sosnick, Assistant to the President for Political Affairs Executive Office of the President, 2nd Floor, West Wing 1600 Pennsylvania Avenue, N.W. Washington, D.C. 20500 Dear Mr. Sosnick: I voted for Clinton in the 1992 election. I want to compliment President Clinton and the members of his Administration for a job well done. However, I am concerned about over-regulation by the Food & Drug Administration (FDA). Newt Gingrich and his fellow Republicans have already discussed plans to completely dismantle the agency. My fear is that Mr. Gingrich and the Republican Party are reaching many Americans with this issue. I think, President Clinton needs to take the contentious issue away for the Republicans. President Clinton has worked hard to reduce the size of the federal bureaucracy, it would be a shame to "lose" this issue because of the FDA and its Commissioner, Dr. David Kessler. Dr. Kessler is often referred to as Washington's most powerful bureaucratic czar. He has regulatory control over a trillion dollars worth of our nation's GNP. Unfortunately, he also has a personal program to regulate everything from the manufacture of shower commode chairs to personal behavior. Under Dr. Kessler, the FDA has experienced an unprecedented expansion of regulatory interference. This at a time when President Clinton, Vice President Fore and many other administration officials have been working hard to trim the fat from government agencies. Dr. Kessler should cooperate with the administration's position on "big government." It will be too bad if the Republicans are successful in eliminating a worthwhile agency such the FDA because of the actions of one bureaucrat. Thank you. James Veler Lamar Allen CC: Mickey Kantor, U.S. Trade Representative THE WHITE HOUSE WASHINGTON June 22, 1995 James B. Hanks 1217 West Third Street Little Rock, AR 72201-1903 Dear Mr. Hanks: Thank you for sending me your proposal on prescription- writing by physician assistants. The President shares your appreciation of the important role that physician assistants play in delivering primary health care. The President's original health care plan included increased funding for training of physician assistants, and since debate on that proposal began, states have dramatically increased their contributions to training programs. Nonetheless, the supply of physician assistants is still insufficient to meet demand. Therefore, the Clinton Administration has continued to support funding increases for training. On September 30, 1994, the President signed into law P.L. 103-333, which provided over $6.5 million for physician assistants' training, an increase of $1.6 million over the previous year's allocation. The Drug Enforcement Administration (DEA) did, in fact, create the mid-level practitioner registration category to which you referred in your proposal. It was finalized and published in the Federal Register on June 1, 1993 (58 FR 31171), and became effective on July 1, 1993. Under this new registration category, advanced practice nurses, physician assistants and others receive individual DEA registrations granting controlled substances privileges consistent with the authority granted them under state law. If you have any questions concerning this registration category, please feel free to contact Andrew McFaul at DEA's Office of Diversion Control Liaison and Policy Section at (202) 307-7297. I have forwarded your proposal to Andrew McFaul and to my health policy staff for further review. Thank you again for writing. I appreciate the information you shared with me based on your investigations of health care professionals. Sincerely, Carol Caroc+Rasco H. Rasco Assistant to the President for Domestic Policy School of Medicine Pm Jennifer K.- Pes. Pes.see see Department of Internal Medicine Office of Administration UNIVERSITY OF MISSOURI-COLUMBIA me. MA434 Medical Sciences Building Columbia, Missouri 65212 Telephone (314) 882-6632 Shanks (314) 882-8031 FAX: [314] 884=4691 February 10, 1995 AR Carol Rasco Assistant to the President for Domestic Policy The White House 1600 Pennsylvania Avenue Washington, DC 20500 Dear Carol: Thanks for the recent information about your family and your life. It is amazing how fast our children grow. Heather was especially interested in the newspaper clipping as she identified Mary Margaret and other friends. I can see why you are so proud of her accomplishments. Who knows, some day she may be our President! I am very interested in working with you regarding some health care reform initiatives. My current boss, Dr. Karl T. Weber, Chairman of the Department of Internal Medicine, has some keen insights into the delivery and financing of health care as it relates to teaching, research and patient care. I would also like to work with you regarding the business of health care reform. Hopefully, all of us should share beneficial plans to help our citizens. If you are interested, please let me know. Maybe you could visit beautiful Missouri to review our accomplishments and make recommendations for improvement and/or we could visit DC and get a picture of Patrick in the Oval Office. Sincerely, Thick Hampton Rick Hampton Send anything In town? Meet w/ me add an equal opportunity institution