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Read the PDF THE AMERICAN ENTERPRISE IN­ EXECUTIVE STITUTE FOR PUBLIC POLICY RE­ COMMITIEE SEARCH, established in 1943, is a publicly supported, nonpartisan re­ Herman J. Schmidt Chairman of the Board search and educational organization. Its purpose is to assist policy makers, William J. Baroody President scholars, businessmen, the press and the public by providing objective Charles T. Fisher III Treasurer analysis of national and international issues. Views expressed in the insti­ Richard J. Farrell Dean P. Fite tute's publications are those of the Richard B. Madden authors and do not necessarily reflect the views of the staff, advisory panels, officers or trustees of AEI. SENIOR STAFF Anne Brunsdale ADVISORY BOARD Director of Publications Paul W. McCracken, Chairman, Ed­ Joseph G. Butts mund Ezra Day University Professor Director of Legislative of Business Administration, Univer­ Analysis sity of Michigan Robert B. Helms Directorof Health Policy R. H. Coase, Professor of Economics, Studies University of Chicago Thomas F. Johnson Milton Friedman, Paul S. Russell Dis­ Director of Research tinguished Service Professor of Eco­ Gary L. Jones nomics, University of Chicago Assistant to the President for Administration Gottfried Haberler, Resident Scholar, American Enterprise Institute for Richard M. Lee Public Policy Research Director of Planning and Development C. Lowell Harriss, Professor of Eco­ Edward J. Mitchell nomics, Columbia University Director, National Energy Project George Lenczowski, Professor of Po­ litical Science, University of Califor­ W. S. Moore nia, Berkeley Director of Legal Policy Studies Robert A. Nisbet, Albert Schweitzer Robert J. Pranger Professor of the Humanities, Colum­ Director of Foreign and bia University Defense Policy Studies James A. Robinson, President, Uni­. Louis M. Thompson. Jr. versity of West Florida Assistant to the President for Communication David G. Tuerck Director, Center for Research on Advertising REFORMING FEDERAL DRUG REGULATION @ Jules Bergman, Moderator @ Michael J. Halberstam William N. Hubbard, Jr. Louis Lasagna Gaylord Nelson Alexander M. Schmidt A Round Table held on February 23, 1976 and sponsored by the Center for Health Policy Research of the American Enterprise Institute for Public Policy Research, Washington, D.C. THIS PAMPIU..ET CONTAINS THE PROCEEDINGS OF ONE OF A SERIES OF AEI ROUND TABLE DISCUSSIONS. THE ROUND TABLE OFFERS A MEDIUM FOR INFORMAL EXCHANGES OF IDEAS ON CURRENT POLICY PROBLEMS OF NATIONAL AND INTERNATIONAL IMPORT. AS PART OF AEI'S PROGRAM OF PROVIDING OPPORTUNITIES FOR THE PRESENTATION OF COMPETING VIEWS, IT SERVES TO ENHANCE THE PROSPECT THAT DECISIONS WITHIN OUR DEMOCRACY WILL BE BASED ON A MORE INFORMED PUBLIC OPINION. AEI ROUND TABLES ARE ALSO AVAILABLE ON AUDIO AND COLOR-VIDEO CASSETTES. © 1976 BY AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH, WASHINGTON, D.C. PERMISSION TO QUOTE FROM OR REPRODUCE MATERIALS IN THIS PUBLICATION IS GRANTED WHEN DUE ACKNOWLEDGMENT IS MADE. ISBN 0-8447-2084-4 LIBRARY OF CONGRESS CATALOG CARD NO. L.C. 76-13424 PRINTED IN UNITED STATES OF AMERICA ULES BERGMAN, science editor of ABC News and J moderator of the Round Table: Good evening. We are gathered for what we hope will be a frank and intelligent discussion of drug regulation and its problems in our society. Perhaps the one thing this panel would agree on, to start with, is that there are vast differences of opinion on how much drug regulation is needed, whether we have the right kind of regulation, whether new drug development is being encouraged or stifled, and whether the Food and Drug Administration [FDA] is doing a proper job. With us to freely and frankly toss bricks at one another are five distinguished experts: Dr. Michael J. Halberstam, a practicing physician in internal medicine and writer; Dr. William N. Hubbard, president of the Upjohn Com­ pany, a little outfit that makes a few drugs; Commissioner Alexander M. Schmidt of the Food and Drug Administra­ tion, an agency that has been in the news a good bit lately; Senator Gaylord Nelson, who has been deeply concerned with the state of legislation in the field of drug regulation and development; and Dr. Louis Lasagna of the University of Rochester, one of the nation's most distinguished phar­ macologists and drug experts and author of one of the definitive books in the field. With that short introduction, I will pose a couple of questions, if I may, to get you gentlemen started. Commissioner Schmidt, whether it is cyclamates, Red Dye Number Two, or whatever, FDA seems to keep crop­ ping up in the news. What is wrong with FDA? [Laugh­ ter.] 1 ALEXANDER M. SCHMIDT, M.D., comm1ss10ner of the Food and Drug Administration: Well, I don't think those necessarily follow each other. [Laughter.] MR. BERGMAN: I can reverse the order. [Laughter.] COMMISSIONER SCHMIDT: The FDA is very much in the news and, in some respects, that's quite flattering, because it means we're newsworthy. It means people are interested in what we're doing and why we're doing it. And I think the reasons are very clear if you stop and think about what you do when you get up in the morning. First, by the time they have finished breakfast, most people have come into contact with twenty or thirty products that we regulate. Everything that you eat, all the drugs you take, your television set, the X-ray machine that looked at your luggage when you came down here on an airplane, every­ thing that you put on your skin or smear on, or what have you, the FDA regulates it. Everybody wants to know about these products. Second, people are very much the experts about what they eat and they have very strong feelings, strong beliefs, about this. When the FDA doesn't meet the expectations of people, there is some disappointment. Putting these two things together, you can come up with the question you asked-which I think is a bad question: what's wrong with FDA? But I'd much prefer to talk about what's right about the FDA. I could use up the whole period of time on that one. MR. BERGMAN: Just try it. [Laughter.] Dr. Halberstam, as a physician dealing :with patients on a daily basis, can you tell our audience why an indi­ vidual patient or consumer should be concerned about drug regulation in our country? MICHAEL J. HALBERSTAM, M.D., internist in private practice and assistant professor of clinical medicine at George Washington University School of Medicine: I think it is clear to most people who read newspapers why they 2 should be concerned about drug regulation, because they can find stories in the press almost daily-particularly in the Washington press-about drugs that may do bad things to them. They should be concerned for another reason, one that does not get into the papers: there are drugs that have not been available to them that can do good things for them, with certain predictable side effects. I'm referring to the so-called drug lag, and though it's been overlooked, it is a real issue. As a practicing physician, when I read the medical journals published in England, Lancet and the British Medical Journal, I feel a bit like a little child with my nose pressed up against the toy-store window, seeing these marvelous things inside that I can't get at. This has been the situation now with a number of drugs for five, six, seven, and eight years. We're doing better on that, but it has been a problem, and it remains a problem for the consumer. MR. BERGMAN: Dr. Lasagna, as an expert in this field, where does the drug lag exist, with what drugs, sir? LOUIS LASAGNA, M.D., chairman of the department and professor of pharmacology and toxicology, University of Rochester: I can give a few examples. There's an ex­ tremely interesting drug called Beclomethasone which is remarkably effective for certain kinds of serious asth­ matics. I find it ridiculous that patients in Rochester, New York, have to go across the Canadian border to Hamilton, Ontario, to get this drug at the moment. Two drugs that are used in the treatment of a variety of cardiovascular diseases have been shown in controlled experiments done elsewhere to cut the mortality of patients who have been discharged from a hospital after a heart attack by about 40 percent on average. We've calculated that that could mean a saving of about 10,000 lives a year in this country, but those drugs are not available here. There are other examples, but these give you a feeling for the problem. MR. BERGMAN: Why aren't they available, Commissioner Schmidt? 3 COMMISSIONER SCHMIDT: Well, there are many dif­ ferent reasons for what people have termed the drug lag-the availability of certain drugs in other countries before they are approved for marketing in the United States. First, in 1962 we established a system of regula­ tion of drug development and marketing in this country that was not in existence in many other countries. Eng­ land, for example, just two-and-a-half years ago got an efficacy requirement-that is, before marketing their drugs had to be shown to be effective for the purposes claimed. We also have rather stringent safety requirements now about how one can develop drugs, how one can use people in doing research. And these requirements have been imposed as a matter of public policy. Undeniably, one pays a price in time, in dollars, and in manpower for requiring that drugs be shown safe and effective before they are marketed in this country; and most people agree that the price is worth paying. So the first element in explaining the drug lag is that you can't compare this country with its requirements with another country that has no such requirements.
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