The FDA'S Caution Is Hazardous To Our Health

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Wednesday, May 8, 2013

The Food and Drug Administration, the oldest comprehensive consumer protection agency in the U.S. federal government, is charged with protecting the public health.  Under this mandate, it regulates drugs and medical devices for their safety and effectiveness.  But is it a failing mandate?  It’s long been argued that the FDA’s long and costly approval processes stifle innovation and keep life-changing treatments from the market.  But the question remains: when it comes to public health, is it ever okay to sacrifice safety for speed?

  • Gotlieb90

    For

    Dr. Scott Gottlieb

    Resident Fellow, American Enterprise Institute

  • huber90x90

    For

    Peter Huber

    Senior Fellow, Manhattan Institute and Author

  • Avorn Jerry90x90

    Against

    Dr, Jerry Avorn

    Professor of Medicine, Harvard Medical School

  • david-challoner90x90

    Against

    Dr. David Challoner

    VP for Health Affairs Emeritus, University of Florida


    • Moderator Image

      MODERATOR

      John Donvan

      Author & Correspondent for ABC News

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Gotlieb90

For The Motion

Dr. Scott Gottlieb

Resident Fellow, American Enterprise Institute

Scott Gottlieb, M.D., is currently a practicing physician and resident fellow at the American Enterprise Institute. From 2005-2007, Dr. Gottlieb served as FDA Deputy Commissioner and before that, from 2003-2004, as a senior advisor to FDA Commissioner Mark McClellan and as the FDA’s Director of Medical Policy Development. He left the FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a senior adviser to the administrator of Medicare and Medicaid Services, where he supported the agency's policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on the cable financial news channel CNBC.

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huber90x90

For The Motion

Peter Huber

Senior Fellow, Manhattan Institute and Author

Peter Huber is a senior fellow at the Manhattan Institute writing on the issues of drug development, energy, technology, and the law. Before joining the Manhattan Institute, Huber served as an assistant and later associate professor at MIT for six years. He clerked on the D.C. Circuit Court of Appeals for Ruth Bader Ginsburg, and then on the U.S. Supreme Court for Sandra Day O'Connor. Huber also is a partner at the Washington, D.C., law firm of Kellogg, Huber, Hansen and Todd. He is the author of The Bottomless Well (2005), co-authored with Mark P. Mills, and the forthcoming book, The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine. Huber earned his law degree from Harvard University and a doctorate in mechanical engineering from MIT.

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Avorn Jerry90x90

Against The Motion

Dr. Jerry Avorn

Professor of Medicine, Harvard Medical School

Jerry Avorn, M.D., is a professor of medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital.  An internist, geriatrician, and drug epidemiologist, he studies the intended and adverse effects of  prescription drugs, physician prescribing practices, and medication policy. Dr. Avorn pioneered the “academic detailing” approach to continuing medical education, in which non-commercial, evidence-based information about drugs is provided to doctors through educational outreach programs run by public-sector sponsors. Such programs are now in use in the U.S., Canada, Australia, and Europe. He has served as a member of the Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines and is the author or co-author of over 400 papers in the medical literature on medication use and its outcomes, and of the book,  Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (2004), now in its 11th printing.  

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david-challoner90x90

Against The Motion

Dr. David Challoner

VP for Health Affairs Emeritus, University of Florida

David R. Challoner, M.D., is Vice President Emeritus for Health Affairs of the University of Florida.  Dr. Challoner has held leadership and health policy positions in many national organizations, including the Association of American Medical Colleges where he holds Distinguished Service Membership, the American Medical Association where he served as Chairman of the Section on Medical Schools, and the American Federation for Clinical Research which he served as President.  From 1988-1990, he was appointed by President Reagan to Chair the President's Committee on the National Medal of Science. He also served as the chairman of the membership committee, as a member of the governing council  of  the Institute of Medicine, and as a member of the governing board of the National Research Council.  He received the 2010 Walsh McDermott Medal of the IOM for Distinguished Service.  He Chaired the IOM’s Committee on the Public Health Effectiveness of the FDA 510K Clearance Process (2011).

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Declared Winner: For The Motion

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Voting Breakdown:
 

43% voted the same way in BOTH pre- and post-debate votes (19% voted FOR twice, 18% voted AGAINST twice, 6% voted UNDECIDED twice). 57% changed their minds (2% voted FOR then changed to AGAINST, 2% voted FOR then changed to UNDECIDED, 12% voted AGAINST then changed to FOR, 2% voted AGAINST then changed to UNDECIDED, 22% voted UNDECIDED then changed to FOR, 17% voted UNDECIDED then changed to AGAINST) | Breakdown Graphic

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    22 comments

    • Comment Link Tibor R. Machan Tuesday, 23 April 2013 11:22 posted by Tibor R. Machan

      Professor Sam Peltzman of the U. of Chicago pointed this out with his research back in the late 1970s but the zealous statists would not listen. These people have infinite faith in bureaucracies and politicians. And, by the way, most government regulations violate the prohibition against prior restraint.

    • Comment Link Pavel Boiko Sunday, 24 February 2013 16:18 posted by Pavel Boiko

      This is a huge topic with lots of debate points and ways to show how ineffective and sometimes negligent the FDA has been, as well as an ability to raise the many examples where FDA processes have gotten in the way of safe and effective drugs entering the market. At the same time, there is no denying that a government organization responsible for monitoring and controlling the substances that get out to the public is absolutely necessary and should be held in the highest regard for keeping public safety. It certainly has done it's job on many fronts, and some may argue that it lacks on others.

      In terms of the motion, a direct statement that the FDA's caution is hazardous, I must say that it's not. As a generalized statement, I think this organization follows it's stated objective of securing public health, while imperfectly, it does pursue this goal. As I'm not in the knowledge of intentional harm caused by the FDA (though I'm sure I can recall cases where more could be done), I think the FDA isn't hazardous to our health.

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