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


    Dr. Scott Gottlieb

    Resident Fellow, American Enterprise Institute

  • huber90x90


    Peter Huber

    Senior Fellow, Manhattan Institute and Author

  • Avorn Jerry90x90


    Dr, Jerry Avorn

    Professor of Medicine, Harvard Medical School

  • david-challoner90x90


    Dr. David Challoner

    VP for Health Affairs Emeritus, University of Florida

    • Moderator Image


      John Donvan

      Author & Correspondent for ABC News

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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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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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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

Online Voting

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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    • Comment Link Nhersh Thursday, 16 May 2013 00:55 posted by Nhersh

      The arguments are too arcane for most. The victors, at least one of whom (Gottlieb), as a financial advisor, have definite conflict of interest, have proven that when it comes to complex scientific issues anecdotal arguments will on average win the day.

    • Comment Link Patrick Tuesday, 14 May 2013 17:50 posted by Patrick

      About time we had a good debater laying out something more in line with my generally libertarian leaning beliefs.

      How many pharmaceutical companies are left? Like 2 or 3? Just think about that for a second, and then tell me about how awesome of a job the FDA is doing. Why do you think medicine is so expensive here? To the point where we have to OUTLAW bringing it in from Canada, even though it is drastically cheaper there!

    • Comment Link GVRange Monday, 13 May 2013 18:23 posted by GVRange

      Even if the FDA Agency was perfectly balanced, managed and staffed to ensure human hazard prevention, we would still be at risk.
      "To label or not to label"
      The truth is not scientific criteria could be defined and confirmed without "Statistics, Math or Scientific knowledge". We need subject study, research & clinical trials, efficacy and adverse events.

      FDA is too large a domain to actually understand potential risks factors.
      DRUGS - Manufacturing, use, interaction, prescript, rejection
      MEDICAL DEVICES - Action, delivery, failure modes, selection procedure, etc
      NON-REGULTED - Products
      GENETIC - In VITRO or Mom & Dad.............

      Then their classification and level of "Regulatory Enforcement"

      We are not devices or robots all built equally.
      We are not Adam & Eve are we?
      Each of us is a complex system affected by internal and external factors and interactivity.
      Would the FDA be responsible for all that also?

    • Comment Link Fernando Saturday, 11 May 2013 12:51 posted by Fernando

      This is one of those examples in which an idea which looks like a terrific idea on the surface has gone terribly wrong when big business learned how to use the tools that big government put at its disposal.

      It reminds, although the analogy is not 100% accurate, what happened with the USPTO.

      Just as the USPTO has basically become a source of material for big companies to intimidate each other (or for said companies to intimidate smaller companies), the FDA is now so infiltrated by Big Pharma that it has become, in effect, the representative of Big Pharma in the federal government.

      The most outrageous example of this collusion is probably Dan Troy, now Senior Vice President & General Counsel at GSK, the company that made the headlines last year when it agreed to pay billions of dollars in order to settle numerous civil and criminal charges for illegal marketing of drugs. Prior to taking that position, Dan Troy was Chief Counsel for the FDA. So it cannot get more explicit than this.

    • Comment Link GEDouglas Saturday, 11 May 2013 07:25 posted by GEDouglas

      Great debate. A debate on the effectiveness and/or necessity of many federal agencies would be welcomed. Needless to say our federal government has become a behemoth. It is a bureaucracy that has become faceless, often heartless, politicized, unaccountable and at times used as a tool against the citizenry by unethical politicians.

    • Comment Link Wanda Thursday, 09 May 2013 22:13 posted by Wanda

      Why does the FDA exist? Think about it. I found my mother's immunization record for something from 1926. In doing research I discovered that the AMA actually fought immunizations because doctors were afraid of losing patients (no pun intended). Some government entity has to be charged with looking out for patients.

    • Comment Link Kevin Wednesday, 08 May 2013 20:47 posted by Kevin

      Government regulations are one of the best ways to create jobs. Recall, we don't have an economic crisis; corporate profits and productivity are at record highs; the DOW hit 15000.


      All the wealth is concentrated at the top. Anything that forces corporate owners to hire is a good thing. Regulations create middle class jobs. In government and in industry.

      Remember, a perfectly efficient corporation would have zero employees and one owner. A social and economic disaster.

    • Comment Link hilary Wednesday, 08 May 2013 20:31 posted by hilary

      Haste makes waste. FDA doing good job. H.

      At end of debate I have changed my mind and am undecided as I feel the FDA has to become more relevant to be current in its form of testing.

    • Comment Link hilary Wednesday, 08 May 2013 19:59 posted by hilary

      Haste makes waste FDA doing good job. H.

    • Comment Link Brian Wednesday, 24 April 2013 12:52 posted by Brian

      Caution, outside regulations, and multiple levels of oversight is the key to protecting public health and safety. This how the FDA is effective. Rushing new products to market will end up with a return to hokum medicine of the 19th century and before. Include that with the power of modern marketing techniques and you will end up will an out of control medical system, as can be seen in the anti-vaccine/homeopathic groups.

      Is the system perfect? No. Is it better than a private regulatory agency? Yes, we can look at the effectiveness of other private ratings agencies and with the exception of the Underwriters Laboratories, they have been failures.

      The next question should be whether people can choose to not abide by FDA regulations and use experimental drugs? This requires a much more complicated answer due to the fact that we are irrational beings without free will. Outside influences are more powerful than we acknowledge and can muddle our decisions.

    • 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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