The FDA Vs. the Health and Safety of Americans

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QUESTION: Which problem is the greatest: the FDA’s approving unsafe drugs, or the FDA’s delaying the approval of life-saving ones?

MY SHORT ANSWER: In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing drug companies to voluntarily pay about $100,000 to get a speedier review. The money went to hire new reviewers.

The fee has grown steadily; it’s now over one million dollars per drug. The part of the FDA that reviews drug applications now receives about 50% of its funding from drug companies. FDA employees (e.g., Dr. David Graham, the whistleblower on Vioxx) have reported being told by supervisors that the drug companies — not the American public — are the FDA’s clients. This should be expected, as he who pays the bills makes the rules.

Does this mean that the FDA now approves unsafe drugs? It depends on how you look at it. Withdrawal rates (the percent of approved drugs removed from the market) from 1962-1992 and 1993-2013 are virtually identical at about 3%. As time goes on, however, more drugs approved during 1993-2013 are likely to be withdrawn. The differences may be small, though, as most withdrawals occur quickly. On the other hand, Vioxx, approved post-PDUFA, was by far the biggest drug disaster in history.

Does the FDA still delay approval of life-saving drugs? Yes! It does so by demanding that companies perform studies taking an average of 13-plus years. Prior to 1962, the average time was about 4 years. I suspect that these delays are still more costly, in terms of lives lost, than approvals of unsafe drugs.

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About the author: Mary Ruwart

Dr. Mary Ruwart is a leading expert in libertarian communication and author of the international bestseller Healing Our World. She is also author of Short Answers to Tough Questions, in which you will find a collection of her answers from this column. In this column she provides Liberator Online readers with answers to questions libertarians are often asked. Dr. Ruwart is a research scientist, ethicist, and a libertarian author/activist. She received her B.S. in biochemistry in 1970 and her Ph.D. in Biophysics in 1974 (both from Michigan State University). She subsequently joined the Department of Surgery at St. Louis University and left her Assistant Professorship there to accept a position with The Upjohn Company of Kalamazoo, Michigan in 1976. As a senior research scientist, Dr. Ruwart was involved in developing new therapies for a variety of diseases, including liver cirrhosis and AIDS. Dr. Ruwart left Upjohn in 1995 to devote her time to consulting and writing. Her communications course for scientists (www.speakingforscientists.com), covering written, oral, and poster presentations has received high praise from attendees. She also provides consulting services for nutraceutical companies, clinical research organizations, and universities. Currently, Dr. Ruwart serves as Chair of the International Society for Individual Liberty (www.isil.org) and Secretary of the Foundation for a Free Society (www.f4fs.org). She has been an At-Large member of the Libertarian National Committee (www.lp.org), served on the Board of both the Heartland Institute (www.heartland.org; Michigan Chapter) and the Fully Informed Jury Amendment Association (www.fija.org).