Is FDA Regulation Hazardous to Our Health?


At the end of last night's Intelligence Squared debate, 53 percent of attendees thought so - up from 24 percent at the beginning.

So what is it that swayed a room of oncologists, physicians, and even celebrities like the father of DNA, Jim Watson? Arguing for the motion were former FDA Deputy Commissioner and American Enterprise Institute Resident Fellow, Dr. Scott Gottlieb, and Manhattan Institute Senior Fellow, Peter Huber. The duo made a compelling, if somewhat wonky (try explaining the difference between Bayesian and frequentist statistics in under a minute), case that the FDA's aging clinical trial requirements are ensuring that the most needed medicines - those that treat diseases like Alzheimer's, antibiotics that are effective against resistant bacteria, and many others - will either never make it to market, or will take years longer than what is reasonable.

Indeed, listening to Dr. Gottlieb and Huber, it becomes evident (as we've discussed on MPT numerous times) that the large population requirements and the onerous statistical certainty that the FDA requires are keeping drug development from progressing - moving from treating the average patient to treating the individual. A glimmer of hope, however, remains. The FDA has demonstrated its ability to be more innovative in the past - its fast track and accelerated approval designations helped get cancer drugs and HIV/AIDS drugs to market in record time. As Huber put it, the very existence of a fast track designation, indicates that there is something patently wrong with the standard trials.

But what about the other side? Surely there is an argument to be made in favor of the FDA's caution. Arguing against the motion was Dr. Jerry Avorn of Harvard Medical School, and Dr. David Challoner, VP for Health Affairs Emeritus at the University of Florida. The crux of the rebuttal, however, was not quite as compelling - in essence, Avorn and Challoner believe that the FDA is approving drugs fast enough, and requiring them to do so any faster would be very risky. The statistical certainty demanded by the FDA is a necessity for an agency charged with ensuring the safety of our food and our medicines. In years that few drugs were approved, they argued, the fault lies with the pharmaceutical industry for not coming up with enough new drug candidates.

The problem with this line of reasoning is twofold: first, Huber's point on the fast track designation is on the money. The fact that fast track and accelerated approval designations were necessary to get urgently needed drugs on the market is in and of itself an indictment of the clinical trial process. Certainly, cancer drugs often do much harm to the patient, and AIDS cocktails were notoriously rife with side effects. But it's hard to imagine that anyone would have preferred having these two drug classes go through the decade-long development process of FDA clinical trials.

The second problem with Avorn and Challoner's reasoning is that it ignores an important class of drugs - antibiotics. Over the past two decades, antibiotic resistance has become a growing public health problem, and many of our last-line antibiotics are beginning to fail (cephalosporins are often not effective against gonorrhea, for instance). New antibiotics are hard to come by, however, because of a variety of reasons (an important one is that the "low-hanging fruit" has already been picked), but chief among them are the stringent requirements for antibiotic trials set by the FDA - these requirements are designed to meet a level of statistical certainty, but this often make antibiotic development impractical or prohibitively expensive.

Nevertheless, this is a debate that is likely to continue. While the FDA has acknowledged that some of its guidelines may need to be updated, the agency has been slow to issue definitive and easy-to-follow guidance to guide the development of personalized medicine. Hopefully, officials at the agency were paying attention to last night's debate.

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