Chicago's Best Ideas: "Clinical Trials on Trial: How Should the FDA Do Its Job?"

One of the major functions of the FDA is to check new drugs for their safety and effectiveness. The chief tool for doing this has been the double-blind clinical trial. Over the past 20 years ago, the requirements for these trials have become ever more stringent, reducing the probability that new chemical entities will be approved, delaying their onset into the market, and increasing their costs. The FDA claims that these stark measures are needed to discharge its chief function of consumer protection.

In this talk, Professor Epstein disputes that contention, to argue that many of the FDA standards are analytically unsound and socially counterproductive. The constant demand for compassionate exemptions on the one hand, and widespread off-label use of approved drugs are clear signs that the current system is out of whack and in need of serious recalibration.

Category:

Education

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