FDA vs. the Individual

Who should make decisions about drug safety—FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments.

It is well known that the FDA has authority to regulate not only for purity, but also for safety and effectiveness. On the first of these questions no one challenges the role of the FDA, either inside the industry or beyond it. But the issues about safety and effectiveness raise serious questions of institutional design, which are not well handled under the current regulatory regime. The key question is this: Where should decisions about drug safety and efficacy be made, upstream by the FDA or downstream by the individual drug user, aided by professional assistance?

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