Bolstering the FDA's Drug-Safety Authority

The modern era of drug development began with the 1962 Kefauver-Harris Drug Amendments, which required that drugs be tested for efficacy as well as safety and gave the Food and Drug Administration (FDA) the authority to require sophisticated clinical trials before approving drugs.1 Today, we can be confident that an approved drug will be effective for its labeled uses. The same cannot be said of the drug's safety. At the time of approval, a drug has typically been tested in several thousand patients, in studies powered to identify only relatively common adverse reactions. For example, a study that includes 3000 . . .