The Drug Industry and Drug Effectiveness

SENATOR Estes Kefauver's greatest legislative success in his distinguished career was the Drug Amendments Act of 1962.1 In the opinion of most commentators, the most important change in the federal drug laws accomplished under this act was the requirement that manufacturers prove the efficacy of their products as well as their safety. In an earlier paper, I asserted, "This meant a fundamental change in the philosophy of public regulation of the drug industry. From a policeman of safety, the FDA was transformed into an arbiter of value, quality, and success in scientific achievement."2 In an extremely important opinion, Upjohn Company . . .