Profitable and Nonprofitable Drugs

IN reaction to the thalidomide tragedy, Congress enacted the Kefauver-Harris amendments to the Food, Drug and Cosmetics Act in 1962 that considerably increased the number of preclinical and clinical tests required by the Food and Drug Administration (FDA) before release of a drug for marketing. The Kefauver-Harris amendments have had profound effects on the development of new drugs. Over the years since 1962, the consumer has been protected from potentially dangerous drugs that might have reached the marketplace under the FDA legislative acts of 1906 and 1938. However, the consumer protection has not been gained without adverse consequences. A major . . .