Kefauver-Harris Amendments (1962)

The Kefauver-Harris amendments (1962) to the Food, Drug, and Cosmetic Act reshaped the landscape of drug regulation in the United States by granting the Food and Drug Administration (FDA) greater authority over the marketing of prescription medication. In particular, the amendments expanded the agency’s powers of regulation and enforcement, meaning that manufacturers were required to demonstrate both efficacy and safety before medications could be released to the market. With the amendments, the FDA took greater control over the premarket testing of drugs and thus gained a foothold into the regulation of clinical trials. FDA approval was now required before any drug could be released to the public. Additionally, the amendments expanded the FDA’s role in the postmarket regulation of medicines by granting it greater power ...