Kefauver-Harris Amendment

The Kefauver-Harris Amendment, enacted in 1962, strengthened U.S. drug regulations by requiring that medications be proven safe and effective before reaching the market. This legislation emerged in response to public outrage over the thalidomide tragedy, where a harmful drug caused birth defects. The amendment mandated that drug manufacturers provide evidence from clinical trials of both safety and efficacy, and it also improved the oversight of drug marketing and advertising. Overall, it aimed to protect consumers by ensuring that drugs are rigorously tested and evaluated before they can be sold.