What led to the development of the kefauver-harris amendment?

Answer 1

The Kefauver-Harris Amendment, enacted in 1962, was primarily driven by the thalidomide tragedy, where the drug caused severe birth defects in thousands of infants. This incident highlighted major gaps in drug approval processes, particularly concerning the safety and efficacy of pharmaceuticals. Additionally, public outcry over drug safety and mounting evidence of the need for stricter regulatory oversight prompted Congress to enhance the authority of the FDA in ensuring that drugs met rigorous standards before reaching the market. The amendment thus aimed to protect consumers by requiring manufacturers to demonstrate both safety and effectiveness for new medications.