Which amendment required drug manufacturers to provide proof of safety and efficacy?

The Kefauver-Harris Amendment is the correct answer because it specifically mandated that drug manufacturers must provide evidence of safety and efficacy before their products could be marketed. Enacted in 1962, this amendment was a significant update to the Food, Drug, and Cosmetic Act of 1938, which primarily focused on safety but did not require proof of efficacy.

The Kefauver-Harris Amendment arose in response to the thalidomide tragedy, where a sedative caused severe birth defects. This led to increased scrutiny over the drug approval process, emphasizing the necessity for manufacturers to demonstrate not only that their products were safe for consumption but also effective for their intended uses, ensuring a higher standard of protection for public health.

Other options reference important legislation in the realm of drug regulation but do not directly address the requirement for proof of safety and efficacy in the same way. The 1938 Food, Drug, and Cosmetic Act established the foundation for drug safety regulations, the Durham-Humphrey Amendment clarified the distinction between prescription and over-the-counter drugs, and the Omnibus Budget Reconciliation Act primarily addressed Medicaid and pharmacy practice standards. Each of these plays a role in the context of pharmaceutical regulation, but the Kefauver-Harris Amendment uniquely established the