Which law requires drugs to be proven effective and safe before being marketed?

The Kefauver-Harris Amendment is indeed the law that requires drugs to demonstrate both efficacy and safety prior to being marketed. This amendment to the Food, Drug, and Cosmetic Act was enacted in response to concerns about the effectiveness of certain drugs, particularly following the thalidomide tragedy in the 1960s, where a drug caused severe birth defects.

As a result of these concerns, the Kefauver-Harris Amendment imposed stricter regulations on the FDA, mandating that pharmaceutical companies provide substantial evidence of a drug’s effectiveness, in addition to its safety, before they could submit applications for approval. This legislative change established a higher standard for drug approval and played a crucial role in ensuring that only safe and effective medications are available to the public.

The other options refer to different aspects of drug regulation. The Food, Drug, and Cosmetic Act laid the foundational framework for drug regulation, but did not specifically impose the requirement for efficacy. The Poison Prevention Packaging Act focuses on the packaging of household products and prescription drugs to prevent accidental ingestion by children. Finally, the Controlled Substances Act regulates the manufacture and distribution of narcotics and other drugs with potential for abuse but does not specifically address the requirements for drug safety and efficacy prior to marketing.