Which legislation made it mandatory for manufacturers to prove drug effectiveness and safety prior to marketing?

The Kefauver-Harris Amendment of 1962 is pivotal in the history of drug regulation in the United States as it made it mandatory for pharmaceutical manufacturers to demonstrate not just the safety, but also the effectiveness of their drugs prior to marketing. This legislation arose as a response to public health concerns, particularly following the thalidomide tragedy, which illustrated the potential dangers of drugs that had not been thoroughly evaluated.

Prior to this amendment, the Food, Drug, and Cosmetic Act of 1938 established the framework for drug safety but did not require manufacturers to prove efficacy. The 1962 amendment strengthened the safeguards around drug approval, thereby significantly impacting the pharmaceutical industry and patient safety by ensuring that only drugs which had undergone adequate testing could be marketed.

The Drug Enforcement Administration Act is related to the regulation of controlled substances and does not pertain to the general requirements for drug safety and efficacy. Similarly, while the FDCA of 1938 laid the essential groundwork for drug regulation, it was the Kefauver-Harris Amendment that specifically mandated proof of effectiveness in addition to safety.