The Kefauver-Harris Amendments were inspired by which tragedy?

• A. Sulfanilamide tragedy
• B. Thalidomide tragedy in Europe
• C. Tylenol cyanide crisis
• D. E. coli outbreak

Answer: (B)

These amendments were inspired by the Thalidomide tragedy in Europe, where widespread use during pregnancy caused thousands of birth defects. The disaster exposed serious gaps in drug testing and safety before marketing. In response, the Kefauver-Harris Amendments of 1962 established that new drugs must prove both safety and efficacy, gave the FDA broader oversight over drug advertising and manufacturing (including good manufacturing practices), and required reporting of adverse effects and informed consent in clinical trials. The other events listed are associated with different regulatory prompts or later incidents, not the specific catalyst for these amendments.