This podcast episode sheds light on Frances Oldham Kelsey's contributions to drug safety and the story of thalidomide, a drug that caused immense suffering and reshaped drug regulations. Beginning as an FDA reviewer, Kelsey scrutinized thalidomide's safety and resisted pressure to approve it without adequate testing, preventing its widespread release in the US. This decision saved countless children from enduring thalidomide's catastrophic side effects, evident in the devastating birth defects in West Germany. The tragedy emphasized the need for rigorous drug evaluation, inspiring the Kefauver Harris Amendment and strengthening the FDA's approval processes. Kelsey remains an unsung hero, highlighting the pivotal role individuals can play in safeguarding public health.
