Stuff You Should Know

Short Stuff: Frances Kelsey: Hero of the FDA

May 10, 2023
Discover the inspiring life of Frances Kelsey, an unsung hero of the FDA who revolutionized drug safety. Her fierce dedication led to the rejection of thalidomide, protecting countless children from devastating birth defects. Explore her pioneering efforts, the importance of rigorous scientific evaluation, and the lasting impact of her work on modern drug approval processes. Fun and educational, this story highlights how one woman's commitment to safety changed healthcare forever.
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ANECDOTE

Kelsey and Thalidomide

  • Frances Kelsey, working at the FDA, scrutinized a drug application for thalidomide.
  • Despite pressure, she repeatedly requested more data, preventing its US release.
INSIGHT

Impact of Kelsey's Actions

  • Kelsey's thoroughness prevented a thalidomide tragedy in the US, unlike Europe and elsewhere.
  • Her actions highlighted the need for more rigorous drug approval processes.
INSIGHT

Recognition and Reform

  • Public recognition of Kelsey's work, sparked by a Washington Post article, led to Kennedy awarding her.
  • This also resulted in the Kefauver-Harris Amendment, strengthening FDA regulations.
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