Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide
Cheryl Krasnick Warsh
Published:
2024
Online ISBN:
9780197632574
Print ISBN:
9780197632543
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Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide
Cheryl Krasnick Warsh
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Cheryl Krasnick Warsh
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Abstract
Thalidomide, a sedative prescribed to women for morning sickness, has haunted the pregnancy experience since the 1960s by demonstrating how toxic chemicals can be to fetuses, and demonstrating that physicians are not all-knowing. Frances Kelsey, a PhD in pharmacology and MD, and medical reviewer at the US Food and Drug Administration (FDA), used her experience with the controversial practice of animal testing to recognize thalidomide’s dangers and prevent it from entering the American drug market. Despite the accolades she received, she faced gendered opposition from some superiors and drug lobbyists throughout her more than forty years at the FDA. After the thalidomide tragedy, the agency’s mandate was expanded to include evidence from drug manufacturers that products were safe, effective, and properly tested. Kelsey negotiated through work pressures and juggled domestic responsibilities with a network of supportive family and friends.
Keywords: Frances Oldham Kelsey, FDA, thalidomide, women, science, pharmacology, animal research, birth defects
Subject
History of Science and Technology
Collection: Oxford Scholarship Online
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