Dr. Frances Oldham Kelsey, who died last week at the age of 101, became a 20th-century North American heroine for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.
In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she was one of only seven full-time and four young part-time physicians reviewing drugs for the FDA. One of her first assignments there was to review an application for the drug thalidomide as a tranquilizer and painkiller for pregnant women for morning sickness. Even though it had already been approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested further studies. Despite pressure from thalidomide’s manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.
After the story received press coverage in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation. Companies were required to demonstrate the efficacy of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies. Read more about Dr. Kelsey…
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