WIKIMEDIA, THE US FOOD AND DRUG ADMINISTRATIONA physician and former medical reviewer for the US Food and Drug Administration (FDA), Frances Oldham Kelsey died last week (August 7). She was 101.
Kelsey is highly regarded for her work in denying approval for the medication thalidomide, which caused birth defects in babies when taken by pregnant women.
“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States,” President John F. Kennedy said of Kelsey, The New York Times reported.
Kelsey was a new medical officer at the FDA in 1960 when the application for thalidomide approval came across her desk. The medication was already used in Europe to treat nausea in pregnant women, but Kelsey was not convinced the treatment was safe. Her hesitation paid off, and evidence of the drug’s hazards began accumulating in the early 1960s.
The tragedy of thalidomide—and ...
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