Kelsey, Frances Oldham

Bren, Linda. Frances Oldham Kelsey FDA Medical Reviewer Leaves Her Mark on History. FDA Consumer 35, no. 2 (March/April 2001) 24-29. This article tells the story behind Kelsey s actions to block the approval of thalidomide and prevent the epidemic of birth defects that occurred in Europe from playing out in the United States. When working for the FDA, she demanded better studies of the drug s long-term safety, after which evidence of harm from Europe emerged and justified her careful approach. 

BrenL. 2001. Frances Oldham Kelsey FDA medical reviewer leaves her mark on history. FDA Consumer Magazine, March-April. 

Mintz, Heroine of FDA Keeps Bad Drug off Market Drug Market Guardian Frances Oldham Kelsey, New York Times. 

Pharmacologist Frances Oldham Kelsey, who rejected the use of the sedative thalidomide in the United States. 

Bren, Linda (2001). Frances Oldham Kelsey FDA Medical Reviewer Leaves Her Mark on History. FDA Consumer 3 5(2) 24—29. Also available from . 

Thalidomide (see the structure below) was synthesized and marketed by a German company in 1957 as an anti-nausea agent for pregnant women as well as a sedative. It was sold in more than 20 countries by 1960, the year before the German company discovered that it was associated with seriously deformed babies and pulled it from the market. In 1960, an American company applied to market thalidomide. The case was reviewed by Frances Oldham Kelsey (1914- ) of the FDA. Despite pressure from the company, Kelsey did not feel that the safety of the drug had been fully established. When news of "thalidomide babies" started to appear in 1961, it became clear that Kelsey s principled stand had saved the United States from a disaster. The company s U.S. application was withdrawn in 1962. 

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