Frances Oldham Kelsey

Frances Oldham Kelsey (July 24, 1914 – August 7, 2015) was a Canadian-American pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize Thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was shown that Thalidomide caused serious birth defects. Kelsey's work on the drug's testing process led to major reforms in the FDA's drug approval process.

Early life and education

Kelsey was born in Cobble Hill, British Columbia, on Vancouver Island, in 1914. She attended McGill University, where she received both her B.S. in 1934 and M.S. in 1935. She was awarded a Ph.D. from the University of Chicago in 1938.

Career

In 1960, Kelsey was hired by the FDA in Washington, D.C. She is best known for her work at the FDA, where she became a reviewer for new drug applications. In this role, she made a significant impact on the future of drug testing and approval processes.

Thalidomide

In 1960, Kelsey received an application from the William S. Merrell Company for the drug Thalidomide, which was already being sold in Europe as a sedative and morning sickness cure. Kelsey was not convinced of its safety and requested further studies. Her insistence on rigorous testing saved countless newborns in the U.S. from the devastating effects of the drug, which was later found to cause severe birth defects.

Legacy

Kelsey's work led to the passing of laws strengthening the FDA's oversight of pharmaceuticals. She was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy, becoming the second woman to receive this award.

See also

• Food and Drug Administration
• Thalidomide
• Pharmacology

References

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Frances Oldham Kelsey

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  Frances Oldham Kelsey

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  Frances Oldham Kelsey at the FDA

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  Frances Oldham Kelsey with John F. Kennedy

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  Frances Oldham Kelsey in 2001