Frances Oldham Kelsey- medicine gatekeeper

Kelsey headshot

Who Was Frances Oldham Kelsey?

Frances Oldham Kelsey was a Canadian-American pharmacologist and physician, best known for rejecting the authorization of the drug thalidomide for sale to the public. This decision saves millions of newborn babies from birth defects.

Pre-career Life

Kelsey was born in Cobble Hill, British Columbia, to Katherine Stuart and Frank Oldham. She graduated from McGill University in 1934 and 1935 with both bachelor and master of science degrees. In 1938, she earned a Ph.D. in pharmacology at the University of Chicago.

Kelsey in a lab

Kelsey’s Early Career

Kelsey joined the faculty at the University of Chicago after earning her Ph.D. She looked for a synthetic cure for malaria, and through this research she realized that some drugs are able to pass through the placenta’s barrier, which would be important for her future work.

Work at the FDA

Kelsey was hired as a medical reviewer for the FDA in 1960. Her first assignment was to review an application for the approval of thalidomide, a drug intended for use as a tranquilizer and painkiller for pregnant women with morning sickness, filed by the Richardson Merrell Company. Although the drug was approved in more than 20 countries, Kelsey withheld the approval and asked for more studies. The company constantly pressured her to approve the drug, but Kelsey stood firmly with her decision. Soon after her decision, thousands of mothers who took thalidomide were found giving birth to deformed infants. Researchers found that thalidomide crossed the placental barrier and caused serious birth defects. After this discovery, Kelsey was seen as a heroine who saved thousands of babies from being born deformed.

Recognition and Awards

Rightfully, Kelsey was recognized for her lifesaving work. Kelsey became the second woman to ever receive the President’s Award for Distinguished Federal Civilian Service on 7 August 1962. She was awarded this by John F. Kennedy, who said “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. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people.” In 2000, she was added to the National Women’s Hall of Fame.

Legacy and Change

Kelsey’s work and decision caused major change in drug regulation in the United States. Congress passed drug testing reforms that began a new era in which the testing and distribution of drugs are now far more strict. The Kefauver Harris Amendment, passed by Congress in October 1962, made it an requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, drug advertising to have accurate information about side effects, and stopped cheap drugs from being marketed as expensive drugs under new names. Clearly, Kelsey has left her mark as a bright strong woman in the world of medicine and drugs.


Wikipedia- Frances Oldham Kelsey

Macroevolution- Frances Oldham Kelsey

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