Kelsey was newly installed as a reviewer for the U.S. Food and Drug Administration in 1960 when she had to pass judgment on a new drug called Kevadon, sold in Europe and other parts of the world to treat morning sickness in pregnant women. She delayed approval of the drug due to concerns about the side effects of its primary substance thalidomide, a very powerful immunomodulatory drug and sedative at the same time.
She demanded that the drug be fully tested before its release, despite pressure from now defunct manufacturer Richardson Merrell to skip the phase. Her concern was proven to be just cause in 1962, when a study found that thalidomide was responsible for birth defects and complications in thousands of infants whose mothers had ingested the drug during pregnancy, with many of them lacking body parts or being semi-paralyzed.
Between 10,000 and 20,000 infants were estimated to being born with birth defects worldwide because of thalidomide. By denying the request for immediate commercialization, Kelsey possibly saved thousands of infants from the effects of the drug. She rapidly became a public heroine, being commended with the President’s Award for Distinguished Federal Civilian Service by President Kennedy the same year.
However, her legacy did not end there. Because of the substantial outcry generated by the truth regarding thalidomide, a 1962 Amendment to the Federal Food, Drug and Cosmetic Act was passed which modeled future drug regulation, for the first time requiring companies to clearly demonstrate effectiveness of new drugs, their side effects and also making them require consent from test subjects. It also required drug advertisements of any form to also state their known side effects.
Kelsey continued to work for the FDA until 2005, when she was 90 years old. In 2000, she was inducted in National Women’s Hall of Fame. The FDA inaugurated an award in her name, the “FDA Kelsey Award” for the service’s most outstanding employee, by awarding her with it. Last but not least, she was also presented with the second-highest Canadian award, the Order of Canada, in June 2015. She died in her London, Ontario home just one day after the region’s Lieutenant-Governor Elizabeth Dowdeswell visited her to personally hand out the insignia which represented her inclusion as a Member of the Order of Canada.
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