Dr. Frances Kelsey was a Canadian-American pharmacologist who worked as a reviewer for the U.S. Food and Drug Administration (FDA) after an impressive career as a faculty member at the University of Chicago and University of South Dakota.
At the FDA, Dr. Kelsey was a member of a very small team whose responsibility it was to review drug applications from pharmaceutical companies, placing a much needed emphasis on evidence-based data. During this time, Dr. Kelsey repeatedly blocked the application for a drug called thalidomide, which was already widely used in Europe. Drawing on her past research of finding evidence of certain drugs that crossed the placental barrier, she was not convinced that thalidomide was safe for pregnant women, especially with the data (or lack of) that was being presented. Despite growing pressure to ram the drug application through (drug company’s bottom line $ of course being their most important worry), Dr. Kelsey and her team stuck to their guns and refused to let a drug with possible serious side-effects into the U.S. market. In the 1960s, births of many deformed infants in Europe started to be linked to thalidomide, and it became widely known that Dr. Kelsey prevented a disastrous medical crisis in the U.S.
In 1962, she became the second woman to be presented the President’s Award for Distinguished Federal Civilian Service by President John F. Kennedy. Dr. Kelsey retired from the FDA in 2005 after 45 years of service.
Thank you to Sarah (a current #WCW in STEM) for sharing the below video and putting Dr. Kelsey on my radar!