During Women’s History Month, the U.S. Food and Drug Administration (FDA) is spotlighting the careers of food safety and public health pioneers such as Frances Oldham Kelsey, M.D. Kelsey’s insistence that there was insufficient evidence to support claims that thalidomide was a safe drug staved off tragedy and aided in the passage of a law reforming drug regulation.
During the 1950s and 1960s, thalidomide was approved for sale in several European countries and prescribed to pregnant women suffering from morning sickness. Reviewing the drug, made by the William S. Merrell Company of Cincinnati, 
was one Kelsey’s first assignments after joining the agency as one of a handful of medical officers in 1960.
Despite heavy and constant pressure form the drug’s maker, Kelsey said the information the company provided did not prove the drug’s safety and therefore could not be approved. About a year after Kelsey denied the drug’s approval, researchers in Germany and Australia linked thalidomide to rare, severe birth defects. Thousands of babies were born with hands or feet projecting directly from the shoulders and hips, others were born with malformed eyes, hearts, digestive tracts or urinary tracts. Worldwide, 10,000 babies were born with thalidomide-related birth defects. Only about half of them survived.
The tragedy abroad helped to pass a pending bill that fundamentally changed drug regulation, the 1962 Drug Amendments. That same year President Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian Service.
Kelsey was born in Cobble Hill, Vancouver Island, B. C., She earned her B. Sc. from McGill Universityi n 1934 and a Master’s degree in pharmacology in 1935. She earned her Ph. D. in pharmacology at the University of Chicago in 1938 and her M.D. in 1950. In 1954, she began teaching pharmacology at the University of South Dakota and practiced general medicine. She led the FDA’s Investigational Drugs Branch, and from the late 1960s until the 1990s she led its Division of Scientific Investigations. She has received many awards including induction into the National Women’s Hall of Fame. In 2010, she became the first person to receive the Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health.
