Frances Oldham Kelsey: Medical reviewer famous for averting a public health tragedy
|President Kennedy confers on Frances Kelsey the President’s Award for Distinguished Federal Civilian Service in 1962.|
Six years later she accepted an offer from the Food and Drug Administration to become one of just a handful of medical officers. Their principal duty was to review new drug applications, a legal requirement in which manufacturers had to provide evidence of a drug’s safety before it could go on the market. One of the first applications she was assigned was for thalidomide, which was already available in dozens of countries around the world. Dr. Kelsey, despite constant pressure from the company, refused to approve the application because of its inadequate evidence.
|Frances Kelsey works with her major professor, E. M. K. Geiling, in the Department of Pharmacology at the University of Chicago, around the late 1930s.|
Dr. Kelsey moved on to head the Investigational Drugs Branch, and from the late 1960s until the 1990s she led the Division of Scientific Investigations, which oversaw clinical investigators, ensuring the scientific integrity of the data on which the agency’s drug decision-making were largely based. Her contributions have been widely recognized through Presidential and other awards, honorary academic degrees, and educational facilities named after her. Also, in October 2000 Dr. Kelsey was inducted into the National Women’s Hall of Fame, and in 2010 Commissioner Hamburg conferred the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health on Dr. Kelsey herself.