On August 7, 1962, President John F. Kennedy awarded Dr. Frances Kelsey the highest honor given to a civilian in the United States: the President’s Award for Distinguished Federal Civilian Service. She was the second woman to ever receive the award. Kennedy acknowledged “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.”
Kelsey helped shape and enforce amendments to FDA drug regulation laws to institutionalize protection of the patient in drug investigations. These regulations required that drugs be shown to be both safe and effective, that informed consent be obtained from patients when used in clinical trials, and that adverse reactions be reported to the FDA.