Overview

Frances Oldham Kelsey, PhD, MD is a naturalized American pharmacologist, born July 24, 1914, most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize Thalidomide for market because she had concerns about the drug's safety. This incident encouraged the passage of laws strengthening the FDA's oversight of pharmaceuticals.

The Kefauver Harris Amendment of 1962 was passed unanimously by Congress, establishing drug testing reforms which required "stricter limits on the testing and distribution of new drugs" to avoid similar problems. The amendments also, for the first time, recognized that "effectiveness [should be] required to be established prior to marketing."

Photo 1962: FDA inspector Frances Oldham Kelsey receives award from President John F. Kennedy for blocking sale of Thalidomide in the United States

References

Frances Oldham Kelsey - wikipedia