Kelsey, Frances Oldham
Kelsey, Frances Oldham,1914–2015, Canadian-American pharmacologist, b. Cobble Hill, British Columbia, as Frances Kathleen Oldham, grad. McGill Univ. (B.Sc. 1934, M.Sc. 1935), Univ. of Chicago (Ph.D. 1938, M.D. 1950). After earning her doctorate, she taught at Chicago and then (1954–57) at the Univ. of South Dakota, and subsequently was a general practitioner in South Dakota. In 1960 she joined the Food and Drug Administration in Washington, D.C., as a medical officer reviewing drug applications. She and other staff members raised concerns about the safety, effectiveness, and quality of thalidomidethalidomide
, sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that it was sold without prescription.
..... Click the link for more information. , a sedative, in 1960, and she refused to approve the drug without additional information. Ultimately her continuing insistence on thorough testing and complete data delayed approval until evidence emerged in Europe of limb malformations in fetuses due to the drug, and the drug application was withdrawn.
Widely recognized for her efforts after news articles in 1962, she subsequently helped shaped legislation that regulated drugs and drug testing and was central figure in the FDA's enforcement of drug regulation and review. Chief of the FDA's investigational section from 1963, she became director of the scientific investigation office in 1967; she later was deputy for scientific and medical affairs in the FDA's drug evaluation and research compliance office from 1995 to 2005.