Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American[1] pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety.[2] Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.
Born in Cobble Hill, British Columbia,[3] Kelsey attended St. Margaret's School from 1928 to 1931 in the provincial capital, graduating at age 15.[4] From 1930 to 1931, she attended Victoria College (now University of Victoria). She then enrolled at McGill University, where she received both a B.Sc. (1934) and an M.Sc. (1935) in pharmacology.[3] Encouraged by one of her professors, she "wrote to EMK Geiling, M.D., a noted researcher [who] was starting up a new pharmacology department at the University of Chicago, asking for a position doing graduate work".[4] Geiling, unaware of spelling conventions with respect to Francis and Frances, presumed that Frances was a man and offered her the position, which she accepted, starting work in 1936.[5][6]
During Kelsey's second year, Geiling was retained by the FDA to research unusual deaths related to elixir sulfanilamide, a sulfonamide medicine. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of diethylene glycol as a solvent. The next year, the United States Congress passed the Federal Food, Drug, and Cosmetic Act of 1938.[4] That same year she completed her studies and received a Ph.D. in pharmacology at the University of Chicago.[4] Working with Geiling led to her interest in teratogens, drugs that cause congenital malformations (birth defects).[7]
Upon completing her Ph.D., Oldham joined the University of Chicago faculty. In 1942, like many other pharmacologists, Oldham was looking for a synthetic cure for malaria. As a result of these studies, Oldham learned that some drugs are able to pass through the placental barrier.[8] During her work, she also met fellow faculty member Fremont Ellis Kelsey, whom she married in 1943.[4]
While on the faculty at the University of Chicago, Kelsey was awarded her M.D. in 1950.[4] She supplemented her teaching with work as an editorial associate for the American Medical Association Journal for two years. Kelsey left the University of Chicago in 1954, decided to take a position teaching pharmacology at the University of South Dakota, and moved with her husband and two daughters to Vermillion, South Dakota, where she taught until 1957.[3]
She became a dual citizen of Canada and the United States in the 1950s in order to continue practicing medicine in the U.S., but retained strong ties to Canada where she continued to visit her siblings regularly until late in life.[2]