In 1960, America had a stroke of luck. That was when the application to begin mass-marketing the drug thalidomide in the United States landed on the desk of Frances Oldham Kelsey, a reviewer at the Food and Drug Administration. Today we know that the drug can cause a range of severe congenital deformities and even infant death when taken by pregnant women for nausea. But at the time, thalidomide’s darker effects were just becoming known.
Between 1957 and 1962, the sedative would result in thousands of infants in Canada, Great Britain and West Germany born with serious deformities, including the shortening or absence of limbs. The U.S., however, never had a crisis of thalidomide-linked deformities on that magnitude. Why not?
What stood between the drug and the health of the American public was none other than Kelsey and the FDA. As a medical reviewer, Kelsey had the power to prevent a drug from going to market if she found the application to be lacking sufficient evidence for safety. After a thorough review, Kelsey rejected the application for thalidomide on the grounds that it lacked sufficient evidence of safety through rigorous clinical trials.
Today we take it for granted that the FDA wisely spurned an unsafe drug. But in many ways, Kelsey’s education and experience up to that point made her especially well-suited for her position as a medical reviewer—and, in particular, for the thalidomide application.