Frances Oldham Kelsey

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After earning her bachelor’s and master’s degrees in pharmacology Frances Oldham Kelsey continued her studies at the University of Chicago. During her second year at the school the US Food and Drug Administration hired the pharmacology department to research a string of unusual deaths related to elixir sulfanilamide . Kelsey assisted with the project verifying that over 100 deaths were caused by using the excipient DEG as a solvent in the medication. As a result, the United States passed the Federal Food, Drug, and Cosmetic Act of 1938.

After earning her doctorate in the same year, she joined the faculty at Chicago and in 1950 she was awarded a medical degree. Hired by the FDA in 1960 she was one of a handful of physicians reviewing drugs for approval following laws that at the time were not rigorously enforced. One of her first assignments was the review of an application for the drug thalidomide. While it had been approved in Canada and more than 20 other countries Kelsey withheld approval and requested further studies. Her request stemmed from a study that had documented a nervous system side effect and the fact that the manufacturer hadn’t provided sufficient evidence that the drug wasn’t harmful.

Even with great pressure from the manufacturer she stood her ground. When it was discovered that the drug was able to cross the placental barrier and cause serious birth defects, her insistence on more testing was vindicated. Hailed as a hero, she was quick to insist that her assistants and her FDA superiors that had backed her strong stance deserved credit as well.

For her successful efforts in blocking the American approval of thalidomide she was awarded the President’s Award for Distinguished Federal Civilian Service. Continuing to work at the FDA, she played a key role in both the creation and enforcement of new regulations. She spent a total of 45 years at the FDA working at the Center for Drug Evaluation and Research and was appointed deputy for scientific and medical affairs. At the age of 90 she retired, and it was announced five years later that the FDA had created the Dr. Frances O. Kelsey Drug Safety Excellence Award.

Written by Angela Goad

Sources:

Changing the Face of Medicine: Dr. Frances Kathleen Oldham Kelsey

Frances Oldham Kelsey, Who Saved U.S. Babies From Thalidomide, Dies at 101

Wikipedia: Elixir sulfanilamide

Wikipedia: Frances Oldham Kelsey

National Women’s Hall of Fame: Frances Oldham Kelsey

See Also:

Introductions Necessary: Helen B Taussig

Wikipedia: Thalidomide