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Frances Kelsey honored for FDA legacy: award notes her work on thalidomide, clinical trials.

WHEN FRANCES OLDHAM KELsey, MD, PhD, began her job as a medical reviewer in a dreary prefabricated building at the US Food and Drug Administration (FDA) in 1960, her first assignment was to review an “easy” application for the US marketing of a drug that was already widely used in Europe and thought to be safe. Neither she nor her supervisors could have predicted that her work on the application would spark changes in drug regulation worldwide and lead to the development of modern standards for clinical research. The application was for thalidomide, a drug then popular in Europe to aid sleep and alleviate nausea during pregnancy. Kelsey and her FDA colleagues found the safety and toxicity data submitted by the company lacking, and she insisted that the company provide better data. Those concerns proved to be well-founded: about a year later a European outbreak of phocomelia, a severe birth defect in which infants are born without limbs or with severely deformed limbs, was linked to the use of thalidomide during pregnancy. Kelsey’s steadfast refusal to approve the application is credited with saving thousands of US children from such a fate. It also helped prompt massive changes in the regulation of drugs in the United States and abroad, changes she helped to shape during her 45year career at the FDA. In September—50 years after Kelsey, now 96 years old, joined the agency—the FDA honored her with an award named for her, and a promise from FDA Commissioner Margaret A. Hamburg, MD, that the agency will carry on Kelsey’s commitment to science and integrity. “This is an opportunity to rededicate ourselves to the science that must drive our decisions as regulators and public health officials,” Hamburg said at the ceremony.