Women You May Not Know

In 1960, Kelsey was hired by the FDA in Washington, D.C. One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide, which had specific indications to treat pregnant women with morning sickness.

Although it had been previously approved in Canada and more than 20 European and African countries she withheld approval for the drug and requested to see clinical trial information.

Kelsey’s insistence that the drug should be fully tested prior to approval was vindicated in November 1961 when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.