Canadian-born Frances Kelsey died this month at the age of 101, but it is not her longevity that she will be remembered for. In 1961, Dr. Kelsey had just begun working at the FDA, and was faced with a decision to allow a new drug called thalidomide to be used for morning sickness in the United States.
Thalidomide had been used by pregnant women in Europe for nausea, and had been sold as a sleeping pill. But Kelsey felt the drug needed more research regarding its safety and purity. She refused to give a rubber stamp of approval for its sale in the United States.
She asked the manufacturer, the William S. Merrell Company, of Cincinnati, to provide more safety evidence. In response, Merrell attempted to pressure her by complaining to her bosses that she was a “petty bureaucrat,” fussy and stubborn. Merrell stood to make millions if the drug could be passed, but Kelsey refused to change her stance and held off approval.
By the end of 1961, the terrible news erupted that thousands of babies in Europe, Britain, Canada and the Middle East were being born with flipper-like arms and legs, as well as other birth defects, such as missing ears or deformities of the digestive tract. Thalidomide was found to cross the placental barrier and retard the growth of the developing fetus.
In the spring of 1962, Merrell withdrew its application to the United States, and the drug was removed from the shelves all over the world.
Because of Kelsey’s actions, countless U.S. women were prevented from bearing children who would have suffered a similar fate. She was given honorary degrees and a medal by Congress, “for service to humanity and (she) passed legislation requiring drug makers to prove that new products were safe and effective before marketing them,” reported the New York Times.
Kelsey was put in charge of the branch in the FDA which is responsible for putting in place more stringent rules to test and regulate new drugs.