Former Food and Drug Administration medical reviewer Dr. Frances Oldham Kelsey, whose dogged refusal to approve the application for the drug thalidomide is credited for averting death and birth defects for thousands of babies, has died at the age of 101, according to reports.
Kelsey, born in Vancouver, British Columbia, in 1914, began her work at the FDA in 1960 as a medical officer assigned to review new drug applications. She was assigned during her first month on the job to review a new prescription sleeping medication that had already been widely used in Europe and several other countries.
The drug, thalidomide, was developed by German-based pharmaceutical firm Chemie Grunenthal and was being sold by the late 1950s as a treatment for morning sickness in pregnant women.
Thalidomide became Kelsey's first assignment, according to a biography posted by the National Institutes of Health. Kelsey was concerned by the lack of data demonstrating safety. Upon investigation, she discovered the drug was linked with dangerous birth defects that the U.S. drugmaker seeking approval did not list in its application.
By 1961 reports of the birth defects related to the use of thalidomide spread worldwide, but by then at least 4,000 children in Europe had been affected. By contrast, a total of 17 children were born in the U.S. with health problems associated with use of thalidomide.
In 1962, President John Kennedy recognized Kelsey with the President's Award for Distinguished Federal Civilian Service, the highest honor given to a civilian, for her work. He cited her for preventing a, “major tragedy of birth deformities in the United States.”
Kelsey was head of the FDA's Division of Scientific Investigation by the time she left the agency in 1995 and is recognized for helping shape the regulatory review process for drugs and medical devices.
Kelsey was inducted into the National Women's Hall of Fame in 2000 and was the first recipient of the Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health in 2010 by then-FDA Commissioner Dr. Margaret Hamburg.
“She applied her knowledge and intellect to the tasks before her,” Hamburg said during the award ceremony honoring Kelsey. “There is no doubt she saved lives and saved many thousand individuals and their families from devastating damage.”
