America's Thalidomide Hero Is Dead
FDA's Frances Kelsey kept dangerous drug off US markets
By Michael Harthorne,  Newser Staff
Posted Aug 8, 2015 1:21 PM CDT
Dr. Frances Oldham Kelsey   (National Library of Medicine)

(Newser) – Dr. Frances Oldham Kelsey, who reshaped drug regulations at the FDA and—in the words of President Kennedy—"prevented a major tragedy" of birth defects in the United States, died yesterday at the age of 101, the New York Times reports. Kelsey joined the FDA in 1960 and was quickly presented with an application from drug-maker Merrell to market thalidomide in the US. The sedative was being used in Europe and elsewhere as a treatment for nausea in pregnant women. Kelsey was unconvinced by Merrell's reports of the drug's safety and demanded more data. "For a critical 19-month period, she fastidiously blocked its approval while drug company officials maligned her as a bureaucratic nitpicker," recounts the Washington Post.

A year later, with Kelsey still refusing approval, reports poured in from Europe of tens of thousands of "thalidomide babies" born with severe deformities. Merrell withdrew its application to market the drug, and Kelsey eventually won widespread praise. Both Congress and the president presented Kelsey with medals for her service, and she was put in charge of a new FDA branch created in 1962 to ensure drug safety. The medical-testing regulations she helped rewrite in the wake of the thalidomide case have since been adopted around the world, and in 2000 she was inducted into the National Women's Hall of Fame, joining the likes of Helen Keller and Eleanor Roosevelt. She retired from the FDA in 2005.