Though her story is nearly forgotten, she was once America's most admired civil servant. Dr. Frances Oldham Kelsey's journey - honored with the FDA's first Kelsey Award - has transformed medical safety in the US and throughout the industrialized world. Thanks to Dr. Kelsey, thalidomide - causing children to be born limbless or with flipper-like arms and legs - had a far more limited effect in the United States than in Europe. Furthermore, the FDA was authorized to demand that drug makers prove their products safe and effective. Dr. Kelsey helped write the rules that now govern nearly every clinical trial in the industrialized world, and was the first official to oversee them. And these accomplishments almost remained unknown.
