Frances Kelsey, a quiet and matter-of-fact woman, insisted that there was insufficient evidence of the drug's safety, and refused to approve it. The manufacturers did everything they could to get around her decision. But when it was discovered that thalidomide was causing severe birth defects around the world, Kelsey became a nationally recognized hero. Her courageous and unwavering integrity proved to be decisive in preventing one of the greatest pharmaceutical disasters of the twentieth century—and fundamentally reforming drug regulation in the United States.
In this first-ever biography, read about the woman who single-handedly stood up to a major pharmaceutical company, did her duty in the face of enormous pressure, and credited her whole team with the accomplishment when she was presented with the highest civic honors. It’s an incredible tale of integrity in the moment of truth, the power of humble courage, and hundreds of thousands of lives saved by one ordinary woman who was unafraid to do what was right.