The thalidomide scandal, which resulted in approximately 10,000 babies being born with birth defects (half of whom died) and untold numbers of miscarriages, could have been significantly worse had it not been for
Frances Oldham Kelsey. Kelsey, a physician and pharmacologist, began work at the U.S. Food and Drug Administration in 1960, when one of her first cases was reviewing the application for thalidomide. Although the drug had already been approved in 20 countries, including her home country of Canada, Kelsey rejected the application six times over concerns for its safety. The drug's manufacturer, Grünenthal GmbH, submitted no proof of its effectiveness or safety, which the FDA did not require at the time. When the drug was exposed in 1962 for causing horrific birth defects, Kelsey was hailed as a heroine for preventing a national tragedy by refusing to allow thalidomide on the U.S. market. After Kelsey revealed the pressure she had been under, the American public was outraged to learn that drugs could get FDA approval so easily. On October 10, 1962, Congress passed a law requiring drug manufacturers to provide proof of the effectiveness and safety of their drugs before receiving FDA approval. That same year, Kelsey received the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy.