During the Kefauver hearings, FDA received an NDA for Kevadon, the brand of thalidomide that the William Merrell Company hoped to market in the U.S. Despite ongoing pressure from the firm, medical officer Frances Kelsey refused to allow the NDA to become effective because of insufficient safety data. By 1962 thalidomide's horrifying effects on newborns became known. Even though Kevadon was never approved for marketing, Merrell had distributed over two million tablets for investigational use, use which the law and regulations left mostly unchecked. Once thalidomide's deleterious effects became known, the agency moved quickly to recover the supply from physicians, pharmacists, and patients. For her efforts, Kelsey received the President's Distinguished Federal Civilian Service Award in 1962, the highest civilian honor available to government employees.

Kelsey receiving the award from President John F. Kennedy in 1962.