Canadian born Dr. Francis Kelsey, a novice regulator at the (US) FDA, was put in charge of the approval process for Thalidomide in September 1960. She refused to approve the drug for use in the United States because she was sceptical about the drug’s safety. At a hearing many years later on whether or not to re-introduce the drug, she said “we were concerned about the peripheral neuritis, even if the companies did not seem to be…. The risk of developing this would not be justified in a drug that was used simply as a hypnotic and sedative, since there were other drugs on the market for this purpose.”
Note: Kelsey, born Frances Oldham in 1914 on Vancouver Island. In her first month on the job at the FDA she refused to approve the release of Thalidomide.