In 1960 the Food and Drug Administration hired Frances Kelsey to review applications for new drugs. One of her first files was an application for thalidomide. Kelsey refused it because the safety evidence was “more anecdotal than clinical.” The company resubmitted it again and again and complained to her superiors. They backed her.
Reports of birth defects then came from Europe. In August 1962 President Kennedy gave Kelsey the President’s Award for Distinguished Federal Civilian Service. The Kefauver-Harris Amendments of the same year required manufacturers to “prove the effectiveness of drug products before they go on the market.”
Here the country honored the official who refused to act before the evidence was in.