President Kennedy signs Kefauver-Harris Amendments, adding efficacy requirement to drug approval

President John F. Kennedy signed the Kefauver-Harris Drug Amendments on October 10, 1962. Named for Senator Estes Kefauver and Representative Oren Harris, the amendments added an efficacy requirement for the first time: drug companies had to prove their products worked, not just that they were safe. The amendments codified the requirement for "adequate and well-controlled investigations" — the statutory language FDA later interpreted to mean two pivotal trials. The law passed eight months after thalidomide's European withdrawal, with Frances Kelsey receiving the President's Award for Distinguished Federal Civilian Service that same year for blocking U.S. thalidomide approval.