Thalidomide In 1961, thousands of reports from western Europe linked a tragic birth defect—of babies born with mutated limbs—to prenatal use of the sleeping pill, Thalidomide. FDA medical officer Dr. Frances Kelsey refused to approve the drug for use in the due to a lack to adequate evidence to establish its safety, despite considerable lobbying by the manufacturer. Her action led to media attention that helped sway public opinion in favor of more stringent food and drug regulations, leading to passage of the 1962 Kefauver-Harris Drug Amendments, a victory for maternal and fetal health c

Thalidomide In 1961, thousands of reports from western Europe linked a tragic birth defect—of babies born with mutated limbs—to prenatal use of the sleeping pill, Thalidomide. FDA medical officer Dr. Frances Kelsey refused to approve the drug for use in the due to a lack to adequate evidence to establish its safety, despite considerable lobbying by the manufacturer. Her action led to media attention that helped sway public opinion in favor of more stringent food and drug regulations, leading to passage of the 1962 Kefauver-Harris Drug Amendments, a victory for maternal and fetal health creating a standard that drugs prove efficacy prior to commercial marketing.

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