Kefauver-Harris Drug passage

Tragedy in the United States was averted by Dr. Kelsey s efforts. Her refusal to approve the thalidomide NDA without further proof of safety occurred just as news from Europe revealed that thalidomide was responsible for a birth defect that caused infants to be born with flipper-like limbs. This near miss in the United States led to passage of the 1962 Kefauver-Harris Amendments to the 1938 act. These amendments established requirements that testing for both safety and proof of drug efficacy had to be conducted in well-controlled clinical trials before an NDA could be approved and a drug allowed to reach the market (Bren, 2001). 

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