Thalidomide Kefauver-Harris

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). 

Thalidomide, a new sedative, was associated with birth defects in thousands of newborns throughout Europe. Fortunately, the medication had not been approved for use within the U.S. In 1962, with the support of Senator Estes Kefauver, another health policy window was opened the amendments were passed to ensure that medications were both safe and efficacious. With the Kefauver-Harris Amendments, the effectiveness of a medication has to be proven by substantial evidence which includes adequate and well-controlled trials. For the first time, pharmaceutical manufacturers had to demonstrate a product s efficacy to the FDA. The Kefauver-Harris Amendments led the way for randomized clinical trials and the FDA drug approval process. 

Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety in response to the thalidomide birth defects disaster. 1965 Drug Abuse Control Amendments are enacted to deal with problems of abuse of depressants, stimulants, and hallucinogens. 

The Kefauver-Harris Act in the USA, after the thalidomide catastrophe, is a good example of response to crisis. Such post hoc legislation results in differential oversight of different types of agents. 

Perhaps the most important consequence of the thalidomide tragedy was the legislation of much more stringent regulations for new-drug approval in the United States. In 1963 President Kennedy signed the Kefauver Harris amendment, which required that a new drug must be shown to be safe and... 

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