Kefauver, Estes

Estes Kefauver, Democratic senator from Tennessee from 1949 to 1963, and vice presidential candidate in the 1956 election, ffe was known for his concern about the concentration of economic power among corporations and was an early critic of high prices for prescription drugs and the pharmaceutical industry, ffe cosponsored the Drug Control Act of 1962, which required that drugs approved by the FDA be proven both safe and effective. 

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. 

Figure 1. President John Kennedy signing the 1962 Kefauver-Harris Amendments to the Food and Drug Act into law. Fie is handing the pen to Estes Kefauver Frances Kelsey is second from the left. (FDA Flistory Office)...

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