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FDA's Hayes begins academic post

JAMA. 1983;250(9):1133. doi:10.1001/jama.1983.03340090009006.
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Arthur Hull Hayes, Jr, MD, 50, commissioner of the Food and Drug Administration for the past 2 1/2 years, becomes dean of the New York Medical College in Valhalla, NY, this month.

Hayes, a cardiologist, was appointed FDA commissioner in April 1981. Among his major accomplishments, as cited by several FDA staffers, are these:

  • Speeding up the new drug approval process. During 1981 and 1982, the agency approved 55 new drugs, the highest number of new chemical entities to be approved on an annual basis since the 1962 Kefauver-Harris Act, which required that drugs be efficacious as well as safe. Hayes also proposed relaxing the regulations governing the initial clinical trials of new drugs. The proposal drew the ire of such perennial FDA critics as Sidney Wolfe, MD, director of the Health Research Group, who charged: "It weakens the protection of human subjects."

  • Developing an orphan drugs products program whose


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