• The Milbank quarterly · Jan 1990

    Clinical Trial

    New rules for new drugs: the challenge of AIDS to the regulatory process.

    • Harold Edgar and David J Rothman.
    • Columbia University.
    • Milbank Q. 1990 Jan 1; 68 (Suppl. 1): 111-42.

    AbstractAIDS is systematically changing attitudes and practices regarding the regulation and use of drugs. The complex framework and rigorous research protocols developed by the Food and Drug Administration prior to the 1980s to minimize risk to subjects is shifting in the epidemic's wake to maximize innovation. The FDA has adopted new procedures hastening access to investigational drugs and easing drug importation for personal use, which, in effect, transfers decisions about the benefits and risks of drugs from the agency's staff to patients and their physicians. While the FDA's tilt toward embracing consumer rights may continue in the near future, disappointing results could prompt the agency to reassert its authority in controlling drug policy more restrictively.

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