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August 5, 1974

Medical News

JAMA. 1974;229(6):619-632. doi:10.1001/jama.1974.03230440003002

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Government report may lead to new rules on drug standards  The Congressional Office of Technology Assessment (OTA) has settled few arguments with its report on Drug Bioequivalence, but probably has set in motion these things:

  • A renewed effort by the Department of Health, Education and Welfare to produce some sort of lowest-cost guidelines for drug reimbursement under Medicare-Medicaid.

  • A tightening-up of Food and Drug Administration standards for judging bioequivalency. Current government standards and regulatory practices "do not assure bioequivalence for drug products," the OTA report concludes.

  • A first move toward what eventually may be a single agency setting standards for drugs. Shortly before the report was announced, the USP and the National Formulary announced plans to merge. This merger might produce the needed body, "but the changes necessary would be extensive," the report concludes.

There is something for both sides in the bioequivalency debate, however, and