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B-164031(2) 1 (1974-02-15)

handle is hein.gao/gaobaagre0001 and id is 1 raw text is: UNITED STATES GENERAL ACCOUNTING OFFICE lou WASHINGTON, D.C. 20548 MANPOWER AND WELFARE F14b Is 7y DIVISION B-164031 ( 2 F 1 74 The Honorable LM096755 The Secretary of Health, Education, and Welfare Dear Mr. Secretary: During our survey of the administration of the fttqaid drug prgsjrz&, we found that the three States included in the survey (California, Ohio, and Texas) were expending significant amounts of f uds(port9,tionsof which, a.re rmbrs-ed~bytheFedera-evern- Mewtt) for prescription drugs that have been declared ineffective or possibly effective by the Food and Drug Administration (FDA). The Department of Health, Education, and Welfare (HEW) has not issued regulations prohibiting the us ,,ofEedera-,unds..for .the purchase fJ'nef.fec'tivandpossibly effective drugs under_he ed.cal-dprogram,. We believe that HEW should expedite the issuance of such regulations. BACKGROUND The 1962 Amendments (P.L. 87-781) to the Federal Food, Drug and Cosmetic Act required that drugs be effective before they can be approved for marketing. Under these amendments, FDA began evaluat- ing the effectiveness of all drugs that it had approved for market- ing under a safety criteria in force before the amendments. After analysis by the National Academy of Sciences/National Research Council of the available data relating to the effectiveness of a drug, FDA publishes in the Federal Register a notice of its initial classification of the drug as being effective, probably effective, possibly effective, or ineffective. If a drug is not classified as effective, a notice of an opportunity for a hearing is also published. If interested parties justify, on the basis of new evidence, the need for a hearing, one is held. After the hearings FDA publishes its final determination of the effectiveness of the drug and declares it to be either effective or ineffective.

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