Answers to Questions on Selected FDA Bureau of Biologics' Regulation Activities

HRD-80-55: Published: Jun 6, 1980. Publicly Released: Jun 6, 1980.

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The efforts of the Food and Drug Administration (FDA), Bureau of Biologics to regulate vaccines and allergenic products were examined.

The review was made in accordance with the provisions of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Results of the review showed that the Bureau was limited by: (1) a relatively weak science base for understanding these products; (2) problems in conducting adequate and well-controlled clinical investigations on these products; and (3) the large number of products on the market.

Matter for Congressional Consideration

  1. Status: Closed

    Comments: Please call 202/512-6100 for additional information.

    Matter: Congress should amend the Public Health Service Act and the Food, Drug, and Cosmetic Act to specifically require that biological products meet effectiveness standards promulgated in regulations to be prepared by the Secretary of the Department of Health, Education, and Welfare (HEW).

Recommendation for Executive Action

  1. Status: Closed

    Comments: Please call 202/512-6100 for additional information.

    Recommendation: The Secretary of HEW should direct the Commissioner of FDA to: (1) inform physicians who prescribe allergenic products of those products that have not been proven effective on the basis of scientific evidence; (2) require some form of patient package labeling or dissemination of information to patients on the lack of effectiveness data for allergenic products while waiting for the final regulations on these products to be published; (3) promulgate regulations to require that manufacturers submit better evidence to insure that the potency of their products will be the same or similar to the potency of the products identified in the license applications and that they establish their product's effectiveness; (4) establish a system that would provide, in summary form, information on the number and types of licensed allergenics produced by each manufacturer; (5) use statistical sampling procedures, in addition to the existing criteria, for determining which product lots to test; (6) require periodic review of all approved biological product labeling to ensure that it is accurate, complete, and current; (7) modify the Bureau of Biologics' annual research report so that it could serve as a formal plan for the Bureau of Biologics' research efforts; and (8) ensure that the newly established Vaccines and Related Biological Products Advisory Committee periodically reviews all of the Bureau of Biologics' research activities and assesses the relative priority of proposed research activities.

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