26.  

The FDA Modernization Act abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use. The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information to individual medical practitioners that could affect their prescribing choices.

27.  

Institute of Medicine. Orphans and Incentives: Developing Technologies to Address Emerging Infections. Workshop Report. PF Harrison, J Lederberg, eds. Washington, D.C.: National Academy Press, 1997. The FDA Modernization Act of 1997 was passed in November and includes measures that may be of particular help in encouraging and expediting the development of new antimicrobial products. The most pertinent measures are the following:

  • Measures to modernize regulation of biological products by bringing them into harmony with regulations for drugs, by eliminating the need for establishment license application as well as the batch certification and monograph requirements for insulin and antibiotics, by streamlining approval processes for drug and biological manufacturing changes, and by reducing the need for environmental assessment as part of a product application.

  • Codification of FDA's regulations and practices to increase patient access to experimental drugs and medical devices and to accelerate the review of important new medications.

  • Reauthorization of the Prescription Drug User Fee Act of 1992, which had made possible the $329 million in user fees paid by the pharmaceutical industry that helped FDA significantly shorten the duration of its drug review processes through managerial reforms and the addition of 696 employees to its drugs and biologics programs.

An FDA Talk Paper (January 14, 1998) reports that in 1997, FDA's Center for Drug Evaluation and Research (CDER), supported by user fees, achieved a median approval time of 12.2 months for 121 new original drugs, which was 18 percent shorter than the year before. Of these drugs, 39 were new molecular entities containing an active substance never before approved for marketing in any form in the United States. The CDER also approved 431 generic products and antibiotics, which are not supported by user fees, 80 more than in 1996 and the highest number of generic approvals in the decade.



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