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Proposal Published on Dissemination of Information on Unapproved Uses
JAMA. 1998;280:12.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has published for comment a proposed rule implementing provisions of the Food and Drug Administration Modernization Act of 1997 that, under specific circumstances, permit drug, biologic, and device manufacturers to disseminate written information concerning the safety, effectiveness, or benefits of a use not described in the product's approved labeling. The information would be permitted to be disseminated to health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or federal or state government agencies. Before passage of the act, such dissemination could have been considered illegal "promotion" of an unapproved use. The material to be disseminated must first be submitted to FDA for review to see how it will be presented and to determine whether the information is objective and balanced and meets other requirements. The information is to be in the form of unabridged reprints or copies of peer-reviewed articles about scientifically sound clinical investigations . . . [Full Text of this Article]
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