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From the Food and Drug Administration |

Proposal Published on Dissemination of Information on Unapproved Uses

Stuart L. Nightingale, MD
JAMA. 1998;280(1):12. doi:10.1001/jama.280.1.12.
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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 published in scientific or medical journals, or in the form of unabridged reference publications pertaining to such investigations. Also, the material is to include the approved labeling and a prominently displayed statement disclosing that the use is not approved by the FDA and, if applicable, a statement that there are products approved for the use. As part of its submission to disseminate information on a particular unapproved use, the manufacturer must certify that it (1) has submitted a supplemental application to the agency for approval of the new use; or (2) has completed the studies needed for such an application and the application will be submitted within 6 months; or (3) has provided the FDA a proposed protocol and schedule for conducting the studies needed for the new use and certifies these will be submitted no later than 36 months after the initial dissemination; or (4) has received an exemption from the requirement to conduct studies. The law provides 2 grounds for exemption from the requirement to conduct studies on the unapproved use: that the necessary studies would be economically prohibitive or that they would be unethical.

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