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FDA Limits on Drug Maker Sponsorship of Information Distribution Too Extensive
Description Court issued an injunction against enforcement of FDA limits on drug-maker involvement in distribution of peer-reviewed journal articles, medical textbooks, and involvement in medical education. Rules were too restrictive on right to truthful commercial speech.
Topic Administrative Law
Key Words Substantial Interest, FDA, Commercial Speech
C A S E   S U M M A R Y
Facts The FDA was sued "from enforcing policies restricting certain forms of manufacturer promotion of off-label uses for FDA-approved drugs and devices." The policies are expressed through complex and detailed Guidance Documents controlling manufacturer distribution of reprints of medical textbooks and peer-reviewed journal articles, and manufacturer involvement in continuing medical education and symposia.
Decision Injunction issued. The FDA was prohibited from limiting any pharmaceutical or medical device manufacturer or other person from disseminating to medical professionals articles and textbooks published by independent publishers and by bona fide peer-review journals. The FDA may also not control the content of independent providers of medical education seminars. The regulations in question violate the Supreme Court’s Central Hudson test for commercial speech. Less intrusive regulations could address the concerns of the FDA, such as full disclosure by manufacturers.
Citation Washington Legal Foundation v. Friedman, —F.Supp.2d— (1998 WL 456372, D.D.C.)
13 F. Supp. 2d 51 (D.C., 1998)

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