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- W2771965624 abstract "The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs — when a manufacturer promotes a drug for a use for which the FDA has not approved it — leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that — as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion — protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority." @default.
- W2771965624 created "2017-12-22" @default.
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- W2771965624 date "2017-01-01" @default.
- W2771965624 modified "2023-09-24" @default.
- W2771965624 title "The Indirect Consequences of Expanded Off-Label Promotion" @default.
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