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- W2266766908 abstract "For over a decade, drug manufacturers have contended that Food & Drug Administration regulations that restrict their ability to promote prescription drugs for off-label uses violate their First Amendment rights. Courts faced with First Amendment challenges to the FDA’s off-label speech restrictions have been reluctant to declare them unconstitutional in their entirety, for fear that the FDA’s new drug approval process would be undermined to the public’s detriment. However, relying in part on a recent Supreme Court decision, Sorrell v. IMS Health Inc., the Second Circuit recently held in United States v. Caronia that the FDA’s speech restrictions, at least in some cases, violate drug manufacturers’ First Amendment rights. Sorrell has raised serious questions as to whether a court should apply strict scrutiny in addressing the constitutionality of the FDA’s off-label speech restrictions. This Note argues that courts addressing First Amendment challenges should not interpret Sorrell as to require strict First Amendment scrutiny in the off-label context, and should continue to adjudge the FDA’s off-label restrictions under Central Hudson’s lesser-exacting, commercial-speech framework. However, this Note ultimately concludes that, even by that standard, the FDA’s off-label restrictions violate drug manufacturers’ First Amendment rights, and proposes several ways in which the FDA/Congress may act to bring the current law into conformance with the First Amendment." @default.
- W2266766908 created "2016-06-24" @default.
- W2266766908 creator A5036126129 @default.
- W2266766908 date "2013-04-24" @default.
- W2266766908 modified "2023-09-23" @default.
- W2266766908 title "A Spoonful of Free Speech Helps the Medicine Go Down: Off-Label Speech & the First Amendment" @default.
- W2266766908 hasPublicationYear "2013" @default.
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