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A Spoonful of Free Speech Helps the Medicine Go Down: Off-Label Speech and the First Amendment

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ABSTRACT: For over a decade, drug manufacturers have maintained that Food and Drug Administration (“FDA”) regulations restricting their ability to promote prescription drugs for off-label uses violate the First Amendment. Courts faced with First Amendment challenges to the FDA’s off-label speech restrictions have been reluctant to declare them facially unconstitutional. These courts fear that declaring such restrictions facially unconstitutional will undermine the FDA’s process for assessing and approving new drugs to the public’s detriment. However, relying in part on the recent Supreme Court decision in Sorrell v. IMS Health Inc., the Second Circuit held in United States v. Caronia that the FDA’s speech restrictions, at least in some cases, violate drug manufacturers’ First Amendment rights.

Sorrell raised serious questions as to whether a court should apply strict scrutiny in addressing the constitutionality of the FDA’s off-label speech restrictions. In light of these questions, this Note argues that courts addressing First Amendment challenges should not interpret Sorrell to require strict scrutiny in the off-label context and should continue to adjudge the FDA’s off-label restrictions under Central Hudson’s less- exacting, commercial speech framework. This Note concludes that, even by Central Hudson’s standard, the FDA’s off-label restrictions violate drug manufacturers’ First Amendment rights, and it proposes several ways the FDA and Congress may bring current law into conformity with the First Amendment.

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