The Tip of the Iceberg: A First Amendment Right to Promote Drugs Off-Label
35 Pages Posted: 2 Jul 2016 Last revised: 23 Feb 2018
Date Written: February 20, 2018
Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. Even more a companion paper shows that, if valid, this First Amendment logic would undermine a wide range of statutory regimes that have similar intent-based structures and that rely on speech as evidence of intent.
Keywords: First Amendment, FDA, pre-market approval, drugmakers, medical devices, off-label, regulation, commercial speech, regulatory regimes
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