Reading list: the First Amendment and the FDA

Christopher Robertson, A Trojan Horse? How Expansion of the First Amendment Threatens Much More than the Regulation of Off-Label Drugs, forthcoming, __ Ohio State Law Journal __ (2017)

Abstract:

Scholars, advocates, and courts have begun to recognize a First Amendment right for drugmakers 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. Review of the seven arguments deployed in the off-label domain finds that they cannot be so limited. Instead, if they were valid, they would undermine the FDA’s entire premarket approval regime, reopening the door to a snake oil market where hype replaces science. Even more, if valid, this First Amendment logic would undermine a wide range of statutory regimes that have similar intent-based structures and rely on speech as evidence of intent. Ultimately, with relevance to First Amendment theory, this article reveals a broad and longstanding coherence in the law.

I find Robertson’s argument compelling as a matter of logic, though I think at least some judges are likely to treat unapproved drugs as just different and therefore think that Caronia and Amarin can be limited to substances approved as drugs for some purpose even absent a sensible theoretical distinction.