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.

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