Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

By Christopher Robertson

Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses.  The case in U.S. v. Caronia; the opinion is here, and here’s the Reuters story.

In First Amendment cases like Western States Medical Center and Sorrell v. IMS, the Supreme Court has been nibbling around the edges of the FDA’s regulatory regime, but nobody — not the industry, the FDA, or the Supreme Court — has seemed eager to really take it on directly.  For decades the FDA has relied on the regulation of speech as a primary tool.  Those regs turn on the distinction between drugs’ on-label uses (for which companies can promote) and off-label uses (for which companies are not allowed to promote, since the companies have declined to prove to the FDA that the drug is safe and effective for those uses).  Physicians are free, however, to use drugs off-label, so the crux of the FDA regulation really is about whether the company can talk about (promote) a transaction that is otherwise perfectly legal.  With Caronia, the Second Circuit is striking right at the heart of this regulatory regime.

Rather than striking down the FDA statute on its face, the Court instead reinterpreted it in a way that makes Caronia innocent:

[U]nder the principle of constitutional avoidance, explained infra, we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns. Because we conclude from the record in this case that the government prosecuted Caronia for mere off-label promotion and the district court instructed the jury that it could convict on that theory, we vacate the judgment of conviction.

The Court characterized “the government’s objective [as] to shepherd physicians to prescribe drugs only on-label.”  In this day, I do not think that is the FDA’s purpose, since off-label use is often the standard of care, and we value the professional judgment of physicians.  The purpose of the regime is more dynamic and epistemic: to create an incentive for companies to do the scientific research that will allow physicians to know whether the drug is safe and effective for the intended use.  Companies can promote their drug for any use they want, as long as they first prove that the drug really works for that use.

To put it another way, this is a regime of warranted speech, with a particular regulatory mechanism for proving that a claim is warranted (i.e., 21 U.S.C. § 355 — well-controlled scientific trials submitted to the FDA for review in advance of the proposed speech).  Instead, following lots of First Amendment doctrine, the Second Circuit focused on whether the speech is truthful, as the touchstone for Constitutional protection.  While arguably correct as a matter of Constitutional doctrine, the Second Circuit decision leaves us with the practical problem that we do not know whether the off-label promotional claims are truthful, and that information is very costly.

If this decision is upheld, we are entering a world where drugs are presumed to cure any disease that the drugmakers say they cure, at least until somebody proves them false.

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About crobertson

Christopher Robertson is a professor at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute. Professor Robertson's research focuses on how the law can improve decisions by individuals and institutions -- attending to informational limits, conflicting interests, and cognitive biases, especially in the domain of healthcare. Blending legal, philosophical, and empirical methods, Robertson's work has been published in the New England Journal of Medicine, New York University Law Review, Cornell Law Review, Emory Law Journal, and the Journal of Empirical Legal Studies. He has received research support from the Robert Wood Johnson Foundation, and runs the Law and Behavior Research Lab at the University of Arizona. Robertson graduated magna cum laude from Harvard Law School, where he also served as a Petrie Flom fellow and lecturer. He earned a doctorate in Philosophy at Washington University in St. Louis, where he also taught bioethics. For 2013-2014, he was a visiting professor at Harvard Law School, and will visit at NYU School of Law in 2016-2017. Robertson's legal practice has focused on complex litigation involving medical and scientific disputes.