April 18, 2013 by Tamara Piety
A few months ago the makers of pharmaceutical drugs got a fairly significant victory in their quest to have the FDA’s regulation of off-label use marketing ruled unconstitutional. In United State v. Caronia the 2nd Circuit overturned the conviction of drug rep Alfred Caronia for conspiring to “introduce a misbranded drug into interstate commerce,” finding that he was convicted in violation of his First Amendment rights on the basis of his speech promoting the drug Xyrem, a drug to treat narcolepsy, for other uses.
As this article in Forbes notes, the decision is potentially a game-changer since the industry has been paying billions of dollars in fines for violation of the off-label use marketing rules. Does Misdemeanor Misbranding Survive Caronia?
There is reason to think that a blanket invalidation of FDA rules relating to off-label use marketing is still a way off since this is still just one circuit and the conviction in Caronia relied so heavily on the speech in question. It is still possible to argue that the misbranding question (which is the actual legal authority under which the off-label use regulation is predicted) is generally unaffected and that, in any case, this decision by no means signals that speech cannot be evidence of misbranding conduct. For more on the case see Free Speech and Off-Label Use Conviction And there is evidence that settlements related to marketing practices continue. Shire Takes $57.5 Charge to Settle Marketing Probe .Yet, it hardly seems like the FDA would want the same Supreme Court that decided Sorrell to review Caronia. And indeed, word is that the FDA is not seeking review. FDA Won’t Appeal Free-Speech Marketing. I wouldn’t either. That doesn’t mean that this decision represents a good development. To the contrary, as I have warned elsewhere, it may well make a good deal of law that we have generally thought of as well-settled, suddenly unstable.
As the dissent noted: “The majority has chosen to apply heightened scrutiny to this case, though we have not done so in other cases involving the use of speech as evidence of intent—for example, in anti-discrimination actions or prosecutions for criminal inducement, attempt, and conspiracy—cases I cannot meaningfully distinguish from this one. The majority’s decision today extends heightened scrutiny further than the Supreme Court ever has, and calls into question a fundamental regime of federal regulation that has existed for more than a century. I respectfully dissent.” (dissenting opinion at 30.
An earlier version of this post first appeared here at Free Speech and Off-Label Use Marketing on The Faculty Lounge.