Now that Amarin has successfully won a preliminary injunction in its First Amendment challenge to the FDA’s regulation of off-label marketing (we blogged about Amarin’s victory here and you can access the decision here), an important question arises: What will the FDA do? The FDA is faced with a resounding defeat, its second in the Second Circuit. In fact, Amarin got everything it asked for. The court ordered that Amarin may discuss off-label uses of its drug, Vascepa, for the treatment of persistently high triglycerides outside the confines of the FDA’s proposed prohibitions. For instance, Amarin can affirmatively discuss the science concerning such off-label use with doctors. It no longer has to await a doctor’s unsolicited request for such information. Amarin’s communications to doctors are no longer required to come from only its medical affairs department. Its sales reps can present summaries of the science to doctors and discuss off-label use. Amarin can now also make statements about the state of the science surrounding Vascepa’s off-label use that the FDA previously reserved only for nutritional supplement manufacturers. The only restriction on any of this speech is that Amarin’s statements must be truthful and non-misleading. And, to boot, the court held that all of Amarin’s proposed communications, as mildly modified by the court, are truthful and non-misleading.
But the problems for the FDA are broader. It lost its battle to read the Caronia decision out of the law books. The FDA argued that Caronia addressed only outright bans on off-label promotion, and that the FDA never does that:
[T]he outcome in Caronia is not controlling. Caronia did not involve speech that was shown at trial to be potentially false or misleading and did not involve the use of speech as evidence of intent. Instead, it involved the constitutionality of a ‘complete and criminal ban on off-label promotion.’ 703 F.3d at 167.
(FDA Br. at 25.) This argument has always seemed strained. It’s as if the FDA was arguing that the regulatory regime at issue inCaronia was entirely different from what the FDA does today. Yet no one who follows the FDA in this arena has seen this sea-change in the FDA’s approach. The argument seemed like nothing more than that—argument. The Amarin court didn’t accept it. Caronia controlled, and the FDA’s attempt to prohibit truthful, non-misleading speech concerning off-label use had to give way to the First Amendment.
And so too did the FDA’s argument that it was not prohibiting speech but merely using speech as evidence that a manufacturer was improperly promoting a drug for an unapproved use. It sure seemed like the FDA was prohibiting Amarin’s speech. The alleged violations were solely limited to Amarin’s speech. TheAmarin court addressed in some detail this hard-to-accept distinction, parsing the difference between mens rea and actus reus. We won’t. It seems unnecessary. The prohibition was what it was—not something else—and the court saw it that way.
So, then, the big question is what does the FDA do? It is by no means clear. The FDA could do what it didn’t do in Caronia and appeal. But as we mentioned in an earlier post, that by necessity tees up a potential appeal to the Supreme Court. That is because, if the FDA takes an interlocutory appeal to the Second Circuit, it can expect little success. The Second Circuit issued theCaronia decision on which the Amarin court relied, and the FDA didn’t appeal Caronia or even petition for an en banc review. That likely means that the FDA will need the Supreme Court to take the case and overturn it. But can the FDA win—and does it really want to continue arguing that prosecutions based solely on speech are prosecutions of something else? We’ll see. If it does, however, our guess is that Amarin is ready for such an appeal and entered this litigation prepared to take it to the Supreme Court if necessary.
Maybe the FDA will reconsider its position that it can use truthful, non-misleading speech as the sole evidence of improper promotion of a drug for an unapproved use. That seems like a good idea. Experts, practitioners, and stakeholders have proposed a number of alternative regulatory approaches that the FDA could take. In fact, the Caronia court made a number of suggestions, all of which the FDA almost off-handedly dismissed in the Amarin case via an affidavit from one of its senior officials. Maybe that wasn’t the best idea. With First Amendment rights hanging in the balance, the FDA could have done more than take (and present to a court) the say-so of one of its senior officials. We posted recently about an article written by a scientist and certain in-house and private counsel (here’s a link to the post and to the article) that proposes a new approach to the FDA’s regulation of drug promotion, one that accounts for the audience, the type of information exchanged and, most important, the First Amendment. Its subtitle seems appropriate—“a new model for the regulation of drug promotion.” The FDA certainly seems to need of one of those.
The FDA may choose a better manner to mitigate its concern that permitting manufacturers to make truthful, non-misleading statements about off-label uses of their approved drugs will remove their incentive to test those drugs for new, approved indications. We understand—at least in theory—the FDA’s concern. But how real is the danger? Doctors already regularly prescribe drugs for off-label uses. The FDA knows that. Often, state-of-the-art treatment for a disease state involves off-label use of an approved drug. The FDA knows that too. Under these circumstances, shouldn’t the FDA allow a freer—rather than restrictive and less complete—exchange of truthful, non-misleading information between doctors and the manufacturers, the entities that often have the most information on a drug’s safety profile? Doesn’t the restriction of such a discussion do damage? Regardless, manufacturers will still have incentive to seek FDA approval for the off-label use. FDA approval is the gold standard, and such approval will certainly increase the number of patients who will use the drug. Moreover, if the manufacturer doesn’t seek such approval, another manufacture might. Accordingly, there is incentive for both the manufacturer and competing manufacturers to test with the goal of getting FDA approval for the unapproved use. More generally, against this background, it certainly seems that the FDA should be able to devise a regulatory regime that upholds the viability of its approval process while not violating the First Amendment.
This was a big victory for Amarin. But bigger now is the next step. What will the FDA do?