Over the past few months, I’ve blogged on the back and forth briefing between Amarin Pharma, Inc. (“Amarin”) and the FDA regarding the prosecution of off-label promotion of Amarin’s drug, Vascepa, and the resulting First Amendment concerns. See May, June, and July Posts. As a quick recap, Amarin commenced an action against the FDA claiming that the Government cannot prosecute the simple promotion of a drug’s off-label use because such an interpretation runs afoul of the First Amendment. Amarin sought a preliminary injunction requesting that the Court hold the FDA’s prohibitions of off-label promotion, as applied to the truthful and non-misleading speech Amarin proposed to make, are unconstitutional. This past Friday, the Southern District of New York issued its highly anticipated decision, granting Amarin’s request. This decision was a great victory for the pharmaceutical industry and will hopefully send yet another message to the FDA that clearer guidance – that is in line with this and other First Amendment case law – is definitely in order.
At the outset, the Court found that Amarin “clearly” had standing in light of the fact that merely ten days prior to filing suit, the FDA expressly threatened to bring a misbranding action against Amarin for promoting Vascepa off-label. Opinion at 40, Amarin Pharma v. United States Food & Drug Administration et al., 15-cv-3588 (PEU) (S.D.N.Y. August 7, 2015), ECF No. 73. In addition, the Court emphasized the FDA’s recent history commencing misbranding actions, which gave Amarin “a solid and real basis to fear such enforcement action.” Id. at 40.
Moving to the substantive requirements for a preliminary injunction, the Court found that Amarin established a substantial likelihood of success on the merits. Closely analyzing the Second Circuit’s decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the Court found that “where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech…cannot be the act upon which an action for misbranding is based.” Id. at 49. The Court explained that the FDA asserted three counterarguments and “none” of them were persuasive. Id. First, the FDA argued that protecting truthful speech aimed at promoting off-label use “has the potential to eviscerate the FDA drug approval regime.” Id. The Court quickly rejected this contention, explaining that the “short answer” to this is that the FDCA’s drug-approval framework predates modern First Amendment law respecting commercial speech. Id. The Court emphasized that the FDA’s problem is “ultimately” with Caronia - despite its failure to seek rehearing or petition for certiorari in that case. Id. at 50. Second, the FDA urged the Court to limit the holding in Caronia to protect only certain types of truthful and non-misleading statements by manufacturers regarding off-label use. Id. The Court recounted the FDA’s position, explaining that it disfavors certain communications over others, for example, those made by sales representatives directly to doctors because those types of statements are “by nature, more likely to reflect a manufacturer’s intent to promote off-label.” Id. The Court responded, however, that Caronia “did not turn on the intent element of misbranding.” Id. Instead, “[i]t turned on the actus reus requirement.” Id.
And, the Court emphasized that Caronia unequivocally held that the FDCA’s misbranding provisions “cannot constitutionally criminalize, and therefore did not reach, the act of truthful and non-misleading speech promoting off-label use.” Id. The Court stressed that this holding was not applicable merely to a “subset of truthful promotion speech[,]” but rather, applied to all truthful off-label promotion of FDA-approved drugs. Id. at 50-51. The Court explained that “the reasons the Circuit gave in Caronia for that holding apply across-the-board to all truthful and non-misleading promotional speech.” Id. at 51. Lastly, the Court emphasized that the FDA’s claim that Caronia permits the Government to rely on off-label speech as evidence that the manufacturer intended to promote off-label is “beside the point here” because Amarin’s suit is “directed instead to the act requirement - the situation in which a misbranding action takes aim at truthful, non-misleading speech.” Id. at 51. The Court explained that Caronia construed the misbranding statute “categorically, not to reach a manufacturer”… “no matter how obvious it was that the speaker’s motivation was to promote such off-label use.” Id. (emphasis added).
One thing the Court did note, however, was that Caronia does leave room for prosecuting off-label marketing as misbranding. Id. at 52. And, to ease the Government’s concerns, the Court highlighted two limits of Caronia – first, that the First Amendment does not protect false or misleading speech and second, it only protects expression, not conduct. Id. As a result, the Court explained that it may be “prudent [for manufacturers] to consult with the FDA before promoting off-label use” since “[r]reasonable minds may differ over whether a given statement is misleading in context; and developments in science or medicine may make a once-benign statement misleading.” Id. at 53.
The Court then discussed, in great detail, the truthfulness of Amarin’s proposed statements regarding Vascepa’s off-label use. Notably, the Court explained that because of the drug’s “unusual and extensive regulatory history” it was possible for it to determine the truthfulness of Amarin’s proposed statements and disclosures, despite the fact that the litigation was still at a preliminary stage. Id. at 54. After analyzing each statement and disclosure in depth, the Court held that Amarin’s proposed statements, as modified, were truthful and non-misleading. Id. at 66. The Court noted, however, the “dynamic nature of science and medicine” and that “[a] statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired.” Id. at 66. Thus, the Court made clear that its approval of the communications was on the present record and that it was Amarin’s responsibility to come forward if anything changed with respect to the truthfulness of the off-label statements.
Lastly, the Court considered the remaining preliminary relief prongs, finding that Amarin established irreparable harm since without relief, its First Amendment rights were chilled by the threat of a misbranding action. The Court further found that the balance of the equities and the public interest “overwhelmingly” favored relief, noting that it would serve the public because it would secure First Amendment rights. In conclusion, the Court declared that Amarin can engage in truthful and non-misleading speech promoting the off-label use of Vascepa and, under Caronia, such speech may not form the basis of a prosecution for misbranding. The Court further declared, more specifically, that Amarin’s proposed statements and disclosures are truthful and non-misleading.
This decision is a great victory for the pharmaceutical industry since it made clear that under Caronia, the Government cannot prosecute the simple promotion of an off-label drug where such statements are entirely truthful and non-misleading. As always, we will report back with any developments, especially with respect to whether the Government decides to appeal this significant decision.