District Court Holds that First Amendment Bars Prosecution for Misbranding Where Conduct is Truthful, Non-Misleading Speech about Off-Label Uses, Declines to Rule on Potential FCA Liability

On August 7, in the first Caronia progeny case, the United States District Court for the Southern District of New York (Engelmayer, J.) granted preliminary relief to Amarin Pharma, Inc. (“Amarin”) in a highly significant case involving First Amendment limitations on the Government’s entitlement to bring misbranding charges based on manufacturers’ truthful, non-misleading speech about off-label uses of drugs.  See Amarin Pharma Inc. v. Food and Drug Admin., No. 1:15-cv-03588 (S.D.N.Y. Aug. 7, 2015).

On May 7, 2015, Amarin filed a complaint for declaratory and injunctive relief, raising an as-applied First Amendment challenge to FDA’s regulations and interpretation of the Food, Drug, and Cosmetic Act (“FDCA”), which prohibit the company from making truthful, non-misleading statements about one of its products, Vascepa.  Though approved only for the treatment of patients with “severe” hypertriglyceridemia (> 500 mg/dl), Vascepa is commonly prescribed off-label to patients with “persistently high” triglyceride levels between 200-499 mg/dl.  Amarin had conducted a double-blind clinical trial demonstrating that the product reduced triglyceride levels in patients with triglyceride levels in that range, but FDA refused to approve the drug for this new indication, citing “uncertainty regarding the benefits of drug-induced changes in lipid/lipoprotein parameters on [cardiovascular] risk among” patients within the new indication.  In a pre-suit letter, FDA warned Amarin that, unless and until the company submitted data supporting a decrease in cardiovascular risk, Vascepa may be considered misbranded if Amarin promoted Vascepa for patients with persistently high triglycerides.  This would not only leave Amarin vulnerable to a criminal misbranding charge but also opened up the possibility of FCA liability.  Amarin’s complaint sought general protection to promote Vascepa truthfully to physicians for the new indication, notwithstanding FDA’s disapproval.  The company also requested the court’s approval to make three specific statements and to distribute selected scientific publications about the use of Vascepa to treat patients with persistently high (but not severe) triglycerides.  To ensure the statements would not be misleading, Amarin offered to contemporaneously make certain disclosures regarding the evidentiary basis for the statements, and FDA’s decision not to approve the new indication.  Separately, Amarin sought “a declaratory judgment to prospectively preclude the government from engaging in enforcement conduct” through the FCA, when it could not constitutionally do so through the FDCA.

One June 5, in an effort to moot the lawsuit, FDA sent a letter to Amarin asserting that some of the proposed communications fell within the scope of existing FDA guidance allowing manufacturers to disseminate truthful, non-misleading publications under certain conditions.  As to the remaining statements Amarin sought to make, the letter explained that FDA would exercise its discretion not to prosecute the company for misbranding, so long as the statements were delivered “in the manner and to the extent” set out by FDA.  Pursuant to these restrictions, FDA proposed its own disclosures and further explained that one of Amarin’s desired statements could only be delivered if the product were repackaged as a dietary supplement.

The district court rejected FDA’s attempt to moot the case.  A live controversy existed due to FDA’s pre-suit threat to bring a misbranding charge against Amarin.  While the letter narrowed the scope of the statements that could serve as the basis for an enforcement action, the remaining statements still subjected Amarin to liability unless it abided by the restrictions set forth in the letter.  “[B]ecause Amarin did not  accept the conditions set [out] in the . . . [l]etter, that letter did not vitiate the . . . threat of a misbranding action or moot this controversy.”  In a footnote, however, the court determined that Amarin’s effort to seek preliminary relief as to the FCA was not yet ripe, because it was “wholly conjectural that (1) a doctor who prescribed Vascepa for an off-label use would falsely claim, in seeking medical reimbursement, to have done so for an approved use, or (2) the FDA would seek to hold Amarin accountable for such conduct by a doctor.”

In determining whether preliminary relief was appropriate because Amarin was likely to prevail on the merits, the district court applied the ruling in United States v. Caronia (discussed here), in which the Second Circuit held that “the misbranding provisions of the FDCA [do] not prohibit[] and criminaliz[e] the truthful off-label promotion of FDA-approved prescription drugs.”  FDA had maintained that Caronia was inapplicable to Amarin’s case because it was limited to the facts and circumstances of the jury instructions in Caronia’s trial.  The court, after parsing the Second Circuit’s opinion, ruled that the plain language of the court’s ruling was not so narrow in scope.

FDA argued that, even if the ruling had broader application, Caronia did not preclude the government from using truthful and non-misleading statements to establish that the defendant intended to promote a drug for off-label use.  The district court rejected that position, explaining that, although speech can be used to establish intent, FDA must still point to “a proper actus reus” that can be constitutionally prosecuted.  Under FDA’s approach, the truthful, non-misleading speech itself would serve as the predicate conduct.  But the district court interpreted Caronia as holding “that the FDCA’s misbranding provisions cannot constitutionally criminalize, and therefore do not reach, the act of truthful and non-misleading speech promoting off-label use.”  The court noted certain limitations to its holding, namely, to the extent a manufacturer engages in “non-communicative activities to promote off-label use,” it cannot seek protection under the First Amendment.  Similarly, if statements are false or misleading, a company is susceptible to enforcement action.

The court then assessed Amarin’s likelihood of success on the merits with respect to the specific communications it sought to disseminate.  Subject to a few small modifications, the court ruled that each of the statements were truthful and non-misleading.

Finally, the court determined that both of the other two factors necessary to obtain preliminary relief—irreparable harm and a balance of the equities and public interest—weighed in favor of granting relief.  It is well-established that loss of First Amendment rights generally gives rise to irreparable harm.  In addition, the court noted that whereas the government does not have an interest in unconstitutional enforcement of the law, it is in the public interest to uphold constitutional rights.  The court also rejected FDA’s sweeping fears that granting a preliminary injunction would undermine the entire drug approval process, explaining that if FDA genuinely believed this risk could occur, it should have sought review of Caronia, which it had opted not to do.

A copy of the court’s decision can be found here.