Here’s a copy of today’s 71-page decision in Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015), in which the court granted a First Amendment-related injunction against the FDA’s prohibition against all off-label promotion, regardless of truth.  First, the court found standing to sue, because the FDA had threatened the company with enforcement action.  “Here, 10 days before Amarin filed suit, the FDA had expressly threatened . . . to bring a misbranding action against it for promoting [the drug] off-label.”  Id. at 40.  That was sufficient “chilling effect” to support litigation.  Id.  Significantly, the court had earlier recognized another possible adverse consequence – that of privately prosecuted False Claims Act litigation also asserting illegal off-label promotion.  Id. at 13.

On the merits, applying U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), the court held that a pharmaceutical company has a First Amendment-protected right to engage in off-label promotion that is “truthful.”

The Court’s considered and firm view is that, underCaronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.  A fair reading of that decision refutes the FDA’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.

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The Second Circuit’s thoroughgoing First Amendment analysis in Caronia, which led it to construe the FDCA’s misbranding provisions so as not to reach truthful speech promoting off-label use, further defeats the FDA’s attempt to marginalize the holding in that case as fact-bound. The Circuit cast the issue as whether a misbranding prosecution that “identified [a defendant’s] speech alone as the proscribed conduct” is constitutionally permissible.  And the Circuit’s ensuing analysis underscored the categorical, rather than case-specific, nature of its holding that it is not.

Amarinslip op. at 45, 47  In light of Caronia, and the FDA’s threats, the company “established a substantial likelihood of success on the merits” for its First Amendment challenge.  Id. at 49.  “Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.”  Id.

Three FDA “counterarguments” were rejected.  First, the FDA could not rest on the FDCA’s 1962-era “framework” because “the FDCA’s drug-approval framework predates modern First Amendment law respecting commercial speech.”  Amarinslip op.at 49.

It follows that the provisions of a 1962 statute that implicate such speech, such as the FDCA’s misbranding provisions, today must be considered, and to the extent ambiguous construed, in light of contemporary First Amendment law, under which truthful and nonmisleading commercial speech is constitutionally protected.

Id.  Second, the FDA could not exempt some kinds of truthful speech, such as direct interactions with physicians, from First Amendment protection:

Caronia . . . construed the misbranding provisions not to reach any “truthful off-label promotion of FDA-approved prescription drugs.”  And the reasons . . . in Caronia for that holding apply across-the-board to all truthful and nonmisleading promotional speech.  Indeed, the speech on which the Caroniaprosecution itself was based involved the very types of statements promoting off-label use that the FDA most disfavors:  proactive oral statements to a doctor by a manufacturer’s sales representative.

Id. at 50 (Caronia citations omitted).  Third, the FDA’s argument that it can use truthful speech as as “intent evidence” was “beside the point.”  Id. at 51.  Given the protected nature of the truthrul off-label speech itself, intent didn’t matter:

Amarin’s lawsuit is directed instead to the act requirement – the situation in which a misbranding action takes aim at truthful, non-misleading speech. And Caronia construed the misbranding statute, categorically, not to reach a manufacturer or its representative under those circumstances.  That construction applies no matter how obvious it was that the speaker’s motivation was to promote such off-label use.

Id. at 51 (emphasis added).

Under the First Amendment the FDA may prosecute false speech – “the First Amendment does not protect false or misleading commercial speech” – and “non-communicative activities to promote off-label use.”  Amarinslip op. at 52.  It cannot, however, prosecute “off-label promotion . . . where it wholly consists of truthful and nonmisleading speech.”  Id.  That’s First Amendment protected, as this blog has been arguing for almost a decade.

Thus the manufacturer gained the right to:

  • “Distribute[] summaries and reprints of the [the relevant] study in a manner or format other than that specified by the FDA.”
  • “[A]rticulate[], in connection with [the drug], the [off-label] claim approved for use on chemically similar dietary supplements.”
  • "[M]a[k]e proactive truthful statements, [and] engage[] in a dialogue, with doctors regarding the off-label use.”

Amarinslip op. at 41.  Anyone interested in the details of the particular off-label promotional statements found by the court to be truthful, and thus immune from prosecution may read pages 53-65 of the opinion.

Finally, the FDA’s bureaucratic empire-building claims – that even truthful off-label promotion undermines drug approval generally – were found to without basis, and undercut by the FDA’s prior decision not to appeal Caronia itself:

[T]he FDA fears that sanctioning Amarin’s off-label promotion “would set a course toward undermining the drug approval process that Congress enacted in 1962 to cure serious public health problems that resulted from abuses under the prior regime.”  But the Court’s recognition that Amarin may engage in truthful and nonmisleading speech about the off-label use of [its drug] merely applies, to one drug, the construction of the misbranding statute adopted in Caronia.  Had the FDA believed that Caroniagravely undermined the drug approval process, it should have sought review of that decision.

Amarinslip op. at 67.  The product was already widely prescribed off-label and the FDA had “no evidence” of any actual harm.  Id. Overall “[t]he balance of equities and the public interest both thus overwhelmingly favor granting relief.”  Id. at 68

Thus, the plaintiff’s position, which the FDA characterized as a “frontal assault on the framework for new drug approval that Congress created in 1962,” slip op. at 35, prevailed.  If the FDA wants to appeal, be our guest.  Once again, as in Caronia, the record places the FDA at a distinct disadvantage.

As we’ve said before, at some point the FDA needs to give up its blunt, speech-based prohibition (which has been around since the early 1950s) and take a more sophisticated approach to off-label promotion and what the First Amendment allows in the twenty-first century.  With the First Amendment handwriting now all over the wall, the FDA sorely needs a fallback plan.