Breaking News – Amarin Hits First Amendment Homer Off Food and drug administration

Here’s a duplicate of today’s 71-page decision in Amarin Pharma, Corporation v. Food and drug administration, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. August.7, 2015), where the court granted an initial Amendment-related injunction from the FDA’s prohibition against all off-label promotion, no matter truth. First, a legal court found standing to file a lawsuit, since the Food and drug administration had threatened the organization with enforcement action. “Here, ten days before Amarin sued, the Food and drug administration had specifically threatened . . . to create a misbranding action against it for marketing [the drug] off-label.” Id. at 40. Which was sufficient “chilling effect” to aid lawsuit. Id. Considerably, a legal court had earlier recognized another possible adverse consequence – those of independently prosecuted False Claims Act lawsuit also asserting illegal off-label promotion. Id. at 13.

Around the merits, using U.S. v. Caronia, 703 F.three dimensional 149 (2d Cir. 2012), a legal court held that the pharmaceutical company includes a First Amendment-protected right to take part in off-label promotion that’s “truthful.”

The Court’s considered and firm view is that, under Caronia, 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.

Amarin, slip op. at 45, 47 Considering Caronia, and also the FDA’s risks, the organization “established a considerable probability of success around the merits” because of its First Amendment challenge. Id. at 49. “Where it at issue includes truthful and non-misleading speech marketing the off-label utilization of an Food and drug administration-approved drug, such speech, under Caronia, can’t be the do something about which an undertaking for misbranding relies.Inches Id.

Three Food and drug administration “counterarguments” were declined. First, the Food and drug administration couldn’t relaxation around the FDCA’s 1962-era “framework” because “the FDCA’s drug-approval framework predates modern First Amendment law improving commercial speech.” Amarin, slip 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 Caronia prosecution 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.”  Amarin, slip 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.”

Amarin, slip 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 Caronia gravely undermined the drug approval process, it should have sought review of that decision.

Amarin, slip op. at 67. The merchandise had been broadly recommended off-label and also the Food and drug administration had “no evidence” associated with a actual harm. Id. Overall “[t]he balance of equities and also the public interest both thus extremely favor granting relief.” Id. at 68

Thus, the plaintiff’s position, that the Food and drug administration characterised like a “frontal assault around the framework for brand new drug approval that Congress produced in 1962,” slip op. at 35, won. When the Food and drug administration really wants to appeal, be our guest. Once more, as with Caronia, the record places the Food and drug administration in a distinct disadvantage.

As we’ve stated before, sooner or later the Food and drug administration needs to stop its blunt, speech-based prohibition (which has been available since the first 1950s) and take a more elaborate method of off-label promotion and just what the very first Amendment enables within the twenty-first century. Using the First Amendment handwriting now all around the wall, the Food and drug administration greatly requires a fallback plan.