We’ve previously covered the back-and-forth between Amarin Pharma and FDA over off-label promotion issues. (My colleague, Emily Pincow, has written a number of insightful pieces on this dispute, including here.) Earlier this week, Amarin and the FDA finalized a long-awaited settlement agreement that has the potential to redraw battle lines for future off-label pharmaceutical promotion disputes over truthful speech.
First, some quick background. Amarin sued the FDA, alleging 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. In May 2015, Amarin sought a preliminary injunction declaring that the FDA’s prohibitions of off-label promotion, as applied to the truthful and non-misleading speech Amarin proposed to make, are unconstitutional. Judge Engelmayer of the Southern District of New York granted Amarin’s request, see Amarin Pharma v. United States Food & Drug Administration et al., 15-cv-3588 (PEU) (S.D.N.Y. August 7, 2015), ECF No. 73, albeit with two precautions: first, that the First Amendment does not protect false or misleading speech; and second, that it only protects expression, not conduct. Consequently, 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 settlement recently inked was much awaited in the wake of the August 2015 ruling. Under the terms of the agreement, FDA “agree[d] to be bound by the court’s conclusion that Amarin may engage in truthful and nonmisleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides.” Amarin, for its part, committed to “assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.” (But note that this language was quoted directly from the favorable court ruling issued in August.)
There is no question that Amarin’s win has reverberated throughout the pharmaceutical industry. Less than one month after the August 2015 ruling, Pacira Pharmaceuticals Inc. sued the FDA over restrictions it sought to impose on Pacira’s promotion off a surgical analgesic. See Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al, 15-cv-07055 (SDNY Sept. 8, 2015). Like Amarin, Pacira alleged that the FDA was attempting to stifle truthful speech in violation of the First Amendment. Two months after the suit was filed, FDA relented and agreed to allow Pacira to include expanded off-label promotional language. Given how quickly this settlement was reached, it would not be surprising if other pharmaceutical makers followed suit when faced with challenges to truthful, not misleading off-label promotional language.
We will continue to follow developments in off-label promotion.
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