A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First Amendment challenge to FDA regulations that prohibit Amarin, a pharmaceutical company, from making completely truthful and non-misleading statements about its product to sophisticated healthcare professionals” (HCPs), including the HCP plaintiffs. Although Amarin’s drug Vascepa® is FDA-approved to treat adult patients with severe hypertriglyceridemia, the FDA recently denied Amarin’s supplemental new drug application (sNDA) to expand the Vascepa indication to include patients with high triglycerides, consistent with the patient population in its ANCHOR clinical trial. Citing United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), Amarin is asking the Court to “hold that FDA’s prohibitions on ‘off-label’ promotion, as applied to the truthful and non-misleading speech Amarin wishes to make, are unconstitutional under the First Amendment, and to declare that Amarin may engage in its proposed speech about Vascepa.”
In an interesting move, on June 8, 2015, the FDA filed with the Court a letter that it issued to Amarin on June 5, 2015, which states that the “FDA does not have concerns with much of the information that you proposed to communicate.” The letter further notes that Amarin did not discuss the matter with the FDA prior to filings it complaint, “as other pharmaceutical companies do”, nor during its discussions with the FDA over many years related to the labeling of Vascepa. The FDA also states that it currently is engaged in a “comprehensive review of its regulations and guidance documents” related to the dissemination of production information and that “new guidance will be forthcoming.”
It appears that the FDA’s letter was a pre-emptive move to undermine Amarin’s lawsuit. We will continue to watch this important case.