Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses. We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington Legal Foundation supporting Amarin’s request for a preliminary injunction to prevent the FDA from taking any enforcement action based on specific statements that Amarin wishes to make about its approved drug Vascepa.
Public Citizen’s has now filed an amicus brief, and predictably it opposes Amarin’s request for a preliminary injunction. Amarin’s filings have explained that it wants to provide doctors with additional information about Vacepa supported by a clinical study, and to make statements about Vascepa that the FDA already permits manufacturers to make about equivalent products (EPA and DHA omega-3 fatty acids) sold as nutritional supplements. But in Public Citizen’s view, “Amarin’s theory would threaten the entire structure of drug regulation under the FDCA.” Public Citizen also argues that Amarin need not be allowed to make its proposed speech under First Amendment law, including Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011) and United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).
For its part, Amarin’s latest filing is its reply brief in support of its motion for preliminary injunction. Amarin notes the central paradox in the FDA’s position: that the same statement—that “supportive but not conclusive research shows that EPA and DHA may reduce the risk of coronary heart disease”—supposedly is at once both false and misleading (as to Vascepa as a drug) and not false and misleading (as to Vascepa as a nutritional supplement). The company also explains why the FDA’s prior letter submission and brief did not moot the live controversy about other speech it wishes to make about its prescription drug either.
Oral argument on Amarin’s motion for preliminary injunction is set for Tuesday, July 7, 2015 at 9 a.m. so there will be further developments—one way or the other—quite soon.