The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes.

Critics, however, have long contended that the FDA’s position violates the First Amendment to the extent it prohibits truthful speech.  See Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51, 56 (D.D.C. 1998); Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999), appeal dismissed, 202 F.3d 331 (D.C. Cir. 2000).  And in 2012, the Second Circuit overturned a pharmaceutical sales representative’s criminal conviction for truthful off-label promotion on First Amendment grounds.  See United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

Most recently, in May 2015, a small drug manufacturer, Amarin Pharma, Inc., and a number of physicians filed a lawsuit against the FDA, Amarin Pharma, Inc. v. United States Food and Drug Administration, 15-cv-3588 (S.D.N.Y.) which may bring this issue to a head.

In 2012, the FDA approved Vascepa—a prescription omega-3 fatty acid commonly known as “EPA”—for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, at defined “very high” levels, to reduce the risk of pancreatitis.

Amarin, however, also wants to disclose to doctors—and the physician plaintiffs want to receive—additional information about Vascepa.  This addition information includes that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease,” results of a clinical trial (“ANCHOR”) demonstrating that Vascepa lowers triglyceride levels in patients with high triglyceride levels not controlled by diet and statin therapy, and the efficacy data from the ANCHOR study.  The information that Amarin wants to provide is truthful, and would be distributed along with the FDA-approved label and other information that would make it not misleading.

As the complaint noted, the FDA already permits omega-3 fatty acid product manufacturers to make the qualified health claim that Amarin wants to make about Vascepa—that “[s]upportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease”—but only about omega-3 fatty acid products labeled as nutritional supplements.

Given concerns that the government would take action against Amarin if it were to distribute the specified information, the complaint seeks a declaratory judgment recognizing that Amarin “may engage in its proposed speech” and preliminary and permanent injunctions against enforcement action by the FDA.  Id.  Amicus briefs have been submitted by the Pharmaceutical Research and Manufacturers of America and the Washington Legal Foundation in support of Amarin’s position.

On June 8, 2015, the government filed a submission with the court enclosing a letter the FDA had sent to Amarin three days earlier regarding the complaint.  Perhaps seeking to avoid a ruling on the relief requested by Amarin, the FDA’s letter advised that it would not consider distribution of most of the information to be “evidence that Vascepa is intended for a use that would render [it] an unapproved new drug or misbranded.”  It also expressed the view that “virtually all of the communications” that Amarin proposes to disseminate” fall within the scope of existing FDA guidance documents, such as the Revised Draft Guidance for Industry, Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices (Feb. 2014). In addition, it also noted that is “currently engaged in a comprehensive review of its regulations and guidance documents regarding manufacturers’ dissemination of information regarding their medical products, and a new guidance will be forthcoming”—although no time frame was specified.

The government’s letter did not completely close the door on possible government action, however, as the FDA did state that it “would potentially consider” the inclusion of the qualified health claim—the statement that “[s]upportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease”—to be “misleading or as evidence of an intent to market the product for an unapproved use” unless the product were “repackaged and re-labeled as a dietary supplement.”

The Amarin lawsuit accordingly merits close continuing observation, and may yet provide clear guidance about the First Amendment and how it applies to truthful speech regarding “off label” uses.