Drug Manufacturer and Doctors Sue FDA Regarding Off-Label Use

Last week, a pharmaceutical company, Amarin Pharma, Inc. (“Amarin”), along with a group of physicians, filed a complaint against the U.S. Food and Drug Administration (“FDA”) in the Southern District of New York challenging the agency’s regulations that prohibit the company from disseminating “truthful and non-misleading statements” to healthcare providers about a drug’s “off-label” use.  Amarin Pharma, Inc. et al. v. United States Food & Drug Administration et al., Compl. at ¶ 1.  Specifically, the Complaint contends that doctors need this information in order to make informed medical decisions, but that the current FDA regulations regarding “off-label” information severely restricts doctors’ access to this information.  Id. at ¶ 2.

The drug at issue is Vascepa, which has been approved by the FDA to reduce triglyceride levels only in patients with “very high” levels.  Id. at ¶ 5.  The Complaint explains that many doctors prescribe the drug to treat patients with “persistently high” triglycerides to lower their levels and/or non-HDL cholesterol for cardiovascular treatment.  Id.  Plaintiffs assert that such “off-label” use is not only lawful, but is “commonplace” in this context.  Id. at ¶ 6.  Furthermore, although there is “not yet definitive clinical evidence affirmatively demonstrating that lowering triglyceride and/or non-HDL cholesterol levels ultimately reduces cardiovascular risk[,]” this practice is nevertheless recommended by cardiovascular treatment guidelines and position papers.  Id.  In fact, Amarin has conducted a double-blind, placebo-controlled clinical trial demonstrating the drug’s favorable effects, but despite these results, the FDA refused to approve the promotion of the drug for such use.  Id. at ¶ 7.

The drug company describes the “bind” that it is currently in: because the FDA refused to approve Vascepa for this application, Amarin cannot disseminate information about the drug’s benefits for such use “without fear of criminal prosecution and civil liability” in light of the FDA regulations, which “forbid promotion of drugs for unapproved or ‘off-label’ uses, even if such promotion is entirely truthful and presented in a non-misleading manner.” Id. at ¶ 8.  The Complaint alleges that these regulations keep doctors “in the dark” about all the options in treating their patients.  Id. at ¶ 9.

The Complaint explains that the Second Circuit recently found that the FDCA cannot “criminalize the simple promotion of drug’s off-label use,” because such a construction would “raise First Amendment concerns.” Id. at ¶ 127 (citing United States v. Caronia, 703 F.3d. 149, 160 (2d. Cir. 2012).  Plaintiffs, however, assert that given the FDA’s interpretation of the regulations, “the threat of criminal prosecution for simple promotion of a drug’s off-label use remains very real.”  Id.  In addition, the Complaint alleges that the Government’s broad interpretation of the False Claims Act “raises the specter of enormous civil liability for simple promotion of a drug’s off-label use.”  Id.  It further contends that although the FDA’s written guidance for treatment of off-label use (although not binding) allows manufacturers to “respond to unsolicited requests for information” it does not allow manufacturers to initiate exchanges regarding off-label uses.  Id. at ¶ 140.  Moreover, Plaintiffs allege that the guidance limits the information a manufacturer can provide in response and prevents doctors from engaging in free dialogue with manufacturers about off-label uses.  Id. at ¶ 139-40.

For relief, Plaintiffs request that the Court 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 further declare that Amarin may engage in such proposed speech about Vascepa.  Id. at ¶ 14.  Plaintiffs contend that the speech Amarin proposes consists of “carefully-circumscribed truthful, and scientifically-accurate statements” regarding the “double-blind, placebo controlled clinical trial” that showed the drug’s effectiveness in lowering triglycerides in those who have persistently high triglycerides.  Id. at ¶ 15.  In addition, the drug company further offers to include “detailed disclaimers” including the fact that the FDA has not approved the drug for such use.  Id. at ¶ 16.

We will continue to monitor this litigation and report back with any new relevant updates on the docket.