Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that Amarin has a constitutional right to make certain “truthful and non-misleading” statements regarding unapproved uses of its drug, Vascepa. This ruling follows a 2012 Second Circuit decision (U.S. v. Caronia), which overturned the conviction of a pharmaceutical sales representative for off-label promotion involving truthful speech.
In his opinion, the district judge granted Amarin’s motion for a preliminary injunction against the FDA, thereby allowing Amarin to engage in truthful speech about the drug’s potential benefits for those patients with “persistently high triglycerides.” This decision allows Amarin to make certain statements regarding uses of the omega-3 drug Vascepa, including the claim that “supportive but not conclusive” research suggests that omega-3 fatty acids help prevent coronary artery disease. In its suit against the FDA, Amarin cited, as evidence of unfair treatment, the fact that dietary supplements with omega-3 fatty acids are already allowed to make this assertion. Currently, Amarin does not have FDA approval for treatment of these patients with Vascepa. While Amarin has shown that the drug reduces triglycerides, the FDA has stated that it needs additional proof of cardiovascular benefits prior to approval of Vascepa for a broader indication.
It will be interesting to watch the FDA’s reaction to this court decision. For example, by allowing certain truthful and non-misleading off-label statements, will the standards established by the Lanham Act, Federal Trade Commission guidance and related action, and the National Advertising Division of the Council of Better Business Bureaus become more of the rule in this area? Also, will this case have an impact on current off-label marketing investigations involving the U.S. Department of Justice?
Amarin Pharma, Inc. et al. v. Food and Drug Administration et al., No. 15-cv-3588-PAE, in the U.S. District Court for the Southern District of New York.