In June, we wrote about Amarin Pharma’s suit asking a federal court to hold that the FDA’s prohibitions on off-label promotion as applied to “speech Amarin proposes to make and [doctors] wish to receive” about its product Vascepa® “are unconstitutional.” June 11, 2015 article. On August 7, the court ruled that Amarin has a constitutional right under the First Amendment to make truthful and non-misleading statements about off-label uses of its prescription drug Vascepa. Op. & Order, Amarin Pharma, Inc., et al. v. U.S. Food and Drug Administration, Case No. 1:15-cv-3588 (S.D. N.Y. Aug. 7, 2015).

Vascepa’s benefits for patients with persistently high trigycerides

Vascepa is an FDA-approved drug, indicated for use as an adjunct to low-fat and low-cholesterol diets to reduce triglyceride levels in adults with “very high” triglyceride levels. In recent years, FDA-reviewed and -approved clinical trials have produced results supporting Vascepa’s further efficacy in reducing triglyceride levels in patients with “persistently high” triglyceride levels. However, the FDA has refused to extend Vascepa’s approval for this use.

Physicians are permitted to exercise their medical judgment to prescribe an FDA-approved drug for any use – whether or not the FDA has approved that particular use. Nevertheless, the FDA has long taken the position that federal law prohibits pharmaceutical companies from providing data to health care providers concerning off-label uses even when such information is accurate, not misleading and reflective of accepted medical treatment. Although the Second Circuit’s December 2012 decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) – overturning the criminal conviction of a pharmaceutical sales representative for conspiring to engage in off-label marketing – seemed to cast doubt on the FDA’s position, the agency maintained that it “d[id] not believe that the Caronia decision will significantly affect the agency’s enforcement” of the FDCA’s misbranding provisions.”

Amarin’s off-label suit

As we previously reported, Amarin brought suit in May 2015 seeking to prohibit the FDA from bringing a misbranding action against it based on truthful and non-misleading statements to doctors regarding the benefits of Vascepa for patients with persistently high triglyceride levels. Amarin told the court it planned to promote Vascepa for those patients by telling doctors about its clinical study supporting that off-label use, and that it would disclose to doctors that this use is not approved by FDA. Compl., Amarin Pharma, Case No. 1:15-cv-3588 (S.D. N.Y. May 7, 2015).

Shortly after the suit was filed, the FDA sent Amarin a letter signed by Dr. Janet Woodcock, director for the FDA’s Center for Drug Evaluation and Research, stating that the FDA would not object to Amarin’s dissemination of clinical trial results related to Vascepa, nor consider their distribution to be evidence of “intended use,” if Amarin agreed to take “reasonable steps outlined in the Letter” and to modify certain statements it proposed to make to doctors. The FDA subsequently argued to the court that Amarin’s acceptance of the conditions set forth in Dr. Woodcock’s letter would moot the controversy. In reply, Amarin declined the FDA’s proposal to moot the controversy, asserting its right to “engage in a full and truthful dialogue with healthcare professionals” aimed at promoting the off-label use of Vascepa. Reply Mem. at 7, Amarin Pharma, Case No. 1:15-cv-3588 (S.D. N.Y. June 30, 2015).

Court rejects FDA arguments

In a 69-page opinion that frequently cites Caronia, U.S. District Judge Paul A. Engelmayer determined that the case presented a live controversy and was not moot. Op. & Order, Amarin Pharma, Case No. 1:15-cv-3588 (S.D. N.Y. Aug. 7, 2015). The court went on to grant Amarin’s motion for a preliminary injunction, ruling that Amarin can make truthful and non-misleading statements promoting Vascepa’s potential benefits for patients with persistently high triglycerides without fear of prosecution. Id. at 69. In doing so, the court rejected the FDA’s contention that it may pursue a misbranding action against a manufacturer based solely on truthful and non-misleading speech evincing the intent to promote an off-label use. As Judge Engelmayer explained, “[t]he Court’s considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment . . . Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based.” Id. at 45.

The court further held that based on current information, the statements Amarin proposed to make to doctors concerning Vascepa’s use to treat patients with persistently high triglycerides are truthful and not misleading. Id. at 61, 69.


The decision appears to be another major blow to the FDA’s ability to take enforcement actions against drug manufacturers and distributors for off-label marketing activities, at least where the challenged statements are truthful and not misleading. Indeed, some commentators believed that Dr. Woodcock’s June 2015 letter was motivated by FDA’s desire to avoid a post-Caronia decision that would further erode its authority to enforce its misbranding regulations. It remains to be seen how the FDA will ultimately react to this ruling, or whether this result will spur other drug makers to begin actively marketing their medications for uses the FDA has not approved.