The U.S. District Court for the Southern District of New York recently granted Amarin Pharma, Inc. preliminary relief against the U.S. Food and Drug Administration’s attempted restriction of certain truthful and non-misleading communications about off-label use of its approved drug, Vescepa. Significantly, this decision reinforces limits to the FDA's ability to restrict off-label promotion since the Second Circuit’s 2012 ruling inU.S. v. Caronia.


Vescepa was approved by the FDA for the treatment of severe hypertriglyceridemia (“very high triglycerides”) in July 2012, but the agency rejected Amarin’s subsequent proposed use of Vescepa to treat high triglyceride levels in patients who were already on statin therapy (“persistently high triglycerides”). Even though the FDA had found that the drug was safe and effective at reducing triglyceride levels, it believed that clinical study data had raised a “substantial scientific issue” as to whether this reduction in the second patient population would reduce their cardiovascular risk. With that denial, the FDA cautioned that marketing Vascepa for this second proposed use would expose Amarin to criminal liability for misbranding under the Federal Drug & Cosmetic Act (FDCA) and to civil liability under the False Claims Act.

Because they perceived this FDA “threat” to restrict Amarin's truthful and non-misleading statements about studies of Vascepa’s use to treat persistently high triglycerides, Amarin and several doctors filed suit against the FDA in May 2015 in the Southern District of New York. The complaint seeks recognition that FDA’s prohibition of off-label promotion—as applied to these statements—violates the First Amendment. It also seeks a ruling to allow Amarin to engage with doctors in these communications without risk of criminal prosecution, even if the communications constitute off-label promotion.

On May 22, 2015, Amarin moved for a preliminary injunction to prevent the FDA from filing a misbranding suit for Amarin’s proposed communications with doctors about Vascepa. Notably, this dispute required Judge Engelmayer to address the parties' disagreement about the scope of the Second Circuit’s Caronia decision, which held that the First Amendment may apply to statements by pharmaceutical manufacturers or their representatives and protect them from misbranding charges when their off-label use promotion consists solely of truthful and non-misleading. In view of Caronia, Amarin reasoned that its statements at-issue were therefore protected from Government prosecution. In response, the FDA attempted to moot this dispute by setting forth specific conditions and statements to which it would not bring a misbranding action. The FDA further argued that Caronia’s did not apply here to protect Amarin’s proposed statements, and the Second Circuit had intended to limit Caronia to its facts.

On August 7, 2015, Judge Engelmayer granted Amarin’s requested preliminary relief. In his opinion, Judge Engelmayer first found that the FDA’s limited acceptance of these statements did not moot the controversy. Not only had Amarin rejected the offer, but FDA’s limited acceptance of Amarin’s proposed communications had in fact highlighted the statements to which FDA had reserved its right to bring a misbranding action.

With regard to Caronia’s application, Judge Engelmayer rejected the FDA’s position and found that the First Amendment prevents the FDA from bringing a misbranding action against solely truthful and non-misleading promotional speech. In line with Caronia, Judge Engelmayer reasoned that the Supreme Court decisions of Central Hudson and Sorrell v. IMS Health, Inc. —holding that the First Amendment provides qualified protection to commercial speech and that pharmaceutical marketing constitutes such speech—place limits upon interpretation of the FDCA misbranding provisions. Thus, Caronia had properly applied the Central Hudsonanalysis to truthful and non-misleading off-label promotion statements to hold that the FDCA’s misbranding provisions do not apply to these communications. Judge Engelmayer also emphasized that the speaker’s intent was not relevant to Caronia’s holding, noting that the Second Circuit had examined “the very types of statements . . . that the FDA most disfavors.”

Potential Impacts and Limits of the Amarin Decision

It remains unclear whether the FDA will appeal this district court’s decision to the same circuit court that authored Caronia. Nonetheless, this development places significant pressure on the FDA to revise its historically stringent enforcement approach against off-label promotion. Even after Caronia, the FDA has maintained its position that it will police and prosecute truthful and non-misleading statements related to off-label use of approved drugs. For example, the FDA issued draft guidance in February 2014, stating it would allow pharmaceutical manufacturers to distribute scientific and medical journal articles that discuss off-label uses for approved drugs, so long as the articles include certain disclosures. The agency warned, however, that it would continue to use as evidence of misbranding any statements by representatives that characterize these articles to support the safety or effectiveness of the off-label use. Moreover, the FDA agreed in June 2014 to comprehensively review its regulations on communications concerning off-label promotion, but it has yet to provide any updates. Judge Engelmayer’s recent decision highlights the growing need for FDA to reexamine and align its longstanding policies with the recent case law.

While Amarin provides support for pharmaceutical companies seeking to make truthful and non-misleading statements about off-label use, the decision highlights Caronia’s distinction between those statements and conduct related to off-label promotion. Whereas the Government cannot prosecute truthful and non-misleading statements alone as misbranding after Caronia, Judge Engelmayer left open the Government’s ability to use these communications as evidence of intent to misbrand in cases involving additional actionable conduct, such as kickbacks.

This decision also emphasizes the impact of scientific and medical developments to potential corporate liability for communications related to off-label promotion. Notably, Judge Engelmayer carefully limited Amarin’s relief to the specific communications at issue. Whereas Amarin’s proposed statements are factually accurate and not misleading based upon the FDA-approved study data and commentary, Judge Engelmayer cautioned that Amarin was responsible for monitoring scientific and medical developments that may impact the statements’ truthful or non-misleading nature. Likewise, pharmaceutical companies seeking to make presently truthful and non-misleading statements related to off-label use must be vigilant of new evidence that may change their nature and give rise to liability for misbranding. Moreover, these companies should take significant measures to assure that representatives are likewise informed of scientific developments and adjust their marketing materials and statements accordingly.