United States: New York Federal Court Allows Truthful And Non-Misleading Off-Label Promotion

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.1 Significantly, this decision reinforces limits to the FDA's ability to restrict off-label promotion since the Second Circuit's 2012 ruling in U.S. v. Caronia2.

Summary

The FDA approved Vescepa for the treatment of severe hypertriglyceridemia ("very high triglycerides") in July 2012, but it rejected a subsequent proposed use to treat high triglyceride levels in patients who were already on statin therapy ("persistently high triglycerides"). Even though the agency had concluded 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 overall 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 its proposed communications with doctors about Vascepa. Notably, this dispute required Judge Engelmayer to address the parties' disagreement about the scope of Caronia. In that 2012 decision, the Second Circuit had held that the First Amendment applied to a pharmaceutical representative's communications regarding off-label use and protected the company and its representative from misbranding charges because he had made only truthful and non-misleading statements. 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 the Second Circuit had intended to limit Caronia to its facts, and the agency therefore could continue to bring misbranding actions against off-label promotion even when it consisted of only truthful and non-misleading statements.

On August 7, 2015, Judge Engelmayer granted Amarin's requested preliminary relief and found that the FDA's limited acceptance of these statements did not moot the controversy. Not only had Amarin rejected the FDA's conditions under which it would not take action, but the agency's limited acceptance of Amarin's proposed communications had highlighted the statements to which the FDA had reserved its right to bring a misbranding action.

With regard to the breadth of Caronia's holding, Judge Engelmayer rejected the FDA's position. Referencing Caronia, Judge Engelmayer reasoned that the Supreme Court decisions in Central Hudson3 and Sorrell v. IMS Health, Inc.4—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's misbranding provisions. Thus, Caronia properly had applied the Central Hudson analysis to truthful and non-misleading statements about off-label use to hold that the FDA could not bring a misbranding action when the act at-issue consists exclusively of these statements. 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 decision to the Second Circuit, the same 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 draft guidance warned, however, that the agency 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 decision underscores the need for FDA to resolve the growing tension between its longstanding policies and recent case law.

While Amarin provides some assurance to pharmaceutical companies seeking to make truthful and non-misleading statements about off-label use, it 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 noted that the Second Circuit preserved 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. In granting the motion, 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 current FDA-approved study data and commentary, Judge Engelmayer cautioned that Amarin bears responsibility to monitor for 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 alter the statements' character 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.

Footnotes

1. Amarin Pharma, Inc. v. U.S. Food & Drug Administration, Case No. 1:15-cv-03588 (S.D.N.Y.).

2. 703 F.3d 149 (2d Cir. 2012).

3. Central Hudson Gas & Elec. Co. v. Public Serv. Comm'n of New York, 447 U.S. 557 (1980).

4. Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011).

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