In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin's request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding "off-label" uses of its prescription drug, Vascepa. Although Vascepa is regulated as a drug, equivalent products (also consisting of EPA and DHA omega-3 fatty acids) are sold as nutritional supplements. More particularly, we wondered what District Judge Paul A. Engelmayer would make of one central paradox in the FDA's position: that the same statement—that "supportive but not conclusive research shows that EPA and DHA may reduce the risk of coronary heart disease"—supposedly is at once both false and misleading (as to omega-3 fatty acids as a drug), and not false and misleading (as to omega-3 fatty acids as a nutritional supplement).
The District Court has now issued its order and granted Amarin the injunction it requested, in what surely will be considered a landmark ruling regarding the First Amendment and truthful, non-misleading off-label promotion, alongside the Second Circuit's United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).
The Amarin Pharma opinion is lengthy and thoughful. In the background section, the court first recognized that off-label uses of approved medical products are not regulated by the FDA and widespread—even essential in areas like oncology and pediatrics—although "the FDA has long taken the position that a drug manufacturer who markets or promotes an approved drug for unapproved uses violates the FDA." Slip Op. at 9.
The court also reviewed the parties' filings, including the FDA's letter response (discussed and linked to here), and its opposition to the motion for preliminary injunction (discussed and linked to here). Although the FDA's filings seemed aimed at mooting the case before the District Court could reach the First Amendment issues, and although these filings did narrow the parties' differences, the District Court recognized that a key disagreement still remained—"whether certain statements Amarin propose[d] to make are, in fact, truthful and non-misleading so as to be constitutionally protected." Slip Op. at 38. If the statements were constitutionally protected, yet still might result in an FDA enforcement action for misbranding [id. at 44]— Amarin properly had standing to pursue its claim [id. at 42].
With regard to the Second Circuit's Caronia decision, Amarin Pharma rejected the FDA's reading of that case as a limited, fact-bound decision. Instead, it recognized that Caronia's holding represented "a definitive one of statutory construction" regarding the constitutionally permissible reach of the FDCA's misbranding statute, as well as a clear rejection of the FDA's authority to use the FDCA to prohibit truthful off-label promotion. Id. at 48-49. As Judge Engelmayer put it:
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 49 (emphasis in original). Moreover, the court was not willing to limit its holding or its reading of Caronia to certain types of truthful and non-misleading manufacturer statements, rejecting FDA's request that it distinguish between "statements made proactively to a doctor as opposed to those responding to a doctor's query," or "statements made to a doctor by a sales or marketing employee, as opposed to those by a scientist or a physician." Id. at 50.
In reviewing the specific promotional speech that Amarin sought to protect through its lawsuit, the court found none of it to be false or misleading, including:
- Article reprints that Amarin wished to distribute (which the FDA did not contend were false or misleading)
- A summary of a clinical study (the Anchor study, which the FDA also did not contend was false or misleading)
- Certain proposed disclosures relating to off-label use of Vascepa
- The statement that the FDA already permits for omega-3 fatty acids marketed as nutritional supplements
Id. at 53-65.
After reviewing Caronia's holding, and the particulars of Amarin's proposed speech to, the District Court ordered that:
(1) Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and under Caronia, such speech may not form the basis of a prosecution for misbranding; and (2) Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high triglycerides, as such communications have been modified herein, is truthful and non-misleading.
Although the FDA is for now enjoined from taking action against Amarin over truthful, non-misleading statements about Vascepa, the order does not conclude the case, and it remains to be seen what the court—and the FDA—decide to do next. In the meantime, for more blog posts and analysis about the decision, check out our colleagues over at the Drug and Device Law Blog as well.
This article is presented for informational purposes only and is not intended to constitute legal advice.