On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs. The decision, Amarin Pharma Inc. v United States Food and Drug Administration (August 7, 2015), granted Amarin’s motion for preliminary injunction, prohibiting FDA from prosecuting the company for making truthful and not-misleading statements to physicians about unapproved uses of one its products. This decision grows out of the landmark decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) and rejects FDA’s efforts to narrowly construe the Second Circuit’s holding in that 2012 case.

FDA has long asserted that drug manufacturers must limit marketing or promotion of their products to their “intended use”—the particular treatment(s) for which the drug was approved. Promoting a drug for a non-approved use (so-called “off-label” promotion) is viewed by FDA as a violation of the Federal Food, Drug, and Cosmetic Act under the theory that unapproved claims about a product make it “misbranded.” Once a drug has been approved, a physician may lawfully prescribe that drug for any therapeutic use appropriate in the physician’s medical judgment.

As we noted previously, in Caronia, the Second Circuit vacated the conviction of a pharmaceutical sales representative for promoting his company’s products for uses not approved by the FDA. The court found that FDA’s enforcement of the prohibition on truthful off-label claims is a content- and speaker-based restriction on speech subject to heightened scrutiny under the First Amendment, and that FDA could not meet its burden of minimizing speech restrictions as much as possible, even when there is a compelling government interest. The court emphasized that only truthful and not misleading speech about off-label uses is entitled to First Amendment protection; Caronia was not alleged to have made any false or misleading statements about the drug he was selling.

The Amarin decision involves the same misbranding provisions that were at issue in Caronia. Amarin manufacturers Vascepa, a triglyceride-lowering drug approved to treat patients at risk of heart disease with “very high” triglyceride levels. Seeking to promote the drug for patients with high (but not very high) triglyceride levels, Amarin proposed to distribute to physicians: 1) results of a clinical study in support of the off-label use; 2) peer reviewed scientific literature indicating the potential effect of the drug’s active ingredient on reducing heart disease; and 3) a statement indicating that research shows consumption of the drug’s active ingredient may reduce the risk of heart disease.

The court agreed with Amarin’s assertion that FDA’s threat to bring a misbranding action for truthful statements promoting off-label use of Vascepa impermissibly burdens Amarin’s First Amendment rights. Rejecting FDA’s narrow reading of Caronia, the court held that its “considered and firm view is that under Caronia, the FDA may not bring a misbranding action against a manufacturer based solely on truthful and non-misleading promotional scope alone.” (Amarin at 45)

If the rulings in the Caronia and Amarin cases are extended beyond the Second Circuit, the government’s ability to regulate the advertising and promotion of prescription products could be broadly curtailed and manufacturers may have limited incentive to seek FDA approval for new uses of their prescription drugs and medical devices. Arent Fox will continue to monitor developments on this issue, which has major implications for all pharmaceutical and medical device manufacturers.