That didn’t take long. Last Monday, we recommended a recent Journal of Law and the Biosciences article proposing a new model under which the FDA could regulate drug promotion consistent with the First Amendment. Three days later, an Irish drug company, Amarin, sued the FDA in the Southern District of New York seeking a declaration that the FDA’s off-label regulations, as applied by the FDA, violate the First Amendment. Amarin Pharma, Inc. v. FDA, 1:2015cv03588, (SDNY May 7, 2015). Amarin also seeks a declaration that the FDA is violating the Due Process clause of the Fifth Amendment by failing to provide clarity on its position regarding off-label promotion, particularly since the Second Circuit issued its Caronia decision. Here’s the complaint.
Amarin’s drug, Vascepa, was approved by the FDA a few years ago for the treatment of very high triglyceride levels. Its active ingredient is EPA, an omega-3 fatty acid. Since then, Amarin has sought an additional indication for Vascepa – the treatment of high (not very high – there’s a difference) triglyceride levels. To get this new indication, Amarin conducted a clinical trial called ANCHOR. ANCHOR’s results showed that Vascepa in fact lowered high triglyceride levels. But Amarin ran into a problem. After ANCHOR began, a number of studies were published that to some extent called into question the link between lowering triglycerides and improving heart health. Since then, the FDA has seemingly taken a different view of the importance of establishing only that a drug lowers triglycerides. The FDA (after convening an advisory panel) did not approve Vascepa for its additional indication. Amarin, feeling that Vascepa had shown its effectiveness at lowering triglycerides, appealed administratively, a number of times. It lost. Trying another approach, Amarin asked the FDA to allow it to include ANCHOR’s efficacy results in Vascepa’s label, along with a disclaimer that use of the drug has not been shown to reduce cardiovascular risk. The FDA denied that as well.
After these (and other) efforts, Amarin filed suit, and did so within the Circuit that issued the Caronia decision. The complaint is long, but Amarin’s central point is simple. It believes that the First Amendment protects its right to share truthful, non-misleading information with doctors about Vascepa. Amarin lays out in paragraph 124 of the complaint what it believes it should be allowed to say, and what it intends to say if the court grants its declaratory judgment. Amarin wants to inform health care professionals of the ANCHOR efficacy results in lowering triglycerides, provide those results, and provide a selection of peer-reviewed articles on the potential effect of EPA on the reduction of the risk of coronary artery disease. Amarin would accompany these materials with disclaimers that the FDA has not approved Vascepa for treating high triglyceride levels or reducing the risk of coronary artery disease, and that Vascepa’s effect on cardiovascular mortality and morbidity has not been determined. Amarin sued because such off-label promotion could subject it to civil or criminal penalties based on violating regulations as applied by the FDA.
Maybe most interesting is Amarin’s request for a declaration that it can use the same marketing language that nutritional supplement companies have used on their omega-3 fatty acid products: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.” The FDA’s decision to allow such marketing of nutritional products to lay people, but disallow it to more sophisticated health care professionals (after positive clinical trial results) will create some tough questions for the court to address.
This complaint lays bare for judicial scrutiny the friction between the FDA’s restrictions on what drug companies can say or give to health care professionals and the First Amendment’s protection of drug companies’ right to disseminate truthful, non-misleading information. We say it a lot. But this one could prove to be very interesting. We’ll keep an eye on it.