Last week, a New York Federal judge ruled that Amarin Pharma Inc. has a constitutional right – and is protected from interference by the FDA – to make certain truthful and nonmisleading statements about off-label uses of its product, Vascepa. In the lawsuit, Amarin Pharma sought an injunction against the FDA to prevent enforcement of rules that would otherwise prohibit the communication to physicians or other healthcare providers of truthful information about unapproved uses of its product Vascepa.
Vascepa is an oral medication that is FDA-approved and indicated only for the treatment of severe hypertriglyceridemia. Amarin Pharma had sought to make statements and present information to physicians about use of the product in patients with lower triglycerides who were already on a statin — a use not indicated in the package labeling.
In granting the injunction, the Court rejected the FDA’s attempt to construe the import of U.S. v. Caronia, and held that, under Caronia, a misbranding action may not be brought against a manufacturer whose conduct consists solely of truthful and non-misleading speech promoting an off-label use of an approved drug. In essence, the Court found that to arise to the level of a misbranding violation (subjecting a firm to civil and criminal liability), there had to be greater conduct than merely speech, or sharing of information.
As with Caronia, this case may have impact on the types of statements compounding pharmacies may make about their products or services. Again, while the drug at issue in this case was FDA-approved (albeit for a different use that what was being promoted), certain analogies can be drawn, and this case signals courts’ views of the importance of First Amendment rights to disseminate truthful information.
Frier Levitt routinely advises compound pharmacy clients on the contours of what constitutes permissible marketing under both Section 503A and 503B. Contact Frier Levitt for assistance in reviewing your pharmacy’s existing marketing materials and practices to ensure compliance with State and Federal laws.
