In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First Amendment challenge to the FDA’s attempt to restrict communications about its postsurgical pain drug, Exparel. Pacira’ s lawsuit, filed in the U.S. District Court for the Southern District of New York, argues that the FDA’s restriction on promotion of Exparel for a range of surgeries violates its First Amendment rights by abridging its “truthful and non-misleading speech.” The genesis of the dispute is a September 2014 warning letter from the FDA that told Pacira to stop promoting Exparel for use in any surgeries other than the two for which it was approved, bunionectomies or hemorrhiodectomies.
What makes the Pacira lawsuit interesting is that is not solely focused on off-label restrictions, which were the core of the Amarin case. It also alleges violations of free speech for prohibiting the sharing truthful and non-misleading information with “sophisticated audiences” about use of Exparel in other surgical sites, its ability to control pain for up to 72 hours and its comparative effectiveness to other products. Some commentators, such as the Collation for Healthcare Communication, claim that “the Pacira complaint may be even more compelling [than Amarin] because it challenges under the First Amendment many traditional theories that the FDA’s Office of Prescription Drug Promotion [OPDP] has used to regulate marketing.” These two cases could signal a trend toward companies becoming more willing to aggressively challenge the FDA when it comes to promotional issues. We continue to watch how the FDA responds and whether Congress will take up the issue as it debates comprehensive biomedical reform in the 21st Century Cures and Innovation for Healthier Americans legislative initiatives.
In addition to the First Amendment claim, the Pacira lawsuit alleges that the FDA violated the Administrative Procedure Act, the Fifth Amendment, as well as its own guidance materials and prior precedent. The full library of Pacira’s materials is available here: http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-lawsuit