A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588).
In a detailed 69-page decision, the Court granted Amarin’s motion for a preliminary injunction, holding that the statements and disclosures proposed by Amarin are truthful and not misleading, and thus may not form the basis for a prosecution based on misbranding. Relying heavily on United States v. Caronia in its analysis, the Court stated that “Amarin has established a substantial likelihood of success on the merits” related to its “First Amendment right to be free from a misbranding action based on truthful speech promoting the off-label use of an FDA-approved drug.” However, the Court makes it clear that Caronia “leaves room for prosecuting off-label marketing as misbranding”, such as situations were a manufacturer uses false or misleading commercial communications or engages in “non-communicative activities” to promote an off-label use.
We will continue to monitor this important case and report significant developments.
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