Last week, a federal judge in the Southern District of New York granted a preliminary injunction in favor of Amarin Pharma, Inc. ("Amarin") in its dispute against FDA asserting free speech rights to promote an approved drug for unapproved uses based on truthful and nonmisleading communications. The court held that, under Second Court precedent of United States v. Caronia, FDA may not prosecute a company for misbranding where the only conduct alleged is truthful and nonmisleading statements promoting "off-label" use. The decision reiterated the Caronia principle that prosecution of such conduct violates the First Amendment by unduly restricting commercial speech. Amarin has petitioned the court to restrain FDA from taking any enforcement action with respect to the company's proposed communications. The preliminary injunction allows for such marketing pending a decision on the merits but cautions Amarin that it bears the responsibility of ensuring that communications to doctors remain truthful and nonmisleading in the future. FDA has 60 days to appeal the district court's decision.
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