Amarin and Off-Label Drug Use: What it Means for the Pharmaceutical Industry

The U.S. District Court for the Southern District of New York recently issued a significant decision in Amarin Pharma, Inc. et al v. United States Food & Drug Administration. Amarin sought and won a preliminary injunction against the FDA to stop it from pursuing a misbranding case against the company associated with off-label promotion of its drug Vascepa.

This is an important decision that builds on the U.S. Court of Appeals for the Second Circuit's decision last year in United States v. Caronia, which held that truthful communications regarding off-label use of a drug is permitted by the First Amendment. The court in Amarin analyzed the issue at a high level under First Amendment law and then at a more granular level, looking at the communications at issue. The court found that any action by the FDA to restrict Amarin's communications at issue would be a violation of its First Amendment rights.

This decision has positive implications for the pharmaceutical industry in connection with off-labeling communications, including:

• It extends and strengthens the holding of the Second Circuit's decision last year in Caronia recognizing First Amendment protection for such communications.
• It gives insight on how the court will ultimately rule.

It is important, however, to recognize the limits of this decision:

• Amarin and Caronia protect only truthful speech or other communication. They do not protect conduct, generally. 
• Because this is a preliminary decision, the FDA has the right to appeal. 
• Finally, Caronia applies only within the Second Circuit, which includes the states of Vermont, Connecticut, and New York, and Amarin applies only in the Southern District of New York.

If the Amarin decision is upheld, it will have long range and significant implications for the pharmaceutical industry in connection with the promotion and marketing of their drugs for off-label use. Physicians have always been free to prescribe or dispense a drug or device off-label, but pharmaceutical companies have been prohibited from disseminating that information. This decision allows them to disseminate the information without a request from a doctor.

If this decision becomes the law of the land, the FDA will have to change its regulations in this area.