Amarin Pharma, Inc., Wins Injunction Against FDA's Off-Label Marketing Ban

Friday, August 21, 2015
By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law

The U.S. District Court for the Southern District of New York granted a preliminary injunction to Amarin Pharma, Inc. (Amarin), prohibiting the Food and Drug Administration (FDA) from enforcing its off-label marketing ban.  The injunction means that Amarin can engage in truthful marketing of Vascepa even when the marketing is used to promote an off-label use of Vascepa.  

FDA Ban on Off-Labeling Drugs.

Off-label use of drugs is the prescribing of a drug for a purpose other than what has been approved by the FDAPhysicians have always been permitted to prescribe FDA-approved drugs for both the FDA-approved purposes and for other purposes not approved by the FDA.  However, the FDA maintains that when a drug manufacturer is marketing or promoting a drug for an off-label use, the manufacturer and its representative can be held criminally liable for misbranding.  A drug is misbranded when its labeling does not contain adequate directions for its use.  The FDA defines "adequate directions" for use as directions sufficient for a layperson to use the drug safely for its intended purpose.  

Amarin manufactures Vascepa, which has been approved for treatment of adults with severe hypertriglyceridemia (triglyceride levels above 500 mg/dL).  Amarin sought FDA approval to market Vascepa for the treatment of persistently high triglycerides (triglyceride levels between 200 and 499 mg/dL and already on statin therapy), which is an off-label use.  The FDA threatened to prosecute Amarin under its misbranding statute, so Amarin filed suit in federal court.

Promoting Off-Labeled Drugs.

The Court reviewed the decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and determined, consistent with Caronia, that the First Amendment prohibited the FDA from prosecuting truthful promotional speech as misbranding.  The FDA argued that Caronia, had limited application to the facts of that case.  The Court disagreed, and said Caronia was a categorical decision prohibiting the FDA from prosecuting truthful speech promoting the off-label use of drugs as misbranding.

According to the Court, the First Amendment gives qualified protection to commercial speech and pharmaceutical qualifies as commercial speech.  This decision is another significant ruling on the First Amendment protections for commercial speech, and the constitutional limits on the FDA's enforcement of the Federal Food, Drug and Cosmetic Act.  To read a copy of the Court's opinion in United States vs. Caronia, click here.


Do you think the FDA should enforce the ban on off-labeled drugs? Please leave any thoughtful comments below.

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About the Author:
Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.


Burton, T. M. (2015, August 8). "FDA Dealt Setback On Off-Label Use." The Wall Street Journal.

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