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Amarin VS FDA: NY Federal Court Rules In Drug Maker’s Favor

Amarin Ruling

In New York, a federal court has ruled in favor of Irish drug manufacturer Amarin Pharma Inc. in a battle with the Food and Drug Administration (FDA) over off-label marketing.

The legal battle ensued after Amarin requested that the court stop the FDA from enforcing its off-label marketing ban with an injunction and the court obliged, the Wall Street Journal reports.

The federal district court in the Southern District of New York’s recent ruling concerns Amarin Pharma’s Vascepa (icosapent) — a drug derived from fish oil. Vascepa, which is available in pill form, is used in conjunction with diet programs to reduce triglycerides in adults with extremely high triglycerides, but it may have other uses and that’s what the ruling is all about: whether Amarin can market the drug’s other possible applications without the FDA’s approval.

U.S. District Judge Paul A. Engelmayer was quoted by U.S. News & World Report as having ruled that the pharmaceutical company can “engage in truthful and non-misleading speech promoting the off-label use of Vascepa.”

Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa.

As a result of the court’s ruling, the Irish drug manufacturer can now give doctors and others truthful accounts of medical studies examining the drug’s ability to reduce moderately high blood fats, regardless of whether or not the FDA has approved it for such use.

Forbes notes in a recent report on the ruling that the government has contended that they’re not attacking honest speech which is protected by the First Amendment, but instead, they’re simply relying on that speech in order to establish that the manufacturer intended to promote off-label use of the drug.

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