Court Sides With Amarin in Off-Label Suit

Regulatory NewsRegulatory News | 10 August 2015 |  By 

On Friday, a New York Court sided with biopharmaceuticals maker Amarin in a suit against the US Food and Drug Administration (FDA) involving the off-label promotion of Vascepa.


Vascepa was initially approved by FDA to reduce triglyceride levels in adults with severe hypertriglyceridemia.

As reported by the FDA Law Blog, Amarin hoped to expand Vascepa's indication after learning that some doctors were using Vascepa off-label to treat patients with persistently high triglycerides. At the time, FDA agreed to accept a supplemental new drug application (sNDA) from Amarin with data from a new phase III study in patients with persistently high triglycerides, on the condition that Amarin would also study Vascepa's for use in reducing cardiovascular events.

However, after reviewing Amarin's sNDA, an FDA advisory committee voted against expanding Vascepa's indication, despite data showing the drug met an agreed upon endpoint, citing other trials that "cast doubt on the clinical benefit of triglyceride lowering."

Amarin Wins Injunction

Following the advisory committee vote, Amarin continued to include certain off-label use information in its promotional materials. 

In May, Amarin sued FDA to prevent it from blocking its right to "commercial speech," which is protected under the First Amendment. In its suit, Amarin said it wanted to share the results of its study and other peer-reviewed studies on eicosapentaenoic acids (EPA) with doctors. Interestingly, before the case, FDA sent a letter stating it did not oppose the information Amarin intended to share, as long as it was made with the appropriate disclaimers and was truthful. In fact, much of Amarin's proposed communications were consistent with the agency's guidance on Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.

For now, the court has issued an injunction, barring FDA from preventing Amarin from conducting "truthful and non-misleading speech promoting the off-label use of Vascepa." The court also cites the Caronia ruling, which established that "speech may not form the basis of a prosecution for misbranding."

It is still unclear how far-reaching the present ruling will be, as FDA did not plan to oppose much of Amarin's proposed promotional statements and Amarin had strong data from a phase III study to support its claims.

Court Order, FDA Law Blog


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