FDA, Amarin Propose to Settle Landmark Off-Label Marketing Case

Regulatory NewsRegulatory News | 08 March 2016 |  By 

Amarin and the US Food and Drug Administration (FDA) late Tuesday announced the proposed settlement terms of a major First Amendment lawsuit over the off-label promotion of a drug.

The settlement comes as FDA and Amarin have been battling in court for a little less than a year over Amarin’s dissemination of promotional materials to doctors on an unapproved indication for its triglyceride lowering drug Vascepa (icosapent ethyl).

The lawsuit was linked to Amarin’s intention to send physicians three types of information relating to the use of Vascepa in patients with persistently high triglycerides, but which FDA had denied since it rejected that indication for the drug. 

In siding with Amarin, the US District Court for the Southern District of New York ruled that the statements Amarin proposes to make to doctors for Vascepa as a treatment of persistently high triglycerides “is truthful and non-misleading.”

John Fleder, an attorney with Hyman, Phelps & McNamara who focuses on FDA litigation, told Focus: “People have to remember that [decisions from] CaroniaVascular and Amarin all said there is no protection to companies for statements and claims that are either untruthful or misleading, and while it may be easy to know in a particular situation whether a claim is untruthful, it is usually much more complicated issue whether a claim is misleading or not.”

He also noted that he thinks FDA, in deciding to settle this case, "undoubtedly weighed the risk of moving forward with further litigation and acknowledged that if it appealed this decision, the FDA would have to go to the same court that ruled against it in Caronia."

Settlement Details

Under the terms of the agreement, which have been in the works for more than six months, FDA and the US government have agreed to be bound by the court’s earlier conclusion from 7 August 2015 that Amarin may engage in “truthful and non-misleading speech” promoting the off-label use of Vascepa.

FDA has also agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims, and both sides have agreed to a dispute resolution provision designed to avoid future litigation.

Under that preclearance provision, Amarin may submit “up to two proposed communications per calendar year about the off-label use of Vascepa before communicating them in promotion to doctors to determine if FDA has concerns,” according to the proposal.

FDA has 60 days to contact Amarin with objections or concerns of the promotional materials (which only include communications that Amarin has never before sent to doctors), though both sides can agree to extend that period. Amarin must then provide a specific response to FDA’s concerns or objections within 45 calendar days, and within 30 days of receiving that response, FDA will notify and detail Amarin of any remaining dispute.

“Should a dispute then remain, either party may file a motion with this Court requesting judicial resolution of the dispute,” according to the proposed settlement.

And nothing in the proposal “shall be construed to prevent FDA from communicating with doctors through whatever channels FDA deems appropriate (e.g., publications, postings on websites, and press releases) after the identification of a dispute.”

A complete copy of the proposed settlement order submitted by the parties for court approval is here.


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