Amarin, FDA Settle Off-Label Promotion Case

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By Dana A. Elfin

March 9 — Amarin Pharma Inc. and the FDA have reached a settlement in Amarin's lawsuit challenging the constitutionality of FDA regulations on the promotion of drugs for unapproved uses, the drugmaker announced March 8.

The settlement is a win for the drugmaker and its physician co-plaintiffs in the litigation because it allows Amarin to promote Vascepa, a high-triglyceride treatment, to doctors for off-label uses as long as it does so in a truthful and nonmisleading way, the same relief the plaintiffs originally sought in the suit.

The U.S. District Court for the Southern District of New York still must sign off on the parties' settlement.

The case dates back to May 2015 when Amarin Pharma and a group of doctors sued the Food and Drug Administration over its off-label use policy . Amarin wanted to be able to tell doctors about how Vascepa (icosapent ethyl) capsules could be used safely and effectively off-label without fear of prosecution or liability.

Under long-standing FDA policy, companies can be subject to criminal prosecution and civil liability if they promote their products for uses for which the FDA hasn’t specifically approved them. Amarin argued that the FDA's restrictions on promotions violated their free speech rights under the First Amendment.

Amarin Pleased

In a March 8 statement, Amarin President and Chief Executive Officer John F. Thero said Amarin was pleased with the outcome.

“We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the U.S. government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner,” Thero said.

“With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides,” he added.

Key Settlement Terms

Under the settlement, the government agreed to be bound by Judge Paul A. Engelmayer's August 2015 ruling in the case, that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa .

The settlement provides that Amarin will be responsible for ensuring that its communications to doctors regarding Vascepa's off-label use are truthful and nonmisleading.

Under the settlement, the FDA will allow Amarin to seek pre-clearance review each year of up to two promotional communications for off-label uses of Vascepa. That provision runs through 2020.

The settlement also establishes a specific timetable and process for resolving any concerns that the FDA may have about any new off-label claims for Vascepa.

FDA Guidance Coming?

Meanwhile, industry groups and drug and device company lawyers are hopeful that the settlement in the Amarin case will push the FDA to revise its guidance in the off-label area. The agency said it would issue revised guidance by the end of 2014, but industry is still waiting.

“Perhaps this resolution will push that process forward in a more enlightened direction,” attorneys Paul E. Kalb and Coleen Klasmeier of Sidley Austin LLP in Washington told Bloomberg BNA March 9. Klasmeier was formerly at the FDA’s Office of Chief Counsel.

Mit Spears, executive vice president and general counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), the brand-name drug industry's lobbying group, said the settlement in the Amarin case “reinforces the need for the FDA to move quickly to help ensure that health care professionals have science-based, methodologically sound medical information available for patient treatment.”

“Now is the time for identifying solutions among varying stakeholders, including the FDA, to provide physicians and patients with the best possible information on treatment options,” Spears said in a March 8 statement.

John Kamp, consulting counsel to Wiley Rein LLP and executive director of the Coalition for Healthcare Communication in New York, agreed. “It’s now time for the FDA to step up and take a leadership role in the policy development over off-label information communication,” he told Bloomberg BNA March 9. The Coalition for Healthcare Communication is an industry group that promotes the free exchange of scientific and medical information.

“The public and the industry have waited long enough for the FDA to accept the fact that the First Amendment applies to these issues and define ‘false and misleading' in a common sense way that allows drug sponsors to share vital information to doctors and patients,” Kamp said in an e-mail.

Amarin Pharma has U.S. offices in Bedminster, N.J., and is part of Ireland's Amarin Corp. plc. Co-plaintiffs in the case are four doctors from New York.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

A copy of the settlement is at