The FDA’s decision to settle Amarin’s First Amendment lawsuit will have broad implications affecting both the drug and device worlds.
Under the deal — which still requires court approval — the agency would be bound by the terms of an August 2015 injunction permitting Amarin to promote Vascepa, used to lower high levels of triglycerides, off-label using court-approved language to ensure that the information is truthful and not misleading.
There is no doubt that the Amarin case, in conjunction with the recent Vascular Solutions trial, changes the landscape regarding off-label promotion in certain ways, says John Fleder of the law firm Hyman, Phelps & McNamara.
“Both cases demonstrate that the government must consider the First Amendment when it is contemplating enforcement actions for both drugs and devices,” he tells IDDM.
The settlement agreement, plus the VSI win and other recent government losses, puts pressure on the FDA to issue guidance on off-label speech for all medical products, says Lisa Dwyer of law firm King & Spalding.
Both industries are likely to be encouraged by Amarin’s success. Further, the outcome of a declaratory judgment action brought by Pacira earlier this year could lead to more of these actions, she tells IDDM.
Moving forward, the settlement likely will increase the FDA’s uphill battle in prosecuting off-label cases. Further, it puts pressure on the government to allege that the statements are false or misleading, which can be more resource intensive, says Dwyer. — Cameron Ayers and Jonathon Shacat