Experts: Amarin Deal Encourages FDA to Prevent Similar Cases

Say “sayonara” to the status quo of pharmaceutical promotional review. That’s the consensus of industry experts weighing the implications of the FDA’s decision last week to settle Amarin’s First Amendment lawsuit.

While none of the experts expect the status quo to evaporate overnight — given that the deal directly applies only to Amarin — most agree it will force the FDA to prevent similar cases from occurring.

Under the deal, which still requires court approval, the agency agrees to be bound by the terms of an August 2015 injunction permitting Amarin to promote its blood pressure drug Vascepa off-label using court-approved language to ensure that the information is truthful and not misleading.