If At First You Don’t Succeed, Try Dispute Resolution

Amarin Corp. PLC’s unsuccessful bid to seek reinstatement of a special protocol assessment for a Vascepa study through FDA’s formal dispute resolution process follows a growing trend, as biopharma companies increasingly turn to this appellate route when a review division gives them advice or a regulatory decision with which they do not agree.

The popularity of the appeal pathway has been on the upswing in the past few years, even though it’s the rare company that actually gets all that it seeks in pursuing formal dispute