Common Contracts

Amarin and FDA Reach Settlement Agreement in Off-Label Speech/First Amendment Case

March 8th, 2016

• Filed
  March 8th, 2016

On March 8, 2016, Amarin Pharmaceuticals, Inc. (“Amarin”) and the Food and Drug Administration (“FDA” or the “Agency”) reached a settlement agreement in a closely followed case involving Amarin’s First Amendment rights to engage in truthful and non-misleading speech promoting an off-label use of Vascepa®. Amarin and FDA had been engaged in settlement talks since last August, when Judge Engelmayer, in the Southern District of New York, granted a motion for preliminary injunction (PI) in favor of Amarin.