Off-Label Preclearance Process Eyed As Potential Fix for FDA’s Policy Dilemma

Joe Lipchitz, a Member in the Mintz Boston office, is quoted in this Informa article referencing the off-label promotion litigation settlement between the Food and Drug Administration (FDA) and Amarin Corp. PLC. The article notes that the preclearance process accorded to Amarin could serve as a solution to the FDA’s policy dilemma, following necessary structural and funding changes.

 

Off-Label Questions Linger: How Much Data Needed to be ‘Truthful’?

Mintz Boston Member Joe Lipchitz provides commentary in this Informa article discussing remaining ambiguity following the Food and Drug Administration’s settlement with Amarin Corp. PLC on the drug Vascepa. Clarity still lacks as to “what constitutes ‘no-misleading’ communications about an unapproved use.”

 

Consumer-Focused Off-Label Promotion Seems Possible After Amarin Settlement

Litigation Member Joe Lipchitz is quoted in this Informa piece on the off-label promotion litigation settlement between Amarin Corp. PLC and the U.S. Food and Drug Administration (FDA). The settlement opens the door for “truthful and non-misleading promotion of unapproved uses [of Vascepa] to consumers.”