5 Questions After Amarin's Off-Label Marketing Triumph

Law360, New York (August 7, 2015, 8:43 PM EDT) -- A landmark court decision on Friday allowing truthful and nonmisleading off-label promotion by Amarin Pharma Inc. provides a roadmap for drugmakers to market products more freely, but attorneys say much uncertainty remains about the ruling's impact on criminal misbranding cases and False Claims Act litigation. Here are five questions raised by Amarin’s victory.

Will the FDA Appeal?

The most immediate question is whether the U.S. Food and Drug Administration will appeal to the Second Circuit, which issued the 2012 ruling in U.S. v. Caronia that was...
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