The Flood Gates Are Open: Amarin’s Win Spurs Another First Amendment Challenge to the FDA’s Regulation of Off Label Promotion [Drug and Device Law]

John Sullivan, a member of Cozen O’Connor’s Commercial Litigation Department, discusses Pacira Pharmaceuticals’ recent First Amendment challenge on their non-opioid pain drug, EXPAREL, in the wake of Amarin’s preliminary injunction win. Pacira has sued the FDA in the same court that decided the Amarin preliminary injunction motion – the Southern District of New York – which is part of the same federal circuit that decided Caronia – the Second Circuit.

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John J. Sullivan


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