Amarin v. FDA Focuses the Spotlight on the First Amendment and the FDA's Regulation of Off-Label Promotion [Drug & Device Law]

John Sullivan, a member of Cozen O'Connor's Commercial Litigation Department, discusses Amarin Pharma, Inc. v. FDA, in which Amarin seeks a declaration that the FDA's off-label regulations, as applied by the FDA, violate the First Amendment and the Due Process clause of the Fifth Amendment by failing to provide clarity on its position regarding off-label promotion.

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John J. Sullivan


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