Amarin Pharma, Inc. v. United States Food & Drug Administration

OPINION & ORDER

PAUL A. ENGELMAYER, District Judge:

In United States v. Caronia, 703 F.3d 149 (2d Cir.2012), the Court of Appeals for the Second Circuit vacated a pharmaceutical sales representative’s conviction for conspiring to introduce a misbranded drug into interstate commerce, in violation of 21 U.S.C. §§ 331(a) and 333(a)(1). The conviction was based" on Caronia’s having promoted a drug for “off-label use,” that is, a use other than the one approved by the U.S. Food and Drug Administration (the “FDA”). Caronia’s conduct to promote the off-label use, however, had consisted solely of…