Law360, New York (March 11, 2016, 11:34 AM EST) -- In an apparent first, the U.S. Food and Drug Administration has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession comes as part of the proposed stipulation and order of settlement submitted to the U.S. District Court for the Southern District of New York in Amarin Pharma Inc. v. FDA on March 8. (View the order here.) The proposed order reflects an agreement by the FDA that appears to embrace all of the principles outlined in the district court's Aug. 7, 2015, opinion, chief of which was that truthful and nonmisleading speech promoting the off-label use of an FDA-approved drug cannot form the basis for a criminal misbranding charge. 119 F.Supp.3d 96 (S.D.N.Y. 2015)....
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