Judge Enjoins FDA From Barring Truthful, Nonmisleading Off-Label Drug Promotion
Mealey's (August 19, 2015, 11:41 AM EDT) -- NEW YORK — A New York federal judge on Aug. 7 ruled that Amarin Pharma Inc. proposes to make “truthful and non-misleading” statements about its prescription fish oil drug and that such speech “may not form the basis of a prosecution for misbranding” by the Food and Drug Administration (Amarin Pharma, Inc., et al. v. United States Food and Drug Administration, et al., No. 15-3588, S.D. N.Y.; 2015 U.S. Dist. LEXIS 103944).
(Opinion available. Document #28-150820-010Z.)
Amarin Pharma Inc. makes a triglyceride-lowering drug called Vascepa, which...