Amarin Off-Label Promotion Decision: A Watched Pot Boils

Law360, New York (August 12, 2015, 10:43 AM EDT) -- It is now just over 21 years since the 1994 filing of the groundbreaking case of Washington Legal Foundation v. Kessler,[1] in which the courts first began to wrestle with a key question for the drug and device industries: consistent with the First Amendment, may the FDA prohibit manufacturers from disseminating truthful, nonmisleading scientific information to doctors to promote their products for uses that have not been approved by the FDA? As litigants have repeatedly advised various courts, not only may doctors legally prescribe drugs and devices for unapproved uses, but such off-label uses are integral to the practice of modern medicine. Yet after all this time, while the above question has often been raised in legal proceedings, its answer remains disputed. Remarkably, in fact, as of Aug. 7, 2015, at 9:00 a.m., the government's position was that the question had never been squarely decided by a single court, apart from a ruling in the Washington Legal Foundation (WLF) litigation that is no longer in effect....

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