In a very significant ruling regarding the First Amendment rights of pharmaceutical companies, Judge Paul Engelmayer of the Southern District of New York ruled that the FDA may not pursue misbranding charges against a drug company for communicating truthful, nonmisleading information about unapproved “off-label” uses of its products. Amarin Pharma Inc. v. FDA (Aug. 7, 2015). While the pharmaceutical industry was busy celebrating its newfound ability to engage in off-label promotion, CCL Chief Litigation Counsel Lou Bograd commented that they should be careful what they wish for: “The First Amendment Ruling in the Amarin Pharma case is a double-edged sword, with huge implications for preemption doctrine, especially for the impossibility preemption defense to generic drug failure-to-warn claims.” As Bograd told Law360 in its article, “Amarin’s Off-Label Victory Opens Door to More Injury Claims,” “If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products.”
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