Tag: sorrell


Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin Pharma Inc.’s request for an injunction to stop the FDA from enforcing rules that prohibit companies from communicating to physicians truthful and non-misleading information about the off-label uses of their products. Below, Coalition for Healthcare […]

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RPM Report: Pandora’s Box Officially Open as New Legal Challenges to FDA’s Off-label Restrictions Emerge

Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, legal experts, drug manufacturers and other industry interest groups are testing the waters to determine whether that opinion leaves the door open for new challenges to certain FDA regulations, specifically the agency’s ban on most […]

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