Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it appears that the FDA may have to begin accepting alternative evidence to support truthful and non-misleading promotional claims, according to Douglas Hallward-Driemeier, partner, Appellate and Supreme Court Practice, Ropes & Gray. As demonstrated by the […]
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caroniaAmarin 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 […]
Read moreCaronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing
Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia as a minor blip on its off-label regulation radar, the decision is part of a growing body of evidence which indicates that the agency will not be able to stay its strident […]
Read moreKamp To Moderate DIA Webinar on Caronia Case Implications
Dec. 18, 2012 – Whether the U.S. Court of Appeals for the Second Circuit’s decision in U.S. v Caronia will reset the legal boundaries between the FDA and pharmaceutical manufacturers’ right to disseminate off-label information about approved drug products will be the topic of discussion at a Jan. 23, 2013, Drug Information Association Webinar moderated […]
Read moreFederal Appeals Court Reverses Conviction of Detailer for “Off-label” Promotion
Regulation of Pharma Speaker’s Truthful Message Violates the First Amendment Dec. 3, 2012 – The U.S. Court of Appeals for the Second Circuit released a long-awaited decision today reversing the conviction of Alfred Caronia, a detailer for Orphan Medical Inc., who admitted that he intentionally promoted Xyrem for uses not approved by the FDA. The decision […]
Read moreRPM 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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