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 off-label promotion, according to an article in The RPM Report.

Kate Rawson writes in the October issue of the publication that the Sorrell decision could lead the U.S. Court of Appeals for the Second Circuit – the same court that “reversed a lower court decision in Sorrell and deemed Vermont’s data mining restrictions to be a violation of the First Amendment” – to overturn the conviction of Alfred Caronia, a sales representative who was charged with promoting a drug for an off-label indication. In light of the Sorrell decision, the Second Circuit considering

Caronia’s appeal asked for briefs regarding the relevance of the Sorrell opinion on this case.

The government dismisses the argument that Sorrell affects “the constitutionality of Caronia’s conviction.” The government also denies that FDA regulations lack the “coherence and clarity” to provide manufacturers with the “guidance they need on off-label promotion.”

The Coalition’s John Kamp is quoted in this comprehensive article covering the current state and future of off-label promotion. Read the full article, “Off Label Changes Coming? Sorrell Ruling Prompts New Legal Challenges,” courtesy of The RPM Report.