Caronia panel: Off-label enforcement paradigm is shifting

01/29/2013

During a Drug Information Association Webinar held last week to discuss the implications of the U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia, a panel of industry experts, moderated by Coalition for Healthcare Communication Executive Director John Kamp, concurred that many questions remain about how the decision will change FDA marketing regulations and related U.S. Department of Justice actions under the False Claims Act. Kamp reminded DIA attendees that even though the ground is shifting, industry should not “read this decision as stripping the FDA of its authority to regulate off-label promotion. FDA’s authority to regulate ‘false and misleading’ promotion is intact and the agency fully intends to use it.” Read more.

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