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New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

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Kamp 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 by Executive Director of the Coalition for Healthcare Communication John Kamp.

The Webinar, to be held 11 a.m. to 12:30 p.m., will encourage speakers Bert Rein, partner, Wiley Rein, Alan Bennett, partner, Ropes and Gray and Mit Spears, General

Counsel, PhRMA (invited), to discuss the Caronia decision, which overturned the criminal conviction of pharmaceutical sales representative Alfred Caronia and may be the most significant commercial free speech decision issued by a federal appeals court in many years.

Legal, regulatory and industry experts will present the facts of the case, discuss possible appeals, and answer questions about how the decision will affect settlements on “false claims” acts prosecutions. The speakers also will cover possible FDA rules on professional and consumer advertising, including social media, and address off-label marketing using comparative effectiveness and economic studies.

For more information, contact DIA at: http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=2131873&EventType=Webinar