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FDA Drug Claims Substantiation after IMS and Caronia: Will Court Scrutiny Based on the First Amendment Lead to Change in Current Policy and Practice?
Session Chair(s)
John Kamp
Washington Counsel, Coalition For Healthcare Communication (CHC), United States
This forum will focus on the emerging law of claims substantiation in light of major court rulings affecting FDA regulation of marketing, particularly the Supreme Court decision in IMS v. Sorrell and the 2nd Circuit decision in US v. Caronia. Among other things, panelists will focus on Citizen Petitions before the FDA by PhRMA and the Information Working Group (IWG) of 13 major biopharmaceutical companies seeking clarity and reform of existing policies.
Learning Objective : Discuss the First Amendment underpinnings of the IMS and Caronia court decisions including how those implicate the prescription marketing rules of the FDA; Recognize the importance of Citizen Petitions and other related actions by PhRMA, Information Working Group (IWG) and others; Identify the possible changes in FDA regulation likely in light of these rulings.
Speaker(s)
Coleen Klasmeier, JD
Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice, Sidley Austin, LLP, United States
Panelist
Alan R Bennett, JD
Senior Counsel, Ropes & Gray, United States
Panelist
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