Hyman, Phelps & McNamara, P.C. ("HP&M") will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 - 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. Nor is it merely high-level positing about the future of off-label promotion prosecutions, such as here and here. This webinar will provide practical tips to address the real-world implications to companies from this significant decision. The impacts go beyond just the pharmaceutical marketing industry - the marketing of devices, dietary supplements, and tobacco products likely will be affected. Hear from experts who evaluate and advise FDA-regulated industries about relevant business considerations that are impacted by Caronia. Participants will gain an understanding of:
- The Caronia decision and other First Amendment court rulings involving FDA and what the government is likely to do as a result of the Caronia decision;
- Views from people familiar with how the FDA Centers (including CDER, CDRH, CFSAN, and CTP) will modify enforcement and other decisions as a result of Caronia;
- Strategies for promotional review committees to use; and
- Defenses to current and future off-label marketing and government reimbursement cases.
There will be an opportunity to submit questions during the webinar. Responses to any questions that are not addressed will be available on the HP&M firm website after the webinar.