Hyman Phelps and McNamara Hyman Phelps and McNamara
Developments in the Law

Real-World Implications of United States v. Caronia
January 31, 2013

Not just another summary of the long-awaited decision by the Second Circuit in United States v. Caronia, or high-level positing about the future of off-label promotion prosecutions. This webinar provides 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.

Learn more about:
  • 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;


  • Defenses to current and future off-label marketing and government reimbursement cases.


Click here to view the presentation in PDF format

Click here to play the recorded webinar

If you have any questions regarding the above information, please contact:
John R. Fleder (202) 737-4580 jfleder@hpm.com
Jeffrey N. Wasserstein (202) 737-9627 jwasserstein@hpm.com
David B. Clissold (202) 737-7545 dclissold@hpm.com
Jeffrey K. Shapiro (202) 737-9633 JShapiro@hpm.com
Kurt R. Karst (202) 737-7544 kkarst@hpm.com
Ricardo Carvajal (202) 737-4586 RCarvajal@hpm.com
Anne K. Walsh (202) 737-4592 awalsh@hpm.com