Current FDA guidance creates the threat of significant legal liability even for companies communicating truthful, scientific information to physicians on off-label uses for their products. As the House Energy & Commerce Committee’s 21st Century Cures Initiative explored at a recent hearing, important information on medicines reaches physicians much more slowly—if at all—than if there were a “safe harbor” that allowed companies to communicate cutting-edge scientific discoveries directly to physician intermediaries.
As senior fellows Paul Howard and James Copland noted in a 2013 Manhattan Institute report, proper dissemination of information dealing with off-label uses, emerging indications, and potential adverse effects helps “to improve medical research and public health by increasing learning about what happens after drugs are licensed and making the best use of pharmaceuticals on the market.”
Please join us as our panel of policy experts, physicians, and legal experts discusses the implications of recent court rulings for the FDA’s ability to regulate truthful off-label speech by companies. Our panelists will explore how an alternative framework could improve communication of valuable scientific information to physicians, who can then deliver better care to their patients.
|10:00 - 10:30 AM||Registration|
|10:30 - 11:15 AM||Panel Discussion
James R. Copland, Senior Fellow & Director, Center for Legal Policy, Manhattan Institute
Paul Howard, Senior Fellow & Director, Center for Medical Progress, Manhattan Institute
Coleen Klasmeier, Former Special Assistant to FDA Chief Counsel; Partner and Global Coordinator, FDA Regulatory Practice, Sidley Austin LLP
Gregory Schimizzi MD, Cofounder, Carolina Arthritis Associate
|11:15 - 11:30 AM||Q&A|