Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA and other enforcement authorities are serious indeed. In this audio conference, our speaker provides background information and examines the current regulatory status of off-label promotion of medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.

This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against medical device companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.

This audio conference covers:

• Overview of FDA regulations concerning off-label information
• Dissemination of off-label information
• Responding to unsolicited requests
• The role of sales representatives and medical science liaisons
• Recent enforcement actions against medical device companies
• Consequences of off-label promotion

About the speakers:

Caryn Silverman, a partner in Sedgwick’s New York office, concentrates her practice on product liability, with a specialty in drug and medical device litigation. She has served as national and local counsel in pharmaceutical mass tort litigation, and is a prolific author and frequent speaker on legal issues pertaining to FDA-regulated products. Ms. Silverman is Chair of the New York State Bar Association's Food, Drug & Cosmetic Law Section. She is admitted to practice in New York and New Jersey and before the U.S. District Courts for the Southern and Eastern Districts of New York and the District of New Jersey. She holds a B.S. from Cornell University and J.D. from Benjamin N. Cardozo School of Law, Yeshiva University.

Who should attend?

• Sales & Business Development
• Marketing Directors/Managers
• Legal Counsel
• Regulatory Affairs Personnel
• Regulatory Counsel