FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.

This audio conference covers:

• Details of the FDA draft guidance on responding to unsolicited requests for off-label information
• How the new guidance is likely to impact company policies and procedures
• The potential impact of the new guidance on enforcement actions
• Defining solicited vs. unsolicited, and public vs. non-public information
• Key points to consider in implementing the new guidelines

About the speakers:

Marian Lee is a partner in the FDA & Life Sciences Practice Group at King & Spalding. Ms. Lee advises life sciences companies on a wide range of FDA regulatory and compliance issues, and has expertise in the FDA and FTC regulation of social media and commercial communications, and mobile health technologies. Ms. Lee graduated from Harvard Law School, where she was Articles Editor of the Harvard Journal of Law and Technology and Co-Chair of the Harvard Asian Pacific American Law Students Association. She graduated from Harvard College with a Bachelor of Arts in History, magna cum laude, and also worked as a research associate on economic policy issues at Harvard Business School.

Beverly H. Lorell, M.D. is the Senior Medical and Policy Advisor with the FDA Lifesciences Practice Group of King & Spalding LLP in Washington, D.C. Dr. Lorell specializes in the areas of clinical trial design for drugs and devices, postmarket safety, and industry-physician relationships. In the area of Clinical Trials/Product Development, Dr. Lorell works with clients in protocol development and preparation of regulatory submissions in industry-sponsored clinical trials as well as issues related to recent healthcare reform legislation and comparative effectiveness research. Dr. Lorell assists regulated industry in issues that arise related to protection of human subjects, investigator-sponsor relationships, and the development of risk assessment and processes for medical affairs and scientific functions.

Dr. Lorell has experience in clinical trials and industry medical affairs functions from three perspectives: clinician investigator, advisor to FDA and NIH, and industry. She was previously Professor of Medicine at Harvard University and Beth Israel Deaconess Medical Center and has over twenty-five years of experience as a practicing interventional cardiologist and heart failure specialist. As a clinical trialist, she had extensive involvement in both pharmaceutical and device clinical trials as an investigator as well as steering committee and DSMC membership. Prior to joining King & Spalding in 2006, Dr. Lorell joined Guidant Corporation in 2003 as Vice President and global Chief Medical and Technology Officer. In this role, she was involved in corporate leadership in product development, strategic clinical trial design for emerging vascular and heart failure therapies, and physician-industry relationships. She has served on the FDA Cardiovascular and Renal Drugs Advisory Committee and NIH Cardiovascular Study Section as well as other federal panels. In addition to serving as co-chairman of the Steering Committee of the FDA-initiated Clinical Trials Transformation Initiative (CTTI), she is currently a member of the Executive Committee of the Board of Directors of NEHI, a national nonprofit foundation focused on research and policy to support innovation in patient healthcare.

Who should attend?

• Regulatory Affairs
• Legal Counsel
• Marketing
• Senior Executives
• Compliance