Food and Drug Administration

Risk Communication Advisory Committee

May 15-16, 2008

FDA

Topic I: DTC Advertising’s Impact on Subsets of the General Population;   Report (FDAAA, Section 901).   May 15, 2008

Overview of Direct-to-Consumer (DTC) Advertising Regulation at FDA, Nancy M. Ostrove, Ph.D., Senior Advisor for Risk Communication, FDA (ppt) (pdf)

Developing a Report (review of what FDAAA requires, what FDA is doing), Kristin Davis, Deputy Director, Division of Drug Marketing, Advertising and Communications, Center for Drug Evaluation and Research, FDA (ppt) (pdf)

Literature Review, Andreas Lord, M.S., Eastern Research Group (pdf)  (2008-4362s1-03) (ppt) (pdf)

Comments from Consultant, J. Craig Andrews, Ph.D., Charles H. Kellstadt Chair in Marketing, Marquette University (ppt) (pdf)

Other FDA Presentations

Ellen Frank, Director, Division of Public Affairs, Office of Training and Communications, Center for Drug Evaluation and Research, (ppt) (pdf)

Mary Hitch, Senior Policy Advisor, Office of External Relations, Office of the Commissioner (ppt) (pdf)

Catherine McDermott, Director, Public Affairs/Information Branch, Division of Federal and State Relations, Office of Regulatory Affairs (ppt) (pdf)

Karen Feibus, M.D., Medical Officer, Office of New  Drugs, Center for Drug Evaluation and Research (ppt) (pdf)

May 16, 2008

Topic II:  Adverse Event Reporting Number Statement Study (FDAAA Section 906) on Product Recalls

Overview of MedWatch Statement in DTC Print Ads & Presentation of Proposed Experimental Study, Amie O’Donoghue, Ph.D., presenting for Kathryn J. Aikin, Ph.D., Social Science Analysts, Division of Drug Marketing, Advertising and Communications, Center for Drug Evaluation and Research (ppt) (pdf)

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