March 3, 2009 Industry Meeting on Risk Evaluation and Mitigation Strategy (REMS) for Certain Opioid Drugs

FDA recognizes that putting together a workable REMS for these widely prescribed opioid products will present challenges. Therefore, we decided to invite all affected sponsors to a meeting to discuss how such a program can best be designed to manage the risks while also considering reasonable burdens to the health care system. This meeting was held on March 3, 2009. FDA presented a high-level overview, regulatory background, and the proposed elements of the REMS followed by questions and comments from the sponsors.

• Agenda (PDF - 23KB)
• Meeting minutes (PDF - 76KB)
• Presentations
  • REMS for Opioid Analgesics: How Did We Get Here? Where are We Going? (PDF - 89KB) - Bob A. Rappaport, M.D., Director, Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research
  • Title IX of FDAAA:  REMS Authorities (PDF - 45KB) - Jane A. Axelrad, J.D., Associate Director for Policy, Center for Drug Evaluation and Research
  • Proposed Opioid REMS (PDF - 88KB) - Sharon Hertz, M.D., Deputy Division Director, Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research