FDA's Long-acting Opioid REMS Proposal to Focus on CME

On July 22-23 The FDA will convene a joint meeting of the Anesthetic & Life Support Drugs Advisory Committee and the Drug Safety & Risk Management Advisory committee to discuss its proposal for class-wide Risk Evaluation Mitigation Strategies for long-acting opioids according to a memo released earlier this month.

As reported by The RPM Report, the proposal includes relying on "physician education with materials pre-approved by FDA as the key post-marketing control tool" for this class of pain medications. The FDA created the proposal based on a "thorough analysis of options and public comments," and is a "product of a broad year-and-a-half-long effort."