Brookings Institution Meeting Explores the Role of CE in REMS
Graham McMahon, MD, MMSc, President and CEO, ACCME; and Kate Regnier, MA, MBA, Executive Vice President, ACCME, were invited to participate in a meeting exploring the challenges and opportunities for incorporating accredited continuing education (CE) in Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) for single drugs. The meeting was hosted by The Brookings Institution in May in Washington, DC. Ms. Regnier gave a presentation discussing the lessons learned from the process of incorporating accredited CE into the Extended Release and Long-Acting (ER/LA) Opioid Analgesics REMS. The ER/LA Opioid Analgesics REMS, approved by the FDA in 2012, was the first REMS to incorporate accredited CE.
Last year, the FDA issued a report Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS), which proposed assessing the feasibility of providing accredited CE associated with other REMS. The ACCME, along with its colleague accreditors in pharmacy and nursing, sent a letter to the FDA in support of the proposal. Since 2009, the ACCME has supported the role of accredited CME as a strategic asset to FDA REMS, provided the proper controls are in place to ensure independence.