ASA Provides Recommendations to FDA on REMS Program

On February 9, 2021, the American Society of Anesthesiologists (ASA) urged the Food and Drug Administration (FDA) to ensure alignment between REMS education programs and existing accreditation and state education requirements.  The request came through formal comments submitted to the Federal Register in response to the FDA's Request for Comments; Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Education Program on Prescribing Behaviors and Patient Outcomes–Exploring the Path Forward for Assessment. ASA’s involvement with the FDA REMS program has a long history, including the agency’s adoption of several recommendations submitted by the ASA in 2011 and more recently, FDA’s decision to expand the program to cover all classes of opioids in 2017.

ASA’s comments praised the FDA for their continuity in tackling the nation’s opioid overdose crisis and for implementing this continuing education (CE) program that comes at no costs to physicians. Key recommendations included encouraging REMS education to follow traditional Accreditation Council for Continuing Medical Education (ACCME) standards for accredited CME providers, conducting a pilot study about the effectiveness of REMS-compliant CE, as well as ensuring REMS education fulfills state education requirements.

The Vice-Chair of ASA’s Committee on Pain Medicine, Michael Harned, MD, provided comments at FDA’s public workshop on December 11, 2020. He offered remarks and presented ASA’s feedback, consistent with the formal comments submitted to the FDA. ASA’s recommendations reflect the organization’s overall commitment to supporting the REMS education program and making it more accessible and influential in reducing opioid overdoses nationwide.