Is it acceptable for providers to develop CME activities based on the FDA blueprint for the Opioid Analgesics REMS?
Yes. Accredited CME providers can base their activities on the FDA blueprint and be in compliance with the ACCME Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities. As with any CME activity, accredited providers within the ACCME system must comply with the ACCME accreditation requirements. There is no special use standard or safe harbor for CME that supports the Opioid Analgesics REMS. The ACCME Standards for Commercial Support create a framework by ensuring that CME is accountable to participants, to the profession of medicine, and to the public for promoting health care quality improvement. The Standards require CME providers to design activities that are independent, free from commercial bias, and based on valid content. Providers must ensure that all decisions related to the content are made free of the control of commercial interests. As with all accredited CME, the ACCME expects that CME that supports the Opioid Analgesics REMS will serve the public interest.