Is it acceptable for an accredited provider to include product-specific content in an activity based on the FDA Opioid Analgesics REMS blueprint?
Yes. There is no ACCME prohibition against including product-specific content in accredited CME. Accredited providers can develop and distribute product-specific content for activities based on the FDA blueprint for the Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) because the blueprint was developed and issued independent of the control of an ineligible company. As with any CME activity, accredited providers must comply with the ACCME accreditation requirements. There is no special use standard or safe harbor for CME that supports the Opioid Analgesics REMS.
FDA Risk Evaluation and Mitigation Strategy (REMS) for Opioid Analgesics: This FDA information page includes links to the REMS blueprint, Q&A, news release, and other resources.