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.
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 any ACCME-defined commercial interest. 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.
The REMS Program Companies (RPC) assigns a unique identifier (RPC ID) to each activity for which it provides commercial support. Accredited providers that offer RPC-supported REMS activities are responsible for entering the RPC ID in the designated field in the REMS section of the Program and Activity Reporting System (PARS). This ensures that their RPC-supported activities can be identified and reported to the RPC and, ultimately, to the FDA. If you are an accredited provider that has received commercial support from the RPC for REMS activities and you have questions about the RPC ID, please contact the RPC.
The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require manufacturers of drugs and biological products to put in place special programs if the FDA determines that safety measures are needed beyond the professional labeling to ensure that the benefits of products outweigh their risks. The manufacturers then implement FDA-monitored actions to address those risks. The FDA calls each of these a Risk Evaluation and Mitigation Strategy (REMS). Read more on our CME for FDA REMS page.