Is it acceptable for an accredited provider to include product-specific content in an activity based on the FDA ER/LA Opioid Analgesics REMS blueprint?

Published Date: 
October 25, 2012

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 Extended-Release and Long-Acting (ER/LA) 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 ER/LA Opioid Analgesics REMS.

Resources:

FDA Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids: This FDA information page includes links to the ER/LA opioid analgesics REMS blueprint, Q&A, news release, and other resources.

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