Is it acceptable to include content developed by a commercial interest for an activity that supports the ER/LA Opioid Analgesics REMS?

Published Date: 
October 25, 2012

No. An accredited CME provider cannot use content developed by an ACCME-defined commercial interest in CME activities because that would be noncompliant with Standard for Commercial Support 1: Independence.

It is acceptable for accredited CME providers to base their activities 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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