November 22, 2013
Accredited CME providers that are interested in conducting the long-term evaluations might provide service in support of the ER/LA Opioid Analgesics REMS in the following ways:
- Providers can conduct the long-term evaluations within their accredited CME programs. In that case, as with any accredited CME activity, providers must comply with all the accreditation requirements including the ACCME Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities (SCS). The providers must control the evaluations. The providers cannot accept any directions from the RPC. The providers can base the evaluations on the FDA specifications, in the same way that they can base their activities on the FDA blueprint, but the providers cannot accept any guidance from the RPC.
- Providers can conduct the long-term evaluations outside of the scope of their accredited CME programs. In that case, the ACCME requirements, including the Standards for Commercial Support, would not be relevant.