Opioid REMS Needs Legislation Mandating Physician Training For Full Implementation
This article was originally published in The Pink Sheet Daily
Training would be required for DEA licensing as FDA goes with advisory committee opinion that it should not be voluntary.
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Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations
Agency has been hesitant to take the steps because of logistical difficulties of creating an enormous program, but has been pushed by its risk management advisory committee, among others.
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.
Requiring training and certification for extended-release opioids would involve at least 320,000 prescribers and impact 21 million outpatient prescriptions, reviewers note in a briefing memo that is more skeptical of the mandatory approach than FDA's leadership has been.