REMS Standardization Could Help Opioid Education Efforts
FDA hopes to begin accepting Risk Evaluation and Mitigation Strategy documents in structured product labeling format later this year.
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The prototype pulls information from the electronic record to fill out enrollment and other forms, but stakeholders say it must work for most, if not all, REMS drugs in order to be widely used.
The recent US advisory committee review of the Transmucosal Immediate-Release Fentanyl REMS program is important as another marker of the fraught climate around prescription opioid abuse. But it may have broader implications for the future of drug safety regulation and the REMS model.
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.