Prometheus’ Lotronex REMS Could Lose Its Sticker Verification Requirement
This article was originally published in The Pink Sheet Daily
FDA seeks advisory committee input on options for revising the irritable bowel syndrome drug’s Risk Evaluation and Mitigation Strategy, including eliminating a requirement for paper-based prescriptions and integrating the REMS into electronic pharmacy management systems.
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FDA’s Drug Safety and Risk Management Advisory Committee endorses replacing paper-based verification system for the irritable bowel syndrome drug with an electronically integrated process that the agency seems to favor; the electronic system currently is used in the REMS for transmucosal immediate-release fentanyl products.
Drug Safety and Risk Management Advisory Committee overwhelmingly favors elimination of paper-based sticker system to verify prescriber enrollment and documentation of safe use conditions under Prometheus’ REMS for the irritable bowel syndrome drug.
The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.