Subsys Makes A Bad Impression On FDA REMS Panel Members
CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.
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University of Kentucky anesthesiologist Raeford Brown says problem with transmucosal fentanyl regulation isn’t the REMS – it's that the products are approved at all.
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.
Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.