Asleep At The Switch? FDA’s TIRF REMS May Not Be A Model After 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.
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US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
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.
CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.