TIRF REMS Debate: Advisory Committee Chair Speaks Out
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.
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Risk committee has joined nearly all opioid reviews over past few years but didn’t for AcelRx's sublingual product; Raeford Brown, the analgesic advisory committee chair who was unable to attend the meeting, voices his displeasure with the vote.
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.
CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.