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TIRF REMS Debate: Advisory Committee Chair Speaks Out

 
• By Michael McCaughan

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. 

Risk Dial

The problems with continued misuse of transmucosal immediate release fentanyl products is not with the US FDA’s Risk Evaluation & Mitigation Strategy – but rather with the availability of the products at all, one of the members of FDA’s Anesthetic & Analgesic Drugs Advisory Committee that reviewed the TIRF REMS says in an email to the Pink Sheet.

“After five years of assessing the positions of the Agency, past mistakes, and the current state I am certain that there was never an indication for this drug, and that...

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