Joint Meeting: FDA Advisory Committees on Drug Safety and Risk Management & Anesthetic and Analgesic Drug Products
The Food and Drug Administration (FDA) will hold a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The committees will discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS), approved in December 2011.
The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency will seek the committees’ assessment as to whether this REMS with elements to assure safe use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also seek the committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met.
Members of the public may attend in person or via webcast. More information is available at the FDA's website.