FDA's continued oversight of the REMS associated with TIRF products

FDA will host this week a public advisory committee meeting to review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products.

FDA will host this week a public advisory committee meeting to review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. At the August 3 meeting, the agency will ask the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to report on findings from the analyses by manufacturers of these products, in addition to further data about their patterns of use and adverse events. "Asking the FDA's advisory committees to take a closer look at this opioid-related REMS reflects our commitment to further evaluating this critical program and making sure we're providing transparency around its effectiveness and whether any modifications may be necessary," notes FDA Commissioner Scott Gottlieb, MD. "These TIRF products are medically important but also pose serious risks." TIRF drugs are indicated for the management of breakthrough pain in adults with cancer who are routinely taking other opioid analgesics around the clock for pain. Since a TIRF REMS was approved in December 2011 there has been a significant decline in prescribing TIRF products. According to Gottlieb, topics to be discussed include how to best evaluate the REMS program, how the TIRF REMS has affected prescribing patterns for TIRF products, and how the TIRF REMS can encourage safe prescribing. "As part of our ongoing commitment to the safe use of these products, the FDA will seek the committee's feedback 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," Gottlieb says.