Senator Markey Blasts FDA’s REMS for Opioid Products

Sen. Edward Markey (D-Mass.) is urging the FDA to overhaul the risk evaluation and mitigation strategy (REMS) program.

“It appears that a wholesale readjustment of the REMS program is necessary to fully protect patients from the dangerous side effects associated with many opioid products,” Markey said in an Aug. 17 letter to FDA Commissioner Scott Gottlieb.

The lawmaker cited allegations in an Aug. 3 article in the New York Times that the FDA ignored warning signs of inappropriate fentanyl product prescribing. The article specifically reported   that the FDA failed to respond to alarms sounded by a REMS for transmucosal immediate-release fentanyl (TIRF), noting that a FOIA request turned up 5,000 pages of documents showing widespread off-label prescribing of the TIRF products.