FDA to Expand Opioid REMS to Include Immediate-Release Painkillers

At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations — which account for 90 percent of the opioid painkiller prescriptions written each year in the U.S.

Gottlieb announced the broad measure alongside commitments to reduce the public’s overall exposure to the class of drugs by making sure they are used only in the proper indications.

“It’s clear there should be fewer prescriptions written for opioids,” Gottlieb said, describing immediate-release formulations as a potential gateway to new addiction.