FDA panel wants stricter opioid REMS

A joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees voted 25-10 against the FDA's proposed REMS for extended-release and long-acting opioids. Although all those who voted against the agency's proposal felt a classwide REMS was necessary, they believed that the FDA's draft was not sufficiently stringent to affect opioid misuse and abuse.

The agency's draft REMS included a prescriber education program in which manufacturers of extended-release and long-acting opioids were required to demonstrate that prescribers had been trained and that knowledge of appropriate use of the drugs was improved. However, prescribers were still permitted to prescribe the drug even if they did not demonstrate evidence of completing the training. The panel members felt that such training should be mandatory. ...