FDA Reexamines Opioid Policies

The FDA is re-examining its approval, REMS and postmarket policies for opioids in response to a growing abuse epidemic and calls to action from lawmakers.

The agency said last week it will re-evaluate its risk-benefit framework for the drugs, with an eye on public health effects. The move won't necessarily make approvals more difficult, but the agency is “certainly going to take a close reassessment of the criteria for opioid approvals,” spokesman Eric Pahon says. He added that the agency will seek more outside advice and counsel.

For example, the agency will convene an advisory panel before approving any new opioids that lack abuse-deterrent properties. It also will consult an advisory panel on any abuse-deterrent opioids with novel issues.