The Food and Drug Administration’s commissioner suggested Tuesday that the agency could push to remove more opioids from shelves.
Commissioner Scott Gottlieb said the agency is conducting more reviews on how opioid painkillers are being abused. The comments come after the FDA made the unprecedented move in June of calling for the opioid Opana Extended Release to be pulled from shelves because of rampant abuse.
Gottlieb said Tuesday that FDA is evaluating whether to pull the entire class of drugs that contains the ingredient oxymorphone, which includes Opana.
“We have data that suggests it is more likely to be abused,” Gottlieb said at an event sponsored by the Hill newspaper. “We are following that up with a scientific study … set in motion probably two or three months ago.”
He hopes to get the study results in the first quarter of 2018.
Gottlieb said the June notice on Opana was unprecedented for the FDA from a regulatory standpoint. Normally the FDA would call for a drug to be pulled if the risks outweigh the benefits. But for Opana, the FDA pulled it because it was being used via injection.
The stepped-up review is part of a larger effort by the FDA to combat the opioid epidemic that federal data show kills 91 Americans a day.
The FDA has to go through an administrative law judge in order to remove a drug from the market.
