The Food and Drug Administration’s new chief doesn’t want to repeat the mistakes made when he was at the agency in the 2000s and the government failed to regulate opioids more, reports USA Today.
“We didn’t get ahead of it. Nobody got ahead of it,” physician Scott Gottlieb said at a National Academy of Medicine conference. “The type of action we need to take to finally (address) this crisis is going to be far more dramatic than we would have had to do had we made certain decisions years ago.”
Now in his third stint at the agency — his first as chief — Gottlieb is advocating shorter-duration opioid prescriptions, increasing oversight of highly addictive immediate-release opioids and tightening requirements for abuse-deterrent formulas.
That’s a “very candid” admission that Gottlieb was at the FDA “at a time when opioid use was rising rapidly in this country and being very inappropriately marketed,” says Josh Sharfstein, the FDA’s principal deputy commissioner in the Obama administration. More than 64,000 people died of all drug overdoses last year, up from fewer than 20,000 in 1999, says the National Institute on Drug Abuse.
Several states have passed laws that would cap first-time opioid prescriptions at seven days, and CVS announced last month that it would limit initial opioid prescriptions to a week.
Immediate-release opioids make up about 90 percent of opioid prescriptions and can be more addictive, yet have had weaker oversight. The FDA plans to regulate these drugs as they do the extended release formulas. The FDA is preparing for an expected onslaught of generic versions of these drugs — which currently don’t exist — and will release guidance for drugmakers soon.