FDA head calls for new rules on opioids

With opioid abuse now an epidemic, new FDA chief steps up the fight

With tens of thousands of deaths recorded each year from opioid overdoses, the head of the Food and Drug Administration is admitting his agency should have addressed the problem years ago. Now FDA Commissioner Scott Gottlieb is backing restrictions on prescriptions, and new rules for dispensing fast-acting drugs such as Percocet.

The National Institute on Drug Abuse estimates that 62 people die every day because of prescription opioids. And as advocates warn that delays in dispensing the drugs literally can be painful, Gottlieb is looking to educate doctors on their use. He is also planning regulations for generic versions of the drugs that have not yet been compounded.

The Food and Drug Administration’s new chief says he doesn’t want to repeat the mistakes made when he was at the agency in the 2000s and the government failed to more aggressively regulate opioids.

“We didn’t get ahead of it. Nobody got ahead of it,” physician Scott Gottlieb said last week 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, increased oversight of highly addictive immediate-release opioids and tightened 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, a doctor who was the FDA’s principal deputy commissioner in the Obama administration.

After his May swearing-in, “Scott was quick out of the gate to take some steps on opioids,” says Sharfstein, now a professor and associate dean at Johns Hopkins University’s Bloomberg School of Public Health. “He recognizes there’s a lot more to be done at the FDA.”

The moves come too late for Chris Barth, 42, who fell hard for the painkiller Percocet the first time he tried it at 15. It was an on-

HENRY TAYLOR, USA TODAY Chris Barth, 42, battled addiction to the painkiller Percocet for nearly 20 years after he first tried it at age 15.

JASPER COLT, USA TODAY NETWORK The FDA failed to do what was needed to head off opioid abuse in the 2000s, new chief Scott Gottlieb says. Jayne O’Donnell