WASHINGTON — 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 regulate opioids more.
“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, 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, 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-again, off-again romance for nearly two decades, fueled in part by prescriptions for his own injuries and the occasional opioid swiped from his parents’ medicine cabinet.
When Percocet, a brand-name version of oxycodone and acetaminophen, became easier to get in the early 2000s, Barth dabbled with the drug. He had a major relapse in 2006 and quit for good six months later when his wife got pregnant.
When Barth’s mother got a 30-day supply of Percocet recently for a knee replacement surgery that only required three days of the drug, Barth was shocked they gave her so many pills.
“Easy access to the drug can create a full-blown addiction in a surprisingly short amount of time,” he said.
More than 64,000 people died of all drug overdoses last year, up from fewer than 20,000 in 1999, according to the National Institute on Drug Abuse. Nearly 35,000 people overdosed on heroin and other opioids in 2015, the latest year available. Every day, 62 people die because of prescription opioids.
Here is some of what‘s being done:
• Prescription limits. 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. The pharmaceutical industry and most other industries have backed the prescription limits, which Gottlieb called “an inevitability.” Perry Lewis of CoverMyMeds — a company that does quick, electronic versions of the approvals needed by insurers for certain prescriptions — is among those pushing FDA to use their authority to issue regulations so the health care industry doesn’t have to meet different regulations in every state.
• Immediate-release opioids. These fast-acting pain pillsmake up about 90% of opioid prescriptions and can be more addictive, yet have had weaker oversight. The FDA now plans to regulate these drugs as they do the extended release formulas. That means drugmakers have to make training available to doctors that includes safe prescribing and non-opioid alternatives. Because the effect of the painkiller wears off faster, patients may think, “I’ll just take another or take three,” says Lewis. “People just want more and more.”
• Abuse-deterrent formulas. 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. Abuse-deterrent drugs can actually lead to riskier behavior, as FDA learned with the drug Opana ER. FDA asked the maker of the purportedly safer opioid to withdraw it in June because a reformulated version led users to inject it. That led one Indiana county to have the highest number of HIV cases in the U.S.
Barth, an electrician, first tried Percocet after a dirt bike crash when he was 15 and immediately had a feeling of “euphoria that is hard to forget.” At 23, he was hit by a drunk driver while walking and was prescribed Percocet again. He asked for a new prescription after going through his 30-day supply and went through “mild withdrawal” when that ran out.
Barth, who is tapering off the opioid blocker Probuphine, says if he was at the “stage I used to be, I certainly would have helped myself to the unused portion” of his mother’s 30-day Percocet prescription.
Gottlieb, a former fellow of the conservative American Enterprise Institute, says he spent years “lamenting the growing federal intrusion into the practice of medicine but I would say that with respect to controlled substances in particular, it’s different.”
Those who advocate for people with chronic pain say federal regulators have already gone too far.
“We’re very concerned about the opioid epidemic; it would be stupid to say you’re not,” says Myra Christopher, who directs the Pain Action Alliance to Implement a National Strategy (PAINS) project. “But the efforts to control it are causing great harm to those who live with chronic pain.”
Lewis has seen both sides of the debate. His 28-year-old son, Chandler, was addicted to a variety of opioids after trying pain medication he found at home. Now working and sober for the past three years, Chandler once even figured out the code to a safe where his father hid his own pain pills after back surgery seven years ago.
“It’s grueling,” says Lewis. “We felt like failures.”
Still, he worries regulatory roadblocks for prescriptions could cause literally painful delays for many patients.
“Are we going too far in putting in restrictions on those who would need it in a timely manner?” asks Lewis.