Early opioid inaction by FDA requires big push now
Chief advocates for prescription limits as overdoses soar
USA TODAY WASHINGTON Chris Barth 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.
That was the 1990s and 2000s, however, when little was known about the deadly consequences of addiction to opioids including Percocet, a brandname version of oxycodone and acetaminophen. So when Barth’s mother got a 30-day supply of Percocet recently for a knee replacement that only required three days of the drug, Barth was shocked that was still done.
Food and Drug Administration Commissioner Scott Gottlieb, now in his third stint at the agency, says he doesn’t want to repeat the mistakes the agendoctors cy made in the 2000s when it failed to regulate opioids more. He’s advocating shorter opioid prescriptions, increasing oversight of highly addictive immediate release opioid formulas and tightening requirements for abuse-deterrent formulas.
“The type of action we need to take to finally (address) this crisis is going to be far more dramatic than it would had to do if we made certain decisions years ago,” Gottlieb, a physician, told a National Academy of Medicine conference last week.
That’s a “very candid” admission that acknowledges 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.
“Scott was quick out of the gate to take some steps on opioids,” says Sharfstein, now a professor and an associate dean at Johns Hopkins University’s Bloomberg School of Public Health. “He recognizes there’s a lot more to do be done at the FDA.”
About 64,000 people died of all drug overdoses last year, up from less 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 opiods. Many people with substance abuse disorder have switched from opioid pain pills to heroin because it’s easier to get and afford.
What’s being done:
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 FDA now plans to regulate these drugs as they do the extended-release formulas. That means drug makers have to make training available to that includes safe prescribing and non-opioid alternatives.
FDA is preparing for an expected onslaught of generic versions of these drugs, which currently don’t exist and will release guidance for drug makers soon.
Perry Lewis, vice president of industry relations at electronic prior authorization company CoverMyMeds, has seen both sides of the debate in often painful ways. His son Chandler, now 28, was addicted to a variety of opioids after trying pain medication he found at home.
“It’s grueling. We felt like failures,” says Lewis. “It breaks families as so many people don’t have the support.”
His company’s software speeds up prior authorizations from about five days to between seconds and a day. He worries roadblocks for prescriptions could cause literally painful delays for many patients.
“We all recognize there’s an opioid problem, but are we going too far in putting in restrictions on those who would need it in a timely manner?” he asked.