The Food and Drug Administration, as part of a sweeping overhaul in how it regulates opioid painkillers, plans to look to some unusual allies to limit the flood of the addictive pills — health insurers and companies that manage prescription drug benefits.
Food and Drug Administration Commissioner Scott Gottlieb plans to meet in September with the benefit payers and insurance administrators, groups the FDA hasn’t typically worked with in its role as a drug regulator. The plan, Gottlieb said, is to stem the tide of addiction to the pills by limiting the number of people exposed to them in the first place.
“Most people who become addicted to opioids are medically addicted,” Gottlieb said in a wide-ranging interview with Bloomberg in New York. “The way to reduce the rate of new addiction is to reduce the rate of exposure, and the way to reduce the rate of exposure is to make sure people are receiving prescriptions when it’s only medically appropriate.”
Gottlieb, who was picked by President Donald Trump earlier this year to lead the agency, said he views it as part of his mandate to tackle the opioid crisis, as well as other issues such as drug costs. The sessions with insurers and pharmacy managers will be his first official meetings with health-care companies, he said. The agency doesn’t have regulatory authority over insurance companies, which are largely overseen by state regulators or other departments within the Health and Human Services Department.
More than 240 million opioid prescriptions were dispensed in the U.S. in 2014, according to the Department of Health and Human Services. Deaths from opioid pain pill overdoses in 2015 totaled almost 23,000 in the U.S., double the number a decade ago, according to the National Institute on Drug Abuse.
Gottlieb said he wants to examine whether insurers and pharmacy benefit managers, or PBMs, can reduce the number of pills dispensed. That could involve changing drug labels or requiring doctor education for longer prescriptions.
“There shouldn’t be 30-day prescriptions for a tooth extraction, or 30-day prescriptions for a hernia repair,” Gottlieb said.
Gottlieb, 45, served in several senior positions at the FDA during the George W. Bush administration. He’s also worked as an adviser to investment firms and as a fellow at the conservative-leaning American Enterprise Institute, a Washington think tank.
“I’m looking at different models that could potentially be less burdensome but be more effective at achieving the goal of making sure that prescribing conforms more closely with clinical guidelines,” Gottlieb said. “They’re not in there right now. There’s no information in the drug label about what the appropriate dispensing should be.”
Gottlieb said that he’s altered the FDA’s focus on certain issues since he was confirmed as commissioner in May, but the agency’s opioids policy has been the biggest change in focus.
“Coming out of the confirmation process, I had a mandate to try to steer the agency in a little bit of a different philosophical direction,” he said. “I talked to 65 senators who all wanted to see the agency act differently.”
In a first, the FDA in June asked Endo International to pull its opioid Opana ER from the market. Endo has since agreed to stop sales of the painkiller that became a favorite of people abusing such drugs and led to a serious outbreak of HIV and hepatitis C linked to shared needles used to inject crushed versions of the drug.
The move marked a shift in FDA policy to consider how opioids are used not just by appropriate patients but also by people addicted to the pills.
“We’re constantly looking retrospectively to what’s on the market and making sure that it still makes sense relative to today’s marketplace and what’s available,” he said.
Gottlieb said the agency will keep looking at how drugs that are already on the market are used, in both medical settings and also illicit ones.
“It’s like I said on the drug pricing thing, there’s no silver bullet,” he said. “There’s not going to be one thing that we’re going to do. We’re going to be doing a long list of things.”