The Food and Drug Administration (FDA), 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.”
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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 U.S. Department of Health and Human Services (HHS).
Millions of Pills
More than 240 million opioid prescriptions were dispensed in the U.S. in 2014, according to HHS. 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.
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Gottlieb, 45, served in several senior positions at the FDA during the George W. Bush administration. He’s also worked as an advisor to investment firms and as a fellow at the conservative-leaning American Enterprise Institute, a Washington think tank.