FDA to Enlist Help from Insurers, PBMs in Fight Against Opioid Epidemic


FDA plans multifaceted attack to reduce the burden of opioids on Americans.

Both federal and state governments have implemented numerous safeguards against the opioid epidemic, including limiting prescriptions and increasing access to treatment; however, opioid overdoses have continued to threaten public health.

The FDA Commissioner Scott Gottlieb, MD, recently told Bloomberg that the agency is looking to health insurers and pharmacy benefit managers (PBMs) to limit the availability of prescription opioids.

A meeting between the groups is expected to happen as soon as September 2017, according to the article published by Bloomberg. This innovative approach includes parties that typically do not work together to pursue a reduction in adverse events related to opioid misuse disorder.

“Most people who become addicted to opioids are medically addicted,” Dr Gottlieb said in the interview. “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.”

In addition to confronting the opioid epidemic, this strategy may also reduce drug costs, according to the interview.

The Department of Health and Human Services reported that more than 240 million opioids were dispensed in the United States alone in 2014, and nearly 23,000 opioid-related deaths in 2015.

Dr Gottlieb is interested in partnering with insurers and PBMs to determine if they can reduce the number of pills being dispensed through changing drug labels or requiring additional physician education for long-term prescriptions, according to Bloomberg.

“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,” Dr Gottlieb told Bloomberg. “They’re not in there right now. There’s no information in the drug label about what the appropriate dispensing should be.”

While Dr Gottlieb has changed the focus of the FDA since he took his role in May 2017, the opioid policy has changed the most. Shortly, after he was confirmed as commissioner, the FDA requested that Endo pull Opana ER from the market due to the high risk of misuse and outbreak of hepatitis C virus and HIV related to injection use of the crushed 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,” Dr Gottlieb told Bloomberg.

The FDA will continue to see how prescription drugs are used to determine the best way to go forward, Bloomberg reported.

“It’s like I said on the drug pricing thing, there’s no silver bullet,” Dr Gottleib told Bloomberg. “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.”

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