Scott Gottlieb, MD, commissioner of the Food and Drug Administration, plans to meet with insurance administrators and pharmacy benefit managers in September to see if the organizations can help reduce the amount of opioids dispensed in the U.S., according to Bloomberg.
Dr. Gottlieb told Bloomberg the possible collaboration could result in alterations to drug labels or additional physician education requirements for longer prescriptions. As a drug regulator, the FDA typically does not work with PBMs and insurers, which are overseen by state regulators and other HHS departments.
"There shouldn't be 30-day [opioid] prescriptions for a tooth extraction, or 30-day prescriptions for a hernia repair," Dr. Gottlieb told 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. They're not in there right now. There's no information in the drug label about what the appropriate dispensing should be."
Since his confirmation in May, Dr. Gottlieb has made the opioid epidemic one of the FDA's top priorities. Under his leadership, the federal agency has proposed new opioid prescribing rules for providers and issued a withdrawal request to Endo International to remove its opioid painkiller Opana ER from the market. The move marked the first time the FDA issued such a request for an opioid due to public health concerns. On July 6, Endo announced it would voluntarily recall the product.
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