FDA Chief plans regulatory overhaul to tackle US opioid crisis

pharmafile | July 25, 2017 | News story | Manufacturing and Production, Sales and Marketing FDA, Scott Gottlieb, biotech, drugs, healthcare, opioid, pharma, pharmaceutical 

The US faces an ongoing crisis in opioid dependency, and FDA Commissioner Scott Gottlieb is prepared to employ unusual tactics to tackle the problem. In an unorthodox move for the organisation, Gottlieb hopes to facilitate cooperation with health insurers and pharmacy benefit managers in a bid to limit the level of exposure citizens have to opioid medications.

“Most people who become addicted to opioids are medically addicted,” Gottlieb explained. “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.”

He plans to meet with these bodies in September – his first official meetings with healthcare companies – in order to discuss ways to limit exposure to opioid medications. This includes reducing the amount of pills dispensed, potentially achieved through modifying drug labels or by limiting longer prescriptions to only be given by doctors. Gottlieb himself noted: “There shouldn’t be 30-day prescriptions for a tooth extraction, or 30-day prescriptions for a hernia repair.”

Gottlieb has taken it upon himself to address the problem in the country. In 2015, 23,000 people died as a result of opioid pain pill overdoses – twice as many as ten years previously. The problem stems both from current access for prescribed patients as well as those who are addicted or use the medicines illicitly.

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

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

Matt Fellows

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