FDA panel calls for overhaul of opioid policies

FDA panel calls for overhaul of opioid policies
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Dozens of advisers to the Food and Drug Administration on Wednesday unanimously called for the agency to rethink its approach to opioid abuse amid a worsening epidemic nationwide.

Thirty leading medical experts voted Wednesday to recommend changes to the FDA’s existing rules on opioids, which have not been updated since the agency approved the policy in 2012.  


While the advisory committee members were not asked to endorse specific changes to the FDA, most made clear that they wanted the agency to take a far more aggressive approach to curbing addiction.

Nearly all members called for mandatory training for physicians who prescribe opioids — a move that has been highly contentious between industry and doctor groups.

Members also said the FDA should broaden its oversight of fast-acting drugs like Percocet and Vicodin, rather than focusing solely on extended-release drugs, which are considered more dangerous.

The vote, which took place Wednesday afternoon, capped a two-day joint meeting of two FDA advisory committees that deal with drug abuse.

The FDA will now decide whether to take up the recommendation, which could mark the agency’s most dramatic change yet to its approach to opioids.

Under the FDA’s current approach to opioids, all manufacturers are required to create a “Risk Evaluation and Mitigation Strategy” to demonstrate they’re working to limit abuse of their drugs.  

Outside advisers have previously criticized the FDA's opioids requirements as outdated and ineffective, but the agency has rejected previous recommendations.

Still, some advocates see hope in 2016: With political pressure nearing a breaking point, many believe the FDA is now willing to consider changes.  

The entire Obama administration has faced mounting pressure to take action on opioids, and the FDA has faced a brunt of the criticism for its more cautious and slow-moving approach.