The FDA plans to make stark changes to its opioid policies in response to the opioid abuse epidemic, according to Medscape.
Here are five highlights:
1. Robert Califf, MD, FDA deputy commissioner for medical products and tobacco, said the FDA will continue to fight this epidemic through a science-based, evolving approach.
2. The FDA's multicomponent plan seeks to focus on policies as well as provide patients effective medication.
3. The agency plans to:
• Reassess the risk-benefit paradigm for opioids and understand their public health effects
• Consult an expert advisory committee before approaching any new drug application for opioid lacking abuse-deterrent properties
• Assemble and consult with the Pediatric Advisory Committee about pediatric opioid labeling framework prior to any new labeling gaining approval
• Create changes to immediate-release opioid labeling
4. The FDA asked the National Academy of Medicine to help create a framework for opioid review, approval and monitoring that takes into account an individual's need for pain control as well as the wider public health consequences of opioid abuse.
5. The agency plans to impose stricter requirements for pharmaceutical companies to produce postmarked data on the long-term impact of using opioids.
"Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis," U.S. Health and Human Services Secretary Sylvia M. Burwell said in the news release. "The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS."
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