- The FDA's plan to combat the country's opioid epidemic was announced on Thursday and involves reworking their approach to opioid medications.
- The announcement comes days after President Obama stated he would request $1.1 billion in his 2017 budget plan to address the epidemic.
- Some of the steps the FDA will take in their new approach include: Changing immediate-release opioid labeling, supporting better pain-management options, and improving access to naloxene and medication-assisted treatment options.
“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, said in a prepared statement. “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."
In 2014, opioids, which include oxycodone, hydrocodone, morphine, and heroin, contributed to 28,648 deaths in the U.S., the CDC reported.
Other measures included in the FDA's plan include:
- Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects;
- Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;
- Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;
- Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
- Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products
The FDA is also working with the National Academy of Medicine to develop a framework for opioid review, approval, and monitoring, and with its Pediatric Advisory Committee to make recommendations for a pediatric opioid labeling framework.
The plan falls within the context of a national campaign to combat the epidemic, including an HHS-led initiative.
“Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis,” HHS Secretary Sylvia M. Burwell said in the 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."