FDA Announces New Measures to Curb Opioid Overdose

The US Food and Drug Administration (FDA) this week announced a new plan to refocus its efforts on curbing opioid-related deaths.

There were 18 893 deaths involving prescription opioids in the US in 2014, up 16% from 2013, according to the National Center for Health Statistics (NCHS). The administration believes synthetic opioids contributed to the increase in prescription opioid-related deaths. Deaths involving drugs like fentanyl and tramadol increased by 79% from 2013-2014.

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Dr Robert Califf, MD, the FDA’s deputy commissioner for Medical Products and Tobacco, along with other leaders from the agency, called for additional policy initiatives to address the country’s epidemic.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” he said in a 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.”

The FDA’s new “far-reaching action” plan to address opioid-related overdoses will zero in on the following:

• 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.
• Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required.
• 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.
• Improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders.
• Support better pain management options, including alternative treatments.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence,” Dr Califf said.

The agency expects to provide updates to the public on an ongoing basis.

Reference

Califf, FDA top officials call for sweeping review of agency opioids policies. US Food and Drug Administration (FDA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm484765.htm. Accessed February 5, 2016.