Food and Drug Administration officials are calling for a sweeping overhaul of the agency’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed.
The initiative focuses on new policies to help reverse the opioid abuse epidemic, while still providing patients in pain with access to effective relief, Dr. Robert M. Califf, FDA deputy commissioner for medical products and tobacco, said in a Feb. 4 announcement.
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” said Dr. Califf, who has been nominated but not confirmed as FDA commissioner. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”
Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.
In a Feb. 4 editorial published in the New England Journal of Medicine, Dr. Califf noted that the number of annual deaths from opioid overdoses now exceeds the number of annual deaths from motor vehicle accidents (doi:10.1056/NEJMsr1601307).
“Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable,” Dr. Califf wrote in the editorial. “As the public health agency responsible for oversight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us.”
Read the full announcement here.
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