FDA leaders are calling for a reassessment of the agency’s approach to opioid medications in response to what it calls an “epidemic of opioid misuse, abuse and dependence.”
Announcing a series of actions they say will lead to change, officials said they will also seek guidance from outside experts in the fields of pain management and drug abuse to address the issue. According to the FDA, the agency has asked the National Academy of Medicine to help develop a plan for “opioid review, approval and monitoring that balances the individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.”
The FDA plan also includes the creation of independent advisory committees that include physicians and other experts, to inform on any approval of new opioid drugs that do not contain abuse-deterrent properties. The agency also said it will call a meeting of its standing Pediatric Advisory Committee, which will recommend a labeling system for pediatric use of opioid medications.
“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” Robert Califf, MD, FDA deputy commissioner for medical products and tobacco, said in a press release. “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.”
According to the FDA, drug-overdose deaths are now the leading cause of injury death in the United States, with prescription opioids, heroin and fentanyl being the leading drivers.
The agency’s announcement comes as part of a larger, national campaign against opioid abuse led by HHS. Other aspects of the FDA’s action plan include:
- Changes to immediate-release opioid labeling, including more warnings and safety information;
- drafting an updated risk evaluation and mitigation strategy requirements for opioids;
- expanding access to, and development of, abuse-deterrent formulations in opioid products;
- improving access to naloxone and other treatments for patients with opioid use issues; and
- supporting better options and alternative treatments for pain management.
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Califf said. “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.” – by Jason Laday
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