In response to the opioid abuse epidemic, Dr. Robert Califf, the Food and Drug Administration’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
The FDA will:
- 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; and
- Support better pain management options, including alternative treatments.
As one of the cornerstones of this plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academies of Sciences, Engineering, and Medicine to help develop a framework for opioid review, approval and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.
“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” Califf said in a news 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.”