Califf, FDA top officials call for sweeping review of agency opioids policies

In response to the opioid abuse epidemic, Robert Califf, MD, FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, has called for a far-reaching action plan to reassess the agency’s approach to opioid medications.

In response to the opioid abuse epidemic, Robert Califf, MD, FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, has 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. FDA will re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects. The agency will also convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. It will assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved. FDA will also develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting opioid analgesics labeling that is currently required. Additionally, it plans to Improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders. "We are determined to help defeat this epidemic through a science-based and continuously evolving approach," said Califf. "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."