FDA Rethinks Opioid Approach Amid Drug Abuse Epidemic

The FDA today announced that it's taking a hard look at how it's addressing the opioid abuse epidemic.

Robert Califf, MD, the FDA’s deputy commissioner for medical products and tobacco, and other FDA leaders said their goal is to implement changes to curb opioid abuse, while also being sensitive to patients’ legitimate pain needs.

Some of the areas that the FDA will explore are the “risk-benefit paradigm for opioids,” as well as better pain management options, including alternative therapies.

In addition, the FDA will consult an advisory committee prior to approving a new drug application for an opioid without abuse-deterrent properties. Another committee will examine pediatric opioid labeling before any new labeling is approved.

For immediate-release opioid labeling, the FDA hopes to include additional warning and safety information.

Following committee recommendations and a review of existing requirements, the FDA said it also aimed to update its Risk Evaluation and Mitigation Strategy requirements for opioids.

The FDA will also work toward expanding access to naloxone and abuse-deterrent formulations of products.

One additional goal is to strengthen the requirements for drug companies to provide data on the long-term impact of using opioids, which the FDA suggested could lead to a better understanding of opioid misuse, abuse, overdose, and death.

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

The FDA noted that fatal drug overdoses are the leading cause of injury death in the nation.