Facing a national opioid abuse epidemic, the U.S. Congress is asking federal agencies to review their specific procedures and action plans on the issue. “Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” said U.S. Food and Drug Administration (FDA) Commissioner Robert Califf. “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.” 

Working with a variety of experts, the FDA will re-examine its procedures and offer new recommendations. Actions include:

  • Expand use of advisory committees. 
  • Develop warnings and safety information for immediate-release (IR) opioid labeling. 
  • Update Risk Evaluation and Mitigation Strategy (REMS) Program. 
  • Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. 
  • Support better treatment. 
  • Reassess the risk-benefit approval framework for opioid use.

With more than 14 million U.S. citizens living with cancer, there is some concern in the oncology community that stricter procedures and guidelines will cut off necessary pain medications from patients who benefit from them to manage chronic pain. 

Chronic pain is a common side effect for patients living after cancer, as well as those currently undergoing treatment. By including for patients with cancer in recommended guidelines, clinicians will be better informed as they work to curb the epidemic without impacting those patients whose quality of life is dependent on chronic pain management and mitigation.