FDA Announces Significant Changes to Opioid Prescribing Guidelines

The US Food and Drug Administration recently announced in an article that it is reassessing the agency’s approach to opioid medications. In a New England Journal of Medicine article titled, “A Proactive Response to Prescription Opioid Abuse,” the agency expressed deep concern about what it called the “growing epidemic of opioid abuse, addiction, and overdose—an epidemic directly related to the increasingly widespread misuse of powerful opioid pain medications.”

The shift is, in part, due to drug overdose epidemic in this country, which is driven by both prescription opioids and illegal drugs—many of which are made from drugs such as fentanyl and other opioids.

While the agency pledged to protect “appropriate access to vitally important pain medications for the patients who need them,” the shift in policy announced yesterday will undoubtedly raise concerns among pain practitioners that the often under-treated pain epidemic will suffer a further blow. The plan will focus on reversing the epidemic without limiting access. How? Among other things, the policy shift aims to:

• 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
• Work closely with its own Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved
• Take a particularly close look at immediate-release opioid labeling, including additional warnings and safety information for patients and practitioners
• Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements
• Encourage manufacturers to continue to pursue abuse-deterrent formulations of opioid products
• Continue to look into alternatives to opioids for pain patients.

“As physicians, we have treated both the intense suffering caused by acute pain and chronic pain with all its exhausting and debilitating consequences,” the authors noted. “But we have also witnessed the devastating results of opioid misuse and abuse, such as the addiction of patients who have been prescribed opioids for pain treatment and, increasingly, diversion to people for whom the prescription was not written. Many Americans are now addicted to prescription opioids, and the number of deaths due to prescription opioid overdose is unacceptable. This past month, our sister agency, the Centers for Disease Control and Prevention (CDC), estimated that in 2014 there were almost 19,000 overdose deaths in the United States associated with prescription opioids.”