In response to the opioid abuse epidemic, particularly the rash of prescription painkiller addiction and overdoses, the U.S. Food and Drug Administration (FDA) is finally taking action. Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, announced a far-reaching action plan to reassess the agency’s approach to opioid medications. While doing their best to reverse the epidemic partially brought on by past FDA policies, the agency will also make sure patients have access to effective pain relief.
When the history of the prescription painkiller abuse epidemic is examined, two damaging FDA mistakes will be highlighted. Both mistakes are related to the FDA’s unwillingness to insist on abuse-deterrent formulations in opioid regimens approved by the agency. The first mistake was the approval of OxyContin in 1995 without an abuse-deterrent formulation. This mistake was not fixed until 2011.
The second mistake was the 2013 approval of Zohydro, an opioid referred to as “OxyContin on steroids” by Vermont Governor Peter Shumlin, without an abuse deterrent formulation. The FDA ignored a negative recommendation by their handpicked advisory panel.
Responding to President Obama’s recent opioid initiatives, the FDA clearly is taking action to fall in line with the program. As one of the cornerstones of their new plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. They will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.
The bigger question is, why are new opioid prescription medications without abuse-deterrent formulations even being considered?
As part of their new opioid action plan, the FDA will:
• 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;
• Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
• Improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders; and
• Support better pain management options, including alternative treatments.
The so-called action plan by the FDA seems to be another government example of too little, too late. Many of their action plan items previously have been part of the FDA’s requirements for opioid drug approvals. Rather than offering something new, it feels like the FDA is saying that they finally will follow their own rules. Given the power of the pharmaceutical lobby, it will be fascinating to see if these words and promises actually become substantive change.