CDC and FDA take new approach toward opioid addiction

Accreditation Insider, February 9, 2016

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The Centers for Disease Prevention and Control (CDC) and the Food and Drug Administration (FDA) have both announced changes to their policies regarding prescription opioids. The agencies hope their changes will slow down the opioid epidemic in America, with 44 people dying every day due to a prescription opioid overdose.

The CDC announced that its draft opioid guidelines had passed a review conducted by the National Center for Injury Prevention and Control’s Board of Scientific Counselors (NCIPC), with only minor changes to the language. The guidelines had been released in early December and recommended finding non-opioid pain treatments and lowering opioid dosages to lower addiction rates.

However, the CDC was forced to put the guidelines on hold within days of their release. Several healthcare professionals and patient groups expressed fears that the guidelines were too restrictive and would be an additional burden on pain-care patients. Some also took issue with the CDC’s drafting process, claiming the guidelines were based on weak evidence and “secretive” review processes.

Read our previous post on the guidelines to learn more about the key points of the CDC guidelines.

On February 4, FDA commissioner nominee Robert Califf released a new policy paper in The New England Journal of Medicine, reassessing the agency’s approach towards opioids. The paper encourages the use of tougher warning labels, improving pain and addiction treatments, and expanding abuse-deterrent medicine use.

“Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents," Califf and coauthors Janet Woodcock, MD, and Stephen Ostroff, MD, said in a press release. "Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable. As the public health agency responsible for oversight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us."

The FDA has already enlisted the help of the National Academy of Medicine to develop a framework for opioid review, approval, and monitoring and is asking other pain management and drug abuse experts to join the effort. With the policy changes, the FDA says it will:

•    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
•    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 those of the extended-release/long-acting opioid analgesics labeling that is currently required
•    Update risk evaluation and mitigation strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements
•    Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products
•    Improve access to naloxone and medication-assisted treatment options for patients with opioid-use disorders
•    Support better pain-management options, including alternative treatments

Update: the FDA has just released its new Opioid Action Plan fact sheet, detailing the agency’s policy changes and the outcomes it hopes will result. Read more about the changes here.

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