FDA Renews Efforts to Stem Epidemic of Prescription Opioid Abuse

News in Context |
February 8, 2016

FDA Renews Efforts to Stem Epidemic of Prescription Opioid Abuse

  1. Amy Orciari Herman, Physician's First Watch

But how will the agency accomplish its objectives?

  1. Amy Orciari Herman, Physician's First Watch

The FDA is renewing its efforts to “deal aggressively with opioid misuse and addiction” in the U.S. and at the same time “protect the well-being of people experiencing the devastating effects of acute or chronic pain.”

In a special report in the New England Journal of Medicine, FDA leaders outline steps the agency is taking toward those ends. Among them:

  • The agency will reexamine its current policies on opioid regulation. The FDA will work with the National Academy of Medicine (formerly the Institute of Medicine) to “develop a regulatory framework for opioid review, approval, and monitoring that balances individual need for pain control with considerations of the broader public health consequences of abuse and misuse.”

  • The FDA will reexamine current opioid labeling and require manufacturers to conduct more extensive postmarketing research.

  • The agency will encourage the development of better abuse-deterrent formulations, as well as prioritize the development of nonopioid pain medications.

  • Two upcoming sessions of the FDA's Pediatric Advisory Committee will examine prescription opioid use in children.

Comment — Psychiatry

  1. Peter Roy-Byrne, MD

This special report is a good start but does not provide much information for clinicians beyond the concept that the FDA will be trying to make some changes in how opioids are approved, labeled, and prescribed. The important question remains: How will the agency accomplish these objectives? The key is providing non-medication alternatives to manage chronic pain, but these alternatives are both more costly to the healthcare system and less palatable to pain sufferers who experience rapid relief of pain and dysphoria with initial opioid treatment, but often find these beneficial effects are quickly lost and result in escalation of dosages. Even then, these higher doses are usually less effective, are required to treat hyperalgesia from the chronic use of opioids, and are frequently accompanied by problematic effects on mood, cognition, motivation, and emotion regulation. To accomplish the complex change to an emphasis on non-medication approaches to pain treatment, incentives for physicians, payers, and patients would have to be quite powerful.

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