Advocacy Update

April 18, 2019: Advocacy spotlight on FDA and CDC issue clarifications on opioid prescribing guidelines


The Centers for Disease Control and Prevention (CDC) issued a clarification that its 2016 CDC Guideline for Prescribing Opioids for Chronic Pain "does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm." The CDC letter (PDF) highlighted that it is currently supporting multiple research projects to evaluate the impact of the CDC Guideline, including whether it has led to unintended consequences. The CDC letter highlighted that its recommendations on opioid dose strength "focuses on initiation."

The AMA continues to advocate against the misapplication of CDC guideline by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients' medical access to opioid analgesia.

In a separate move, the U.S. Food and Drug Administration (FDA) issued a statement indicating it will provide updated labeling information regarding opioid analgesic tapering.

"With overdoses and deaths continuing to plague communities across the country, the AMA welcomes the FDA's decision to include tapering guidance on the labels of prescription opioids," said AMA President Barbara L. McAneny, MD. "This patient-centric approach will encourage discussions between patients and physicians on whether a decrease in dose or discontinuation of the opioid is the best approach. If so, the patient and physician should discuss how to safely decrease dosages. The FDA notes that there is no standard tapering schedule suitable for all patients. The right approach depends on conversations between patients and physicians, including a decision to maintain the patient on a current dose if the benefits outweigh the risks."