On March 22, 2016, the US Food and Drug Administration (FDA) issued a safety announcement that includes required labeling changes for immediate-release (IR) opioid pain medication (and the entire class of opioid drugs) and recommendations and information for patients and health care professionals. The FDA’s new safety warnings and required labeling changes come shortly after the Senate unanimously passed Senate Bill 483 (114th Congress) on March 17, 2016 requiring greater federal oversight of opioid prescribing practices.
Most notably, the FDA is requiring a new “black-box” warning on approved opioid drug and biological products to include a description of the risks associated with opioid drug misuse and abuse. Specifically, the FDA will require that the boxed warning address the risks associated with addiction, abuse and misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, and, where appropriate, product-specific drug interactions with potentially adverse effects.
The FDA also issued a labeling template and draft letter to New Drug Application (NDA) holders that include model language reflecting the safety labeling changes. Companies holding NDAs for opioid drugs should anticipate and heed these changes, which are forthcoming.
*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.