NCHR Testimony at the FDA about Pediatric Labeling for Butrans

September 14, 2017. It is important for this panel and the FDA to make decisions about drug labeling based on good science and strong data. We concur with the 2016 Advisory Committee that because pediatric patients are vulnerable to drug use and addiction due to ongoing brain development; proper prescribing, patient selection, and education are crucial to optimize safety in this population. Results of Study 3031 do not provide sufficient evidence to inform health care providers about the safe use and proper dosing of Butrans in the management of pain for pediatric patients. We urge this Advisory Committee to advocate for pediatric patient safety and urge the FDA to require that the drug be appropriately evaluated before allowing information about Butrans to the pediatric section of the labeling.

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