Lawmakers Question FDA About Opioid Labeling

House Energy and Commerce Committee leaders July 7 sent a letter to the FDA asking why the labels of immediate-release (IR) opioids don’t have the same warnings as extended release and long-acting (ER/LA) opioids.

In 2013, the Food and Drug Administration adopted safety labeling changes for ER/LA opioids, the lawmakers said 176 DER A-4, 9/11/13, 11 PLIR 1102, 9/13/13. At that time, the agency required manufacturers to adopt the most restrictive language that can be found in drug labeling, a “black box” warning about their potential for abuse, the risk of fatal overdose and a warning that maternal use ...