This week the House of Representatives passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 (H.R. 5333) by a voice vote. This legislation makes changes to the over-the-counter (OTC) drug approval process. The current process for the Food and Drug Administration (FDA) to update OTC monographs is cumbersome and complex, making it hard for FDA to keep up with scientific developments, address safety concerns, and accommodate innovation. Much of the pediatric drug labeling included in the OTC monograph was based on evidence that no longer meets today’s standards for safety and efficacy or was based on incorrect assumptions about how adult data should inform the labeling of drugs in children.
Upon passage, AAP President Colleen Kraft issued a statement applauding the House for passing the bill and calling on the Senate to pass its OTC reform legislation without delay.