Skip Navigation LinksAAPStatementHouseOTCMonographBill

aaa print

AAP Statement on House Passage of Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018

7/17/2018 by: Colleen Kraft, MD, MBA, FAAP, President, American Academy of Pediatrics

​"The American Academy of Pediatrics (AAP) applauds the U.S. House of Representatives for passing the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 (H.R. 5333) yesterday evening. This legislation takes important, long overdue steps to improve the safety and efficacy of over-the-counter (OTC) drugs for children.

"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 rigorous safety and efficacy standards or incorrect assumptions about how adult data should inform the labeling of drugs for children.

"Pediatricians have long been urging Congress to undertake and pass meaningful OTC reform; the legislation passed by the House aims to do just that. The legislation will help FDA improve and modernize OTC medicines for children. The bill would also ensure that FDA has the authority to make certain that product packaging keeps children safe from accidental ingestion of OTC drugs.

"The Academy calls on the U.S. Senate to advance its OTC reform legislation without delay. Children are not little adults; we must take the steps needed to ensure OTC drugs for children are safe and effective."


The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit and follow us on Twitter @AmerAcadPeds.