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AAP Statement on Senate Passage of the FDA Reauthorization Act of 2017

8/3/2017 by: Fernando Stein, MD, FAAP, President, American Academy of Pediatrics

"Today's Senate passage of the FDA Reauthorization Act of 2017 is a missed opportunity to ensure all children, especially children with rare diseases, benefit from medications studied in and labeled for their use. The bill, which reauthorizes U.S. Food and Drug Administration (FDA) user fees and contains provisions related to pediatric drugs and devices, failed to make improvements to the recently-passed House bill.

"The bill makes meaningful progress for children with cancer by including changes that will facilitate more labeling of drugs used to treat that disease, but misses an opportunity to allow all children with rare diseases to benefit from medical and scientific advancements, as AAP urged. Since the majority of rare diseases occur in childhood, the orphan exemption has a profound effect on children's health. The Academy now calls on FDA to address the exemption of drugs to treat rare pediatric diseases.

"Unfortunately, meaningful reform to the FDA's over-the-counter (OTC) drug monograph system was unable to be included in the legislation. The current process for 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. The Academy urges Congress to pass meaningful OTC reform reflecting the principles that pediatricians and others in the medical provider and public health community have identified.

"As we evolve our understanding of the best ways to treat devastating diseases, we must ensure that children are not forgotten. That means we need to support pediatric research to determine the safety and efficacy of drugs and devices in children so that they can benefit from cutting-edge technology and life-saving medical innovations."


The American Academy of Pediatrics is an organization of 66,000 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.