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 The leading web portal for pharmacy resources, news, education and careers October 23, 2017
Pharmacy Choice - Pharmaceutical News - AAP Responds to FDA Reauthorization Act of 2017 as Passed by House Subcommittee - October 23, 2017

Pharmacy News Article

 5/19/17 - AAP Responds to FDA Reauthorization Act of 2017 as Passed by House Subcommittee

WASHINGTON, May 18 The American Academy of Pediatrics issued the following news release:

The FDA Reauthorization Act of 2017 (H.R. 2430) passed today by the U.S. House of Representatives Energy and Commerce Health Subcommittee to reauthorize U.S. Food and Drug Administration (FDA) user fees is a missed opportunity for children. The House vote comes one week after the U.S. Senate Committee on Health, Education, Labor and Pensions passed its own version of user fee reauthorization legislation. The two bills now must advance to the floors of their respective chambers and eventually be reconciled.

While the Academy appreciates the long-standing history of bipartisan support for consideration of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) as part of user fee reauthorization legislation, the bill passed today fails to make needed improvements to these essential laws.

"Children are not just little adults; medical devices and medications work differently in children and must be studied specifically for their use," said AAP President Fernando Stein, MD, FAAP. "The bill passed today misses critical opportunities to ensure that all drugs used in children are studied in children, to advance appropriate and safe medical devices available for children, and to strengthen FDA's pediatric expertise."

The FDA Reauthorization Act of 2017 (H.R. 2430) also fails to address the following AAP priorities:

* Ensure that drugs for rare diseases can be required to be studied in children under PREA despite their status as orphan drugs.

* Empower FDA to apply PREA to molecularly targeted drugs, which are now mainstay of new drug development for cancer, including in children.

* Revise FDA's over-the-counter (OTC) drug monograph system so FDA can better keep up with scientific developments, address safety concerns, and accommodate innovation.

* Continue building upon efforts to improve pediatric medical and surgical devices for children through the inclusion of the Pediatric Device Development Act.

"As we evolve our understanding of the best ways to treat devastating diseases, we must ensure that children can benefit from cutting-edge technology and life-saving medical innovations," said Dr. Stein. "As the FDA user fee bill advances, the Academy looks forward to working with members of Congress and FDA to make sure that children are not forgotten."

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

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