Washington, DC – The FDA Reauthorization Act of 2017 (H.R. 2430), passed today by voice vote in the U.S. House of Representatives. The bill, which reauthorizes U.S. Food and Drug Administration (FDA) user fees, also makes changes to and reauthorizes expiring portions of key pediatric drug and medical device laws, including the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). The Senate version of the bill awaits consideration by the full chamber.
The FDA Reauthorization Act of 2017 includes needed extensions of programs that benefit children, which will give FDA the authority to ensure appropriate pediatric labeling of drugs and biologics. Importantly, the bill includes changes that will facilitate more labeling of drugs used to treat children with cancer under PREA. However, this provision only relates to pediatric cancer, and does not update PREA so that all children with rare diseases can benefit from medical and scientific advancements, as AAP urged. In addition, a provision to close an orphan drug loophole so that companies cannot use a pediatric-specific orphan drug designation as a means to be exempted from pediatric study requirements was not included.
"The FDA user fee bill passed by the House today represents meaningful progress for children with cancer but is a missed opportunity to strengthen BPCA and PREA, especially for children with other rare diseases," said AAP President Fernando Stein, MD, FAAP. "While the Academy welcomes the outcome that children battling cancer will now benefit from new pediatric drug options, we regret that children suffering from other rare diseases will not have the same opportunity."
The FDA Reauthorization Act of 2017 reauthorizes key pediatric medical device provisions through the inclusion of parts of the Pediatric Device Development Act (S. 1093) but much more work must be done to improve the availability and labeling of medical devices for children. Unfortunately, the House bill also does not revise FDA's over-the-counter drug monograph system so the agency can better keep up with scientific developments, address safety concerns, and accommodate innovation. The Academy will turn to the Senate to find a way forward on these needed improvements to drugs and devices for children as it considers legislation.
"As we evolve our understanding of the best ways to treat diseases, we must ensure that children can benefit from therapies and treatments," said Dr. Stein. "As the FDA user fee bill advances, the Academy thanks Rep. Anna Eshoo (D-Cali.) for her leadership, and urges the U.S. Senate to improve upon the House bill so that it better meets the needs of all children."
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 www.aap.org and follow us on Twitter @AmerAcadPeds.