Give Kids a Chance Act of 2025

The Give Kids a Chance Act of 2025 would modify how the FDA approves new pediatric cancer treatments by allowing researchers to test new drugs in combination with already-approved medications. Currently, researchers face restrictions when combining new drugs with existing treatments. This bill would permit such combinations if the existing drug is already standard care for a pediatric cancer or is an approved adult cancer treatment targeting the same molecular pathways as the pediatric disease. The FDA would be required to issue guidance on these changes and report to Congress on implementation efforts.

The bill would also renew the FDA's Rare Pediatric Disease Priority Review Voucher program, which expired in December 2024. This program incentivizes pharmaceutical companies to develop treatments for rare pediatric diseases by awarding vouchers that speed up FDA review of future drug applications. The renewal would extend the program through September 30, 2029. The Government Accountability Office would be required to evaluate how effectively these changes promote pediatric cancer drug development and whether the voucher program successfully encourages companies to create treatments for rare pediatric diseases.

If enacted, this bill would aim to accelerate the development and availability of new pediatric cancer treatments by reducing regulatory barriers to combination drug research and maintaining financial incentives for companies to develop therapies for rare childhood diseases. The bill is currently in its early stages and has not yet advanced to committee review.