Mikaela Naylon Give Kids a Chance Act of 2025

The Mikaela Naylon Give Kids a Chance Act of 2025 proposes to expand the types of clinical trials allowed for childhood cancer treatments. Specifically, it would permit researchers to study new drugs used in combination with existing treatments that are already considered the standard of care or are approved for adult cancers. This change aims to help doctors find more effective ways to treat pediatric cancers by testing how new therapies work alongside established medicines, rather than testing them in isolation.

Additionally, the bill would restart and extend the Rare Pediatric Disease Priority Review Voucher program through September 30, 2030. This program, which expired in late 2024, provides a special voucher to drug companies that successfully develop treatments for rare childhood diseases. These vouchers can be used to speed up the FDA review process for a future drug or can be sold to other companies, creating a financial incentive for pharmaceutical firms to invest in medicines for small populations of sick children. The bill also requires government audits to ensure these programs are effectively improving patient access to life-saving treatments.