Mikaela Naylon Give Kids a Chance Act of 2025

Key Points

• Congress would broaden when the FDA can require drugmakers to study certain cancer drugs in children, including some drug combinations.
• These required pediatric cancer studies must aim for useful results for kids, including the right drug form for different ages and data on dose, safety, and early signs it works.
• The FDA would have to decide early whether a drug application falls under the pediatric study rules, so companies know expectations sooner in development.
• Health and Human Services would have to publish guidance on how the new pediatric cancer study rules work, and the changes would start 3 years after the law is enacted.
• Congress would extend the rare pediatric disease “priority review voucher” program through September 30, 2030, and change when the voucher user fee is due (when the application is submitted).