Mikaela Naylon Give Kids a Chance Act

[AI summary unavailable — showing source text] Give Kids a Chance Act of 2025 This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research.  Specifically, the bill modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs in combination with active ingredients that have already been approved, provided certain conditions are met; permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirement; renews the FDA’s authority to award priority review vouchers to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029; and reauthorizes through FY2027 certain funding for the National Institutes of Health to support priority pediatric research.  The bill also provides statutory authority for the FDA’s interpretation of the orphan drug exclusi…