Mikaela Naylon Give Kids a Chance Act
The Give Kids a Chance Act of 2025 strengthens requirements for pharmaceutical companies to study their cancer drugs in children when those drugs target molecular pathways relevant to pediatric cancers. The bill expands the FDA's authority to require pediatric cancer investigations for new drugs, including certain drug combinations, and establishes clearer enforcement mechanisms for companies that fail to complete required pediatric studies. Additionally, the legislation extends the rare pediatric disease priority review voucher program through 2029, clarifies orphan drug exclusivity rules, establishes an FDA office in an Abraham Accords country to facilitate international regulatory cooperation, and makes several reforms to the organ transplantation system.
Key Points
- 1Requires molecularly targeted pediatric cancer investigations for new cancer drugs that target pathways relevant to childhood cancers, including certain combination therapies with standard-of-care treatments or previously approved drugs
- 2Strengthens enforcement by making companies subject to penalties under Section 303 of the Federal Food, Drug, and Cosmetic Act if they demonstrate a lack of "due diligence" in completing required pediatric studies
- 3Extends the rare pediatric disease priority review voucher program through September 30, 2029, which provides incentives for developing treatments for rare childhood diseases
- 4Clarifies that orphan drug exclusivity applies only to the specific approved use or indication, not the entire disease or condition, potentially allowing more competition
- 5Authorizes $25 million annually for fiscal years 2025-2027 for the pediatric drug studies program