Bill > S3302

This bill, called the Mikaela Naylon Give Kids a Chance Act of 2025, aims to improve pediatric cancer drug research and development by modifying existing FDA regulations. The bill makes several key changes to how the FDA handles drug applications for molecularly targeted pediatric cancer treatments, including expanding the types of investigations that can be required for new drug applications. Specifically, the bill allows the FDA to require pediatric cancer investigations for drugs that can be used in combination with existing cancer treatments, either those already approved for adult cancers or those considered standard of care for pediatric cancers. The investigations must be designed to provide meaningful data about dosing, safety, and preliminary effectiveness for different pediatric age groups. The bill also extends the authority to issue priority review vouchers for rare pediatric disease treatments until September 30, 2030, and requires the Government Accountability Office (GAO) to conduct a comprehensive study on the effectiveness of these vouchers in stimulating drug development for rare pediatric diseases. Additionally, the bill mandates that the Secretary of Health and Human Services issue guidance on implementing these changes within 12 months and submit a report to Congress within 6 years detailing efforts to implement the new regulations.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3302/all-info