Give Kids a Chance Act of 2025
Give Kids a Chance Act of 2025
Plain Language Summary
# Give Kids a Chance Act of 2025 - Summary **What It Does:** This bill would make it easier for researchers to conduct clinical trials testing new drug combinations to treat pediatric (children's) cancers. Currently, FDA rules restrict testing new drugs alongside already-approved cancer medications. This bill would relax those restrictions, allowing researchers to combine new drugs with existing approved treatments—either those already standard practice for childhood cancers or drugs approved for adult cancers that target similar biological pathways. The bill also renews the FDA's ability to award "priority review vouchers" to companies developing treatments for rare childhood diseases, which speeds up the approval process. **Who It Affects:** Children with cancer and pharmaceutical companies developing new pediatric cancer treatments would be the primary beneficiaries.
The bill aims to accelerate drug development by removing research barriers while maintaining FDA oversight through required guidance and reporting. **Current Status:** The bill is currently in committee (S 932, 119th Congress), sponsored by Senator Markwayne Mullin (R-OK). It has not yet been voted on by the full Senate. The bill requires the FDA to issue implementation guidance and the Government Accountability Office to report on whether these changes actually improve drug development for childhood cancers.
CRS Official Summary
Give Kids a Chance Act of 2025This bill authorizes certain targeted clinical trials involving combinations of drugs to treat pediatric cancer, and renews the Food and Drug Administration’s (FDA’s) authority to award priority review vouchers (PRVs) to sponsors of new products for rare pediatric diseases.Specifically, the bill modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs used in combination with active ingredients that have already been approved and that (1) have been determined to be part of the standard of care for treating a pediatric cancer, or (2) have been approved to treat an adult cancer and are directed at molecular targets for pediatric cancer.The FDA must issue guidance on the implementation of these provisions and report to Congress on its efforts to ensure implementation. The Government Accountability Office (GAO) must report on the effectiveness of the bill's changes with respect to the development of pediatric cancer drugs.The bill also renews the FDA’s authority to issue PRVs to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029. This is known as the Rare Pediatric Disease PRV program. The program expired in December 2024.GAO must report on the effectiveness of the Rare Pediatric Disease PRV program, including to what extent PRVs were successful in promoting drug development and expediting patient access to drugs for the treatment or prevention of rare pediatric diseases.
Latest Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.