S-932 : Still Just a Bill

The "Give Kids a Chance Act of 2025" (S. 932) aims to improve pediatric cancer research and drug development. Here's a breakdown:

• Molecularly Targeted Pediatric Cancer Investigations:
  • The bill amends the Federal Food, Drug, and Cosmetic Act to refine requirements for investigating drugs with molecular targets relevant to pediatric cancers.
  • It allows for studies of drug combinations, especially when one drug is already a standard treatment for pediatric cancer or targets a molecule relevant to pediatric cancer growth.
  • The Food and Drug Administration (FDA) is instructed to issue guidance on implementing these changes.
• Rare Pediatric Disease Priority Review Vouchers:
  • The legislation extends the program that awards priority review vouchers for developing treatments for rare pediatric diseases until September 30, 2029.
  • It modifies the user fee payment structure for these vouchers.
• Reports to Congress:
  • The Secretary of Health and Human Services must report on the implementation of the molecularly targeted pediatric cancer investigation amendments.
  • The Government Accountability Office (GAO) is required to study and report on the effectiveness of both the pediatric cancer drug development requirements and the priority review voucher program.