S. 932: Give Kids a Chance Act of 2025

This bill, titled the Give Kids a Chance Act of 2025, aims to amend existing laws regarding pediatric cancer treatments and drug development. The main points of the bill are as follows:

Research on Pediatric Cancer Treatments

The bill proposes enhancements to the Federal Food, Drug, and Cosmetic Act to streamline and improve the investigation of molecularly targeted cancer therapies specifically for children. Key amendments include:

• Molecularly Targeted Pediatric Investigations: The bill introduces a clearer framework for studies aimed at pediatric populations involving specific drugs and their combinations, particularly those that are considered standard care for treating pediatric cancers.
• Data Collection Requirements: Investigations must be designed to collect clinically meaningful data regarding dosing and safety for different age groups to support appropriate pediatric labeling of medications.
• Application Specifics: New guidelines will detail the requirements for drug applications, ensuring that preclinical studies relevant to pediatric treatment plans are submitted alongside applications for pediatric investigations.

Implementation and Guidance

The Secretary of Health and Human Services is tasked with providing guidance on implementing the amendments. This guidance must be drafted within 12 months of the bill's enactment and finalized shortly thereafter.

Extended Authorities for Drug Review Vouchers

The bill extends the authority to issue priority review vouchers for treatments related to rare pediatric diseases for an additional period until September 30, 2029. These vouchers incentivize drug development by allowing expedited review processes for qualifying drugs.

Evaluation and Reporting

• Impact Assessment: A study will be conducted within eight years to evaluate the effectiveness of the current laws in promoting pediatric drug development for cancers and rare diseases, focusing on both benefits and burdens.
• Congressional Reports: The Secretary must report to Congress on the implementation process and other studies regarding the priority review vouchers and their effects on drug development in the pediatric category.

Applicability of Amendments

The new rules will apply to drug applications submitted three years after the bill becomes law, ensuring time for adjustment to the new regulations.

Relevant Companies

None found.