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119-s-932119th CongressWALLET

Give Kids a Chance Act of 2025

Sponsored By: Senator Mullin, Markwayne [R-OK-2]

Introduced

Summary

The Give Kids a Chance Act of 2025 would _accelerate pediatric cancer drug development_ by clarifying when molecularly targeted pediatric investigations may be required, extending the rare pediatric disease priority review voucher program, and forcing FDA guidance plus multi-year oversight reviews.

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  • Families and children: Would push drug sponsors to generate age-appropriate formulations and pediatric data on dosing, safety, and early efficacy to support pediatric labeling. The pediatric study rules would apply to applications submitted three years after enactment.
  • Drug developers: Would let FDA require studies of the submitted product alone or in combination with certain approved adult cancer drugs. Required combinations are limited to either a single new active ingredient or multiple ingredients already approved for adult cancers and FDA may ask for preclinical results with the initial pediatric study plan.
  • Voucher program and oversight: Would extend the rare pediatric disease priority review voucher program to September 30, 2029 and require the voucher user fee when the voucher is used at application submission. It also mandates Comptroller General (GAO) studies and a GAO findings report to Congress to assess program effects five years after enactment.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 0 costs, 2 mixed.

New pediatric cancer study rules

This bill would let FDA require molecularly targeted pediatric cancer studies on a drug alone or in set drug combinations. Studies would have to use age-appropriate formulations and produce data on dosing, safety, and early effectiveness to inform pediatric labeling. The FDA must say which rule applies before a sponsor files its initial pediatric study plan. The FDA could also require preclinical study results with that plan. The new rules would apply to applications filed three years after enactment. If enacted, this could speed pediatric evidence but also add study requirements and workload for drug makers.

Rare pediatric drug voucher changes

This bill would extend the rare pediatric disease priority review voucher program through September 30, 2029. It would also require the priority review user fee to be paid when a drug application using a voucher is submitted. GAO would study the PRV program and report findings within about five years. If enacted, the extension preserves an incentive for developers but earlier fee timing could affect sponsors' cash flow.

Sponsors & CoSponsors

Sponsor

Mullin, Markwayne [R-OK-2]

OK • R

Cosponsors

  • Sen. Bennet, Michael F. [D-CO]

    CO • D

    Sponsored 3/11/2025

  • Sen. Klobuchar, Amy [D-MN]

    MN • D

    Sponsored 4/4/2025

  • Sen. Shaheen, Jeanne [D-NH]

    NH • D

    Sponsored 4/4/2025

  • Sen. Marshall, Roger [R-KS]

    KS • R

    Sponsored 4/4/2025

  • Sen. Scott, Rick [R-FL]

    FL • R

    Sponsored 4/8/2025

  • Sen. Collins, Susan M. [R-ME]

    ME • R

    Sponsored 4/8/2025

  • Sen. Coons, Christopher A. [D-DE]

    DE • D

    Sponsored 10/23/2025

  • Sen. Capito, Shelley Moore [R-WV]

    WV • R

    Sponsored 10/23/2025

  • Sen. Kelly, Mark [D-AZ]

    AZ • D

    Sponsored 10/23/2025

  • Sen. Husted, Jon [R-OH]

    OH • R

    Sponsored 10/23/2025

  • Sen. Kim, Andy [D-NJ]

    NJ • D

    Sponsored 10/23/2025

  • Sen. Sheehy, Tim [R-MT]

    MT • R

    Sponsored 10/23/2025

  • Sen. Moody, Ashley [R-FL]

    FL • R

    Sponsored 10/30/2025

  • Sen. Hickenlooper, John W. [D-CO]

    CO • D

    Sponsored 10/30/2025

  • Sen. Duckworth, Tammy [D-IL]

    IL • D

    Sponsored 11/6/2025

  • Sen. Boozman, John [R-AR]

    AR • R

    Sponsored 11/6/2025

  • Sen. Schiff, Adam B. [D-CA]

    CA • D

    Sponsored 11/18/2025

  • Sen. Kennedy, John [R-LA]

    LA • R

    Sponsored 11/18/2025

  • Sen. Reed, Jack [D-RI]

    RI • D

    Sponsored 11/18/2025

  • Sen. Schmitt, Eric [R-MO]

    MO • R

    Sponsored 11/19/2025

Roll Call Votes

No roll call votes available for this bill.

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