United States 119th Congress Status: In Committee Bipartisan · 20 D · 18 R cosponsors

S 3302 — Mikaela Naylon Give Kids a Chance Act of 2025

Last action — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill is in committee in the Senate. Introduced December 02, 2025. It must pass committee before a floor vote.

Next likely step: a committee vote, then a floor vote in the Senate.

Prognosis

Advancing 42% · moderate confidence

Where this bill stands today.

Odds of enactment

Low

How often bills like it became law.

  • In Committee

    Current position in the legislative process.

  • 38 sponsors

    1 primary, 37 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (20 D · 18 R) — cross-party backing.

Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.

Summary

Mikaela Naylon 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, 2030. 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.

Bill Text

How this bill changes current law

5 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends existing law to clarify and enhance the requirements for molecularly targeted pediatric cancer investigations and extends the authority for issuing priority review vouchers for rare pediatric diseases.

  • 21 U.S.C. 355c(a)(3)

    subparagraph (A) → (A) In general.--For purposes of paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of-- (i) the drug or biological product for which the application referred to in such paragraph is submitted; or (ii) such drug or biological product used in combination with-- (I) an active ingredient of a drug or biological product-- (aa) for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and (bb) that is determined by the Secretary, after consultation with the applicant, to be part of the standard of care for treating a pediatric cancer; or (II) an active ingredient of a drug or biological product-- (aa) for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and (bb) that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.

    This change clarifies the criteria and circumstances under which molecularly targeted pediatric cancer investigations must be conducted.

  • 21 U.S.C. 355c(e)(1)

    The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) applies with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A). → The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) applies with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).

    This provision will allow for clear determination of applicable requirements for applications related to pediatric drug studies.

  • 21 U.S.C. 355c(a)(1)

    No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B). → No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B).

    This rule of construction clearly delineates the applicability of different investigative requirements based on the application type.

  • 21 U.S.C. 360ff(b)(5)

    December 20, 2024, unless → September 30, 2030.

    The extension of the prior authority for priority review vouchers encourages ongoing treatment efforts for rare pediatric diseases.

  • 21 U.S.C. 360ff(c)(4)

    subparagraph (A) → In general.--The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.

    This amendment specifies the timing and conditions under which user fees for priority review vouchers are collected.

Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Sponsorship breakdown

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1 sponsors · 37 co-sponsors · 509 not signed on

Sponsors (1)

Co-sponsors (37)

Not signed on (509)

509 members have not signed on to this bill.

Show all 509 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare education health-insurance
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Frequently asked questions

What does S 3302 do?
Mikaela Naylon 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, 2030. 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.
Who sponsors S 3302?
S 3302 is sponsored by Mullin, Markwayne (Republican), Bennet, Michael F. (Democratic), Klobuchar, Amy (Democratic), Shaheen, Jeanne (Democratic), Marshall, Roger (Republican), Scott, Rick (Republican), Collins, Susan M. (Republican), Coons, Christopher A. (Democratic), Capito, Shelley Moore (Republican), Kelly, Mark (Democratic), Husted, Jon (Republican), Kim, Andy (Democratic), Sheehy, Tim (Republican), Moody, Ashley (Republican), Hickenlooper, John W. (Democratic), Duckworth, Tammy (Democratic), Boozman, John (Republican), Schiff, Adam B. (Democratic), Kennedy, John (Republican), Reed, Jack (Democratic), Schmitt, Eric (Republican), Markey, Edward J. (Democratic), Booker, Cory A. (Democratic), Justice, James C. (Republican), Budd, Ted (Republican), Gillibrand, Kirsten E. (Democratic), Slotkin, Elissa (Democratic), Daines, Steve (Republican), Warner, Mark R. (Democratic), Blumenthal, Richard (Democratic), Curtis, John R. (Republican), Fischer, Deb (Republican), Warnock, Raphael G. (Democratic), Heinrich, Martin (Democratic), Banks, Jim (Republican), McCormick, David (Republican), Van Hollen, Chris (Democratic), and Gallego, Ruben (Democratic).
What is the current status of S 3302?
This bill is in committee in the Senate. Introduced December 02, 2025. It must pass committee before a floor vote.
Where can I track S 3302?
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