# 119-s-3302: Mikaela Naylon Give Kids a Chance Act of 2025

119-s-3302, Mikaela Naylon Give Kids a Chance Act of 2025, is a 119th Congress bill sponsored by Rep. Mullin, Markwayne [R-OK-2] (R-OK); status introduced; PRIA reads it as touching household money (as of 2026-06-13).

- Canonical: https://policyrisk.com/legislation/119-s-3302
- As of: 2026-06-13
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-3302
- Congress: 119
- Title: Mikaela Naylon Give Kids a Chance Act of 2025
- Status: introduced
- Introduced: 2025-12-02
- Sponsor: Rep. Mullin, Markwayne [R-OK-2] (R-OK)
- Cosponsors: 37
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-06-13

## Summary

**Clearer rules for molecularly targeted pediatric cancer studies.** The Mikaela Naylon Give Kids a Chance Act of 2025 broadens when a pediatric investigation can target a drug alone or in combination with certain adult-approved cancer treatments, and it sets deadlines for FDA guidance and later Congress/GAO reviews. - Children and families: Trials must be designed to produce clinically meaningful pediatric data with appropriate age-group formulations, dosing, safety information, and preliminary efficacy to help inform pediatric labeling. - Drug developers: The bill expands what counts as a molecularly targeted pediatric investigation, including certain combinations with adult-approved cancer drugs that are part of standard care, and may require relevant preclinical study results when submitting the initial pediatric study plan; the rules apply to applications submitted 3 years after enactment. - FDA and oversight: The FDA must publish draft guidance within 12 months and finalize it within a year after the comment period; the law also requires a congressional report within 6 years and a later Government Accountability Office study to assess effectiveness.

## Cosponsors (37)

- Sen. Bennet, Michael F. [D-CO] (D-CO), 2025-12-02T00:00:00.000Z
- Sen. Klobuchar, Amy [D-MN] (D-MN), 2025-12-02T00:00:00.000Z
- Sen. Shaheen, Jeanne [D-NH] (D-NH), 2025-12-02T00:00:00.000Z
- Sen. Marshall, Roger [R-KS] (R-KS), 2025-12-02T00:00:00.000Z
- Sen. Scott, Rick [R-FL] (R-FL), 2025-12-02T00:00:00.000Z
- Sen. Collins, Susan M. [R-ME] (R-ME), 2025-12-02T00:00:00.000Z
- Sen. Coons, Christopher A. [D-DE] (D-DE), 2025-12-02T00:00:00.000Z
- Sen. Capito, Shelley Moore [R-WV] (R-WV), 2025-12-02T00:00:00.000Z
- Sen. Kelly, Mark [D-AZ] (D-AZ), 2025-12-02T00:00:00.000Z
- Sen. Husted, Jon [R-OH] (R-OH), 2025-12-02T00:00:00.000Z
- Sen. Kim, Andy [D-NJ] (D-NJ), 2025-12-02T00:00:00.000Z
- Sen. Sheehy, Tim [R-MT] (R-MT), 2025-12-02T00:00:00.000Z
- Sen. Moody, Ashley [R-FL] (R-FL), 2025-12-02T00:00:00.000Z
- Sen. Hickenlooper, John W. [D-CO] (D-CO), 2025-12-02T00:00:00.000Z
- Sen. Duckworth, Tammy [D-IL] (D-IL), 2025-12-02T00:00:00.000Z
- Sen. Boozman, John [R-AR] (R-AR), 2025-12-02T00:00:00.000Z
- Sen. Schiff, Adam B. [D-CA] (D-CA), 2025-12-02T00:00:00.000Z
- Sen. Kennedy, John [R-LA] (R-LA), 2025-12-02T00:00:00.000Z
- Sen. Reed, Jack [D-RI] (D-RI), 2025-12-02T00:00:00.000Z
- Sen. Schmitt, Eric [R-MO] (R-MO), 2025-12-02T00:00:00.000Z
- Sen. Markey, Edward J. [D-MA] (D-MA), 2025-12-02T00:00:00.000Z
- Sen. Booker, Cory A. [D-NJ] (D-NJ), 2025-12-02T00:00:00.000Z
- Sen. Justice, James C. [R-WV] (R-WV), 2025-12-02T00:00:00.000Z
- Sen. Budd, Ted [R-NC] (R-NC), 2025-12-09T00:00:00.000Z
- Sen. Gillibrand, Kirsten E. [D-NY] (D-NY), 2025-12-09T00:00:00.000Z
- Sen. Slotkin, Elissa [D-MI] (D-MI), 2025-12-10T00:00:00.000Z
- Sen. Daines, Steve [R-MT] (R-MT), 2025-12-16T00:00:00.000Z
- Sen. Warner, Mark R. [D-VA] (D-VA), 2025-12-16T00:00:00.000Z
- Sen. Blumenthal, Richard [D-CT] (D-CT), 2025-12-16T00:00:00.000Z
- Sen. Curtis, John R. [R-UT] (R-UT), 2025-12-17T00:00:00.000Z
- Sen. Fischer, Deb [R-NE] (R-NE), 2025-12-17T00:00:00.000Z
- Sen. Warnock, Raphael G. [D-GA] (D-GA), 2025-12-17T00:00:00.000Z
- Sen. Heinrich, Martin [D-NM] (D-NM), 2026-01-15T00:00:00.000Z
- Sen. Banks, Jim [R-IN] (R-IN), 2026-01-15T00:00:00.000Z
- Sen. McCormick, David [R-PA] (R-PA), 2026-01-15T00:00:00.000Z
- Sen. Van Hollen, Chris [D-MD] (D-MD), 2026-01-29T00:00:00.000Z
- Sen. Gallego, Ruben [D-AZ] (D-AZ), 2026-01-29T00:00:00.000Z

## Provisions PRIA read

- Clear pediatric cancer trial rules: benefit, low. If enacted, the bill would redefine molecularly targeted pediatric cancer studies and set two clear ways FDA may allow combination testing. It would require studies to produce useful pediatric data for each age group, covering dosing, safety, and early effectiveness. The agency must decide which pa…
- Changes to rare pediatric vouchers: benefit, low. If enacted, the bill would let rare pediatric disease priority review vouchers be awarded through September 30, 2030. The priority review fee when a voucher is used would be due when the drug application is submitted. Other user fees for that application would still be due as required. The fee timi…

## Related bills

- 119-sres-585: A resolution honoring the life, achievements, and legacy of Ben Nighthorse Campbell.
- 119-sres-255: A resolution honoring the life, achievements, and legacy of former United States Senator Christopher "Kit" Bond of Missouri.
- 119-sres-159: A resolution honoring the life of the Honorable John Bennett Johnston, Jr., former Senator for the State of Louisiana.
- 119-sres-148: A resolution honoring the life of the Honorable Alan K. Simpson, former Senator for the State of Wyoming.
- 119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former United States Senator for the State of Kansas.
- 119-sres-897: A resolution honoring the life, service, and legacy of the Honorable Jon Llewellyn Kyl, former Senator for the State of Arizona.

## Sources
- [119-s-3302 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/3302)

## Related
- [119-sres-585: A resolution honoring the life, achievements, and legacy of Ben Nighthorse Camp…](https://policyrisk.com/legislation/119-sres-585)
- [119-sres-255: A resolution honoring the life, achievements, and legacy of former United State…](https://policyrisk.com/legislation/119-sres-255)
- [119-sres-159: A resolution honoring the life of the Honorable John Bennett Johnston, Jr., for…](https://policyrisk.com/legislation/119-sres-159)
- [119-sres-148: A resolution honoring the life of the Honorable Alan K. Simpson, former Senator…](https://policyrisk.com/legislation/119-sres-148)
- [119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former Uni…](https://policyrisk.com/legislation/119-sres-913)
- [119-sres-897: A resolution honoring the life, service, and legacy of the Honorable Jon Llewel…](https://policyrisk.com/legislation/119-sres-897)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-3302 (as of 2026-06-13).