S. 3302: Mikaela Naylon Give Kids a Chance Act of 2025
This bill, designated as the Mikaela Naylon Give Kids a Chance Act of 2025, aims to enhance research and development for pediatric cancer treatments by amending the Federal Food, Drug, and Cosmetic Act. The key points of the bill are as follows:
1. Pediatric Cancer Research Enhancements
The bill introduces several amendments to improve the approval process for drugs and biological products intended for treating pediatric cancers. These amendments include:
- Molecularly Targeted Investigations: It mandates investigations for molecularly targeted pediatric cancer drugs and clarifies the types of studies required, ensuring they are designed to produce useful data for pediatric populations.
- Application Requirements: The bill specifies that the Secretary of Health and Human Services will determine the specific requirements for pediatric studies at the time an application is submitted.
- Data Gathering: Investigations must collect data on dosing, safety, and preliminary efficacy that is applicable to various age groups among children.
2. Extension of Priority Review Vouchers
The legislation extends the authority to issue priority review vouchers for treatments aimed at rare pediatric diseases from December 20, 2024, to September 30, 2030. This extension is designed to encourage the development of drugs addressing pediatric diseases that are less commonly studied or treated.
3. Reporting and Oversight
Several reporting requirements are established within the bill:
- The Secretary of Health and Human Services must provide a report to Congress about the implementation of the amendments within six years of the bill's enactment.
- The Government Accountability Office (GAO) is tasked with conducting studies on the effectiveness of these amendments and the priority review vouchers, with findings to be reported after eight to ten years.
4. Implementation Timeline
The amendments made by this act apply to any applications submitted three years after the date of the bill's enactment.
5. Clarifications and Definitions
Definitions and clarifications are provided for terms throughout the bill to ensure precise understanding of the requirements related to pediatric investigations and the use of priority review vouchers.
Relevant Companies
- AMGN (Amgen Inc.): Amgen develops biologic drugs and may be impacted by requirements for pediatric cancer investigations and studies under this bill.
- PFE (Pfizer Inc.): Pfizer might need to adjust its pediatric drug development strategies to comply with new investigation requirements introduced in the legislation.
- NVO (Novo Nordisk A/S): With a portfolio that includes treatments for various conditions, Novo Nordisk may find itself examining how it approaches pediatric studies in light of the bill.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
33 bill sponsors
-
TrackMarkwayne Mullin
Sponsor
-
TrackMichael F. Bennet
Co-Sponsor
-
TrackRichard Blumenthal
Co-Sponsor
-
TrackCory A. Booker
Co-Sponsor
-
TrackJohn Boozman
Co-Sponsor
-
TrackTed Budd
Co-Sponsor
-
TrackShelley Moore Capito
Co-Sponsor
-
TrackSusan M. Collins
Co-Sponsor
-
TrackChristopher A. Coons
Co-Sponsor
-
TrackJohn R. Curtis
Co-Sponsor
-
TrackSteve Daines
Co-Sponsor
-
TrackTammy Duckworth
Co-Sponsor
-
TrackDeb Fischer
Co-Sponsor
-
TrackKirsten E. Gillibrand
Co-Sponsor
-
TrackJohn W. Hickenlooper
Co-Sponsor
-
TrackJon Husted
Co-Sponsor
-
TrackJames C. Justice
Co-Sponsor
-
TrackMark Kelly
Co-Sponsor
-
TrackJohn Kennedy
Co-Sponsor
-
TrackAndy Kim
Co-Sponsor
-
TrackAmy Klobuchar
Co-Sponsor
-
TrackEdward J. Markey
Co-Sponsor
-
TrackRoger Marshall
Co-Sponsor
-
TrackAshley Moody
Co-Sponsor
-
TrackJack Reed
Co-Sponsor
-
TrackAdam B. Schiff
Co-Sponsor
-
TrackEric Schmitt
Co-Sponsor
-
TrackRick Scott
Co-Sponsor
-
TrackJeanne Shaheen
Co-Sponsor
-
TrackTim Sheehy
Co-Sponsor
-
TrackElissa Slotkin
Co-Sponsor
-
TrackMark R. Warner
Co-Sponsor
-
TrackRaphael G. Warnock
Co-Sponsor
Actions
2 actions
| Date | Action |
|---|---|
| Dec. 02, 2025 | Introduced in Senate |
| Dec. 02, 2025 | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Corporate Lobbying
0 companies lobbying
None found.
* Note that there can be significant delays in lobbying disclosures, and our data may be incomplete.
