Mikaela Naylon Give Kids a Chance Act
Latest action · Dec 2, 2025 Received in the Senate.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 12, 2025
- Passed HouseDec 1, 2025
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Give Kids a Chance Act of 2025
This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research.
Specifically, the bill
- modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs in combination with active ingredients that have already been approved, provided certain conditions are met;
- permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirement;
- renews the FDA’s authority to award priority review vouchers to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029; and
- reauthorizes through FY2027 certain funding for the National Institutes of Health to support priority pediatric research.
The bill also provides statutory authority for the FDA’s interpretation of the orphan drug exclusivity period. The bill specifies, consistent with FDA regulations, that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drugs) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. (In Catalyst Pharmaceuticals, Inc. v. Becerra, a court rejected the FDA’s interpretation and held that orphan drug exclusivity extends to all uses or indications for the disease or condition.)
Cosponsors 313
Members who signed on, in the order they did. Signatures ran from Feb 12, 2025 to Oct 31, 2025; 10 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-TX | Dan Crenshaw | Original | Feb 12, 2025 |
| D-MI | Debbie Dingell | Original | Feb 12, 2025 |
| R-TN | Diana Harshbarger | Original | Feb 12, 2025 |
| D-CA | Doris O. Matsui | Original | Feb 12, 2025 |
| R-FL | Gus M. Bilirakis | Original | Feb 12, 2025 |
| D-FL | Kathy Castor | Original | Feb 12, 2025 |
| D-WA | Kim Schrier | Original | Feb 12, 2025 |
| D-MA | Lori Trahan | Original | Feb 12, 2025 |
| R-PA | Mike Kelly | Original | Feb 12, 2025 |
| R-TX | Randy K. Weber, Sr. | Original | Feb 12, 2025 |
| R-VA | Ben Cline | Feb 24, 2025 | |
| R-FL | Carlos A. Gimenez | Feb 24, 2025 | |
| R-WV | Carol D. Miller | Feb 24, 2025 | |
| R-LA | Clay Higgins | Feb 24, 2025 | |
| D-FL | Darren Soto | Feb 24, 2025 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Feb 12, 2025Markup Sep 17, 2025Reported Oct 31, 2025 |
Actions 12
Everything that happened, newest first.
- Dec 2, 2025Received in the Senate.
- Dec 1, 2025Considered under suspension of the rules. (consideration: CR H4929-4935)
- Dec 1, 2025Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
- Dec 1, 2025Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
- Dec 1, 2025DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
In the Congressional Record 4
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Senate | Debate and remarks S8820–S8822 | Bernard Sanders I-VT, Bill Cassidy R-LA, Margaret Wood Hassan D-NH, Markwayne Mullin R-OK | Dec 17, 2025 |
| House | Debate and remarks H4929–H4935Text printed H4929–H4932 | Debbie Dingell D-MI, Earl L. "Buddy" Carter R-GA, Frank Pallone, Jr. D-NJ, Gus M. Bilirakis R-FL, Jay Obernolte R-CA, Michael T. McCaul R-TX | Dec 1, 2025 |
| Extensions | Debate and remarks E898 | Lori Trahan D-MA | Sep 26, 2025 |
| House | Debate and remarks H1341 | John Joyce R-PA | Mar 31, 2025 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 171, no. 29, February 12, 2025, page H678.
Related bills 10
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 532 | OPTN Fee Collection Authority Act | Related bill | Feb 12, 2025 |
| S 891 | Bipartisan Health Care Act | Related bill | Mar 6, 2025 |
| S 932 | Give Kids a Chance Act of 2025 | Related bill | Mar 11, 2025 |
| HR 1768 | Lower Costs for Everyday Americans Act | Related bill | Mar 3, 2025 |
| HR 1794 | United States-Abraham Accords Cooperation and Security Act of 2025 | Related bill | Mar 3, 2025 |
| S 2751 | Permanent OPTN Fee Authority Act | Related bill | Sep 10, 2025 |
| S 3302 | Mikaela Naylon Give Kids a Chance Act of 2025 | Related bill | Dec 2, 2025 |
| S 3716 | RARE Act | Related bill | Jan 28, 2026 |
| HR 5259 | Permanent OPTN Fee Authority Act | Related bill | Sep 10, 2025 |
| HR 7148 | Consolidated Appropriations Act, 2026 | Related bill | Feb 3, 2026 |
Titles 5
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
- Short Title(s) as Introduced
- Give Kids a Chance Act of 2025
- Short Title(s) as Reported to House
- Give Kids a Chance Act of 2025
- Short Title(s) as Passed House
- Mikaela Naylon Give Kids a Chance Act
- Official Title from EH (Engrossed in House) bill text
- To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Arab-Israeli relations
- Bahrain
- Cancer
- Child health
- Computers and information technology
- Congressional oversight
- Drug safety, medical device, and laboratory regulation
- Executive agency funding and structure
- Food and Drug Administration (FDA)
- Government information and archives
- Government studies and investigations
- Health
- Health information and medical records
- International law and treaties
- Israel
- Licensing and registrations
- Medical research
- Organ and tissue donation and transplantation
- Performance measurement
- Prescription drugs
- Research administration and funding
- Telephone and wireless communication
- United Arab Emirates
- User charges and fees
Text 3
Each version as it was printed, newest first.
- Dec 1, 2025Engrossed in House
- Oct 31, 2025Reported in House
- Feb 12, 2025Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
