Bill · H.R. 1262· House(119-HR-1262)
Mikaela Naylon Give Kids a Chance Act
- Introduced
- 2/12/2025
- Last activity
- 12/2/2025 — Received in the Senate.
- Sponsored by
- Michael McCaul
- Cosponsors
- - 132 - 180
- Introduced
- Passed House
- Awaiting Senate
What this bill would do
This Act, known as the "Mikaela Naylon Give Kids a Chance Act," amends the Federal Food, Drug, and Cosmetic Act regarding several medical and regulatory areas. It focuses heavily on expanding research and authorities for molecularly targeted pediatric cancer drugs. The legislation also extends priority review vouchers for rare pediatric diseases and adjusts orphan drug exclusivity rules. Additionally, it modifies the Organ Procurement and Transplantation Network and establishes the Abraham Accords Office within the FDA. Finally, it addresses generic drug application transparency and increases funding for the Medicare Improvement Fund.
Yes· 3 of 8
Would children be better off under this?+9
The bill focuses heavily on pediatric cancer research and rare pediatric diseases.
Does this put more money into medical research?+8
The bill provides significant funding and expanded authority for pediatric cancer research.
Does this put more money into Medicare, the health coverage for people over 65?+7
The bill significantly increases the funding for the Medicare Improvement Fund.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Expanded Pediatric Cancer Research: The bill allows for investigations into molecularly targeted pediatric cancer drugs, including combinations with existing treatments, to yield clinically meaningful data regarding dosing, safety, and efficacy (Section 2).
-
Encouraging Rare Disease Treatments: The authority to issue priority review vouchers to encourage treatments for rare pediatric diseases is extended through September 30, 2029 (Section 5).
-
Improved Organ Transplant Systems: The bill encourages the integration of electronic health records among hospitals and transplant centers to facilitate automated electronic hospital referrals (Section 8).
-
Increased Transparency for Generic Drugs: The Secretary is required to inform applicants whether a drug is qualitatively and quantitatively the same as the listed drug, disclosing specific ingredients or deviations if they are not the same (Section 10).
-
Increased Medicare Funding: The funding for the Medicare Improvement Fund is increased from $1,403,000,000 to $2,622,000,000 (Section 11).
Potential Negative Impacts for People
-
Restrictions on Enforcement for Pediatric Studies: The Secretary is prohibited from issuing certain enforcement actions under section 303 for failures regarding drugs or biological products that are no longer marketed (Section 3).
-
Limitations on Orphan Drug Exclusivity: The bill amends the rules for exclusive approval or licensure of orphan drugs by narrowing the scope to specific approved uses or indications within a rare disease or condition (Section 6).
-
New Fees for Organ Transplants: The Secretary is authorized to collect registration fees from members of the Organ Procurement and Transplantation Network for each transplant candidate placed on a list (Section 8).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Increases Research Funding+8Increases Medicare Funding+7Improves Healthcare Access+6
- Demographic And Interest Groups
- Good For Children+9
- Education And Technology
- Increases Scientific Research Funding+7
- Economy And Finance
- Improves Consumer Protection+5
- National Security And Foreign Policy
- Improves International Alliances+5
- Governance And Ideology
- Improves Government Transparency+4
- 12/2/2025
- Received in the Senate.
- 12/1/2025
- Motion to reconsider laid on the table Agreed to without objection.
- Passed/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)
- On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
- DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
- Considered under suspension of the rules. (consideration: CR H4929-4935)
- Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
- 10/31/2025
- Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
- Placed on the Union Calendar, Calendar No. 304.
- 1 Cosponsor added.
- 10/28/2025
- 2 Cosponsors added.
- 10/17/2025
- 3 Cosponsors added.
- 10/14/2025
- 1 Cosponsor added.
- 10/10/2025
- 1 Cosponsor added.
- 10/8/2025
- 5 Cosponsors added.
- 10/3/2025
- 2 Cosponsors added.
- 9/30/2025
- 2 Cosponsors added.
- 9/26/2025
- 8 Cosponsors added.
- 9/18/2025
- 3 Cosponsors added.
- 9/17/2025
- Committee Consideration and Mark-up Session Held
- Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
- 1 Cosponsor added.
- 9/16/2025
- 16 Cosponsors added.
- 9/15/2025
- 2 Cosponsors added.
- 9/4/2025
- 2 Cosponsors added.
- 9/3/2025
- 5 Cosponsors added.
- 9/2/2025
- 8 Cosponsors added.
- 8/19/2025
- 3 Cosponsors added.
- 8/8/2025
- 6 Cosponsors added.
- 8/1/2025
- 13 Cosponsors added.
- 7/25/2025
- 1 Cosponsor added.
- 7/23/2025
- 2 Cosponsors added.
- 7/22/2025
- 2 Cosponsors added.
- 7/21/2025
- 2 Cosponsors added.
- 7/17/2025
- 17 Cosponsors added.
- 7/16/2025
- 4 Cosponsors added.
- 7/15/2025
- 3 Cosponsors added.
- 7/14/2025
- 7 Cosponsors added.
- 7/2/2025
- 1 Cosponsor added.
- 6/27/2025
- 1 Cosponsor added.
- 6/26/2025
- 3 Cosponsors added.
- 6/23/2025
- 2 Cosponsors added.
- 6/11/2025
- 3 Cosponsors added.
- 6/10/2025
- 1 Cosponsor added.
- 6/9/2025
- 1 Cosponsor added.
- 6/6/2025
- 1 Cosponsor added.
- 6/4/2025
- 1 Cosponsor added.
- 6/3/2025
- 7 Cosponsors added.
- 5/21/2025
- 3 Cosponsors added.
- 5/20/2025
- 8 Cosponsors added.
- 5/14/2025
- 1 Cosponsor added.
- 5/13/2025
- 8 Cosponsors added.
- 5/7/2025
- 2 Cosponsors added.
- 5/6/2025
- 2 Cosponsors added.
- 5/5/2025
- 4 Cosponsors added.
- 5/1/2025
- 1 Cosponsor added.
- 4/28/2025
- 2 Cosponsors added.
- 4/24/2025
- 7 Cosponsors added.
- 4/10/2025
- 2 Cosponsors added.
- 4/8/2025
- 4 Cosponsors added.
- 4/7/2025
- 1 Cosponsor added.
- 4/3/2025
- 7 Cosponsors added.
- 4/1/2025
- 4 Cosponsors added.
- 3/31/2025
- 12 Cosponsors added.
- 3/26/2025
- 2 Cosponsors added.
- 3/25/2025
- 16 Cosponsors added.
- 3/11/2025
- 8 Cosponsors added.
- 3/10/2025
- 12 Cosponsors added.
- 3/4/2025
- 4 Cosponsors added.
- 3/3/2025
- 6 Cosponsors added.
- 2/27/2025
- 6 Cosponsors added.
- 2/26/2025
- 4 Cosponsors added.
- 2/25/2025
- 14 Cosponsors added.
- 2/24/2025
- 20 Cosponsors added.
- 2/12/2025
- Referred to the House Committee on Energy and Commerce.
- 10 Cosponsors added.
- Introduced in House
10 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
- 119-HR-1768: Lower Costs for Everyday Americans Act
- 119-HR-1794: United States-Abraham Accords Cooperation and Security Act of 2025
- 119-HR-5259: Permanent OPTN Fee Authority Act
- 119-HR-7148: Consolidated Appropriations Act, 2026
- 119-S-532: OPTN Fee Collection Authority Act
- 119-S-891: Bipartisan Health Care Act
- 119-S-932: Give Kids a Chance Act of 2025
- 119-S-2751: Permanent OPTN Fee Authority Act
- 119-S-3302: Mikaela Naylon Give Kids a Chance Act of 2025
- 119-S-3716: RARE Act
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