119th Congress · introduced in the Senate · Dec 2, 2025
Mikaela Naylon Give Kids a Chance Act of 2025
Official title from Congress.gov
Latest action (Dec 2, 2025): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in Senate (Dec 2, 2025)
Mikaela Naylon Give Kids a Chance Act of 2025
This 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.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Actions from Congress.gov, newest first.
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
7 citations.
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: AKIN GUMP STRAUSS HAUER & FELD
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
Issues related to Rare Pediatric Disease Priority Review Voucher Program reauthorization; Issues related to H.R. 1262 / S. 3302 - Mikaela Naylon Give Kids a Chance Act of 2025; Issues related to the Consolidated Appropriations Act, 2026 (P.L. 119-75), including the extension of authorit…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: AKIN GUMP STRAUSS HAUER & FELD
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
Issues related to Rare Pediatric Disease Priority Review Voucher Program reauthorization; Issues related to H.R. 1262/S. 3302 - Mikaela Naylon Give Kids a Chance Act of 2025; Issues related to the Consolidated Appropriations Act, 2026 (P.L. 119-75), including the extension of authorit…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GLAUKOS CORPORATION · lobbying firm or registrant: GLAUKOS CORPORATION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 10, 2026 · issue area: Medical/Disease Research/Clinical Labs
$280,000
Spent on own lobbying
Legislation regarding FDA regulation of combination products H.R. 1261/ S. 3302 Mikaela Naylon Give Kids a Chance Act Bill
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RAFAEL HOLDINGS, INC. · lobbying firm or registrant: TWENTY-FIRST CENTURY GROUP, INC.
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Mar 25, 2026 · issue area: Health Issues
$24,000
Paid to lobbying firm
Issues related to rare pediatric disease Priority Review Vouchers; H.R. 1262/S. 932, Give Kids a Chance Act; S. 3302, Mikaela Naylon Give Kids a Chance Act of 2025.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICAN CANCER SOCIETY CANCER ACTION NETWORK INC · lobbying firm or registrant: AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, INC.
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$2,380,000
Spent on own lobbying
…edicaid programs can cover specialized treatment regardless of where the child lives and where their care is received. Give Kids and Chance Act of 2025, S.932, S. 3302, H.R. 1262. Legislation that would accelerate pediatric cancer treatments and expand access to live-saving therapies for children battling rare diseases, spur…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GLAUKOS CORPORATION · lobbying firm or registrant: GLAUKOS CORPORATION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Medical/Disease Research/Clinical Labs
$60,000
Spent on own lobbying
Legislation regarding FDA regulation of combination products H.R. 1261/ S. 3302 Mikaela Naylon Give Kids a Chance Act Bill
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
RAFAEL HOLDINGS, INC. · lobbying firm or registrant: TWENTY-FIRST CENTURY GROUP, INC.
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 19, 2026 · issue area: Health Issues
$24,000
Paid to lobbying firm
Issues related to rare pediatric disease Priority Review Vouchers; H.R. 1262/S. 932, Give Kids a Chance Act; S. 3302, Mikaela Naylon Give Kids a Chance Act of 2025.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing