Mikaela Naylon Give Kids a Chance Act of 2025
Legislative Progress
Introduced
December 2, 2025
Latest Action
December 2, 2025
Primary Sponsor
Markwayne MullinRepublican(OK)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
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0d open
vs 5,674 other S bills in the 119th — cohort avg 32d
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.
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Filing registrants (5)
2026 · second_quarter · Health Issues
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
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 authority to issue priority review vouchers to encourage treatments for rare pediatric diseases; Issues related to the biotech ecosystem, including most-favored-nation drug pricing; Issues related to PBM reform, PAHPA reauthorization; and PDUFA reauthorization.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Pharmacy
HR 1262 - Give Kids a Chance Act of 2025 S 3302/S 932 - Give Kids a Chance Act of 2025 HR 1762 - Lower Costs for Every Day Americans Act 42 CFR Part 513/514 - Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Models EO 14297 - Exemption for Orphan Drugs from MFN Proposals
Client expense: $110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
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 authority to issue priority review vouchers to encourage treatments for rare pediatric diseases.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Medical/Disease Research/Clinical Labs
Legislation regarding FDA regulation of combination products H.R. 1261/ S. 3302 Mikaela Naylon Give Kids a Chance Act Bill
Client expense: $280,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
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.
Client expense: Not reported · Firm income: $24,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
Access to Care One Big Beautiful Bill, P.L. 119-21. Advocate to protect cancer patients in implementation of changes to Medicaid under the law. Health Care Affordability Act, H.R.247, S.46. Bill would permanently extend the enhanced Affordable Care Act tax credits. Association Health Plans Act, H.R.2528, S.1847. This bill would amend the Employee Retirement Income Security Act of 1974 to treat association health plans as employers. Self-Insurance Protection Act, H.R. 2571. This bill would amend the Employee Retirement Income Security Act of 1974 to exclude from the definition of health insurance coverage certain medical stop-loss insurance. Access to Breast Cancer Diagnosis Act, H.R. 3037/S.1500. To amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations. Women and Lung Cancer Research and Preventative Services Act of 2025, H.R.2319, S.1157. This bill requires the Department of Health and Human Services working with the Department of Defense, to conduct an interagency review to evaluate the status of and identify opportunities for research on women and lunch cancer preventative services. Education and Awareness Requires Learning (EARLY) Act, H.R. 4541, S. 2339. This bill would reauthorize the CDC program that supports young and high-risk women as well as their providers to better understand breast health. Safe Step Act, H.R. 5509, S. 2903. Bill would require an exceptions process for any medication step therapy protocol in commercial insurance plans. Bipartisan Premium Tax Credit Extension Act, H.R. 5145, Bill would extend the enhanced ACA tax credits for one year. Breaking the Gridlock Act, H.R. 1834. Bill would extend the enhanced Affordable Care Act tax credits for three years. Common Ground for Affordable Health Care Act, H.R.6575. Bill would extend the enhanced Affordable Care Act tax credits for one year and make other adjustments. Bipartisan Health Insurance Affordability Act, H.R.6501. Bill would extend the enhanced Affordable Care Act tax credits for two years and make other adjustments. Medically Tailored Home-Delivered Meals Demonstration Pilot Act, H.R.5439, S.2834. The bill would create a pilot program in Medicare for beneficiaries with diet-related diseases to receive medically tailored meals to their own home. Health Disparities Nancy Gardner Sewell Medicare Early Detection Screening Coverage Act, H.R. 842, S. 339. Legislation to improve access to new and innovative cancer screenings for Medicare beneficiaries by creating a pathway to allow Medicare to initiate coverage of multi-cancer tests following FDA approval if a clinical benefit is shown. Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer Act, H.R. 2381, S.1866. Reauthorizes the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) through 2030 to provide the program greater flexibility in providing access to lifesaving screening, diagnostic, and treatment services and continue its innovative work aimed to reduce disparities and advance health equity in breast and cervical cancer. Prostate-Specific Antigen Screening for High-Risk Insured Men (PSA Screening for HIM) Act, H.R. 1300, S. 297. Legislation to remove cost sharing of PSA testing for those at the highest risk of being diagnosed with prostate cancer. Lung Cancer Screening and Prevention Act, H.R.1406. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Data Equity. Legislative and regulatory funding to support the collection of detailed demographic data toward reducing disparities in cancer prevention, detection, and treatment. Equality Act, H.R. 15, S. 1503. This bill prohibits discrimination based on sex, sexual orientation, or gender identity with respect to businesses, employment, housing, federally funded programs, and other settings. Henrietta Lacks Congressional Gold Medal Act, H.R. 3498, S.1893. Legislation to award posthumously a Congressional Gold Medal to Henrietta Lacks, in recognition of her immortal cells which have made invaluable contributions to global health, scientific research, our quality of life, and patients' rights. Prevent HPV Cancer Act of 2025, H.R. 6561. This bill would create a national public awareness campaign to promote education and awareness of HPV and HPV-associated cancers and would increase funding for the NBCCED program to boost breast and cervical cancer screening. Childhood Cancer Childhood Cancer Survivorship, Treatment, Access, and Research Reauthorization Act (STAR) Act. Continued implementation and funding of the Childhood Cancer STAR Act to promote the development of new, safer therapies for children with cancer. Our appropriations request includes $30 million for the Childhood Cancer STAR Act and $50 million for the Childhood Cancer Data Initiative. Accelerating Kids Access to Care Act, S.752, H.R.1509. Legislation that alleviates these burdens for families and providers by facilitating coordination across state lines and clarifying the process by which state Medicaid 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 drug development for pediatric rare diseases, improve outcomes for patients, and close gaps in pediatric drug research. One Big Beautiful Bill, P.L. 119-21, Advocate to protect pediatric cancer patients in implementation of changes to Medicaid under the law. Quality of Life Palliative Care Palliative Care and Hospice Education and Training Act (PCHETA), S. 22870, H.R. 4425. Legislation to facilitate access to palliative care and coordinated care management. Palliative Care Research Funding. Funding to focus and expand national research programs in palliative care at the National Institutes of Health. Specifically, ACS CAN is working to include funding for palliative care research in the FY26 LHHS Appropriations bill. Federal Health Care Programs Department of Defense Cancer Research Funding. Ensure continued funding for cancer research within the DOD's Congressionally Directed Medical Research Program. Clinical Trials Clinical Trial Modernization Act, H.R. 3521. Increase access to clinical trials for all persons with cancer to participate by reducing barriers to enrollment. Barriers may include ancillary (non-medical) costs, such as transportation and lodging, and remote access to trials, particularly for people who are underrepresented, including certain racial and ethnic groups, older adults, rural residents, and those with limited incomes. To amend the Internal Revenue Act of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants.
2025 · fourth_quarter · Medical/Disease Research/Clinical Labs
Legislation regarding FDA regulation of combination products H.R. 1261/ S. 3302 Mikaela Naylon Give Kids a Chance Act Bill
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
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.
Client expense: Not reported · Firm income: $24,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Republican |
| FL |
| Chris Van Hollen | Democratic | MD |
| Christopher A. Coons | Democratic | DE |
| Cory A. Booker | Democratic | NJ |
| David McCormick | Republican | PA |
| Deb Fischer | Republican | NE |
| Edward J. Markey | Democratic | MA |
| Elissa Slotkin | Democratic | MI |
| Eric Schmitt | Republican | MO |
| Jack Reed | Democratic | RI |
| James C. Justice | Republican | WV |
| Jeanne Shaheen | Democratic | NH |
| Jim Banks | Republican | IN |
| John Boozman | Republican | AR |
| John Kennedy | Republican | LA |
| John R. Curtis | Republican | UT |
| John W. Hickenlooper | Democratic | CO |
| Jon Husted | Republican | OH |
| Kirsten E. Gillibrand | Democratic | NY |
| Mark Kelly | Democratic | AZ |
| Mark R. Warner | Democratic | VA |
| Martin Heinrich | Democratic | NM |
| Michael F. Bennet | Democratic | CO |
| Raphael G. Warnock | Democratic | GA |
| Richard Blumenthal | Democratic | CT |
| Rick Scott | Republican | FL |
| Roger Marshall | Republican | KS |
| Ruben Gallego | Democratic | AZ |
| Shelley Moore Capito | Republican | WV |
| Steve Daines | Republican | MT |
| Susan M. Collins | Republican | ME |
| Tammy Duckworth | Democratic | IL |
| Ted Budd | Republican | NC |
| Tim Sheehy | Republican | MT |
| HR 1262 |
119th |
| Related bill |
Client expense: $2,380,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE