The bill
Stem Cell Therapeutic and Research Reauthorization Act of 2026
S. 4109, 119th Congress — read as touching Biotech & Research.
Sponsored by
Sen. Reed, Jack [D-RI]
ID: R000122
Follow the money
The bill
S. 4109, 119th Congress — read as touching Biotech & Research.
The sponsor
Every bill has someone who introduced it. That name is where the paper trail starts.
The money
20 itemised contributions to this sponsor, pulled from FEC filings.
The alignment
This bill's text tracks the "Department of Health and Human Services" section, p. 530-532 of the Mandate for Leadership.
Track this bill's progress through the legislative process
Latest Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 443.
June 21, 2026
📍 Current Status
Next: The bill will be reviewed by relevant committees who will debate, amend, and vote on it.
1. Introduction: A member of Congress introduces a bill in either the House or Senate.
2. Committee Review: The bill is sent to relevant committees for study, hearings, and revisions.
3. Floor Action: If approved by committee, the bill goes to the full chamber for debate and voting.
4. Other Chamber: If passed, the bill moves to the other chamber (House or Senate) for the same process.
5. Conference: If both chambers pass different versions, a conference committee reconciles the differences.
6. Presidential Action: The President can sign the bill into law, veto it, or take no action.
7. Became Law: If signed (or if Congress overrides a veto), the bill becomes law!
**Stem Cell Therapeutic and Research Reauthorization Act of 2026 (S. 4109): A Diagnostic Summary**
**1. Main Purpose & Objectives** The stated goal of S. 4109 is to reauthorize the Stem Cell Therapeutic and Research Act of 2005—essentially extending federal funding and policy frameworks for umbilical cord blood collection, banking, and transplantation through 2031. Ostensibly, this is about saving lives: expanding access to stem cell therapies for patients with blood disorders, immune deficiencies, and cancers. But let’s be honest—this isn’t altruism. It’s bureaucratic life support for a program that’s been limping along since the Bush administration, now juiced with a $2 million annual bump to keep the cord blood banks from flatlining. The real objective? Keep the appearance of progress while avoiding the harder work of innovating beyond 2005-era science.
**2. Key Provisions & Changes to Existing Law** The bill makes three core changes, all dressed up as “modernization”: - **Funding Increase**: Bumps annual appropriations for the C.W. Bill Young Cell Transplantation Program from $31,009,000 to $33,009,000 (FY 2027–2031). A whopping 6.4% increase—just enough to cover inflation and the lobbying fees of the cord blood industry. - **Inventory Goals Overhaul**: Replaces the rigid target of “150,000 new units” with a vague, Secretary-determined “sufficient supply.” Translation: we gave up on measurable outcomes and now trust bureaucrats to guess how much cord blood we need. - **Operational Flexibility**: Adds provisions allowing the Secretary to transfer cord blood units from failing or non-compliant banks to qualified entities, and to manage inventory based on “current scientific and clinical evidence.” In plain terms: we’re finally admitting some banks are junkyards of unusable units, and we need a way to dump the dead weight without admitting failure. - **Definitions & Reporting**: Updates the definition of “high-quality cord blood unit” to align with FDA standards (a belated nod to reality) and extends reporting requirements through 2031—because nothing says accountability like another five years of paperwork.
**3. Affected Parties & Stakeholders** - **Cord Blood Banks**: The real winners. They get guaranteed funding, looser inventory mandates, and a lifeline for underperforming facilities via unit transfers. Think of it as Medicaid for private biotech. - **Patients**: Theoretically benefit from broader access and potentially better-matched units—but only if the banks actually collect useful donations, not just chase volume to hit old quotas. - **Taxpayers**: Foot the bill for a program that’s more about sustaining an industry than curing disease. The $2M/year increase is pocket change in federal terms—but it’s $10M over five years that could’ve gone to, say, actual regenerative medicine research. - **FDA & NIH**: Gain more discretion to manage inventory and quality—power without much oversight. Ideal for empire-building. - **Politicians**: Get to slap a “pro-science,” “pro-patient” label on a bill that mostly renews the status quo. A win-win for reelection ads and industry donors.
**4. Potential Impact & Implications** This bill is legislative comfort food: familiar, bland, and minimally disruptive. It won’t revolutionize stem cell therapy—it’ll just keep the cord blood pipeline from collapsing under its own inefficiencies. By replacing hard metrics with Secretary discretion, it risks creating a black box where funding flows based on political pull, not clinical need. The unit transfer provision is a tacit admission that the current system is bloated with substandard banks—yet instead of cutting them loose, we’re shuffling their units around like deck chairs on the Titanic. In short: S. 4109 is less about advancing medicine and more about managing decline with a smile. It’s not a cure—it’s a placebo for a Congress that prefers the illusion
Sen. Reed, Jack [D-RI]
Congress 119 • 2024 Election Cycle
No PAC contributions found
No organization contributions found
No committee contributions found
This bill has 3 cosponsors. Below are their top campaign contributors.
ID: S001184
Top Contributors
26
ID: S001203
Top Contributors
34
ID: L000575
Top Contributors
22
Hub layout: Politicians in center, donors arranged by type in rings around them.
Showing 34 nodes and 41 connections
Total contributions: $41
Showing top 17 donors by contribution amount
Which industries are materially affected by specific provisions in this bill. 2 helped.
Section 2 reauthorizes and increases funding for the C.W. Bill Young Cell Transplantation Program, which supports research and development of stem cell therapies, benefiting the biotech industry.
The reauthorization of the C.W. Bill Young Cell Transplantation Program in Section 2 may lead to increased access to stem cell therapies for hospitals and health systems, potentially benefiting their patients and operations.
This bill shows semantic similarity to the following sections of the Project 2025 policy document.AI-enhanced analysis provides detailed alignment ratings.
AI Analysis:
"The bill supports stem cell research and cord blood banking, which aligns with Project 2025's broader HHS goal of advancing medical innovation and equitable healthcare access, though it does not explicitly target underserved communities or address the specific priorities outlined in the Strategic Goal 1 excerpt."
— 498 — Mandate for Leadership: The Conservative Promise ENDNOTES 1. U.S. Department of Health and Human Services, Strategic Plan, FY 2018–2022, p. 50, https://aspe.hhs.gov/ sites/default/files/documents/feac346aca967bfadc446398679e14ec/hhs-strategic-plan-fy-2018-2022.pdf (accessed February 7, 2023). 2. “Strategic Goal 1: Protect and Strengthen Equitable Access to High Quality and Affordable Healthcare” in ibid. “In the context of HHS, this Strategic Plan adopts the definition of underserved communities listed in Executive Order 13985: Advancing Racial Equity and Support for Underserved Communities through the Federal Government to refer to ‘populations sharing a particular characteristic, as well as geographic communities, who have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life’; this definition includes individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. Individuals may belong to more than one underserved community and face intersecting barriers. This definition applies to the terms underserved communities and underserved populations throughout this Strategic Plan.” Ibid. Emphasis in original. 3. Karen Weintraub, “Americans’ Life Expectancy Continues to Fall, Erasing Health Gains of the Last Quarter Century,” USA Today, December 22, 2022, https://www.usatoday.com/story/news/health/2022/12/22/us-life- expectancy-continues-fall-erasing-25-years-health-gains/10937418002/ (accessed February 6, 2023). 4. Apoorva Mandavilli, “The C.D.C. Isn’t Publishing Large Portions of the Data It Collects,” The New York Times, updated February 22, 2022, https://www.congress.gov/117/meeting/house/114450/documents/HHRG-117- IF02-20220302-SD004.pdf (accessed March 22, 2023). 5. Zachary B. Sluzala and Edmund F. Haislmaier, “Lessons from COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing,” Heritage Foundation Backgrounder No. 3696, March 28, 2022, https://www. heritage.org/public-health/report/lessons-covid-19-how-policymakers-should-reform-the-regulation-clinical. 6. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Centers for Disease Control and Prevention (C),” https://www.cdc.gov/maso/pdf/cdcmiss.pdf (March 16, 2023). 7. Judith Garber, “CDC ‘Disclaimers’ Hide Financial Conflicts of Interest,” Lown Institute Accountability Blog, November 6, 2019, https://lowninstitute.org/cdc-disclaimers-hide-financial-conflicts-of-interest/ (accessed February 6, 2023). See also U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “CDC Foundation Active Programs (October 1, 2014–September 30, 2015),” https://www. cdcfoundation.org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2015.pdf (accessed February 7, 2023); “CDC Active Programs (October 1, 2015–September 30, 2016),” https://www.cdcfoundation. org/sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2016.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2016–September 30, 2017),” https://www.cdcfoundation.org/ sites/default/files/upload/pdf/CDCFoundation-ActivePrograms-FY2017.pdf (accessed February 7, 2023); “CDC Foundation Active Programs (October 1, 2017–September 30, 2018),” https://www.cdcfoundation.org/sites/default/ files/upload/pdf/CDCFoundation-ActivePrograms-FY2018.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2018–September 30, 2019,” https://www.cdcfoundation.org/sites/default/files/upload/ pdf/CDCFoundation-ActivePrograms-FY2019.pdf (accessed February 7, 2023); “CDC Foundation Active Programs, October 1, 2029–September 30, 2020,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY20?inline (accessed February 7, 2023); and “CDC Foundation Active Programs, October 1, 2020–September 30, 2021,” https://www.cdcfoundation.org/CDCF-ActivePrograms-CDC-FY21?inline (accessed February 7, 2023). 8. Joel White and Doug Badger, “In Order to Defeat COVID-19, the Federal Government Must Modernize Its Public Health Data,” Heritage Foundation Backgrounder No. 3527, September 3, 2020, https://www.heritage. org/sites/default/files/2020-09/BG3527_0.pdf. 9. S. 15, Ensuring Accurate and Complete Abortion Data Reporting Act of 2023, 118th Congress, introduced January 23, 2023, https://www.congress.gov/118/bills/s15/BILLS-118s15is.pdf (accessed March 22, 2023), and H.R. 632, Ensuring Accurate and Complete Abortion Data Reporting Act of 2023, 118th Congress, introduced January 30, 2023, https://www.congress.gov/118/bills/hr632/BILLS-118hr632ih.pdf (accessed March 22, 2023). 10. Doug Badger, “How Congress Can Make Real Progress on Drug Prices,” Heritage Foundation Issue Brief No. 5016, December 9, 2019, https://www.heritage.org/sites/default/files/2019-12/IB5016_1.pdf. — 499 — Department of Health and Human Services 11. Sluzala and Haislmaier, “Lessons From COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” 12. Ibid. 13. H.R. 5471, Clinical Laboratory Improvement Amendments of 1988, Public Law No. 100-578, 100th Congress, October 31, 1988, https://uscode.house.gov/statutes/pl/100/578.pdf (accessed March 17, 2023). 14. Sluzala and Haislmaier, “Lessons From COVID-19: How Policymakers Should Reform the Regulation of Clinical Testing.” 15. Edmund F. Haislmaier, “Ensuring Americans’ Access to Pharmaceuticals: A Primer and Road Map for Policymakers,” Heritage Foundation Backgrounder No. 3545, October 20, 2020, https://www.heritage.org/ sites/default/files/2020-10/BG3545.pdf. 16. 18 U.S.C. 1461, https://www.law.cornell.edu/uscode/text/18/1461 (accessed March 16, 2023), and 18 U.S.C. 1462, https://www.law.cornell.edu/uscode/text/18/1462 (accessed March 16, 2023). 17. H.R. 1308, Religious Freedom Restoration Act of 1993, Public Law No. 103-141, 103rd Congress, November 16, 1993, https://www.congress.gov/103/statute/STATUTE-107/STATUTE-107-Pg1488.pdf (accessed March 18, 2023). 18. Charles Piller, “Is FDA’s Revolving Door Open Too Wide?” Science, Vol. 361, No. 6397 (July 6, 2018), p. 21, https://www.science.org/doi/epdf/10.1126/science.361.6397.21 (accessed February 6, 2023). 19. Joel Achenbach, “NIH Halts $100 Million Study of Moderate Drinking That Is Funded by Alcohol Industry,” The Washington Post, May 17, 2018, https://www.washingtonpost.com/news/to-your-health/wp/2018/05/17/nih- halts-controversial-study-of-moderate-drinking/ (accessed February 6, 2023). 20. Alexander Tin, “Moderna Offers NIH Co-ownership of COVID Vaccine Patent amid Dispute with Government,” CBS News, November 15, 2021, https://www.cbsnews.com/news/moderna-covid-vaccine-patent-dispute- national-institutes-health/ (accessed February 6, 2023). 21. Informed Consent Action Network, “NIH Officials Profiting from COVID-19 Vaccine,” June 3, 2021, https://www. icandecide.org/nih-officials-profiting-from-covid-19-vaccine/ (accessed February 6, 2023). 22. Adam Andrzejewski, “Substack Investigation: Fauci’s Royalties and the $350 Million Royalty Payment Stream HIDDEN by NIH,” Open the Books Substack, May 9, 2022, https://openthebooks.substack. com/p/faucis-royalties-and-the-350-million?utm_source=/profile/24758236-adam-andrzejewski&utm_ medium=reader2&s=w (accessed February 6, 2023). 23. Robert E. Moffit, “Time to Reverse Hospital Market Consolidation,” Heritage Foundation Commentary, January 5, 2022, https://www.heritage.org/health-care-reform/commentary/time-reverse-hospital-market-consolidation. 24. H.R. 3590, Patient Protection and Affordable Care Act, Public Law No. 111-148, 111th Congress, March 23, 2021, https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf (accessed March 16, 2023). 25. Brian J. Miller, Robert E. Moffit, James Ficke, Joseph Marine, and Jesse Ehrenfeld, “Reversing Hospital Consolidation: The Promise of Physician-Owned Hospitals,” Health Affairs Forefront, April 12, 2021, https:// www.healthaffairs.org/do/10.1377/forefront.20210408.980640/ (accessed February 13, 2023). 26. Robert E. Moffit, “Medicare’s Future: Challenges and Opportunities,” testimony before the Special Committee on Aging, U.S. Senate, November 21, 2022, https://www.heritage.org/testimony/medicares-future-challenges- and-opportunities. 27. 42 U.S. Code § 256b, https://www.law.cornell.edu/uscode/text/42/256b (accessed March 16, 2023). 28. H.R. 3590, Patient Protection and Affordable Care Act, § 3022. 29. H.R. 5376, Inflation Reduction Act of 2022, Public Law No. 117-169, 117th Congress, August 16, 2022, https:// www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf (accessed March 16, 2023). 30. Robert E. Moffit, “Reducing Patient Access to New Medications Is the Left’s Latest Medicare Price-Fixing Scheme,” Heritage Foundation Commentary, July 22, 2022, https://www.heritage.org/medicare/commentary/ reducing-patient-access-new-medications-the-lefts-latest-medicare-price-fixing, and Badger, “How Congress Can Make Real Progress on Drug Prices.” 31. Nina Owcharenko Schaefer, “Medicaid at 55: Understanding the Design, Trends, and Reforms Needed to Improve the Health Care Safety Net,” Heritage Foundation Backgrounder No. 3604, April 14, 2021, https:// www.heritage.org/sites/default/files/2021-04/BG3604_0.pdf, and Brian C. Blase, “Punishing Conservative States: Payment Cuts to Hospitals Where Federal Spending Is Already Low,” Paragon Health Institute, December 2021, https://paragoninstitute.org/wp-content/uploads/2022/06/Punishing-Conservative-States- HTML.html (accessed February 13, 2023).
AI Analysis:
"The bill focuses on reauthorizing stem cell research and cord blood banking programs, while the Project 2025 policy excerpts center on healthcare civil rights, abortion-related legislation, gender-affirming care guidance, and administrative rulemakings—there is no substantive thematic or policy overlap between the two."
— 501 — Department of Health and Human Services 54. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, Office of Civil Rights, and Office of the Secretary, “Special Responsibilities of Medicare Hospitals in Emergency Cases and Discrimination on the Basis of Disability in Critical Health and Human Service Programs or Activities,” draft of Proposed Rule, January 14, 2021, https://www.hhs.gov/sites/default/files/infants-nprm.pdf (accessed March 17, 2023). 55. H.R. 26, Born-Alive Abortion Survivors Protection Act, 118th Congress, introduced January 9, 2023, https:// www.congress.gov/118/bills/hr26/BILLS-118hr26pcs.pdf (accessed March 17, 2023). 56. H.R. 7, No Taxpayer Funding for Abortion and Abortion Insurance Full Disclosure Act of 2023, 118th Congress, introduced January 9, 2023, https://www.congress.gov/118/bills/hr7/BILLS-118hr7ih.pdf (accessed March 17, 2023). 57. S. 401, Conscience Protection Act of 2021, 117th Congress, introduced February 24, 2021, https://www.congress. gov/117/bills/s401/BILLS-117s401is.pdf (accessed March 17, 2023). 58. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, and Office of the Secretary, “Nondiscrimination in Health Programs and Activities,” Notice of Proposed Rulemaking; Notice of Tribal Consultation, Federal Register, Vol. 87, No. 149 (August 4, 2022), pp. 47824–47920, https://www.govinfo. gov/content/pkg/FR-2022-08-04/pdf/2022-16217.pdf (accessed March 17, 2023). 59. Ibid., p. 47916. 60. The regulation was not finalized before the end of the Administration. U.S. Department of Agriculture, Food and Nutrition Services, “Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP),” Proposed Rule, Federal Register, Vol. 84, No. 142 (July 24, 2019), pp. 35570–55581, https:// www.federalregister.gov/documents/2019/07/24/2019-15670/revision-of-categorical-eligibility-in-the- supplemental-nutrition-assistance-program-snap (accessed March 17, 2023). 61. 45 Code of Federal Regulations § 75.300(c) and (d), https://www.ecfr.gov/current/title-45/subtitle-A/ subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.300 (accessed March 17, 2023). 62. H.R. 1750, Child Welfare Provider Inclusion Act of 2021, 117th Congress, introduced March 10, 2021, https:// www.congress.gov/117/bills/hr1750/BILLS-117hr1750ih.pdf (accessed March 17, 2023), and S. 656, Child Welfare Provider Inclusion Act of 2021, 117th Congress, introduced March 10, 2021, https://www.congress.gov/117/bills/ s656/BILLS-117s656is.pdf (accessed March 17, 2023). 63. S. 3949, Trafficking Victims Protection Reauthorization Act of 2022, Public Law No. 117-348, 117th Congress, January 25, 2023, https://www.congress.gov/117/plaws/publ348/PLAW-117publ348.pdf (accessed March 17, 2023). 64. Kelsey Y. Santamaria, “Child Migrants at the Border: The Flores Settlement Agreement and Other Legal Developments,” Congressional Research Service In Focus No. IF11799, April 1, 2021, https://crsreports.congress. gov/product/pdf/IF/IF11799 (accessed March 17, 2023). 65. Report, Building a Happy Home: Marriage Education as a Tool to Strengthen Families, Social Capital Project Report No. 1-22, March 2022, p. 17, https://www.jec.senate.gov/public/_cache/files/3d102525-6f0d-48ed- 92f4-d71edd468ad6/building-a-happy-home.pdf (accessed March 17, 2023). The cover of the report reflects that the Social Capital Project is “[a] project of the Joint Economic Committee – Republicans.” 66. See, for example, Alan J. Hawkins, “Are Federally Supported Relationship Education Programs for Lower-Income Individuals and Couples Working? A Review of Evaluation Research,” American Enterprise Institute, September 2019, https://www. congress.gov/117/plaws/publ228/PLAW-117publ228.pdf (accessed March 17, 2023). 67. H.R. 8404, Respect for Marriage Act, Public Law No. 117-228, 117th Congress, December 13, 2022, https://www. congress.gov/117/plaws/publ228/PLAW-117publ228.pdf (accessed March 17, 2023). 68. Madison Marino, “Over 1,000 Safety Violations Mar Head Start. Children Deserve Better,” Heritage Foundation Commentary, November 10, 2022, https://www.heritage.org/education/commentary/over-1000-safety- violations-mar-head-start-children-deserve-better. 69. American Hospital Association v. Becerra, 596 U.S. ___ (2022), https://www.supremecourt.gov/ opinions/21pdf/20-1114_09m1.pdf (accessed March 17, 2023). 70. U.S. Department of the Treasury, Internal Revenue Service; U.S. Department of Labor, Employee Benefits Security Administration; and U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, “Coverage of Certain Preventive Services Under the Affordable Care Act,” Notice of Proposed Rulemaking, Federal Register, Vol. 88, No. 22 (February 2, 2023), pp. 7236–7281, https://www. govinfo.gov/content/pkg/FR-2023-02-02/pdf/2023-01981.pdf (accessed March 17, 2023). — 502 — Mandate for Leadership: The Conservative Promise 71. 42 U.S. Code § 238n, https://www.law.cornell.edu/uscode/text/42/238n (accessed March 17, 2023). 72. U.S. Department of Health and Human Services, Health Resources and Services Administration, “Early Childhood Health,” last reviewed October 2022, https://mchb.hrsa.gov/programs-impact/focus-areas/early- childhood-health (accessed March 17, 2023). 73. American Pregnancy Association, “Having a Doula—What Are the Benefits?” https://americanpregnancy. org/healthy-pregnancy/labor-and-birth/having-a-doula/#:~:text=Other%20studies%20have%20shown%20 that%20having%20a%20doula,massage%20to%20reduce%20stress%20and%20anxiety%20during%20labor (accessed March 17, 2023). 74. S. 2372, VA MISSION [Maintaining Internal Systems and Strengthening Integrated Outside Networks] Act of 2018, Public Law No. 115-182, 115th Congress, June 6, 2018, https://www.congress.gov/115/plaws/publ182/ PLAW-115publ182.pdf (accessed March 17, 2023). 75. U.S. Department of Health and Human Services, “Securing Updated and Necessary Statutory Evaluations Timely,” Final Rule, Federal Register, Vol. 86, No. 11 (January 19, 2021), pp. 5694–5764, https://www.govinfo. gov/content/pkg/FR-2021-01-19/pdf/2021-00597.pdf (accessed March 22, 2023). 76. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, “Compliance with Statutory Program Integrity Requirements,” Final Rule, Federal Register, Vol. 84, No. 42 (March 4, 2029), pp. 7714–7791, https://www.govinfo.gov/content/pkg/FR-2019-03-04/pdf/2019-03461.pdf (accessed March 18, 2023). 77. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, “Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services,” Final Rule, Federal Register, Vol. 86, No. 192 (October 7, 2021), pp. 56144–56180, https://www.govinfo.gov/content/ pkg/FR-2021-10-07/pdf/2021-21542.pdf (accessed March 18, 2023). 78. S. 624, Title X Abortion Provider Prohibition Act, 118th Congress, introduced March 2, 2023, https://www. congress.gov/118/bills/s624/BILLS-118s624is.pdf (accessed March 18, 2023). 79. 50 U.S. Code Chapter 55, https://www.law.cornell.edu/uscode/text/50/chapter-55 (accessed March 22, 2023). 80. 18 U.S. Code § 13, https://www.law.cornell.edu/uscode/text/18/13 (accessed March 18, 2023). 81. Bowen v. American Hospital Association, 476 U.S. 610 (1986), https://tile.loc.gov/storage-services/service/ll/ usrep/usrep476/usrep476610/usrep476610.pdf (accessed 22, 2023). 82. U.S. Department of Health and Human Services, Office of the Secretary, “Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972,” Federal Register, Vol. 86, No. 99 (May 25, 2021), pp. 27984–27985, https://www.govinfo.gov/content/pkg/FR- 2021-05-25/pdf/2021-10477.pdf (accessed March 18, 2023). 83. U.S. Department of Health and Human Services, Office for Civil Rights, “HHS Notice and Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy,” March 2, 2022, https://www.hhs.gov/sites/default/files/hhs- ocr-notice-and-guidance-gender-affirming-care.pdf (accessed March 18, 2023). 84. Heckler v. Chaney, 420 U.S. 821 (1985), https://caselaw.findlaw.com/us-supreme-court/470/821.html (accessed March 18, 2022). 85. U.S. Department of Health and Human Services, Office for Civil Rights, “Guidance to Nation’s Retail Pharmacies: Obligations Under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services,” content last reviewed July 14, 2022, https://www.hhs.gov/civil-rights/for-individuals/ special-topics/reproductive-healthcare/pharmacies-guidance/index.html (accessed March 18, 2023). 86. H.R. 3103, “Health Insurance and Portability and Accountability Act of 1996, Public Law No. 104-191, 104th Congress, August 21, 1996, https://www.congress.gov/104/plaws/publ191/PLAW-104publ191.pdf (accessed March 18, 2023). 87. U.S. Department of Human Services, “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care,” content last reviewed June 29, 2022, (accessed March 18, 2023). See also “Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet,” content last reviewed June 29, 2022, https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/ cell-phone-hipaa/index.html (accessed March 18, 2023).
AI Analysis:
"The bill focuses on reauthorizing stem cell research and cord blood banking programs, which is unrelated to Project 2025's HHS priorities such as abortion data reporting, gender identity data collection, FDA regulatory reforms, drug shortages, or abortion pill restrictions."
— 456 — Mandate for Leadership: The Conservative Promise abortion providers and whether better prenatal physical, mental, and social care improves infant outcomes and decreases abortion rates, especially among those who are most vulnerable. The Ensuring Accurate and Complete Abortion Data Reporting Act of 20239 would amend title XIX of the Social Security Act and Public Health Service Act to improve the CDC’s abortion reporting mechanisms by requiring states, as a condition of federal Medicaid payments for family planning services, to report streamlined variables in a timely manner. The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities. FOOD AND DRUG ADMINISTRATION (FDA) The FDA’s mission includes ensuring the safety and efficacy of drugs, biological products, and medical devices. Federal Laws That Shield Big Pharma from Competition. Because generics generally cost far less than brand-name drugs, consumers begin to save money as soon as a generic product comes on the market. The vast majority are very afford- able with 93 percent of generic products costing $20 or less. Savings would be even higher under proposals that prevent brand-name man- ufacturers from slowing down or impeding the entrance of generic products into the marketplace. Specifically, the FDA should prohibit pharmaceutical companies from purposely sitting on their legally available right to be the first to sell generic versions of their drugs. Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.10 Approval Process for Laboratory-Developed or Modified Medical Tests. Learning from the failed early COVID-19 testing experience, Congress and the FDA should focus on reforming laws and regulations governing medical tests, especially with respect to laboratory-developed tests. Commercial tests are developed with the intention of being widely marketed, distributed, and used, while laboratory-developed tests are created with the intention of being used solely within one laboratory. A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a “new” laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlab- oratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories with- out the current regulatory burdens.11 — 457 — Department of Health and Human Services The “laboratory-developed tests” category currently encompasses a range of possible tests, many of which would be characterized more appropriately as “lab- oratory-modified tests” because they are not truly novel tests but rather modified versions of existing tests. To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.12 Finally, the FDA has long held that it has regulatory authority over such tests, while others have argued that they should be considered clinical services regulated by the Centers for Medicare and Medicaid Services (CMS). The FDA currently has regulatory authority over in vitro diagnostics, and under the Clinical Lab- oratory Improvement Amendments (CLIA),13 the CMS ensures that labs meet analytical validity standards for test methods. Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.14 Drug Shortages. The very thin profit margins and the regulatory burdens associated with generic drug manufacturing discourage inventory and capacity investments by manufacturers and contribute to drug shortages. HHS and the FDA should encourage more dependable generic drug manufacturing. The FDA should expand its current pass/fail approach to drug facility inspec- tions into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability. The FDA should also add facility codes to drug packaging and construct a searchable database that cross-references product codes and facility codes. That would enable wholesalers and pharmacy benefit managers to identify and preference drugs manufactured at more reliable facilities, thus encouraging generic drug manufacturers to compete on reliability as well as on price. For its part, HHS should exempt multi-source generic drugs from requirements to pay rebates to Medicaid and other federally funded health programs, as those provisions penalize new investments in expanding manufacturing capacity when supply is unable to meet demand.15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or conducting its own. Abortion Pills. Abortion pills pose the single greatest threat to unborn chil- dren in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical. The abortion pill regimen is typically a two-part process. The first pill, mifepris- tone, causes the death of the unborn child by cutting off the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes con- tractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home. The abortion-pill regimen is currently approved for up to 70 days
Showing 3 of 5 policy matches
Policy matches are calculated using a hybrid approach: initial candidates are found using semantic similarity between bill summaries and Project 2025 policy text, then an AI model (Llama 3.1 70B) provides detailed alignment ratings and analysis. Ratings range from 1 (minimal alignment) to 5 (very strong alignment). This analysis does not imply direct causation or intent.