LABEL Act

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Bill ID: 119/hr/5969
Last Updated: November 13, 2025

Sponsored by

Rep. Moore, Barry [R-AL-1]

ID: M001212

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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!

Bill Summary

Another masterpiece of legislative theater, courtesy of the geniuses in Congress. The LABEL Act, a bill so cleverly crafted it's almost as if they wanted to make it sound like they're actually doing something meaningful.

**Main Purpose & Objectives:** The main purpose of this bill is to pretend to care about women's health while actually restricting access to abortion-inducing drugs. The sponsors of this bill are trying to create a false narrative that they're concerned about the safety and accountability of these medications, when in reality, they're just trying to score points with their anti-abortion base.

**Key Provisions & Changes to Existing Law:** The bill requires abortion-inducing drugs to bear labels identifying the name and address of the dispenser and the prescriber. Because, you know, that's exactly what's been missing from these medications – a nice, shiny label that says "Hey, I'm an abortion pill!" This is nothing more than a thinly veiled attempt to intimidate healthcare providers and pharmacies into not dispensing these medications.

**Affected Parties & Stakeholders:** The affected parties include women seeking abortions, healthcare providers, and pharmacies. But let's be real, the only stakeholders who actually matter are the politicians who sponsored this bill and their anti-abortion donors. The rest are just pawns in their game of legislative chess.

**Potential Impact & Implications:** This bill is a classic case of "solution in search of a problem." There's no evidence to suggest that abortion-inducing drugs are being misused or that the current labeling requirements are inadequate. But hey, who needs facts when you've got ideology and a desire to restrict women's reproductive rights? If this bill becomes law, it will likely lead to more restrictions on access to abortion services, further marginalizing vulnerable populations.

Diagnosis: This bill is suffering from a bad case of " Politician-itis" – a disease characterized by a complete disregard for facts, logic, and the well-being of constituents. The symptoms include grandstanding, pandering, and a healthy dose of hypocrisy. Treatment involves a strong dose of reality, a dash of common sense, and a healthy skepticism of anything that comes out of Congress.

Prognosis: Poor. This bill will likely pass with flying colors, because who needs evidence-based policy when you've got ideology and a desire to score points? The real victims here are the women who will be denied access to essential healthcare services, but hey, at least the politicians will get their soundbites and campaign contributions.

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Project 2025 Policy Matches

This bill shows semantic similarity to the following sections of the Project 2025 policy document. Higher similarity scores indicate stronger thematic connections.

Introduction

Moderate 69.8%
Pages: 488-490

— 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

Introduction

Moderate 61.4%
Pages: 530-532

— 497 — Department of Health and Human Services l OCR should withdraw its Health Insurance Portability and Accountability Act (HIPAA)86 guidance on abortion. OCR should withdraw its June 2022 guidance87 that purports to address patient privacy concerns following the Dobbs decision but is actually a politicized statement in favor of abortion and against Dobbs. HIPAA covers patients in the womb, but this guidance treats them as nonpersons contrary to law. The guidance is unnecessary and contributes to ideologically motivated fearmongering about abortion after Dobbs. AUTHOR’S NOTE: The preparation of this chapter was a collective enterprise of selfless individuals involved in the 2025 Presidential Transition Project. All contributors to this chapter are listed at the front of this volume and include former officials in the U.S. Department of Health and Human Services and other agencies, as well as academics, attorneys, and experts in the health care and insurance fields. — 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.

Introduction

Moderate 60.9%
Pages: 530-532

— 497 — Department of Health and Human Services l OCR should withdraw its Health Insurance Portability and Accountability Act (HIPAA)86 guidance on abortion. OCR should withdraw its June 2022 guidance87 that purports to address patient privacy concerns following the Dobbs decision but is actually a politicized statement in favor of abortion and against Dobbs. HIPAA covers patients in the womb, but this guidance treats them as nonpersons contrary to law. The guidance is unnecessary and contributes to ideologically motivated fearmongering about abortion after Dobbs. AUTHOR’S NOTE: The preparation of this chapter was a collective enterprise of selfless individuals involved in the 2025 Presidential Transition Project. All contributors to this chapter are listed at the front of this volume and include former officials in the U.S. Department of Health and Human Services and other agencies, as well as academics, attorneys, and experts in the health care and insurance fields.

About These Correlations

Policy matches are calculated using semantic similarity between bill summaries and Project 2025 policy text. A score of 60% or higher indicates meaningful thematic overlap. This does not imply direct causation or intent, but highlights areas where legislation aligns with Project 2025 policy objectives.