Pregnancy Is Not an Illness Act of 2025

Bill Number: H.R. 795
Origin Chamber: House
Congress: 119th Congress, Session 1
Policy Area: Health
Status: Introduced
Latest Action: 2025-01-28: Referred to the House Committee on Energy and Commerce.
Last Updated: 2025-05-09T08:06:05Z

AI-Generated Summary

Purpose

The "Pregnancy Is Not an Illness Act of 2025" (H.R. 795) aims to prevent the Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), from classifying pregnancy as an illness when evaluating or approving drugs intended to induce abortions. This legislation seeks to redefine the regulatory framework for abortion medications by emphasizing that pregnancy is a natural condition, not a disease requiring medical treatment via abortion drugs.

Key Provisions

Prohibition on Treating Pregnancy as an Illness: HHS and the FDA are barred from considering pregnancy as an illness in two main areas:
Approving abortion drugs under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which governs the safety and effectiveness testing for new drugs.
Implementing or maintaining Risk Evaluation and Mitigation Strategies (REMS) under Section 505-1 of the FD&C Act, which are safety plans to manage known or potential risks of certain medications.
Nullification of Existing Approvals: Any prior FDA approvals of abortion drugs that were based wholly or partly on treating pregnancy as an illness are automatically revoked. This explicitly includes the current approval of mifepristone (a common abortion drug) as of the day before the bill's enactment.

Significant Changes to Existing Law

The bill alters the FDA's drug approval process under the FD&C Act by prohibiting the use of pregnancy as a qualifying "illness" for regulatory purposes, which has historically allowed abortion drugs to be evaluated similarly to treatments for other medical conditions.
It introduces a retroactive nullification clause, effectively revoking approvals like that of mifepristone without requiring new hearings or reviews, marking a direct intervention in ongoing FDA decisions.
No changes are made to approvals of non-abortion drugs or to other aspects of reproductive health regulations.

Potential Impacts

On Government Agencies: HHS and the FDA would face operational restrictions in drug reviews, potentially requiring them to revise guidelines, protocols, and databases for abortion-related medications. This could lead to increased legal and administrative workloads to implement nullifications and ensure compliance.
On Citizens: Individuals seeking medication abortions (e.g., via mifepristone) may lose access to FDA-approved options, affecting reproductive healthcare choices, particularly in areas with limited surgical abortion services. This could disproportionately impact low-income or rural populations reliant on these drugs.
On International Relations: Minimal direct impact, though it might influence U.S. positions in global health discussions on reproductive rights or drug safety standards, potentially straining relations with countries or organizations promoting abortion access.

Main Stakeholders Affected

Government Entities: HHS and FDA, as they must adjust approval processes and enforce nullifications.
Pharmaceutical Companies: Manufacturers of abortion drugs, such as those producing mifepristone, who could face market disruptions, lost revenues, and the need to seek re-approval under new criteria.
Healthcare Providers: Doctors, clinics, and pharmacies that prescribe or dispense abortion medications, potentially facing supply shortages or legal uncertainties.
Citizens and Advocacy Groups: Women of reproductive age, as well as pro-life organizations (who may support the bill) and pro-choice groups (who may oppose it), with broader effects on reproductive rights advocates and patients.

Notable Legal, Constitutional, or Political Implications

Legal Implications: The bill challenges the FDA's interpretive authority under the FD&C Act by mandating a specific view of pregnancy, which could invite lawsuits over administrative overreach or arbitrary nullification of approvals. It may also conflict with court precedents on drug regulation.
Constitutional Implications: Post the 2022 Supreme Court decision in Dobbs v. Jackson Women's Health Organization (which ended federal protection for abortion rights), this legislation could raise questions about federal interference in state-level abortion laws or equal protection under the law, though it focuses on drug approval rather than outright bans.
Political Implications: As an introduced bill in the 119th Congress (referred to the House Committee on Energy and Commerce), it reflects partisan divides on abortion, potentially fueling debates in an election-year context without immediate enforcement unless passed into law.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Miller, Mary E. [R-IL-15]

Cosponsors (11)

Rep. Babin, Brian [R-TX-36], Rep. Moore, Riley [R-WV-2], Rep. Ogles, Andrew [R-TN-5], Rep. Webster, Daniel [R-FL-11], Rep. Tenney, Claudia [R-NY-24], Rep. Harris, Andy [R-MD-1], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Harris, Mark [R-NC-8], Rep. Green, Mark E. [R-TN-7], Rep. Brecheen, Josh [R-OK-2], Rep. McGuire, John J. [R-VA-5]

Recent Actions

2025-01-28: Referred to the House Committee on Energy and Commerce.
2025-01-28: Introduced in House
2025-01-28: Introduced in House

Bill Versions

Pregnancy Is Not an Illness Act of 2025 — issued 2025-01-28 — PDF (3 pages)