H.R. 383House118th Congress (2023-2025)In Committee

To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

Introduced January 17, 2023

AI-Generated Summary

Updated January 20, 2026 at 2:15 AM UTC

The bill seeks to cancel the Food and Drug Administration’s January 2023 changes to the risk evaluation and mitigation strategy (REMS) for the abortion medication mifepristone. It also bars the Department of Health and Human Services from creating any new REMS provisions that are substantially similar to the cancelled changes. This would affect how mifepristone is regulated and accessed by patients and healthcare providers.

Key Provisions

  • Nullify the FDA’s January 2023 modifications to the REMS for mifepristone.
  • Prohibit the Secretary of Health and Human Services or any HHS official from establishing, implementing, or enforcing any REMS provision for mifepristone that is substantially similar to the nullified changes.

Legislative Activity

Stay on top of the latest movement without scrolling through every action

2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

January 27, 2023

View full timeline
HouseIntro Referral

Introduced in House

January 17, 2023

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

January 17, 2023

HouseCommittee

Referred to the Subcommittee on Health.

January 27, 2023

Bill Text

Latest available legislative text

Reading Mode
Latest
Introduced in HouseIssued January 17, 2023

I

118th CONGRESS

1st Session

H. R. 383

IN THE HOUSE OF REPRESENTATIVES

January 17, 2023

Mrs. Harshbarger (for herself, Mr. Hern, Mr. Lamborn, Mr. Baird, Mr. Carter of Georgia, Mr. Weber of Texas, Mrs. Miller of Illinois, Mr. Banks, Mr. Jackson of Texas, Mr. Webster of Florida, Mr. Duncan, Mr. Feenstra, Mr. Smith of New Jersey, and Mr. Gosar) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes.

1.

Nullification of modifications to REMS for mifepristone

(a)

Nullification

The modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for mifepristone are hereby nullified.

(b)

No substantially similar provisions

The Secretary of Health and Human Services (or any head of any office, department, or agency of the Department of Health and Human Services) shall not establish, implement, or enforce any provision of a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for mifepristone that is substantially similar to any of the modifications nullified by subsection (a).