119-hr679

HR
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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.

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Introduced:
Jan 23, 2025
Policy Area:
Health

Bill Statistics

3
Actions
17
Cosponsors
1
Summaries
5
Subjects
1
Text Versions
Yes
Full Text

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Latest Action

Jan 23, 2025
Referred to the House Committee on Energy and Commerce.

Summaries (1)

Introduced in House - Jan 23, 2025 00
<p>This bill nullifies certain changes made by the Food and Drug Administration (FDA) to dispensing requirements for mifepristone. (Mifepristone is a drug that is approved to end pregnancies through 10 weeks gestation when used in conjunction with the drug misoprostol. The procedure is often referred to as medication abortion or the abortion pill.)</p> <p>The FDA regulates the use of mifepristone through the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program. The program requires health care providers to comply with certain requirements in order to prescribe or dispense mifepristone to end a pregnancy; the program previously included an in-person dispensing requirement that required mifepristone to be directly dispensed to patients in clinics, medical offices, or hospitals. During the COVID-19 public health emergency, the FDA temporarily stopped enforcing the in-person dispensing requirement, which allowed mail-order pharmacies to fill and dispense mifepristone prescriptions. </p> <p>In January 2023, the FDA modified program requirements so as to (1) remove the in-person dispensing requirement, and (2) require pharmacies to be certified in the program in order to dispense mifepristone. The modifications allow retail pharmacies, after receiving certification, to dispense mifepristone pursuant to prescriptions that are written by program-certified prescribers.</p> <p>The bill nullifies the January 2023 changes and prohibits any similar changes in the future.</p>

Actions (3)

Referred to the House Committee on Energy and Commerce.
Type: IntroReferral | Source: House floor actions | Code: H11100
Jan 23, 2025
Introduced in House
Type: IntroReferral | Source: Library of Congress | Code: Intro-H
Jan 23, 2025
Introduced in House
Type: IntroReferral | Source: Library of Congress | Code: 1000
Jan 23, 2025

Subjects (5)

Abortion Drug safety, medical device, and laboratory regulation Drug therapy Health (Policy Area) Prescription drugs

Cosponsors (17)

Text Versions (1)

Introduced in House

Jan 23, 2025

Full Bill Text

Length: 2,097 characters Version: Introduced in House Version Date: Jan 23, 2025 Last Updated: Nov 15, 2025 6:25 AM
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 679 Introduced in House

(IH) ]

<DOC>

119th CONGRESS
1st Session
H. R. 679

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.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

January 23, 2025

Mrs. Harshbarger (for herself, Mr. Hern of Oklahoma, Mr. Bost, Mrs.
Miller of Illinois, Mr. Weber of Texas, Mr. Babin, Mr. Moolenaar, Mr.
Webster of Florida, Mr. Baird, Mr. Higgins of Louisiana, Mr. Feenstra,
Mr. Yakym, Mr. Biggs of Arizona, Mr. Palmer, and Mr. Guest) 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.

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1.

(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.
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.
Act (21 U.S.C. 355-1) for mifepristone that is substantially similar to
any of the modifications nullified by subsection

(a) .
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