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HR 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.

119th Congress Introduced by Brian Babin and 16 co-sponsors

HR 679 nullifies recent FDA changes to mifepristone's risk evaluation strategy, limiting HHS's authority and potentially impacting access to medical abortion services.

Introduced in House
0
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Bill Summary · HR 679

Summary of HR 679: Nullification of FDA Modifications to Mifepristone Risk Evaluation and Mitigation Strategy

Bill Overview

  • Bill Number: HR 679
  • Title: 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.
  • Status: Introduced in the House of Representatives
  • Introduced On: January 23, 2025
  • Classification: Legislative Bill

Purpose and Intent

The primary purpose of HR 679 is to nullify specific modifications made by the Food and Drug Administration (FDA) in January 2023 regarding the risk evaluation and mitigation strategy (REMS) for mifepristone, a medication used for medical abortions. The bill aims to prevent the enforcement of any similar provisions that could be established by the Department of Health and Human Services (HHS) in the future.

Key Provisions

  1. Nullification of FDA Modifications:

    • The bill explicitly nullifies the modifications made by the FDA to the REMS for mifepristone as of January 2023.

  2. Prohibition on Similar Provisions:

    • It prohibits the Secretary of Health and Human Services, or any head of an office, department, or agency within HHS, from establishing, implementing, or enforcing any REMS provisions for mifepristone that are substantially similar to those nullified by the bill.

Affected Parties

  • Patients: Individuals seeking medical abortions using mifepristone may be directly affected by changes in the regulatory landscape surrounding the drug.
  • Healthcare Providers: Medical professionals who prescribe or administer mifepristone may experience changes in the regulatory requirements and guidelines they must follow.
  • FDA and HHS: The bill directly impacts the authority and regulatory framework of these agencies concerning mifepristone.

Legislative Actions

  • January 23, 2025: The bill was introduced and referred to the House Committee on Energy and Commerce for further consideration.

Sponsors

The bill is sponsored by:
- Primary Sponsor: Diana Harshbarger
- Cosponsors:
- Daniel Webster
- Kevin Hern
- Gary J. Palmer
- Sheri Biggs
- Randy Feenstra
- Keith Self
- Michael Guest
- James R. Baird
- Andy Harris
- Andy Biggs
- Mary E. Miller
- Rudy Yakym
- John R. Moolenaar
- Brian Babin
- Mike Bost
- Clay Higgins

Conclusion

HR 679 seeks to reverse recent FDA changes to the risk evaluation and mitigation strategy for mifepristone, aiming to limit the regulatory authority of HHS over this medication. The bill's implications could significantly affect access to medical abortion services and the regulatory environment surrounding reproductive health. As it progresses through the legislative process, stakeholders in healthcare and reproductive rights will be closely monitoring its developments.

Compiled from official sources — confirm details with the bill’s official record.

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