Restoring Safeguards for Dangerous Abortion Drugs Act
- Bill Number
- H.R. 5646
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-09-30: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2025-12-05T22:54:01Z
AI-Generated Summary
Purpose This legislation aims to restore a specific, stricter risk evaluation and mitigation strategy (REMS) for the drug mifepristone and to limit its importation and distribution through new liability rules and restrictions.
Key Provisions
- The Secretary of Health and Human Services must withdraw the current REMS for mifepristone within 90 days and replace it with the version approved in June 2011.
- The Secretary is required to maintain this exact 2011 REMS and cannot approve any different strategy.
- A new federal civil liability is created for telehealth providers, pharmacies, or others who import or transport mifepristone in violation of 18 U.S.C. 1462; affected individuals may sue for compensatory damages, punitive damages, and attorney fees.
- Section 801 of the Federal Food, Drug, and Cosmetic Act is amended to prohibit importation of mifepristone, including by mail.
- The bill defines mifepristone (also known as Mifeprex, Korlym, or RU-486) as the "covered medication."
Significant Changes to Existing Law
- Overrides the normal FDA process under 21 U.S.C. 355-1 by mandating a specific REMS rather than allowing updates or modifications.
- Adds a new private right of action for harm linked to mifepristone obtained through certain interstate or foreign commerce activities.
- Imposes an explicit statutory ban on mifepristone importation, expanding beyond current FDA authority.
Potential Impacts
- Government agencies: Requires the Department of Health and Human Services and FDA to revert to and maintain an older regulatory framework for this drug, limiting administrative flexibility.
- Citizens: May restrict access to mifepristone for certain medical uses by reinstating stricter distribution rules and creating new legal risks for providers and importers.
- International relations: Directly prohibits importation, including through mail, which could affect cross-border shipments and related commerce.
Main Stakeholders Affected
- Women using mifepristone for medical purposes.
- Health care providers, telehealth services, and pharmacies involved in distribution.
- The Department of Health and Human Services and FDA.
- Importers and entities handling interstate or foreign shipments of the drug.
Notable Legal, Constitutional, or Political Implications
- The mandated REMS and import ban could raise questions about federal preemption of state laws or challenges under existing constitutional protections related to medical access.
- The new tort provision adds federal court options for claims but does not override state remedies.
- The bill references existing criminal statutes (18 U.S.C. 1462) to define prohibited conduct, potentially expanding their application to this medication.
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 (8)
Rep. Moore, Barry [R-AL-1], Rep. Biggs, Sheri [R-SC-3], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Harrigan, Pat [R-NC-10], Rep. Burchett, Tim [R-TN-2], Rep. LaMalfa, Doug [R-CA-1], Rep. Guest, Michael [R-MS-3], Rep. Harris, Andy [R-MD-1]
Recent Actions
- 2025-09-30: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-30: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-30: Introduced in House
- 2025-09-30: Introduced in House
Bill Versions
- Restoring Safeguards for Dangerous Abortion Drugs Act — issued 2025-09-30 — PDF (4 pages)