Restoring Safeguards for Dangerous Abortion Drugs Act

United States119th CongressHR-5646House of Representatives
Updated: Sep 30, 2025

Summary

The act directs the Secretary of Health and Human Services to withdraw the current risk evaluation and mitigation strategy (REMS) for mifepristone and to re‑approve the identical strategy that was adopted in June 2011. It bars the Secretary from approving any REMS that differs from that 2011 plan, ensuring that the drug’s distribution remains governed by the older safeguards. The requirement must be completed within 90 days of enactment. The bill creates a federal tort that holds any covered entity —such as a telehealth provider or pharmacy—that knowingly imports or transports mifepristone in violation of federal law liable for bodily injury or mental‑health harm. Victims may sue for compensatory and punitive damages, as well as attorney’s fees, in either federal or state court. Additionally, the act amends the Food, Drug, and Cosmetic Act to prohibit the importation of mifepristone , including by mail, reinforcing the ban on the drug’s entry into the United States.

Bill texts

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Introduced (House)View official text

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Timeline

Latest companion bill action

S-1631: Restoring Safeguards for Dangerous Abortion Drugs Act

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  1. 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.

    House of Representatives

  2. Introduced in House

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