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Restoring Safeguards for Dangerous Abortion Drugs Act

USA119th CongressS-1631| Senate 
| Updated: 5/6/2025
Josh Hawley

Josh Hawley

Republican Senator

Missouri

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill, titled the "Restoring Safeguards for Dangerous Abortion Drugs Act," mandates significant changes to the regulation of mifepristone , defined as a "covered medication." It requires the Secretary of Health and Human Services to withdraw the current Risk Evaluation and Mitigation Strategy (REMS) for mifepristone within 90 days and reinstate the strategy identical to the one approved in June 2011 . Furthermore, the bill permanently prohibits the Secretary from approving any future REMS for mifepristone that deviates from this reinstated 2011 version, effectively imposing stricter regulatory controls on its distribution. The legislation also establishes a new federal cause of action, holding "covered entities" liable for harm caused by mifepristone. These entities include telehealth providers or pharmacies knowingly importing or transporting the drug in violation of federal law, and they can be sued for bodily injury or mental health harm attributable to such illegally distributed medication. Individuals may seek compensatory and punitive damages, as well as attorney's fees, with this provision taking effect 90 days after enactment and not preempting state remedies. Finally, the bill amends the Federal Food, Drug, and Cosmetic Act to impose a comprehensive ban on the importation of mifepristone into the United States, explicitly including its mailing to individuals.
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Timeline
May 6, 2025
Introduced in Senate
May 6, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 30, 2025

Latest Companion Bill Action

HR 119-5646
Introduced in House
  • May 6, 2025
    Introduced in Senate


  • May 6, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • September 30, 2025

    Latest Companion Bill Action

    HR 119-5646
    Introduced in House

Health

Related Bills

  • HR 119-5646: Restoring Safeguards for Dangerous Abortion Drugs Act

Restoring Safeguards for Dangerous Abortion Drugs Act

USA119th CongressS-1631| Senate 
| Updated: 5/6/2025
This bill, titled the "Restoring Safeguards for Dangerous Abortion Drugs Act," mandates significant changes to the regulation of mifepristone , defined as a "covered medication." It requires the Secretary of Health and Human Services to withdraw the current Risk Evaluation and Mitigation Strategy (REMS) for mifepristone within 90 days and reinstate the strategy identical to the one approved in June 2011 . Furthermore, the bill permanently prohibits the Secretary from approving any future REMS for mifepristone that deviates from this reinstated 2011 version, effectively imposing stricter regulatory controls on its distribution. The legislation also establishes a new federal cause of action, holding "covered entities" liable for harm caused by mifepristone. These entities include telehealth providers or pharmacies knowingly importing or transporting the drug in violation of federal law, and they can be sued for bodily injury or mental health harm attributable to such illegally distributed medication. Individuals may seek compensatory and punitive damages, as well as attorney's fees, with this provision taking effect 90 days after enactment and not preempting state remedies. Finally, the bill amends the Federal Food, Drug, and Cosmetic Act to impose a comprehensive ban on the importation of mifepristone into the United States, explicitly including its mailing to individuals.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 6, 2025
Introduced in Senate
May 6, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 30, 2025

Latest Companion Bill Action

HR 119-5646
Introduced in House
  • May 6, 2025
    Introduced in Senate


  • May 6, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • September 30, 2025

    Latest Companion Bill Action

    HR 119-5646
    Introduced in House
Josh Hawley

Josh Hawley

Republican Senator

Missouri

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 119-5646: Restoring Safeguards for Dangerous Abortion Drugs Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted