US Federal 2025-2026 Regular Session

US Federal House Bill HB5646

Introduced
9/30/25  

Caption

Restoring Safeguards for Dangerous Abortion Drugs Act

Impact

The enactment of HB 5646 would likely lead to significant changes in how mifepristone is regulated and prescribed. It establishes a legal framework requiring that any covered medication, specifically mifepristone, adheres to stricter safety protocols. Additionally, the bill introduces civil liability for telehealth providers and pharmacies that engage in activities violating the terms of import and distribution of this drug. This could deter such entities from participating in the supply chain of mifepristone, potentially impacting access for individuals seeking medication abortions.

Summary

House Bill 5646, titled 'Restoring Safeguards for Dangerous Abortion Drugs Act', mandates that the Secretary of Health and Human Services develop a risk evaluation and mitigation strategy for mifepristone that mirrors the strategy approved earlier in June 2011. This legislation aims to enhance oversight of the medication, which is widely used in medical abortions. By requiring the withdrawal of current approval and reinstating prior strategies, the bill is intended to ensure that the risk management protocols are robust and align with past practices deemed safer for public health.

Contention

The bill has sparked contention among various stakeholders. Supporters argue that it protects women by ensuring that only safe, appropriately evaluated medications are available for abortion, thereby safeguarding against any potential adverse effects. Conversely, opponents highlight concerns about restricting access to crucial reproductive health options and suggest that increased regulatory hurdles may disproportionately impact women, particularly those in underserved areas. The underlying debates focus on balancing safety and accessibility, with advocates on both sides presenting strong arguments regarding women's health rights and the regulation of abortion drugs.

Companion Bills

US SB1631

Same As Restoring Safeguards for Dangerous Abortion Drugs Act

Previously Filed As

US SB1631

Restoring Safeguards for Dangerous Abortion Drugs Act

US HB7902

Safeguarding Women from Chemical Abortion Act

US SB4066

Safeguarding Women from Chemical Abortion Act

US HB1525

Protecting Life from Chemical Abortions Act

US HB679

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.

US HB6509

SAFE Drugs Act of 2025 Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025

US SB1082

Safeguarding Medicaid Act

US SSB3115

A bill for an act relating to abortions including informed consent, dispensing abortion-inducing drugs, and reporting abortion-inducing drug complications.

US HF2563

A bill for an act relating to abortions including informed consent, dispensing abortion-inducing drugs, and reporting abortion-inducing drug complications.(Formerly HSB 704; See HF 2788.)

US SB3794

SAFE Drugs Act of 2026 Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026

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