Restoring Safeguards for Dangerous Abortion Drugs Act

Bill Summary: Restoring Safeguards for Dangerous Abortion Drugs Act (H.R. 5646)

Overview

The Restoring Safeguards for Dangerous Abortion Drugs Act seeks to restrict the distribution and importation of mifepristone (known by brand names Mifeprex and Korlym, or the code name RU-486). The bill aims to revert the medication's safety protocols to more restrictive standards, ban its importation, and create a federal legal pathway for individuals to sue providers who distribute the drug outside of these regulations.

Key Provisions

1. Reinstatement of 2011 REMS Protocols

The bill mandates that the Secretary of Health and Human Services (HHS) withdraw the current Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Within 90 days of enactment, the Secretary must replace it with a strategy identical to the one approved in June 2011.
* Impact: This effectively reverses more recent updates to the drug's distribution guidelines, returning it to the more stringent oversight and dispensing requirements in place over a decade ago.

2. Ban on Importation

The bill amends the Federal Food, Drug, and Cosmetic Act to explicitly prohibit the importation of mifepristone into the United States.
* Scope: This ban specifically includes the mailing of the drug to individuals, closing loopholes that might allow for international shipment of the medication.

3. Federal Civil Liability (Private Right of Action)

The legislation creates a new federal tort allowing individuals to sue "covered entities" for damages.
* Who is affected: "Covered entities" include telehealth providers, pharmacies, or any person who knowingly imports or transports mifepristone in violation of federal law.
* Basis for lawsuit: An individual may sue if they suffer bodily injury or harm to their mental health (including psychological, emotional, or physiological harm) that is attributable, in whole or in part, to the use of the illegally imported or transported medication.
* Recoverable Damages: Plaintiffs may seek:
* Compensatory damages
* Punitive damages
* Attorney's fees and costs

Affected Parties

• Telehealth Providers and Pharmacies: These entities would face significant legal liability and potential lawsuits if they distribute mifepristone outside of the reinstated 2011 REMS guidelines or via prohibited importation channels.
• Patients: Individuals seeking mifepristone via mail or telehealth services may find these avenues restricted or illegal.
• HHS Secretary: Given a strict 90-day mandate to change federal regulatory approvals for the drug's distribution.

Timeline and Procedural Status

• Introduced: September 30, 2025.
• Current Status: Referred to the Committee on Energy and Commerce and the Committee on the Judiciary.
• Implementation: If passed, the REMS reversal and the federal tort provisions would take effect 90 days after the date of enactment.