Restoring Safeguards for Dangerous Abortion Drugs Act
This bill, the Restoring Safeguards for Dangerous Abortion Drugs Act, would reinscribe a very restrictive regulatory framework around the abortion drug mifepristone (also known as Mifeprex, Korlym, RU-486). Within 90 days of enactment, the Secretary of Health and Human Services would withdraw the current risk evaluation and mitigation strategy (REMS) for mifepristone and require a new REMS that is identical to the June 2011 version, prohibiting any REMS that differs from that older framework. Separately, the bill creates a federal tort regime that holds certain “covered entities” liable for injuries allegedly caused by imported or transported mifepristone, and it imposes a broad ban on importing the drug into the United States (including mailing it to individuals). The net effect would be stricter control over how mifepristone is regulated, imported, and accessed, with a legal framework that can facilitate private civil suits for injuries associated with the drug. Key provisions include: (1) redefining and limiting the REMS for mifepristone to the June 2011 version; (2) establishing a private right of action and damages for bodily and mental-health injuries tied to imported/transported mifepristone by “covered entities”; (3) a nationwide import ban on mifepristone, including mailing to individuals; and (4) specific effective dates for the REMS/tort provisions and the import ban.
Key Points
- 1Reinstatement of REMS identical to the June 2011 approval for mifepristone. The Secretary must withdraw the current REMS and approve a new one that is exactly the same as the 2011 version, and may not approve any REMS that differs from that version.
- 290-day deadline for REMS actions. The Secretary must act within 90 days after enactment to withdraw the existing REMS and approve the identical 2011 REMS.
- 3Federal tort liability for harm from imported/transported mifepristone. A “covered entity” (a telehealth provider, pharmacy, or any person knowingly importing or transporting mifepristone in interstate or foreign commerce in violation of law) could be sued by individuals for bodily injury or harm to mental health attributable to using the drug, with available compensatory and punitive damages and attorney’s fees.
- 4Private right of action, with state options. Individuals harmed by the drug can sue in federal or state courts for damages; the provision preserves the possibility of pursuing other remedies under state law.
- 5Broad import ban on mifepristone. The bill would amend import provisions to prohibit any importation of mifepristone into the United States, including mailing the drug to individuals, effectively blocking access via mail-order or cross-border routes.
- 6Effective dates. The REMS/tort provisions take effect 90 days after enactment; the import ban is (by its language) effective upon enactment, subject to any other applicable legal constraints.
- 7Defined term “covered medication.” The bill uses “covered medication” to mean mifepristone, including its brand names and development code RU-486.