This bill mandates the reinstatement of the 2011 safety protocols for mifepristone, bans its importation, and creates a federal cause of action for harm resulting from illegally distributed abortion drugs.
Mary Miller
Representative
IL-15
The Restoring Safeguards for Dangerous Abortion Drugs Act mandates that the FDA immediately revert the safety requirements for mifepristone to the 2011 Risk Evaluation and Mitigation Strategy (REMS). This legislation also establishes a new federal cause of action allowing individuals harmed by illegally imported abortion drugs to sue the responsible entities. Finally, the Act explicitly bans the importation of mifepristone into the United States.
New Bill Forces FDA to Roll Back Abortion Pill Safety Rules to 2011 Standards and Bans All Imports
The aptly named “Restoring Safeguards for Dangerous Abortion Drugs Act” is a laser-focused bill aimed squarely at one medication: mifepristone. This legislation doesn't mess around with broad policy; it zeroes in on the drug used in medication abortion, demanding immediate and specific changes to how it is regulated, distributed, and accessed in the U.S.
The Regulatory Time Machine: Back to 2011
The biggest regulatory shift is tucked into Section 3, which deals with the drug’s Risk Evaluation and Mitigation Strategy (REMS). Think of the REMS as the FDA’s special safety playbook for drugs with serious risks. The bill mandates that, within 90 days, the Secretary of Health and Human Services must scrap the current safety rules for mifepristone and replace them with the exact requirements that were in place back in June 2011. Even more critically, the bill explicitly strips the FDA of its usual flexibility, stating the agency can never approve a safety plan for this drug that is different from that 2011 version. For busy people, this means the FDA loses its ability to update safety protocols based on new data and real-world experience, locking the drug into more than decade-old rules. This change could directly impact access, as the 2011 rules were generally much stricter regarding who could prescribe and dispense the medication compared to today’s standards.
Border Control for Pills: The Importation Ban
Section 5 introduces a total ban on importing mifepristone into the United States, overriding any other laws that might allow it. This includes mailing the drug to individuals. This isn't just about large pharmaceutical shipments; it’s about any form of the drug crossing the border. For patients and providers, this provision immediately cuts off any supply chain that relies on international sourcing, potentially tightening the overall domestic supply and making the drug harder to get, especially in areas where access is already limited.
New Liability Risks for Telehealth and Pharmacies
Section 4 creates a brand new federal cause of action, or the right to sue, against “covered entities.” A covered entity is defined as a telehealth provider, pharmacy, or anyone else who knowingly imports or transports the medication illegally (violating Title 18, Section 1462 of the U.S. Code). If a person uses one of these illegally sourced pills and suffers physical injury or mental health harm as a result, they can sue the entity that brought it in for compensatory damages, punitive damages, and their legal fees. This provision is designed to punish illegal distributors, but it also introduces a significant new layer of legal risk for any provider or pharmacy involved in distributing the drug, even if they are operating legally, as they now face potential federal lawsuits if the drug is deemed illegally imported or transported. This new liability could push providers and pharmacies to stop offering the drug altogether to avoid the legal headache, making access even harder for regular people.