Sponsors (19)
This bill increases access to and reduces administrative burdens for medication abortion, but does so by removing FDA safety controls and statutory tools—trading greater access and simplicity for reduced regulatory safeguards and potential legal uncertainty.
Women and other people seeking medication abortion will face fewer regulatory barriers and gain faster, broader outpatient access to mifepristone.
Clinicians, clinics, and health systems will have simpler compliance obligations, reducing administrative burden and the potential for service delays.
Removing some FDA safety controls for mifepristone could increase the risk of rare but serious adverse events for patients who use the drug.
Reducing or eliminating REMS provisions will limit the FDA's ability to impose targeted safety measures in the future, weakening regulatory flexibility to respond to emerging safety concerns.
Potential legal and administrative conflicts between federal agencies and courts could create uncertainty for providers and patients, disrupting implementation and access to care.
Based on analysis of 2 sections of legislative text.
Nullifies the FDA's January 2023 REMS changes for mifepristone and bars HHS from imposing substantially similar REMS provisions.
Nullifies the FDA's January 2023 changes to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone and bars the Department of Health and Human Services (HHS) or any HHS component head from creating, carrying out, or enforcing any REMS provision for mifepristone that is substantially similar to those nullified changes. The text does not provide funding, enforcement details beyond the prohibition, or an explicit effective date.
Introduced January 23, 2025 by Diana Harshbarger · Last progress January 23, 2025