Sponsors (14)
The bill aims to expand post-mifepristone information and referrals via mandated labeling and a federal hotline, trading potential increases in immediate support and centralized referrals for risks of restricted access to comprehensive care, labeling that may conflict with medical consensus, legal/regulatory disputes, and added costs for taxpayers and manufacturers.
Women who take mifepristone would have access to a 24/7 centralized HHS hotline for immediate support and standardized referrals, potentially improving post-medication-abortion assistance and connecting callers with APR providers.
Patients and clinicians would receive mandated labeling within 6 months about asserted interactions between mifepristone and natural progesterone, increasing information available at the point of care.
Women’s access to comprehensive post-abortion care could be restricted because referrals would be limited to APR providers, narrowing the range of evidence-based counseling and services available after medication abortion.
Labeling claims required by the bill could conflict with current medical consensus and FDA-reviewed guidance, causing confusion among patients and clinicians about the safety and efficacy of mifepristone.
Mandating specific medical claims on federal drug labeling substitutes congressional findings for FDA scientific determinations, creating legal and regulatory risks and potential challenges to existing regulatory processes.
Based on analysis of 2 sections of legislative text.
Requires mifepristone labels to warn that natural progesterone can counteract its effects and directs HHS to run a 24/7 hotline that refers callers only to APR providers.
Requires drug makers to add a conspicuous warning on mifepristone labeling that natural progesterone can counteract its abortifacient effects and may increase chances of fetal survival, and directs readers to a 24/7 federal hotline. Directs the Department of Health and Human Services to establish or maintain a toll-free hotline that provides support to people seeking to "reverse the effects" of mifepristone and to refer callers only to providers who offer abortion-pill-reversal (APR) services.
Introduced January 28, 2025 by Mary E. Miller · Last progress January 28, 2025