Sponsors (14)
The bill creates a federally run hotline and mandated labeling intended to increase post-mifepristone support and information, but it risks substituting congressional claims for FDA science, creating medical confusion, narrowing referral choices, and imposing costs on manufacturers and taxpayers.
Women who take mifepristone would have access to a 24/7 federal hotline that provides immediate support and standardized referrals to APR providers, potentially improving timely access to follow-up care.
Patients and clinicians would receive mandated labeling within six months about asserted interactions between mifepristone and natural progesterone, increasing information available at the point of care.
Mandating specific medical claims on federal drug labeling substitutes congressional findings for FDA scientific determinations, creating substantial legal and regulatory risk and likely litigation.
Women and clinicians may receive labeling claims that conflict with current medical consensus and FDA-reviewed guidance, causing confusion about the safety and efficacy of mifepristone and potentially leading to inconsistent care.
Limiting referrals only to APR providers narrows the range of evidence-based medical counseling and services available after medication abortion, restricting patient choice and access to broader follow-up care.
Based on analysis of 2 sections of legislative text.
Requires a warning on mifepristone labeling about progesterone reversing its effects and creates a 24/7 HHS hotline that refers callers only to APR providers.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to require a warning label advising that the effects of mifepristone can be counteracted, to amend the Public Health Service Act to establish a hotline to provide information to women seeking to counteract the effects of mifepristone, and for other purposes.
Introduced January 28, 2025 by Mary E. Miller · Last progress January 28, 2025
Requires drug labeling for mifepristone to include a conspicuous warning that natural progesterone can counteract its abortifacient effects, increase the chance of fetal survival, and that a professional group has found progesterone safe in the first trimester; the labeling requirement takes effect six months after enactment. Creates a new Title X duty for HHS to operate or contract a 24/7 toll-free hotline to provide support to women seeking to "reverse the effects" of mifepristone and to refer callers only to providers who offer abortion pill reversal (APR) services.