Sponsors (12)
Prohibits HHS/FDA from treating pregnancy as an illness for approving abortion drugs or REMS and voids approvals that relied on that rationale, including mifepristone.
This bill seeks to void certain FDA approvals tied to treating pregnancy as an illness — which would curb access to medication abortion and create significant health, cost, legal, and supply-chain harms for patients and providers, while offering limited, primarily ideological benefits to those who oppose abortion.
Americans and groups who oppose abortion (including some religious and pro-life advocates) would see reduced availability of medication abortion, aligning drug approvals with their policy and moral goals.
The bill could force regulatory reassessment of FDA approvals for pregnancy-related uses, which proponents may argue improves legal consistency between statutory definitions and drug approvals.
Pregnant people seeking medication abortion would lose access to FDA-approved mifepristone and potentially other abortion drugs because the statute voids approvals that treated pregnancy as an illness.
People needing abortion care and hospitals could face higher out-of-pocket costs and more invasive treatment because medication abortion would be unavailable or limited, shifting care toward surgical procedures or unapproved alternatives.
Clinicians, pharmacists, and health systems could face legal and regulatory uncertainty or increased liability when prescribing or dispensing abortion drugs if prior FDA approvals are invalidated, disrupting clinical practice and access.
Based on analysis of 2 sections of legislative text.
Prohibits the Department of Health and Human Services (including the FDA) from treating pregnancy as an illness when approving or imposing REMS on abortion drugs, and voids any existing drug approvals that relied in whole or in part on treating pregnancy as an illness — explicitly including the existing approval of mifepristone. Effectively, approvals of abortion medications that used pregnancy-as-illness reasoning would be declared invalid from the start.
Official title: To prohibit the Department of Health and Human Services from treating pregnancy as an illness for purposes of approving abortion drugs.
Introduced January 28, 2025 by Mary E. Miller · Last progress January 28, 2025