HR 795119th CongressIn Committee

Pregnancy Is Not an Illness Act of 2025

Introduced: Jan 28, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

This bill, the Pregnancy Is Not an Illness Act of 2025, would prevent the Department of Health and Human Services (including the FDA) from treating pregnancy as an illness when approving abortion drugs under the federal drug approval law (the FD&C Act). It would block approvals and any risk management mitigations (REMS) that were based, in whole or in part, on treating pregnancy as an illness, and it would retroactively nullify such prohibited approvals. Notably, the bill explicitly includes the abortion drug mifepristone as an example of an approval that could be impacted if it relied on pregnancy being treated as an illness, even if that approval was already in effect on the day before enactment. The short title given to the bill is the “Pregnancy Is Not an Illness Act of 2025.” The bill was introduced in the House and referred to the Committee on Energy and Commerce. In short, the bill would overturn or invalidate certain abortion-drug approvals by changing the legal basis used to grant them, with potential retroactive effects, and would narrow the FDA’s reasoning for approving abortion medications.

Key Points

1Prohibition on treating pregnancy as illness: The bill bars HHS, including the FDA, from using pregnancy being an illness as part of the basis for approving an abortion drug (under FD&C Act sections 505 and 505-1, which cover drug approvals and REMS programs).
2Nullification of affected approvals: Any abortion-drug approval that relied on the notion of treating pregnancy as an illness would be nullified under the bill.
3Definition of prohibited approvals: A prohibited approval is one granted under section 505 that depended at least in part on treating pregnancy as illness; this includes mifepristone if its approval relied on that treatment premise and was in effect on the day before enactment.
4Retroactive scope: The bill expressly addresses abortions drugs already approved and in effect prior to enactment, potentially overturning those decisions if they meet the “relied on pregnancy as illness” criterion.
5Legislative status and citation: Introduced in the House on January 28, 2025, sponsored by multiple Representatives, and referred to the Committee on Energy and Commerce.

Impact Areas

Primary group/area affected- Pregnant individuals seeking abortion and those seeking abortion medications (e.g., mifepristone).- Healthcare providers (clinicians, pharmacists) who prescribe or dispense abortion drugs, as well as clinicians who counsel patients about access.Secondary group/area affected- Drug manufacturers and the FDA (regulatory staff and processes) who would need to reassess approvals and REMS tied to the bill’s rationale.- Healthcare systems and insurers that cover abortion medications, potentially facing changes in product availability or required documentation.Additional impacts- Legal and regulatory uncertainty: Retroactive nullification of approvals could trigger legal challenges, patient safety concerns, and confusion among states, providers, and patients about the existing status of abortion medications.- State-federal dynamics: States may respond with their own rules or access restrictions, potentially interacting with the bill’s changes in unpredictable ways.- Public health and access implications: Depending on how approvals are affected, access to medically supervised abortion options could be expanded, narrowed, or disrupted.FD&C Act 505: The provision governing the approval of new drugs in the United States.FD&C Act 505-1: Provisions dealing with risk evaluation and mitigation strategies (REMS) to ensure safe use of certain drugs.Mifepristone: A widely used abortion medication whose FDA approval could be impacted if its approval relied on pregnancy being treated as an illness under the bill’s framework.

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