Safeguarding Women from Chemical Abortion Act
Summary
What This Bill Does
The Safeguarding Women from Chemical Abortion Act deems FDA approval withdrawn for brand-name mifepristone and generic versions indicated for termination of intrauterine pregnancy, effective 14 days after enactment. Introducing those drugs into interstate commerce is then treated as an unapproved-drug violation. Mifepristone is treated as misbranded if its label says it may be used alone or with another drug to terminate pregnancy.
Separately, 90 days after enactment, a manufacturer of covered mifepristone is liable to an individual for bodily injury or mental-health harm attributable in whole or in part to use of its product. The individual may sue in federal district court or a competent state court for compensatory damages, punitive damages, attorney fees, and costs.
The federal tort does not preempt a state law offering another remedy. A final rule of construction says the Act does not affect section 1461 of title 18.
The approval withdrawal applies to the abortion indication identified in the text. The bill does not create a tort claim against a prescriber or pharmacy in section 3, state a damages cap, or displace additional state remedies. The 14-day withdrawal and 90-day tort effective dates are distinct.
Who Benefits and How
Individuals who establish covered physical or mental harm gain a federal cause of action, broad causation language, multiple damages categories, and fee recovery. Plaintiffs' attorneys gain compensable cases. State-law claimants retain other remedies. People concerned about exposure to mifepristone for abortion may view withdrawal as reducing drug-related risk.
Who Bears the Burden and How
Brand and generic mifepristone manufacturers lose the abortion-indication market and face federal tort exposure, punitive damages, and litigation costs. Patients seeking medication abortion lose access to the covered approved drugs and may face travel, delay, continued-pregnancy, or procedural-alternative costs. Prescribers, pharmacies, and abortion providers lose a treatment option and related revenue. FDA must implement withdrawal, misbranding, and interstate-commerce enforcement. Federal and state courts receive new claims.
Key Provisions
- Withdraws covered mifepristone approvals after 14 days.
- Prohibits interstate introduction of the withdrawn drugs.
- Treats abortion-use labeling as misbranding.
- Creates manufacturer liability after 90 days.
- Authorizes compensatory and punitive damages.
- Provides attorney fees and litigation costs.
- Preserves additional remedies available under state law.
- Protects the continued legal effect of 18 U.S.C. 1461.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Withdraws federal approval of brand and generic mifepristone for terminating intrauterine pregnancy after 14 days, treats interstate sale and abortion labeling as federal violations, and after 90 days creates a federal manufacturer tort for physical or mental harm with compensatory damages, punitive damages, attorney fees, preserved state remedies, and no change to 18 U.S.C. 1461.
Key Policy Areas
Mifepristone Approval, Medication Abortion, Federal Drug Enforcement, Pharmaceutical Product Liability, Reproductive Health Access
Primary Purpose
Withdraws federal approval of brand and generic mifepristone for terminating intrauterine pregnancy after 14 days, treats interstate sale and abortion labeling as federal violations, and after 90 days creates a federal manufacturer tort for physical or mental harm with compensatory damages, punitive damages, attorney fees, preserved state remedies, and no change to 18 U.S.C. 1461.
Policy Domains
Sections 2 through 4 mifepristone withdrawal, tort, and construction
Identified Gains
- Mifepristone users proving covered injury
- Claimants seeking compensatory damages
- Claimants seeking punitive damages
- Plaintiffs attorneys bringing covered actions
- State-law claimants retaining additional remedies
- Patients avoiding covered drug exposure
Identified Costs
- Brand-name mifepristone manufacturers
- Generic mifepristone manufacturers
- Patients seeking medication abortion
- Clinics providing medication abortion
- Pharmacies dispensing covered mifepristone
- FDA drug-withdrawal enforcement staff
- Courts hearing new manufacturer claims
- Product-liability insurers covering manufacturers
Sponsors
Legislative Progress
In CommitteeReferred to the Committee on Energy and Commerce, and in …
Introduced in House
Mrs. Harshbarger introduced the following bill; which was referred to …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Claimants seeking compensatory damages, Claimants seeking punitive damages, Manufacturer defense counsel
Positive-direction: Claimants seeking compensatory damages, Claimants seeking punitive damages, Plaintiffs attorneys bringing covered actions, State-law claimants retaining additional remedies
Negative-direction: Manufacturer defense counsel
Brand-name mifepristone manufacturers, Generic mifepristone manufacturers, Manufacturers facing fee-shifting exposure
Injured users recovering litigation costs, Mifepristone users proving covered injury
Federal courts hearing covered claims, State courts hearing covered claims
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "court"
- → Federal or state court hearing a covered tort claim
- "patient"
- → Patient seeking medication abortion
- "claimant"
- → Individual suffering covered harm after using mifepristone
- "regulator"
- → Food and Drug Administration
- "manufacturer"
- → Manufacturer of brand or generic mifepristone
Note: {'scope_ids': ['mifepristone_withdrawal_and_tort'], 'description': 'The bill has distinct 14-day and 90-day effective dates; the tort runs against manufacturers rather than prescribers in its text, preserves other state remedies, and expressly leaves 18 U.S.C. 1461 unaffected.'}
Key Definitions
Terms defined in this bill
Physical, psychological, emotional, or physiological harm attributable in whole or in part to use of covered mifepristone.
A person manufacturing covered mifepristone for introduction into interstate commerce.
Brand or generic mifepristone approved with an indication for termination of intrauterine pregnancy.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology