Sponsors (3)
Want the plain-English version? I'll explain what this bill does.
This is not an official government website.
Copyright © 2026 PLEJ LC. All rights reserved.
Removes FDA approval for the drug mifepristone when it is used to terminate an intrauterine pregnancy, makes interstate distribution of such products unlawful, and treats labeling that indicates use for pregnancy termination as misbranding. It also creates a new federal civil cause of action allowing anyone harmed by use of that drug for pregnancy termination to sue the manufacturer for compensatory and punitive damages, with attorney’s fees and preservation of state-law remedies; that civil-liability remedy becomes effective 90 days after enactment. The Act also clarifies it does not alter an existing criminal statute (18 U.S.C. §1461).
The bill shifts control and legal accountability around mifepristone toward state enforcement and private litigation: it strengthens remedies for people claiming harm from the drug but simultaneously reduces nationwide access, raises legal and economic risks for providers and manufacturers, and can—
State governments and residents of states that restrict abortion gain stronger ability to enforce state-level limits on mifepristone and reduce cross-state shipment of the drug.
People who claim physical or mental-health injury from mifepristone can sue the manufacturer in federal or state court and seek compensatory and punitive damages plus attorney’s fees, increasing access to financial remedies.
Courts, law enforcement, and regulated parties have clearer legal certainty because the Act explicitly preserves existing federal obscenity/mail statutes (18 U.S.C. §1461) and states that this Act does not alter those provisions.
Pregnant people and others seeking medication abortion will lose access to an FDA‑approved mifepristone option nationwide, making care harder to obtain, increasing travel and delays, and raising health risks and costs (especially for low‑income patients).
Healthcare providers, clinics, pharmacies, and distributors face criminal, civil, or regulatory liability for prescribing, dispensing, or shipping mifepristone across state lines, creating legal risk that may limit provision of care.
Pharmacies, manufacturers (including generic makers), and distributors could lose approvals, revenue, and market access—reducing generic competition and likely raising medication prices while disrupting supply chains and jobs.
Manufacturers may face increased litigation and liability costs that could prompt them to limit or stop supplying mifepristone in the U.S., further reducing availability and potentially increasing consumer healthcare costs via higher prices or insurance premiums.
Establishes the official short title of the Act as the "Safeguarding Women from Chemical Abortion Act".
Deems withdrawn the FDA approval under 21 U.S.C. § 355(b) for mifepristone (marketed as Mifeprex, also known as RU‑486) for the indication of termination of intrauterine pregnancy, and deems withdrawn any 21 U.S.C. § 355(j) applications for drugs with the same indication that list mifepristone as the reference drug.
Treats the introduction or delivery for introduction into interstate commerce of any drug whose approval was withdrawn under paragraph (1) as a violation of 21 U.S.C. §§ 331(d) and 355 and of the FD&C Act sections 301(d) and 304.
Defines the drug mifepristone as misbranded under FD&C Act sections 301 and 304 if its labeling states it may be used to terminate intrauterine pregnancy or be used with another drug for that purpose.
Defines "covered entity" as a person that manufactures a covered medication for introduction into interstate commerce.
Who is affected and how:
Broader effects and dynamics:
Uncertainties and interactions:
Affirms that nothing in this Act shall be construed to affect any provision of 18 U.S.C. 1461 (prohibitions related to obscene matter).
This section treats the introduction or delivery for introduction into interstate commerce of mifepristone (after withdrawal of approval) as a violation of section 331 and declares certain labeling to render the drug misbranded under section 331.
This section deems approvals under 21 U.S.C. 355(b) and (j) for mifepristone (for termination of intrauterine pregnancy) to be withdrawn under subsection (e) of section 355, and treats introduction into interstate commerce after such withdrawal as a violation of section 355.
Expand sections to see detailed analysis
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced March 11, 2026 by Joshua David Hawley · Last progress March 11, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate