Sen. Josh Hawley (R–Mo.) has introduced new legislation that would rescind federal approval of the abortion drug mifepristone.
Titled the Safeguarding Women from Chemical Abortion Act, the measure declares that the Food and Drug Administration’s approval of mifepristone for terminating intrauterine pregnancies—along with any generic versions referencing that approval, would be “deemed to have been withdrawn” 14 days after the bill becomes law. The proposal targets mifepristone as marketed under the brand name Mifeprex and as RU‑486, as well as any follow‑on applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act.
Under the bill, once that 14‑day window closes, it would become a violation of federal law to introduce or deliver mifepristone for abortion into interstate commerce, because the drug would be treated as lacking a valid FDA approval. The bill also specifies that mifepristone would be considered “misbranded” if its labeling indicates it may be used, alone or with another drug, to terminate an intrauterine pregnancy, exposing any such product to additional enforcement under sections 301 and 304 of the Act.
Beyond regulatory withdrawal, the legislation creates a new federal tort aimed at manufacturers of Mifepristone used for abortion. Any “covered entity” that manufactures the drug for interstate commerce could be sued by individuals claiming bodily injury or harm to mental health, including “physical, psychological, emotional, or physiological harm,” that is attributable, in whole or in part, to their use of the medication.
The bill authorizes affected individuals to bring civil actions in either federal district court or state court against manufacturers of Mifepristone. Plaintiffs would be able to seek compensatory and punitive damages, as well as recovery of attorney’s fees and litigation costs, and the statute explicitly preserves any additional remedies available under state law rather than preempting them.
The withdrawal of FDA approval would take effect 14 days after enactment, while the new federal tort provisions would become operative 90 days after the bill is signed into law. The bill also states that nothing in its text alters or affects 18 U.S.C. § 1461, a federal criminal provision related to the mailing of certain materials, leaving that separate framework intact.
As of now, the bill has only just been introduced and referred to committee.