Sen. Josh Hawley, R-Mo., unveiled legislation Wednesday to ban the chemical abortion drug mifepristone, one of two drugs approved by the Food and Drug Administration for medication abortions.
"It is time for Congress to ban the use of mifepristone for abortion," Hawley said at a news conference that included testimony from women who said they were harmed by the drug.
"And it is time for Congress to give the victims, the survivors, many of whom are here today, the right to recover against this company that has inflicted harm on them solely for the purpose of making profits."
Abortions using mifepristone and misoprostol accounted for nearly two-thirds of all abortions in the United States in 2023, according to the Guttmacher Institute.
The FDA, which approved mifepristone in 2000, said on its website that the drug "is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy Program."
But a report released last year by the conservative Ethics and Public Policy Center said that among 865,727 prescribed mifepristone abortions from 2017 to 2023, nearly 11% of women experienced sepsis, infection, hemorrhage, or another serious adverse event within 45 days.
The report said that rate was at least 22 times higher than the "less than 0.5%" summary figure listed on the drug's label.
"Only Congress can address this situation," Hawley said. "Only Congress is placed to regulate the flow of interstate drugs. Only Congress can withdraw the FDA's approval, rendered way back in the Clinton administration, for this drug that has proved to be inherently dangerous and inherently prone to abuse."
Hawley's Safeguarding Women from Chemical Abortion Act would withdraw FDA approval of mifepristone for abortion use.
It would also make distributing or labeling mifepristone for abortion a violation of the federal Food, Drug, and Cosmetic Act, and create a private right of action allowing women harmed by abortion drugs to sue manufacturers for damages.
Rep. Diana Harshbarger, R-Tenn., who introduced similar legislation in January 2025 aimed at restricting mifepristone, voiced support for Hawley's legislation in a news release.
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said in a statement that the legislation would address the use of mifepristone "head on by withdrawing the politicized FDA approval of these dangerous abortion drugs."
"We are thankful to Sen. Hawley and Congresswoman Harshbarger for understanding the gravity of this situation and for their work to find ways that Congress can step up to address it," Dannenfelser said.
The Supreme Court in 2024 threw out a lawsuit brought by a group of conservative doctors who argued that mifepristone should be removed from pharmacy shelves nationwide. In a unanimous ruling, the justices did not decide the merits of the abortion-pill dispute, instead holding that the challengers lacked standing to sue.
Mifepristone has come under renewed scrutiny in President Donald Trump's second term.
Health and Human Services Secretary Robert F. Kennedy Jr. said in a 2025 letter that the FDA was conducting a new safety review of the drug and would consider "the latest data" on mifepristone. The review remains ongoing.
Hawley's legislation comes amid a fight in his home state. Missourians are gearing up for a statewide vote in November on a proposed constitutional amendment that would repeal the abortion-rights measure voters approved in 2024 and again allow broad abortion restrictions.
Michael Katz ✉
Michael Katz is a Newsmax reporter with more than 30 years of experience reporting and editing on news, culture, and politics.
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