Sen. Josh Hawley (R-Mo.) has introduced legislation to ban the chemical abortion drug mifepristone and remove its approval by the Food and Drug Administration (FDA).
During a March 11 press conference on the legislation, Hawley said the bill would allow women to sue the manufacturer for alleged harms caused by the drug.
“The science is clear: the chemical abortion drug is inherently dangerous to women and prone to abuse. Yet major companies like Danco Laboratories are making billions off it,” Hawley said.
Mifepristone can be used to facilitate abortions at up to 70 days, or 10 weeks, of gestation.
The legislation would not only revoke FDA approval of the drug for abortions but also make the distribution and labeling of the same drug for abortions a violation of the Food, Drug, and Cosmetic Act, which allows the FDA to regulate safety, labeling, and marketing of food, drugs, cosmetics, and medical devices.
Additionally, it would create a right of action for women who have been harmed by chemical abortions through using the drug to sue manufacturers for damages.
Concerns about the drug led to an FDA review, Health Secretary Robert Kennedy Jr. announced in October 2025. As of the last update to the FDA’s website in February of this year, the agency is continuing to collect data on the use of the drug.
Senate Democrats spoke out against the review, writing a letter to the Department of Health and Human Services and the FDA, questioning the move.
“Decades of evidence and hundreds of studies prove the safety and efficacy of mifepristone, which is not only the most common method of abortion in the United States, but is also frequently prescribed to women to help manage early pregnancy loss or miscarriage,” the senators said in their letter to Kennedy and FDA Commissioner Martin Makary.
The lawmakers said they were “alarmed by the department’s obvious attempts to politicize the review, regulation, and approval of mifepristone at the FDA.”
Under President Joe Biden, the FDA loosened restrictions on obtaining those drugs, including allowing women to bypass in-person visits with doctors.
This came just a few months after FDA officials approved another generic variety of mifepristone.
Rep. Diana Harshbarger (R-Tenn.) will introduce companion legislation in the House.
She said that the evidence supports “real-world risks” to women that are greater than what has been acknowledged by the federal government.
“As a pharmacist, I believe every drug approved in the United States must meet the highest standards of safety, transparency, and medical oversight,” Harshbarger said.
“Yet the FDA under previous administrations has steadily dismantled critical safety safeguards surrounding the abortion drug mifepristone—removing in-person dispensing requirements, allowing the drug to be shipped through the mail, and limiting adverse-event reporting so that most serious complications are no longer tracked.”
