U.S. Senator Josh Hawley (R-Mo.) introduced legislation to ban chemical abortion drug mifepristone and allow women harmed by the drug to sue its manufacturers.
Hawley hosted a press conference Tuesday with women who have used mifepristone providing testimonies about how the abortion pill harmed them. Pro-life representatives were part of the press event and lobbied for the removal of mifepristone from the market.
“The science is clear,” Hawley said. “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’s bill is titled the Safeguarding Women from Chemical Abortion Act.
The legislation would:
- Withdraw the FDA’s approval of mifepristone for abortion.
- Make distributing and labeling mifepristone for pregnancy termination violations of the Federal Food, Drug, and Cosmetic Act.
- Create a private right of action for women harmed by chemical abortion to sue manufacturers for damages.
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Chemical abortion drug mifepristone has long been the subject of criticism over safety issues associated with the drug and insufficient regulation.
Mifepristone has a REMS classification, one of some 73 drugs in the category, a fraction of the thousands of prescription medications approved by the U.S. Food and Drug Administration (FDA).
The FDA’s REMS, or Risk Evaluation and Mitigation Strategies, is a drug safety program that the agency can require for "certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks,” according to the FDA.
Mifepristone also has an FDA Black Box Warning, the highest level of safety warning.
The REMS for mifepristone have been loosened in steps over the last 10 years under the Obama and Biden administrations, including an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding and infection. The requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System was also eliminated.
Allowing mifepristone to be mailed and dispensed by pharmacies followed, and the Biden FDA permanently removed the in-person dispensing requirement in 2023.
This paved the way for abusers to acquire chemical abortion drugs on-line and force or otherwise coerce pregnant women into taking them and for abortion activists to sell the drugs across state lines where they may be prohibited by law.
Pro-life and pregnancy help advocates continually call for the FDA to review the safety standards for mifepristone, the review promised by the Trump administration but seemingly dragging out.
A report release in April 2025 by conservative think tank Ethics and Public Policy Center (EPPC) said that nearly 11% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days of taking the drug. The analysis of 865,000 insurance claims of women who were prescribed mifepristone abortions between 2017 and 2023 found that mifepristone is 22 times more dangerous than previously recognized in FDA data.
A more recently released analysis from the EPPC indicates that removing the REMS for the abortion pill has increased risks for women, in particular when the drug is prescribed without an in-person medical visit.
Tweet This: “The science is clear: the chemical abortion drug is inherently dangerous to women and prone to abuse" - U.S. Sen. Josh Hawley
A statement from Hawley’s office on his proposed legislation said:
The chemical abortion drug, mifepristone, is not safe for women. One recent study found that nearly 11% of women who use mifepristone experience sepsis, infection, hemorrhaging, an emergency room visit, or another serious adverse event within 45 days. New data indicates that these complications were even more common after safety measures—such as in-person dispensing—were removed by President Joe Biden.
Shady corporate manufacturers of the abortion drug are profiting handsomely while women are harmed. The maker of mifepristone, Danco Laboratories, first registered in the Cayman Islands and received backing from prominent liberal billionaires, including George Soros and private equity managers. Its ownership structure is designed to evade scrutiny and escape liability. In 2022, the company’s CFO said investments in the company had been “extremely profitable.” Chemical abortion rates, and the harm to women, have only increased since then.
Congresswoman Diana Harshbarger (TN-01), a pharmacist, will introduce companion legislation in the U.S. House.
“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.”
“Evidence now suggests that the real-world risks to women are far greater than the federal government has acknowledged,” Harshbarger said.
Hawley’s legislation is supported by Susan B. Anthony Pro-Life America, Family Research Council, Alliance Defending Freedom, Concerned Women for America, Live Action, Students for Life of America, Ethics and Public Policy Center, and the American Association of Pro-Life OBGYNs. The groups read their statements of support at the March 11 press conference.
The full text of the Safeguarding Women from Chemical Abortion Act is available HERE, and the press conference can be viewed HERE.
