Sen. Josh Hawley (R-MO) introduced legislation Tuesday to strip federal approval from mifepristone and ban its use for abortions across the country.
The Safeguarding Women from Chemical Abortion Act would revoke the FDA’s approval of the drug and classify its distribution for abortion as a violation of federal law. The bill also gives women who suffer complications the right to sue manufacturers.
“The science is clear: The chemical abortion drug is inherently dangerous to women and prone to abuse,” Hawley said in a statement. “Yet major companies like Danco Laboratories are making billions off it. That’s why I am introducing new legislation to ban the use of mifepristone for abortion and empower women to sue its manufacturers. Congress must act now to protect the health and safety of women.”
Mifepristone was used in 63% of all abortions in the United States in 2023, according to data from the Guttmacher Institute. The same organization estimates there were more than 1 million clinician-provided abortions in 2024.
Research from the Ethics and Public Policy Center found side effects from mifepristone occur at a rate 22 times higher than what is indicated on the FDA-approved drug label. The study examined 865,727 insurance claims filed between 2017 and 2023 by women who used the medication to terminate a pregnancy. It found more than 1 in 10 women reported experiencing infection, hemorrhaging, or another serious or life-threatening adverse event.
The drug can be taken up to 70 days from the first day of a woman’s last menstrual period, per FDA guidelines.
Under the Biden administration, the FDA revised its rules to allow mifepristone to be prescribed via telehealth, meaning patients no longer had to physically visit a doctor to obtain the drug. That change dramatically expanded access.
Hawley raised the issue directly with the current FDA chief. Last May, the senator sent a letter to Commissioner Marty Makary, whom Hawley had questioned during his Senate confirmation hearing.
“During your confirmation hearing, you pledged to me that you would ‘review the totality of the data and ongoing data’ to inform action on the drug,” Hawley wrote. “I urge you to follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone. The health and safety of American women depend on it.”
