Josh Hawley

“President Trump’s record on protecting unborn life and defending women’s health is unmatched,” a department spokesperson said in a statement. “The Department of Justice will continue to advance those priorities by asking courts to allow the FDA to complete its review of mifepristone safety data and by investigating any person or entity that engaged in illegal conduct putting women or unborn children at risk.”

Mifepristone, which blocks a hormone necessary to sustain pregnancy and is typically followed by misoprostol, now accounts for more than 70% of abortions in the United States, Hawley told the DOJ in a letter first reported on by Fox News. The senator cited a recent analysis of insurance claims data covering more than 865,000 cases between 2017 and 2023, which found that about 10.9% of women experienced sepsis, infection, hemorrhaging, or another serious adverse event within 45 days of taking the drug.

“Women are being harmed by this chemical abortion drug at far higher rates than advertised on the drug label,” Hawley wrote, adding that “large, secretive pharmaceutical corporations like Danco must be held accountable.”

Federal regulators have maintained that mifepristone is safe. The Food and Drug Administration says it has received reports of serious complications, including 36 deaths associated with the drug since its approval in 2000, but continues to stand by its overall safety profile. Advocates who support abortion access have fought to expand the availability of the drug.

Hawley also raised concerns about Danco’s corporate structure, describing it as largely shielded from public view, with undisclosed investors and offshore incorporation. He argued that the company’s lack of transparency, combined with the drug’s widespread use, warrants closer federal scrutiny.

The Missouri Republican said his Senate subcommittee has already opened an investigation and is seeking DOJ involvement to expand it. His request calls for examining possible deceptive marketing practices, manufacturing and distribution pipelines, and whether safety risks have been fully disclosed to patients and regulators.

The pressure campaign extends beyond Capitol Hill. In a separate letter sent Monday, dozens of anti-abortion organizations urged the DOJ to reverse its prior support for abortion drug policies and instead back states challenging the wide distribution of abortion pills by mail.

There is currently no clear timeline for the completion of the FDA’s safety review of mifepristone, though the DOJ has maintained a legal posture consistent with its statement on Tuesday.

Earlier this month, a federal judge in Louisiana agreed to pause a lawsuit challenging the FDA’s approval of mifepristone pending its safety review. The lawsuit surrounds a 2023 rule change during the Biden administration that allowed mifepristone to be dispensed by mail, which critics say increased the health risks for women.

ACTING ATTORNEY GENERAL PRESSURED TO UNDO ABORTION PILL LIBERALIZATION

While the DOJ’s requests to pause litigation, such as in the case in Louisiana and other states, has frustrated some anti-abortion advocates, a more clear strategy by the Trump administration could reveal itself once the FDA is finished with its review.