The U.S. Food and Drug Administration is conducting a new safety review of the abortion drug mifepristone.
On June 5, White House spokesman Kush Desai confirmed on social media that the study was underway after a Wall Street Journal report first disclosed its existence.
Desai called it “a gold standard science study that will be rigorous and unassailable.”
The news was welcomed by pro-life advocates who have been warning of the dangers of the abortion drug for many years.
“The FDA is finally launching a safety study of the abortion pill mifepristone. This is long overdue,” said Lila Rose, founder and president of Live Action. “But the agency should not wait while women are put at risk and preborn children are dying. Immediate action is needed now: end mail order abortion pills and pull mifepristone from the market!”
Mifepristone is the first drug in the two-pill chemical abortion regimen. It works by blocking progesterone, causing the pregnancy to stop developing before a second drug, misoprostol, is taken to expel the pregnancy tissue.
Chemical abortions now account for roughly two-thirds of all abortions in the United States, according to the Guttmacher Institute. The number significantly increased after the FDA, under the Biden Administration, allowed certified retail pharmacies in 2023 to dispense mifepristone and misoprostol directly to patients.
The current safety review of mifepristone may also have implications in an ongoing Louisiana lawsuit challenging the FDA’s mail-order abortion pill policies. A federal judge overseeing the case ordered the FDA to provide an update on the study by Oct. 7, indicating that the agency’s findings could become relevant as the litigation moves forward.
Earlier this year, Louisiana Attorney General Liz Murrill brought the lawsuit, citing the case of a Louisiana woman who said she took abortion drugs obtained online by her then-boyfriend after facing pressure and fearing for her safety. Louisiana argued that the FDA’s removal of in-person dispensing requirements made such situations more likely and undermined states’ ability to protect women and unborn children.
On May 6, 2026, the Fifth Circuit Court of Appeals ruled that mifepristone could no longer be prescribed through telehealth or mailed to patients while the case proceeds. However, on May 14, 2026, the U.S. Supreme Court blocked that ruling and left current FDA regulations in place during the litigation. As a result, mifepristone remains available through telehealth and mail-order distribution nationwide while the broader legal challenge continues through the courts.
In March, Missouri Senator Josh Hawley introduced the Safeguarding Women from Chemical Abortion Act, legislation that would revoke FDA approval of mifepristone. Hawley called the drug “a grave threat to the health and safety of American women.” Congresswoman Diana Harshbarger (TN-01) introduced companion legislation in the House of Representatives.
At a Capitol Hill press conference, Hawley and Harshbarger were joined by women who shared testimony about complications they experienced after taking the drug.
“The evidence is now clear. Mifepristone is almost always fatal to the unborn child, but it is also significantly dangerous for women,” Hawley said. “The drug companies that make this drug know this but continue to profit from nearly unregulated distribution, largely insulated from liability. Congress can no longer ignore these dangers.”