Sen. Josh Hawley, R-Mo., on Wednesday introduced legislation that would strip the Food and Drug Administration of its approval for the abortion drug mifepristone, setting off a new round of debate over one of the most widely used medications tied to the nation’s long-running abortion fight.
The proposal has already drawn support from major anti-abortion organizations, though the path forward in Congress remains uncertain given the drug’s widespread use and the political divisions surrounding the issue.
Mifepristone, first approved by the FDA in 2000, has been used by an estimated 7.5 million women in the United States to terminate pregnancies. The medication, typically taken alongside the drug misoprostol, can end pregnancies up to 70 days into gestation. In recent years, the method has grown increasingly common, accounting for 63 percent of all abortions in the country in 2023.
Hawley’s legislation represents an ambitious effort to reverse that trend by removing the FDA’s certification of the drug for abortion use. At the same time, the bill would allow the medication to continue being prescribed for treating Cushing’s syndrome, a rare disorder linked to prolonged high cortisol levels.
The Missouri senator argued that the drug poses greater risks than many advocates acknowledge and said its growing use has coincided with what he described as weakened safety standards.
“We’ve known for years that mifepristone is risky but it’s really just in the last few years that we’ve learned that this drug is inherently dangerous and it is inherently prone to abuse,” Hawley said.
He pointed to a study examining 875,000 mifepristone prescriptions which concluded that roughly 11 percent of cases involved “serious adverse health” effects. Hawley said those complications can include internal infections, sepsis, emergency room visits and other potentially life-threatening conditions.
However, the study cited by Hawley, produced by the Ethics and Public Policy Center, has been challenged by numerous fact-checking organizations that dispute its conclusions. Federal regulators report far lower complication rates. The FDA places the rate of serious adverse effects at approximately 0.5 percent, while other research reviewed by KFF has produced similar findings.
Despite the disagreement over the data, Hawley said official figures underestimate the true scope of injuries linked to the medication. He also argued that expanded access to the drug — including prescriptions sent across state lines — has created opportunities for misuse.
Hawley noted that about a dozen men across the country have been charged with using mifepristone to force abortions on girlfriends or female acquaintances without their consent, pointing to those cases as evidence the drug can be abused.
Changes to federal policy in recent years have contributed to its increased use. The Supreme Court’s decision overturning the federal right to abortion, combined with pandemic-era adjustments by the FDA that eased certain restrictions, accelerated the growth of medication-based abortions.
Hawley said those changes departed significantly from the rules originally imposed when the FDA approved the drug more than 25 years ago.
“Because the drug comes in capsule form and because it is at this juncture almost completely unregulated, it is inherently prone to abuse,” he said.
He further accused previous Democratic administrations of loosening safeguards for political reasons.
“Over the years, one liberal administration after another, President Obama and then President Biden, removed almost all of the safety protocols around mifepristone,” Hawley said, arguing that the decisions were tied to broader abortion politics.
The legislation would also create a legal pathway for women who experienced medical complications after taking the drug to sue its manufacturer.
Still, the bill faces political hurdles even within Hawley’s own party. Moderate Republicans such as Sens. Susan Collins of Maine and Lisa Murkowski of Alaska may prove difficult to persuade.
Hawley urged his colleagues to unite behind the proposal, saying congressional action is necessary if the drug’s approval is to be permanently withdrawn.
“This is something for Congress to do,” he said. “Only Congress at this stage can withdraw the certification for abortion for mifepristone in an effective way.”
At a press conference in the Senate Judiciary Committee hearing room, Hawley also highlighted personal stories from women who said they suffered serious medical consequences after taking the drug.
Among them was Shanyce Thomas, a nursing student in Maryland, who described developing a severe infection after using mifepristone that ultimately required a partial hysterectomy.
“I developed a severe infection behind my uterus that went undetected until it became life-threatening,” Thomas said. “My condition deteriorated so rapidly that I was rushed into the ICU.”
She said she was placed in a medically induced coma for a month and required multiple blood transfusions during her recovery, underscoring the deeply personal stakes surrounding a debate that continues to divide the country.
