WASHINGTON — Sen. Josh Hawley rolled out long-shot legislation this week to override the Food and Drug Administration’s approval of mifepristone, part of a two-drug regimen responsible for the majority of abortions in the US.
Hawley (R-Mo.), flanked by pro-life activists and women who have suffered adverse effects from the controversial drug, argued Wednesday that safety concerns about mifepristone have been suppressed and its widespread availability has led to abuse.
“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,” he contended, citing a study that found 11% of 875,000 analyzed mifepristone prescriptions for abortion led to “serious adverse health” issues.
Mifepristone, which works to terminate a pregnancy, is typically used in conjunction with misoprostol, which helps empty the womb, to cause a medical abortion.
Chemical abortions accounted for 63% of all such procedures in the US in 2023, up from 53% in 2020, according to the pro-choice Guttmacher Institute. More than 7.5 million women are believed to have used mifepristone for abortion.
Usage of mifepristone grew after the Supreme Court overturned Roe v. Wade, which had guaranteed the nationwide right to abortion access, in 2022. Pro-choice groups have been mailing abortion pills into red states with restrictive laws in a bid to undermine those policies.
The FDA initially approved mifepristone in 2000 before relaxing the rules to expand access in 2016 and 2021. Hawley has pushed the Trump administration to conduct an FDA review of mifepristone, which is ongoing.
Back in 2024, the Supreme Court rejected a push to restrict the FDA’s approval of mifepristone. That case was argued by Hawley’s wife, Erin, who joined him in rolling out the legislation.
In addition to yanking FDA approval, the Safeguarding Women from Chemical Abortion Act would allow women harmed by the drug to sue manufacturers and restrict the distribution of it for the purposes of terminating pregnancy.
Rep. Diana Harshbarger (R-Tenn.) is leading the House version of Hawley’s bill.
“As a pharmacist, I believe every drug approved in the United States must meet the highest standards of safety, transparency, and medical oversight,” she said in a statement.
“Yet the FDA under previous administrations has steadily dismantled critical safety safeguards surrounding the abortion drug mifepristone,” she added, “allowing the drug to be shipped through the mail, and limiting adverse-event reporting so that most serious complications are no longer tracked.”
Pro-choice groups have hit back against concerns about the safety of mifepristone and argued that pro-life advocates have been using questionable studies to make their case.
The study cited by Hawley Wednesday, which was conducted by the Ethics and Public Policy Center, has faced criticism about its methodology. The FDA estimates that the rate of adverse effects from mifepristone is around 0.5%.
Hawley was joined by women who suffered side effects from mifepristone, including Shanyce Thomas, a Maryland nursing student who recalled being in a medically induced coma for a month and needing multiple blood transfusions.
“I developed a severe infection behind my uterus that went undetected until it became life-threatening. My condition deteriorated so rapidly that I was rushed into the ICU,” she recounted.
Mifepristone is also used to treat Cushing’s syndrome, an excess of stress hormones leading to rapid weight gain and other adverse effects.