U.S. Sen. Josh Hawley is calling on Congress to withdraw federal approval of a drug commonly used in abortions.
The Missouri Republican introduced a bill Wednesday that would strip the pill mifepristone of its approval from the Food and Drug Administration, ban its use for pregnancy termination and create a pathway for women who say they've been harmed by the drug to pursue legal action against its manufacturer.
It's the latest move in a full-court press from lawmakers and politicians who oppose abortion to curb access to the medication, which is commonly used as part of a two-pill regimen to terminate pregnancies.
"We're here to call on the United States Congress to stand up and to protect the innocent unborn, to protect the health and safety of women whose lives are endangered abortion drug known as mifepristone," Hawley said in a news conference announcing the legislation. "Only Congress can withdraw the FDA approval rendered way back in the Clinton administration for this drug that has proved to be inherently dangerous and inherently prone to abuse."
Professional medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, support the use of mifepristone and say it's safe and effective.
Hawley cited a recent study of insurance data claims compiled by the Ethics and Public Policy Center, a conservative think tank that says it works to apply "the riches of the Jewish and Christian traditions to contemporary questions of law, culture and politics." The study claims more than 1 in 10 people experience "adverse effects" after taking mifepristone.
The report has not been peer reviewed. According to representatives from the organization, "the peer-review process is broken. It is terribly biased against conservatives, especially social conservatives, particularly pro-lifers."
The study's findings in some circumstances align with mifepristone's existing labeling. Other data points indicated hemorrhaging and other adverse health reactions are more common than indicated on the existing FDA-approved label.
Elizabeth Gillette, an advocate from Oregon, said she experienced post-traumatic stress disorder after taking the drug. She said she shook, vomited, sweat and bled profusely.
"This is not safe. This is not easy. This is not something that our women need to be experiencing," she said during the news conference. "You start adding up the psychological and emotional ramifications, the PTSD, the complex PTSD, suicidal ideations, broken relationships, the victims start to expand exponentially."
In 2023, the FDA eliminated a rule that required mifepristone to be dispensed in person in a clinic or hospital. Pharmacies were allowed to dispense the drug directly to patients who had a prescription.
Hawley on Wednesday decried what he described as an erosion of regulations governing the drug's use.
"One liberal administration after another, President Obama and then President Biden, removed almost all of the safety protocols around mifepristone, such that today it is almost wholly unregulated," he said. "They did it because they wanted to turn mifepristone into the driver of abortion on demand. And we have to admit today, they largely succeeded."
Advocates and health providers said that reams of real-life data show the pill is safe and that claims it's dangerous are politically motivated and not rooted in evidence.
Policy researcher Blair Darney of the Guttmacher Institute, a think tank that studies abortion data and supports abortion rights, said mifepristone is backed by "decades of solid data."
Hawley's claims that the use of mifepristone is unregulated are false, she said.
"The Food and Drug Administration regulates all drugs and devices on the market in the U.S.," she said. "Mifepristone went through this rigorous process before it was originally approved in 2000 ... so mifepristone has been a highly studied and highly regulated drug."
According to the FDA's website, mifepristone is safe to use.
"The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use."
Further reviews have "not identified any new safety concerns," the website states.
Chief Medical Officer Margaret Baum of Planned Parenthood Great Rivers said the data underlying the EPCC claims is faulty.
"The 'data' – and I'm going to put data in quotes – that Josh Hawley is projecting is not backed up by rigorous scientific data that has studied this medication very well," Baum said.
"[Mifepristone] is highly effective in terminating a pregnancy, and at very low levels of risk. Of course, any medication has risks, but the main risks that we worry about – bleeding, infection, needing a procedure – all of those are much less than 1%."
Health and Human Services Secretary Robert F. Kennedy Jr. said last year he would review the drug's labeling in light of the EPCC data. A lawsuit seeking to overturn the 2023 rule change has been transferred from Texas to Missouri, and Missouri Attorney General Catherine Hanaway has challenged the labeling of generic mifepristone in federal court.
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