Hawley unveils bill to ban abortion pill, strip FDA approval

WASHINGTON (CN) — Missouri Senator Josh Hawley rolled out new legislation Wednesday to immediately withdraw federal safety approvals for the medication abortion drug mifepristone.

It’s a measure that comes months after the Trump administration said it’s taking another look at the medicine’s safety — and years after the Supreme Court threw out a challenge to mifepristone’s longstanding status as an approved abortion medication by the U.S. Food and Drug Administration.

Hawley argued it’s time for Congress to step in and address medication abortions, claiming pharmaceutical companies had pushed mifepristone despite what he claimed were the medicine’s “devastating health effects.”

“We’ve known for years that mifepristone is risky, but it’s really just in the last few years that we’ve learned this drug is inherently dangerous and it’s inherently prone to abuse,” Hawley said during a news conference.

Mifepristone, which has been permitted for use in certain abortions for more than two decades, has become the primary vehicle for the procedure in the years since the high court overturned Roe v. Wade and the constitutional right to have an abortion. More than 60% of abortions took place in 2023 using abortion pills.

Hawley told reporters his proposed legislation would strip FDA approval from mifepristone if made law. “Only Congress can address this situation,” he said. “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.”

Physicians and health care experts say abortion medication is safe and effective. Studies show that 99.6% of pregnancies are successfully terminated with abortion pills if taken nine weeks into gestation, and that the risk of major complications sits at less than 1%.

Hawley cited a 2025 study from conservative think tank the Ethics and Public Policy Center, which found among 865,000 insurance claims for mifepristone abortions, around 11% of women reported a “serious adverse event” related to the procedure. But a Washington Post analysis at the time found the study was not peer reviewed and lacked transparency in its dataset — and that researchers used an expansive definition of “serious event” when categorizing adverse cases.

Still, the Missouri Republican used the study as a springboard to criticize pharmaceutical companies that make medication abortion drugs, arguing they were raking in profits while exposing women to danger.

“They know it,” said Hawley. “They don’t care, because they’re making billions of dollars off of it. It is time for Congress to do something about this racket.”

The senator said that, in addition to stripping FDA approval from mifepristone, his proposed legislation would also give women harmed by medication abortions an avenue to “recover” against drugmakers.

Joining Hawley at Wednesday’s news conference were women who experienced adverse effects from medication abortion procedures. Also alongside the senator was his wife, Erin Hawley, a lawyer who led the 2024 challenge to mifepristone’s FDA approval and argued the case in front of the Supreme Court.

“The proabortion left tells us that abortion is empowering,” she said. “You’ve just heard from these women that it is anything but. Make no mistake, abortion drugs are not about women’s health. They are reckless — they are a black box drug that sends one in 25 women to the hospital.”

The Supreme Court in 2024 threw out the lawsuit, brought by a group of conservative doctors, contending that mifepristone should be removed from pharmacy shelves nationwide. But the justices in their unanimous decision did not rule on the merits of medication abortion, holding instead that federal courts were the wrong venue for the doctors to air their concerns.

Under the second Trump administration, mifepristone has come under renewed scrutiny. Health and Human Services Secretary Robert F. Kennedy, Jr. said in an October 2025 letter that the FDA was conducting a new safety review of the drug. Kennedy said the survey, which remains ongoing, will consider “the latest data” on mifepristone.

The secretary’s letter cited the same Ethics and Public Policy Center report as Hawley.

Mifepristone was first approved by the FDA in 2000, and the agency in subsequent years relaxed regulations to make the medication easier to access. During the Covid-19 pandemic, the FDA deemed it safe for physicians to prescribe the drug via telehealth services.

In addition to its use in abortions, mifepristone is also used in combination with misoprostol to stabilize patients who experience heavy bleeding after giving birth.

The abortion pill is safer than other widely prescribed drugs, such as Viagra and penicillin. It is also statistically 14 times safer than childbirth.

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