A new federal lawsuit challenges the FDA’s medically unnecessary restrictions on mifepristone, arguing they are politically motivated, not science-based—and a judge’s ruling could reshape access to abortion pills nationwide.
Over 7.5 million women have safely used the abortion pill mifepristone since the U.S. Food and Drug Administration approved the medication in 2000—yet the antiabortion movement has fought relentlessly to restrict or ban the medication, falsely claiming it is unsafe.
- In late 2023, they filed a lawsuit to do just that: Alliance for Hippocratic Medicine v. FDA, which the Supreme Court dismissed last summer, and three states are now trying to revive.
- Project 2025 calls for restrictions on mifepristone, and last week Trump’s FDA announced they planned to scrutinize mifepristone approval because of a pseudoscientific report recently released by an antiabortion organization.
Lost in all the din of antiabortion attempts to ban and restrict mifepristone is the fact that abortion pills are in fact overregulated—not underregulated.
The FDA maintains burdensome, medically unnecessary restrictions on mifepristone, which is used in combination with another medication—misoprostol—for early pregnancy termination. This combination of medications is safer than Viagra and Tylenol and is now used in approximately two-thirds of all abortions in the United States. That percentage is less than many European countries, where the medication is not so tightly restricted.
Over the last decade, the FDA has removed some of the restrictions on mifepristone, including a requirement that the medication be dispensed in person by doctors, but the agency still requires prescribers and pharmacies to register with the drug maker and requires patients to sign a counseling form with redundant, inaccurate and confusing information, all of which has decreased access to the medication.
To remove these requirements, the Center for Reproductive Rights (CRR) filed a lawsuit in May 2023, Whole Woman’s Health Alliance v. U.S. Food and Drug Administration, asking a federal district court in Charlottesville, Va., to order the FDA to lift these restrictions on mifepristone.
On Monday, May 19, 2025, the court heard oral arguments on cross motions for summary judgment in the case.
CRR filed the case on behalf of Whole Woman’s Health clinics in Virginia; Blue Mountain Clinic in Montana; All Families Healthcare and Helen Weems in Montana; and Trust Women in Kansas. The lawsuit seeks to eliminate the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, which impedes patient access to the medication by limiting the number of providers who prescribe mifepristone and pharmacies that dispense it.
The plaintiffs challenged three aspects of the REMS:
- The requirement that prescribers register with the drug manufacturer, which deters providers from offering the medication for fear registration could expose them to antiabortion violence or harassment;
- The requirement that pharmacies be specially certified in order to dispense mifepristone that requires special training for staff to maintain copious and burdensome records; and
- The requirement that patients review and sign a counseling form that is duplicative, inaccurate and confusing, and can be distressing for patients taking mifepristone for miscarriage management because the form mandates they acknowledge they “have decided to take mifepristone and misoprostol to end [their] pregnancy.”
These FDA restrictions on mifepristone are a vestige of antiabortion pressure on the FDA during the approval process in the 1990s and ongoing antiabortion politics that have made the FDA move with extreme caution in regulating the drug, despite over 100 peer-reviewed scientific studies showing mifepristone is very safe.
On Aug. 21, 2023, the federal court in Charlottesville denied CRR’s request for a preliminary injunction but acknowledged the safety and importance of mifepristone. Both CRR and the FDA then filed motions for summary judgment.
In their summary judgement brief, the plaintiffs argued the FDA violated the Administrative Procedure Act (APA) by failing to make the determinations required by Congress before subjecting a medication to a REMS and refusing to consider evidence that the REMS does not enhance patient safety. According to the plaintiffs, the FDA categorically excluded several critical categories of relevant data for consideration, including statements by medical professional societies, safety data from Canada’s deregulation of mifepristone, qualitative studies, healthcare professional narratives, and logistic data on accessing abortion care.
The plaintiffs also argued that the FDA acted in an arbitrary and unreasonable manner. While only 73 of more than 20,000 FDA-approved medications are subject to REMS, mifepristone is regulated far more restrictively than other drugs that pose similar or more serious risks, such as acetaminophen and aspirin. The plaintiffs argued that the FDA’s failure to explain its differential treatment of mifepristone is “arbitrary and capricious” in violation of the APA.
They also point out that the FDA approved 300 mg mifepristone tablets—used daily to treat Cushing’s syndrome under the brand name Korlym—without a REMS, despite many more adverse events than the one-time 200 mg mifepristone tablet used for pregnancy termination.
The FDA’s briefs argued the plaintiffs lacked standing and that their arguments are meritless.
At the May 19 hearing, senior counsel at CRR Linda Goldstein argued the FDA’s burdensome restrictions limit the number of clinicians and pharmacies providing and dispensing mifepristone, which impedes access to this time-sensitive care. She argued the agency has never justified why mifepristone, despite its safety record, remains more heavily restricted than drugs with far greater risks, noting “the FDA has acknowledged that staying pregnant is more dangerous than not staying pregnant.”
U.S. District Judge Robert S. Ballou, appointed by Democratic President Joe Biden, reportedly appeared sympathetic to this argument.
In response, DOJ attorney Noah Katzen argued that the FDA believed there was “not sufficient” evidence to conclude the REMS was no longer necessary. He said the FDA had “in the past” considered mifepristone to be safe and effective overall, but declined to say whether the agency still believes the medication is safe.
The May 19 hearing was the first time Trump administration lawyers appeared before a court to address FDA’s regulation of abortion pills.
Judge Ballou did not immediately rule in the case but said he would do so soon.
“The Trump administration has made it clear that they do not care about science, or our health and safety,” said CRR on social media. “They only care about taking away our rights. But we refuse to let that happen. We’re ALL IN on this fight.”
Removal of the mifepristone REMS would significantly increase access to medication abortion—a critical avenue for accessing abortion and an increasingly threatened option for patients in post-Dobbs America.
