In spite of strong safety recordthe abortion and miscarriage drug mifepristone has been taken to court in several conflicting lawsuits, with some plaintiffs arguing the drug should be easier to access and others saying it should be more restricted.
The drug, sometimes prescribed via telehealth and sent to patients by mail, has provided access to abortions across the United States and has become a prime target for abortion opponents.
A group of ongoing federal lawsuits is challenging the U.S. Food and Drug Administration’s 2023 decision to maintain specific requirements for the abortion pill, with a federal court in Washington upholding the FDA’s decision, a federal court in Hawaii asking the FDA to justify its decision and a court in Virginia still to rule. Another lawsuit, filed Nov. 13 by the American Civil Liberties Union, challenges the FDA under the Freedom of Information Act, alleging that the agency refused, without reason, to disclose the parameters of the mifepristone review and related communications with outside groups.
Heidi Purcell et al. v. Robert F. Kennedy Jr. et al.
Court: US District Court for the District of Hawaii
Claims: Originally named Chelius v. Wright and filed on October 3, 2017 by the American Civil Liberties Union on behalf of a family physician and several medical associations, this lawsuit challenges the FDA’s mifepristone restrictions as unduly burdensome and arbitrarily restrictive, in violation of the Administrative Procedure Act.
Bet: This case could determine whether the FDA can continue to require special certifications for patients and providers, which the plaintiffs argue prevent and delay care and present privacy risks for patients and providers afterRoe. If the plaintiffs are successful, mifepristone could become easier to distribute and access across the country.
Situation: On October 30, Judge Jill Otake, nominated by Republican President Donald Trump, ruled the FDA did not justify it properly 2023 decision or consider all the evidence when deciding to maintain the current restrictions on mifepristone. He ordered the agency to reconsider its decision. The plaintiffs did not seek to invalidate the regulations in their lawsuit, so they remain in place for now pending the outcome of the review and the FDA’s response in court. A joint status report from plaintiffs and defendants on how the case should proceed December 4 deadline.
Whole Woman’s Health Alliance et al. v. US Food and Drug Administration et al.
Court: US District Court for the Western District of Virginia
Claims: On May 8, 2023, abortion providers in Virginia, Montana, and Kansas challenged the FDA’s mifepristone rules as unduly burdensome and arbitrarily restrictive, similar to claims in Purcell vs. Kennedy.
Bet: If the plaintiffs are successful in this case, mifepristone could become easier to distribute and access.
Situation: U.S. District Judge Robert S. Ballou, nominated by Democratic President Joe Biden, heard oral arguments on the motions for summary judgment in May, but has yet to rule.
Washington et al. v. FDA et al.
Court: US District Court for the Eastern District of Washington
Claims: On February 23, 2023, Washington and initially 11 other states challenged the FDA’s mifepristone regulations as burdensome and unnecessary.
Bet: Extending mifepristone access was risky in this case.
Situation: It ended. Judge Thomas O. Rice, nominated by former Democratic President Barack Obama, ruled this summer that the FDA’s review and decision regarding mifepristone restrictions was reasonable, not arbitrary or capricious;
American Civil Liberties Union v. FDA
Court: US District Court for the District of Maryland
Claims: On November 13, 2025, the ACLU sued the FDA alleging that it failed to comply with the Freedom of Information Act. The nonprofit law firm in August sought an expedited record on the parameters of the FDA’s ongoing review of mifepristone and communications with outside groups. The ACLU claims the agency has not provided a decision on the request.
Bet: Records released as part of this lawsuit could bring transparency to HHS’s review of the abortion pill.
Situation: The government has yet to file a written response to the lawsuit, which is assigned to Judge Timothy J. Sullivan.
Another group of lawsuits challenges state restrictions on abortion pills, arguing that the federal law, which allows medication abortions to be prescribed via telehealth and by mail up to ten weeks into pregnancy, supersedes state laws.
GenBioPro v. Kristina Raynes et al.
Court: US Court of Appeals for the Fourth Circuit (on appeal from the US District Court for the Southern District of West Virginia)
Claims: In 2023, generic mifepristone manufacturer GenBioPro sued West Virginia after the state criminalized abortion and expressly prohibited the telemedicine prescription of mifepristone. The company argued that federal law preempted the West Virginia law and that Congress only authorized the FDA to impose restrictions on access to mifepristone.
Bet: A ruling in favor of the plaintiffs could have eased access to abortion drugs in a state that in most cases has blocked access to termination of pregnancy.
Situation: It ended. District Court Judge Robert C. Chambers, nominated by former Democratic President Bill Clinton, found in 2023 that the Food and Drug Administration Amendments Act did not prompt West Virginia’s abortion regulation. The US Court of Appeals for the Fourth Circuit affirmed the lower court’s decision in July.
Amy Bryant v. Timothy Moore et al.
Court: US Court of Appeals for the Fourth Circuit (on appeal from the US District Court for the Middle District of North Carolina)
Claims: In 2023, Dr. Amy Bryant of North Carolina sued her state over medication abortion restrictions, arguing that the FDA’s mifepristone policy preempts state restrictions, which require in-person prescribing, dispensing and administration. prohibit non-physician providers from prescribing mifepristone; mandate the scheduling of an in-person follow-up appointment; and require non-fatal adverse events to be reported to the FDA.
Bet: The case could limit states’ ability to restrict medication abortions.
Situation: Chief Justice Catherine C. Eagles, nominated by Obama, found that some restrictions were preempted by federal law but respected other state requirements, including mandatory ultrasounds and waiting periods. The case is pending appeal.
Birthmark Doula Collective et al. v. Louisiana et al.
Court: 19th Court of Louisiana
Claims: On October 31, 2024, birth workers, health professionals and a pregnant woman challenged a Louisiana law that classifies mifepristone and misoprostol as controlled dangerous substances, even though the FDA does not. They argue that the classification delays access to these drugs during emergencies, putting the health and safety of miscarriage patients at risk.
Bet: Medications used for emergencies during pregnancy could be more easily accessible for providers if the plaintiffs prevail.
Situation: It is pending in state court. In May, the court held a hearing on a motion to dismiss and ruled that the appeal could proceed.
Another group of lawsuits seeks to reimpose more restrictions on mifepristone and argues that the FDA erred in its decision to allow abortion drugs to be prescribed via telehealth and sent by mail. Both cases cite anecdotes about women who were coerced or drugged by their partners to argue that in-person visits are in the best interest of abortion patients.
Missouri et al. v. FDA et al.
Court: US District Court for the Eastern District of Missouri
Claims: Originally filed Nov 18, 2022 by a group of anti-abortion doctors and groups who claimed mifepristone is extremely dangerous and the FDA illegally relaxed restrictions. The US Supreme Court threw out the case last summer, ruling the plaintiffs lacked standing to sue, and sent it back to lower courts.
Bet: If the plaintiffs prevail, the FDA could ban telehealth and mail-order delivery of abortion drugs, which would limit access across the country.
Situation: THE treatment resurrected by the attorneys general in Idaho, Kansas and Missouri. it was transferred last month from Trump appointee Matthew Kascmaryk’s trial in Texas to Trump appointee Cristian Stevens’ trial in Missouri.
Louisiana et al. v. FDA et al.
Court: US District Court for the Western District of Louisiana, Lafayette Division
Claims: Filed October 6, 2025 The state of Louisiana and resident Rosalie Markezich sued to overturn the FDA’s 2023 decision to eliminate the in-person administration requirement. Markezich says she was forced by an ex-partner to take the abortion pill, which she says he ordered in her name and received in the mail.
Bet: If the plaintiffs prevail, the FDA could ban telehealth and mail-order delivery of abortion drugs, which could limit access across the country.
Situation: The case is pending in district court before Trump-appointed Judge David C. Joseph.
This article was republished by News from the United Statespart of States Newsroom. Read the original story by Sofia Resnick here.
