Mifepristone on trial: Where lawsuits stand over a key abortion drug

Federal regulation of mifepristone, which has provided access to abortion across the United States, is being challenged in multiple lawsuits from opposing sides. (Getty Images)

Despite powerful safety recordthe abortion and miscarriage drug mifepristone has been brought to court in several conflicting lawsuits, with some plaintiffs arguing that access to the drug should be easier and others arguing that it should be more narrow.

The drug, sometimes prescribed via telehealth and mailed to patients, has opened up abortion access across the United States and has become a major target of abortion opponents.

A group of ongoing federal cases are challenging the U.S. Food and Drug Administration’s 2023 decision to maintain special requirements for abortion pills: a federal court in Washington upheld the FDA’s decision, a federal court in Hawaii asked the FDA to justify its decision, and a court in Virginia still hasn’t ruled. Yet another lawsuit, filed Nov. 13 by the American Civil Liberties Union, challenges the FDA under the Freedom of Information Act, accusing the agency of disclosing mifepristone review parameters and related communications to outside groups without cause.

For more information and updates on ongoing Mifepristone cases, please visit Mifepristone Litigation and Federal Action Tracker from the Center for Reproductive Health, Law and Policy at the University of California, Los Angeles.

Heidi Purcell et al. v. Robert F. Kennedy Jr. et al.

• Court: United States District Court for the District of Hawaii
• Claims: Originally called Chelius v. Wright and filed on October 3, 2017, by the American Civil Liberties Union on behalf of GP and several medical associations, this lawsuit challenges the FDA’s restrictions on mifepristone as unduly burdensome and arbitrarily restrictive, violating the Administrative Procedure Act.
• Pool: This case may determine whether the FDA can continue to require special certifications from patients and providers, which plaintiffs argue discourages and delays care and poses privacy risks for patients and providers after the Roe Act takes effect. If the plaintiffs are successful, it could be easier to dispense and access mifepristone across the country.
• Status: On October 30, Judge Jill Otake, nominated by Republican President Donald Trump, ruled The FDA did not justify this properly 2023 decision or consider all evidence when deciding whether to maintain the current restrictions on mifepristone. She ordered the agency to reconsider its decision. The plaintiffs did not seek a repeal of the regulations in their lawsuit, so for now they remain in effect until the FDA completes its review and responds to the court. The joint status report prepared by the plaintiffs and defendants regarding the further proceedings in the case is: deadline December 4.

Whole Woman’s Health Alliance et al. v. US Food and Drug Administration et al.

• Court: United States 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 regulations as unduly burdensome and arbitrarily restrictive, similar to Purcell v. Kennedy.
• Pool: If plaintiffs are successful in this case, it may be easier to dispense and access mifepristone.
• Status: U.S. District Judge Robert S. Ballou, an appointee of Democratic President Joe Biden, heard the hearing oral arguments on motions for summary judgment in May, but has not yet issued a decision.

Washington et al. v. FDA et al.

• Court: United States 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.
• Pool: In this case, the idea was to expand access to mifepristone.
• Status: Completed. Judge Thomas O. Rice, an appointee of former Democratic President Barack Obama, ruled this summer that the FDA’s review and decision regarding mifepristone restrictions was reasonable and not arbitrary or capricious.

American Civil Liberties Union v. FDA

• Court: United States District Court for the District of Maryland
• Claims: On November 13, 2025, the ACLU sued the FDA, arguing that it failed to comply with the Freedom of Information Act. In August, the nonprofit law firm sought expedited documentation regarding parameters of the FDA’s ongoing mifepristone review and communications with outside groups. The ACLU accuses the agency of failing to report findings on the request.
• Pool: Documents released in this lawsuit could bring transparency to HHS’ review of the abortion pill.
• Status: The government has not yet filed a brief in response to the lawsuit, which has been assigned to Justice of the Peace Timothy J. Sullivan.

Another group of lawsuits is challenging state restrictions on abortion pills, arguing that federal law, which allows medication abortions to be prescribed via telehealth and by mail up to 10 weeks of pregnancy, supersedes state laws.

GenBioPro v. Kristina Raynes et al.

• Court: United States Court of Appeals for the Fourth Circuit (on appeal from the United States District Court for the Southern District of West Virginia)
• Claims: In 2023, manufacturer of generic mifepristone GenBioPro sued West Virginia after the state criminalized abortion and explicitly banned the prescribing of mifepristone via telemedicine. The company argued that federal law preempted West Virginia law and that Congress only authorized the FDA to impose restrictions on access to mifepristone.
• Pool: A ruling in favor of the plaintiffs could facilitate access to abortion drugs in a country that has cut off access to abortion services in most cases.
• Status: Completed. U.S. District Court Judge Robert C. Chambers, an appointee of former Democratic President Bill Clinton, found in 2023 that the Food and Drug Administration Amendments Act did not repeal West Virginia’s abortion laws. U.S. Court of Appeals for the Fourth Circuit upheld the lower court’s July decision.

Amy Bryant v. Timothy Moore et al.

• Court: United States Court of Appeals for the Fourth Circuit (on appeal from the United States 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 that require in-person prescription, dispensing, and administration; prohibit providers other than physicians from prescribing mifepristone; order the scheduling of an in-person follow-up meeting; and require reporting of nonfatal adverse events to the FDA.
• Pool: This case could limit states’ ability to restrict medical abortion.
• Status: Chief Justice Catherine C. Eagles, an Obama appointee, found that federal law invalidated some restrictions but upheld 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 District Court of Louisiana
• Claims: On October 31, 2024, labor and delivery workers, doctors and a pregnant woman challenged a Louisiana law that classifies mifepristone and misoprostol as controlled unsafe substances, even though the FDA does not. They argue that the classification delays access to these drugs in emergencies, endangering the health and safety of patients who experience miscarriage.
• Pool: Emergency medications during pregnancy may become more readily available to healthcare providers if plaintiffs prevail.
• Status: Pending trial in state court. In May, the court held a hearing on the motion to dismiss the complaint and ruled that the complaint could proceed.

Another group of lawsuits seeks to reimpose more restrictions on mifepristone and claims that the FDA erroneously decided to allow abortion drugs prescribed via telehealth and mailed. Both cases cite anecdotes of women being coerced or drugged by their partners to argue that in-person visits are in the best interests of abortion patients.

Missouri et al. v. FDA et al.

• Court: United States District Court for the Eastern District of Missouri
• Claims: : Originally filed November 18, 2022 by a group of doctors and anti-abortion groups claiming that mifepristone is highly unsafe and that the FDA has illegally loosened restrictions. Last summer, the U.S. Supreme Court dismissed the case, ruling that the plaintiffs lacked standing, and remanded the case to a lower court.
• Pool: If plaintiffs prevail, the FDA could ban telehealth and the delivery of abortion medications by mail, which would limit access to them nationwide.
• Status: : lawsuit it was resurrected by attorneys general in Idaho, Kansas and Missouri. It was transferred last month from Trump appointee Matthew Kascmaryk in Texas to Trump appointee Cristian Stevens in Missouri.

Louisiana et al. v. FDA et al.

• Court: United States District Court for the Western District of Louisiana, Lafayette Division
• Claims: Filed on October 6, 2025, the State of Louisiana and resident Rosalie Markezich bring suit to overturn the FDA’s 2023 decision to eliminate the in-person dispensing requirement. Markezich claims her ex-partner forced her to take the abortion pill, which she says he ordered on her behalf and received in the mail.
• Pool: If plaintiffs prevail, the FDA could ban telehealth and the delivery of abortion medications by mail, which could limit access to them nationwide.
• Status: The case is pending in district court before Trump-appointed Judge David C. Joseph.

Read more about FDA’s safety review of abortion pills.

Tomorrow we’ll look at efforts to strengthen and crack shield laws across the country.