Federal regulations around mifepristone, which has provided abortion access across the United States, are being challenged in multiple lawsuits from opposing directions. (Getty Images)

Despite its strong safety record, the abortion and miscarriage drug mifepristone has been taken to court in several conflicting lawsuits, where some plaintiffs argue the drug should be easier to access, and others say it should be more restricted. 

The medication, sometimes prescribed through telehealth and sent to patients by mail, has provided abortion access across the United States and become a prime target for abortion opponents. 

A group of ongoing federal lawsuits challenges the U.S. Food and Drug Administration’s 2023 decision to maintain special 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. Yet another lawsuit, filed Nov. 13 by the American Civil Liberties Union, challenges the FDA under the Freedom of Information Act, alleging the agency has, without giving a reason, refused to disclose the parameters of its mifepristone review and related communications with outside groups. 

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

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

• Court: U.S. District Court for the District of Hawaii
• Claims: Originally named Chelius v. Wright and filed Oct. 3, 2017, by the American Civil Liberties Union on behalf of a family doctor 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.
• Stakes: This case could determine whether the FDA can continue requiring special certifications for patients and providers, which plaintiffs argue deter and delay care, and present privacy risks for patients and providers post-Roe. If plaintiffs succeed, mifepristone could become easier to dispense and access throughout the country.
• Status: On Oct. 30, Judge Jill Otake, nominated by Republican President Donald Trump, ruled the FDA did not properly justify its 2023 decision or consider all of the evidence when it decided to maintain current restrictions on mifepristone. She ordered the agency to reconsider its decision. Plaintiffs did not seek to vacate the regulations in its lawsuit, so for now they remain in place pending the outcome of the FDA’s review and response to the court. A joint status report from plaintiffs and defendants on how the case should proceed is due Dec. 4.

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

• Court: U.S. 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 the claims in Purcell v. Kennedy.
• Stakes: If plaintiffs succeed in this case, mifepristone could become easier to dispense and access.
• Status: 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 not yet issued a decision.

Washington et al. v. FDA et al.

• Court: U.S. District Court for the Eastern District of Washington
• Claims: On Feb. 23, 2023, Washington and initially 11 other states challenged the FDA’s mifepristone regulations as burdensome and unnecessary.
• Stakes: Expanding mifepristone access was on the line in this case.
• Status: Terminated. Judge Thomas O. Rice, nominated by former Democratic President Barack Obama, ruled this summer that the FDA’s review and decision regarding the mifepristone restrictions was reasonable, not arbitrary or capricious.  

American Civil Liberties Union v. FDA

• Court: U.S. District Court for the District of Maryland
• Claims: On Nov. 13, 2025, the ACLU sued the FDA arguing it has not complied with the Freedom of Information Act. The nonprofit law firm in August sought  expedited records around the parameters of the FDA’s ongoing review of mifepristone and communications with outside groups. The ACLU alleges the agency has failed to provide a determination regarding the request.
• Stakes: Records released as part of 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 Magistrate Judge Timothy J. Sullivan. 

Another group of lawsuits challenge state abortion pill restrictions, arguing that federal law, which allows medication abortions to be prescribed via telehealth and by the mail up to 10 weeks’ gestation, supersedes state laws.

GenBioPro v. Kristina Raynes et al.

• Court: U.S. Court of Appeals for the Fourth Circuit (on appeal from U.S. District Court for the Southern District of West Virginia)
• Claims: In 2023, mifepristone generic manufacturer GenBioPro sued West Virginia after the state criminalized abortion and explicitly banned prescription of mifepristone by telemedicine. The company argued federal law preempts West Virginia law and that Congress authorized only the FDA to impose restrictions on access to mifepristone.
• Stakes: A ruling in plaintiffs’ favor could have made abortion drugs easier to access in a state that has cut off access to pregnancy termination in most circumstances.
• Status: Terminated. 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 preempt West Virginia’s abortion regulation. The U.S. Court of Appeals for the Fourth Circuit affirmed the lower court’s decision in July. 

Amy Bryant v. Timothy Moore et al.

• Court: U.S. Court of Appeals for the Fourth Circuit (on appeal from U.S. District Court for the Middle District of North Carolina)
• Claims: In 2023, North Carolina Dr. Amy Bryant sued her state over medication abortion restrictions, arguing the FDA’s mifepristone policy preempts state restrictions, which require in-person prescribing, dispensing and administering; prohibit providers other than physicians from prescribing mifepristone; mandate the scheduling of an in-person follow-up appointment; and require non-fatal adverse events reported to the FDA.
• Stakes: The case could limit states’ ability to restrict medication abortion.
• Status: Chief Judge Catherine C. Eagles, nominated by Obama, found that some restrictions were preempted by federal law 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: Louisiana’s 19th Judicial District Court
• Claims: On Oct. 31, 2024, birth workers, medical 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 the classification delays access to these medications during emergencies, risking the health and safety of patients experiencing miscarriages.
• Stakes: Drugs used for emergencies during pregnancy could become easier for providers to access if plaintiffs prevail.
• Status: Pending in state trial court. In May, the court held a hearing on a motion to dismiss and ruled the challenge can proceed.

Another group of lawsuits seek to reimpose more restrictions on mifepristone and argue the FDA erred in its decision to allow abortion medication prescribed through telehealth and sent through the mail. Both cases cite anecdotes of women being coerced or drugged by partners to argue in-person visits are in the best interest of abortion patients. 

Missouri et al. v. FDA et al.

• Court: U.S. District Court of Eastern District of Missouri
• Claims: Originally filed Nov. 18, 2022 by a group of anti-abortion doctors and groups that claimed that mifepristone is highly dangerous and the FDA unlawfully loosened restrictions. The U.S. Supreme Court rejected the case last summer, determining plaintiffs did not have standing to sue and remanded it to lower courts.
• Stakes: If plaintiffs prevail, the FDA could bar telehealth and mail delivery of medication abortion, which would curtail access throughout the country.
• Status: The lawsuit was resurrected by attorneys general in Idaho, Kansas and Missouri. It was transferred last month from Trump appointee Matthew Kascmaryk’s court in Texas to Trump appointee Cristian Stevens’ court in Missouri. 

Louisiana et al. v. FDA et al.

• Court: U.S. District Court for the Western District of Louisiana Lafayette Division
• Claims: Filed Oct. 6, 2025, the state of Louisiana and resident Rosalie Markezich are suing to vacate the FDA’s 2023 decision to remove the in-person dispensing requirement. Markezich says she was coerced by a former partner to take the abortion pill, which she says he ordered in her name and received by mail.
• Stakes: If plaintiffs prevail, the FDA could bar telehealth and mail delivery for abortion medication, which could curtail access throughout the country.
• Status: The case is pending in district court before Trump appointee Judge David C. Joseph.

Read more about the FDA’s high-stakes abortion pill safety review.

Tomorrow, a look at efforts to both reinforce and crack shield laws across the country.