Despite his strong safety recordThe abortion and miscarriage drug mifepristone has been taken to court in several conflicting lawsuits, with some plaintiffs claiming the drug should be more easily accessible and others saying it should be restricted.
The drug, sometimes prescribed via telehealth and mailed to patients, has opened up abortion access across the United States and become a prime target for abortion opponents.
A group of ongoing federal lawsuits are challenging 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 yet to rule. Yet another lawsuit, filed Nov. 13 by the American Civil Liberties Union, challenges the FDA under the Freedom of Information Act, alleging that the agency has refused, without explanation, to disclose the parameters of its mifepristone review and related communications with outside groups.
Heidi Purcell et al. v. Robert F. Kennedy Jr. et al.
Court: United States District Court for the District of Hawaii
Claims: Originally titled Chelius v. Wright and filed on October 3, 2017 by the American Civil Liberties Union on behalf of a primary care physician and several medical associations, this lawsuit challenges the FDA’s mifepristone restrictions as unnecessarily burdensome and arbitrarily restrictive, in violation of the Administrative Procedure Act.
Stake: This case could determine whether the FDA can continue to require special certifications for patients and caregivers, which plaintiffs say deters and delays care and poses privacy risks to patients and caregivers.Roo. If the plaintiffs are successful, mifepristone could become more readily available and accessible across the country.
Status: On October 30, Judge Jill Otake, nominated by Republican President Donald Trump, ruled the FDA has not properly justified this Decision from 2023 or considered all the evidence when it decided to maintain current restrictions on mifepristone. She has ordered the organization to reconsider its decision. The plaintiffs did not seek to lift the regulations in their lawsuit, so for now they remain in place pending the outcome of the investigation and the FDA’s response to the court. There will be a joint status report from plaintiffs and defendants on how the case should proceed expected on December 4.
Whole Woman’s Health Alliance et al. v. U.S. 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 rules as unnecessarily burdensome and arbitrarily restrictive, similar to the claims in Purcell vs. Kennedy.
Stake: If the plaintiffs in this case are successful, mifepristone could become more readily available and accessible.
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 made 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 eleven other states challenged the FDA’s mifepristone regulations as burdensome and unnecessary.
Stake: In this case, expanding access to mifepristone was at stake.
Status: Terminated. Judge Thomas O. Rice, nominated by former Democratic President Barack Obama, reigned this summer that the FDA’s review and decision regarding the restrictions on mifepristone 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, alleging failure to comply with the Freedom of Information Act. The nonprofit law firm sought expedited data in August on the parameters of the FDA’s ongoing review of mifepristone and communications with outside groups. The ACLU claims the agency failed to make a decision on the request.
Stake: Documents released as part of this lawsuit could bring transparency to HHS’s 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 challenges state abortion pill restrictions, arguing that federal law, which allows medication abortions to be prescribed via telehealth and by mail up to 10 weeks of pregnancy, supersedes state law.
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 manufacturer of mifepristone GenBioPro has sued West Virginia after the state criminalized abortion and explicitly banned mifepristone prescribing via telemedicine. The company argued that federal law preempts West Virginia law and that Congress alone authorizes the FDA to impose restrictions on access to mifepristone.
Stake: A ruling in favor of the plaintiffs could have made access to abortion drugs easier in a state that has closed access to terminations of pregnancy in most circumstances.
Status: Terminated. District Court Judge Robert C. Chambers, nominated by former Democratic President Bill Clinton, ruled in 2023 that the Food and Drug Administration Amendments Act did not preempt abortion regulations in West Virginia. The United States 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 drug abortion restrictions, arguing that the FDA’s mifepristone policy overrides state restrictions requiring in-person prescribing, dispensing, and administration; prohibit providers other than physicians from prescribing mifepristone; mandate for scheduling an in-person follow-up appointment; and require non-fatal adverse events to be reported to the FDA.
Stake: The case could limit states’ ability to restrict medication abortion.
Status: Chief Justice Catherine C. Eagles, nominated by Obama, ruled that some restrictions were undermined 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 October 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 that the classification delays access to these medications during emergency situations, endangering the health and safety of patients experiencing miscarriage.
Stake: Drugs used for emergencies during pregnancy could become easier to access for healthcare providers if plaintiffs prevail.
Status: Pending in state court. In May, the court held a hearing on a motion to dismiss and ruled that the challenge could proceed.
Another group of lawsuits is again seeking to impose more restrictions on mifepristone, claiming the FDA erred in its decision to allow abortion drugs to be prescribed via telehealth and sent by mail. In both cases, anecdotes of women being coerced or drugged by partners are cited 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 submitted November 18, 2022 by a group of anti-abortion doctors and groups claiming that mifepristone is very dangerous and that the FDA has unlawfully relaxed restrictions. The U.S. Supreme Court dismissed the case last summer, ruling that the plaintiffs lacked standing and remanded the case to lower courts.
Stake: If the plaintiffs prevail, the FDA could ban telehealth and mail delivery of abortion drugs, which would limit access nationwide.
Status: The court case was raised by attorneys general in Idaho, Kansas and Missouri. It was transferred last month from the Trump-appointed Matthew Kascmaryk court in Texas to the Trump-appointed Cristian Stevens court 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 filed suit seeking to revoke the FDA’s 2023 decision to eliminate the in-person dispensing requirement. Markezich says she was forced by an ex-partner to take the abortion pill, which he said he ordered in her name and received by mail.
Stake: If the plaintiffs prevail, the FDA could ban telehealth and mail delivery for abortion drugs, which could limit access nationwide.
Status: The case is pending in district court before Trump-appointed Judge David C. Joseph.
This article is republished from News from the United Statespart of States Newsroom. Read Sofia Resnick’s original story here.
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