Mifepristone Litigation and Federal Action Tracker
Our two legal trackers, the Mifepristone Litigation Tracker and Mifepristone Federal Action Tracker, provide timely, regularly updated, information on the status of current litigation and new federal administrative actions that could shape regulation of and access to mifepristone.
Background on Mifepristone
Mifepristone is one of two drugs (along with misoprostol) commonly used in medication abortion. Medication abortion is used in nearly two-thirds of all abortions in the United States. The U.S. Food and Drug Administration (FDA) approved mifepristone in 2000, and its safety has been rigorously tested—decades of studies analyzing tens of thousands of patient experiences have conclusively proven that mifepristone is safer than many common medications, including Tylenol.
Based on this overwhelming safety record, FDA lifted some prior restrictions on how the drug is administered, including by revising mifepristone’s Risk Evaluation and Mitigation Strategy (REMS)—special restrictions placed on some FDA-regulated prescription drugs. Most notably, FDA decided in 2021 to temporarily remove the requirement that mifepristone only could be dispensed in person at clinics, medical offices, and hospitals (permanently removing that requirement in 2023). Prior to that, in 2016, it ended the requirement of physician-only prescribing and allowed healthcare providers with prescriptive authority under state law (such as nurse practitioners, nurse midwives, and physician assistants) to become certified prescribers of mifepristone. These decisions have allowed a broader group of health care providers to administer mifepristone, including by telehealth, increasing access to the medication.
Despite FDA’s recent removal of some restrictions, mifepristone is far more regulated than other drugs with similar safety profiles. FDA still subjects mifepristone to a REMS requiring patients to certify they have decided to take mifepristone to end their pregnancy, clinicians to certify their qualifications to prescribe mifepristone in a form submitted to the pharmacy or distributor, and pharmacies to comply with tracking and reporting obligations to become certified before dispensing mifepristone. Many states have also imposed laws and policies restricting access to mifepristone beyond FDA’s regulations.
Litigation and Federal Action
Despite mifepristone’s record of safety and effectiveness, anti-abortion activists have pursued various strategies to ban or undercut access to it. In recent years, anti-abortion activists have brought litigation challenging FDA’s recent decisions relaxing some of the restrictions on the drug.
At the same time, because mifepristone is still subject to more rigorous restrictions than other drugs with a similar safety profile, health care providers and advocacy organizations have challenged regulations of mifepristone that create unnecessary barriers to access under various legal theories. These include that FDA’s existing regulatory scheme is overly restrictive and burdensome, that states cannot impose additional restrictions on mifepristone beyond what FDA has imposed, and that the state restrictions violate state law. Ongoing litigation also seeks to prevent any enforcement of a future court decision that might suspend mifepristone’s approval. Stay updated on the cases that could affect access to mifepristone through the Mifepristone Litigation Tracker.
The federal government may also independently take administrative and agency actions, apart from its involvement in any litigation, that could affect regulation of and access to mifepristone. For example, the FDA may modify the current regulations governing mifepristone including in response to the citizen petition process, by which people may issue formal requests for the agency to take action. Stay updated on the federal government’s actions related to mifepristone since January 1, 2025, through the Mifepristone Federal Action Tracker.
The Mifepristone Litigation Tracker
To date, mifepristone litigation includes:
7 cases filed to protect or expand current access:
- Three FDA Decisionmaking Cases addressing whether current FDA regulations on mifepristone are overly burdensome and restrictive given mifepristone’s safety and effectiveness
- Two Federal Preemption Cases addressing whether federal law preempts (supersedes) and invalidates additional state restrictions on mifepristone beyond FDA’s regulations
- One State Law Case addressing whether additional state restrictions on mifepristone are invalid under state law
- One Due Process Case seeking to prevent any enforcement of a court decision suspending FDA approval of mifepristone without due process
1 case filed to restrict current access:
- One FDA Decisionmaking Case challenging FDA’s decisions removing prior restrictions on mifepristone, including the in-person dispensing requirement, and seeking to reimpose those restrictions
The Mifepristone Litigation Tracker was last updated in June 2025. Download a PDF version here.
|
Case |
Court |
Date and Location Filed |
Summary of Challenge |
What’s at Stake |
Current Status |
|---|---|---|---|---|---|
|
U.S. Court of Appeals for the Fourth Circuit (on appeal from U.S. District Court for the Southern District of West Virginia)
|
January 25, 2023 |
GenBioPro, a manufacturer of generic mifepristone, argues that federal law preempts West Virginia laws banning abortion in almost all cases and banning prescription of mifepristone by telemedicine because Congress authorized only FDA to impose restrictions on access to mifepristone. GenBioPro also challenges as preempted West Virginia restrictions on mifepristone requiring counseling and a waiting period that are not currently in effect but would be reimposed if the state’s general abortion ban were struck down. GenBioPro argues that the state’s ban and restrictions also burden interstate commerce in violation of the U.S. Constitution’s Commerce Clause. The district court granted defendants’ motion to dismiss GenBioPro’s claim related to West Virginia’s general abortion ban, reasoning that the ban restricts when an abortion may be performed rather than how mifepristone may be prescribed and thus is not in conflict with or preempted by FDA’s regulations. The court also concluded that the general abortion ban does not violate the Commerce Clase because it does not impede the flow of mifepristone nationally. The court dismissed GenBioPro’s claims regarding the counseling and waiting period requirements since they are not currently in effect. However, the district court denied defendants’ motion to dismiss GenBioPro’s claim regarding the telemedicine ban, holding that West Virginia’s restriction on prescribing mifepristone via telemedicine is in direct conflict with and preempted by FDA’s regulations, which permit prescription via telemedicine. GenBioPro appealed the decision to the U.S. Court of Appeals for the Fourth Circuit. |
This case could affect access to mifepristone by deciding whether states may impose burdensome restrictions on mifepristone beyond FDA’s regulations, including by banning mifepristone for its approved use in almost all circumstances and barring prescription via telehealth or otherwise making it more difficult to access. |
The case is currently pending before the U.S. Court of Appeals for the Fourth Circuit. The parties have submitted briefs, and the court held oral argument on October 29, 2024. A decision has not yet been issued. |
|
|
U.S. Court of Appeals for the Fourth Circuit (on appeal from U.S. District Court for the Middle District of North Carolina) |
January 25, 2023 North Carolina |
Plaintiff, a medical provider in North Carolina, asserts that federal law preempts North Carolina laws imposing additional restrictions on mifepristone beyond FDA’s requirements. The district court upheld other challenged state requirements for an in-person advance consultation, ultrasounds, an in-person examination, blood type testing, and adverse event reporting to state health authorities, concluding that these provisions were not expressly considered and rejected by FDA or “focus more on the practice of medicine and a patient’s informed consent,” and thus are not preempted. Plaintiff, the defendant state Attorney General (who agrees with plaintiff that the state laws are preempted), and several legislative leaders (who have intervened as defendants in the case and argue that the state laws are not preempted) have all appealed the district court’s judgment to the U.S. Court of Appeals for the Fourth Circuit. |
This case could affect access to mifepristone by deciding whether states may impose burdensome restrictions on mifepristone beyond FDA’s regulations, including those barring administration via telehealth or otherwise making mifepristone more difficult to access.
|
The case is currently pending before the U.S. Court of Appeals for the Fourth Circuit. The parties have filed briefs, but the case is temporarily suspended pending a decision by the U.S. Court of Appeals for the Fourth Circuit in GenBioPro, Inc. v. Raynes (Case No. 23-2194) (see above). |
|
|
U.S. District Court for the District of Hawaii |
October 13, 2017 Hawaii |
Plaintiffs—a health care provider, Society of Family Planning, and the California Academy of Family Physicians—challenge FDA’s current set of restrictions (the Risk Evaluation and Mitigation Strategy (REMS)) on mifepristone as unduly burdensome and arbitrarily restrictive given mifepristone’s safety and effectiveness. Plaintiffs argue that these restrictions—which require patients to certify they have decided to take mifepristone to end their pregnancy and limit who can prescribe and dispense the drug by requiring providers and pharmacies to undergo a special certification process—delay care, deter qualified providers and pharmacies from prescribing and dispensing mifepristone because of the burdens related to certification, and impede research and training on mifepristone at academic institutions. Plaintiffs assert claims under the equal protection guarantee of the Fifth Amendment and the Administrative Procedure Act, alleging they are treated differently from other similarly situated parties without a sufficient state interest, and that FDA’s imposition of the REMS was not based on a reasoned decision or rational basis. |
The case could affect access by eliminating or leaving intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it. The case could also determine whether FDA may continue to require the patient agreement form, which plaintiffs assert presents privacy risks for patients and providers. |
The case is currently pending in federal district court in Hawaii. In October 2024, plaintiffs filed a motion for summary judgment. In December 2024, defendants filed a cross-motion for summary judgment, arguing that plaintiffs’ claims should be dismissed on the merits, and that plaintiffs lack standing. Oral argument on the motions for summary judgment is scheduled for August 22, 2025. |
|
|
Washington et al. v. U.S. Food and Drug Administration et al., |
U.S. District Court for the Eastern District of Washington |
February 23, 2023 Washington |
17 states and Washington, D.C. (the States) challenge FDA’s mifepristone REMS as unduly burdensome and arbitrarily restrictive given mifepristone’s safety and effectiveness. The States argue that these restrictions—which require patients to certify they have decided to take mifepristone to end their pregnancy and limit who can prescribe and dispense the drug by requiring providers and pharmacies to undergo a special certification process—are unnecessary barriers that make it more difficult to access care. The States argue that FDA violated the Administrative Procedure Act by imposing the REMS against evidence showing the restrictions are unnecessary, and violated the equal protection guarantee of the Fifth Amendment by treating providers, pharmacists, and patients who prescribe, dispense, or use mifepristone worse than those who prescribe, dispense, or use other medications. |
The case could affect access by eliminating or leaving intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it. The case could also determine whether FDA may continue to require the patient agreement form, which the States assert presents privacy risks for patients and providers. |
The case is currently pending in federal district court in Washington. In October 2024, the States filed a motion for summary judgment. In December 2024, defendants filed a cross-motion for summary judgment, arguing that the States’ claims should be dismissed on their merits, and that the States lack standing to challenge the prescriber certification and patient agreement form requirements. Defendants also argue that the States’ claims should be dismissed because they did not administratively exhaust them by first raising them with FDA. Oral argument on the motions for summary judgment has not yet been held. |
|
GenBioPro v. U.S. Food and Drug Administration, et al., |
U.S. District Court for Maryland |
April 19, 2023 Maryland |
GenBioPro, a manufacturer of generic mifepristone, filed suit in April 2023 to prevent other federal court rulings (including those issued by the district court and Fifth Circuit in Alliance for Hippocratic Medicine v. FDA) from stripping FDA approval of generic mifepristone without following the required statutory and regulatory procedures for suspension of a drug’s approval. GenBioPro argues that suspending approval of mifepristone without proper process would violate the Administrative Procedure Act, the All Writs Act, and the due process guarantee of the Fifth Amendment. GenBioPro asserts that any enforcement action characterizing its mifepristone as misbranded and without an effective drug approval based on federal court rulings that did not provide a constitutionally adequate procedure for suspending drug approval would be unlawful. |
The case could affect access to mifepristone by determining whether court decisions may suspend its approval. |
This case was stayed while the Supreme Court resolved Alliance for Hippocratic Medicine v. FDA, and remains stayed until August 15, 2025, awaiting the Texas federal district court’s decision on pending motions to dismiss Missouri v. FDA, Case No. 2:22-cv-00223. |
|
Whole Woman’s Health Alliance et al. v. U.S. Food and Drug Administration et al., |
U.S. District Court for the Western District of Virginia |
May 8, 2023 Virginia |
Abortion providers in Virginia, Montana, and Kansas challenge FDA’s current mifepristone REMS as unduly burdensome and arbitrarily restrictive given mifepristone’s safety and effectiveness. The providers argue that these restrictions—which require patients to certify they have decided to take mifepristone to end their pregnancy and limit who can prescribe and dispense the drug by requiring providers and pharmacies to undergo a special certification process—are unnecessary barriers that make it more difficult to access care. Plaintiffs argue that FDA violated the Administrative Procedure Act by imposing the REMS against evidence showing the restrictions are unnecessary, and violated the equal protection guarantee of the Fifth Amendment by treating providers, pharmacists, and patients who prescribe, dispense, or use mifepristone worse than those who prescribe, dispense, or use other medications. |
The case could affect access by eliminating or leaving intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it. The case could also determine whether FDA may continue to require the patient agreement form, which plaintiffs assert presents privacy risks for patients and providers. |
The case is currently pending in federal district court in Virginia. In October 2024, plaintiffs filed a motion for summary judgment. In December 2024, defendants filed a cross-motion for summary judgment, arguing that plaintiffs’ claims should be dismissed on the merits, and that plaintiffs lack standing and did not administratively exhaust their claims by first raising them with FDA. The court held oral argument on the motions for summary judgment on May 19, 2025. The court has not yet issued a decision. |
|
Missouri et al. v. U.S. Food and Drug Administration et al., |
U.S. District Court for the Northern District of Texas |
November 18, 2022 Texas |
Missouri, Kansas, and Idaho (the States) seek to revive a prior case, Alliance for Hippocratic Medicine, et al., v. FDA, in which the States had intervened. In June 2024, the Supreme Court held that the plaintiffs in AHM v. FDA—anti-abortion doctors and activists who never prescribed and never experienced harm related to mifepristone—lacked standing, and all claims in AHM v. FDA were dismissed. In October 2024, the States filed an amended complaint in the same federal district court in Texas that presided over AHM v. FDA. The States claim FDA decisions in 2016, 2021, and 2023 relaxing prior restrictions on mifepristone and FDA’s 2019 approval of the generic form of the drug were not supported by adequate evidence and as a result violate the Administrative Procedure Act. The States seek to rescind the 2019 generic approval and reimpose restrictions on mifepristone that FDA has determined are medically unnecessary, including the pre-2021 requirement that it be dispensed in-person, and the pre-2016 restrictions requiring three office visits, limiting prescription of mifepristone to only certified physicians, indicating it could only be used for pregnancies up to 7 weeks (rather than 10 weeks), and requiring the reporting of all serious non-fatal adverse events to FDA. The States also seek an order prohibiting provision of mifepristone to adolescents. |
This case could affect access to mifepristone by imposing burdensome restrictions on mifepristone FDA has determined are medically unnecessary, including requirements for in-person dispensing and office visits (which would prohibit mifepristone’s administration via telehealth) and limitations on which health care providers can prescribe mifepristone. The case could also affect adolescent access to mifepristone. |
Defendants have moved to dismiss this case, arguing that it should be dismissed or transferred because the States have no connection to the Texas district in which they filed their complaint. Defendants additionally argue that the case should be dismissed because the States haven’t demonstrated they suffered any injury as a result of FDA’s decisions, failed to first raise their claims through FDA’s review process, and some of the claims are barred by the statute of limitations. The parties have completed briefing on defendants’ motion to dismiss. Next, Judge Kacsmaryk, who previously ruled in favor of the anti-abortion doctors and activists in AHM v. FDA, will decide whether to dismiss the case. |
|
Birthmark Doula Collective v. State of Louisiana, |
Louisiana State Trial Court (19th Judicial District Court) |
October 31, 2024 Louisiana |
Plaintiffs—birth workers and other medical professionals, advocates, and a pregnant person—challenge a Louisiana law classifying mifepristone and misoprostol, safe medications with no risk of abuse or dependence, as controlled dangerous substances. Plaintiffs argue that this classification delays access to the medication, risking the health and safety of patients, including those carrying pregnancy to term and experiencing miscarriages. Plaintiffs assert that the law discriminates based on physical condition thereby violating Louisiana’s constitutional right to equal protection. Plaintiffs also argue that the legislature violated state constitutional requirements (the single object requirement and germane amendment rule) in amending a bill introduced to create the crime of coerced abortion to add the unrelated matter of classifying mifepristone and misoprostol as controlled substances. |
This case could impact emergency care for pregnant people in Louisiana. Classification of mifepristone and misoprostol as controlled dangerous substances delays access to care, posing a particular threat to the health and safety of people experiencing obstetric emergencies. |
The case is currently pending in Louisiana trial court. On May 15, 2025, the court held a hearing on defendants’ motion requesting dismissal of the case and ruled that plaintiffs’ challenge can proceed. |
The Mifepristone Federal Action Tracker
The Mifepristone Federal Action Tracker covers federal actions since January 1, 2025, and was last updated in June 2025. Download a PDF version here.
|
Date |
Summary of Action |
What’s at Stake |
Current Status |
|---|---|---|---|
|
June 5, 2025 |
California, Massachusetts, New York, and New Jersey file a Citizen Petition requesting FDA eliminate the current REMS for mifepristone or in the alternative, cease enforcing the restrictions as unnecessary. |
According to a representative of the states, in response to the filing of this petition, FDA will need to consider the ample scientific research of mifepristone’s safety and effectiveness, including newer research, and it cannot change its current regulation of mifepristone while the petition is pending. In response to the petition, FDA may decide to eliminate or leave intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it. FDA may also determine whether to continue to require the patient agreement form. |
FDA acknowledged receipt of the petition on June 6, 2025. FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. |
|
May 14, 2025 |
U.S. Health Secretary Robert F. Kennedy Jr. testifies before the Senate Health, Education, Labor and Pensions Committee that he has ordered FDA administrator Martin A. Makary to conduct a “complete review” of mifepristone regulations. In response to a question from Senator Hawley, Kennedy agreed that FDA review of mifepristone is necessary in part because of a recent report on mifepristone released by anti-abortion activists that was not peer-reviewed or published in a medical journal. (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40) In contrast, more than one hundred scientific studies conducted over the last 30 years have conclusively proven mifepristone’s safety.
|
If FDA were to impose additional restrictions on mifepristone, whether reimposing prior restrictions or creating new ones, it could decrease access throughout the country, including in states where abortion is legal. |
Kennedy indicated FDA review of mifepristone is ongoing. (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40) |
|
May 12, 2025 |
An individual, James Brinkruff, files a Citizen Petition requesting immediate suspension of the approval of mifepristone for medication abortion, an FDA study of mifepristone when used via telehealth, and imposition of requirements for in-person dispensing and a follow-up appointment. |
If FDA were to suspend approval of mifepristone for medication abortion, it would severely affect access to abortion throughout the country—medication abortion is currently used in nearly two-thirds of all abortions in the United States. Imposing additional restrictions on mifepristone would also decrease access throughout the country, including in states where abortion is legal. |
FDA acknowledged receipt of the petition on May 14, 2025. FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. |
|
March 6, 2025 |
Dr. Marty Makary (then-nominee, now head of the FDA), states during his confirmation hearing that he would review whether FDA should re-impose an in-person dispensing requirement for mifepristone. |
FDA’s imposition of an in-person dispensing requirement for mifepristone would significantly decrease access, particularly for rural and underserved communities, and those who can’t travel or take time away from work. |
Kennedy has since indicated that FDA review of mifepristone is ongoing. (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40) |
|
January 31, 2025 |
The American College of Obstetricians and Gynecologists, Society of Family Planning, and Society for Maternal-Fetal Medicine submit a Citizen Petition requesting FDA eliminate the current REMS for mifepristone or in the alternative refrain from taking any action that would further reduce patient access to mifepristone or increase the burdens associated with prescribing or dispensing mifepristone. |
FDA may decide to eliminate or leave intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it. FDA may also determine whether to continue to require the patient agreement form. |
FDA acknowledged receipt of the petition on February 4, 2025. FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. |
|
January 29, 2025 |
Robert F. Kennedy Jr. (then-nominee, now Secretary of Health) states during his confirmation hearing: “President Trump has asked me to study the safety of mifepristone. He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.” |
If FDA were to impose additional restrictions on mifepristone, whether reimposing prior restrictions or creating new ones, it could decrease access throughout the country, including in states where abortion is legal. |
Kennedy has since indicated that FDA review of mifepristone is ongoing. (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40) |
|
January 7, 2025 |
American Association of Pro-Life Obstetricians and Gynecologists submit a Citizen Petition noting that there had been news reports that mifepristone’s manufacturer had planned to apply to add miscarriage management as an indication for mifepristone, and requesting that if FDA approve that indication it establish a REMS prohibiting telehealth, requiring an in-person follow-up appointment with an ultrasound, and requiring reporting of all adverse events. Students for Life of America had also filed a Citizen Petition in December 2024, requesting that FDA refrain from modifying the approved usage of mifepristone to include miscarriage care. |
Currently, mifepristone is commonly prescribed off-label for miscarriage management. In all areas of medicine, “off-label” use of medications to reflect evolutions in evidence-based practice is permissible, common, and necessary to ensure that clinical care is not undermined by scientifically outdated labeling. Imposition of stricter restrictions than currently exist for mifepristone’s use to treat miscarriages—as requested by this petition—would unnecessarily limit access and burden providers and patients. |
On June 4, 2025, FDA denied the petition filed by American Association of Pro-Life Obstetricians and Gynecologists, stating that to the extent there is any pending application to add miscarriage management as an approved indication for mifepristone, FDA had not issued a final determination to approve it and consideration of the issues presented in the petition outside FDA’s approval process would be procedurally improper. Citing the same reasons, FDA denied the petition filed by Students for Life of America on May 21, 2025. |