Understanding Mifepristone Regulations

The Food and Drug Administration (FDA) is a federal agency that regulates prescription and over-the-counter drugs to ensure their safety and effectiveness for public use. Mifepristone is an oral medication used with misoprostol to terminate a pregnancy within the first 10 weeks of gestation. It was first approved by the FDA in 2000. Mifepristone is regulated through a Risk Evaluation and Mitigation Strategy (REMS), which manages the safety risks of drugs by determining how the drug is prescribed and distributed. In January 2023, the FDA revised the REMS for mifepristone, removing the old regulation that only allowed access to the medication if it was received in person at a clinic. After the REMS revision, healthcare professionals could prescribe the medication through telehealth, and certified pharmacies were able to mail the medication to patients.

The FDA’s revision to the REMS quickly became controversial, specifically in states with strict abortion laws. In January 1973, Roe v. Wade established the right to an abortion under the Due Process Clause of the Fourteenth Amendment. Alongside Roe, in 1992, the Supreme Court upheld the right to abortion in Planned Parenthood v. Casey and gave the states more authority to regulate abortion such as requiring waiting periods or parental consent for minors. In June 2022, the Supreme Court concluded in Dobbs v. Jackson Women’s Health Organization that the Constitution did not guarantee the right to an abortion. The decision returned the authority to regulate or ban abortion to state governments and Congress. Some states implemented strict abortion laws, such as Louisiana, where abortion is banned at all stages of pregnancy, unless there are complications or life-threatening circumstances. In Louisiana, mifepristone is outlawed for elective abortions. This made the REMS revision contentious, given that out-of-state providers could potentially prescribe mifepristone to Louisiana residents through telehealth channels.

What is Louisiana v. FDA?

In October 2025, Rosalie Markezich, a Louisiana woman, filed a lawsuit alleging that her boyfriend coerced her into taking an abortion pill that was received through the mail from a doctor in California in October 2023. The Alliance for Defending Freedom, a nonprofit legal advocacy organization, represented Rosalie in the lawsuit. Louisiana’s Attorney General Liz Murrill became involved and represented Louisiana’s interests in the case. 

Alongside ADF attorneys, Louisiana and Rosalie filed suit as coplaintiffs, naming the FDA as the defendant because they were challenging the FDA’s REMS revision under the Administrative Procedure Act (APA). The APA is a federal law that protects the public from unlawful agency actions, allowing the public to challenge federal rules and regulations. Louisiana stated that removing the in-person clinic visit requirement to receive mifepristone infringed on state sovereignty. Additionally, Louisiana argued that the FDA violated the Comstock Act of 1873, which prohibits the mailing of abortion medication. The case of Louisiana v. FDA raises questions about the balance of power between federal and state governments in regulating abortion.

Legal Background

On October 3, 2025, Louisiana filed a complaint in the U.S. District Court for the Western District of Louisiana, which challenged the FDA’s REMS revision under the APA. On April 7, 2026, the Federal District Court denied the state’s request to block the FDA’s rules, but ruled that Louisiana had legal standing to challenge the FDA’s revision. The district court paused the suit, at the request of the FDA, while the FDA reviewed the mifepristone regulations. Louisiana was found likely to succeed on the merits and was considered to be suffering irreparable harm. Louisiana was dissatisfied with the April 7 decision, and appealed the denial of its preliminary injunction to the Fifth Circuit.

Then, on May 1, 2026, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit granted Louisiana’s request to block the FDA’s 2023 REMS, which would have reinstated the in-person requirement for mifepristone access. In response, on May 2, mifepristone manufacturers Danco Laboratories and GenBioPro issued an emergency appeal to the Supreme Court, requesting it to block the Fifth Circuit’s ruling.

Shortly after on May 4, 2026, Supreme Court Justice Samuel Alito, the justice responsible for Fifth Circuit emergency appeals, put the Fifth Circuit’s order on hold for one week. The order permitted the FDA’s 2023 REMS revision to remain in effect, allowing access to mifepristone through mail and telehealth. On May 11, Justice Alito extended the same stay until May 14, while the Supreme Court evaluated the emergency application. Finally, on May 14, 2026, the Supreme Court issued an order to stay the Fifth Circuit Court’s ruling and preserve the status quo allowing remote mifepristone access while litigation continues in the lower courts.

What Did Louisiana Argue?

In Louisiana v. FDA, Louisiana is represented by the Alliance Defending Freedom (ADF), a major conservative Christian legal advocacy group, alongside Louisiana Attorney General Liz Murrill. In its arguments, Louisiana contended that under the APA, allowing remote access to mifepristone is “arbitrary and capricious.” The APA was established to ensure agencies follow government regulations, and it serves as a system of checks and balances for federal agencies. Louisiana’s legal team highlighted that, in order to justify updating the REMS to relax in-person prescription requirements for mifepristone, the FDA had cited a lack of reports of adverse events tied to mifepristone in their reporting system called FAERS. However, the lack of adverse events could have been the result of the FDA eliminating requirements for reporting non-fatal adverse events to FAERS years earlier. 

Louisiana also broadly challenged the FDA’s revision of the 2023 REMS on the grounds of state sovereignty. Removing the in-person requirement allowed Louisiana citizens to access abortion care remotely. Therefore, Louisiana argued that the FDA’s revision infringed on Louisiana’s state sovereignty, because it undermined the state’s strict abortion regulations. 

In addition, Louisiana argued that the spending of state Medicaid funds to treat residents from out-of-state abortion pills has caused economic harm to the state. Louisiana cited that in 2025, the state government had to pay “over $92,000 in Medicaid dollars … for emergency room care and hospitalization resulting from just two mifepristone-induced abortions in 2025.” Louisiana argued that reinstating the in-person clinic intake requirement for mifepristone would reduce economic impact. Alongside this, Louisiana claimed to have spent over $17,000 to investigate three cases where mifepristone was mailed from out of state. 

What Did the FDA Argue?

The FDA argued that Louisiana’s claim of Medicaid harm lacks valid standing because the impacts are too indirect and unpredictable. Danco Laboratories and GenBioPro, major drug manufacturers of mifepristone, intervened as defendants in the case, and led the emergency appeal to the Supreme Court, arguing that reinstating the in-person requirement for mifepristone would cause harm to patients and providers. The FDA mentions concerns that Louisiana’s claim may set a precedent that if a state does not agree with the federal government, it has the right to sue. 

The FDA also argues that mifepristone has been established as a safe medication through decades of research. According to the FDA, from 2000 through June 2025, approximately 5.6 million women in the United States have used mifepristone, and only 28 have died. Furthermore, research affirms that there is no difference in prescribing mifepristone remotely versus in person in terms of safety or effectiveness. 

Additionally, the FDA argues that prohibiting remote access to the abortion pill will lead to medical inequities. Blocking telehealth or mail abortion services disproportionately affects low-income, rural, disabled patients. Research shows that “69% of disabled people report barriers to accessing reproductive care.” The FDA argues that a ban on telehealth prescriptions for mifepristone in abortion ban states will force patients to incur additional costs from travel, childcare, and taking time off work.

Court Decisions and Future Outlook

Currently, remote access to mifepristone remains legal under federal law. The Fifth Circuit Court of Appeals has scheduled oral arguments for September 9, 2026, where it will thoroughly review the legal arguments in the case with a full panel of judges. Shortly after, the FDA will be required to submit a progress report on safety data for mifepristone on October 7, 2026. As Louisiana v. FDA has raised many questions about state and federal authority regarding abortion policy, the Circuit Court’s resolution of the standing question will determine whether the case advances to a substantive ruling on federal and state power to regulate abortion policy.

Proposed Solutions

Questions about state and federal power in abortion policy remain, and several solutions have been proposed. Louisiana Attorney General Liz Murrill has contended that state-level abortion regulations will not prohibit people from receiving abortion medications, and she believes federal regulatory changes are needed. The Alliance for Defending Freedom has gone even further to propose banning mail and pharmacy delivery entirely, which would ensure state abortion regulations are abided by. On the other hand, some advocacy organizations suggest that another policy alternative would be to expand state shield laws to ensure that medical providers and professionals are protected from criminal charges when prescribing safe treatments like mifepristone via telehealth.

Others advocate for a middle-ground approach where Congress could pass legislation that clarifies the FDA’s authority over state laws. This solution might permit the use of mifepristone for medical uses such as miscarriage, while allowing states to restrict access to the medication for abortions.

As these proposals show, the debate over mifepristone access ultimately reflects a broader unresolved question about how authority should be divided between federal regulators and state governments when their policies conflict.

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