Louisiana v. FDA: Access to Mifepristone Back at the Supreme Court

Medication abortion—most commonly a two-drug regimen of mifepristone and misoprostol—has become a central legal battleground in the years since Dobbs v. Jackson Women’s Health Organization. Over 25 years ago, the U.S. Food and Drug Administration (FDA) approved mifepristone, along with a requirement that the drug be dispensed in person by a physician. In 2023, after reviewing research that continued to demonstrate its safety even when dispensed through telehealth, the FDA eliminated the requirement that the drug be dispensed in person, enabling the drug to be mailed or dispensed by retail pharmacies. This change has allowed clinicians to dispense the drug via mail and enabled tens of thousands of patients to access medication abortion in states where the provision of abortion is outlawed.

Multiple lawsuits filed after 2022 have focused specifically on the FDA’s role in regulating mifepristone: whether the agency can set conditions of use through its Risk Evaluation and Mitigation Strategy (REMS), whether courts can override the agency’s scientific and administrative judgments, and how state abortion bans interact with federal drug regulation. In 2024, the Supreme Court ruled in Alliance for Hippocratic Medicine v. FDA, that a group of doctors, associations and organizations that oppose abortion lacked legal standing to challenge the FDA’s approval of mifepristone, but did not reach the merits of their claims.

Three state-led lawsuits are now claiming that FDA policy enabling remote prescribing and mailing of mifepristone harms states by undermining their abortion restrictions and generating downstream costs. Several provider- and organization-led cases argue the opposite: that FDA restrictions – which allow mifepristone to be mailed, but only through certified prescribers and pharmacies — remain unlawfully burdensome given the drug’s safety record. This brief reviews the case now before the Supreme Court, Louisiana v. FDA, provides an overview of the other pending litigation involving mifepristone, and the mounting tension between states seeking to protect abortion and states banning the provision of abortion.

Overview of the Case

In October 2025, Louisiana filed a lawsuit against the FDA claiming the agency violated the Administrative Procedure Act (APA) when it approved the 2023 REMS for mifepristone. Louisiana also claims that the 2023 REMS violates an 1873 anti-obscenity law, the Comstock Act, which prohibits the mailing of any medication used for abortion. The 2023 REMS no longer required that the drug be dispensed in person to patients and enabled the medication to be mailed or dispensed at retail pharmacies like most prescription drugs. The state of Louisiana alleges that this revised dispensing requirement has harmed the state and interferes with their ability to regulate abortion in their own state (Louisiana bans the provision of abortions). The Trump Administration defended the FDA and said that an internal review was already underway to examine the 2023 approval decision and the medication’s safety record in light of the updated dispensing policies. In April 2026, the U.S. District Court for the Western District of Louisiana paused the litigation for six months to give the FDA time to continue its review of the drug’s safety. Louisiana appealed this decision to the 5th Circuit Court of Appeals.

On May 1, 2026, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit granted Louisiana’s request to roll back the FDA rules that enabled remote prescribing, mailing and retail pharmacy dispensing while the appeal proceeds. This decision, which required mifepristone to be dispensed only in person, took effect immediately with implications for abortion access nationwide, not just in states where abortion is banned. That evening Danco Laboratories, one of the drug manufacturers and an intervenor-defendant, filed an emergency motion asking the Fifth Circuit to pause its decision for one week to allow them time to appeal to the U.S. Supreme Court. The following day, after the Fifth Circuit did not respond to Danco’s motion, Danco and GenBioPro (another mifepristone manufacturer) filed emergency appeals to the Supreme Court. Justice Alito granted a one-week administrative stay of the Fifth Circuit’s decision.

On appeal the Supreme Court will first consider whether the Plaintiffs have legal standing to bring this case; without legal standing, the case does not proceed. Both the district court and the Fifth Circuit Court of Appeals found Louisiana has legal standing because it has shown injury caused by the FDA’s 2023 REMS that can be alleviated by a court decision. However, in a similar case, Alliance for Hippocratic Medicine v. FDA, the Supreme Court ruled that a group of doctors and health providers did not have standing for multiple reasons including that they could not show a concrete injury resulting from the updated FDA mifepristone dispensing requirements.

In this lawsuit Louisiana asserts that the policy of allowing mifepristone to be mailed has harmed the state’s ability to enforce its abortion ban and has caused the state to spend state Medicaid funds on patients who took mifepristone received by mail and then needed emergency care for complications. Specifically, “Louisiana identifies $92,000 it paid in Medicaid costs from two women who needed emergency care in 2025 from complications caused by out-of-state mifepristone.” 

The FDA, and the drug manufacturers (GenBioPro and Danco), claim that Louisiana has failed to show legal standing. The FDA regulates drugs and has no oversight over states or providers. They assert that the FDA’s 2023 REMS does not implicate the State’s sovereign “power to create and enforce a legal code.” The Defendants further argue that Louisiana’s alleged Medicaid-based economic harm is too “attenuated” to establish standing, suggesting Louisiana cannot show that the FDA’s policy of allowing mifepristone to be mailed led to their alleged economic harm. Patients could obtain mifepristone out of state, bring it back to Louisiana, and suffer the same complications, they argue.

The Defendants (the FDA, Danco and GenBioPro) assert that if Louisiana is granted standing in this case, a state could challenge any federal policy alleged to have caused a visit to a doctor or a hospital for which the state pays the bills. The Defendants cite to the examples the Supreme Court provided in the decision denying the Alliance for Hippocratic Medicine standing: “EPA roll[ing] back emissions standards for power plants,” “[a] federal agency increas[ing] a speed limit from 65 to 80 miles per hour,” and the federal government “repeal[ing] certain restrictions on guns.”

The FDA’s Tightrope Walk—Defending Agency Authority While Not Defending the 2023 REMS

The FDA’s posture in this case and the related litigation has been complicated by the transition from the Biden administration, which embraced reproductive rights, to the Trump administration, which supports abortion restrictions. The agency is defending the lawsuits. But, after pressure from anti-abortion organizations and state attorneys general, in September 2025, the FDA announced it was conducting a comprehensive review of mifepristone, including the 2023 REMS. When announcing the review, the FDA wrote, “HHS’s decision to do so is informed by the lack of adequate consideration underlying the prior REMS approvals, and by recent studies raising concerns about the safety of mifepristone as currently administered.” The Fifth Circuit relied on that statement in its ruling, finding that the FDA conceded in the September 2025 letter that it did not comply with the Administrative Procedures Act when removing the in-person dispensing requirement.

The Trump administrations FDA position contrasts with the administrative record underlying the FDA’s 2023 REMS decision, which shows the FDA’s removal of the in-person dispensing requirements was grounded in more than two decades of experience with mifepristone. The 2023 analysis included: its 2021 review of published literature; safety information submitted during the COVID-19 pandemic; more than five years of adverse data; a separate one-year assessment report for the REMS; and information provided by advocacy groups, individuals and manufacturers. The FDA found that all this information supported the safety of the REMS modification in 2023. The FDA further found there were “no new safety concerns” related to the removal of the in-person dispensing requirement. It therefore concluded that, “[r]emoving the in-person dispensing requirement will render the REMS less burdensome to healthcare providers and patients and provided all other requirements of the REMS are met, including the additional requirement for pharmacy certification, the REMS will continue to ensure that the benefits of mifepristone for medical abortion outweigh the risks.”

Enforcement of a Court Decision Directed at the FDA

A court order to rescind the 2023 REMs would again require in person dispensing, resulting in regulatory pressure on Mifepristone manufacturers (Danco, GenBioPro and Evita Solutions) to ensure that providers certified to dispense mifepristone comply with a court order, and only dispense the medication in person. Furthermore, it is unprecedented for a federal court to compel the FDA to modify the REMS for an approved medication and could potentially undermine the agency’s authority to determine and regulate drug safety.

Even if the Court suspends the FDA’s policy of dispensing mifepristone by mail, that will not end the use of telehealth in the provision of medication abortions. Some clinics and providers will respond by switching to a misoprostol-only regimen. While this single drug regimen is less effective (approximately 80-100% depending on the regimen and pregnancy duration) than using the highly effective mifepristone and misoprostol regimen (between 91.9 to 99.7% depending upon the gestational duration and route or interval of misoprostol administration) it is still a demonstrated protocol that is used in many countries. While misoprostol alone is effective, it can also cause abortion patients to experience more side effects, including greater pain, bleeding, and gastrointestinal effects than the regimen with mifepristone and misoprostol combined.

Conflict Between States

Interstate Conflict and the Rise of Shield Laws

Many states that are protective of abortion rights have implemented so-called “shield laws.” These laws are designed to protect telehealth providers prescribing and mailing mifepristone in their state from criminalization across state lines. As GenBioPro and Danco highlight in their appeals to the Supreme Court: “Louisiana’s filings below made clear—the alleged frustration of Louisiana’s laws occurs because other “states have enacted ‘shield laws’ to protect medical practitioners in their states from extradition for prescribing” mifepristone. This difference in state policies is yet again a natural result of this Court “return[ing]” abortion policy to the states,” in the Dobbs ruling.

Under shield laws, in June 2025 approximately 55% of telehealth medication abortions were provided to people living in states with abortion bans or telemedicine bans according to the #WeCount project of the Society of Family Planning. That month, 45% of telehealth medication abortions were mailed to patients in states without restrictions reflecting the uneven availability of abortion even in states where abortion is not restricted. Texas and Louisiana have attempted to prosecute or fine telehealth providers in California and New York but have been blocked by shield laws.

New State Laws Regulating Mifepristone

Beyond regulating abortion generally, states have implemented new laws specifically targeting medication abortion. These laws often prohibit the prescription, dispensing, or mailing of abortion-inducing drugs within state borders, and in some instances impose criminal penalties on providers. Such measures operate in direct tension with the FDA’s policy set forth in the REMS for mifepristone. For example, Mississippi recently passed a new law (effective July 1, 2026) that makes it unlawful to manufacture, distribute, dispense or prescribe abortion medication. Anyone who violates the law may face civil liability and up to 10 years in prison. Louisiana has enacted a law that classifies mifepristone and misoprostol as controlled substances, which limits the appropriate storage and dispensing; however, this law is currently being challenged in state court. Texas also passed a new law that allows private citizens to sue individuals or entities that provide, mail, or transport abortion medication to or from Texas.

Proposed Federal Bills and Investigations

Dissatisfied with the pace of the FDA review, Senator Josh Hawley, an anti-abortion leader, has introduced a bill that would rescind the FDA’s approval of mifepristone. He has also launched an investigation into mifepristone manufacturers Danco Laboratories and GenBioPro seeking information about adverse events associated with the drug, claiming that the drug is risky based on the results of the same study cited by HHS officials. In April 2026, Indiana Senator Jim Banks sent a letter to the Federal Trade Commission Chairman urging the Commission to investigate abortion drug manufacturers for allegedly engaging in deceptive trade practices and promoting misleading safety claims.

Other Cases Involving the FDA and Medication Abortion

In recent years, courts have issued conflicting rulings on the FDA’s 2023 decision to eliminate the in-person dispensing requirement. (Table 1) In July 2025, a federal court in Washington upheld the REMS revisions, while in October 2025, a federal court in Hawaii (Purcell v. Kennedy) ruled that the FDA violated the Administrative Procedure Act, “by failing to provide a reasoned explanation for its restrictive treatment of the drug ”when it maintained restrictions on access to mifepristone in 2023. The court has ordered the FDA to review evidence it allegedly overlooked including, “the wealth of peer-reviewed evidence proving mifepristone’s safety, including when delivered by telemedicine as well as how FDA’s restrictions burden patient access.”

Additional lawsuits underway brought by states, Missouri, Idaho, Kansas, Florida, and Texas, also challenge either the FDA’s original approval or subsequent modifications to the REMS. Florida and Texas have agreed to pause their litigation while the FDA continues its internal review.

Whole Woman’s Health Alliance, an independent abortion provider in Virginia with other independent abortion providers in Montana and Kansas, filed a lawsuit (Whole Woman’s Health Alliance v. FDA) against the FDA in May 2023, asserting that the FDA violated the Administrative Procedure Act when imposing REMS on mifepristone. The lawsuit seeks to remove all the REMS for mifepristone. This case is ongoing, and the Plaintiffs have opposed a stay to allow the FDA to continue its internal review.

Separate litigation is also testing whether the FDA’s regulation of mifepristone preempts state restrictions. In GenBioPro v. Raynes (West Virginia), GenBioPro challenged the state’s near-total abortion ban; in July 2025, the Fourth Circuit affirmed dismissal of the case, holding that the FDA’s mifepristone policies do not preempt West Virginia’s ban. In a second case, brough in North Carolina, Bryant v. Stein(formerly Bryant v. Moore), a physician argues that the FDA’s dispensing framework for mifepristone preempts additional state-law restrictions—on the theory that the FDA considered more stringent limits on mifepristone and chose not to adopt them, so states may not impose those same restrictions. There is a Louisiana state court challenge brought by Birthmark Doula Collective to Louisiana’s law which classifies mifepristone and misoprostol as controlled substances, subjecting these medications to controlled-substance storage, prescribing and dispensing rules. This case tests whether a state can use controlled-substance classification to restrict access to medication.

Looking Ahead

The return of mifepristone to the Supreme Court underscores how many questions remain post-Dobbs about how state authority to regulate abortion intersects with federal authority to regulate drugs. In Louisiana v. FDA, the immediate question before the Court is whether Louisiana has legal standing to challenge FDA’s 2023 REMS. Justice Alito issued an administrative stay of the Fifth Circuit’s decision until May 11, 2026. How the Supreme Court handles the emergency appeal once that stay expires will determine whether the rollback of the 2023 REMS remains in effect while the case proceeds and will signal how the Supreme Court views deference to the FDA on matters of drug approval and safety.

While the Supreme Court considers this case, related lawsuits are pulling in opposite directions—other state-led challenges also seeking to restore the in-person dispensing requirement for mifepristone, provider-led cases arguing the current REMS are unlawfully burdensome, and preemption cases testing whether states can restrict an FDA-approved drug. At the same time, state shield laws offer protections to providers who prescribe and mail medication abortion to patients in states with abortion bans, intensifying interstate conflict and raising new questions about enforcement and jurisdiction.