Access to Mifepristone in Flux Following Recent Fifth Circuit and Supreme Court Action

On Friday, May 1, the Fifth Circuit issued a temporarily limiting nationwide access to mifepristone, introducing significant uncertainty in access to a medication used in a majority of U.S. abortions, as well as in managing miscarriages. Although the U.S. Supreme Court entered an administrative stay on Monday, May 4, preserving the status quo for now, the legal landscape remains highly unstable. At least through May 11, mifepristone may continue to be prescribed via telehealth and dispensed by mail or through certified pharmacies, but future access depends on how the Supreme Court ultimately resolves the Fifth Circuit’s ruling.

The Longstanding Dispute Over Mifepristone REMS

Mifepristone plays a central role in abortion care, as medication abortions now comprise over of all U.S. abortions. Access to this drug has been at the center of litigation since the Supreme Court overruled Roe v. Wade. Mifepristone was originally approved by the Food & Drug Administration (FDA) in 2000 with significant restrictions, including required in‑person dispensing by or under the supervision of a physician, which were later formalized under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program in 2011. The FDA substantially modified these requirements in 2016 by extending the approved gestational age, reducing required in‑person visits and expanding prescriber eligibility beyond physicians.

During the COVID‑19 public health emergency, the FDA temporarily suspended the in‑person dispensing requirement and, following further review, permanently that requirement in 2023. The final REMS allowed mifepristone to be prescribed via telehealth and dispensed by certified retail pharmacies or by mail.

This regulatory evolution has been the subject of sustained litigation. Earlier challenges brought by anti‑abortion physician organizations culminated in a 2024 Supreme Court decision those cases for lack of Article III standing. Following that decision, several states—including , (joined by Kansas and Idaho) and (joined by Texas)—brought new challenges to the FDA’s 2023 REMS modifications.

In Louisiana v. FDA, the district court that the state had standing and was likely to succeed on the merits of its challenge but declined to enjoin the 2023 REMS while the case proceeded. That decision rested in significant part on the FDA’s concession that its prior REMS analyses suffered from deficiencies and its September 2025 that it was undertaking an independent, comprehensive review of its mifepristone policies—the agency urged the court to refrain from granting relief pending completion of that review. Accepting that posture, the court stayed the case, ordering the FDA to complete its review and report back within six months.

On May 1, 2026, the U.S. Court of Appeals for the Fifth Circuit an emergency request by the Louisiana Attorney General to reinstate the requirement that mifepristone be dispensed in-person at a clinic, medical office or hospital. As a result, the court effectively eliminated access to the medication via telehealth and mail-order pharmacy across the country, including where abortion is legally permitted. The court did so through an administrative stay of the FDA’s 2023 modification to the mifepristone REMS—a procedural mechanism designed to preserve the status quo while litigation proceeds but used here to suspend a long‑standing FDA regulatory policy with immediate nationwide effect.

Such judicial intervention is unprecedented, both as to this procedural posture and as to the substance. Aside from the prior phases of this mifepristone litigation, the courts have not interfered in FDA’s decisions about drug and device approvals, which rest on FDA’s expert assessment of the medical evidence. As highlighted in the many amicus briefs filed throughout this litigation, this type of judicial intervention risks undermining the FDA’s role as the primary decisionmaker on drug and device safety.

In response, the manufacturer of mifepristone (Danco Laboratories) filed an with the U.S. Supreme Court on May 2, 2026, seeking to stay the Fifth Circuit’s order while further appellate review proceeds. On May 4, 2026, Justice Alito issued an administrative stay, effective through May 11, to afford the Supreme Court additional time to consider the drug manufacturers’ emergency applications seeking to set aside the Fifth Circuit’s order while the litigation proceeds. As of publication, mifepristone can once again be prescribed and dispensed via mail following a telehealth encounter.

Implications for Providers if the Fifth Circuit’s Ruling Takes Effect

1. Risks of Non‑Compliance with Federal REMS Requirements

Under the Fifth Circuit’s order reinstating the in‑person dispensing requirement, any provider or dispenser who furnishes mifepristone outside the terms of the REMS could face enforcement risk, even when caring for patients in states where abortion otherwise remains lawful. As a formal matter, REMS obligations generally run to the drug sponsor, so FDA enforcement would be directed at the manufacturer if the distribution system fails to comply with REMS requirements. However, prescribing and dispensing practices that fall outside the REMS may also create downstream risk for individual providers and pharmacies, as described below, including potential scrutiny or enforcement by state licensing authorities and professional boards.

2. Uncertainty Regarding Protections Under State Shield Laws

In response to the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, more than 20 states enacted “” that were designed to limit out‑of‑state civil, criminal or professional enforcement actions against in‑state providers who provided abortion services via telehealth.

Relying on these protections, many providers have developed telehealth‑based models to expand access to medication abortion, including for patients located in abortion‑restrictive states. Some providers dispense the medication themselves, while others partner with certified pharmacies to dispense mifepristone by mail following a telehealth encounter, as permitted under the FDA’s 2023 mifepristone REMS.

Importantly, however, these shield laws remain largely untested, and there is active litigation—including various enforcement efforts by Texas and Louisiana against out‑of‑state providers—challenging the scope and effectiveness of these protections. To date, the shield laws in states such as New York and California have prevented those out-of-state enforcement actions from having any practical effect, since the courts, public agencies and other actors in these states have declined to enforce out-of-state judgments, provide information to support investigations or extradite providers for prosecution, among other protections. The ultimate fate of these enforcement actions remains uncertain due to ongoing litigation, and the risk landscape may change if affected providers travel outside their home state, particularly if they travel to the state in which they face active enforcement actions.

If the Supreme Court ultimately allows the Fifth Circuit’s ruling to take effect, that would materially alter how these regimes interact. Although shield laws generally protect the provision of “legally protected health care activity” by providers located within state lines acting consistent with applicable law, those protections cannot override federal law. Thus, the shield laws may not provide significant protection against federal enforcement actions. And with respect to out-of-state enforcement actions, adversarial states may argue that the shield laws should no longer protect telehealth-based abortion prescribing or dispensing if the 2023 REMS is blocked in the courts. Providers who prescribe and mail mifepristone to patients in restrictive states would face a materially different risk profile, including increased exposure to out‑of‑state civil, criminal or licensure actions.

The same risks would extend beyond clinicians to others (such as telehealth platforms and data vendors) who facilitate the provision of medication abortion services to patients in banned states under aiding‑and‑abetting or facilitation theories. As a result, we may see increased pressure and vulnerability as shield‑law protections against compelled disclosure are tested.

The Supreme Court’s administrative stay temporarily preserves the 2023 REMS and allows existing care models to continue for the moment under the protection of state shield laws.

3. Misoprostol‑Only Regimens

Even if the Court were to roll back the 2023 REMS, telehealth would likely continue to play a major role in the provision of medication abortion. Importantly, the Fifth Circuit’s order applied only to mifepristone and does not affect misoprostol, the second drug in the standard medication‑abortion regimen, which is not subject to a REMS and remains available for telehealth‑based prescribing. While mifepristone is almost always taken in combination with misoprostol, misoprostol alone remains a clinically valid alternative. That said, a misoprostol‑only regimen is generally less effective than the combined mifepristone–misoprostol regimen and may be associated with higher rates of side effects compared to the two‑drug protocol.

What’s Next? Contingency Planning Amid Ongoing Litigation

With the Supreme Court’s administrative stay in place, the procedural posture of the case leaves those who support access to mifepristone via telehealth in limbo. Although access to mifepristone currently remains governed by the 2023 REMS, that could again change next week. In the interim, providers, pharmacies, telehealth platforms and state officials should:

• Monitor Supreme Court action closely, particularly whether the Court extends the administrative stay or allows the Fifth Circuit’s order to take effect during further proceedings.
• Prepare for rapid regulatory shifts and operational flexibility for providers and pharmacies, including the ability to pivot between telehealth‑based dispensing and in‑person models on short notice.
• Evaluate alternative care pathways, including reliance on misoprostol‑only regimens, which are not subject to REMS restrictions.
• Update patient and provider communications to ensure clear guidance in the event of further court‑ordered changes.