Fifth Circuit Sets September 9 Oral Argument in Louisiana's Challenge to Telehealth Prescribing of Mifepristone

A federal appeals court is about to take up one of the most consequential telemedicine questions in reproductive health law: whether the FDA lawfully allowed mifepristone to be prescribed by telehealth and delivered without an in-person visit. The U.S. Court of Appeals for the Fifth Circuit is scheduled to hear oral argument on September 9, 2026, in State of Louisiana et al. v. FDA, docket No. 26-30203. The case does not decide whether abortion is legal. It tests the administrative record behind a specific dispensing rule, and the outcome could shape how a common medication reaches patients through remote care.

What the case is about

At issue is the FDA's Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, one of two drugs used in medication abortion. The FDA temporarily lifted the in-person dispensing requirement during the COVID-19 public health emergency in 2021, then in 2023 permanently revised the REMS so that mifepristone could be dispensed by mail and through certified retail pharmacies rather than only in person at a clinic or medical office. That 2023 change is what makes telehealth prescribing practical: a certified prescriber can evaluate a patient remotely, and a certified pharmacy can fill and ship the prescription.

State of Louisiana et al. v. FDA challenges that 2023 revision. According to the Georgetown Law Health Care Litigation Tracker, the plaintiffs are the State of Louisiana and an individual, Rosalie Markezich; the defendants include the FDA, FDA Commissioner Martin A. Makary, the Department of Health and Human Services, and HHS Secretary Robert F. Kennedy Jr. The manufacturers of mifepristone, Danco Laboratories and GenBioPro, have entered the case as intervenor-defendants.

What Louisiana argues

Louisiana contends the 2023 REMS revision was arbitrary and capricious, an abuse of discretion, and contrary to law under the Administrative Procedure Act. The state also invokes the 1873 Comstock Act, which it reads to prohibit mailing drugs used for abortion, and it points to costs it says it incurred, including roughly 92,000 dollars in Medicaid spending it attributes to emergency care for two patients in 2025. These are the state's legal arguments and asserted injuries, not findings by the court.

What the FDA and the manufacturers argue

The FDA has defended the 2023 decision as consistent with its safety review authority and asked the courts to leave the current rules in place. A central threshold dispute is standing: the intervenor-defendants argue that Louisiana cannot show the FDA's dispensing policy caused the economic harm it alleges, and that the state therefore lacks a legal basis to sue. If the panel agrees, it could resolve the appeal without reaching the merits of the REMS decision.

How the case reached the Fifth Circuit

The suit was filed in the U.S. District Court for the Western District of Louisiana. In April 2026 the district court granted the FDA's request to pause the litigation for roughly six months while the agency conducts its own review of the mifepristone REMS. Louisiana appealed on April 8, 2026.

• May 1, 2026: A Fifth Circuit motions panel granted Louisiana a stay pending appeal that would have reinstated the in-person dispensing requirement nationwide.
• Early to mid May 2026: The manufacturers sought emergency relief at the Supreme Court. After a brief administrative stay entered by Justice Samuel Alito, the Supreme Court stayed the Fifth Circuit's order.
• Result: The FDA's current rules, which permit telehealth prescribing plus mail and pharmacy dispensing, remain in effect while the appeal is decided.
• September 9, 2026: Oral argument is scheduled before the Fifth Circuit.

Why this matters for telemedicine

The 2023 REMS change is the regulatory foundation that lets mifepristone be prescribed without an in-person visit and delivered by mail or pharmacy. A ruling that vacates or narrows that change could, depending on its scope, reinstate an in-person dispensing step and disrupt the remote-care model that many patients and clinicians now use. The dispute also illustrates a broader pattern in telehealth law: access to a service often depends less on the video visit itself than on the dispensing, prescribing, and mailing rules that sit underneath it, which are set by agencies and can be challenged in court.

What this means right now

Oral argument is a step in the appeal, not a decision. As of the argument date, the Fifth Circuit has not ruled on the merits, the Supreme Court stay leaves current access unchanged, and the FDA's own REMS review is ongoing. Any of those tracks, a merits ruling, a standing dismissal, or an FDA decision after its review, could change the picture, and appellate cases of this kind can take months to resolve after argument.

Practical notes and limits

This article is general information, not medical or legal advice. It summarizes a pending case and does not predict how the court will rule. Patients with questions about medication access should speak with a licensed clinician, and anyone tracking the litigation should rely on the primary court records and the FDA's official REMS materials rather than secondhand summaries. The facts here are drawn from the sources listed below and reflect the record as of the publication date; a pending appeal can move quickly.