On Friday, May 1, 2026, a unanimous three-judge panel of the U.S. Court of Appeals for the Fifth Circuit granted the State of Louisiana’s emergency motion for a stay pending appeal in State of Louisiana v. FDA, No. 26-30203. The order immediately reinstated the in-person dispensing requirement for mifepristone, which was previously rolled back in 2021 (and formalized in 2023) by the FDA’s Risk Evaluation and Mitigation Strategy (REMS). In plain English: health care providers can now only prescribe mifepristone in-person and may no longer prescribe it virtually via telehealth. However, early on Monday, May 4, 2026, the Supreme Court issued an administrative stay of the Fifth Circuit's order until May 11, effectively restoring the status quo for at least a week. This blog post analyzes the Fifth Circuit's order and actions companies should consider during this interim time.

Mifepristone is used in most medication abortions in the United States (in a regimen with misoprostol); it is also widely used in miscarriage care. This ruling does not impact the FDA’s approval of mifepristone, though it may create legal and practical obstacles to accessing mifepristone. For example, patients may face barriers and longer wait times to pick up the medication in person, even in states where abortion remains legal, and even when mifepristone is being used for non-abortion purposes, like miscarriage management. This case is one of several actions brought by states seeking to prohibit telehealth and remote dispensing of mifepristone to patients in states with abortion bans, and the outcome here may influence those parallel proceedings. 

Friday’s ruling overturned the Western District of Louisiana’s April 2026 decision, which refused to stay the 2023 REMS requirements. There, the district court held that while the State of Louisiana demonstrated standing, a strong likelihood of success, and irreparable harm, the balance of equities and public interest weighed against Louisiana. Instead, the Western District of Louisiana stayed the entire case to allow FDA to complete its ongoing comprehensive review of the mifepristone REMS. On appeal, the Fifth Circuit held that the district court abused its discretion when balancing the equities and public-interest, as the Fifth Circuit emphasized that the likelihood of success and irreparable harm factors are the most critical factors upon which to focus.

In granting the administrative stay, Justice Alito did not evaluate the merits of either the district court's or the Fifth Circuit's holdings. Rather, the 7-line Order merely granted the stay and set deadlines for a response and expiration of the stay.

Background

Mifepristone was approved by FDA in 2000 for use in combination with misoprostol to end early pregnancy and for early miscarriage management, and has been subject to successive REMS modifications. A REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

When initially approved, the REMS imposed significant access restrictions, which included three in-person visits and mandatory reporting of serious adverse events. Over time, the barriers to access mifepristone were progressively lowered. In 2016, the FDA allowed nurse practitioners to prescribe mifepristone after one in-person visit and limited reporting to only fatalities. During the COVID-19 pandemic, the FDA issued a Non-Enforcement Decision, by which FDA removed the in-person dispensing requirement entirely, permitting mail-order and pharmacy dispensing without an in-person visit, which were later formalized in the 2023 REMS.

In October 2025, Louisiana challenged the 2023 REMS under the Administrative Procedure Act (APA), arguing that FDA’s justifications for permitting remote dispensing relied on flawed or nonexistent data and that the 2023 REMS changes led to illegal abortions in Louisiana and unrecoverable Medicaid costs for alleged complications. Danco Laboratories and GenBioPro (the brand and generic manufacturers of mifepristone) intervened as defendants. The district court denied Louisiana’s motion for preliminary relief and stayed the litigation pending FDA review. Louisiana then appealed to the Fifth Circuit. 

The Fifth Circuit’s opinion begins by invoking the post-Dobbs landscape of state-level regulation and noting that President Biden’s Executive Order No. 14076 directed federal agencies to expand access to medication abortion. The Court also highlights FDA’s own recent concession—made when it announced its comprehensive review of mifepristone late last year—that the prior REMS approvals suffered from a “lack of adequate consideration.” Together, this contextual framing sets the stage for the Court’s decision to grant Louisiana’s emergency motion for a stay pending appeal, discussed further below. 

Key Holdings on the Stay Factors Under 5 U.S.C. § 705

Louisiana sought a stay of the 2023 REMS under 5 U.S.C. § 705, which authorizes courts to “postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings.” The Court applied the standard four-factor test as follows:

1. Strong Likelihood of Success. The Court held Louisiana is likely to prevail on its APA claim, calling the scientific literature supporting the 2023 REMS modification inadequate and a “textbook example of arbitrary and capricious agency action.” 

2. Irreparable Harm. The Court held Louisiana has shown that it is irreparably harmed without a stay, pointing to Louisiana’s argument that the 2023 REMS undermines Louisiana’s abortion laws and causes financial harm to Louisiana from Medicaid expenditures.

3. Equities and Public Interest. The Court agreed with Louisiana that the district court erred by finding Louisiana's irreparable harms are outweighed by FDA’s interest in continuing its review and Danco’s financial interests in selling mifepristone. The Court held that “[n]either the FDA nor the public has any interest in enforcing a regulation that violates federal law,” noting this was the third time the Fifth Circuit has found that FDA's relaxation of mifepristone's safeguards “likely lacked a basis in data and scientific literature.” The Court emphasized that FDA itself concedes the 2023 REMS was marred by “procedural deficits” and a “lack of adequate consideration,” and that “the public interest is not served by perpetuating a medical practice whose safety the agency admits was inadequately studied.”

The Fifth Circuit's order is applied nationwide, goes into effect immediately (subject to the Supreme Court's temporary administrative stay), and does not disturb the underlying FDA approval of mifepristone itself or the continued review that the FDA is conducting. The Court cautioned that while this ruling has nationwide effect, it should not be construed through the same lens as other nationwide injunctions given that this is a remedy of the Administrative Procedure Act, and therefore appropriate. In other words, though this ruling functions practically as a nationwide injunction, it does not violate the Supreme Court’s 2025 limitations on universal injunctions, as the § 705 stay “temporarily voids the challenged authority,” and here, the challenged authority is a nationwide regulator action.

Key Implications

For pharmaceutical manufacturers, pharmacies, telehealth platforms, health systems, distributors, and other stakeholders, Friday's order creates immediate compliance and operational obligations under the reinstated, pre-2023, REMS. Though the Supreme Court has temporarily issued an administrative stay, companies should nonetheless consider the below recommendations in the event the stay is soon lifted:

• REMS Compliance and Enforcement Risk: Unless the Supreme Court's administrative stay is extended, certified pharmacies and distributors will need to immediately revert to in-person-only dispensing protocols for mifepristone. Mail-order and telehealth-based fulfillment of mifepristone prescriptions would be prohibited. Manufacturers should be prepared to promptly update REMS materials, labeling, distribution agreements, and training to reflect the pre-2023 framework. 

• Telehealth and Virtual Care Disruption: Unless the Supreme Court's administrative stay is extended, providers and platforms offering medication abortion or miscarriage management involving mifepristone via telehealth must require in-person evaluations or clinic-based dispensing. This will disproportionately impact access in rural or restrictive jurisdictions and may create tension with state shield laws in permissive states. 

What’s Next?

On Friday night, mere hours after the Fifth Circuit issued its decision, Danco Laboratories, filed for an emergency one-week administrative stay of the Fifth Circuit’s order to allow Danco time to seek relief in the United States Supreme Court. The motion requested a decision by the Fifth Circuit by 9 pm on Friday. Shortly after that deadline passed, Danco then filed an application for an emergency stay to the Supreme Court. Applications from the Fifth Circuit go to Justice Samuel Alito for initial review, who can then either rule on the application individually or refer it to the full court for review. As of Monday morning, Justice Alito administratively stayed the Fifth Circuit's order until 5:00 pm EDT on Monday, May 11, 2026. A response to the manufacturers' application for a stay is due by 5:00 pm EDT on Thursday, May 7, 2026. 

Meanwhile, FDA's comprehensive review of mifepristone, which began in September 2025 and will include consideration of the 2023 REMS, continues in the background, though the agency has not committed to a timeline for completing its review. The results of that review could also influence the ongoing proceedings in this and other cases.

While the Supreme Court's temporary administrative stay has restored the status quo, within weeks it could lift that say, reinstating the in-person dispensing requirement in full effect. Notwithstanding the administrative stay, manufacturers, pharmacies, telehealth providers, and health systems should evaluate immediate operational changes and consider strategic engagement with FDA where appropriate. 

Reed Smith will continue to track developments in the post-Dobbs abortion landscape and the regulation of mifepristone in particular. If you have questions about how this decision affects your REMS compliance program, distribution practices, or telehealth operations, please reach out to the health care lawyers at Reed Smith.