State of Louisiana et al. v. Food and Drug Administration et al.

Docket No.
26-30203
Appellate Court
Fifth Circuit

Goal

  • Compel agency action
  • Declaration that agency action is unlawful
  • Vacate agency action

Issues

Case History

Why This Matters:

There are two pending applications before the Supreme Court in this case; all relevant Supreme Court filings can be found here (Danco’s application) and here (GenBioPro’s application).

Why This Matters:

In 2023, the FDA revised the Risk Evaluation and Mitigation Strategy for mifepristone to, among other changes, remove a requirement that the medication be dispensed in-person in a medical facility. This revision allowed prescribers to send, and their patients to receive, the medication by mail. Plaintiffs challenge the FDA’s revision as arbitrary and capricious, an abuse of discretion, and contrary to law in violation of the Administrative Procedure Act. Reinstating the in-person dispensing requirement, which has not been in effect since 2020, would create a serious barrier for women seeking reproductive care. In this appeal, plaintiffs challenge the district court’s decision to deny preliminary relief and stay the litigation while the FDA conducts a “review” of mifepristone’s safety record.

Potential Impact:

Potential Impact:

Unnecessary restrictions on safe and effective drugs can create obstacles for doctors to promote medically appropriate care and jeopardize the health and safety of patients.

News And Analysis (1)

17 Major Filings

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Related Litigation

Current Status

Appeal Filed

Motion for Stay Pending Appeal Granted

Legal Issues

Administrative Procedure Act - Arbitrary and Capricious, Administrative Procedure Act - Contrary to Law

Topic(s)

Medication Abortion

Date Filed
April 8, 2026
Case Type
Civil
Court Type
Appellate Court
Court
Fifth Circuit
Plaintiff(s)
State of Louisiana; Rosalie Markezich
Lead Counsel For Plaintiff(s)
Government; Johnson, Siebeneicher & Ingram
Defendant(s)
Food and Drug Administration; Martin A. Makary; George F. Tidmarsh; Department of Health and Human Services; Robert F. Kennedy Jr.
Lead Counsel for Defendant(s)
Government
Intervenor Defendant(s)
Danco Laboratories LLC; GenBioPro Inc.
Amicus Briefs for Defendant(s)

Reproductive Health Initiative for Telehealth Equity & Solutions et al.; Legal Voice; Honeybee Health Inc.; Vet Voice Foundation; Disability Rights Education and Defense Fund et al.