Danco Laboratories, LLC v. Louisiana
Order lets FDA’s 2023 rule allowing mail distribution of mifepristone remain in effect while appeals proceed, making it easier for people in states like Louisiana to receive the drug.
Real-world impact
- Keeps FDA’s 2023 safety rule allowing mail distribution of mifepristone in effect during appeals.
- Allows manufacturers and certified pharmacies to continue mailing the drug while litigation continues.
- Temporarily maintains easier access to medication abortion in states that restrict abortion like Louisiana.
Topics
Summary
Background
Danco and GenBioPro are manufacturers and distributors of mifepristone. Louisiana sued the FDA under the Administrative Procedure Act, arguing the FDA improperly removed an in-person dispensing requirement from mifepristone’s 2023 REMS (FDA safety rules). The Fifth Circuit issued a May 1 order suspending the 2023 REMS changes, and the manufacturers asked the Supreme Court to stay that suspension so the 2023 REMS would remain in effect.
Reasoning
The Court granted the manufacturers’ applications for stays, pausing the Fifth Circuit’s May 1 order while the appeal and any petition for Supreme Court review proceed. The order says the stay ends automatically if the Supreme Court denies review or when the Court’s judgment is sent down if review is granted. Justice Thomas and Justice Alito dissented. Justice Thomas argued shipments of mifepristone violate federal criminal statutes and that profits from such shipments cannot justify a stay. Justice Alito argued the manufacturers failed to show imminent, irreparable harm and that equity does not protect profits tied to unlawful activity; he also noted the FDA has not taken a position and is conducting a safety review.
Real world impact
As a practical matter, the decision keeps the FDA’s 2023 REMS in place for now, permitting distribution practices that allow certified pharmacies to ship mifepristone to users while litigation continues. This affects access in States that restrict abortion, including Louisiana, and is temporary pending further appeals or Supreme Court action.
Dissents or concurrances
Both dissents would have denied stays: Thomas emphasized criminal statutes and unlawful profit; Alito emphasized lack of imminent harm and equitable considerations.
Questions, answered
Ask questions about the entire case, including all opinions (majority, concurrences, dissents). Try:
- “What was the Court's main decision and reasoning?”
- “How did the dissenting opinions differ from the majority?”
- “What are the practical implications of this ruling?”