## Facts

- The FDA approved mifepristone in 2000 with restrictions on distribution and conditions of use.
- In 2016, 2019, and 2021, the FDA modified the regulatory regime, including easing certain conditions and permitting mail dispensing under specified requirements.
- Medical organizations and physicians sued, alleging the FDA’s 2000 approval and later changes were unlawful under the Administrative Procedure Act and related statutes.
- The district court issued an order that would have effectively suspended or rolled back the FDA’s approval and subsequent modifications, threatening nationwide access under the then-current regime.
- The Fifth Circuit partially stayed the district court’s order but left in place restrictions that would have reinstated earlier, more stringent conditions.
- Danco Laboratories and the federal government filed emergency applications in the Supreme Court seeking a stay of the district court’s order as modified by the Fifth Circuit.

## Issues

1. Whether to stay the district court’s order (as it would operate pending appeal) altering the regulatory status of mifepristone while appellate proceedings continued.
2. Whether the applicants satisfied the traditional stay factors: likelihood of success, irreparable harm, balance of equities, and public interest.

## Decision

- The Supreme Court granted the applications for stays, keeping the district court’s April 7, 2023 order from taking effect while the case proceeded in the Fifth Circuit and through any timely petition for certiorari.
- The stay was set to terminate automatically if certiorari were denied, or upon issuance of the Supreme Court’s judgment if certiorari were granted.
- Justice Thomas noted he would deny the stays; Justice Alito dissented in writing.

## Legal Principles

- A stay pending appeal is an equitable, discretionary remedy governed by four considerations: probability of success, irreparable harm, balance of equities, and the public interest.
- In emergency posture, the Supreme Court may issue a stay to maintain existing regulatory conditions pending lower-court review and potential Supreme Court review.
- A stay order is procedural and does not decide the merits of the underlying statutory or administrative-law claims.

## Conclusion

The Court’s stay preserved the then-existing FDA regulatory regime for mifepristone during ongoing appellate proceedings, preventing immediate implementation of lower-court orders that would have reinstated earlier restrictions or otherwise disrupted access pending further review.


Danco Laboratories, LLC v. Alliance for Hippocratic Medicine, 143 S. Ct. 1075 (2023)