Fifth Circuit Issues Mifepristone Decision: Case Likely to Move to Supreme Court
On Wednesday, August 16, 2023, a panel for the United States Court of Appeals for the Fifth Circuit vacated in part and affirmed in part a previous Texas federal district court decision that revoked the Food and Drug Administration (“FDA”) approval of the abortion-inducing drug, mifepristone.
While the latest Fifth Circuit ruling did not undo the FDA’s approvals of both the brand (issued in 2000) and generic (issued in 2019) forms of mifepristone, the Fifth Circuit held that later FDA actions post-2016 easing access to the drug were unlawful. Specifically, the Fifth Circuit held that the following FDA standards related to the provision of mifepristone would no longer be effective:
- Increasing the maximum gestational age from forty-nine days to seventy days;
- Allowing non-physicians (mid-level practitioners) to prescribe mifepristone;
- Removing the requirement that the administration of misoprostol and the subsequent follow-up appointment be conducted in person;
- Eliminating prescribers’ obligation to report non-fatal adverse events;
- Switching the method of administration for misoprostol from oral to buccal;
- Changing the dose of mifepristone (600 mg to 200 mg) and misoprostol (400 mcg to 800 mcg); and
- Allowing mifepristone to be prescribed via telemedicine and dispensed via a mail-order pharmacy.
At a high-level, if the Fifth Circuit’s ruling takes effect, mifepristone may only be prescribed and dispensed in person by a physician for a pregnancy with a maximum gestational period of 7 weeks. However, pursuant to the Supreme Court’s order in Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) earlier this year, the Fifth Circuit’s holding is stayed pending its ultimate disposition before the Supreme Court. As such, mifepristone will continue to be available under the current FDA standards listed above until the Supreme Court weighs in on this issue, which may not occur until late 2024 or 2025.
The United States Department of Justice filed a statement shortly after the Fifth Circuit’s ruling on August 16th, stating that they will be seeking Supreme Court review.1 If the Supreme Court does not take the case, the Fifth Circuit’s restrictions will likely go into effect, absent any further litigation or stays that might be sought by the parties. If the Supreme Court does take the case, the outcome will be decided by the Supreme Court and the corresponding restrictions (or lack thereof) will take effect as indicated by the Supreme Court.
While the exact timing for this process may vary, it’s likely that it will take a few months from the submission of the appeal for the Supreme Court to decide whether to take the case. If the Supreme Court does decide to take the case, the briefing process, oral arguments, and other administrative steps can take well over a year.
Quarles will continue to monitor this case and provide any updates as appropriate. If you have questions regarding this litigation, please contact your Quarles attorney or:
- Brenda Maloney Shafer: (602) 229-5774 / brenda.shafer@quarles.com
- Richard Davis: (414) 277-5844 / richard.davis@quarles.com
- Monica Wright: (317) 399-2836 / monica.wright@quarles.com
End Notes