5th Circuit Affirms District Court's Decision re: Mifepristone

This is complicated, but the bottom line is this: The FDA's loosened rules for access to mifepristone remain in effect, at least until the case gets to the Supreme Court. Here's the breakdown:

1. In April, U.S. District Judge Matthew J. Kacsmaryk ruled that the FDA failed to consider important safety issues when it (in 2023) approved a rule change that permanently lifted a restriction requiring in-person dispensing of the abortion pill and permitted pharmacies to fill mifepristone prescriptions for customers directly, as well as various FDA approvals of mifepristone dating back to the agency's initial decision to greenlight the drug in 2000. The district judge granted an injunction against sales under the FDA's new rule pending an appeal to the Fifth Circuit.

2. On August 16 the Fifth Circuit Court of Appeals disagreed with a few of the trial court's conclusions and orders, but unsuprisingly affirmed others. Here's their summary:

After extensive briefing and oral argument, we hold that the district court’s stay order should be VACATED in part and AFFIRMED in part.  We conclude that the Medical Organizations and Doctors’ claim as to the 2000 Approval is likely barred by the statute of limitations.  Accordingly, that component of the district court’s order must be VACATED.  This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016.

 

We also VACATE the portion of the order relating to the 2019 Generic Approval because the Medical Organizations and Doctors have not shown that they are injured by that particular action.  The generic version of mifepristone will also be available under the same conditions as Mifeprex.

 

We AFFIRM the components of the stay order that concern the 2016 Amendments and the 2021 Non-Enforcement Decision.  Those agency actions—which generally loosen the protections and regulations relating to the use of mifepristone—will be stayed during the pendency of this litigation.

 

Finally, we note that our holding is subject to the prior order of the Supreme Court, which stayed the district court’s order pending resolution of this appeal and disposition of any petition for writ of certiorari.  Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.).  

 3. Bottom line, mifepristone will remain available without restrictions imposed by the trial judge and affirmed by the appellate court. 

Expect intense motion practice in the Supreme Court to modify or rescind their stay earlier this year. And on the merits of the case, this will go to the same conservative Supreme Court that wiped out Roe v. Wade last year. This is also a case with a serious administrative law overlay, and this is a Court that has been skeptical of agencies' expertise and increasingly skeptical of tradition doctrines (like Chevron) that call for judicial deference to many if not most agency determinations.