Fifth Circuit says mifepristone stays approved during appeal, but questions remain
Appeals court ruling would bring back many restrictions that have been loosened starting in 2016 and likely will conflict with another court order out of Washington. [Update: DOJ is going to SCOTUS.]
Under a federal appeals court ruling issued late Wednesday night, mifepristone — one of the two drugs used in medication abortions — will remain approved while the Justice Department and maker of the drug appeal a lower court ruling that threw the drug’s 2000 approval into question.
But several changes have been made to the restrictions for the drug’s use since 2016, including ending the in-person dispensing requirement for the drug, and questions remain about the status of those changes in the wake of the appeals court ruling and in light of a likely conflicting order from a different federal court.
Mifepristone was approved for use in medication abortions by the U.S. Food and Drug Administration in 2000, but a district court ruling from a conservative Trump appointee on April 7 out of Texas purported to halt approval of the drug.
That ruling, from U.S. District Judge Matthew Kacsmaryk, was originally slated to go into effect on Saturday. DOJ and the drugmaker, Danco Laboratories, have appealed the ruling to the U.S. Court of Appeals for the Fifth Circuit and they also asked the appeals court to put the ruling on hold during their appeal.
The Fifth Circuit’s ruling, however, only stayed stayed the part of Kacsmaryk’s order addressing the 2000 approval.
Kacsmaryk’s order also purported to halt changes the FDA made in 2016 and since to the drug’s approval — changes that make mifepristone more readily available and available for a wider range of medication abortions. Those changes included decreasing the number of in-person visits in 2016 and ultimately ending the in-person dispensing requirements in 2023. They also included increasing the maximum gestational age from 50 days to 70 days.
The three-judge panel of the Fifth Circuit made up of all Republican appointees (two Trump appointees and a George W. Bush appointee)rejected DOJ and Danco’s requests to stay that part of Kacsmaryk’s ruling during the appeal — meaning the 2000 mifepristone approval would remain in effect during the appeal but not those loosened restrictions on its use.
The court got there after consideration of the primary legal issues in the case before Kacsmaryk — about standing, timeliness, exhaustion, and the merits of the challengers’ case — as well as the additional legal factors for granting a stay.
There’s a lot to criticize about how the Fifth Circuit reached its result, but, in short, the Fifth Circuit agreed with Kacsmaryk’s already heavily criticized ruling on almost all major points — except for in a critical decision that the challenge to the 2000 approval of the drug was likely brought too late.
Update, 4 p.m.: For much more criticism of the Fifth Circuit’s ruling, with particular attention to its standing ruling, see Adam Unikowsky’s newsletter today.
Under the Fifth Circuit’s ruling, mifepristone will remain approved during the appeal. But, the loosened rules from 2016 and beyond for its use would no longer apply as of Saturday — and the initial restrictions at the drug’s approval when issued back in 2000 would apply once again.
Here is how the Fifth Circuit summarized those restrictions:
Now, two major questions remain before we can know what this decision ultimately means:
First, does anyone seek further review of this stay decision?
The challengers, seeking to vacate the stay that was granted, or DOJ or Danco, seeking a stay of the rulings regarding the post-2000 changes, could try for further review.
[Update, 11:50 a.m.: The Justice Department announced that it will be seeking U.S. Supreme Court review. In a statement, Attorney General Merrick Garland said, “The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal. We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”]
Second, how does this interact with and/or conflict with the order out of a federal court in Washington?
In that case, brought by 18 Democratic attorneys general, the FDA has been ordered not alter the availability of mifepristone in those 17 states and the District of Columbia from under the January 2023 rules.
If the Fifth Circuit ruling stands, then, within those 17 states and DC, the Fifth Circuit ruling and the Washington district court ruling almost certainly would conflict come Saturday. That could, itself, form the basis for some party seeking further review.
In addition, there is also a motion pending to clarify the Washington order that DOJ filed earlier this week. A ruling on that motion could lead to an avoidance of — or could further crystallize — the conflict.
In any event, those two questions could — and likely will — mean that further litigation is on its way before Saturday.
And, beyond all of this, the Fifth Circuit’s ruling is only a stay pending appeal. The court also expedited the appeal itself, and Wednesday night’s stay — keeping mifepristone’s approval in place — could be lifted by the argument panel if they side with Kacsmaryk similarly on the other issues and on whether the challenge to the 2000 approval is timely. That would almost certainly lead to filings at the U.S. Supreme Court.
This story was expanded and updated after initial publication, with the final update at 4:00 a.m. April 13. Law Dork will cover further developments as soon as possible.
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Although it was styled as a per curiam opinion, meaning “for the court,” a footnote from Judge Catharina Haynes — the George W. Bush appointee — stated that she would have granted an administrative stay in the case and deferred to the argument panel for any decision on the motions for a stay pending appeal. As such, this is really a ruling from the two Trump appointees on the panel: Judges Kurt Engelhardt and Andy Oldham.
The Fifth Circuit held that “it appears” the plaintiffs in the challenge have standing, that the challenge to the 2000 approval was likely brought too late but that challenges to all of the latter changes are still timely, that the claims were properly exhausted as to seeking agency review or that Kacsmaryk did not abuse his discretion to waive the ordinary exhaustion requirement, and that DOJ did not show “at this preliminary stage” that their actions — as to the post-2000 changes — were not arbitrary and capricious. The appeals court then also held that the FDA “does not articulate any irreparable harm that FDA will suffer absent a stay,” calling that “critical.”
I could do more of that criticizing in this post, but things are moving quickly right now, and I wanted to make sure I had published a full assessment of what had happened and where the next steps could be before I dove too far into the criticism of how they did it, so that others would have this post available from first thing this morning.
I'm curious--how exactly did plaintiffs here exhaust their administrative remedies? Wasn't the lead plaintiff CREATED just before the suit?
Scariest is what may happen to the concept of standing. How were any of the plaintiffs actually hurt by the approval OR the changes in distribution? They had to treat patients with side effects (which are clearly stated by the FDA). Isn't that their job? Should we ban skateboarding because doctors have to treat the "side effects" when someone falls off?
It's painful watching our judiciary twist itself into pretzels to derive a predetermined result based on culture war positions vs agency independence (or any semblance of stare decisis).