The nationwide injunction against the Food and Drug Administration’s 2000 approval of the mifepristone-based abortion pill RU-486 (also known as Mifeprex) has kicked up a predicted and predictable storm of controversy — in fact, the legal left has been lobbing ad hominem attacks on Judge Matthew Kacsmaryk ever since the case was filed in his courtroom. As National Review‘s editorial noted, Judge Kacsmaryk reached two major conclusions. First, he determined that the FDA in 2000 improperly used Subpart H, a rule for drugs that treat “serious or life-threatening illness,” to get the pill approved before the incoming George W. Bush administration took over. To do so, the FDA had to characterize pregnancy as the kind of grave illness for which Subpart H (an AIDS-epidemic provision) was created. Think about that one for a moment. Second, he ruled that the 1873 Comstock Act barred Joe Biden’s FDA from deciding, in 2021, to allow mailing the pill, because the law very explicitly bans sending abortion drugs in the mail, and Biden doesn’t just get to ignore duly enacted federal laws. Judge Kacsmaryk likewise enjoined a series of other changes the FDA made (primarily in 2016 and 2021) to loosen restrictions on the pill, concluding that the other later decisions by the FDA — including approval of a generic version of the pill, changing the gestational age at which it can be used, and removing required doctor’s visits — were arbitrary and capricious, a standard of review that often gives judges leeway (too much, in fact) to find ways to impose their own policy preferences on administrative agencies that are themselves acting out of raw politics.

While both of the district court’s major conclusions were well-supported in the law, the decision striking the 2000 approval faced a serious statute of limitations defense. The FDA had sat on a 2002 administrative objection for 14 years, but even starting the clock when it finally ruled in March 2016, the six-year limitations period for filing suit ran out in 2022 a few months before the current suit was filed in November. Judge Kacsmaryk relied upon a legal doctrine that treats some subsequent administrative decisions as reopening the initial decision (specifically, because Subpart H requires a unique procedure for ongoing post-approval review of safety for drugs approved under its accelerated provisions), but it is a stretch to say that the FDA in 2016 or 2021 was actually reconsidering approval of the pill when it significantly watered down the original safety precautions under which it was approved and eliminated some requirements for reporting adverse health reporting.

Late yesterday, the Fifth Circuit court of appeals ruled on the Biden administration’s emergency appeal from Friday’s order. Because this was an emergency order, the appeals court decided only whether to stay Judge Kacsmaryk’s ruling while a full appeal can be briefed and argued. However, orders of this nature typically give a good indication of where the court is likely to come out when it takes its time, and the court churned out a 42-page opinion in two days. The appeals court temporarily struck down the order on the 2000 approval, concluding that the statute of limitations barred the challenge (although it allowed that the plaintiffs “might very well prevail” on a full appeal on the argument that a full 2021 review reopened that question). It upheld the injunction against the FDA’s other decisions, which means that it effectively withdrew the generic form of the pill and banned its mailing. While the Fifth Circuit declined to “definitively interpret the Comstock Act,” it rejected the Biden administration’s argument that the law has been implicitly repealed. The panel was composed of two Trump appointees, Kurt Engelhardt and Andrew Oldham (the former of whom was originally a district judge appointed by George W. Bush), and a George W. Bush appointee Catharina Hayes. Judge Hayes did not write a separate opinion, but a footnote indicated that she would have preferred to simply enter a brief stay of the entire order and expedite a full hearing of the appeal before ruling.

The Abortion Pill Isn’t Advil

Aside from the statute of limitations issue, there are also standing-to-sue questions in the case, which the Fifth Circuit addressed up front. The standing issues get into the weeds of doctrines of associational standing regularly used by left-leaning activist organizations to get into the courthouse door. The plaintiffs in the case are led by an association of pro-life obstetricians and gynecologists, along with individual doctors and the American College of Pediatricians. They argue that they can sue the FDA because its decisions harm patients; that the doctors have standing to represent their patients, as well as suing in their own right because the drugs cause women to show up in their offices and emergency rooms requiring urgent care; and that associations of doctors can, in turn, represent the doctors themselves.

Courts in the past, including the Supreme Court as recently as 2020’s June Medical decision, have regularly allowed pro-abortion doctors to sue on behalf of patients in abortion cases, although the Fifth Circuit noted that the majority opinion in Dobbs described these as cases that “ignored the Court’s third-party standing doctrine,” and so it treated that line of cases as dubious — even though basically everyone who has criticized Judge Kacsmaryk’s standing ruling continues to argue that pro-abortion doctors have standing to sue over abortion restrictions. The Fifth Circuit noted that the doctors in this case testified specifically to having treated women who took the pill and “required blood transfusions, overnight hospitalization, intensive care, and even surgical abortions,” and so the doctors had shown that they had standing to challenge FDA decisions that put women at risk of showing up in these doctors’ offices suffering these complications. The Fifth Circuit concluded:

We do not hold that doctors necessarily have standing to raise their patients’ claims. . . . We do not hold that doctors have constitutional standing whenever they’re called upon to do their jobs. And we do not hold that doctors have standing to challenge FDA’s actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug. Rather, we hold that on the record before us applicants [the FDA and HHS] know that hundreds of thousands of women will — with applicants’ own statistical certainty — need emergency care on account of applicants’ actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way.

The court eviscerated the FDA’s ludicrous argument that allowing doctors to sue would open the floodgates to challenges to drug approvals because mifepristone was no more risky than ibuprofen:

FDA’s own documents show that mifepristone bears no resemblance to ibuprofen. In the 2000 Approval, FDA imposed a “Black Box” warning on mifepristone. FDA requires “Black Box” warnings when a drug “may lead to death or serious injury.”. . . In its 2000 Approval, FDA conditioned its approval of mifepristone on the inclusion of this “Black Box” warning…Ibuprofen’s label, which FDA helpfully provided in its stay addendum, obviously bears no resemblance to the “Black Box” warning on mifepristone’s label. . . . To the contrary, FDA has a special regulation regarding ibuprofen so all manufacturers of that over-the-counter medicine include the same information on their labels. . . . It says nothing about REMS, surgery, emergencies, Emergency Rooms, or death. . . . In sum, applicants’ own documents . . . prove that emergency room care is statistically certain in hundreds of thousands of cases. Plaintiff doctors have provided that emergency room care and are statistically certain to provide it in the future.

Federal Law Still Binds the President

Ed Whelan has been all over the Comstock Act issue in this case, and filed an amicus brief making the case that the law still bars mailing abortion drugs. (Ed is writing more today on the decision). There are really two legal questions. One, which the Fifth Circuit explicitly rejected, is the Biden team’s argument that a 2007 law, the Food and Drug Administration Amendments Act, quietly repealed an express criminal statute that has been on the books since 1873 and has been repeatedly renewed and revised even into the 1990s. But repeals by implication are disfavored, and “We hesitate to find ‘clear and manifest’ intention to repeal a 150-year-old statute that Congress has otherwise repeatedly declined to alter in the far reaches of a single section of the cavernous FDAAA.” The court looked a bit askance at the other argument — that the Comstock Act doesn’t bar mailing but only criminalizes it when specifically intended to violate state laws — but determined that it wasn’t necessary at the emergency-stay stage to resolve it:

Failing all else, the applicants argue that the Comstock Act does not mean what it says it means. Or rather, that judicial gloss and lax enforcement over the past century act to graft relevant exceptions onto it. The applicants rely on a memo authored by the Office of Legal Counsel to press this position….That memo’s thorough exploration of this topic notes that a variety of aging out-of-circuit opinions and a single footnote within one Supreme Court dissent favor the applicants’ position…The speed of our review does not permit conclusive exploration of this topic.

Aftermath

The court reached other issues as well, upholding the decision that the FDA had acted arbitrarily and capriciously, and finding that the exorbitant 14-year delay in responding to the initial complaint — when FDA regulations required a response within 180 days — showed that the plaintiffs were not required in perpetuity to keep filing administrative complaints. The court also noted that the FDA hadn’t shown an urgent need to lift the injunction on the FDA’s more recent decisions to relax restrictions on the pill, “given that the Nation operated — and mifepristone was administered to millions of women — without them for sixteen years following the 2000 Approval.”

The Comstock Act issue, in particular, seems bound for the Supreme Court, as it involves yet another clash between Biden and the laws passed by Congress, although whether the issue reaches the Court depends in good part upon how squarely the Fifth Circuit ends up addressing it. If the Fifth Circuit decides to bar all mailing of the pill, it is hard to see how the Biden administration, politically, could decline to challenge that.

Of course, decisions about what restrictions to apply, or even whether to reconsider approval of the pill, could quite reasonably be reopened again in the future by a new Republican-run FDA. The serial decisions by the Clinton, Obama, and Biden-run FDAs have stripped away medical supervision of the pill and stymied reporting of illness and injury associated with its use. There is no reason why those political decisions should be insulated from reconsideration by the executive branch.