The abortion pill combination of mifepristone and misoprostol will remain available in the United States, but only under the original safety protocols the Food and Drug Administration adopted in 2000, the Fifth Circuit Court of Appeals held on Thursday. The FDA’s authorization of a generic version of the drugs and its ruling that the drug may be distributed through the mail remain on hold, however — unless the Supreme Court intervenes.
Last Friday, in a 67-page opinion in Alliance for Hippocratic Medicine v. FDA, a federal judge “stayed” the FDA’s Sept. 28, 2000, approval of the abortion pill and the agency’s follow-up decisions from 2016, 2019, and 2021 that increasingly loosened safety restrictions. The Biden administration immediately filed a notice of appeal with the Fifth Circuit Court of Appeals and then asked the federal appellate court to freeze the trial court’s ruling that, in effect, banned distribution of the abortion pill.
Early yesterday, a three-judge panel ruled partially in favor of the Biden administration, staying the stay of the FDA’s 2000 approval of the abortion pill. But the panel otherwise refused to put on hold the trial court’s decision in favor of the plaintiffs. Now without Supreme Court intervention and until the Fifth Circuit considers the merits of the FDA’s appeal, distribution of the abortion pill will be governed by the 2000 FDA approval, not the changes the FDA adopted in 2016.
Arbitrary and Capricious
The differences between the two FDA approvals are significant. In 2000, the FDA approved the drug for a maximum gestational age of 49 days, but in 2016, the federal agency upped that age to 70 days. In 2016, the FDA also reduced the number of required in-person office visits from three to one and allowed non-doctors to prescribe and administer the chemical abortion drugs. Finally, in 2016, the FDA eliminated “the requirement for prescribers to report non-fatal adverse events from chemical abortion.”
The Fifth Circuit agreed with the analysis of the trial court, Trump-appointee Judge Matthew Kacsmaryk, who held the FDA acted arbitrarily and capriciously in removing those requirements in 2016 because the agency “eliminated [the] safeguards based on studies that included those very safeguards.”
“Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts,” the Fifth Circuit analogized, and “then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures.” Such a decision is “obviously arbitrary and capricious,” the court concluded.
The Fifth Circuit also refused to stay Kacsmaryk’s ruling freezing the FDA’s approval of a generic version of the abortion drug in 2019 and its decision in 2021 to allow mail-order distribution of the chemical abortion pharmaceuticals. Here, the appellate court stressed that in 2016, the FDA “eliminated the requirement that non-fatal adverse events must be reported to FDA,” before turning around and declaring that “the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”
“This ostrich’s-head-in-the-sand approach is deeply troubling,” the Fifth Circuit stressed, suggesting the FDA’s actions are “outside the zone of reasonableness.”
In striking the FDA’s authorization of mail-order abortion pills, the Fifth Circuit also noted the Comstock Act of 1873 prohibits the mailing of “any drug, medicine, article, or thing designed, adapted or intended for producing abortion.” While the FDA argued that “the Comstock Act does not mean what it says it means,” the Fifth Circuit found that position weak — especially the Biden administration’s dependence on a memo authored by its Office of Legal Counsel that relied on questionable precedent and “a single footnote within one Supreme Court dissent.”
But the court held it need not, at this stage, resolve whether the Comstock Act barred the FDA’s approval of mail-order abortions because it had already concluded that a stay of that portion of Kacsmaryk’s opinion was not appropriate.
While the Fifth Circuit refused to stay those portions of Kacsmaryk’s opinion, the panel entered a stay on his ruling freezing the 2000 approval of the abortion drug. Here, the appellate court reasoned that while a close question, it appeared the six-year statute of limitations may prevent the plaintiffs from challenging the FDA’s initial approval. Significantly, though, the Fifth Circuit noted the plaintiffs may nonetheless be able to establish later that the FDA had reopened its 2000 approval decision, thereby subjecting that decision to challenge too. At this preliminary stage, however, the Fifth Circuit was unwilling to decide that question, which would effectively pull the abortion pill entirely from the U.S. market.
Standing to Sue
This analysis came only after the federal appellate court resolved two other preliminary questions, the first being the plaintiffs’ standing, or their right to sue. The Fifth Circuit held that the plaintiffs adequately established standing on two different theories: injury to doctors and injury to the plaintiffs’ medical associations.
The FDA’s failure to properly regulate the abortion pill injured the medical associations, the court concluded, because the safety deficiencies forced the organizations to expend “time, energy, and resources” to educate the public on the danger of the drugs. The doctors also suffered concrete and real injuries by being forced to “devote significant time and resources to caring for women experiencing mifepristone’s harmful effects,” which created “enormous stress and pressure.”
The Fifth Circuit opinion provided detailed examples of the types of emergency care needed after women took the abortion pill, including admission to intensive care units for sepsis and intravenous antibiotics. And while the FDA continued to claim its regulation of the abortion pill should be equated to its decision to sell Advil over-the-counter, the court rejected that argument because ibuprofen’s label “obviously bears no resemblance to the ‘Black Box’ warning on mifepristone’s label,” which includes death.
After determining the plaintiffs had standing to sue, the court considered whether those plaintiffs had properly “exhausted” their challenges to the FDA regulation by presenting their arguments to the agency first. It concluded they had — but alternatively held it would be futile to force the plaintiffs to present their claims first to the FDA.
The court further concluded that Kacsmaryk acted reasonably in waiving the exhaustion requirement given the FDA’s failure to respond to the citizen petitions within 180 days, as required by statute: “Instead of timely responding, FDA responded to plaintiffs’ first petition fourteen years after it was filed,” and responded to the second petition over two years later. These outrageous delays justified waiving the “exhaustion” requirement.
While the Fifth Circuit’s standing and exhaustion analysis may seem tangential, without standing the courts cannot reach the merits. If the claims are not exhausted, or the exhaustion requirement waived, for instance, the case will be tossed. Thus the Fifth Circuit’s analysis of those preliminary points proves as important as its decision on the substance of the stay request.
The Biden administration has already moved to appeal the Fifth Circuit’s denial of its stay request to the Supreme Court. Given that the abortion pill was not pulled from the market and instead remains available just as it was for nearly two decades under the terms of the original 2000 approval, it seems unlikely the high court will intervene at this point, but watch for the three liberal justices to dissent.
The Supreme Court’s refusal to grant a stay, however, will not end this case. The Fifth Circuit must still consider the merits of Kacsmaryk’s decision freezing the various FDA decisions. And the three-judge panel that considers that appeal may view the various questions vastly differently than the two Trump-appointed judges did yesterday.
No matter the outcome, however, the case is educating the public on the dangers of chemical abortions much beyond what the Planned Parenthood pill-pushers have been doing for the last 20-plus years.