In 2000, in the last months of the Clinton administration, the Food and Drug Administration approved the mifepristone-based abortion pill commonly known as RU-486 or Mifeprex. From the beginning, the pill was given favored regulatory treatment, with accelerated approval under Subpart H, a program designed for emergency AIDS drugs. Utilizing this fast-track approval process required the FDA to characterize pregnancy, preposterously, as a “serious or life-threatening illness.”
A legal challenge was filed with the FDA in 2002, as is generally required before filing suit, and the agency sat on it for nearly 14 years in order to thwart judicial review while the pill expanded its market share. The mifepristone pill, once a sideshow in the national abortion debate, has become a central battleground. It now accounts for a majority of all U.S. abortions. Meanwhile, the safety and reporting protocols put in place were watered down by the Obama FDA on its way out the door in 2016, and by the Biden administration in 2021, initially using the pandemic as its all-purpose excuse, then dropping that excuse a few months later to make the emergency rules permanent. Pandemics, what can’t they do?
The Biden administration is promoting the pill’s mailing across state lines in order to undermine red-state abortion bans, even though this stance places this administration in its accustomed posture of simply ignoring a federal law it does not like. In 1873, Congress — under the Republicans who banned slavery and oversaw Reconstruction — unanimously passed the Comstock Act, which was signed into law by Ulysses S. Grant. The first federal pro-life legislation, it bars anything that produces abortion from being sent through the mails or by interstate carriers. The law included its share of since-discarded Victorian prudery, but the ban on mailing abortion drugs was preserved even through updates of the statute signed by Bill Clinton in 1994 and 1996. An appeals court in 1915 described the law as reflecting “a national policy of discountenancing abortion as inimical to the national life.” The administration’s grounds for nullifying it are openly implausible in light of the clear language and purpose of the statute.
Worse, the administration claims that FDA approval of the abortion pill preempts state laws that ban the killing of unborn children by this or any other means. Thus, the administration is simultaneously flouting federal law passed by Congress, while claiming that federal regulatory permission deprives states of the most basic element of police power: the power to prevent the people of the state from killing one another. The conceptual problem of comparing this case to other FDA regulatory permissions, or to challenges to other FDA drug approvals, arises from the central reality that most drugs approved by the FDA are not intended to take a human life. No court can or should be blind to that reality.
In a republic of laws, none of this would happen. In modern America, what we get instead is two federal district judges issuing competing multi-state injunctions. If the federal government complies with one of them, it has to ignore the other. On Friday, Judge Matthew Kacsmaryk of the Northern District of Texas struck down the FDA’s 2000 approval of the pill nationwide under Subpart H, while Judge Thomas Rice of the Eastern District of Washington rushed to strip away even the modest remaining safety precautions around the pill in 17 states and D.C. Judge Rice, laughably, claimed that the states did not need to go through the FDA’s Kafkaesque mansion of delay before going to court because the Biden administration displayed “administrative bias” against liberalizing rules for abortion. The administration, which barely contested the lawsuit before Judge Rice, is immediately appealing the ruling by Judge Kacsmaryk.
If there is one virtue to these two lawsuits, it is that both the Biden FDA and the coalition of blue states in the Washington case have been compelled to tell some unpleasant truths about surgical abortions that the abortion industry typically conceals. In the Texas case, the FDA argues that avoiding “an invasive surgical procedure and anesthesia” is an important health benefit. The Biden administration’s appeal brief says that “surgical abortion can entail greater health risks for some patients, such as patients allergic to anesthesia.” In the Washington lawsuit, the states say that “increased surgical abortions” drive up state Medicaid costs. In 2021, when the Supreme Court struck down an order by a rogue district judge in Maryland who tried to force the FDA to dispense the pill with no in-person visit during Covid, Justice Sonia Sotomayor similarly complained that surgical abortions were “invasive.” You don’t say?
In fact, chemical abortions have their own risks, and peer-reviewed research suggests that these may be greater than the risks from surgical abortions. Moreover, the FDA’s decision to stop tracking adverse health events short of death from the abortion pill stymies efforts to collect official data on the topic.
Judge Kacsmaryk makes a compelling case that the Clinton administration’s use of Subpart H to approve the pill was an abuse of the law, and that the order was properly judicially reviewable. While judges should not substitute their medical judgment for that of the FDA, they are on firm ground reading the rules for what procedures the agency may use. We are skeptical, however, that his order striking down the initial approval will, or should, be upheld given that the six-year statute of limitations passed between the FDA’s belated 2016 ruling on that approval and the filing of suit.
The Texas case also raises contested standing issues — as does the Washington case — but ones mostly within the normal range of Article III standing case law.
Judge Kacsmaryk is on much stronger grounds in enjoining the FDA’s 2021 rules, which present no similar issue of untimeliness. He is correct that those rules openly flout the Comstock Act by allowing the dispensing of the mifepristone pill through the mail. (Ed Whelan, a contributor to these pages, filed an amicus brief in the Texas case that argued against the Biden administration’s evisceration of the Comstock Act.) We commend Judge Kacsmaryk’s courage in saying so, and in describing unborn children accurately as human beings, in the face of a torrent of media abuse heaped upon him in advance of his ruling.
Prominent Democrats in Congress are now demanding that the Biden administration ignore Judge Kacsmaryk’s decision rather than let the normal appeals process play out. Republican politicians, who have been conspicuously silent at best in response to the rulings, should rebuke both these lawless calls for massive resistance and the Biden administration’s efforts to defy federal law and subvert states’ pro-life laws.
More broadly, however, there should be a strong legal presumption against the issuance of nationwide injunctions by individual district judges. Nationwide injunctions should be avoided when unnecessary, but challenges to federal administrative decisions are inherently national, and judge-shopping is a bipartisan affliction that torments administrations of both parties. It is overdue for Congress to fix the system to prohibit any one judge from having such powers, and create a more expedited system for the review of lawsuits seeking such relief.
Editor’s Note: This editorial has been updated to reflect that the injunctions affected numerous states, but only one was national in scope.