On Friday, the Supreme Court handed down a ruling in the abortion pill case (Alliance for Hippocratic Medicine v. FDA).
In the short term, the Court’s ruling means that the abortion pills continue to be available under the latest FDA rules — used up to 10 weeks of pregnancy, no requirement of a personal visit, prescriptions by non-doctors, and pills available at local retail pharmacies. This may strike people as a disappointment, but it was an unsurprising ruling at this point in the litigation.
This case raises a crucial point of contention about the structure, powers, and accountability of the administrative state. It will have enormous significance for administrative law in general, and for future cases involving actions by regulatory agencies that involve vulnerable human lives and other significant issues.
What They’re Up Against
The first thing people need to understand about this case is how difficult it is to overturn an action by the Administrative State.
We all remember from civics class that the federal government has three branches – the legislature (which writes the laws), the executive (which executes and enforces them), and the judiciary (which interprets laws and adjudicates disputes). These three branches preserve the rule of law and protect our individual freedom by operating within distinct spheres (“separation of powers”) and preventing abuses of power by each other (“checks and balances”).
But there’s actually a de facto fourth branch of government — the Administrative State. This consists of the myriad federal agencies that are created by acts of Congress and empowered to perform certain functions that require a degree of expertise. They ostensibly fall under the authority of the president and their actions are subject to review by the courts. But in reality, these agencies act executive, legislature, and judiciary all rolled into one, without effective oversight from any of them.
The administrative state inherently undermines the basic constitutional structure of our constitution by gravely weakening the separation of powers and checks and balances.
The FDA is one of these agencies, and it has very broad powers. It makes laws by enacting formal regulations and informal interpretations of those rules. It enforces the laws by bringing actions against people who break the rules. And it rules on appeals from those rules, which lets it be the judges of their own cases. Its high-level officials may be appointed by the president and approved by the Senate. But the actual work is dominated by permanent civil servants who are virtually unaccountable to the political process and likely to be disproportionately liberal.
Challenging the actions of the FDA, or any other agency of the Administrative State, is very difficult. The process of adopting regulations requires that they solicit public comments, but there’s no public debate over the regulations, no hearings with witnesses for and against, and they can just ignore whatever comments they don’t like. Unlike under the constitutional system, there’s no public vote, Congress has no say in the matter (although they may try to revoke the rule later), and the President doesn’t have to sign off on them.
Once a regulation is adopted, you can challenge it by filing a petition. But the agency can basically ignore that, even though there is supposedly a legal deadline to respond. Even if the agency considers the petition, they act as the judge of their own case.
If you try to challenge the agency in court, you have significant procedural and substantive difficulties. You must establish that you have “standing”, which requires proof that you were actually harmed or are facing imminent harm from the agency’s action. You also have to bring the case within the statute of limitations. Both of these requirements have proven to be very difficult for the plaintiffs in the abortion pill case, as I have explained elsewhere.
If you can get past those procedural hurdles, then you must attack the substance of the action or the agency’s authority. The grounds for this include that the decision was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
According to the Supreme Court, the agency has a duty to “examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made.” The agency’s decision would be arbitrary and capricious if they “entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.”
That would seem to require a close look by the courts at the justification for the agency’s decisions. But the Supreme Court has warned lower courts that “the scope of review under the ‘arbitrary and capricious’ standard is narrow and a court is not to substitute its judgment for that of the agency”.
Federal judges are lawyers and not scientists, and they are generally not qualified to second-guess technical decisions beyond their ken or to resolve disputes between experts. So even though they have the authority to review the reasonableness of an agency’s decisions, in practice courts show tremendous deference to the judgment of the experts in the agency.
The bottom line is that it is very difficult to overturn an action by the Administrative State. That’s what the plaintiffs are up against in this lawsuit.
The Court Action So Far
In 2000, the FDA approved the use of mifepristone under a provision of the law that permitted fast-tracked approval for new drugs that “have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments”. 21 C.F.R. § 314.500. Its safety rules included requiring dispensing and administration of the drug at the doctor’s office, limiting prescription to doctors only, and allowing use only in the first 7 weeks of pregnancy.
In 2016, the FDA modified that regimen, extending use to 10 weeks of pregnancy, removing the requirement for taking the drug at the doctor’s office, and permitting non-doctors to prescribe. In 2021, they further loosened the requirements by permitting prescription by telehealth (i.e., without an in-person doctor’s visit) and allowing the pills to be dispensed by local retail pharmacies.
The present lawsuit was filed in 2022 in federal court in Texas. The plaintiffs are several pro-life medical organizations and individual doctors. They challenged the original approval of mifepristone by the FDA in 2000 and the subsequent modifications of the rules in 2016 and 2021. They argued that the FDA abused its authority by ignoring evidence of risks and that further availability of the drug poses a serious danger to women.
The district judge agreed with all the plaintiffs’ arguments and issued a preliminary injunction stopping any further use of mifepristone. He put the injunction on hold for a short time (the technical term is a “stay”) pending an appeal by the government and review by the Fifth Circuit Court of Appeals.
The circuit court took up the case on a very fast schedule. They found that the plaintiffs’ challenge to the original approval of the pill was barred by the statute of limitations. But they agreed that the FDA had abused their authority in making the 2016 and 2021 changes to the usage regimen. They then issued an order permitting the abortion pill mifepristone to stay on the market, but only under the original 2000 regimen.
Continuing the accelerated pace of the case, the Supreme Court took up the case on an emergency basis – on its so-called “shadow docket” – without full briefing or oral argument.
The Court decided to send the case back to the Fifth Circuit – but they issued a full stay of the district court’s original injunction. That meant that the abortion pill continues to be available, but once again under the extremely loose 2021 regimen.
The case will continue to move fast. Briefs have to be filed in the circuit court before the end of May, and oral arguments soon thereafter. A decision will probably be handed down this summer, and the losing party will undoubtedly petition the Supreme Court to take the case again.
Pushing Back Against the Pill
The goal of the lawsuit is to establish that the FDA abused its authority when it originally approved the drug in 2000 and when it modified the usage regimen in 2016 and 2021.
The plaintiffs have argued that in the beginning, the FDA has never adequately studied the drug for safety. The plaintiffs compiled an impressive number of studies on the dangers to women. They also had declarations from emergency room doctors about their experiences treating women who had taken the drug and suffered side effects or an incomplete abortion. The government, of course, presented their own array of studies.
But both the district court and the Fifth Circuit agreed that the plaintiffs appeared to have the better part of this battle of experts. Perhaps this had something to do with the government’s patently ridiculous and obviously bad faith claim that mifepristone was just as safe as Advil (ibuprofen).
The most compelling argument for the FDA’s abuse of authority was their use of the special fast-track authority when they first approved the drug in 2000. It is manifestly absurd to characterize pregnancy or a desire for an abortion as a “serious or life-threatening illness”. Pregnancy is perfectly natural and is not seriously dangerous in the vast majority of cases. And if anything is “life-threatening”, it’s an abortion.
It is also nonsense to argue that mifepristone provides any meaningful therapeutic benefits compared to surgical abortions. In both cases, one of the patients invariably dies and there are much more common and serious side-effects with the drug than with surgery.
It was a gross abuse of discretion – motivated by pro-abortion ideology – for the FDA to rely on that fast-track authority. The timing gives the game away.
Within days of taking office in 1993, President Clinton ordered the FDA to legalize chemical abortion drugs. The FDA and the White House then convinced the French manufacturer of the drug to donate its patent to a pro-abortion American non-profit, the Population Council. The FDA then worked hand in glove with the Population Council to fashion the application for approval and the clinical studies.
The FDA granted initial approval of this controversial drug in September 2000. That was within the last few months of the pro-abortion Clinton Administration, and just weeks before an election in which George W. Bush, a pro-life Republican candidate, stood a good chance of winning.
The later modifications to the pill’s regimen were also clearly connected to electoral politics rather than science. Those changes took place in the last year of one pro-abortion Democratic administration (2016) and within months of the beginning of another (2021). The pattern is clear.
The FDA’s ideological bias can also be seen in its disgraceful neglect of the two citizen petitions that objected to its approval of the drug. The law requires that the FDA respond to citizen petitions within 180 days. Yet the first petition, which was filed in 2002, languished in someone’s desk drawer for fourteen years. The FDA sat on the second petition, filed in 2019, for a further two years. If sixteen years’ worth of delays aren’t an “abuse of discretion”, then nothing is.
The political motives of the FDA are also illustrated by their cavalier attitude towards the Comstock Act. That law was originally passed in 1873 (yes, you read that correctly – it was signed into law by President Grant!) and is still on the books at 18 U.S. Code § 1461 and 1462. It unambiguously outlaws the use of the mail or any other common carrier to send or deliver “any drug, medicine, article, or thing designed, adapted, or intended for producing abortion”. There is no ambiguity there.
The Comstock Act presents a fatal problem for the FDA’s most recent changes to the mifepristone regimen. If it is against the law to mail the drug, then it cannot be lawful to ship it to local pharmacies to dispense it. The government certainly cannot authorize something that is already against the law, without explicitly repealing that law.
The Biden Administration’s Justice Department has issued a flimsy legal opinion, claiming that the Comstock Act only applies if a person knows that the drug will be used for an illegal abortion. But that’s a perfect example of magical thinking – you can’t make the law mean something different than what it really says, just by imagining it. Both the district court and the Fifth Circuit noted this flaw in the government’s case. It’s hard to see how that will ultimately stand up in court.
As noted above, the case is now back in the Fifth Circuit for a full appellate review of the district court’s decision to overturn the FDA’s approval of mifepristone. A decision is likely in a few months, and the case will certainly be going back to the Supreme Court.
The procedural issues of standing and the statute of limitations are important to the resolution of the case. But either the Fifth Circuit or the Supreme Court will in the end have to address the substance of the case – whether the FDA abused its authority by ignoring the warning signs of risks to women and putting ideology ahead of science.