As a Texas federal judge mulls whether to halt the Food and Drug Administration’s longstanding approval of an abortion pill, 12 liberal states have filed a separate lawsuit in a federal district court in Washington state that seeks to force the FDA to drop some restrictions on the drug.
Both suits target mifepristone, one of the two drugs used in medical, non-surgical abortion — now the most common way to terminate a pregnancy. And both suits, in different ways, undercut the FDA’s authority. And it is likely that both suits will end up at the U.S. Supreme Court.
It’s hard to imagine the current justices ruling in favor of the pro-choice state attorneys general. The lawsuit may therefore be intended strategically, to allow the justices to appear to take a middle ground and decide an eventual Supreme Court case in favor of the status quo. But it’s risky to file strategic lawsuits when it comes to protecting abortion rights. Especially in the era of the current super-conservative Supreme Court.
To understand the new lawsuit, you need to know a bit of the backstory. When mifepristone was first approved in the U.S., in 2000, it was subject to a strict set of regulations that required at least two physician visits and administration of the pill in a clinical setting. Any health care provider seeking to prescribe it had to get special certifications and also had to be willing to dispense it directly to patients.
Over time, those regulations have been gradually relaxed. The two physician visits became one. And during the COVID-19 epidemic, the requirement of having the pill administered in the clinic was waived. None of these relaxations of the regulatory regime had any measurable negative consequences for people seeking to end pregnancies.
There are now three special rules that apply to mifepristone. These three are at issue in the pro-choice states’ case. All could plausibly be lifted without endangering patients.
First, physicians who prescribe mifepristone must undergo a special certification process in which they show that they can properly date a pregnancy, diagnose an ectopic pregnancy and provide surgical intervention or a referral in case of complications. This isn’t required for the vast majority of other drugs regulated by the FDA. And it can deter physicians from providing mifepristone, since registering is a public fact that could be known by antiabortion protesters who have threatened and even killed providers. The capacity to date pregnancy and diagnose an ectopic pregnancy is part of ordinary medical training.
Second, dispensing pharmacies are also required to be specially certified. This means the prescribing physician can’t just ask the patient which pharmacy to send the prescription to. It creates significant inefficiencies in the process, without providing any clearly measurable benefits.
Third, the FDA’s regime requires the patient to sign a form that reads, “I have decided to take mifepristone and misoprostol to end my pregnancy.” Although informed consent is a standard component of all medical treatment, you typically don’t have to sign a special, treatment-specific form for other drugs. The form also creates a legal record of the abortion decision, which many women might balk at, particularly given the many states that now prohibit or restrict abortion. What’s more, the form is not accurate in some cases, because many physicians prescribe mifepristone to manage miscarriages.
Although these existing FDA restrictions are not medically necessary, that is not the end of the legal question. Necessity isn’t the legally relevant test of whether an FDA rule is valid.
Rather, under the law, the FDA may adopt such regulations only when the medication in question is “associated with a serious adverse drug experience,” which includes the risk of death or the necessity of a surgical intervention. And the regulations must not be “unduly burdensome.” The pro-choice AGs argue that mifepristone is so safe that it shouldn’t fall under the category of serious adverse consequences, and that the regulations unduly burden providers and patients.
Here things get complicated — and interesting. Ordinarily, in deciding whether an administrative agency like the FDA has correctly applied the law in the area of its expertise, the courts defer to the agency’s expertise provided the agency has acted reasonably and explained its logic clearly. To hold in favor of the pro-choice states, the court would have to say that the agency got it wrong despite its expertise.
In the pro-life case filed in federal court in Texas, the plaintiffs are also asking the court to overrule the agency’s expertise. Here, the plaintiffs are arguing that the agency’s expert judgment was wrong in deciding that mifepristone is safe. The best legal response is to say that the agency’s expertise should be respected.
The upshot is that, if the Supreme Court were to consider both cases at the same time, the best outcome for mifepristone access would be for the court to defer to the FDA’s expertise. That would mean the pro-choice suit would also lose.
The state AGs know this, of course. So it may be that this lawsuit is intended as a kind of strategic counterpart to the pro-life suit. The idea would be that the Supreme Court could present itself as taking a middle ground, rejecting demands from both the pro-life and pro-choice side to overturn FDA regulation.
But it any lawsuit questioning the expertise of the FDA is a risky idea at a moment where pro-choice advocates badly need the Supreme Court to reaffirm the agency’s authority. When it comes to mifepristone, the justices will do whatever they want. A strategic lawsuit on the pro-choice side may show supporters that their side is willing to fight. But it isn’t likely to result in a legal victory.
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ABOUT THE WRITER
Noah Feldman is a Bloomberg Opinion columnist. A professor of law at Harvard University, he is author, most recently, of “The Broken Constitution: Lincoln, Slavery and the Refounding of America.”
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
