Abortion-rights lawsuit is a gamble

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, nonsurgical 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 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.

When mifepristone was first approved in 2000 in the U.S., 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 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 protesters who have threatened and even killed providers.

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 inefficiencies in the process, without providing any 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.” The form creates a legal record of the abortion decision, which many women might balk at, particularly given the many states 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 burden providers and patients.

Ordinarily, in deciding whether an administrative agency 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, 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 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. So it may be that this lawsuit is intended as a kind of strategic counterpart to the pro-life suit.

But 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 victory.