Safety of Women Hangs in Balance After Oral Arguments on Abortion Pill Regulation

The Supreme Court on Tuesday heard oral arguments in two combined cases regarding the Food and Drug Administration’s regulation of abortion drugs.

In Alliance for Hippocratic Medicine v. Food and Drug Administration, the court below—the 5^th U.S. Circuit Court of Appeals—had concluded that the FDA’s decisions in 2016 and 2021 to drop the safety rules for obtaining and using mifepristone were unlawful.

The high court combined the appeals from the FDA and Danco Labs, the maker of a generic version of the drug, and will announce its decision in the case before its current term ends in June.

The FDA approved mifepristone, under the brand name Mifeprex, in 2000 under strict safety restrictions. It could be prescribed only by physicians with the requisite training to handle potential complications, and women had to obtain it in person. Doctors were also required to report all medical complications from its use. These were unusual restrictions, but they reflected the FDA’s concern about the risks of using this drug.

Medical associations first challenged the FDA’s decision by way of a “citizen petition,” bringing their concerns to the FDA itself and arguing that the evidence did not justify concluding that mifepristone was safe and effective.

Not only did the FDA refuse to reconsider its original approval, but in 2016 and 2021 it actually dropped two sets of original safety restrictions. As a result, doctors no longer have to report any nonfatal complications arising from use of mifepristone, women can use the drug during the first 10 weeks of pregnancy (an increase from the previous seven-week limit), and women never have to see a doctor for an ultrasound or examination before obtaining the drug.

Four medical associations and four individual doctors filed a lawsuit in federal court in November 2022. They challenged both the original approval of mifepristone and both decisions to drop its safety restrictions.

A U.S. District Court in Texas agreed with them that the FDA did not have a sufficient basis for either approving mifepristone or for dropping its safety rules.

On appeal, the 5th Circuit said that the lawsuit was filed too late to challenge the original approval of mifepristone, but that the decisions to drop the safety rules were unlawful. The original plaintiffs, the FDA, and Danco Labs each appealed the part of the 5th Circuit’s decision that they lost.

The Supreme Court agreed to consider only whether the FDA had made its 2016 and 2021 decisions to drop mifepristone’s safety restrictions properly, and in accordance with federal law.

The case raised two main issues: whether the medical associations and doctors had legal standing to file the lawsuit and, if so, whether the FDA had a sufficient basis for its 2016 and 2021 decisions and had adequately explained them.

U.S. Solicitor General Elizabeth Prelogar argued on behalf of the FDA; Jessica Ellsworth argued on behalf of Danco Labs; and Erin Hawley, senior counsel with the Alliance Defending Freedom, argued for the medical associations and doctors.

Discussions on standing—the legal doctrine enacting Article III of the Constitution and giving federal courts the power to adjudicate only live “cases or controversies”—occupied most of the oral arguments.  

To establish standing, a plaintiff must demonstrate three things: a concrete legal injury, one that was caused by the defendant, and that a court can remedy. The FDA and Danco Labs attacked all three elements of standing.

The doctors argued that the FDA’s decisions make mifepristone less safe to use and, therefore, increase the risk that women will need emergency room care and, therefore, that these medical associations’ members will have to treat them.

That treatment may include having to perform a surgical abortion or otherwise address an incomplete chemical abortion. Doing so can violate the conscience of doctors who have otherwise devoted their practice to delivering babies.

But while it was clear that the FDA’s decisions to loosen safety regulations in 2016 and 2021 made the use of the pill more likely to be dangerous, the justices probed whether the respondent doctors could prove that they were directly injured by those decisions.

Could the work that these doctors do in the emergency room caring for women who are experiencing complications from the use of the abortion pill be tied directly to the FDA’s 2016 and 2021 actions, or were they simply related to the baseline dangers of using the drug in the first place?  

The justices’ final determination will hinge on the answer to that question.

Prelogar and Ellsworth insisted that, especially since the doctors do not prescribe mifepristone, their “injuries” were only speculative or hypothetical, rather than actual or concrete. Prelogar stressed that any injury to the doctors relied only on mere probabilities or on what she called a “chain of remote possibilities.”

Justice Elena Kagan also made this point, describing the doctors’ standing argument as “very probabilistic” rather than actual or concrete. Prelogar, along with Justice Ketanji Brown Jackson, also noted that federal conscience laws like the Church Amendments and state conscience laws would protect the right of medical personnel against being forced to perform abortions.

Hawley, however, effectively explained that, in actual emergency rooms, doctors may not know what they will have to do until they face a patient, without the luxury of requesting the protection of a federal statute and knowing whether or not they may exercise their religious liberty right to “opt out.”

Ellsworth and Kagan expressed another critique of the doctors’ theory of standing. The Supreme Court is not considering their challenge to the FDA’s original approval of mifepristone in 2000, which allowed the drug to be on the market at all. It is only considering the FDA’s decisions to drop the original safety rules.

Ellsworth and Kagan argued, therefore, that the doctors would have to trace the harms they allege only to what they claim is an “increased risk” that women will need emergency room care, not to the “original risk” that would otherwise exist from taking the pill.

Kagan questioned Hawley: “What about those … doctors gives you the kind of imminent injury, let alone the traceability, that we’ve typically required?”

Justice Brett Kavanaugh was unusually quiet during arguments, but Justice Neil Gorsuch seemed quite concerned with the medical association’s requested remedy: a nationwide injunction. That kind of relief would return the 2016 and 2021 safeguards for the pill and reinstate the status quo dating back to 2000—when the pill was available, but more highly regulated and safer to use.

While Gorsuch said that lower courts have “run” with those kinds of remedies, the Supreme Court has avoided them.   

Justices Clarence Thomas and Samuel Alito raised an issue that the Supreme Court is unlikely to address. The Comstock Act is a 19^th-century federal law prohibiting using the U.S. mail or any common carrier to send anything designed or intended to produce abortion.

The plaintiffs argued in the lower courts that, by making it possible to receive abortion drugs through the mail, the FDA had acted in violation of the Comstock Act. Because the 5th U.S. Circuit Court of Appeals did not consider the issue, the Supreme Court is unlikely to do so, either. But Thomas did press Ellsworth about why Danco Labs, as a private company, should be free to violate the Comstock Act, which clearly covers a drug like mifepristone.

Now, the Supreme Court must weigh the evidence, and decide whether every federal agency is bound to follow the law, or whether the FDA gets a pass simply because it thinks its choices were justified.

For the sake—and safety—of American women and girls, let’s hope they decide correctly.