Access Barriers Remain After Abortion Pill Decision

In FDA v. Alliance for Hippocratic Medicine, a unanimous U.S. Supreme Court rejected a lawsuit filed by doctors and associations opposing abortion that sought to challenge FDA approval decisions for abortion pills. The Court’s decision ended this particular challenge, but it is not the end of the fight over mifepristone.

The U.S. Food and Drug Administration (FDA) first approved mifepristone pills in 2000. At that time, it authorized mifepristone pills called Mifeprex to be marketed for terminating pregnancies up to seven weeks. FDA placed several restrictions on the use and distribution of Mifeprex, including that patients appear for three in-person visits. Since that time, research has shown that Mifeprex pills are safe and effective in practice.

In 2016, FDA loosened some of the restrictions on the use and distribution of Mifeprex. For example, it allowed Mifeprex to be marketed to terminate pregnancies up to ten weeks and reduced the number of required in-person visits to a single visit. In subsequent years, FDA approved a generic version of Mifeprex and relaxed other restrictions, such as the in-person visit requirement. Studies have found that abortion pills continue to be safe and effective, even when prescribed via telehealth.

In 2022—over two decades after Mifeprex was first approved—several doctors and medical associations sued FDA, challenging each of FDA’s decisions about the approval, use, and distribution of mifepristone for abortions. After a contentious and complicated appeal through the U.S. Court of Appeals for the Fifth Circuit, the Supreme Court held that the lawsuit could not proceed to the merits because it did not meet the threshold standing requirement of Article III of the U.S. Constitution.

Article III requires plaintiffs to show concrete injuries to have standing to bring lawsuits. In a straightforward application of longstanding constitutional principles, the Court held that the doctors and associations who brought this lawsuit did not have standing. The only injury that the plaintiffs had shown was that they were opposed to the use of mifepristone for abortions. Yet, mere opposition to FDA’s decisions does not allow parties to challenge those decisions in court.

The plaintiffs in this lawsuit fundamentally sought to stop other people from accessing mifepristone based merely on their own objections to its use. The Court explained that FDA’s regulation of others, however, does not cause a constitutional injury. The plaintiffs, who did not prescribe or use mifepristone, did not show that FDA’s actions caused any concrete injury to them specifically.

The doctors unsuccessfully raised arguments based on injuries to their consciences. They asserted that loosening restrictions on mifepristone might require them to treat patients against their consciences if patients sought emergency care for complications after taking mifepristone. But the doctors did not show that they had been or could be forced to provide such care over conscience objections. The Court emphasized that federal conscience laws allow health care professionals to refuse to participate in treatments that violate their religious beliefs or moral convictions. In any case, such complications from mifepristone are extremely rare.

Economic injury arguments similarly failed. The doctors contended that they might need to expend resources on treating patients suffering from mifepristone complications. But the Court reasoned that doctors cannot challenge the loosening of general public safety requirements “simply because more individuals might then show up at emergency rooms.” Such an approach would allow doctors to broadly challenge any policy that affects public health without any limiting principle. Similarly, the associations could not manufacture standing simply by spending money to advocate against FDA’s actions.

The Court’s decision is a positive development for reproductive rights—and for autonomy over individual decisions about health care generally. It limits the ability of third parties to seek to stop others from prescribing and using pharmaceutical products. But other barriers to accessing mifepristone remain, and the Court’s decision leaves questions about those other obstacles unresolved.

One major unresolved question is how much states can regulate access to mifepristone, notwithstanding FDA decisions. North Carolina, for example, has passed a law that adds restrictions on mifepristone use beyond what FDA requires, such as in-person advance consultation and ultrasound requirements. Other states have enacted restrictive, and even total, abortion bans. Litigation about whether this type of state regulation of mifepristone is constitutional remains pending in both North Carolina and West Virginia.

The Supreme Court’s broad statements about the reach of federal conscience protections also could impede access to reproductive care in certain areas. The Court opined that federal conscience protections remain even in a “healthcare desert, where other doctors are not readily available.”

Furthermore, although the Court concluded that the specific plaintiffs in FDA v. Alliance for Hippocratic Medicine did not have standing to sue, it did not foreclose the possibility that others might. Several states have also joined in litigation challenging FDA decisions about mifepristone. These states allege that they are suffering economic harm by having to pay for increased care for mifepristone complications through their Medicaid programs. The district court judge in that case has not yet ruled on whether the states have established standing.

In the end, even though the Court’s decision in FDA v. Alliance for Hippocratic Medicine limited the ability of activists who merely oppose abortion to bring lawsuits in courts, the battle over access to mifepristone continues on.

Laura Dolbow is an Associate Professor of Law at the University of Colorado Boulder.