The Supreme Court’s Mifepristone ruling & its implications for self-funded health plans

The mifepristone case, FDA v. Alliance for Hippocratic Medicine, attracted a lot of national attention not only because of its implications for reproductive rights, but also because of the question related to the FDA’s regulatory power. On June 13, 2024, the decision of the Supreme Court of the United States resulted in access to mifepristone, an abortion medication, remaining unchanged, but the decision was based on a procedural issue rather than an effort to protect reproductive rights.

Back in 2022, the abortion rights that were once federally protected under Roe v. Wade were overturned by the Court in Dobbs v. Jackson Women’s Health Organization. Determining that the Constitution did not confer a right to an abortion, the Court ruled that the power to regulate abortion should return to the states. Since that time, there have been a host of new laws in various states, some protecting the right to abortion, some instituting limitations, and some banning abortion entirely.

Meanwhile, mifepristone remains a prevalent option for women seeking an abortion. It is part of a two drug regimen (coupled with misoprostol), which is prescribed by health care providers for a medication abortion. In 2023, medication abortion accounted for 63% of all abortions in the U.S., a higher percentage than that of the preceding year. The prevalent usage of this drug for abortion and the increased number of medication abortions overall relative to other methods highlight the significance of the FDA v. Alliance for Hippocratic Medicine decision.

In FDA v. Alliance for Hippocratic Medicine, the Court was addressing two actions of FDA: (1) the relaxed restrictions provided in 2016 that approved a dosage regimen of only one in-person visit (as opposed to the previous three in-person visit requirement), and (2) the 2021 FDA guidance that the initial in-person visit requirement would no longer be enforced. Based on these two issues, the potential outcomes of this case were noteworthy. It was thought that the Court’s decision would provide guidance on the FDA’s regulatory power, which would have significant implications for drugs in the U.S.

Additionally, the Court’s decision had the potential to build on previous decisions and further limit access to abortions. However, the Court’s decision did not provide guidance on these issues. Instead, the Court unanimously determined that the plaintiffs did not have standing to bring the case. Standing requires that the plaintiffs demonstrate both injury in fact and causation. The Court determined that the plaintiffs were unregulated parties who sought to challenge the FDA’s regulations of others rather than themselves, as the plaintiffs did not prescribe or use mifepristone. Additionally, the Court rejected the theories of causation proposed by the plaintiffs, concluding that no theory was enough to connect the FDA’s actions to the alleged injuries. Consequently, the Court’s decision was based on a lack of standing, and there was no discussion of the FDA’s regulatory power.

Related: The case for abortion care as an employee benefit

Since the Court reversed and remanded the case, access to mifepristone was unaffected by the ruling. Thus, as it relates to self-funded health plans, the status quo has not changed. Employers who seek to offer broad reproductive rights, including abortion, may continue to do so. Of course, health plans must be conscious of state law and its relation to the health plan. For ERISA plans, a state law attempting to regulate the design and operation of a health plan would likely not prevent a plan from having broad reproductive health benefits because of ERISA preemption. For non-ERISA plans subject to state law, they must be aware of state regulations and should be sure not to offer benefits contrary to applicable law.

This case did not have a significant impact on reproductive rights because it was reversed and remanded on a procedural basis. However, this decision leaves the door open for other plaintiffs who may bring a similar challenge against the FDA and mifepristone in the future. Given that the nature of abortion and reproductive rights is the source of much debate, the possibility of a similar case in the future is not implausible.