June 17, 2024

Supreme Court Abortion Pill Ruling Doesn't Challenge FDA's Authority

Holland & Knight Healthcare Blog
Michael J. Werner | Sara M. Klock
Healthcare Blog

The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for the abortion pill mifepristone (Mifeprex and its generic version), which blocks progesterone that is needed for a pregnancy to continue. While the ruling keeps the drug available, the Court did not address FDA's authority to impose these regulations or its authority to approve the drug.

The case, Food and Drug Administration, et. al. v Alliance for Hippocratic Medicine, was closely watched not only because it involved the politically charged topics of reproductive rights and abortion, but also because it could have significant implications for FDA's regulatory authority.

The Court's unanimous opinion held that the Alliance for Hippocratic Medicine (the Alliance) did not have standing to sue – neither the organization itself nor its individual physician members – as neither suffered an "injury in fact," and they could not establish that even if there was an injury, that injury was caused by FDA's actions. In effect, because FDA does not require a physician to prescribe mifepristone or treat a patient who has taken the drug, these physicians are not suffering any damage from FDA's regulations.

Aside from the issues surrounding abortion, the stakes of the case were potentially high, as some feared that a different Court ruling could raise questions about the FDA's authority to regulate drugs. Along those lines, it is important to note that the Court only reviewed issues relating to two sets of FDA regulatory policies. The first, issued in 2016, deemed Mifeprex safe to terminate pregnancies up to 10 weeks (changed from 7 weeks), allowing healthcare providers such as nurse practitioners to prescribe Mifeprex and approving a dosing regimen that required just one in-person visit to receive the drug. The second was issued in 2021, when FDA announced that it would no longer enforce an in-person visit requirement. Thus, the policy did not involve FDA's approval of Mifeprex and its generic equivalent.

Regardless, the broader issues relating to FDA's authority and jurisdiction were not mentioned in the Court's opinion or in Justice Clarence Thomas's concurring opinion, and there was no discussion about FDA's authority to approve or regulate drugs. Thus, the Court's view of FDA's jurisdiction and regulatory authority – including any potential limits to that authority – remains undecided under this ruling.

Of course, reproductive issues and abortion remain salient to elected leaders. Toward that end, the Court's ruling does not in any way end that controversy. Additional litigation is expected, as well as legislative efforts and ballot initiatives. In fact, the Court did say that the political and legislative processes might be the best way for the Alliance and its members to accomplish its goals.

Holland & Knight will continue to monitor issues related to FDA's regulatory jurisdiction. If you have questions about the ruling and its potential impact to your business, please contact the authors.

Related Insights