Food and Drug Administration v. Alliance for Hippocratic Medicine

Today, the Supreme Court issued a unanimous decision in Food and Drug Administration v. Alliance for Hippocratic Medicine (consolidated with Danco Laboratories v. Alliance for Hippocratic Medicine). The case had the potential to fundamentally redefine not only how medication abortion is accessed throughout the country but also how the FDA approves and regulates drugs. The Court held that the Alliance for Hippocratic Medicine and the individual doctors who challenged the FDA’s actions lacked standing under Article III.

What You Need to Know

  • What Was Before the Court: Whether anti-abortion doctors and organizations have Article III standing to bring their challenge to the FDA’s initial 2000 approval of mifepristone, one of two drugs most commonly used in medication abortion, and subsequent changes to how the drug may be prescribed in 2016 and 2021, whether the FDA’s 2016 and 2021 actions were arbitrary and capricious, and whether the district court erred in granting preliminary relief that would have pulled mifepristone from the market entirely.
  • What Happened at Oral Argument: A significant amount of time was dedicated to a discussion on standing, particularly whether the purported injury to this set of doctors and organizations was specific and direct enough to allow them to challenge the FDA’s decisions. Justice Samuel Alito asked a series of questions on whether the FDA decisions could be challenged by any party and whether the agency was “infallible” and the advocates and several justices highlighted the role tort law can play in serving as a check to the agency’s actions and drug companies’ sale of approved drugs. Justice Ketanji Brown Jackson voiced the concern that “there is a significant mismatch in this case between the claimed injury and the remedy that’s being sought.” A majority of the justices seemed skeptical that this group of plaintiffs could challenge the FDA’s actions in such a way that would result in access to mifepristone being rolled back nationwide.
  • What Did the Court Decide: In a 9-0 decision, the Court held that the plaintiffs lack standing to challenge the FDA’s actions. Justice Kavanaugh, writing for the Court, noted that “legal, moral, ideological and policy objections …. alone do not establish a justiciable case or controversy in federal court.” Notably, no justice chose to write a concurrence focused on the Comstock Act, despite several questions that arose during oral argument. Justice Thomas did pen a concurrence questioning the constitutionality of associational standing.
  • Practical Effect: With today’s decision, the status quo of mifepristone access is preserved. If you or someone you know is seeking access to mifepristone or other abortion care, you can visit to receive up-to-date information on access options.