SCOTUS Update: Supreme Court Clarifies Organizational Standing in FDA-Related Ruling

In FDA v. Alliance for Hippocratic Medicine, the Supreme Court held that plaintiffs lacked Article III standing to challenge the US Food and Drug Administration’s (FDA) actions regarding the regulation of mifepristone, a drug that can be used in combination with another drug to end a pregnancy. 

Mifepristone was initially approved under the brand name Mifeprex in 2000 for use in terminating pregnancies up to seven weeks under specified — and particular — conditions, including multiple in-person office visits, but the conditions for its use were loosened by the FDA in 2016 (one office visit) and in 2021 (no office visits). 

In 2016 and 2021, the FDA had approved certain regulatory requirements for the drug, making it easier for doctors to prescribe and patients to access mifepristone.  The plaintiffs, including pro-life doctors and medical associations, sued the FDA alleging that these changes violated the Administrative Procedure Act (APA).  The Supreme Court’s recent decision barred this challenge, holding that “a plaintiff’s desire to make a drug less available for other doctors does not establish standing to sue” under Article III of the US Constitution.   

What’s in the Ruling?

Federal law charges the FDA with ensuring that drugs on the market are safe and effective when used as directed. Relevant here, two pro-life medical associations petitioned to have the FDA withdraw its 2016 modifications in 2019. The FDA denied this petition, and the plaintiffs sued under the APA challenging the lawfulness of the initial 2000 approval as well as the 2016 and 2021 actions modifying mifepristone’s conditions of use.  After finding that the groups had standing, a Texas district court enjoined the FDA’s approval of mifepristone and in essence, ordered the drug off the market. 

The Texas district court purported to “stay” the effective date of FDA’s 2000 approval of Mifeprex and all subsequent challenged FDA actions related to that approval, an action that would effectively render FDA’s Mifeprex and generic mifepristone approvals defunct. The Fifth Circuit Court of Appeals ruled on the Texas district court order in August 2023, upholding the district court’s order but allowing the continued use of mifepristone under the more stringent 2000 requirements. The Supreme Court thereafter stayed the district court’s decision in its entirety until the Fifth Circuit addressed the appeals and ultimate resolution by the Supreme Court. As a result of the Supreme Court’s stay, Mifeprex remained available under the relaxed 2016 and 2021 requirements. Thereafter, the Fifth Circuit determined that the plaintiffs had standing but were not likely to succeed in their challenge of the 2019 approval of generic mifepristone. The Supreme Court then agreed to hear the case, with the Supreme Court’s stay of the district court’s decision continuing.

What Does it Mean to Have Standing?

Whether plaintiffs have standing to sue under Article III of the US Constitution is a “bedrock constitutional requirement” applied in all cases to protect constitutional separation of powers. While the executive branch has the broad ability to enforce laws passed by Congress, courts’ abilities are more limited. To establish standing, a plaintiff must demonstrate that he or she will “suffer an injury in fact,” said injury was likely caused by the defendant, and that the injury likely would be addressed by the requested relief.  The “injury in fact” requirement is designed to screen out plaintiffs who might have only general legal or policy objections to a particular action.  Causation, in turn, is difficult for plaintiffs to establish when they challenge government action or inaction that affects others.

The plaintiffs in Alliance for Hippocratic Medicine sought to challenge the FDA’s regulation of mifepristone even though none of them used or proscribed the drug.  Accordingly, plaintiffs presented various theories of how they could establish standing, all of which the Court rejected.  These theories were as follows:

• The FDA’s relaxed regulation of mifepristone could result in more emergency abortions and that women could seek treatment from some of the plaintiff doctors.  The Court rejected this argument because plaintiffs failed to provide any instances where this hypothetical situation actually happened or demonstrate that federal conscience laws which continue in effect — and that protect doctors with objections to the morality of abortion from providing them — were insufficient to protect them from liability. 
• The regulations caused downstream economic injuries, such as time spent treating patients who had used mifepristone.  The Court rejected this argument, noting that the law does not permit doctors to challenge loosening of public safety requirements simply because more patients might be injured.  In essence, the doctors here were merely “concerned bystanders” who had no right to pursue claims in court. 
• The medical organizations who were plaintiffs were “impaired” in their ability to provide services and incurred costs to oppose the FDA’s actions.  Costs included drafting citizen petitions to the FDA and engaging in public advocacy and education, resulting in the diversion of resources from other priorities.  The Court rejected this theory, noting that “an organization that has not suffered a concrete injury cannot spend its way into standing” by expending money to argue against a policy.  
• Finally, the Court rejected that the plaintiffs here must have standing because otherwise “no one” would have standing to challenge the FDA’s loosening of mifepristone regulations.  In the Court’s view, the remedy in such situations is through the political branches. 

The Court’s rejection of plaintiffs’ theories of standing protects the FDA’s mifepristone-related decisions from this round of attacks in court, and leaves regulation of mifepristone to the legislative and executive branches for the time being.

What’s Next?

The Court focused in part on the district court’s standing decision as being an outlier that was incorrectly upheld by the Fifth Circuit.  If that was most significant to the holding, the effects of this decision may be limited to standing jurisprudence in the Fifth Circuit.  

That being said, standing plays a major role in many environmental cases and the organizational standing principles here may have broader repercussions. As we have discussed, the Fifth Circuit itself has upheld organizational standing when a “categorical injury” is alleged. Two years ago in Environment Texas Citizen Lobby Inc. v. ExxonMobil Corp., the Fifth Circuit held that nongovernmental entity plaintiffs that allege broad injuries — e.g., that the facility’s illegal emissions made plaintiffs less likely to recreate in an area — do not need to demonstrate that any particular facility violation caused the broad, alleged injuries.

Whether this holding is consistent with the Fifth Circuit’s holding in Alliance for Hippocratic Medicine is unclear, but with the Supreme’ Court’s decision, organizations that challenge regulations may face a heightened burden to demonstrate that their “core business activities,” not their issue advocacy, was harmed.  This is not a new consideration. In 1982, the Supreme Court decided Havens Realty Corp. v. Coleman in which it stated that “diversion of resources,” particularly monetary resources, may establish standing when the resources are related to a plaintiff’s core business activities.  Alliance for Hippocratic Medicine simply clarifies that advocacy activities are not “core business activities.”  

We will keep an eye out for further developments.  Stay tuned. 

ArentFox Schiff routinely monitors the Supreme Court’s docket for cases of interest to the regulated community. For questions on the above alert, reach out to members of the firm’s Environmental, Food, Drug, Medical Device & Cosmetic, and Reproductive Health Task Force teams.