A Lack of Standing to Challenge FDA

In 2000, FDA approved a new drug application submitted by Danco Laboratories, LLC for mifepristone, a prescription drug used for, among other indications, terminating pregnancies. In 2016, FDA approved labeling changes and relaxed certain of the risk evaluation and mitigation strategies applicable to the drug, including deeming mifepristone safe to terminate pregnancies up to 10 weeks, allowing healthcare providers (such as nurse practitioners) to prescribe mifepristone, and approving a dosing regimen that required just one in-person visit to receive the drug. In 2019, FDA approved a generic version of the drug. In 2021, in light of the COVID-19 pandemic, FDA relaxed other risk strategies in both its original and generic versions.

In 2022, Alliance for Hippocratic Medicine, a pro-life interest group comprised of medical associations and doctors, sued FDA in the U.S. District Court for the Northern District of Texas, challenging FDA’s initial approval and subsequent regulatory actions on mifepristone. Specifically, plaintiffs alleged that FDA's actions to relax the restrictions were procedurally flawed and must be rescinded. The District Court found that plaintiffs had standing to pursue their challenges and preliminarily enjoined the sale of mifepristone until the District Court reaches a final decision, which triggered a flurry of filings before the U.S. Court of Appeals for the Fifth Circuit and SCOTUS, and ultimately lead to SCOTUS’ stay on the District Court’s injunction. At appeal, the Fifth Circuit agreed with the District Court that the plaintiffs had standing to assert their claims, but disagreed that the plaintiffs were likely to succeed on their merits challenges related to FDA’s 2000 and 2019 approvals of the drug and its generic version.

On June 13, 2024, SCOTUS unanimously reversed the Fifth Circuit’s decision on the ground that plaintiffs lacked standing to pursue their claims under Article III of the United States Constitution. Justice Kavanaugh wrote for the unanimous Court to reiterate that Article III standing is a “bedrock constitutional requirement” for which a plaintiff cannot be a mere bystander, but instead must have a “personal stake” in the dispute. To establish standing, a plaintiff must demonstrate that it (i) has suffered a particularized injury, (ii) which the defendant caused or is likely to cause, and (iii) which the requested relief can likely address. SCOTUS rejected the plaintiffs’ argument alleging that they had suffered or were likely to suffer an injury if mifepristone remained on the market. Noting that the plaintiff physicians did not actually prescribe mifepristone themselves but sought to challenge others’ access to mifepristone, SCOTUS reasoned that “a plaintiff’s desire to make a drug less available for others does not establish standing to sue.” SCOTUS also rejected plaintiffs’ reliance on conscience and various economic injuries to establish standing as too “speculative” or “attenuated” to establish that FDA’s regulatory actions caused them injuries. SCOTUS further rejected plaintiffs’ assertion of organizational standing, confirming that an organization may not “spend its way into standing” by creating injury through expending money to gather information and advocate against FDA’s actions. Because the plaintiffs failed to establish an injury identified in the SCOTUS jurisprudence to demonstrate causation, the challenge was reversed and remanded for further proceedings consistent with this opinion.

Implications for the Pharmaceutical Industry

Over the past year, multiple pharmaceutical companies, executives, investors, and pharmaceutical trade associations filed amicus briefs urging SCOTUS to uphold FDA’s regulatory authority in approving new drugs. The status quo is unchanged for the manufacturers. FDA v. Alliance for Hippocratic Medicine affirmed that mifepristone will remain available to patients without in-person dispensing requirements and for pregnancies up to 10 weeks. However, while SCOTUS focused on the Article III standing as a threshold issue, SCOTUS did not address the broader question of whether FDA acted within its regulatory authority to approve mifepristone and relax certain risk strategies. As such, SCOTUS’ view of FDA’s jurisdiction is still undecided on this matter, which may have left an opening for other interested groups and individuals to continue challenging FDA’s approval and other regulatory actions related to the drug. Thus, additional litigation, electoral initiatives, and legislative changes—both at the federal and state levels—are likely to follow. As Justice Kavanaugh wrote, our system of government leaves many crucial decisions to the political, legislative, and democratic processes.

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We will continue to monitor the issues related to FDA's regulatory authority and the implications for the industry. If you have any questions about the ruling and its impact, please contact the authors.