In brief

On June 13, 2024, the Supreme Court of the United States (SCOTUS) unanimously held in FDA v. Alliance for Hippocratic Medicine that plaintiff physicians and pro-life medical associations lacked Article III standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone, a prescription drug primarily used in terminating pregnancy. Following the ruling, mifepristone remains available and approved. Also importantly, SCOTUS reasoned that a desire to make a drug less available for others does not establish standing to sue FDA. Since SCOTUS focused on standing as a threshold issue, the  broader question of whether the FDA acted within its authority and jurisdiction to approve mifepristone remains unanswered. As such, the current ruling still leaves a potential opening for other interested parties with Article III standing to challenge FDA’s drug approval process.

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 Specifically, plaintiffs alleged that FDA’s actions to relax the restrictions were procedurally flawed and must be rescinded.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.


Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and heads our US Food and Drug Law Practice. Clients describe Xin as "His dedication to his clients stands out; he goes above and beyond to do whatever we need. He's really pragmatic with his advice too." (Chambers USA Client Interview - 2024). A former research scientist, Xin brings a deep understanding of the complex scientific issues that relate to the US legal compliance and government enforcement issues, enabling him to help clients with all phases of product development, manufacturing, and marketing. As the science and technology continues to evolve, Xin supports our clients to constantly innovate and push the boundaries of what's possible in the world of science. Xin's practice focuses on advising high-growth companies and investors in life science, healthcare, E-commerce, and technology industries globally. As part of the firm's US Government Enforcement Practice, he has represented many global companies during high-stake US government investigations (including actions initiated by the US Congress, U.S. Department of Justice (DOJ), and U.S. Food and Drug Administration (FDA)) around the world. Xin also has a strong track record in US consumer product recall matters, and with a deep understanding of the intricacies involved in navigating the complex and interrelated legal and scientific issues, Xin can creatively and effectively represent companies in these bet-the-company cases. As a seasoned US government regulatory and enforcement counsel, Xin works closely with global companies with novel pharmaceutical, medical device, food, and cosmetic applications that require US government's pre-market approval or clearance and FDA Current Good Manufacturing Practices (cGMP) compliance. Xin has extensive experience advising both emerging and established companies on the strategy with launching and promoting innovative products such as cell-cultured meat, cellular and gene therapy products and AI/ML-enabled medical devices. Xin also draws on his scientific expertise and experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Anti-Kickback Statute (AKS).


Lois is a member of the Firm's Litigation & Government Enforcement Practice Group in the FDA sub-group, based in Washington, DC. Prior to joining Baker McKenzie, Lois worked as an associate for another multinational law firm. As a former pharmacist and a research fellow at a major teaching hospital, Lois has an extensive understanding of various regulatory issues related to clinical research and development, marketing strategy, product approval, and government enforcement activities. Lois represents clients in numerous highly regulated industries, including biologic and pharmaceutical manufacturers, medical device companies, academic medical centers, contract research organizations, pharmacies, and physician groups. Lois guides clients through a wide spectrum of healthcare fraud and abuse issues, FDA regulatory concerns, clinical trial matters, mergers and acquisitions, and federal and state compliance. Lois also offers advice to healthcare providers and investors in the healthcare and life sciences industries concerning transactional affairs, specifically addressing the regulatory risks associated with the federal anti-kickback statue, false claims act, and state corporate of medicine restrictions.


Jack Yang is summer associate in the Washington office of Baker McKenzie.