Food and Drug Administration v. Alliance for Hippocratic Medicine (2024) and the Question of Standing

Introduction

What does life, liberty, and the pursuit of happiness truly mean in the context of female autonomy? For decades, abortion has has been at the forefront of American ethical and legal debates. Questions surrounding maternal rights in the face of her fetus have become entrenched in religious and moral discourse, leaving what used to be an inherent fact of life during the early days of the nation on shaky ground. In the 1960s, public contention reached a zenith with abortion law reform pushing to liberalize the service, and by 1973, the Supreme Court established nationwide access to the procedure in its historic Roe v. Wade decision [1]. However, in Dobbs v. Jackson Women’s Health Organization (2022), the Court decided that the previously established right was not protected by the U.S Constitution, overturning the 1973 Ruling and leaving states to independently decide their abortion policies. Heated responses erupted across the American populace as women and men alike were appalled by the apparent insignificance of female bodies in the eyes of the Court [2]. But this past summer, the nation’s citizens seemingly saw a light at the end of the dark tunnel activists had been navigating for two years.

On June 13, 2024, the Supreme Court ruled against legislation looking to suspend the approval of mifepristone, one of the two drugs used in medication-based abortions, in Food and Drug Administration v. Alliance for Hippocratic Medicine (2024). In a unanimous decision, the Court determined that the Alliance for Hippocratic Medicine (AHM), a coalition of physicians committed to abolishing abortion due to their firm Christian beliefs, lacked the legal right to bring their case forward. According to the Court, “a plaintiff’s desire to make a drug less available for others does not establish standing to sue” [3]. In other words, unless the AHM could prove that they personally were affected by ubiquitous access to abortion medication, they did not have the jurisdiction to initiate such a rollback [4]. However, in contrast to the Supreme Court’s ruling, lower courts chose to grant AHM their legal foundation, thus deciding the merits of whether the U.S. Food and Drug Administration (FDA) was correct to curtail access to mifepristone.

When ruling in Food and Drug Administration v. Alliance for Hippocratic Medicine (2024), the United States Court of Appeals for the Fifth Circuit concluded that AHM members were harmed by the FDA’s expansion of access to mifepristone under the doctrine of associational standing. According to the Fifth Circuit, “the organizations contend that they have standing because their members are likely to sustain injuries as a result of FDA’s actions” [5]. Under this premise, an organization is allowed to sue on behalf of its dignitaries if they have been harmed. In the context of this case, if a large number of women who take mifepristone experience adverse effects from the drug, it is likely inevitable that AHM doctors would have to provide abortion care, thus harming their religious devotions.

To the Supreme Court, this decision had far too many contingencies to prove sufficient standing. However, to the Fifth Circuit and District Court, these possibilities were plausible enough to justify a re-evaluation of FDA mifepristone approval.

The United States Court of Appeals for the Fifth Circuit ruling was fueled by right-wing bias when granting the Alliance for Hippocratic Medicine standing in Food and Drug Administration v. Alliance for Hippocratic Medicine (2024). Because federal law does not demand any doctor to offer medical treatments that infringe upon their religious or moral beliefs, the United States Supreme Court was legally correct to deny the organization grounds to curtail access to the commonly used abortion drug, mifepristone. The Supreme Court’s ruling upholds the objectivity of the law while preserving FDA jurisdiction over critical issues such as reproductive health.

Mifepristone and Food and Drug Administration v. Alliance for Hippocratic Medicine (2024)

Before digressing into the importance of Food and Drug Administration v. Alliance for Hippocratic Medicine (2024), it is important to first understand the history of mifepristone. First approved in America in September 2000 to be used alongside another abortion-related drug, misoprostol, in terminating a pregnancy up to seven weeks, mifepristone is now used in approximately half of all U.S abortions. However, its path to widespread distribution was wrought with contention, with countless anti-abortion groups around the nation challenging the drug since its FDA approval [6].

Initial access to mifepristone was granted only in hospitals and FDA-regulated medical facilities. In 2007, the FDA Amendments Act introduced Risk Evaluation and Mitigation Strategies (REMS), which strengthened FDA jurisdiction over all prescription drug approvals. However, while REMS tightened restrictions on mifepristone, medication-induced abortions still steadily gained popularity. By 2015, mifepristone and similar pharmaceuticals accounted for a third of all abortions performed in the United States. In March 2016, in response to clinical success as well as high public demand, the FDA loosened their regulations. Medical practitioners were allowed to prescribe mifepristone, and mifepristone and misoprostol could be used in terminating pregnancies up to ten weeks. In response to the COVID-19 pandemic, in April 2021, the FDA began to permit mail distribution from FDA-certified sources, and by 2023, any approved pharmacy could distribute the pills [7]. While the intersection of science and social need prompted this gradual increase in mifepristone accessibility, several states remained firm in their desire to restrict the drug’s sale.

Though mifepristone had been FDA approved since 2000, the 2022 Court overturn of the constitutional right to abortion seemingly opened the door for anti-abortion groups, such as the AHM, to again voice their opposition to the widespread use of the drug. Claiming inadequate oversight nearly twenty years prior, the AHM made headway with a federal district court judge in April 2023, suspending the FDA’s approval. Note that AHM strategically originated the lawsuit in Amarillo, Texas where a notoriously anti-abortion judge hears all cases. The ruling inevitably agreed that mifepristone’s approval should be revoked [8]. The U.S Court of Appeals for the Fifth Circuit partially held this ruling, letting the drug remain FDA approved but overturning the 2016 decision to ease access to mifepristone in August 2023. However, the U.S. Department of Justice filed a request for Supreme Court review, believing the lower courts were not accurately evaluating the case. On June 13, 2024, the Supreme Court released their final decision, allowing mifepristone to remain widely accessible under the 2000, 2016, and 2023 FDA guidelines [9]. While AHM found this ruling staunchly against their beliefs, the Court was right to preserve access to mifepristone. Considering the drug has been frequently used since the 2000s with limited controversy, it did not make sense to curtail the reproductive rights of women on account of the religious subjectivity of unrelated male doctors.

A Question of Standing

In Food and Drug Administration v. Alliance for Hippocratic Medicine (2024), the Fifth Circuit and Supreme Court maintained different conceptions of what constitutes legal standing, which ultimately contributed to contrasting rulings. In the rulings of both courts, each opinion called attention to the fact that the duties of the judges were to determine whether AHM had standing before digressing into the merits of the FDA approval of mifepristone since such an analysis would be improper if the plaintiffs failed to have justifiable jurisdiction. This idea, upheld by the Supreme Court, requires the plaintiff organizations to show “that he has suffered or is imminently threatened with a ‘concrete’ injury” to have grounds to sue [10]. The Fifth Circuit operates under a similar doctrine; however, differing interpretations of such a statement is where the disconnect in this case occurred. However, it is important to note that the difference between the Fifth Circuit and the Supreme Court was likely based on legislative bias, invalidating the credibility of their ruling.

In the case of Food and Drug Administration v. Alliance for Hippocratic Medicine (2024), Associate Justice Brett Kavanaugh of the Supreme Court asserted that the Alliance for Hippocratic Medicine could not present a lawsuit on the fact that they sought to “make a drug less available for others” [11]. Rather, they needed to demonstrate how they were personally impacted by the approval of mifepristone. According to Kavanaugh, “Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences—and therefore breaks any chain of causation between FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors” [12]. In other words, because the plaintiffs did not use or prescribe mifepristone, and are not required by the FDA to do so, they were unaffected by its increase in market accessibility. This clear framework and logical progression of argumentation presented by the Supreme Court upholds the objectivity of the law and the principled legal reasoning that forms the foundation of America’s judicial system.

However, the Fifth Circuit saw the case in a contrasting, and right-wing-motivated light. In the eyes of the Fifth Circuit, “a ‘substantial risk’ does not require that the threatened injury be ‘literally certain’ [13]. Furthermore, when thinking about the impact a case has to have on a party for the group in question to bring their claim forward, the Fifth Circuit falsely held that: “the prospect of future injury becomes significantly less speculative where, as here, plaintiffs have identified concrete and consistently-implemented policies claimed to produce such injury” [14]. In other words, according to the Fifth Circuit, when looking at past “injuries” and medical history of mifepristone in the context of AHM, there is “substantial risk” that the FDA’s expansion of the abortion medication would bring mifepristone-related emergencies to the coalition’s front door. To the Fifth Circuit, this “risk” proved to be sufficient standing. However, it is critical to note the difference between “risk” and fact, especially when shaping laws that have tremendous impact over not only women’s bodies, but the larger rights of the American people. The Fifth Circuit’s reliance on “risk” to prove their opinion suggests the extremist right-wing policy positioning that has subsumed the court’s credibility.

When taking a closer look into the reason for the juxtaposition of the Fifth Circuit and Supreme Court decision, it is clear that judicial bias and disparities in factual analysis invalidates the Fifth Circuit’s conclusions regarding the supposed standing of AHM. According to publications like Vox, Democracy Docket, Cap20 and more, the once ideologically diverse court has now shifted to becoming an outlier among the nation’s federal appellate courts. Vox senior correspondent Ian Millhiser explains that: “because the Fifth Circuit oversees federal litigation arising out of Texas, whose federal trial courts have become a pipeline for far-right legal decisions, the Fifth Circuit’s judges frequently create havoc with national consequences” [15]. Cap20 writers Jeevna Sheth and Devon Ombres agree, stating that: “[n]ot only has the 5th Circuit relied on increasingly unmoored legal analyses, but it also continues to bypass procedural norms to reach extreme ends” [16]. Both of these opinions are arguably correct and are corroborated by the language of the Fifth Circuit’s opinion in Food and Drug Administration v. Alliance for Hippocratic Medicine (2024).

When considering questions of bias that may have spurred such differences in conclusions regarding standing, there are subtle differences in language between the two opinions that are incredibly telling. For instance, it is interesting how the Supreme Court calls attention to the fact that AHM is a “pro-life” medical organization when first introducing the coalition in the opinion, but the Fifth Circuit refers to them as “an association of doctors who research, teach, and advocate for ethical medical Practices” [17, 18]. Now, while both descriptions are true, the Supreme Court called attention to a primary reason AHM is so opposed to the expansion of mifepristone whereas the Fifth Circuit describes AHM as most would describe any independent medical organization. Naturally the religious affiliations of AHM are of paramount importance in this case. However, it is likely that the Fifth Circuit chose not to mention the topic of religion when describing the AHM to avoid subjectivity allegations since Texas is largely anti-abortion state. Nonetheless, this blatant avoidance suggests that the Fifth Circuit was personally motivated to curtail access to mifepristone, meaning that the court would have had to grant AHM standing to reach the merits of Food and Drug Administration v. Alliance for Hippocratic Medicine (2024).

Furthermore, throughout their opinion, the Fifth Circuit failed to dispute the results of any of the clinical studies the FDA cited in their scientific approvals of mifepristone. It does not make sense for the Fifth Circuit to create an analogy where the supposed high probability of medical complications surrounding the drug in question would inexorably implicate AHM when they do not explore the FDA’s reasoning behind relaxing regulation on mifepristone. Furthermore, Justices Samuel Alito, Brett Kavanaugh, and John Roberts all stressed the importance of deferring to the professional expertise of the FDA in Mutual Pharmaceutical v. Bartlett (2013) and Merck v. Albrecht (2019). Thus, the Fifth Circuit should have at least addressed such research before coming to their conclusions [19, 20]. Therefore, the logical premises the Fifth Circuit held to prove their associational standing are flawed.

The Supreme Court effectively exposes the biases of the Fifth Circuit while calling attention to AHM’s complete lack of association via FDA guidelines, and thus legal standing, to mifepristone. The court wrote, “[p]laintiffs are pro-life, oppose elective abortion, and have sincere…objections to mifepristone being prescribed and used by others. Because plaintiffs do not prescribe or use mifepristone, plaintiffs are unregulated parties who seek to challenge FDA’s regulation of others” [21]. This overt call for accuracy is vital to affirm the strength of the American judicial system and the principles of American democracy.

Ultimately, The Fifth Circuit’s conclusions on standing and decision to evaluate the merits of Food and Drug Administration v. Alliance for Hippocratic Medicine (2024) are flawed. The Supreme Court’s clear understanding of firm standing coupled with their acknowledgment of the FDA’s expertise when ruling on such issues lends itself to greater confidence in their rejection of AHM’s standing and thus their decision in this case.

Looking to the Future

The United States Court of Appeals for the Fifth Circuit was incorrect to grant AHM precedent, thus ruling on the merits of mifepristone instead of legal precedent like the United States Supreme Court. Since federal law does not permit any doctor to have to perform a procedure they do not feel comfortable offering, the Alliance for Hippocratic Medicine was unaffected by the expansion of access to mifepristone. The Supreme Court’s ruling maintains the importance of keeping the law impartial, regardless of the opinions of the judges in question.

The stakes in affirming the Supreme Court’s decision are tremendous. If the Fifth Circuit ruling were to have prevailed, widespread access to medically-induced abortions would have been severely curtailed in both the 17 states that currently have an abortion ban and the 33 states who chose to preserve the use of mifepristone. Furthermore, the Fifth Circuit’s ruling would extrapolate to greater speculation and scrutiny surrounding FDA approval on abortion-related medication, which would have dangerous implications on women’s reproductive healthcare. The Fifth Circuit is heading in a dangerous direction, with their blatant right-wing bias continuing to affect the validity of their decisions. Although the Supreme Court was able to distinguish between precedent and merit in this case, in advance of the presidential administration change in January and potentially new Supreme Court appointments, this objectivity may not last. Thus, it is vital that the Fifth Circuit shifts back to the objective legal principles the American judicial system was based on.

Bibliography

[1] Winny, Annalies. “A Brief History of Abortion in the U.S.” Hopkins Bloomberg Public Health. November 2, 2022. https://magazine.publichealth.jhu.edu/2022/brief-history-abortion-us.

[2] “Roe v. Wade and Supreme Court Abortion Cases.” Brennan Center for Justice. September 28, 2022. https://www.brennancenter.org/our-work/research-reports/roe-v-wade-and-supreme-court-abortion-cases#:~:text=Justice%20Clarence%20Thomas%2C%20who%20was,text%20of%20the%20Fourteenth%20Amendment.%E2%80%9D.

[3] Food and Drug Administration v. Alliance for Hippocratic Medicine 235 U.S. 2 (2023).

[4] Howe, Amy. “Supreme Court Preserves Access to Abortion Pill.” SCOTUSblog. June 13, 2024. https://www.scotusblog.com/2024/06/supreme-court-preserves-access-to-abortion-pill/.

[5] https://www.ca5.uscourts.gov/opinions/pub/23/23-10362-CV1.pdf, page 14

[6] Lupkin, Sydney. “Here's What Really Happened During the Abortion Drug's Approval 24 Years Ago.” NPR. March 26, 2024. https://www.npr.org/sections/health-shots/2023/04/14/1169859888/abortion-drug-mifepristone-history-fda-approval-supreme-court.

[7] “Food and Drug Administration v. Alliance for Hippocratic Medicine.” Oyez. Accessed October 30, 2024. https://www.oyez.org/cases/2023/23-235.

[8] Klibanoff, Eleanor. “Federal Judge at Center of FDA Abortion Drug Case has History with Conservative Causes.” The Texas Tribune. March 15, 2023. https://www.texastribune.org/2023/03/15/federal-judge-amarillo-abortion-fda/.

[9] “Alliance for Hippocratic Medicine v. FDA.” Center for Reproductive Rights. Accessed October 30, 2024. https://reproductiverights.org/case/alliance-for-hippocratic-medicine-v-fda/.

[10] ArtIII.S2.C1.6.4.2 Concrete Injury

[11] Food and Drug Administration v. Alliance for Hippocratic Medicine 235 U.S. 1 (2023).

[12] Food and Drug Administration v. Alliance for Hippocratic Medicine 235 U.S. 17 (2023).

[13] https://www.ca5.uscourts.gov/opinions/pub/23/23-10362-CV1.pdf, page 13

[14] Ibid

[15] Millhiser, Ian. “The Trumpiest Court in America.” Vox. Decehttps://www.vox.com/policy-and-politics/2022/12/27/23496264/supreme-court-fifth-circuit-trump-court-immigration-housing-sexual-harrassment.

[16] Sheth, Jeevna and Devon Ombres. “The 5th Circuit Court of Appeals Is Spearheading a Judicial Power Grab.” Cap20. May 15, 2024. https://www.americanprogress.org/article/the-5th-circuit-court-of-appeals-is-spearheading-a-judicial-power-grab/

[17] Food and Drug Administration v. Alliance for Hippocratic Medicine 235 U.S. 1 (2023).

[18] https://www.ca5.uscourts.gov/opinions/pub/23/23-10362-CV1.pdf, page 1

[19] Mutual Pharmaceutical Co. v. Bartlett 570 U.S. (2013).

[20] Merck Sharp & Dohme Corp. v. Albrecht 290 U.S. (2018)

[21] Food and Drug Administration v. Alliance for Hippocratic Medicine 235 U.S. 2 (2023).