December 30th 2024 | Clare Levine
Edited by Natalie Bernstein
The use of mifepristone and misoprostol, two medicines that lead to medicated abortion when combined, was contested by The Alliance for Hippocratic Medicine (AHM) following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that held that the Constitution does not confer the right to abortion [1]. The AHM and other plaintiffs argued in the Supreme Court case Food and Drug Administration v. Alliance for Hippocratic Medicine against the Food and Drug Administration’s (FDA) use of these medications, as well as the extended access to these medications approved by the FDA over the past two decades [2]. Mifepristone was approved by the FDA in 2000, yet was initially limited to being used in hospitals and medical facilities. The FDA expanded mifepristone’s access in 2016, approving doctors’ prescriptions of the medication and extending its usage in pregnancy. The FDA further expanded the medicine’s access during the Coronavirus pandemic, allowing mail distribution. In 2023, the FDA approved pharmacies’ distribution of mifepristone, expanding its access yet again. Mifepristone, one drug used in common medicated abortions, is used in more than 50% of all abortions in the United States. This Supreme Court case is an example of contestations of access to abortion following its removed legality in the eyes of the Constitution. This paper will analyze the Supreme Court’s decision regarding Article III standing, as well as the FDA’s actions in expanding access to the drugs.
The issue at hand in this situation is the Food and Drug Administration v. Alliance for Hippocratic Medicine Supreme Court case regarding the use of the medicines mifepristone and misoprostol, two medications that, when combined, lead to medicated abortion [3]. The legality behind this issue stems from the change in abortion protection in the United States, following the Supreme Court’s decision regarding Dobbs v. Jackson Women’s Health Organization that overturned the landmark case of Roe v. Wade, effectively discarding the national right to abortion [4][5]. While it was evident that certain states would alter the previous abortion laws as abortion regulations are now determined at the state level rather than the federal one, one of the main reasons this case made its way up to the Supreme Court was due to the questioning of the AHM’s Article III standing.
Article III Section II of the Constitution can be known as the “cause or controversy” clause and has been explained by the Supreme Court as the plaintiff’s need to show injury, causation, and redressability [6]. Part of the AHM’s argument surrounds the FDA’s expansion regulations and amendments regarding the medications at hand. The FDA extended access to mifepristone in some form in 2000, 2016, 2019, 2021, and 2023. Mifepristone, or its brand name Mifeprex, was first approved by the FDA in 2000 to be used for medicated abortion for the first seven weeks of pregnancy [7]. In 2016, its access was expanded to the first ten weeks of pregnancy while also permitting medical practitioners to prescribe the drug. The FDA approved generic mifepristone in 2019. Due to the COVID-19 pandemic, the FDA approved certified mail distribution of mifepristone rather than just in-person distribution. In 2023, pharmacies were granted approval to allocate the medication. The level of extended access is what is being challenged in Food and Drug Administration v. Alliance for Hippocratic Medicine, as lower courts found in favor of the AHM regarding issues in the expansion of the drug [8].
The precedent for this case comes from Dobbs v. Jackson Women’s Health Organization as well as Roe v. Wade [9][10]. The former effectively overturned the latter, eliminating the federal right to abortion. As mifepristone and misoprostol are two medications involved in medicated abortion, certain states, organizations, and groups, such as the AHM, argued for these medications’ access to be restricted. The decision from Dobbs v. Jackson Women’s Health Organization led to this case, as the AHM believed the expanded access to this drug was unconstitutional [11]. Thus, abortion rights and abortion medication are being argued in this case due to the prior foundation that removed the constitutional right to abortion.
This case matters as it is the first of its kind following abortion no longer existing as a constitutional right. While many were, and still are, concerned about how Dobbs v. Jackson Women’s Health Organization would affect the right to abortion nationally, this decision proves that not all hope is lost [12]. The case is also evidence that proceedings against abortion – whether it is medicated abortion or not – are becoming more and more common in a post-Roe world. Dobbs v. Jackson Women’s Health Organization was decided in the 2021-2022 Supreme Court term, and the Food and Drug Administration v. Alliance for Hippocratic Medicine case comes in the 2023-2024 Supreme Court term, just two terms later [13]. Hence, cases against the right and access to abortion are more prominent and are rising up the courts in the United States.
In the unanimous opinion delivered by Justice Kavanaugh, he stated that the FDA’s expanded access regarding the drugs mifepristone and misoprostol has no direct effect or injury on the AHM. Therefore, the plaintiff does not have Article III standing in this case, as they cannot simply file a lawsuit to “make a drug less available for others” due to their beliefs against abortion [14]. Justice Kavanaugh further states that the plaintiff “cannot be a mere bystander, but instead must have a ‘personal stake’ in the dispute,” with this “personal stake” existing as more than the plaintiff searching for inconsistencies or issues within the government [15]. Justice Kavanaugh states that the AHM, of whom none prescribe the medications, have no current evidence of injury to them due to the FDA’s expanded access of mifepristone, nor do they have evidence of any future injury to themselves; their argument has no personal effect on them. Rather, they are concerned with the FDA’s regulations regarding other people, which is not grounds to sue under Article III standing. Thus, the Supreme Court unanimously held that the plaintiffs “lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone” [16]. It is important to state that Justice Thomas authored a concurring opinion regarding associational standing and third-party standing. While agreeing with his fellow Justices, Justice Thomas noted that associational standing would allow an organization to file a lawsuit on behalf of its members when “its members would otherwise have standing to sue in their own right” if “the interests it seeks to protect are germane to the organization’s purpose,” and if “neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit” [17]. Justice Thomas states that associational standing is a version of third-party standing and that, in certain scenarios, it is acceptable for an organization to file proceedings without the affected members themselves. Despite stating that the Supreme Court should explain and/or justify associational standing and third-party standing in relation to Article III standing in a future case, he voted alongside the other Supreme Court Justices as, in this particular scenario, the AHM lacked standing to sue. Justice Kavanaugh’s opinion stated that third-party standing is not relevant in this case, as the relationship between a doctor and their patient cannot be considered as an infringement on the patient’s rights without showing evidence of injury to the doctor as well. Despite conflicting viewpoints on third-party standing, Justices Kavanaugh and Thomas, as well as their seven fellow Justices, all agreed that in the Food and Drug Administration v. Alliance for Hippocratic Medicine case, the AHM lacked Article III standing to sue [18].
The result of this case illustrates that in a post-Roe world, unfounded claims against abortion are not tolerated at the highest level of judiciary in this country, the Supreme Court. Organizations cannot simply sue regarding abortion without having the standing to do so. Despite nationwide concern following the Dobbs decision in 2022, the Food and Drug Administration v. Alliance for Hippocratic Medicine provides insight that the Court can still agree on legal decisions, especially in evident cases such as this one [19]. Abortion is a highly contested issue in this country, now more than ever, and if this decision had been the opposite, it would have opened the door to even further national restrictions on abortion. Yet, some hope is still alive as the Court opined in favor of the FDA, negating the AHM’s argument that the FDA’s expanded access to medicated abortion was illegal. Mifepristone and misoprostol exist as two forms of medicated abortion whose access was not restricted by this case but rather reaffirmed, as the AHM did not have the Article III standing to argue this case, nor did the FDA break any regulations by expanding their access to medicated abortion over the last two decades.
Sources:
[1] Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215. 2022.
[2] Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367. 2024.
[3] Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367. 2024.
[4] Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215. 2022.
[5] Roe V. Wade, 410 U.S. 113. 1973
[6] The Alliance for Hippocratic Medicine v. Food and Drug Administration, No. 23-235 (June 13, 2024). https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf.
[7] “Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation.” FDA.gov. Last modified September 1, 2023. Accessed November 9, 2024. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#:~:text=The%20FDA%20first%20approved%20Mifeprex,ten%20weeks%20gestation%20in%202016.
[8] Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367. 2024.
[9] Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215. 2022.
[10] Roe V. Wade, 410 U.S. 113. 1973
[11] Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215. 2022.
[12] Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215. 2022.
[13] Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367. 2024.
[14] The Alliance for Hippocratic Medicine v. Food and Drug Administration, No. 23-235 (June 13, 2024). https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf.
[15] The Alliance for Hippocratic Medicine v. Food and Drug Administration, No. 23-235 (June 13, 2024). https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf.
[16] The Alliance for Hippocratic Medicine v. Food and Drug Administration, No. 23-235 (June 13, 2024). https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf.
[17] Hunt v. Washington State Apple Advertising Comm’n, 432 U.S. 333, 343. 1977
[18] Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367. 2024.[19] Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367. 2024.
JHULR 
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