Reproductive Rights in the Administrative Era: Lessons from FDA v. Alliance for Hippocratic Medicine

Over the past few years, the US has experienced an increase in the amount of discourse surrounding abortion. Many medical organizations have voiced grievances about the ethics behind abortion rights. [1] One milestone case had to do with the FDA’s approval of the abortion-inducing drug mifepristone, in which it effectively allowed mifepristone, a prescription medication used to terminate an early pregnancy, to be generically used on pregnancies up to 10 weeks. Four pro-life medical associations, together known as the Alliance for Hippocratic Medicine,  moved for an injunction, where the FDA would have to rescind either approval of mifepristone or its previous regulatory actions. [2] The litigation in FDA v. Alliance for Hippocratic Medicine shows that the real issue is not the safety of mifepristone but the legal authority of the FDA. By allowing courts to revisit the agency’s scientific decisions, the case highlights how reproductive rights have become tied to larger questions of administrative law–raising the risk of destabilizing the entire drug approval system. [3]

The FDA’s statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA), allows it to regulate the safety, efficacy, and labeling of human and veterinary drugs, medical devices, food, cosmetics, tobacco products, and radiation-emitting electronic products. This authority allows the FDA to set standards, approve new products, conduct inspections, enforce regulations against misbranding and adulteration, and issue recalls for non-compliant products. [4] The FDA first approved mifepristone (under the brand name Mifeprex) on September 28, 2000, for use in termination of pregnancy through seven weeks gestation. [5] Over time, the FDA adjusted the drug’s labeling and regulatory constraints based on accumulating scientific and clinical evidence. In March 2016, the FDA adopted a revised regimen and updated the drug’s labeling to extend permissible use through 10 weeks (70 days) of pregnancy, reflecting new evidence about safety and effectiveness. [6]

Between 2016 and 2023, the FDA continued to affirm mifepristone’s safety through additional reviews and regulatory adjustments, including a 2021 decision to lift the in-person dispensing requirement, allowing the medication to be prescribed via telehealth and shipped by mail. [7] Studies confirmed the drug’s effectiveness and low complication rate, supporting the agency’s regulatory stance. [8] These developments prompted opposition from anti-abortion organizations, several of which filed suit in 2022 challenging the FDA’s approval process. The case, Alliance for Hippocratic Medicine v. FDA, began in the Northern District of Texas, where Judge Matthew J. Kacsmaryk issued a preliminary injunction in April 2023 that would have suspended mifepristone’s approval nationwide. [9]

The litigation began in the Northern District of Texas, where Judge Matthew J. Kacsmaryk issued a preliminary injunction in April 2023 that would have suspended the FDA’s approval of mifepristone nationwide. [10] The court accepted the Alliance for Hippocratic Medicine’s argument that its physician members faced a “concrete injury” because they might be required to treat patients experiencing complications from the medication, which the court held was sufficient to establish Article III standing. [11] Judge Kacsmaryk further concluded that the FDA’s 2000 approval of mifepristone, as well as its later regulatory modifications—including the 2016 change that extended the drug’s use from seven to ten weeks of gestation—were “arbitrary and capricious” and “not in accordance with law” under the Administrative Procedure Act. [12]

On appeal, the U.S. Court of Appeals for the Fifth Circuit narrowed the district court’s order. [13] The judges ruled that the plaintiffs had waited too long to challenge the FDA’s original 2000 approval of mifepristone so that part of the injunction could not stand. However, the court agreed with the plaintiffs, in part, by blocking the FDA’s more recent changes to the drug’s regulations. As a result, the court’s decision would have limited mifepristone’s use to seven weeks of pregnancy, required patients to see a doctor in person, and prohibited the drug from being sent by mail.

The court explained that the FDA may not have properly justified these later regulatory changes under the Administrative Procedure Act. [14] By stepping in, the Fifth Circuit showed a willingness to question the FDA’s scientific and medical decisions. Normally, courts defer to agencies like the FDA when it comes to technical issues, following the principle laid out in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. [15] This made the Fifth Circuit’s decision unusual and important for administrative law.

After the Fifth Circuit’s decision, the case went to the Supreme Court, which agreed to hear it in 2024. [16] The Court focused mainly on the question of standing rather than the merits of the FDA’s regulatory changes. [17] On June 13, 2024, the Supreme Court unanimously held that the Alliance for Hippocratic Medicine did not have Article III standing to challenge the FDA’s approval of mifepristone. [18] This meant the Court did not decide whether the FDA’s scientific judgments or regulatory updates were correct, leaving the agency’s rules in place for now. [19]

The Court also noted that the case had been consolidated with Danco Laboratories v. Alliance for Hippocratic Medicine, emphasizing that the litigation concerned the authority of courts to intervene in FDA decision-making, rather than the safety of the drug itself. [20] By refusing to reach the merits, the Supreme Court highlighted the limits of judicial power over administrative agencies and reinforced the idea that agency expertise generally deserves deference.

Overall, the Supreme Court’s decision in FDA v. Alliance for Hippocratic Medicine ultimately maintained the boundaries of judicial powers over scientific and administrative organizations. By dismissing the case, based on a lack of standing, SCOTUS preserved not only access to mife, but also the integrity of to mifepristone, but also the integrity of the FDA’s decision-making process. However, this case is a foundation for how disputes about reproductive rights can lead to broader conflicts over the authority of administrations, and the role in evaluating their efficacy. 

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Sources

1. American Medical Association. “AMA Holds Fast to Principle That Reproductive Care Is Health Care.” American Medical Association. March 14, 2023. https://www.ama-assn.org/public-health/population-health/ama-holds-fast-principle-reproductive-care-health-care? 

2. Upadhyay, Ushma D., and James Trussell. “Abortion and Women's Health in the United States: Evidence and Policy.” PMC Articles, National Center for Biotechnology Information, 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5431366 

3. FDA v. Alliance for Hippocratic Medicine, 602 U.S. ___ (2024), https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf 

4. Harvard Law Review. “FDA v. Alliance for Hippocratic Medicine.” Harvard Law Review, Vol. 138. https://harvardlawreview.org/print/vol-138/fda-v-alliance-for-hippocratic-medicine/

5. National Center for Biotechnology Information. “Federal Food, Drug, and Cosmetic Act (FDCA).” In StatPearls [Internet], edited by StatPearls Publishing, 2023. https://www.ncbi.nlm.nih.gov/books/NBK585046/#:~:text=The%20FDCA%20authorizes%20the%20FDA,%2C%20medical%20devices%2C%20and%20cosmetics

6. Guttmacher Institute, “Public Health Implications of FDA Update on Medication Abortion Label,” Guttmacher Institute, June 2016, https://www.guttmacher.org/article/2016/06/public-health-implications-fda-update-medication-abortion-label.

7. U.S. Food and Drug Administration, Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation (Silver Spring, MD: U.S. Department of Health and Human Services, December 2021), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation 

8. Aiken, Abigail R. A., Jennifer E. Starling, Rebecca Gomperts, et al., “Effectiveness, Safety, and Acceptability of No-Test Medical Abortion Provided via Telemedicine: A National Cohort Study,” New England Journal of Medicine 386, no. 8 (2022): 795–796; Ushma D. Upadhyay, Suji Y. Desai, Vanessa Zlidar, et al., “Incidence of Emergency Department Visits and Complications After Abortion,” Contraception 92, no. 6 (2015): 486–491. 

9. FDA v. Alliance for Hippocratic Medicine, 602 U.S. ___ (2024), https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf

10. Alliance for Hippocratic Medicine v. FDA, No. 2:22-cv-223-Z, 2023 WL 370067, at *1 (N.D. Tex. Apr. 7, 2023), https://law.justia.com/cases/federal/district-courts/texas/txndce/2:2022cv00223/370067/137/.

11. Alliance for Hippocratic Medicine v. FDA, No. 2:22-cv-223-Z, slip op. at 15–18 (N.D. Tex. Apr. 7, 2023).

12. Alliance for Hippocratic Medicine v. FDA, No. 2:22-cv-223-Z, slip op. at 45–46 (N.D. Tex. Apr. 7, 2023).

13. Alliance for Hippocratic Medicine v. FDA, 78 F.4th 210, 219 (5th Cir. 2023), https://law.justia.com/cases/federal/appellate-courts/ca5/23-10362/23-10362-2023-08-16.html.

14. Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), https://supreme.justia.com/cases/federal/us/467/837/.

15. FDA v. Alliance for Hippocratic Medicine, 602 U.S. ___, slip op. at 1 (2024), https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf.

16. Ibid. at 5–6.

17. Ibid. at 6–7.

18. Ibid. at 14.

19. Ibid. at 1.

20. Ibid. at 12–13.