Food and Drug Administration v. Alliance for Hippocratic Medicine


Should the Court uphold the FDA’s modifications to the usage conditions of the drug mifepristone and defer to the FDA’s expertise before issuing preliminary relief, and do associations of doctors or medical groups have Article III legal standing to challenge the FDA's modifications due to safety concerns?

Oral argument: 
March 26, 2024

This case presents the Supreme Court with the issue of whether the Food and Drug Administration (“FDA”) can uphold its modifications to the usage guidelines of the drug mifepristone despite challenges from the Alliance for Hippocratic Medicine, who assert that these changes are capricious and unnecessarily elevate patient risk. Petitioner, the FDA, argues that Respondent, the Alliance for Hippocratic Medicine, lacks standing and that the FDA’s mifepristone-related decisions were based on solid clinical data and expert evaluations affirming the drug's safety and effectiveness. Respondent, the Alliance for Hippocratic Medicine, contends that it has standing and that the FDA's actions in 2016 and 2021 lack adequate safety studies and do not provide a cogent rationale for the modifications, thereby jeopardizing patient and healthcare provider safety. The Court's decision will determine whether mifepristone will stay subject to the lower court's injunction or if the FDA's decision to relax usage guidelines in 2016 and 2021 stands as justified.

Questions as Framed for the Court by the Parties 

(1) Whether respondents have Article III standing to challenge the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use; (2) whether the FDA’s 2016 and 2021 actions were arbitrary and capricious; and (3) whether the district court properly granted preliminary relief.


In 1996, the United States Food and Drug Administration (“FDA”) received a new drug application (“NDA”) for the drug mifepristone from the Population Council. Alliance for Hippocratic Medicine v. U.S. Food And Drug Administration at *2. Mifepristone is a progesterone blocker that, when used with misoprostol that causes cervical softening, can terminate pregnancies that have been ongoing for 70 days or less. MedlinePlus. In February 2000, the FDA expressed concerns that the NDA did not contain sufficient evidence indicating mifepristone was safe and effective for its proposed use. Id. However, some months later, the FDA approved mifepristone for use with misoprostol through an “accelerated approval” procedure. Id. At *3. The FDA’s approval included post-approval restrictions to ensure safety: only women and girls seven weeks or less into their pregnancy could use the drug, individuals had to attend three in-person office visits to a doctor trained in administering the mifepristone-misoprostol regimen, and doctors had to report all adverse events resulting from the regimen. Id.

In 2002, the American Association of Pro-Life Obstetricians & Gynecologists (“AAPLOG”) and the Christian Medical & Dental Associations (“CDMA”) filed a petition with the FDA challenging its approval of mifepristone. Id. In 2016, the FDA rejected their petition, and on the same day revised their regulations covering the mifepristone-misoprostol regimen, including removing or altering all of the post-approval restrictions. Id. At *4.

In 2019, AAPLOG and the American College of Pediatricians (“ACP”) filed a petition with the FDA challenging its 2016 removal and alteration of the post-approval restrictions. Id. At *5. That same year, the FDA approved the abbreviated new drug application of a generic version of mifepristone. Id. In 2021, the FDA rejected most of the 2019 petitions by AAPLOG and ACP and revised its regulations to permit mail delivery of mifepristone. Id.

On November 18, 2022, AAPLOG, CDMA, ACP, and The Alliance for Hippocratic Medicine (“AHM”) (collectively “the Alliance”) filed suit against the FDA in the U.S. District Court for the Northern District of Texas, seeking preliminary injunctions against the FDA’s 2000 and 2019 approvals of mifepristone, 2016 changes made to mifepristone’s regulations, and 2021 approval of mail distribution of mifepristone. Id. At *1, *5. On February 6, 2023, the district court granted a motion by Danco Laboratories, LLC to intervene as a defendant. Id. At *5.

On April 7, 2023, the district court granted the preliminary injunctions for the Alliance. Id. At *67. The district court found that the Alliance had associational and organizational standing under Article III of the Constitution. Id. At *7, *11. The district court also found that the FDA’s pre-2021 actions were arbitrary and capricious, that there was a substantial threat of irreparable harm if the court did not grant the preliminary injunctions, and that preliminary injunctions would serve the public interest. Id. At *49, *61, *63.

On appeal, the U.S. Court of Appeals for the Fifth Circuit partially reversed the district court’s decision, vacating the preliminary injunctions against the 2000 and 2019 approvals. Alliance for Hippocratic Medicine v. Food & Drug Administration, at *222. The Fifth Circuit found that the statute of limitations barred the Alliance’s claim against the FDA’s 2000 approval and that the Alliance had not shown sufficient injury to have standing regarding the 2019 approval. Id. However, the Fifth Circuit found that the Alliance had associational standing regarding every claim other than the FDA’s 2019 approval and that the FDA’s 2016 and 2021 actions were arbitrary and capricious. Id. At *233, *256.

On September 8, 2023, the FDA petitioned for a writ of certiorari; the Supreme Court granted certiorari on December 13, 2023. SCOTUSblog.



Petitioner, the FDA, argues that judicial standing is a fundamental constitutional necessity for any legal case in the United States to ensure that federal courts address only actual, concrete disputes and maintain their designated role within the government's separation of powers framework. Brief of Petitioner, Food and Drug Administration, at 15. The FDA contends that the standing doctrine demands that a plaintiff prove a direct, personal injury that is attributable to the defendant’s conduct and can be alleviated by the Court’s intervention. Id. at 15-16. The FDA further asserts that, in cases where an association represents its members, it must establish that at least one member has experienced or is imminently at risk of specific, tangible harm. Id. at 16. The FDA maintains that allegedly causing or potentially causing harm to members—who are medical professionals openly opposed to abortion—does not confer standing. Id.

The FDA claims that the Alliance's arguments for associational standing hinge on speculative and indirect harm based on the actions of unrelated third parties. Id. at 16-18. According to the FDA, the Alliance speculates a scenario where the loosened restrictions would allow other doctors to prescribe mifepristone and more women to seek emergency care due to the side effects of mifepristone, potentially forcing physicians to perform abortions against their conscience. Id. at 17-18. The FDA contends that this argument relies on a series of conjectural events and does not demonstrate that any member faces a concrete and imminent injury directly traceable to the FDA's 2016 and 2021 actions regarding mifepristone. Id. at 18-20, 28-32. The FDA maintains that the Alliance’s approach mirrors hypothetical or statistical theories that lack specific, identifiable harm to establish standing, thus previously rejected by the lower court. Id. at 19-21.

The FDA also argues that the Alliance’s organizational standing claims are equally tenuous. Id. at 32. In response to the Alliance’s claims that the FDA's actions have forced the doctors to divert resources and hindered their ability to counsel against chemical abortions, the FDA asserts that these impacts do not constitute direct legal injuries. Id. at 32-33. The FDA further contends that the Alliance’s claims stem from their opposition to the FDA's decisions rather than from any actions by the FDA that directly affect their legal rights or operational capacities. Id. at 33-34. Thus, the FDA concludes that the speculative nature of the claimed injuries, the indirect causal chain connecting the injuries to the FDA's actions, and the absence of any direct, personal harm to the respondents or their members undermine the standing claims. Id. at 15 - 16.

The Alliance counters that they have standing to challenge the FDA’s actions. Brief of Respondent, Alliance for Hippocratic Medicine, at 17. The Alliance notes that standing requires “(1) an injury in fact, (2) a sufficient causal connection, and (3) a likelihood at the injury will be redressed” (internal quotation marks excluded). Id.

Specifically, AHM claims it can show an injury in fact because its doctors would have to violate their conscience to meet the relevant FDA standards. Id. at 18. The Alliance argues that the FDA requirements would demand that doctors participate in elective abortions that they find to be unethical. Id. The Alliance contends that the doctors would also have to treat complications from abortion drugs in emergencies which often require prioritizing the mother’s life over that of the fetus. Id. at 20-21. The Alliance also alleges an injury in fact because it must use its limited time and resources to facilitate elective abortions rather than doing other tasks required of obstetrician gynecologists (“OB/GYNs”). Id. at 21. The Alliance argues that doctors must deal with emergency complications from abortion drugs, pulling them away from their other patients and that OB/GYNs are not well-suited to do emergency medicine. Id. at 22.The Alliance also contends that it faces an injury in fact in the form of emotional and spiritual distress to doctors as a result of having to participate in abortions. Id. at 22-23. The Alliance asserts that it would also face increased insurance costs. Id. at 23. Additionally, the Alliance argues that its risks of malpractice would increase since its doctors would spend an increased amount of timedealing with more emergency and high-risk situations. Id. At 24.

The Alliance highlights that there is a substantial risk these injuries would occur, and the harm is not speculative because the existence of abortion drugs virtually guarantees that those drugs will have complications that OB/GYNs must deal with. Id. The Alliance argues that the FDA has repeatedly stated that emergency room care is necessary to deal with abortion drug complications. Id. at 15. Additionally, the Alliance contends that over half of the women who have gotten abortions have used abortion drugs like mifepristone, and of those, about 3-5 percent go to the emergency room. Id. at 26.

The Alliance argues that the injuries are traceable to the FDA’s actions because the deregulation of the abortion drugs led to an increased usage of those drugs. Id. at 33-34. In other words, the Alliance claims, the increase usage of those drugs are the “predictable effect of government action” sufficient to generate standing. Id. The Alliance also states that its claims can be redressed by simply restoring the original safety standards for the drugs, which the Alliance claims would result in fewer emergency room visits and reduce the strain on doctors and lower the overall risks they face. Id. at 41-42.


The FDA argues that, by overlooking the deferential standard that should be applied in such regulatory contexts, the Fifth Circuit erroneously deemed as arbitrary and capricious the FDA's actions concerning mifepristone adjustments in 2016 and the removal of in-person dispensing requirements in 2021. Brief of Petitioner, Food and Drug Administration, at 34. The FDA claims that in 2016, it judiciously expanded mifepristone's use window and reduced unnecessary clinical visits by allowing non-physician healthcare providers to prescribe the drug. Id. at 34-35. The FDA states that these modifications are supported by extensive scientific studies conducted over two decades demonstrating safety and efficacy compared to the original protocols, reinforcing its commitment to evidence-based decision-making. Id. at 36-41.

The FDA argues that the lower court also misunderstood the rationale behind the 2021 decision to remove the in-person dispensing requirement for mifepristone. Id. at 42. This decision, according to the FDA, is backed by thorough reviews and evidence from its use during the pandemic, demonstrating that patient safety was not compromised. Id. The FDA contends that their rigorous evaluation process and reasoned explanations, respecting the complex and dynamic nature of healthcare and pharmaceuticals, underscore the lawfulness of their decision. Id. at 42-44. The FDA concludes that deference to the FDA's expertise is essential, particularly when the agency navigates the nuanced terrain of medical and pharmaceutical regulations to protect and advance public health objectives. Id.

The Alliance counters that the FDA’s removal of safeguards for mifepristone was arbitrary and capricious. Id. at 47. The Alliance asserts that the FDA changed a longstanding policy with no justification provided. Id. at 47-49. Additionally, the Alliance argues that the FDA relied on reports that it knew were inaccurate and incomplete when making its decision. Id. at 50. The Alliance further contendsthat the FDA is also responsible for insufficient or weakdata on the use of the drug since it removed reporting requirements on abortion drug providers. Id. at 51. The Alliance contends that the FDA also relied on studies that it agreed could not be generalized to the U.S. population because of the studies’s small sample sizes and inclusion of other kinds of pre-abortion safeguards. Id. at 52. The Alliance finally emphasizes that the FDA ignored studies suggesting an increased risk to people as a result of reducing safeguards. Id. at 53.

Finaly, the Alliance claims that the FDA’s removal of the requirement of people seeking abortion drugs to attend an in-person visit violates the Comstock Act. Id. at 56. The Alliance argues that the text of the Comstock Act prohibits the mailing of any abortion drugs even if the abortions are lawful (and additionally, Congress considered and rejected an amendment limiting the law to illegal abortions). Id. at 56-57.



263 members of Congress, in support of the FDA and Danco Laboratories, argue that overturning the injunctions against the FDA’s mifepristone policies would provide pregnant individuals with a safer and cheaper alternative to procedural abortions, as well as allow those living in states with abortion prohibitions to have abortions. Brief of Amici Curiae 263 Members of Congress, in Support of Petitioners at 12, 17. The 263 Congress members highlight the FDA’s conclusion that “mifepristone remains safe and effective [even] with the in-person dispensing requirement removed” and express concerns that the injunctions may compel some individuals to undergo an unwanted pregnancy. Id. at 17. Doctors for America and the Reproductive Health Coalition add that overturning the injunctions will help doctors provide effective and desirable care options for patients with different treatment considerations, such as for sexual abuse victims, for whom traditional surgical abortion may be traumatizing. Brief of Amici Curiae Doctors for America and The Reproductive Health Coalition, in Support of Petitioners at 16-17, 21.

145 members of Congress, in support of the Alliance, counter that upholding the injunctions against the FDA’s mifepristone regulations would protect pregnant individuals who rely on misleading statistics downplaying mifepristone’s serious health and safety risks from the FDA’s 2016 and 2021 modifications. Brief of Amici Curiae 145 Members of Congress, in Support of Respondents at 9, 13. The 145 Congress members contend that the FDA artificially lowered adverse response statistics for mifepristone by eliminating requirements for medical professionals to conduct follow-up appointments with individuals taking mifepristone, which allowed non-physician prescriptions of mifepristone and mail-order delivery of mifepristone. Id. at 13-14. Moreover, mifepristone victims and former abortion providers (collectively “Mifepristone Victims”) argue that the FDA’s misleading adverse response statistics have led to individuals being unprepared for mifepristone’s negative effects and so suffer psychological trauma. Brief of Amici Curiae Women and Families Harmed by Mifepristone and Former Abortion Providers (“Mifepristone Victims”), in Support of Respondents at 25-27. Mifepristone Victims further contend that permitting mail-order delivery and self-administration of the mifepristone-misoprostol regimen has led to individuals suffering psychological trauma in their own homes. Id. at 23-24.


The American College of Obstetricians and Gynecologists et al. (collectively, “American Medical Societies”), writing in support of the FDA and Danco Laboratories, argue that overturning the injunctions against the FDA’s mifepristone policies will help doctors better address miscarriages and provide maternal care. Brief of Amici Curiae American College of Obstetricians and Gynecologists et al. (“American Medical Societies”), in Support of Petitioners at 30. The American Medical Societies also describes an imbalance between studies indicating mifepristone’s risks and “the overwhelming weight of credible, peer-reviewed, evidence-based work,” alleging that mifepristone is safer than common medications such as ibuprofen or Viagra. Id. at 16. GenBioPro additionally observes that upholding the injunctions would reduce the approved period for mifepristone use from ten to seven weeks – when “a substantial percentage of patients [would] not know they [were] pregnant” – and set mifepristone dosage guidelines at unsafe dosages. Brief of Amicus Curiae GenBioPro, in Support of Petitioners at 27.

The U.S. Medical Association (“USMA”), writing in support of the Alliance, counters that upholding the injunctions will protect patients from serious health risks associated with mifepristone, including significant hemorrhaging and uterine ruptures. Brief of Amicus Curiae United States Medical Association (“USMA”), in Support of Respondents at 5. The USMA highlights studies produced by the FDA, Congress, and Planned Parenthood as indicating mifepristone to be unsafe, and argues that the FDA skewed the evidence regarding mifepristone’s risks by removing requirements for physician consults and ultrasounds. Id. at 6-7, 9. Mifepristone Victims also assert that FDA documents and warnings regarding mifepristone’s risks indicate that mifepristone is not as safe as ibuprofen. Brief of Mifepristone Victims at 15. The USMA also contends that medical supervision is necessary for safely administering mifepristone and that overturning the injunction against the FDA’s approval of mail-delivery mifepristone may lead to life-threatening situations for individuals self-administering mifepristone. Brief of USMA at 5-6.



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