Two years ago, the Supreme Court revoked the right to abortion in Dobbs v. Jackson Women’s Health Organization, disrupting nearly fifty years of precedent. The Dobbs decision precipitated various state strategies — including lawsuits — to limit access to reproductive health care and penalize the clinicians and organizations that support these services.
Food and Drug Administration v. Alliance for Hippocratic Medicine (FDA v. AHM), which exemplifies these efforts, challenges the U.S. Food and Drug Administration’s (FDA) approval of medication abortion and measures taken to expand access to that medication. On March 26, the Supreme Court heard oral argument in this case and will issue its decision by the end of this term in June. In addition to limiting access to safe abortion, this case could limit how federal agencies may exercise their authority granted by Congress, furthering an ongoing deregulatory effort this Supreme Court term.
The Supreme Court will hear a second abortion case, United States v. Idaho, this spring. There, the Court will determine whether an Idaho law that criminalizes abortions except in very narrow circumstances conflicts with the Emergency Medical Treatment and Labor Act (EMTALA), which requires hospitals to provide stabilizing care to patients experiencing emergency medical conditions. This litigation challenges federal guidance affirming that EMTALA protects clinicians’ ability to provide an abortion when, based on professional medical judgment, it is required to stabilize a patient in an emergency.
This Expert Column summarizes the lower court decisions in FDA v. AHM, discusses the central themes raised during the Supreme Court oral argument, and highlights the stakes of the impending Supreme Court decision.
Background on FDA v. Alliance for Hippocratic Medicine
On November 18, 2022, the Alliance for Hippocratic Medicine (AHM) filed its lawsuit in a northern Texas federal court, challenging the FDA’s approval of Mifeprex (the brand name of mifepristone) in 2000. AHM also questioned the safety and efficacy data that the FDA relied upon to expand access to mifepristone in 2016, challenged the FDA’s approval of generic mifepristone in 2019, and asked the court to review the FDA’s denial of two citizen petitions. AHM strategically filed this lawsuit in Amarillo, Texas, a jurisdiction where Judge Matthew J. Kacsmaryk — an outspoken critic of the right to an abortion — hears all federal civil cases. This practice of strategically filing in places to target specific judges is often referred to as “forum shopping.” Recently, the Judicial Conference of the United States adopted a new policy to limit the practice. However, despite the policy’s focus, the North District of Texas judges decided not to change how they assigned their cases.
Mifepristone is currently approved to safely end a pregnancy through ten weeks of gestation and is used by millions of people across the country. AHM asked the court to suspend enforcement of the FDA approval and subsequent actions. Danco LLC., the manufacturer of Mifeprex, joined the lawsuit as well.
Judge Kacsmaryk temporarily barred the 2000 approval of mifepristone and the FDA’s subsequent actions to expand access. He reasoned that the FDA’s actions violated the Administrative Procedure Act (APA), which governs agency rulemaking, because the FDA’s actions were not adequately reasoned and contradicted federal laws. Additionally, he found that the measures the FDA took to increase access to abortion medication — eliminating the in-person dispensing requirement and allowing mifepristone to be mailed — violated the Comstock Act. The Comstock Act is an 1873 anti-obscenity law that prohibits the mailing of unlawful abortion materials, which anti-abortion groups have attempted to resuscitate post-Dobbs. In their amicus brief, U.S. Department of Justice (DOJ) officials noted that the Comstock Act does not apply to FDA safety and efficacy determinations. They wrote that, regardless, the FDA did not violate the act, per DOJ guidance, since the agency is not illegally distributing mifepristone.
The federal government and Danco appealed the District Court decision, asking the Fifth Circuit to pause the ruling through the appeals process. The Fifth Circuit narrowed the District Court’s ruling and suspended the FDA’s actions to expand access to mifepristone — rolling back the agency’s evidence-based measures to ensure that the drug’s original approval kept pace with advances in technology and science.
In response to an appeal brought by the government and Danco, the Supreme Court agreed to review the circuit court’s decision, consolidated both cases, and allowed the drug to remain available while the case went through appeal. During oral argument, the justices asked about whether AHM could bring this suit in the first place, how an adverse ruling would affect the FDA and reproductive health, the appropriate relief for AHM’s alleged injury, and whether the Comstock Act applied to the FDA and Danco.
In the following section, we unpack the major themes that emerged during the oral argument.
Major Themes in the Supreme Court Oral Argument
Standing
The majority of the oral argument focused on standing. As a threshold matter, standing requires AHM to show that it has been harmed or is likely to be harmed by the FDA’s actions before the Court can hear the merits of AHM’s claims. Both the District Court and Fifth Circuit found that AHM members were likely harmed by the FDA’s initial approval of mifepristone and its subsequent actions based on the doctrine of “associational standing.” Under that doctrine, an organization may sue on behalf of its members if the members have been harmed. Both courts’ standing determination relied on an attenuated causal chain, reasoning that if a certain number of women who take mifepristone were to experience some adverse event requiring emergency care, AHM’s members would likely have to provide such care and be harmed in the process.
During the oral argument, the justices questioned whether AHM had shown current or future harm due to the FDA’s actions. Pushing back against the lower courts’ findings, Solicitor General Elizabeth Prelogar noted that AHM’s claims were speculative and “rest[ed] on a long chain of remote contingencies.” The solicitor general argued that, even if a woman experiencing complications sought care from one of AHM’s members, “federal conscience protections would guard against the injury the doctors face.” In response to Justice Amy Coney Barrett’s question regarding the interplay between this case and the upcoming EMTALA challenge, Prelogar clarified that EMTALA ensures hospitals provide emergency care when appropriate (but does not override conscience protections for the individual doctor).
Justice Sonia Sotomayor noted that AHM’s argument relied on two members who work in states that have blocked access to abortion, finding that the probability of these doctors being harmed is “infinitesimally small.” Justice Barrett was skeptical about whether the declarations submitted by AHM members showed that they were forced to perform abortions, given that the medical procedure cited in the declaration could also be performed following a miscarriage. AHM’s attorney, Erin Hawley, alluded that performing this procedure violated broader conscience protection, even if it was carried out to treat a miscarriage. Justice Ketanji Brown Jackson seemed unswayed by this argument and attempted to clarify the scope of this broader conscience protection, asking if it extends to everyone working in the emergency room or someone who merely hands the patient a water bottle.
Agency Authority Under the APA
A key issue is whether the FDA’s actions to expand access to abortion medication in 2016 and 2021 were proper. The Food, Drug, and Cosmetic Act requires the FDA to evaluate the risks of certain drugs to ensure safety and efficacy. Reiterating the Fifth Circuit’s concern that the FDA improperly evaluated changes made to the drug’s conditions of use in 2016, Justice Samuel Alito questioned whether “the changes would be more dangerous in combination than they were individually.” The solicitor general responded that the FDA relied on numerous studies that looked at both individual and combined effects of these changes and that they align with the current standard of care. Justice Alito similarly questioned the FDA’s decision to alter adverse reporting requirements. Danco’s attorney, Jessica Ellsworth, stressed that this decision was based on fifteen years of data and that “no drug on the market today…requires the kind of reporting that plaintiffs say should be reimposed here.”
This case comes at the heels of continued judicial attacks on the power and expertise of administrative agencies. Justice Jackson recognized this by asking about how an adverse decision in Corner Post, Inc. v. Board of Governors, where the Court’s decision could significantly expand the period during which parties could challenge agency decisions, may affect settled agency actions. Prelogar acknowledged that an adverse decision in Corner Post could open the door to plaintiffs entering the medical field or emergency medicine, “unsettl[ing] longstanding agency actions that may [have] occurred decades previously.”
In the same vein, Justice Jackson questioned Hawley on how much deference “courts owe the opinion of the expert agency concerning the safety and efficacy of drugs” — a question the Court will directly address when it decides the fate of the Chevron doctrine later this year. Justice Jackson noted that the district court’s opinion went far beyond scrutinizing agency opinion by relying on now-discredited studies. She questioned whether courts have the specialized knowledge “with respect to pharmaceuticals” needed to parse medical and scientific studies and make such determinations. As noted by Justice Elena Kagan, according to the government, this case marks the only time “any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.”
Scope of and Harms Caused by the Remedy
Various justices also raised concerns about the scope of the remedy that AHM is seeking. Justice Jackson characterized the remedy as “overbroad” because it did not match the claimed injury. Several justices suggested that federal conscience protections for providers who object to providing an abortion would be more appropriate than asking the FDA to change the conditions of the use of mifepristone.
Justice Neil Gorsuch highlighted the “rash of universal injunctions” that lower courts have issued in recent years. In his opinion, “this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on…an FDA rule or any other federal government action.”
Prelogar stressed that the “sweeping nationwide relief” requested by AHM would destabilize the system for approving and regulating drugs — causing profound harm to both the FDA and the pharmaceutical industry. Ellsworth echoed the same concerns, explaining how the industry depends “on FDA’s gold standard review process to…approve their drugs and then to be able to sell their products in line with that considered judgment.” Prelogar also highlighted how the relief requested would inflict grave harm on millions of women across the nation who need access to medication abortion. She stressed that “[s]ome women could be forced to undergo more invasive surgical abortions,” while others would likely “not be able to access the drug at all.”
Application of the Comstock Act
A few justices inquired about how the Comstock Act applies to both the FDA’s and Danco’s actions. Justice Alito said that the FDA should have considered Comstock — calling it a “prominent provision” — when it allowed mifepristone to be provided via telehealth. Prelogar pushed back by noting that the Comstock Act’s provisions do not apply to the FDA, since the FDA’s role is to evaluate the safety and efficacy of drugs. According to Prelogar, even if they did apply, the FDA followed the administration’s guidance on Comstock.
Similarly, Justice Clarence Thomas asked Ellsworth whether Danco, as a private party, violated the Comstock Act by distributing mifepristone. Ellsworth pointed to the FDA’s approval of mifepristone and allowance of telehealth medication abortions as authority for distributing the drug. She also emphasized that “this statute has not been enforced for nearly a hundred years” and that the Court should “think hard about the mischief it would invite” if it found that the FDA was responsible for enforcing the Comstock Act.
Conclusion
The justices’ questions during oral argument suggest they may not reach the substance of AHM’s legal claims in this case, given that they spent significant time asking whether AHM was sufficiently harmed to bring this lawsuit. The Court’s decision about whether AHM has standing could affect how federal agency actions are challenged going forward. Moreover, if the Court ultimately finds that AHM can bring this case, they could establish a harmful precedent that would enable judges without medical or scientific knowledge to second-guess the FDA’s subject-matter expertise. The opinion’s exact scope and specificity will also determine whether certain states that joined the case at the District Court level (but unsuccessfully attempted to join at the Supreme Court level) can re-litigate the same claims.
Regardless of whether the Court addresses the applicability of the Comstock Act in this decision, how certain justices analyzed the statute could lay the groundwork for later administrations to enforce that law to the detriment of reproductive health and other rights. The stakes of this case are incredibly high. Limiting access to mifepristone would increase barriers to a medication proven to be both safe and effective — placing the health and well-being of people across the country at risk.
DISCLAIMER: The views and opinions expressed in this piece are those of the authors and do not reflect the views of the O’Neill Institute.
