On June 13, 2024, the U.S. Supreme Court issued its much anticipated decision in FDA v. Alliance for Hippocratic Medicine ("AHM") and Danco Laboratories v. AHM (collectively, the "AHM Litigation"), holding that the plaintiffs lack standing to challenge the FDA's actions regarding the regulation of mifepristone. As described in prior Ropes & Gray Alerts (here and here) and a podcast episode, the AHM Litigation generated substantial attention from pharmaceutical and health care industry stakeholders because of the far-reaching consequences for FDA's authority that could have resulted had the decision of the U.S. Court of Appeals for the Fifth Circuit been upheld. Instead, a unanimous Supreme Court reversed the lower court's decision, thereby preserving access to mifepristone under the FDA approvals and risk evaluation and mitigation strategy ("REMS") currently in effect. Ropes & Gray had filed an amicus brief with the Supreme Court on behalf of the Association of American Medical Colleges in support of the FDA and Danco Laboratories.
This Alert summarizes the Supreme Court's decision in the AHM Litigation, as well as the latest developments in other ongoing mifepristone-related litigation.
AHM Litigation
As summarized in a prior Ropes & Gray Alert, in April 2023, the Supreme Court granted emergency applications to stay certain lower court decisions in the AHM Litigation. Subsequently, the Fifth Circuit ruled in August 2023 that the plaintiffs did have standing to challenge the FDA's changes to the mifepristone labeling and REMS that occurred in 2016 and 2021 and that the plaintiffs' challenge was likely to succeed on the merits. The upshot of the Fifth Circuit's decision would have been that mifepristone for medication abortion, both branded and generic, would remain approved but only under the FDA approval conditions that existed before the 2016 changes to the labeling and the REMS. However, because of the Supreme Court's April 2023 stay, the Fifth Circuit's decision did not have immediate effect.
Following petitions by both FDA and Danco Laboratories, the Supreme Court granted certiorari in December 2023. In addition to contesting whether the plaintiffs had Article III standing to challenge the FDA's actions in the first place, the petitioners also argued that the FDA's actions in 2016 and 2021 were not arbitrary and capricious and that the remedy granted by the lower court was improper.
On June 13, 2024, the Supreme Court unanimously ruled that the plaintiff medical associations and doctors—who neither prescribe nor use mifepristone and are unregulated by FDA—lacked standing to challenge the agency actions at issue because they failed to show causation and an injury in fact. Writing for the Court, Justice Kavanaugh explained that while unregulated parties may sometimes challenge agency action, the types of injuries alleged in this case were not sufficient to establish standing.
The Court found plaintiffs' standing theories were unavailing as the links of causation they attempted to draw were too speculative and attenuated. Justice Kavanaugh emphasized, "Under Article III of the Constitution, a plaintiff's desire to make a drug less available for others does not establish standing to sue." The Court did not conclusively rule on whether any parties would have a cognizable claim against the agency, but Justice Kavanaugh clarified that precedent makes clear that even if no one would have Article III standing, that fact is not sufficient to show standing as "some issues may be left to the political and democratic processes."
Finding plaintiffs' claims would not enable them to get in the courthouse door, the Court did not address whether FDA's actions were arbitrary and capricious nor rule on issues of FDA's authority or deference to FDA's scientific judgment—topics which were extensively discussed in the briefs and at oral argument. These issues were of key concern to drug manufacturers and stakeholders across the industry, as a ruling affirming this agency challenge on the merits could have jeopardized FDA's science-driven approval process and the continued availability of approved drugs.
Recent Developments in Other Mifepristone Litigation
The AHM Litigation was not the only mifepristone-related legal challenge ongoing in the federal courts. Other cases that may affect FDA regulation of mifepristone at the federal level or access to mifepristone in particular states are summarized below. If successful, these cases could lead to the elimination of the remaining mifepristone REMS requirements or potentially provide greater access to medication abortion in certain states that have restrictive abortion laws.
- In Washington v. FDA, a group of 17 states and the District of Columbia filed suit in the U.S. District Court for the Eastern District of Washington alleging FDA's January 2023 changes to the mifepristone REMS were unlawful in that FDA should instead have eliminated the remaining REMS requirements altogether.1 In April 2023, the district court granted plaintiffs' request for preliminary relief, enjoining the FDA from "altering the status quo and rights as it relates to the availability of mifepristone" under the January 2023 REMS in the plaintiff states. While this order has persisted despite ongoing proceedings in the AHM Litigation, the U.S District Court for the Eastern District of Washington deferred setting a schedule for summary judgment until after the Supreme Court issued its decision. The U.S. Court of Appeals for the Ninth Circuit is in parallel considering whether the district court erred in denying several additional states' motion to intervene.2 After oral arguments in the Ninth Circuit earlier this year, further appellate proceedings were stayed while the Supreme Court considered the AHM Litigation. On June 27, 2024, the parties submitted supplemental briefs to the Ninth Circuit addressing the effect of the Supreme Court's decision in the AHM Litigation. The proposed state intervenors argued that the Supreme Court's decision supports their standing to intervene, while the appellees argued that the Supreme Court's decision reinforced the inappropriateness of the proposed intervention.
- In Whole Woman's Health Alliance v. FDA, abortion providers in three states sued FDA, the Department of Health and Human Services ("HHS"), and several agency officials in May 2023 in the U.S. District Court for the Western District of Virginia, challenging the mifepristone REMS as unconstitutional and violative of the Administrative Procedure Act ("APA").3 Similar to the plaintiffs in Washington v. FDA, the plaintiffs in this case are seeking to expand the availability of medication abortion. The plaintiffs seek a permanent injunction enjoining FDA from enforcing or applying the REMS. After the district court denied plaintiffs' motion for preliminary relief in August 2023, further proceedings were stayed pending the Supreme Court's decision in the AHM Litigation.
- In Chelius v. Becerra, a physician and two health care associations challenged FDA's mifepristone REMS in the U.S. District Court for the District of Hawaii, raising APA and constitutional claims seeking the removal of the mifepristone REMS.4 Although initially filed in 2017, the case was stayed and subsequently administratively closed for several years until plaintiffs filed an amended and supplemental complaint against FDA and HHS officials to challenge the January 2023 REMS. The case remains pending before the district court.
- In GenBioPro, Inc. v. FDA, prior to the Supreme Court's April 2023 stay, the manufacturer of generic mifepristone in the U.S. sued FDA, HHS, the U.S. Department of Justice ("DOJ"), and agency officials in the U.S. District Court for the District of Maryland. GenBioPro argued that FDA cannot consider generic mifepristone to be unapproved and unlawful without first following the statutory and regulatory processes for withdrawing an approved drug application.5 In August 2023, the parties agreed to stay the case until after the Supreme Court's decision in the AHM Litigation. Given the Supreme Court's decision, we expect that this case will likely be dismissed in the near term.
- In GenBioPro v. Raynes, the U.S. manufacturer of generic mifepristone sued two state prosecutors in January 2023 in the U.S. District Court for the Southern District of West Virginia, alleging West Virginia abortion laws that restrict the prescription and sale of mifepristone are preempted by federal law (i.e., the January 2023 REMS) and impermissibly restrict patients' access to mifepristone within the state.6 After the district court dismissed the complaint, GenBioPro appealed to the U.S. Court of Appeals for the Fourth Circuit, where the case remains pending.7
- In Bryant v. Stein, an abortion provider challenged North Carolina abortion laws restricting the prescribing and dispensing of mifepristone in the U.S. District Court for the Middle District of North Carolina.8 In April 2024, the district court partially granted the parties' cross-motions to dismiss. It concluded state law was preempted to the extent it imposes safety restrictions that FDA had implemented and later removed, such as state requirements limiting the prescribing of mifepristone to only physicians and requiring in-person prescribing, dispensing, and administration. The district court found North Carolina law was not preempted, however, to the extent it imposes requirements that were either not expressly considered and rejected by the FDA or narrowly focused on issues related to the practice of medicine and a patient's informed consent. The district court issued a judgment and permanent injunction pursuant to this order on June 3, 2024. On June 20, 2024, the state legislators appealed adverse portions of the district court's decision to the U.S. Court of Appeals for the Fourth Circuit.
Key Takeaways
The Supreme Court's ruling in the AHM Litigation preserves the status quo regarding FDA approval and regulation of mifepristone. Attorney General Merrick Garland lauded the Supreme Court's decision for "ensur[ing] that mifepristone remains available for women across the country on the terms approved by the [FDA]."9
By ruling on standing grounds, the Supreme Court avoided grappling with complex questions of judicial deference to FDA's exercise of its scientific decision-making in the review of medical products. Whether such issues are raised again to the Supreme Court in the context of the Washington, Whole Women's Health Alliance, or Chelius cases that seek to eliminate the mifepristone REMS altogether remains to be seen. It is also possible that standing questions are re-raised in those cases, although the plaintiffs would likely argue that their interests are more directly implicated by federal mifepristone regulation than the plaintiffs in the AHM Litigation.
In the meantime, mifepristone prescribers and pharmacies should continue to follow the requirements of the January 2023 REMS, which, among other things, established a new pharmacy certification process to enable certain retail pharmacies to dispense mifepristone directly to patients with a prescription from a certified prescriber. News outlets reported earlier this year that some major chain pharmacies, including CVS and Walgreens, had completed the REMS certification process and begun dispensing mifepristone in select states in March 2024.10
Ropes & Gray will continue to monitor developments in this area. If you have any questions regarding this Alert, please reach out to any of the attorneys listed below or your usual Ropes & Gray advisor.
Footnotes
1 Washington v. FDA, No. 1:23-cv-3026 (E.D. Wash. Feb. 23, 2023).
2 Washington v. FDA, 23-35294 (9th Cir. May 1, 2023).
3 Whole Woman's Health Alliance v. FDA, No. 3:23-cv-19 (W.D. Va. May 8, 2023).
4 Chelius v. Becerra, No. 1:17-cv-493 (D. Haw. Oct. 3, 2017).
5 GenBioPro, Inc. v. FDA, No. 1:23-cv-1057 (D. Md. Apr. 19, 2023).
6 GenBioPro, Inc. v. Raynes, No. 3:23-cv-58 (S.D.W. Va. filed Jan. 25, 2023). The former Prosecuting Attorney General of Putnam County Mark Sorsaia was dismissed from the case in fall 2023 when he left office. The current Prosecuting Attorney of Putnam County, Kristina Raynes, is now the named defendant.
7 GenBioPro, Inc. v. Raynes, No. 23-2194 (4th Cir. Nov. 15, 2023).
8 Bryant v. Stein, No. 1:23-cv-77 (M.D.N.C. Jan. 24, 2024).
9 Press Release, U.S. Department of Justice, Attorney General Merrick B. Garland Statement on the Supreme Court's Decision in FDA v. Alliance for Hippocratic Medicine (June 13, 2024), https://www.justice.gov/opa/pr/attorney-general-merrick-b-garland-statement-supreme-courts-decision-fda-v-alliance.
10 Pam Bulluck, CVS and Walgreens Will Begin Selling Abortion Pills This Month, N.Y. Times (March 1, 2024), https://www.nytimes.com/2024/03/01/health/abortion-pills-cvs-walgreens.html.
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