Amicus brief of over 300 reproductive health researchers supports mifepristone's safety and effectiveness

INTRODUCTION

On January 30, 2024, researchers from Advancing New Standards in Reproductive Health (ANSIRH) at the University of California San Francisco (UCSF), the Center on Reproductive Health, Law, and Policy at the University of California Los Angeles School of Law (CRHLP), and the law firm Paul, Weiss, Rifkind, Wharton & Garrison filed the accompanying amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case concerning access to mifepristone, one of the two drugs commonly used in medication abortion.

SUMMARY OF THE CASE

Medication abortion accounts for nearly two-thirds of all abortions across the US¹ and its safety has been rigorously tested.^2-4 Despite mifepristone's 24-year record of safety and effectiveness, anti-abortion doctors and organizations (referred to collectively herein as Alliance for Hippocratic Medicine, or AHM) filed suit in federal district court in Texas in November 2022,⁵ challenging the US Food and Drug Administration's (FDA) original approval of mifepristone in 2000,⁶ and FDA's 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label.^{7, 8} The challenged modifications included FDA's 2021 decision to remove the requirement that mifepristone be dispensed only in person in clinics, medical offices, and hospitals and FDA's 2016 decision to extend the gestational limit to 70 days, modify the dosing regimen, reduce the number of recommended in-person visits, and allow healthcare providers with prescriptive authority under state law (such as nurse practitioners, nurse midwives, and physician assistants) to become certified prescribers of mifepristone.^{7, 8}

In its complaint, Alliance for Hippocratic Medicine argued that FDA's decisions were based on insufficient evidence and harmed their members, who could potentially be required to treat individuals who take mifepristone, experience complications, and seek emergency care.³ They sought a preliminary injunction ordering FDA to suspend its original approval of mifepristone and its subsequent decisions increasing access to mifepristone.⁵

In response, FDA and the drug's manufacturer, Danco Laboratories, L.L.C. (Danco), argued that FDA reviewed more than sufficient evidence of mifepristone's safety and effectiveness in issuing the drug's original approval and in modifying its REMS Program and label in 2016 and 2021.^{9, 10} FDA and Danco also argued that the doctors and organizations within AHM—who did not prescribe mifepristone and had never been forced to provide emergency care for someone experiencing adverse events after mifepristone use—did not meet the requirements to establish standing, a legal concept which requires anyone bringing a federal lawsuit to demonstrate that they have suffered a concrete, non-speculative harm.^{9, 10}

The district court granted AHM's motion, suspending authority for FDA's 2000 approval of mifepristone, and its 2016 and 2021 decisions.³ The effects of this decision were temporarily stayed by the US Supreme Court while FDA and Danco appealed.¹¹ On appeal, the Fifth Circuit Court of Appeals upheld the district court's conclusions related to FDA's 2016 and 2021 decisions, but reversed as to mifepristone's original approval in 2000, concluding that challenge was likely barred by the statute of limitations.¹²

All parties petitioned for writ of certiorari in the US Supreme Court—FDA and Danco asked the Court to review whether AHM had standing and the Fifth Circuit's decision suspending authority for FDA's 2016 and 2021 actions,^{13, 14} and AHM asked the Court to review the Fifth Circuit's decision related to the initial 2000 approval of mifepristone.¹⁵ The Court granted only FDA's and Danco's petitions.^{13, 14, 16} As a result, FDA's 2000 approval of mifepristone was not under review. Instead, the Supreme Court's review was limited to whether AHM had standing to bring this case and, if they did, whether they were likely to prevail in their challenges to FDA's 2016 and 2021 decisions.

SUMMARY OF THE AMICUS BRIEF

Many individuals and organizations submitted amicus curiae (“friend of the Court”) briefs to provide the Court with perspectives and expertise relevant to its decision. ANSIRH, CRHLP, and Paul, Weiss, Rifkind, Wharton & Garrison filed the accompanying amicus brief on behalf of over 300 leading reproductive health researchers from the US and worldwide to identify and summarize the key studies relevant to the safety and effectiveness of mifepristone and the changes before the Court. While AHM argued that mifepristone is unsafe and FDA's regulatory decisions were not supported by adequate scientific evidence, the amicus brief detailed how FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of these changes. In contrast, two studies that were relied on by the district court to find that mifepristone was unsafe were recently retracted by the journals in which they were published for undisclosed conflicts of interest and methodological issues.^{17, 18} The amicus brief urged the Supreme Court to rely on the clear scientific record and reverse the Fifth Circuit's decision, preserving access to mifepristone without reimposing restrictions.

SUMMARY OF THE ORAL ARGUMENT

Oral argument in the case was held March 26, 2024.¹⁹ At argument, the justices primarily focused on standing, appearing skeptical that AHM had demonstrated any injury given that no member doctor had been required to treat a patient experiencing a rare serious adverse event over their objection. The justices also questioned whether AHM's alleged harm was traceable to FDA's 2016 and 2021 actions and whether AHM sought the appropriate remedy—a nationwide injunction reimposing unnecessary restrictions on mifepristone—where existing federal conscience protections would remedy the individual doctors' alleged harm. Attorneys for the Government and Danco also highlighted the strength of the evidentiary record before FDA, and in response to questioning and AHM's argument, stressed that the scientific record before FDA included studies considering multiple 2016 changes in combination. The risks of court interference with agency expertise were also discussed: the justices raised concerns about courts parsing medical and scientific studies, and Danco's attorney argued that plaintiffs' arguments “would upend not just Mifeprex but virtually every drug approval and REMS modification FDA has made for decades.”¹⁹

SUMMARY OF THE COURT'S DECISION

On June 13, 2024, the Supreme Court issued its decision reversing the Fifth Circuit on the basis that AHM did not have standing to challenge FDA's 2016 and 2021 decisions.²⁰ This ruling means that FDA's 2016 and 2021 regulations affecting access to mifepristone remain unchanged for now, permitting dispensing of mifepristone via telehealth, by providers with prescriptive authority under state law, and outside of hospital or clinical settings. It also means that the drug label will continue to recommend the 70-day gestational limit and updated dosing regimen.

However, the challenge to FDA's 2016 and 2021 decisions related to mifepristone has not been conclusively resolved. Because the Supreme Court decided the case based on AHM's lack of standing, the Court did not reach the merits of AHM's claim that FDA's decisions were based on insufficient evidence. The states of Idaho, Kansas, and Missouri have intervened in the district court, and it is possible the challenge to FDA's decisions could continue with the states as parties at the district court in this case. Alternatively, these states or new parties could file a new case advancing similar claims. The outcomes of such cases will affect the landscape of mifepristone and abortion access across the country.