by Amanda Barrow, Cathren Cohen, Jaclyn Serpico, Melissa Goodman, Daniel Grossman, Sarah Raifman, Ushma Upadhyay
Perspectives on Sexual and Reproductive Health, Comment: 29 July 2024. Free access
Abstract
On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case concerning the regulatory status of mifepristone, one of two drugs used in medication abortion. In this Comment we summarize the legal challenge, responses from the FDA and drug manufacturer to these challenges, oral arguments presented before the Court, and the implications of the Court’s decision on access to mifepristone in the US. We also summarize the content of the accompanying amicus brief.
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 US and its safety has been rigorously tested. 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, challenging the US Food and Drug Administration’s (FDA) original approval of mifepristone in 2000, and FDA’s 2016 and 2021 decisions modifying mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) Program and label. 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.
In its complaint, Alliance for Hippocratic Medicine (AHM) 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….
[After a great deal of legal dealing…the Supreme Court decided that ] 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 Supreme 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. 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.