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This federal lawsuit, brought on behalf of a Hawaii doctor and several professional health care associations, challenges the lawfulness of the FDA鈥檚 Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, a safe and effective medication used in nearly two-thirds of U.S. abortions and for miscarriage management.

The 鈥� including the American Medical Association and the American College of Obstetricians and Gynecologists 鈥� support lifting the mifepristone REMS restrictions. While all drugs have risks, these medical authorities have that 鈥渕ifepristone is not just safe 鈥� it is far safer than countless other medications and among the safest medications or devices approved by FDA and being used in medical practice.鈥� Nearly 6 million people in the United States have used mifepristone since the FDA first approved it in 2000, and the FDA has found that serious complications occur in fewer than one percent of patients. As these leading medical groups make clear, mifepristone is safer than Viagra, safer than penicillin, and as safe as Advil.

Nevertheless, the FDA unlawfully subjects mifepristone to a REMS 鈥� a special set of restrictions above and beyond the normal layers of protections that apply to virtually every other prescription drug.

In April 2021, (then called Chelius v. Becerra), the FDA agreed to undertake a comprehensive review of the mifepristone REMS.

In January 2023, the FDA issued an updated REMS. While the agency eliminated one key aspect of the restrictions 鈥� a requirement that all patients travel to a hospital, clinic, or medical office just to pick up their pill, even when they have already been thoroughly counseled and evaluated through telemedicine 鈥� the FDA maintained the REMS program overall, including requirements that mifepristone prescribers and pharmacies be specially certified and that patients review a special counseling form.

The 2023 REMS continues to significantly impede patients鈥� access to mifepristone 鈥� including by (1) creating administrative hurdles for clinicians seeking to integrate mifepristone into their health care systems that delay or altogether derail their efforts to provide this care; (2) requiring clinicians to register as mifepristone prescribers with the drug manufacturer and/or each pharmacy to which they send mifepristone prescriptions, deterring some qualified health care providers who fear anti-abortion violence and harassment if their registration were ever exposed; (3) deterring pharmacies from dispensing mifepristone because of the burdens of certification; (4) impeding research and training on mifepristone at academic institutions because of stigma arising from a REMS classification; (5) undermining the informed consent process and provider-patient relationship by mandating counseling that is at best duplicative 鈥� and often inaccurate, confusing, and distressing; and (6) jeopardizing mifepristone patients鈥� privacy by requiring them to sign and take with them a form stating 鈥淚 have decided to ... end my pregnancy.鈥�

Plaintiffs argue that the FDA鈥檚 decision to maintain a REMS for mifepristone violates the Equal Protection Clause of the U.S. Constitution and the federal Administrative Procedure Act, because the FDA is irrationally singling out mifepristone for restrictions that the agency does not impose on other comparably or less safe drugs; declined to consider certain evidence proving that the mifepristone REMS is unnecessary and harmful; and exceeded the strict limitations that Congress has imposed on the agency鈥檚 authority to burden access to an approved medication through a REMS program.

The current plaintiffs in this litigation are Dr. Heidi Purcell, the Society of Family Planning, and the California Academy of Family Physicians. They are represented by attorneys with the ACLU, the ACLU of Hawaii, and Arnold & Porter Kaye Scholar LLP.