红杏视频

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� Approximately 7.5 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.

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�

On October 30, 2025 a federal district court granted Plaintiffs鈥� Motion for Summary Judgment, ruling that FDA鈥檚 2023 REMS decision violated federal law. While this ruling does not change patients鈥� ability to access medication abortion in the near term, it affirms the FDA鈥檚 legal obligation to consider the overwhelming evidence of mifepristone鈥檚 safety and not to impose restrictions that unduly burden patient access to this essential medication. The court's finding that the agency failed to justify its restrictions on access to mifepristone comes as the Trump administration appears to be gearing up to make it even harder for people to get the medication nationwide. Under the Court鈥檚 ruling, FDA will need to consider the wealth of peer-reviewed evidence proving mifepristone鈥檚 safety, including when delivered by telemedicine, as well as how FDA鈥檚 restrictions burden patient access.

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 红杏视频, the 红杏视频 of Hawaii, and Arnold & Porter Kaye Scholar LLP.