The American Civil Liberties Union (ACLU), the ACLU of Hawaii, and Arnold & Porter Kaye Scholar LLP, are challenging a U.S. Food & Drug Administration (FDA) restriction that severely limits where and how patients can access mifepristone, a safe and effective medication used for early abortion and miscarriage care.
The federal lawsuit, brought on behalf of a Hawaii doctor and several professional health care associations, challenges the constitutionality of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, because it severely restricts access to abortion care with no medical basis, imposing particularly significant burdens on low-income patients, people of color, and people living in rural areas. Plaintiffs also argue that the REMS restrictions violate the federal Administrative Procedure Act, because the FDA acted arbitrarily and exceeded the strict limits Congress established for REMS programs.
Numerous studies and more than 20 years of clinical data confirm that mifepristone is a safe, effective prescription medication, which patients have used for decades to end an early pregnancy in the privacy and comfort of home. As the FDA acknowledges, mifepristone’s “safety … [is] well-established by both research and experience.” Nevertheless, the FDA unlawfully subjects mifepristone to a REMS—a set of restrictions beyond the drug’s labeling that Congress permits FDA to impose only when necessary to ensure that a drug’s benefits outweigh its risks. Leading medical associations—including the American Medical Association and the American College of Obstetricians and Gynecologists—support lifting the REMS restrictions.
The centerpiece of the REMS is a requirement that patients be handed the medication at a clinic, medical office, or hospital from a health care provider who has pre-registered with the drug manufacturer and arranged to order and stock the abortion pill in their health care facility. For a variety of reasons, many clinicians across the country are unable to satisfy these requirements—leaving patients with no option but to seek this care elsewhere, if they can obtain it at all.
Moreover, the FDA requires patients to obtain mifepristone in person at a health center even when they have already received all evaluation and counseling via telemedicine—and even though patients are free to self-administer the mifepristone tablet, unsupervised, at the location of their choice. Of more than 20,000 FDA-approved drugs mifepristone is the only one the FDA requires patients to pick up in a clinical setting even though they do not have to take it under clinical supervision. (The FDA has temporarily suspended this in-person requirement during the COVID-19 Public Health Emergency, prompted by separate ACLU litigation).
The REMS requirements force patients to engage in needless and burdensome travel. For instance, Plaintiff Dr. Chelius’s patients live on the island of Kauaʻi and must make a 300-mile round trip flight to another island to access the abortion pill, or any abortion care. This requirement delays a patient’s abortion – typically by weeks – while they arrange and pay for transportation, time off work, and child care. This delay pushes some patients past the point at which they can use this early medication method; others cannot access abortion care at all.
Plaintiffs argue that the REMS restrictions violate their patients’ and members’ rights to liberty, privacy and equal protection as guaranteed by the U.S. Constitution by imposing significant burdens on abortion access without proof of a valid medical justification. Plaintiffs further argue that the REMS restrictions violate the federal Administrative Procedure Act.
Plaintiffs seek declaratory relief to hold the REMS regulations unconstitutional and injunctive relief prohibiting Defendants from requiring a REMS for mifepristone.
The Plaintiffs in this litigation are Dr. Chelius, 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