In October 2017, the American Civil Liberties Union filed suit on behalf of a Hawai‘i doctor and several professional health care associations to challenge federal restrictions that significantly limit access to medication abortion.
The federal lawsuit filed in the U.S. District Court for the District of Hawaii challenges FDA restrictions (known as a Risk Evaluation and Mitigation Strategy or REMS) on where a woman may receive the abortion pill Mifeprex, a safe and effective method of ending an early pregnancy up to 10 weeks. Currently, a patient may not fill a prescription for this medication at a retail pharmacy, which delays and in some cases blocks entirely a woman’s access to abortion. Plaintiffs argue that the REMS restrictions impose significant burdens on women seeking abortion with no medical basis, violating federal constitutional guarantees of privacy and equal protection.
The FDA mandates that, rather than fill a prescription for Mifeprex at a retail pharmacy like people do for most drugs, the patient must 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 a patient with no option but to seek this care elsewhere, if they can obtain it at all. These restrictions harm and burden patients, particularly those in rural and medically underserved areas.
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 woman’s abortion – typically by weeks – while she arranges and pays for transport, time off work, and child care. This delay pushes some women past the point at which they can use this early medication method; others cannot access abortion care at all.
At a time when access to abortion care at a clinic is increasingly limited and sometimes hundreds of miles away, making medication abortion available by prescription at a pharmacy would offer women who cannot get to a clinic a safe option for ending a pregnancy at home.
Plaintiffs include Dr. Chelius, Society of Family Planning, California Academy of Family Physicians, and Pharmacists Planning Services Inc. They are represented by attorneys with the ACLU and the ACLU of Hawaii.
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 Mifeprex.