The American Civil Liberties Union (ACLU) and the ACLU of Hawaii filed a lawsuit to challenge a U.S. Food & Drug Administration (FDA) restriction that severely limits where a woman can get the abortion pill, a safe and effective method of ending an early pregnancy. Currently, a patient may not fill a prescription for this medication at a retail pharmacy, which delays, and in some cases prevents, a woman’s access to abortion.
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, also known as REMS, because it places restrictions on where a woman may receive the abortion pill (Mifeprex®). 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.
This lawsuit comes more than a year after the landmark Supreme Court decision in Whole Woman’s Health v. Hellerstedt, which emphasized that health regulations must in fact serve patient health and cannot burden access to abortion without proof of a valid medical justification.
A REMS is a set of restrictions that the FDA may impose only when necessary to ensure that a drug’s benefits outweigh its risks. Plaintiffs argue that the FDA’s restrictions on medication abortion are not medically justified and therefore fail that test.
The FDA mandates that, rather than fill a prescription for Mifeprex at a retail pharmacy, 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 she 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.
Numerous studies and 17 years of clinical data confirm that the abortion pill is a safe, effective medication, and 3 million women in the United States have used this method to end an early pregnancy (up to 10 weeks) in their own homes and on their own terms. Leading medical associations—including the American College of Obstetricians and Gynecologists—support ending the REMS and making the abortion pill available at the pharmacy by prescription.
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.