The American Civil Liberties Union (ACLU) [advocacy website] filed a lawsuit [complaint] in the US District Court for the District of Hawaii [official website] Tuesday against the US Food and Drug Administration (FDA) [official website] related to regulations for the administration of the abortion pill Mifeprex. The pill enables a person to end a pregnancy up to 10 weeks.

The FDA restrictions do not allow an individual with a prescription for Mifeprex to be obtain it from a retail pharmacy. Instead, Mifeprex can only be obtained from a clinic, medical office, or hospital “under the supervision of a health care provider who has registered with the drug manufacturer, attested to their ability to safely prescribe Mifeprex, and then arranged to order and stock Mifeprexin their health care facility.”

The restrictions are in place due to the drug being subject to a Risk Evaluation and Mitigation Strategy with Elements to Assure Safe Use. These restrictions are imposed by the FDA when “necessary because of the ‘inherent toxicity or potential harmfulness’ of a drug.” The ACLU notes that there are several other prescription abortion drugs which are not subject to these requirements.

The ACLU argues that the restrictions do not improve the health or safety of patients who have already received a prescription for Mifeprex. They also argue that the restrictions impose a significant burden on women in rural and medically undeserved areas who have to travel farther distances to reach an approved facility and that this causes psychological burdens that would otherwise not be experienced. In some cases, the complaint states that the burdens could force some individuals to instead carry the pregnancy to term. The ACLU argues that the benefits of the burdens of the requirements do not outweigh the harms imposed on the patient.

Abortion rights in the US have been a heavily contested topic for many years. In September, Illinois enacted [JURIST report] a law which removed many restrictions on the funding of abortions. In June the Supreme Court of Georgia ruled [JURIST report] that the state was immune from litigation regarding a lawsuit challenging a 20-week abortion ban law. Also in June the Delaware legislature approved [JURIST report] a bill guaranteeing abortion access and lifting any restrictions on abortions prior to the stage where a fetus reaches viability. The Delaware bill was signed [Bill Status] into law by Delaware’s Governor on June 8.