Attorney General Anne Lopez is calling on a federal judge in Spokane, Washington, to rule against the U.S. Food and Drug Administration's (FDA) restrictions on mifepristone, an abortion medication. The request is part of a multistate lawsuit claiming that these restrictions violate the Administrative Procedure Act.
Hawaiʻi Deputy Attorney General Erin Lau stated, "Since 2000, more than 5.6 million patients have safely used mifepristone. We should not be afraid to increase access to a medication whose safety and efficacy is based in science and proven over time. Artificial limitations on safe and effective medication are actual limitations on access to healthcare."
The lawsuit was filed last year in the U.S. District Court for the Eastern District of Washington by 17 states, including Hawaiʻi, along with the District of Columbia.
Mifepristone is one of only 73 drugs subject to extra FDA restrictions known as Risk Evaluation and Mitigation Strategy (REMS). Additionally, it has further restrictions called Elements to Assure Safe Use (ETASU), which are typically reserved for riskier medications like certain cancer drugs.
Despite some relaxation over time, specific requirements remain for prescribing mifepristone. Health care providers must obtain special certification from the drug distributor and submit this certification to every pharmacy where they send prescriptions for mifepristone—a requirement unique to this drug. Pharmacies must also be certified before dispensing it.
Patients must sign an agreement with their provider confirming their decision to use mifepristone for ending a pregnancy or treating a miscarriage—common uses for the drug. The lawsuit argues these requirements are excessive given mifepristone's safety record.
The plaintiff states contend that these restrictions are overly burdensome and unnecessary, limiting access to an important medication while exposing providers and patients to privacy risks amid increasing criminalization of abortion following the Supreme Court's decision in Dobbs v. Jackson Women’s Health Organization.
A motion for summary judgment has been filed by the plaintiff states asking the FDA to review whether mifepristone still requires REMS with ETASU based on its safety profile. The motion argues that extensive data demonstrate mifepristone's safety and effectiveness and criticizes ongoing FDA restrictions as unnecessary compared to other medications like Tylenol or Viagra.
Attorneys general from Arizona, Colorado, Connecticut, Delaware, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, Washington state joined Attorney General Lopez in this legal action.