Lopez joins effort to safeguard access to abortion medication mifepristone in Hawaiʻi

Hawaiʻi Attorney General Anne Lopez is urging a federal judge in Spokane, Washington, to rule that the US Food and Drug Administration’s restrictions on the abortion medication mifepristone are inconsistent with the Administrative Procedure Act, and order the federal agency to create new, less restrictive regulations around the common abortion medication.

Attorney generals from 17 plaintiff states, including Hawaiʻi, recently filed the motion for summary judgment to push for a resolution to an on-going lawsuit, which was filed last year in the US District Court for the Eastern District of Washington. In the motion, the attorney generals argue that FDA regulations for mifepristone unnecessarily and unlawfully limit access to a medication, despite the fact the drug was approved more than 20 years ago and is considered highly safe and effective.

“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,” said Hawaiʻi Deputy Attorney General Erin Lau.

Of the more than 20,000 drugs approved by the FDA, only 73 drugs have extra restrictions known as a Risk Evaluation and Mitigation Strategy (REMS), including highly addictive drugs such as Oxycontin. An even smaller subset of drugs carries additional restrictions known as Elements to Assure Safe Use (ETASU), including certain risky cancer drugs and high-dose sedatives. Mifepristone has both a REMS and an ETASU restriction.

Although the REMS and ETASU restrictions have been relaxed over time, certain restrictions remain. To prescribe mifepristone, health care providers must be specially certified by the drug distributor and submit their certification form to every pharmacy to which they send a mifepristone prescription—an administratively burdensome requirement that is unique to mifepristone. The pharmacy must also be specially certified with the drug distributor before it can dispense a prescription.

To receive the prescription, the patient and their provider must sign an agreement that certifies the patient has decided to take the medication to end the pregnancy—regardless of whether they are seeking an abortion or are being treated for a miscarriage, which is a common use for mifepristone. The motion argues that these requirements are excessive when considering mifepristone’s safety profile.

The restrictions on prescribing and dispensing mifepristone come amid state laws to criminalize and penalize for abortions in the wake of the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. The Dobbs case overturned a half-century of precedent, stripping away the constitutional right to abortion recognized by the Court’s Roe v. Wade decision.

The plaintiff states summary judgement motion seeks to require the FDA to review whether mifepristone still meets the statutory requirements to impose a REMS with ETASU restriction based on its safety profile. The motion argues that decades of data conclusively show that mifepristone is safe and effective, and that medical experts have long opposed the FDA’s restrictions on the medication. By keeping the restrictions on mifepristone, the states argue that the FDA is unnecessarily and unlawfully limiting access to a medication that is safer than Tylenol, Viagra and insulin.

Along with Attorney General Lopez, attorneys general for Arizona, Colorado, Connecticut, Delaware, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, Washington and Washington, D.C. joined the case.