Attorney General Phil Weiser joins multistate FDA lawsuit over unlawful, unnecessary restrictions on medication abortion drug

Feb. 24, 2023 (DENVER)—Attorney General Phil Weiser has joined a multistate federal lawsuit against the U.S. Food and Drug Administration, accusing it of singling out one of the two drugs used for medication abortions and the management of miscarriages for excessively burdensome regulation.

The lawsuit was filed in U.S. District Court for the Eastern District of Washington. Oregon, Nevada, Delaware, Arizona, Illinois, Connecticut, Vermont, New Mexico, Michigan, Rhode Island, and Washington also joined the lawsuit. The attorneys general also asked the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.

“The level of attacks on reproductive rights and access to reproductive health care must be met with vigilance. We will continue to fight for women’s access to medication abortions and effective treatment of miscarriages. This action is designed to protect those rights, and ensure that they are not impeded,” Weiser explained.

Of the more than 20,000 drugs approved by the FDA, only 60 — including mifepristone — fall under a unique set of restrictions known as Risk Evaluation & Mitigation Strategies, or REMS. REMS restrictions are supposed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others.

To prescribe mifepristone, health care providers must be specially certified by the drug distributor in advance. To receive the prescription, patients and providers must sign an agreement that certifies the patient has decided to take the drugs to end their pregnancy — regardless of whether they are seeking an abortion or are being treated for a miscarriage, which is another common use for mifepristone. A copy of this agreement must be included in the patient’s medical records. To dispense mifepristone, pharmacies must also be specially certified before they can fill a prescription.

The lawsuit asserts the level of restrictions placed on the prescribing and dispensing of mifepristone are unduly burdensome, harmful, and unnecessary, and expose providers and patients to unnecessary risks. These risks are exacerbated by the growing criminalization and penalization of abortion care around the country in the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health. The Dobbs case overturned nearly a half-century of precedent, stripping away the constitutional right to abortion care recognized by the court’s Roe v. Wade decision.

Disclosure of a provider’s or pharmacy’s certification to prescribe mifepristone, or a patient’s agreement to receive it, all required by the FDA, risks exposing them to violence, harassment, or abuse. This documentation also could be used to threaten providers or patients with legal liability in states with extreme anti-abortion laws.

Since its FDA approval in 2000, mifepristone has been safely used in the U.S. for medication abortions. Despite mifepristone’s strong safety record, the FDA has declined to remove the REMS restrictions on the medication. The lawsuit asks the court to find the FDA’s REMS restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains accessible to patients as a safe and effective drug for abortion care and the management of miscarriages.

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