WASHINGTON – Washington State Attorney General Bob Ferguson has announced he is leading a multi-state lawsuit against the Food and Drug Administration (FDA) over restrictions placed on mifepristone, one of the two drugs used for medication abortions.
The lawsuit, co-led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum, was filed in U.S. District Court for the Eastern District of Washington. Nevada, Delaware, Arizona, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan and Rhode Island also joined the lawsuit.
Ferguson’s lawsuit asserts that the FDA exceeded its authority by “continuing its unnecessary and extremely burdensome restrictions on mifepristone.” Ferguson also asserts that the FDA’s actions violate the constitutional principle of equal protection.
“The federal government has known for years that mifepristone is safe and effective,” Ferguson said. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”
Ferguson also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.
According to Ferguson’s office, nearly 60% of the abortions in Washington state are medication abortions.
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.
The FDA-approved regimen for medication abortion involves a dose of mifepristone, followed by a second drug, misoprostol. 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.
