Feb. 24, 2023
Lawsuit accuses the FDA of ignoring more than a quarter century of science showing that mifepristone is extremely safe
Carson City, NV – Today, Attorney General Ford announced that Nevada has joined a multistate federal lawsuit against the Food & Drug Administration accusing it of singling out one of two drugs used in medication abortions for excessively burdensome regulation, despite ample evidence that the drug, mifepristone, is safer than Tylenol.
This lawsuit, which asserts the FDA exceeded its authority and violated the constitutional principle of equal protection, asks the court to find the FDA’s current restrictions on mifepristone unlawful and to bar the federal agency from enforcing or applying them to mifepristone. The attorneys general also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.
“While our country continues to grapple with the fact that abortion rights were stripped away from many Americans, we must stand against actions that would further restrict this right,” said AG Ford. “The FDA’s regulations regarding mifepristone do not protect those seeking abortions, but they do make reproductive health care harder to access.”
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, such as opioids like fentanyl and high-dose sedatives used by psychiatric patients.
The FDA itself has acknowledged that “serious complications have proven to be extremely rare” with mifepristone. In the lawsuit, the attorneys general note that mifepristone is associated with fewer serious side effects and deaths than common drugs like Tylenol or Viagra — neither of which are regulated under REMS restrictions. In fact, according to the FDA, zero deaths can be attributed to mifepristone during its entire history of use in the United States.
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, 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 restrictions on prescribing and dispensing mifepristone are unduly burdensome, harmful and unnecessary, and expose providers and patients to unnecessary privacy and safety risks. The risks are exacerbated by the growing criminalization and penalization of abortion 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 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, could expose them to violence, harassment or abuse. This documentation may also be used to threaten providers or patients with legal liability in states with extreme anti-abortion laws.
While safeguards exist to protect the privacy of medical records, the patient agreement documentation required by the FDA creates an added risk for patients who travel for medical treatment from states where their abortion is illegal. The documentation of their abortion remains in their medical records and can be viewed by providers in their home state. In addition, health care providers who may move to other states in the future to practice might think twice about completing a certification to prescribe mifepristone, as it may expose them to liability or professional consequences in the future.
The lawsuit, 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. Alongside Washington, Oregon and Nevada, the attorneys general of Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, New Mexico, Rhode Island and Vermont also joined the lawsuit.
Download a copy of the filed complaint and motion for preliminary injunction.