Lawsuit Seeks REMS Removal on Mifepristone
Washington attorney general Bob Ferguson and Oregon attorney general Ellen Rosenblum are leading a multistate lawsuit against FDA accusing it of singling out one (mifepristone) of the two drugs used for medication abortions through “excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol,” the officials announced 2/24. The lawsuit comes as a federal judge in Texas is nearing a decision in a separate case brought by anti-abortion groups that seek a reversal of FDA’s mifepristone approval.
The lawsuit contends that FDA-placed Risk Evaluation and Mitigation Strategies (REMS) restrictions on prescribing and dispensing mifepristone “are unduly burdensome, harmful and unnecessary, and expose providers and patients to unnecessary privacy and safety risks,” they say. “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.”
The lawsuit notes that the regimen for medication abortion involves a dose of mifepristone, followed by a dose of misoprostol. To prescribe mifepristone, the REMS requires health care providers to be 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,” the state officials argue. “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 says that “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 — even when the care is legal in Washington.”
The lawsuit is asking the court to find the REMS restrictions unlawful and to stop FDA from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains available to those seeking its use.