Ferguson urges federal judge to unravel restrictions on mifepristone

Washington leads coalition of 18 AGs to force FDA to open up access to abortion drug

SPOKANE - Attorney General Bob Ferguson is urging a federal judge in Spokane to rule that the Food & Drug Administration's severe restrictions on the abortion medication mifepristone are unlawful, and order the federal agency to go back to the drawing board on regulating the drug.

Ferguson and Oregon Attorney General Ellen Rosenblum are co-leading the multistate lawsuit filed last year in the U.S. District Court for the Eastern District of Washington. Judge Thomas O. Rice already granted Ferguson's request for a preliminary injunction in April of 2023, barring the FDA from doing anything to reduce the availability of the medication abortion drug mifepristone in Washington, 16 other states and the District of Columbia.

In his ruling granting Ferguson's request for a preliminary injunction, Judge Rice found that the FDA likely did not follow the requirements in the law when it placed the severe restrictions on mifepristone.

Ferguson's summary judgment motion, filed late Thursday, asks the judge to decide the case without a trial. The FDA is well aware of decades of data conclusively showing that mifepristone is safe and effective, and that medical experts have long opposed the FDA's restrictions on the drug. By keeping the restrictions on mifepristone, Ferguson argues that the FDA is unnecessarily and unlawfully limiting access to a drug that is safer than Tylenol, Viagra and insulin.

"We are continuing to fight for reproductive freedom, including access to mifepristone," Ferguson said. "The FDA must remove its unnecessary and unlawful restrictions on this safe and effective medication. Attacks on scientifically proven abortion medication won't cease, but we will keep fighting for the right to access mifepristone in Washington."

"Mifepristone is a very safe drug, yet the FDA makes it unnecessarily difficult for people who need it to get it," Rosenblum said. "The restrictions (REMS) simply are not medically necessary. In fact, they put patients at risk. We believe the real motive for them is political, rather than scientific, and we don't believe there is a genuine argument about that. As a result, we are asking a federal judge to invalidate the misguided and paternalistic restrictions imposed by the FDA. I am proud to fight alongside other Attorneys General protecting access to medications that are necessary for true reproductive freedom."

The preliminary injunction in Ferguson's case came on the same day that a judge in Texas stayed the FDA's approval of mifepristone. The U.S. Supreme Court unanimously overturned the Texas ruling earlier this year in Food & Drug Administration v. Alliance for Hippocratic Medicine. Ferguson's case has proceeded in federal court in Washington while the Texas case was appealed up to the Supreme Court.

In addition to Washington and Oregon, attorneys general for Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Pennsylvania, Rhode Island, Vermont and Washington, D.C. joined the case.

Case Background

Ferguson's lawsuit accuses the FDA of singling out mifepristone - one of the two drugs used for medication abortions - for excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol.

Approximately 60% of the abortions in Washington state are medication abortions.

The lawsuit is one of Ferguson's 11 cases filed against the Biden administration. Of those cases, Ferguson's office has six legal victories and has yet to lose a case.

Of the more than 20,000 drugs approved by the FDA, only 73 - including mifepristone - have extra restrictions known as a Risk Evaluation & Mitigation Strategy, or REMS. An even smaller subset of drugs, including mifepristone, carry additional restrictions known as Elements to Assure Safe Use (ETASU), which are supposed to be reserved for high-risk drugs, including certain risky cancer drugs 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. 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 with the drug distributor before they can fill a prescription. Moreover, prescribers must send their certification form to every pharmacy to which they send a mifepristone prescription - an administratively burdensome requirement that is unique to mifepristone.

Ferguson's lawsuit asserts the restrictions on prescribing and dispensing mifepristone are unduly burdensome, harmful and unnecessary, reduce access to a critically important drug, 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 health care providers, patients and pharmacies 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.

Restrictions reduce access to care, endanger providers & patients

The FDA's restrictions on mifepristone reduce access to health care and create unnecessary risk for Washington state medical providers, patients and people who travel to the state to receive abortion care.

While safeguards exist to protect the privacy of medical records, the patient agreement documentation required by the FDA creates an added risk for patients - particularly for those patients who travel to Washington for medical treatment from states where abortion is illegal. The documentation of their abortion remains in their medical records, and there is a risk it could be viewed by providers in their home state.

Abortion providers have also been targets for hackers seeking to steal information about both patients and providers. In 2021, for example, hackers accessed the data of roughly 400,000 patients from Planned Parenthood Los Angeles. Providers in Washington report frequent cyberattacks aimed at illegally obtaining information about patients and providers. This is especially concerning because abortion providers and patients can be targeted for harassment and extremist violence. The extra documentation required by the mifepristone REMS exacerbates these risks and, moreover, discourages many qualified providers from prescribing the drug.

The FDA's strict requirements also hamper access to safe reproductive care. The stigma and administrative burdens associated with becoming "specially certified" to prescribe and dispense an abortion medication deters many health care providers and pharmacies from signing up to do so in the first place. The certification requirement for providers and pharmacists also opens them up to potential liability if they serve patients from other states like Idaho that have restrictive abortion laws, even if the provider is in full compliance with Washington law.

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.

Keeping the REMS restrictions in place unnecessarily impedes access to abortion care in the parts of our state where reproductive health care is already difficult to obtain. For example, access to abortion care is already an issue in eastern Washington, which is why Ferguson filed the lawsuit in the Eastern District court. In addition to disproportionately impacting rural communities, this burden is especially harsh for patients whose access to health care is already diminished by poverty, language barriers, lack of transportation, racial discrimination or other factors.

Without the unnecessary REMS restrictions, any qualified health care provider would be able to prescribe mifepristone - just as they can for any other prescription drug, including high-risk drugs such as opioids.

Solicitor General Noah Purcell, First Assistant Attorney General Kristin Beneski, Wing Luke Civil Rights Division Chief Colleen Melody, Deputy Solicitor General Tera Heintz and Assistant Attorneys General Andrew Hughes and Lauryn Fraas, Paralegal Jennah Williams and Legal Assistant Jessica Buswell are handling the case for Washington.

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