Other LanguagesInjunction bars FDA from reducing the availability of the drug in states that joined Ferguson’s lawsuit
SPOKANE — Attorney General Bob Ferguson announced today that a federal judge in Spokane barred the Food & Drug Administration (FDA) from doing anything to reduce the availability of the medication abortion drug mifepristone in Washington, 16 other states and the District of Columbia. The states sued the FDA over access to the drug.
The ruling in Ferguson’s case came on the same day that a judge in Texas stayed the FDA’s approval of mifepristone. The Texas order is not currently in effect because it gives the FDA a week to appeal. The preliminary injunction in Ferguson’s case, granted by U.S. District Court Judge Thomas O. Rice, preserves access to mifepristone in the states who sued, and takes effect immediately.
Ferguson and Oregon Attorney General Ellen Rosenblum are co-leading the lawsuit filed in February in U.S. District Court for the Eastern District of Washington.
“Today’s ruling will preserve vital access to mifepristone while our case continues,” Ferguson said. “Mifepristone is scientifically proven to be safe and effective after more than 20 years of use in the United States. Attacks on reproductive freedom will continue, but we will continue to fight for the right to access mifepristone in Washington.”
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.
Nearly 60% of the abortions in Washington state are medication abortions.
The lawsuit is Ferguson’s tenth case filed against the Biden administration. Of those cases, Ferguson’s office has five legal victories and has yet to lose a case.
Of the more than 20,000 drugs approved by the FDA, only 60 — including mifepristone — have extra restrictions known as a Risk Evaluation & Mitigation Strategy, or REMS. Mandatory REMS restrictions, known as Elements to Assure Safe Use (ETASU), are supposed to be reserved for 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. 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 — a requirement that does not apply to any other drug.
Ferguson’s 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 health care providers 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 endanger Washington providers and patients
The FDA’s restrictions on mifepristone 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 cyber attacks 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.
The FDA’s strict requirements also hamper access to safe reproductive care. The certification requirement for providers and pharmacists 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. And the administrative burdens associated with becoming “specially certified” deter health care providers and pharmacists from signing up to prescribe and dispense mifepristone in the first place.
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.
Access to abortion care is already an issue in eastern Washington, which is why Ferguson filed the lawsuit in the Eastern District court. Of the 20 eastern Washington counties, only nine have abortion providers. Even the student medical center at Washington State University has no REMS-certified providers, and its campus pharmacy is also not certified to dispense mifepristone. But for 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 inherently dangerous drugs like opioids.
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. In addition to disproportionately impacting rural communities, this burden is especially harsh for patients whose access to healthcare is already diminished by poverty, language barriers, lack of transportation, racial discrimination or other factors.
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.
Efforts to protect access to reproductive care
In February, Ferguson partnered with 21 other attorneys general to file a friend of the court brief in a case in federal court in Texas defending the FDA’s original approval of mifepristone. The case, filed in November of 2022 by four doctors and several anti-abortion medical associations, seeks to overturn the FDA’s decades-old approval of the drug. Today, the judge in that case stayed the FDA’s approval of mifepristone, but gave the federal government time to file an appeal before his ruling goes into effect.
In their brief, the states argue that mifepristone has been proven to be safe and effective, and is critical to protecting the health, safety and rights of their residents to have safe access to essential reproductive health care.
Also in February, Ferguson joined 22 other attorneys general to urge CVS and Walgreens to continue with plans to dispense abortion pills, despite threats from states that have severely restricted abortion.
The same month, Ferguson announced that he has partnered with advocacy organizations and Washington law firms to make pro bono legal counsel available to abortion providers, individuals traveling to Washington for care and others seeking to understand their rights in Washington state. Help can be found at a new legal services website managed by the Lawyering Project — abortiondefensenetwork.org.
Last May, Ferguson sent a letter to the members of the Washington Medical Commission, the Washington State Board of Osteopathic Medicine and Surgery, the Washington State Pharmacy Quality Assurance Commission, and the Washington State Nursing Care Quality Assurance Commission asking the boards to exercise discretion when licensing out-of-state medical providers who have been penalized for providing abortion services criminalized in other states.
Ferguson has also produced a “know your rights” brochure and a specific form for Washingtonians to file complaints about violations to their reproductive rights. The brochure, available on the Attorney General’s website, is a guide to Washington state law’s protections for abortion and contraception access.
Anyone with complaints or concerns about violations of reproductive rights under state law is encouraged to file a complaint with the Attorney General’s Office.
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