Lawsuit accuses the FDA of ignoring more than a quarter century of science showing that mifepristone is safe
OLYMPIA — Attorney General Bob Ferguson announced today he is leading a multistate federal lawsuit against the Food & Drug Administration (FDA) accusing it of singling out one of the two drugs used for medication abortions for excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol.
Today’s lawsuit is Ferguson’s tenth case filed against the Biden administration. Of those cases, Ferguson’s office has four legal victories and has yet to lose a case.
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.
“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.
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.
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 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.
Originally approved in 2000
The FDA approved mifepristone for use in the United States in combination with misoprostol for medication abortions in 2000. Before its approval in the U.S., mifepristone was widely used in Europe, beginning in France in the late 1980s. Since its FDA approval, mifepristone has been safely used more than 5 million times in the U.S.
The FDA itself has acknowledged that “serious complications have proven to be extremely rare” with mifepristone. In the lawsuit, Ferguson notes 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 2021, nearly 60% of the more than 15,000 abortions in Washington state were medication abortions. Fewer than a tenth of one percent resulted in a complication that required hospitalization. According to the FDA, not one single death can be attributed to mifepristone during its entire history of use in the United States.
Despite mifepristone’s extremely strong safety record, the FDA has repeatedly declined to remove the REMS restrictions on the medication.
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 their abortion is illegal. The documentation of their abortion remains in their medical records, and can 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 data 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 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 of Washington. 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.
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.
Lawsuit details
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 lawsuit asks the court to find the FDA’s REMS restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains accessible, as a safe and effective drug that Washingtonians commonly rely on.
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 are handling the case for Washington.
Efforts to protect access to reproductive care
Earlier this month, 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.
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.
Earlier this month, Ferguson also 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.
Ferguson announced this week 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.
In 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 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.