In a joint lawsuit with 18 other attorneys general filed last year in the U.S. District Court for the Eastern District of Washington in Spokane, Ferguson and his staff argued that restrictions on mifepristone are illegal, and that the FDA should reevaluate its policies on the drug.
In April 2023, Judge Thomas O. Rice approved a preliminary injunction requested by Ferguson that prevents the FDA from interfering with the availability of mifepristone in Washington, Oregon, the District of Columbia, and 16 other states that have signed on to the lawsuit.
Rice’s ruling last year was released the same day another decision on mifepristone came out in a Texas lawsuit, in favor of anti-abortion advocates who argued that the already unusually restrictive rules around mifepristone were inadequate. That ruling, which would’ve rescinded FDA approval for the drug, made its way to the U.S. Supreme Court, where, in June, the Court disagreed, deciding unanimously that the anti-abortion advocates who brought the suit in Texas lacked a legal right to sue.
While that case was rejected, abortion challenges are not likely over. Trump has bragged publicly about the reversal of Roe v. Wade enabled by the Supreme Court picks he made during his first presidency, while abortion was an issue in both federal and state elections this year.
Mifepristone is limited under what’s known as a Risk Evaluation & Mitigation Strategy, a set of regulations the FDA requires for just 73 drugs, including those with well-established addictive properties or that are known to cause birth defects, for example opioids, thalidomide, and isotretinoin. Mifepristone is also restricted under a policy called Elements to Assure Safe Use, which is typically applied to drugs that carry high risk.
For years, abortion rights advocates and providers have argued that the restrictions on mifepristone are scientifically baseless and burdensome, pointing out that there are no similar requirements when mifepristone is prescribed for purposes aside from pregnancy termination. Mifepristone is also commonly used to manage high blood sugar in patients with Cushing syndrome.
“There is, truly, zero science or medicine to support it,” said Sarah Prager, a Seattle-area abortion provider and professor of obstetrics and gynecology at the University of Washington.
According to Prager, recent changes in how mifepristone is prescribed have made it even more challenging to provide it to patients. “Each individual provider now needs to be registered with each pharmacy that will dispense the medication for them,” she said. “Additionally, mifepristone is a medication safer than many over-the-counter medications and should not have ANY restrictions in use.”
The Washington Attorney General’s Office agrees, saying that “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.” But without the FDA rules, “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.”
Oregon Attorney General Ellen Rosenblum, who is co-leading the lawsuit with Ferguson, agrees: “The restrictions simply are not medically necessary.” In medication abortions, mifepristone is typically paired with a second drug, misoprostol, to end a pregnancy. The same FDA rules do not apply to misoprostol, which can also be used on its own to end a pregnancy, a protocol reproductive health care providers have indicated they would pivot to if mifepristone is further restricted.
Beyond broader questions of access, the Attorney General’s Office is also concerned that current restrictions on mifepristone could introduce privacy concerns for patients, especially for those seeking care in Washington from states with abortion-hostile policies enacted since Dobbs v. Jackson Women’s Health was decided more than two years ago. That’s because the restrictions on mifepristone currently include written agreements stating that the drug is being used to induce an abortion or resolve a miscarriage, evidence that could leave patients vulnerable to investigation or prosecution by abortion-hostile state officials.
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