Rulings in the two federal lawsuits were both released on Friday, April 7, potentially setting up the abortion debate for another showdown in the U.S. Supreme Court.
Washington Attorney General Bob Ferguson and his staff sued the FDA to prevent the federal agency from implementing any new restrictions on the abortion pill in 16 states and the District of Columbia. They described their effort to sue the FDA as “the opposite of what’s going on in Texas” in a news conference a few days before the twin rulings. They sought to expand access to the drug, not restrict it further.
Since 2011, the U.S. Food and Drug Administration has restricted access to mifepristone, commonly used in medication abortion in combination with the abortion drug misoprostol, through the same rigid standard applied to opioids. While the Texas lawsuit argued restrictions on the drug don’t go far enough, Ferguson’s staff made the case that even before the Texas suit, there was never any medical basis for the limitations on the drug — and that efforts to classify it in a group of drugs known to be dangerous are baseless and illegal.
Kristin Beneski, first assistant attorney general, argued the case, filed in federal court in the Eastern District of Washington. After mining available medical information and opinions from leading medical groups, the attorney general’s staff could find no medical reason for the restrictions on a drug that is “demonstrably safer than Tylenol, safer than many common medications, so our take is that from day one, they’ve been not only arbitrary and capricious, but also unlawful,” Beneski said.
Mifepristone was approved by the FDA in 2000, and is currently restricted under what’s known as a risk evaluation and mitigation strategy, commonly referred to as a REMS; the restrictions were approved in 2011. These restrictions apply to only about 60 drugs on the market, including several known to cause severe birth defects, like Accutane, whose prescribing information includes a requirement that patients taking the drug also use two types of birth control, and thalidomide, which caused severe birth defects or death in an estimated 10,000 babies after its introduction in 1957. REMS restrictions are also common for synthetic opioids like fentanyl, which were involved in 68,630 overdose deaths in 2020 alone, accounting for 74.8% of overdose deaths, according to the Centers for Disease Control and Prevention.
But unlike with mifepristone, which can be dispensed only by specially certified medical providers, the REMS restrictions on opioids are optional, Beneski said. They also don’t apply to mifepristone when it’s prescribed as a treatment for Cushing’s disease. Only when the drug is dispensed for the purpose of inducing an abortion or as treatment for miscarriage is it subject to these restrictions, despite arguments from mainstream medical organizations that the pills are safe and documentation showing complications are extremely rare.
The World Health Organization recommends mifepristone in combination with misoprostol as a safe and effective method of self-managed abortion, which often does not include clinician involvement at all. “Evidence has demonstrated that in the first trimester, individuals can safely and effectively manage their own medical abortions using mifepristone and misoprostol in combination,” wrote the group in its recommendations on self-management of medical abortion in 2020. “This strategy can offer crucial support in providing access to safe abortion care.”
For an amicus brief released in February, the American Congress of Obstetricians and Gynecologists reviewed scientific evidence on mifepristone spanning a 23-year period and concluded that “The data overwhelmingly illustrate the safety of this essential medication,” with major side effects like infections and hospitalization occurring in less than 1% of patients, and “major adverse events” occurring in less than 0.3%. “The risk of death is almost non-existent,” reported the group. In contrast, they said, “There is a greater risk of complications from wisdom tooth removal, colonoscopy, and Viagra use.”
Mifepristone’s safety record was the rationale behind a major effort among reproductive health providers in 2021 to temporarily suspend the in-person dispensing requirement for the drug, a measure designed to maintain abortion access during the pandemic. The Biden administration responded by lifting that requirement in April 2021, allowing providers to prescribe medication abortion remotely by mailing pills to patients. In a letter to the American Congress of Obstetricians and Gynecologists, FDA acting commissioner Janet Woodcock said at the time that shifting to virtual protocols did not raise major safety concerns.
Last year that rule change became permanent. But the FDA also added new dispensing requirements for mifepristone. Some media accounts cheered the new regulations, framing them as an expansion of access because they included a policy that would theoretically allow retail pharmacies to dispense the pills. In practice, however, there is little evidence to suggest that this is happening. “[A]s far as I’m aware, none of the major pharmacy chains in the United States have gotten certified yet,” said Beneski. “So this is largely, or perhaps entirely, a theoretical expansion of access. It sure hasn't done much yet.”
And as other states move to ban abortion after the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women’s Health, the focus has intensified on states that still offer abortions, like Washington, and on the medication involved in most of these procedures.
“As a result of that decision and the criminalization and restriction of access to abortion care in a number of states in the U.S., Washington and Oregon and the other plaintiff states in our lawsuit are seeing a really significant influx of patients into our states seeking care that they cannot get in their home states,” Beneski said. “And this is putting a lot of pressure on our health care systems in our states, and lifting the REMS restrictions would alleviate that new pressure.”
In the lawsuit, Ferguson asked for two forms of relief: that mifepristone’s availability in the plaintiff states be maintained, and that the FDA no longer enforce any of the REMS restrictions on the drug, allowing it instead to be dispensed “just like any other prescription medication,” said Beneski.
The Department of Justice is appealing the ruling in the Texas case, which takes a week to go into effect. In the Washington case, U.S. District Court Judge Thomas O. Rice has enjoined the FDA from imposing new restrictions on mifepristone in Washington, 16 other states, and the District of Columbia.
“Today’s ruling will preserve vital access to mifepristone while our case continues,” Ferguson said Friday in a media release. “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.” The preliminary injunction goes into effect immediately.
