A federal appeals court ruled to limit access to a widely used abortion pill, mifepristone, upholding portions of a lower court decision by a federal judge in Texas to suspend the drug’s FDA approval. Mifepristone, the generic abortion pill, remains on the market for now.
In a 2-1 decision, a panel of conservative judges said that some previous Food and Drug Administration (FDA) decisions broadening access to the pill, such as allowing it to be distributed by mail, were unlawful.
The Wednesday ruling does not have any immediate impacts on its availability thanks to an emergency stay issued by the US supreme court in April.
But abortion care researchers and physicians say constant efforts to change abortion laws creates “chaos and confusion” for patients and health care providers.
Where is mifepristone legal?
For now, mifepristone remains widely available in 20 states and Washington DC, including by mail and via clinics, while 15 states require a prescription from a doctor or physician and in some cases, an in-person visit.
Mifepristone is largely unavailable in 15 states with near-total abortion bans, but it is unclear which of those directly restrict obtaining pills by mail from out-of-state providers. Eighteen states restrict abortion care through telehealth. The Department of Justice said the US Postal Service can continue to deliver mifepristone, even if its destination bans abortion.
States with sweeping bans are Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas and West Virginia, according to the reproductive rights policy group Guttmacher Institute. Wisconsin providers have paused abortion care services because of an 1849 state law that criminalizes abortion in all cases except to prevent the death of the pregnant person. And in Indiana, where a sweeping abortion ban took effect on 1 August, most providers have stopped providing care.
“Everyone should know that mifepristone remains FDA-approved, and medication abortion remains safe and effective,” Kelly Baden, vice-president for public policy at the Guttmacher Institute, said in a phone interview.
What does the latest ruling seek to change?
The Wednesday federal appeals court ruling seeks to reverse several FDA decisions that widened access to the drug. It would decrease the amount of time a person can take mifepristone from 10 weeks to seven weeks, according to FDA guidelines, and restrict non-physicians from prescribing it, overturning several decisions the agency made in 2016.
It would also require mifepristone to be dispensed in-person, reversing a 2021 decision that permanently lifted that regulation, limiting telehealth options.
Having mifepristone available via telemedicine, particularly in the post-Dobbs era, has been a “game-changer,” said Kristyn Brandi, the board chair of the group Physicians for Reproductive Health and a New Jersey OB-GYN. Plus, mifepristone offered patients living in states where abortion is restricted an option to seek care.
“We know it’s safe and effective,” said Brandi. “The data hasn’t changed, but whether or not the legality of the medication changes is a different thing.”
How does mifepristone work?
Medication abortion accounts for more than half of all US abortions, according to a 2022 study by the Guttmacher Institute, and 98% of medication abortions in 2020 used mifepristone. Mifepristone blocks a hormone called progesterone that is needed for a pregnancy to continue, and misoprostol, a different hormone, empties the uterus.
The two-pill regimen is also how doctors treat other pregnancy complications, such as miscarriages and ectopic pregnancies, and managing maternal health has become more complicated post-Dobbs.
“Medical organizations across the board agree that this medication, mifepristone, is like the first-line treatment that we should give for people that are managing miscarriages, that are ending pregnancies for a lot of different reasons,” said Brandi.
While misoprostol-only treatments are safe and effective, they have been found to be slightly less effective than when taken with mifepristone and can carry additional side effects.
What does the ruling mean for other FDA-approved drugs?
In their Wednesday ruling, the judges said the FDA did not follow proper processes when it loosened regulations on mifepristone.
Some abortion care providers warn that upholding a decision that challenges drugs approved by the FDA, the federal agency responsible for protecting public health, could create a dangerous precedent for other types of medication.
“We are getting closer to this answer about, ‘What happens to all these other medications that the FDA approves?’” said Brandi. “This is going to set the standard about if the legal system can overturn decisions that the FDA makes based on scientific studies.”
What happens now?
The Department of Justice is expected to appeal the ruling, putting the case before the conservative-majority supreme court, whose term begins in October and typically recesses in late June or early July.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” wrote Judge Jennifer Walker Elrod in the Wednesday decision. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”
Elrod also wrote that the FDA failed to consider the cumulative effect of lifting several safeguards at the same time, and that it failed to demonstrate that mifepristone could be used safely without being prescribed and dispensed in person.
Judge Cory Wilson, a Trump-appointee, agreed with Elrod in her decision. Judge James Ho, also a Trump-appointee, dissented in part but wrote in his opinion that “the FDA has approved the use of a drug that threatens to destroy the unborn children”. All three judges on the Wednesday ruling have supported abortion restrictions and raised issues with the FDA.
The “legal whiplash” around abortion access since the supreme court overturned Roe v Wade has been especially harmful for patients seeking abortion care, said Baden, of Guttmacher.
“It’s wildly confusing for people who might need abortions, people who have abortion appointments right now, to yet again have another major news headline that kind of throws more chaos into an already confusing legal landscape and situation,” said Baden.