UPDATE (April 14, 4:40 p.m.): As of April 14, the Supreme Court has issued a temporary stay on restrictions of mifepristone while the justices evaluate whether they will issue a formal stay. Two days prior, the Fifth Circuit Court of Appeals issued a partial stay of Judge Matthew Kacsmaryk’s ruling, affecting only his decision to invalidate the original 2000 approval of mifepristone — not subsequent updates to the FDA’s regulations surrounding the drug’s use. Under the Fifth Circuit’s ruling, mifepristone can still be sold and used, but cannot be distributed through the mail and must be dispensed in-person at a clinic, hospital or by a certified medical provider, a process that involves multiple visits. It is unclear how this pause interacts with a ruling from a federal court in Washington state that orders the FDA to continue dispensing mifepristone under the newer, telehealth-friendly regulations.
A federal judge in Texas just issued a ruling that could dramatically change the landscape of abortion access for the second time in less than a year.
The ruling says that mifepristone, which is one of the drugs currently used for nearly all medication abortions in the U.S., was unlawfully approved by the Food and Drug Administration back in 2000. The decision, which was handed down by Judge Matthew Kacsmaryk, places a hold on the FDA approval — but won’t go into effect for seven days, to give the government time to appeal. (The Department of Justice has since filed a notice of appeal to the Fifth Circuit Court of Appeals.)
Texas judge suspends approval of abortion drug | FiveThirtyEight
The question now is whether a higher court — whether it’s the conservative Fifth Circuit or the U.S. Supreme Court — reverses the injunction. If that doesn’t happen, the FDA will have to decide what to do. Some lawmakers and abortion-rights advocates have pushed for the Biden administration to keep mifepristone on the market regardless of the judge’s ruling, and several abortion clinics announced ahead of the ruling that they will continue to prescribe mifepristone until they receive a directive from the FDA to stop, but others may decide to comply with the ruling. To make matters even more complicated, a federal judge in Washington state issued a dueling decision less than an hour after Kacsmaryk’s, responding to a separate case filed by over a dozen Democratic attorneys general by saying that the FDA cannot pull mifepristone from the market. Together, the rulings increase the likelihood that the Supreme Court will weigh in.
The stakes are very high: If the FDA ultimately complies with the Texas judge’s order, abortion clinics will not have access to mifepristone until the injunction is lifted or the case is concluded, which will be especially disruptive for the large chunk of abortion providers who only provide medication abortion.
The mifepristone lawsuit is a broadside against abortion-rights advocates’ primary strategy for maintaining abortion access in the states where abortion remains legal. More and more women have been opting to terminate their pregnancies using medication over the past few years — the Guttmacher Institute estimated that more than half of abortions in 2020 happened using pills, up from 37 percent in 2017. Early during the COVID-19 pandemic, the FDA temporarily loosened its restrictions on medication abortion — making it possible for clinicians to prescribe abortion pills through telehealth — and then made those new rules permanent in late 2021. In the past few years, several telehealth-only abortion companies have jumped into the game, and it’s now relatively common for women to obtain abortion pills without seeing a doctor in person.
The rise of medication abortion has changed the game for abortion clinics, too. Forty percent of the abortion clinics that were open in December 2022 were only scheduling appointments for medication abortions, according to Caitlin Myers, an economics professor at Middlebury College who studies abortion. Those clinics tend to be concentrated in rural areas of states like Maine, Washington and Oregon, where abortion providers can reach a larger group of patients by allowing other clinicians to prescribe abortion pills through telehealth.
Now, if a higher court doesn’t step in and the FDA complies with the judge’s order, clinics will have a choice. It’s possible to safely terminate a pregnancy by taking several doses of misoprostol, the drug that’s used with mifepristone under normal practice now. Misoprostol-only abortions are common globally, particularly in countries where abortion access is restricted, but the mifepristone-misoprostol combination was widely adopted in the U.S. because it’s more effective — and less painful. A randomized controlled trial of 400 women in Vietnam found that 96.5 percent of patients who took the pill combination successfully completed their abortion without further intervention, compared to 76.2 percent of women who took misoprostol alone. Medication abortions are already uncomfortable for many women, but side effects like cramping can be more pronounced with misoprostol alone.
Many clinics — particularly independent clinics — are planning to stay open. “Our plan is to be as transparent as possible with patients about what’s changing, and how it might affect them,” said Evelyn Kieltyka, senior VP of program services at Maine Family Planning, a network of abortion clinics in rural Maine that relies heavily on medication abortion. “If someone is three hours from a place where you can get an aspiration abortion, we’ll say, ‘If you need follow-up care, how would you do that? Could someone drive you? Would you need child care?’ To make sure they are making the choice with their eyes open.”
Some medication-only abortion providers may instead choose to temporarily close, rather than switch to a different pill regimen. A spokesperson for Planned Parenthood Federation of America told FiveThirtyEight that its affiliates will make their own decisions about which abortion regimen to offer, which could lead to a patchwork of availability. Depending on how many clinics stay open, Myers said, the impact of the judge’s ruling could be as sweeping as the decision in Dobbs v. Jackson Women’s Health Organization last summer, when the Supreme Court overturned the constitutional right to abortion. “A large number of facilities may not be able to provide abortions at all — even in states that are very supportive of abortion,” she said.
Fewer abortion clinics won’t just mean fewer places to get an abortion in a given region — it could affect providers across the country. “The facilities that are left are suddenly going to be receiving much bigger numbers of people looking for abortions, and they may have very limited appointment availability,” Myers said.
The vast majority of abortions take place early in pregnancy, so medication abortion — which the FDA had approved for use within the first 10 weeks of pregnancy — is an option for many women. But with more women traveling out of state for abortions, wait times for abortions in key areas of the country are still high. Myers, who has been surveying wait times at every clinic in the country since before the Dobbs ruling, found that the median wait time for a medication abortion in early December was four days, while the median wait time for a surgical abortion was five days. But there’s a lot of variation depending on where you are — in Grand Rapids, Michigan, for example, the median wait time for any kind of abortion was 26 days, compared to one day in Los Angeles. Even deep-blue states have plenty of cities with long waits: Four cities in Washington had a wait time of more than two weeks, and New York had 11 cities with median wait times of at least seven days.
And of course, even if another court doesn’t step in, today’s ruling is still temporary. The judge who issued the injunction is one of the most conservative in the country, so it’s possible that higher courts will ultimately disagree with his decision. Kacsmaryk was appointed to his post in Amarillo, Texas, by former President Donald Trump in 2019. Kacsmaryk, who worked for a conservative Christian legal group before becoming a federal judge, has already issued controversial rulings. In December, for example, he overturned a federal rule that prohibited family planning providers from informing parents when teenagers request birth control. He’s quickly becoming known — along with a couple other judges in Texas — as a judge who’s sympathetic to conservative arguments that likely wouldn’t gain traction in other courtrooms.
Plus, the decision isn’t likely to be popular. A February Ipsos poll conducted on behalf of the EMAA Project, a group that advocates for medication abortion, found that 65 percent of Americans want medication abortion to remain legal. When respondents in the poll were given specific information about the case, only 29 percent said that the judge should override the FDA’s approval of mifepristone, banning abortion nationwide. (The poll didn’t ask about a situation where another medication abortion regimen was available.) Another February poll, from Navigator Research, found, similarly, that 61 percent of voters want early medication abortion to remain legal, including a plurality (43 percent) of Republicans. And a Morning Consult poll conducted in March found that 47 percent of Americans oppose a ruling overturning the FDA’s approval of mifepristone, while 29 percent were in support and 23 percent said they didn’t know or had no opinion.
But the lawsuit is now in the hands of the Fifth Circuit Court of Appeals, arguably the most conservative appeals court in the country. So it’s hard to predict what will happen next. And the ultimate decision may rest with the U.S. Supreme Court, which has veered in a much more conservative direction over the past five years.