Last we told you about the abortion pill case, an appeal was in the hands of the rightwing Fifth Circuit. That court was considering what to do about a rogue federal judge in Texas who wants to pull the drug mifepristone totally off the market.
In a ruling posted after midnight on Thursday, a three-judge Fifth Circuit panel said the statute of limitations had run out for Matthew Kacsmaryk to fully revoke the FDA’s approval from September 2000, so the drug can stay on the market. But while the case proceeds, the appeals court is going to overturn really crucial labeling updates from 2016, 2019, and 2021. Two of the judges were appointed by Donald Trump, and one by George W. Bush.
It’s important to note that this isn’t the final say in the matter; the Biden administration will very likely file an appeal to the Supreme Court (audience boos). There’s also a separate, conflicting mifepristone case ongoing out of Washington state.
But for now, let’s break down what the latest ruling means:
The first change the Fifth Circuit wants to undo is a 2021 Biden administration policy permanently allowing mifepristone prescriptions to be mailed—so, no more telemedicine for medication abortions, in-person appointments only. And back in 2019, the FDA approved a generic version of mifepristone, which lead to there being a grand total of two (2) distributors of the drug in the U.S. The appeals court want to roll that back to just one, which is bad for supply chain issues as well as pricing.
Then we get to the court seeking to overturn hugely consequential labeling updates in 2016, based on loads of medical research. Before 2016, people who wanted medication abortions:
- could only get a prescription from an MD, not a nurse or physician’s assistant
- could only take mifepristone up to 7 weeks of pregnancy, not 10
- had to take a higher dose of mifepristone that led to more side effects
- had to swallow the mifepristone in front of said doctor, not at the time of their choosing
- had to go back a second time to take the misoprostol (usually dissolved in the cheeks) in front of said doctor
- in many cases, had to go back a THIRD time for a follow-up appointment to confirm the abortion was complete, which can actually be accomplished by waiting and taking a pregnancy test
So, this Fifth Circuit said the drug can stay on the market, but it has to get prescribed the way it was in the year 2000. It’s kind of like putting women and pregnant people in a metaphorical time machine and requiring them to have Y2K-era abortions. That is, if they can even make it to clinics to get those abortions—which is pretty much the whole point.
If this ruling were to take effect, many providers could prescribe mifepristone off-label through 10 weeks and at the lower dose because research shows both to be safe and effective—healthcare providers go off-label all the time. But they couldn’t get around the appeals court’s rules on mailing or again requiring the prescription to come from a physician, not a nurse.
These changes from May 2016 helped the abortion pill take off in popularity versus procedures. Reuters reported in October 2016 that “in three states most impacted by that change—Ohio, Texas and North Dakota—demand for medication abortions tripled in the last several months.” Medication abortions made up 54 percent of all abortions done in clinical settings in 2020, and it was likely higher in 2021 and 2022 because of telemedicine.
But wait, there’s more! The court claimed that the Comstock Act of 1873 bans the mailing of any item used for abortions, which could include things like the second drug used in medication abortion, misoprostol. Misoprostol can also be used on its own, and some providers have that as a back-up plan. As Greer Donley, associate professor at the University of Pittsburgh Law School, told Jezebel in December, “Comstock is really terrifying,” because any clinic that gets supplies shipped across state lines could be found in violation of the law. “If anyone were to find that that law is still active, that ends abortion nationwide—all abortion.”
Kirsten Moore, director of the Expanding Medication Abortion Access Project (EMAA Project), said in a statement that this ruling “rolls back years of medical progress” and shows why courts have no business interfering in healthcare. “The FDA followed decades of science and evidence when it expanded access to mifepristone—a court with no medical experts that has a long history of extremist rulings on abortion has no place taking that away.”
So now we—gulp—wait to see what happens at the Supreme Court.