Last Friday, the U.S. awaited action from the Supreme Court in the biggest case involving abortion since Roe v. Wade was overturned. That case traces back to a recent ruling by federal judge Matthew Kacsmaryk in Amarillo, who revoked FDA approval for the abortion pill mifepristone which has been widely available since the early 2000s.
Within minutes of the Amarillo ruling, another federal judge in Washington State issued an order for the FDA to keep mifepristone available – a direct challenge to competing court orders. To prevent regulatory chaos, the Biden administration asked the Supreme Court to intervene.
In an order released last Friday, the Supreme Court said that mifepristone would remain available for now. But this likely is not the last the U.S. will hear about this issue from the Supreme Court. The Amarillo order, which would effectively ban mifepristone, is being challenged in the Fifth Circuit Court of Appeals.
Depending on the outcome, the ripple effects could run beyond the issue of abortion per se. To explore where the country stands and what could come next, the Standard spoke with University of Texas Law professor Stephen Vladeck. Listen to the story above or read the transcript below.
This transcript has been edited lightly for clarity:
Texas Standard: What were the options before the Supreme Court? They could have let the Amarillo court’s ruling stand.
Stephen Vladeck: Yeah, there is the Amarillo ruling that the court could have left intact. The federal appeals court – the Fifth Circuit– had actually paused some of the Amarillo ruling, so the Supreme Court could have sided with the Fifth Circuit.
Of course, that would have raised a whole ton of messy questions come Saturday morning, when the Amarillo ruling was supposed to go into effect, about what kind of access was still available to mifepristone, or to generic mifepristone. I think the justices really just took the easy way out here, which was to freeze the status quo as it existed before the Amarillo ruling.
They basically said, “this case is going to work its way through the courts, maybe it’s going to come back to us, but we’re not going to upset the apple cart until then.” So, what was true about mifepristone last week is going to be true next week, and probably at least until sometime next year at the earliest.
What is the status quo ante? There’s considerable confusion about that. In places like Texas – where abortion is illegal – mifepristone is not available. But that’s not the case in other states, so has this become an issue of varying state regulation?
I think it’s worth stressing that when the FDA has approved a pharmaceutical and when medical professionals are prescribing that pharmaceutical, that approval overrides state law. So, it is possible that there are people in Texas who have legal prescriptions for mifepristone, who have legal access to mifepristone.
The critical point about Friday’s ruling is that nothing has changed: the law still is what it was before we ever got any ruling from Amarillo. There’s still some uncertainty about what that is. But no one should think that the rules have changed in the last three weeks. Now, the rules are the same today as they were a month ago. They’re going to be the same for the foreseeable future.
Let’s talk about the foreseeable future. When is the Fifth Circuit expected to take up this case on full appeal?
The federal government and one of the U.S. sponsors of mifepristone, Danco Laboratories, have appealed Judge Kacsmaryk’s ruling. The Fifth Circuit has expedited that appeal. It’s set to hear oral arguments pretty quickly on May 17 – just a couple of weeks from now. We’ll probably get a ruling from the Fifth Circuit sometime over the summer.
That ruling might actually side with the appeal and might say that Judge Kacsmaryk went too far and that the case should be dismissed. There are huge procedural obstacles to the plaintiffs claims in these cases, including whether they have standing. The doctors who are challenging the FDA actions are claiming that they’re injured by the fact that they might have to treat patients in the future who were harmed by mifepristone. That’s not usually the kind of injury that the courts allow to provide a basis for suits.
So, it’s not a given that the Fifth Circuit is ultimately going to side with Judge Kacsmaryk in Amarillo. But whether or not it does, its ruling also won’t change the status quo. The status quo is going to remain until and unless this case goes back to the Supreme Court, and the Supreme Court issues a ruling on the merits. That won’t be until the earliest late this year or early next year.
Underneath a lot of this is the FDA’s own authority and the process of drug approval. The abortion pill isn’t the only thing at stake here.
That’s exactly right. I think part of why the justices were probably inclined to put a hold on this whole situation is because Judge Kacsmaryk’s ruling, if it were to go into effect, would have implications not just for mifepristone, but for other challenges to just about any action the FDA has ever taken – whether it’s regarding the approval of medication, the approval of vaccinations, you name it.
This was really a potential floodgate situation where now I think the Supreme Court has, at least for the moment, put the toothpaste back in the tube. They’re going to want to lower the temperature of all this litigation so that there’s no dramatic overnight change in the access to or approval of any medication, including mifepristone.
It’s going to take some time. The Supreme Court’s going to see what it wants to do. Only after the Supreme Court has had a full opportunity to consider the merits, are we going to have to talk about what, if any, consequences are going to follow for folks on the ground.