Latest Mifepristone Legal Debates Raise More Questions, Confusion for Health Care Professionals

In an interview with Pharmacy Times, Ron Lanton III, Esq., partner at Lanton Law, discussed the latest legal decisions and the Supreme Court’s involvement in mifepristone access. Following 2 opposing decisions from judges in Texas and Washington State, Lanton said the issue is back in the Supreme Court.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times and I'm here with Ron Lanton, partner at Lanton Law, to discuss the latest updates on the mifepristone legal debates and decisions and what they all mean. So, quite a bit has happened in the last 6 weeks or so with 2 conflicting decisions from judges, and now the issue is back in the Supreme Court. So, can you kind of get us up to speed?

Ron Lanton III, Esq.: Sure. It’s been a lot, you're right, that has happened since the last time we spoke. And for those that really want to understand completely about what we're talking about here, this really goes back to the Dobbs decision from last year, the Dobbs v. Jackson Women’s Health Organization. And in that case, we had both Roe v. Wade and Casey v. Planned Parenthood overturned by the Supreme Court on the basis that abortion was not protected by the Constitution. So basically, the court ruled that states could ban abortion at any time, because states actually control that outcome. So, I remember the last time that we had a couple of these discussions, we discussed, you know, what's next? Is it mifepristone, is it contraception, and it turns out now it's mifepristone. So, we've had 2 different decisions that you mentioned in the first question here.

So, the first case was from a federal judge in Amarillo, Texas. And that happened on April 7, and that judge suspended the approval of mifepristone by stating that the FDA had improperly approved the drug 23 years ago, which was very interesting. And you go back to what he specifically said about it, and he said, well, the court doesn't second guess the FDA’s decision-making authority specifically. So, he doesn't second guess the FDA’s decision making lightly. But here, [he says] the FDA acquiesced on legitimate safety concerns and violation of the statutory duty is based on plainly unsound reasoning and studies that don't support its conclusions. And that's very interesting, because you don't really see that kind of talk from a judge normally, as it’s the FDA that's been tasked to make those decisions based on scientific studies and whatnot.

So, you can tell that this whole debate has been tightly choreographed, because minutes after that decision in Texas was released, we had another decision in Washington State that was contrary. So, in that case, there were 17 states, including the District of Columbia, that sought to expand the use of mifepristone. And the judge basically said, everything's going to remain status quo in those states. So, he was watching the case in Texas and basically issued his ruling to protect the states where you can get mifepristone. So that automatically—well, not automatically—it's definitely going to trigger the Supreme Court's interest in taking this case, because now you have split courts and, you know, where do we go? And when that happens, sometimes the court doesn't take up things and it just kind of leaves it as is, to where some states, you can do this and some states, you could do that. But on this particular issue, the Supreme Court definitely took this up.

So, besides those differences in the 2 rulings that I have talked about, I want to mention that the Fifth Circuit has made this a little bit more complicated, because after the ruling with the Amarillo Federal District Court, it went to the Fifth Circuit. And basically, the Fifth Circuit ruled that the statute of limitations for challenging any kind of FDA approval for this drug has long passed. But the appeals court said that mifepristone could continue to be used up to 7 weeks into pregnancy in states where abortion is legal. But if you actually look at the FDA approval for mifepristone, it's 10 weeks, so there's a definite contradiction there about what you should and shouldn't do. Additionally, what the Fifth Circuit did was that they rolled back the rules that were adopted back in 2015, where they were trying to get more people to get access to mifepristone. And what the Fifth Circuit said was that they're saying alright, we cannot have patients getting this by mail or talking to doctors about this through telemedicine. So, that's interesting, and it's also has put things back in 2016, as well, with the Fifth Circuit with this ruling. It's very complicated when you look at it, but it basically says that now, you have to have 3 in-person appointments for anybody that wants to use mifepristone, and they've also banned the cheaper generic version of mifepristone. And so, the intent is clear. They're really trying to shrink down the access to mifepristone. So, it's just how are they going to get that done?

Aislinn Antrim: Definitely. And so, with so many things, just moving pieces all at once, can you explain what happened at the Supreme Court so far?

Ron Lanton III, Esq.: Yeah, so basically, it blocked the lower court decision that banned or limited the FDA approved use of mifepristone, for now. The court has left the case back to the Fifth Circuit and there, the oral arguments, I believe were scheduled for May 17. So regardless of what happens, I think that this case definitely comes back to the Supreme Court. The Courts’ action for now means that at least the drug will be available in those states where abortion is legal for up to 10 weeks into a pregnancy. So, we're not out of the woods yet, as far as, you know, getting some kind of clarity around the issue. They're still fighting this out. So, it just remains to be seen where the court goes from here.

Aislinn Antrim: Wonderful. So, where does the case currently stand with this? Do we have any sort of timeline or an idea of when we might get more information?

Ron Lanton III, Esq.: We don't, unfortunately. We're just going to have to wait. So, I think it just depends on what happens on the 17th, this month, with that Fifth Circuit. And no one said anything is fast tracked. We really don't know; we're kind of at the mercy of what the Supreme Court wants to do.

Aislinn Antrim: Interesting. So, at its core, the most recent debate in this whole saga seems to be about whether judges in the legal system can overturn or change FDA decisions. Is that is that really what the court is considering? Is that kind of this broader issue, even beyond mifepristone?

Ron Lanton III, Esq.: No. Every time I hear this question, I just can't believe that we're even at this point right now, because who would have thought, right? And I guess that's the nature of law and how things go. The FDA decision is kind of an indirect thing that we're now faced with trying to understand. It just kind of happen that way. Most of the time, when you're dealing with a drug case, it's like a patent case, or products liability case, or something like that, not whether or not the drug should be there in the first place. So, I think a lot of people sometimes forget, even though law is meant to be neutral and it's meant to look at the facts and only the facts, law is very political. And when it comes to hot button issues like this—I don't want to say sometimes, because this has never happened before, this is the first time, there's no precedent for anything like this. So, the possibility is there for anything to happen. And that's where we're at.

Aislinn Antrim: Definitely. You already answered my next question. Is there any precedent for this?

Ron Lanton III, Esq.: No, there's no precedent. And I think it's important to get this correct. When this happened, I was surprised by the reaction from the pharmaceutical community. There was a letter with about 400 pharmaceutical executives that were basically saying, “What are you doing with this?” And, you know, it's like, if something like this were to happen and the FDA decision was overturned, I get the issue. But when you really look at the issue, again, I mentioned how a lot of this is political. You know, vaccines were highly politically charged during COVID, and do we now go back on that, based on a political reason or scientific reason? So, you're going to throw a lot of doubts and chaos into the system if we're not careful with our next step.

Aislinn Antrim: Yeah, absolutely. How is it possible that judges or the legal system could potentially have the ability to kind of meddle in FDA decisions? How is that legally an option?

Ron Lanton III, Esq.: Well, I mean, you know, anything's possible. There is no rule that prevents a judge from saying you can't do this, right? It's just we've had these kinds of unwritten rules, of things that we just don't do or things that we just don't talk about. And somehow, we’ve found ourselves talking about this from something else. So, like I said, this is one of those crossroads where, hey, I get the question, and it's whether or not we're really trying to restrict mifepristone. But is this the right way to get this done? And I don't know, if we keep pushing in this direction, I think that it's just going to cause a lot of confusion for really any drug that can be out there. And anything could be turned into public debate. Anything, like I said, especially vaccines, that was one of the things that we all saw publicly, and how many people at the at HHS were actually vilified for trying to get a vaccine out, you know? So this is where we find ourselves.

Aislinn Antrim: Are there any signs or any ideas about what the justices might be thinking, or kind of where they're heading on this issue?

Ron Lanton III, Esq.: No, that's the interesting thing about it. I think the Dobbs decision, which was written by Justice Alito, I mean, we pretty much know where Alito stands with that. We also, I think, know where Justice Thomas stands. He had a dissent in this last Supreme Court ruling that we've just talked about. But every question is different, so we don't really know where the justices fit, it really depends on what the Fifth Circuit is going to say.

Now, it’s interesting when it comes to something like this, because you think about things that are called judicial dicta. This is when a judge writes an opinion and then the judge leaves little breadcrumbs throughout the opinion to say, “Well, if we had to create policy on something, this is where we might do it.” So, are we going to see things like that in upcoming Supreme Court decisions where we're walking that fine line about, all right, are we going to invalidate the FDA or not? And then go back to your earlier question. You know, I'm just shocked that we're here at this point, because I mentioned in past interviews the importance the Supremacy Clause was going to play. And if we're now talking about, you know, a state and what they think versus, you know, the FDA and what it thinks, clearly, the Supremacy Clause, I mean, I would think, would win out and the FDA would win out. I mean, that's what we've designed the system to do. But that question hasn't specifically been asked yet. So, I'm not sure if we're going to get to it through a judicial dicta like I was saying. Which is, alright, well, maybe we'll see the breadcrumbs and say the FDA is fine because of the Supremacy Clause, or if they're just going to issue an opinion and that's it. And then if that's it, where does everything else sit? So, stay tuned; we don't know.

Aislinn Antrim: Yeah, it'll be very interesting. Is there anything you want to add or anything that I didn't ask about?

Ron Lanton III, Esq.: No. This is complicated. That's what makes law interesting. We just have to continue to watch and see and, you know, I think that our next conversation about this is definitely going to stem from what happens in the Fifth Circuit on May 17. We’ll see. And so that's what I would watch and we can get a better sense of where this debate is going to go.