Law Dork Video: Abortion law experts discuss upcoming SCOTUS mifepristone case

A new feature, launching with law professors Rachel Rebouché, David Cohen, and Greer Donley talking about medication abortion and the Supreme Court.

On Tuesday, March 26, the U.S. Supreme Court is set to hear arguments over access to medication abortion in the most important abortion cases it has considered since overruling Roe v. Wade nearly two years ago.

I spoke on March 12 with three of the leading national experts on abortion and reproductive rights law — law professors David Cohen, Greer Donley, and Rachel Rebouché — about the cases, briefs that they filed with the Supreme Court, and what they’ll be watching on Tuesday in a new Law Dork video feature that I am debuting tonight due to the pivotal importance of these cases. (More on this to come!)

The challenge to mifepristone, one of two drugs used in medication abortion in the United States, has been in the national news much of that time — particularly since U.S. District Judge Matt Kacsmaryk tried to end nationwide access to the drug altogether in an April 2023 ruling. Although that was too far for even the U.S. Court of Appeals for the Fifth Circuit, the conservative appeals court did agree with Kacsmaryk that changes made by the U.S. Food and Drug Administration in 2016 and 2021 to ease access to the drug violated the requirements of the Administrative Procedure Act.

The changes relate to the “risk evaluation and mitigation strategy,” referred to as the REMS, for mifepristone — limits that the FDA can require “to ensure that the benefits of the drug outweigh the risks of the drug.” Here, the FDA amended the REMS in 2016 to change how far along in a pregnancy a person can take mifepristone, changing the number of medical visits required, and changing the dosage. Then, initially due to Covid and later made permanent, the FDA eliminated the in-person prescription and dispensing requirement.

If the Fifth Circuit’s ruling is upheld by the Supreme Court, then all of those changes would be wiped out and mifepristone would only be able to be accessed under the restrictions in place before 2016.

The Biden administration and Danco Laboratories, the maker of Mifeprex, asked the justices to take up the case, which it did. In their appeal, they are asking for the justices to keep all of the current access rules in place. Before even getting to that, though, they argue that the anti-abortion medical plaintiffs, led by the Alliance for Hippocratic Medicine, lack standing to bring their lawsuit. Additionally, they argue that the preliminary remedy ordered by Kacsmaryk — which was affirmed by the Fifth Circuit — of suspending the 2016 and 2021 changes by “postponing” the effective date of the changes is “improper.”

Rebouché is the dean of Temple University’s Beasley School of Law, Cohen is a professor at Drexel University’s Kline School of Law, and Donley is an associate professor at University of Pittsburgh’s School of Law. The trio regularly work together — on both significant legal scholarship and pieces outside of academia, appearing in publications that include The New York Times and, most recently, Slate — about the Comstock Act (more on that in the interview).

Cohen and Rebouché submitted their own amici brief in the mifepristone cases, and Donley helped to lead a different amici brief submitted on behalf of food and drug law scholars.

I was very grateful to get their thoughts in advance of this case, and I hope you find it as enlightening as I did.

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This transcript has been edited and condensed for clarity.

LAW DORK: We have Greer Donley, David Cohen, and Rachel Rebouché here to talk about the pair of cases that we all have been paying attention to for the past year, since Judge Matthew Kacsmaryk first announced he was going to hold a closed hearing on a case over a challenge to the 2000 approval of mifepristone and the subsequent loosening of restrictions on that drug. We are now a year forward, and the oral arguments are coming up at the Supreme Court on March 26. To start us off, this drug was initially approved in 2000. How did we get here?

GREER DONLEY: I think that we've seen a huge politicization of science, obviously, over the last few years. So, some of this has to do with cultural changes, I think that we've seen for a long time, but that really have been going on in the anti-abortion movement for decades, and longer than that. So, the three of us wrote, in our abortion pills paper, that abortion pills were going to be this huge focus because they were radically changing how abortion was accessed and allowing people to get access to abortion even when their state banned abortion in its borders. That put a huge target on medication abortion and allowed the anti-abortion movement to take advantage of some of the cultural things that were going on and to really attack this medication, which has been approved since 2000, and is one of the safest and most effective drugs on the market.

LAW DORK: So we had this case brought, and obviously, it was brought by Alliance Defending Freedom, representing this brand new organization that happened to appear in the Northern District of Texas, the Alliance for Hippocratic Medicine. And the case, because of that, went before Judge Matthew Kacsmaryk, who has been a choice judge to file cases in front of because he's in a single judge division. Although, on March 12, the rules surrounding how cases are going to be handled going forward have changed, so this sort of forum shopping might be a little different going forward. But can you walk us through what the impact of this case having started with Matt Kacsmaryk has done?

DAVID COHEN: Strategically choosing to file a case where they did knowing that they would get Judge Kacsmaryk, who has a long history of being a part of the anti-abortion movement, being a part of the anti-LGBTQ movement. He really comes from that background. And everyone knew it. That was part of his confirmation hearings, and he was confirmed anyway. So they knew they were going to get the most favorable forum possible for this claim. And he has delivered. He, initially, like you said, wanted to have a closed-door hearing and then ultimately, there was not. There were reporters there. But then what he delivered was, he basically agreed with every claim that the Alliance for Hippocratic Medicine made. He said they had standing, he said they could challenge this approval from 23 years ago, said no statute of limitations problem, and he said the approval was unlawful, the changes were unlawful. So, they got everything they wanted from him. And then the emergency appeal to the Fifth Circuit modified it a little.

But you know, it's sort of — I like to call it a cheat code. Until [March 12], interestingly, to file it before a judge that you know is going to rule in a conservative fashion, and then have the appellate court be the Fifth Circuit, which is a very conservative court, it's a way to game the system. And they were able to do that with this case.

Surprisingly, I think to some of us, the U.S. Supreme Court issued a stay that has lasted until now and for a few more months. But, there's the potential to have the Fifth Circuit ruling come back into effect.

LAW DORK: And under the Fifth Circuit ruling, basically, they pulled back this part of Kacsmaryk's ruling that that would have gotten rid of the 2000 approval, but the Fifth Circuit kept in place Kacsmaryk's ruling as to both the 2016 and 2021 loosening of restrictions. Rachel, what would that do if that was that part of the ruling even was upheld?

RACHEL REBOUCHÉ: I think it would have varying consequences. But I do think it's worth noting that even the Fifth Circuit was ambivalent about the 2000 approval, and the Supreme Court was uniformly against reviewing a decision of the FDA from now 24 years ago. There's something there to really consider about where the Supreme Court is.

I believe that rolling back the regulations to before 2016 would be an affront to science and research, all of the things in the last 10 years that have showed us that medication abortion is safe through 10 weeks, it's safe through the first trimester, medication abortion does not need follow-up visits, it does not need to be delivered in person. But as my co-authors know, I think that the real crux of this litigation is the in-person pick-up restriction that was repealed in 2021. That is what really is being litigated, because that, as we argue in our paper, is the linchpin that liberates medication abortion in a way that is very hard to control.

LAW DORK: We've mentioned now this this Supreme Court ruling last April that essentially froze the law to the current status while this litigation is going on. What did what did that tell us? Did that mean — it seems like the traditional rules about likelihood of success are sort of just a juggling ball in the air right now? Do any of you think that it told us anything significant?

REBOUCHÉ: I do, because I think that Alito opened the door for that and the majority opinion [in Dobbs]. In that last paragraph in the majority decision, where he says anything goes, any state interest is a valid state interest in restricting and regulating abortion — earliest moment of pregnancy, against discrimination on the behalf of the unborn fetus — to restrict procedures. He essentially announced, "States, anything you want to do, it's opened." And now we're seeing litigation that's unfolding, not just in this context, but for EMTALA, for exceptions, because the Supreme Court did not put any safeguards — they had no guardrails of what would be the implementation of Dobbs that would be something that was measurable. It forecasted what we're seeing now, as the legal landscape and the chaos that we're in.

LAW DORK: Now, we're at the Supreme Court. We've got these arguments coming up. The briefs really focus in on the standing question, whether the 2016 and 2020 and 2021 actions were arbitrary and capricious, whether the remedy was proper at this preliminary stage, and whether the consideration at all was appropriate in light of the incomplete administrative record. Now, all three of you submitted amicus briefs in the case or were part of amicus briefs. David and Rachel, yours focuses on the standing dispute in particular, focusing on both causation and redressability. Can one or both of you, one of you can pick one and one the other, talk to us about what it is that that you were telling the court.

COHEN: So much has been made in this case about the fact that there's no [injury]. So, standing requires three things: injury, causation, and redressability. Every plaintiff going into federal court needs to have all three of those things. A lot of this litigation has been focused on whether the Alliance for Hippocratic Medicine has been injured, because they're really talking about something that might happen in the future — that their doctors may treat a patient who has some kind of post-medication abortion desire to go get treatment, not even a complication, just they feel they need to be seen. And so that's hypothetical, it's in the future, the possibility of any one of their doctors as opposed to any of the other doctors in the country.

Our amicus brief focused on the other two requirements of standing because they have been not as central to the litigation, but we think they're also flawed. So on causation. They're suing the FDA. And so the FDA approves the drug and puts in place the restrictions. The FDA doesn't cause doctors to prescribe it to any particular patient, the FDA does not cause any particular patient to choose medication abortion over procedural abortion, the FDA does not cause patients who receive medication abortion to say they need follow-up care. And the FDA does not cause them to then go to any particular doctor part of Alliance for Hippocratic Medicine as opposed to the doctor who prescribed it or another medical care professional, or their own healthcare professional they have a relationship with. There's such a long chain of causation between the defendant, which is the FDA, and the claimed injury, that we argue that that's not sufficient, under longstanding Article III jurisprudence from the Supreme Court about standing. So that's the causation argument.

LAW DORK: What about redressability?

COHEN: So the redressability point is that part of the court's record — and what we know — is that abortion providers in this country are planning, if mifepristone is now restricted in a way that doesn't work with how they want to prescribe it, they are planning — and this is part of the record — to switch to a misoprostol-only regimen. Misoprostol is the second drug in the regimen that's approved in the United States. But it is not being challenged in this case, because it's an ulcer medicine that's used off-label for abortion. And it is an approved abortion drug on its own around the world by the World Health Organization. The American College of Obstetricians and Gynecologists approve misoprostol alone as a form of abortion. Whatever happens in this case, misoprostol will remain available. It can be mailed it can be prescribed by non-doctors, and it is much cheaper and much easier to access. There are none of the restrictions. And so if abortion providers switch to misoprostol, which is a very likely outcome, if mifepristone is restricted, then the same injuries — maybe even more, because misoprostol leads to more cramping and bleeding and nausea — the same injuries or more would would happen. And you need to show, in order to get into court, that the remedy you want will likely redress your injury. And we don't think that that's true here.

REBOUCHÉ: I want to bring in Greer's amazing brief, that she wrote with colleagues, but, she has been a mastermind of really calling out the Kacsmaryk decision and the Fifth Circuit for misunderstanding what the FDA can actually do. Like, what are their powers in the wake of a decision and what happens next?

LAW DORK: Yes, Greer, the food and drug law scholars brief. I thought it was really interesting by focusing — it was both an in-the-nitty-gritty brief and a big-picture, what-we-need-to-be-paying-attention-to brief, because it focused both on the specifics of these 2016 and 2021 changes and why they should be respected, but also the larger implications for both the FDA and public health. If this challenge succeeds, can you talk through a little bit about why and how this brief came together and what you think is most important about it?

DONLEY: Yeah, it came together really, my colleague Patti Zettler and I, the second this case was filed in the District Court, she's an FDA law scholar, and we were texting about it. And we roped in another colleague and got a law firm to help us write it, and that's kind of how it all happened. The brief really tries to make the point that this is actually an extremely simple case from FDA law perspective. In some ways, we've gotten lost a little bit — it feels like we're debating about science. And it's hard to debate about science when you're not a scientist. But the truth is, if you just look at the standards that the Congress in their statutes said that FDA had to use when they made changes to a drug, we're in the land of really evaluating the changes that FDA has made — and there's two different types.

I'm going to try not to get into the nitty-gritty, but one is removing REMS elements, and one is adjusting the label. And Congress has made it pretty clear what's required when you adjust the label. You have to have one clinical trial, essentially. I'm paraphrasing. In this instance, when they were adjusting the dosing, for instance, they had 22 clinical trials. So we're talking about so much more information than was necessary.

But even more importantly, for removing REMS, there's no clinical trial requirement at all. So the Fifth Circuit made this huge, huge point about how there was no one clinical trial that evaluated everything, all at once, in one fell swoop, as if there needed to be a clinical trial at all. And they reviewed clinical trial evidence that combined multiple factors into different — the evidence here is so unbelievably overwhelming. So we try to really make that nitty gritty-point clear by going through the statute, going through the evidence that was before the agency.

And then we tried to say, "If the if the Court were to say that this wasn't good enough, this is going to have huge implications for pharmaceutical innovation more broadly." Because, guess what, what's good for the goose is good for the gander. There's going to be all sorts of other drugs that are going to come under fire. We started the call talking about the politicization of science. So, what about gender-affirming care? What about contraceptives? There's going to be all sorts of incentives to try to go after different types of controversial drugs — and, all of a sudden, there's a standard that the courts are basically requiring more than Congress required by a significant amount.

REBOUCHÉ: And also, what about vaccines? What about mental health care drugs? What about — fill in the blank — any drug that some other company has a reason to contest and proffer their own evidence, no matter how in the minority it is, evidence of efficacy and safety. I think it really does relate to redressability in that there's so much science on the side of why medication abortion works. Miso alone, or mife with miso. There's any number of reasons why we think the FDA would say, "Yeah, this is not a problem that we need to address and use our enforcement discretion." So that's another standing point: The FDA does not have to act in response to this quote unquote problem because it's not actually a problem.

LAW DORK: When the arguments begin, and we're looking at the justices hearing this case on March 26 — I'll do a round robin — what's the top thing that you're going to be watching for?

DONLEY: Well, I am afraid that we're all going to say the same thing.

LAW DORK: Well, you get to go first Greer.

DONLEY: It's not fair. OK, well, David and Rachel, raise your hand if you were going to say Comstock. So, I think that we're all very hyper-focused on whether that comes into account and how the court is thinking about it.

LAW DORK: You all, most recently at Slate, wrote this, this op-ed about how Joe Biden should have raised the Comstock Act in the State of the Union address and, how it’s raised in this case, and it likely would be a big part of efforts to cause further abortion restriction should a second Trump administration come into play? First, I guess, how is that in effect here in this case?

COHEN: Part of the claim from the Alliance for Hippocratic Medicine is that the FDA did not appropriately approve mailing abortion pills in the 2021 change that we are talking about because there's a law on the books that prohibits mailing anything that produces an abortion. That's the Comstock Act. It was written in 1873, and has been slightly changed over the years, but it has this provision which says that you cannot use the mail or any kind of express mail service to mail anything that can produce an abortion. And so the argument from the Alliance for Hippocratic Medicine is that, on top of the arguments we've been talking about that the science doesn't back mifepristone and the other changes. They're also saying that the FDA could not lawfully have approved mailing abortion pills because Comstock prohibits doing so.

The challenge here for them is that for almost 100 years, circuit courts — not the Supreme Court, because it's never gotten to the Supreme Court, but circuit courts — have said, dating back to the '20s and '30s, that the Comstock Act only applies to unlawful abortion. And in 2022, right before New Year's 2023, the Biden administration's Department of Justice wrote a memo explaining that that is the correct interpretation and their understanding of the Comstock Act. So, basically, it only applies to unlawful abortion — so it wouldn't change anything with respect to mailing pills. But the anti-abortion movement right now is saying, "Well, the word ‘unlawful’ is not in the text." Which, it isn't. It's not like we disagree about what's in the text. The text is the text. It's not in the text, so they say that that's the incorrect interpretation. It bans mailing all abortion pills and so that should be another reason why the FDA acted inappropriately here.

The risk is that if that this interpretation gets adopted by the Supreme Court, it could have ramifications beyond pills. Because the law does not just say drugs to produce an abortion — it says anything to produce an abortion. And so that would mean supplies and equipment that are used in abortion clinics for procedural abortions, they're also covered. And so if they can't deliver those for them, then how is any abortion clinic anywhere going to operate? It's going to basically shut down abortion. And thankfully, there are people on the anti-abortion side who are being very explicit in making this argument now. Jonathan Mitchell, Mark Lee Dickson, the Heritage Foundation, they are making this argument and they're saying that Comstock, in effect, can be a nationwide abortion ban if interpreted the way they think is correct. And so, getting back to your question, why we're so focused on this, if the justices are interested in Comstock, it's going to be scary to see how they think it should be interpreted and what that might mean, in 10 months, if we have a change in administration.

LAW DORK: Rachel, is there anything else that you're going to be particularly focused on?

REBOUCHÉ: So I — and David and Greer have to forgive me for saying this — but, as I mentioned earlier, I think that the Supreme Court is going to be laser-like focused on the in-person pick-up reversal of the REMS. I think that that is the easiest thing to target. I don't think it's right to target it. But I think that that is it. If you think about going in a time machine and making the country go back to 2015, for abortion access, where it's seven weeks, not 10 weeks, some of them can be undone — from off-label prescription and the like — but not all of them. I'm not saying that would be an easy lift.

It's really, I think, mail medication abortion that is the threat to the post-Dobbs reality that the majority of the Supreme Court had in mind. When they returned abortion to the States, I think they truly thought that there would be this clean-cut, set of policies of like, "Abortion is not legal in Texas, it's not legal in Alabama, but maybe it is in Massachusetts. I don't think they contended with the fact that the anti-abortion movement doesn't want to just stop abortion in Texas. It wants to stop it everywhere. And Texas was never going to just be satisfied with applying a law and then dealing with the messy thing that happens when you apply a law that's really badly written. I truly believe that the Supreme Court believed, or at least Justice Alito believed in writing for the majority, that he was doing something that was more workable for the country. But as we've argued, in many places —

LAW DORK: Before and after.

REBOUCHÉ: — there's nothing workable about this. The thing that makes this truly unworkable is mail medication abortion, and to stop that, I think, is the impetus for this litigation. That's my opinion. So, I am watching for the Supreme Court to shut down virtual clinics, telehealth for abortion, and the ability for online pharmacies to mail abortion pills across the country. Because, we've already seen the proliferation of pills. And I think that's what they're gonna be focused on.

COHEN: And just to set one piece of context, Chris, the most recent data we have is from 2020, showing that 53% of abortions are through medication abortion. That's before the pandemic where people became more familiar with telehealth, that's before the changes in the REMS in 2021 that ease the restrictions. So it is very likely that we're approaching 65-70% of abortions that are medication abortion, and so the risk with any of these restrictions being reimposed is that we're taking away or seriously cutting into a form of abortion that is close to two-thirds, maybe even three-quarters of abortions in this country.

LAW DORK: Thank you so much for all of that.

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This isn’t all from Cohen, Donley, and Rebouché.

I will have more thoughts from this trio to come over the weekend!