Dueling Decisions on the Regulation and Distribution of Mifepristone: AHM v. FDA & WA v. FDA

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Chayila Kleist:  Hello, and welcome to The Federalist Society's Webinar call. Today, June 21, 2023, we discuss the Dueling Decisions on the Regulation and Distribution of Mifepristone: Alliance for Hippocratic Medicine v. The Food and Drug Administration and The State of Washington v. The FDA.

My name is Chayila Kleist, and I'm an Assistant Director of Practice Groups here at The Federalist Society. As always, please note that all expressions of opinion are those of the experts on today's program, as The Federalist Society takes no position on particular legal or public policy issues. In the interest of time, I'll keep my introductions brief. But if you'd like to know more about any of our speakers today, you can access their impressive full bios at fedsoc.org.

Today, we're fortunate to have with us Thomas Jipping, who is a Senior Legal Fellow for the Edwin Meese III Center for Legal and Judicial Studies, which is part of the Institute for Constitutional Government at the Heritage Foundation. Mr. Jipping joined Heritage in May 2018 after 15 years on the staff of U.S. Senator Orrin Hatch, including several as his chief counsel of the Senate Judiciary Committee. He spent the previous 13 years at 2 public policy organizations, including Concerned Women for America, where he was Senior Fellow in Legal Studies, and the Free Congress Foundation, where he served as Vice President for Policy and Director of the Center for Law and Democracy.

Also joining us today is Adam Unikowsky, who is the partner at Jenner & Block's Appellate and Supreme Court Practice Group, where he's worked since 2011. His areas of focus include aerospace and defense, appellate and Supreme Court communications, internet technology, life sciences, Native American law, patent litigation and counseling technology, and AI. Prior to his time at Jenner & Block, Mr. Unikowsky served as a judicial law clerk to Justice Antonin Scalia. He also previously clerked for Judge Douglas Ginsburg at the U.S. Court of Appeals for the D.C. Circuit.

Finally, joining us today as our moderator is Jennie Lichter, who is currently Deputy General Counsel at the Catholic University of America and a Senior Fellow at the Religious Freedom Institute. She previously served as the White House Deputy Assistant to the President and Deputy Director for the White House Domestic Policy Council. Prior to her White House service, Ms. Lichter -- excuse me -- worked on policy issues and federal judicial, including Supreme Court confirmation efforts at the Office for Legal Policy at the U.S. Department of Justice. She previously served as in-house counsel for the Archdiocese of Washington and as an associate at Jones Day. And I'll leave it there.

One last note. Throughout the panel, if you, our audience, have any questions, please submit them via the question and answer feature, which can likely be found at the bottom of your Zoom screens so that our speakers will have access to them when we get to that portion of today's webinar. With that, thank you all for being with us today. Ms. Lichter, the floor is yours.

Jennie Bradley Lichter:  Thank you, Chayila, for the introduction and for setting us up for what I know will be a great conversation. And good afternoon, everyone. As Chayila said, we're here to discuss the ongoing litigation over the FDA's approval of and parameters for the use of the drug mifepristone, which is the first step in the standard two-drug regimen for chemical abortion.

If that topic is not what you thought you were getting, you are in the wrong webinar. But we hope you're going to stick with us. And before we get into the meat of the discussion, I'm going to take just a few minutes to set the stage by briefly reviewing the litigation history, and then I will step aside and we'll hear from Adam and Tom.

So in November 2022, an organization called the Alliance for Hippocratic Medicine filed a lawsuit in the Northern District of Texas along with other plaintiffs, including a handful of other medical organizations and several individual doctors. The plaintiffs claim that the FDA's 2000 approval of mifepristone and then several subsequent FDA actions over the years—loosening its conditions of use, essentially—were unlawful under the APA. I believe that our panelists are going to provide some more details about those other key regulatory actions that are under review here.

And the plaintiffs moved for a preliminary injunction asking the FDA to withdraw or suspend that original approval from 23 years ago and the relevant subsequent agency actions. On April 7 of this year, the district court granted the plaintiff's request, staying the FDA's approval of mifepristone. It simultaneously stayed the applicability of its own order in anticipation of an emergency appeal from the government. And that emergency appeal by the government to the Fifth Circuit was indeed quickly forthcoming.

On April 12, the Fifth Circuit granted, in part, the government's request for a stay of the district court order pending appeal. The Fifth Circuit panel specifically stayed the district court order as to the 2000 approval—the plaintiff's challenged, to which it determined to be time barred—but it declined to stay the district court's order as to the FDA's subsequent relaxation of some of the original parameters and conditions of use. So it can be a little hard to keep track of stays on top of stays on top of stays.

So what does this mean concretely? It means that after the Fifth Circuit ruling, mifepristone could remain on the market but with the circa 2000 parameters in place. Okay.

Next, the government then asked the Supreme Court for a stay, which it granted. On April 21, the Court put in place a stay of the rulings below pending the Fifth Circuit appeal and disposition of an eventual writ of cert if one is ultimately sought. Justices Thomas and Alito registered their dissent. In other words, they would have denied the stay.

Justice Alito wrote for himself to explain his rationale. And again, I believe our panelists will have more to say about that. So, practically speaking, the Supreme Court stay leaves in place the status quo, that is, mifepristone is on the market under the same conditions as it was on the day the lawsuit was filed.

Meanwhile, oral argument was heard in the Fifth Circuit on May 17, and we are still waiting for that decision. There's a lot to discuss here with regards to this litigation—a lot of legal weeds in which to wander, if you will. There are really interesting legal questions about standing, timeliness, exhaustion, separation of powers questions perhaps, and then, of course, the cultural impact of the wide availability of mifepristone and of the potential impact of pulling it off the market.

Our panelists are each going to give opening remarks, starting with the big picture—maybe getting to some of the legal weeds—but starting at least, in part, with, what is this case that has gotten so much media attention? What is it really about? Then I will ask some follow-up questions, and then we are looking forward to taking some questions from viewers.

I think we're going to start with Tom Jipping. So, Tom, please, go ahead.

Thomas Jipping:  Thanks, Jennie, and it's good to be here with everybody and with Adam. The anniversary of the Supreme Court's decision in Dobbs v. Jackson Women’s Health Organization regarding the right to abortion is just a few days away. And everybody has seen, in that context, how easy it is for politics to sort of overwhelm everything else, especially when it's court cases that are involved. And that's certainly the case with the litigation we're talking about now.

I perused a few headlines about the litigation over mifepristone, and one of them said, “No drug is safe. Drug developers decry Texas abortion pill ruling.” Another headline, “Abortion ruling could undermine the FDA's drug approval authority.” Neither one of those is true. The sky is not falling.

This litigation is not about whether abortion drugs should be legal, whether they're safe. It's not about how abortion drugs should be regulated or whether the FDA was right or wrong in 2000. The litigation is about whether the FDA followed the law in making those decisions, the ones that Jennie referred to, the original approval and the subsequent decisions to drop the safety rules regarding -- so this is about how those decisions were made, not what those decisions are.

I know that it's sometimes difficult—especially if you really feel strongly about an issue—to separate those two. And it's probably harder than ever for folks in our society to separate the political from the legal. But it's really important in this case because the one headline said, “Abortion ruling could undermine the FDA's authority.”

Well, requiring the FDA to follow the law—which is what this litigation is about—can't undermine its legitimate drug approval authority. That's where its authority comes from. Several aspects of how the FDA approached those decisions do raise red flags, and that's why medical groups filed what's called a “citizens petition” two years after the approval in 2002.

The original decision was made under a fast-track regulation that's intended for drugs to treat life-threatening illnesses, like HIV or cancer. And, of course, pregnancy itself is not a life-threatening illness. The FDA does not really -- does not approve drugs in the abstract. They say that they're safe and effective for certain proposed uses under particular circumstances.

And arguably, the FDA did not study mifepristone under the actual circumstances of its proposed use before giving its “okay.” For example, the FDA approved mifepristone for all pregnant women, but they didn't have any evidence as to its effect on minors. The FDA dropped safety rules by citing research of mifepristone’s effects with those safety rules in place.

It's some of those kinds of things that have raised serious questions about whether the FDA properly went through the decision-making process. Jennie mentioned the case up in Washington, Washington State v. FDA. Some of the coverage has suggested that they're virtually identical cases. They just came out different ways. But they're really not identical cases at all.

The Texas plaintiffs are doctors, and they were seeking to reinstate certain safety rules. The Washington plaintiffs are states, and they're seeking to eliminate all safety rules. And the U.S. district judge in Washington had some pretty critical things to say about the FDA and what it did with regard to approving mifepristone. I'm just quoting here.

It said, “The FDA did not assess whether mifepristone qualifies for these safety rules based on the criteria set forth in the statute. It appears FDA failed to consider important aspects of the problem. The record demonstrates potentially internally inconsistent FDA findings regarding mifepristone’s safety profile.” So it's not just the plaintiffs in the Texas litigation that have raised some really serious questions about the FDA's decision-making process for this abortion drug.

And then one other issue that has come up in the litigation. It was also raised in the oral argument—most recently in the Fifth Circuit, and that's what's referred to as the Comstock Act—that is, a nineteenth century statute that prohibits -- and it's codified today as 18 U.S.C. 1461. It prohibits using the mail to send any article or thing that is designed, adapted, or intended to produce abortion.

Now, the reason that's relevant to this litigation is that the APA says that a court shall hold unlawful and set aside agency action found to be not in accordance with law. The Supreme Courts recognized that, too, and said that that means any law.

So when the FDA approved mifepristone in 2000, when it took its other decisions in 2016, for example, the rules under which mifepristone was to be distributed and used involved using the mail. So if the Comstock Act means what it says, then the FDA approved a distribution regime for this abortion drug that is “not in accordance with law.” So that's why that issue has also come up, and I think it will have to be addressed going forward as well.

The issues -- and I know Adam will address some of these as well. There are obviously some procedural or jurisdictional issues that have already been addressed as the case went through the district court in the Fifth Circuit—issues like standing and timeliness and exhaustion.

It's interesting that in the 21 CFR in the Code of Federal Regulations, it says, “It's the position of the FDA that an interested party is affected by and thus has standing to obtain judicial review of final agency action.” When the FDA denied or rejected the citizen petitions challenging these actions, those were final agency actions. And according to the FDA's own regulations, that gave these parties standing. And there's several other standing issues as well.

The Fifth Circuit did recognize—as did Judge Kacsmaryk at the district court level—that both individual doctors and these associations of doctors have a standing to challenge these agency decisions. And also on the issue of timeliness, there is a six-year statute of limitations on going to court after a final agency action for whatever reason. Even though federal law requires the FDA to respond to citizen petitions within 180 days, they waited 14 years to respond to the 2002 petition regarding the original approval.

I don't know how an agency is held to account for something like that—FDA certainly hasn't. Except that now, it does affect the statute of limitations, the six-year window, that an interested party has to seek judicial review of an agency action or a final agency action. And that raises an obscure administrative law doctrine called the “reopening doctrine”—whether a subsequent decision regarding, in this case, these drugs, was of the kind that could be said to have reopened the original approval, which would restart with the six-year statute of limitations.

It's interesting that the Fifth Circuit, that was the one issue that they disagreed with the district court on, but they were very tentative in their decision. They said that it was a “close question” whether that idea of reopening was valid here and that “plaintiffs might very well prevail on that claim later in this litigation.”

And they described how when the FDA took its subsequent decisions regarding the safety rules—2016, 2019—that they went way beyond what the citizen petitions asked them to and did a full review of the entire safety rule regime and that that could be considered a step that reopened the original 2000 approval of mifepristone. And therefore, the lawsuit with regard to its original approval could still be timely. So there's all of these issues.

There were some writers, including Adam, who before this started were very certain that there was just no merit to any of these issues. But the first two steps, the courts have agreed with the plaintiffs here that they do have standing and that there's real questions about whether the FDA complied with the APA.

So I just want to reemphasize that this isn't about abortion per se. It's not about abortion drugs per se. It's about whether the government -- the government certainly requires us to follow the law, and it's about whether the government has to do so as well.

When it goes through decision making processes, you got these powerful administrative agencies making decisions about things that affect millions of people's lives. I think people assume that the government's going to follow the law when they do that. This is one of the case -- the kind of cases that really test whether that has happened. I'll stop there and hand it over to Adam.

Adam Unikowsky:  Great. Thank you for that introduction. Let me just first begin by thanking The Federalist Society for inviting me. I definitely appreciate The Federalist Society's commitment to the free exchange of ideas, and I really think it's great to have open debate over the very significant issues presented by the litigation. Also, thank you to Jennie for moderating and such a distinguished co-panelist, Thomas. So I really am pleased to be here this afternoon.

So let me begin by a point of raging agreement with my colleague, Thomas. I do agree that this case is not about abortion. It's not about the morality, the ethics, or the safety of abortion. It's not even about the morality, ethics, and safety of mifepristone. It's about the specific legal issues that have been raised.

And I think that we're both totally in accord that although members of the public citizens can debate the morality, safety, ethics of abortion, the task of the courts in this case is to resolve the particular legal contentions raised by the plaintiffs according to law. And I think the concern that I guess me and other observers have had is that the Court isn't doing that.

And Justice Scalia—back when the courts were composed very differently—frequently used to express concern that the Court's jurisprudence was skewed in abortion cases in a pro-abortion direction. As he said in his celebrated dissent in Hill v. Colorado, “The jurisprudence of this Court has a way of changing when abortion is involved.”

Now, of course, he was saying in that case that the Court was too pro-abortion and was skewing from neutral principles. But his view is that the Court should apply principles neutrally. And I think that's just as true here, even when perhaps there's a concern that the courts have skewed too much in the other direction.

So I do think that the plaintiffs’ claims have some significant flaws. And it was a case that wasn't about abortion, they wouldn't win, in my view. So let me begin with standing. So the plaintiffs have a strong philosophical and ideological disagreement with abortion, and that's fine. They are certainly free to associate and express their views and persuade their fellow citizens.

But to win a lawsuit, it's not enough to just believe something. You have to be personally affected by whatever it is that you're challenging. And on this issue, the plaintiffs’ claim is quite a bit weaker. The plaintiffs are organizations of pro-life doctors as well as some individual doctors. But the plaintiffs do not prescribe mifepristone. There's no law requiring them to do that. Their patients don't take it.

They allege that they have standing because of the theoretical possibility that the following things will happen in sequence: A different doctor will prescribe mifepristone to some patient. The patient will have some adverse impact. The patient will sort of randomly, at that point, decide to switch doctors and come to the emergency room or some other doctor. And then the plaintiffs are going to see those patients.

There will be no way for the plaintiffs to take advantage of conscience rules that allows them to refer them -- the patient to another doctor. They'll have absolutely no choice but to see the patient. And then they'll perhaps save the patient's life, and this will divert their attention away from their other patients. Or maybe they'll feel complicit in the fact that the patient decided to take the drug previously. And therefore, they are harmed because of the theoretical possibility that one of those patients will switch doctors.

So there's a lot of problems with this theory under existing standing law. So to begin, the actual specific claims in the declarations by the plaintiffs are quite weak. None of the plaintiffs have actually ever even attested they've ever even seen a patient who had an adverse reaction from taking one of these drugs.

The Fifth Circuit's order quotes a statement from a declaration from a doctor saying that she had done that. But if you actually go to the declaration, she's actually quoting the fact that someone else did so. And at the oral argument in the Fifth Circuit, I think that the lawyer for the plaintiff said something like, “Well, these are citizens. They're not drafted by lawyers. You have to construe them broadly.”

But, I mean, the plaintiffs are very sophisticated. They're the leaders of pro-life organizations. They're represented by sophisticated counsel. I mean, if they can't even say in their own declarations that they had never seen a patient under these circumstances, it's very hard to show that they're going to be harmed.

But second, even just taking a step back, the Supreme Court has required a strong showing of certainly impending harm. And it has rejected the view that a large organization can establish standing merely by speculating that one member in the organization statistically might be harmed by a particular rule, which is this case, at least in my view.

And taking one further step back, I think this case really does implicate substantial separation of powers concerns. I think there's legitimate reasons to be concerned that, essentially, one group of plaintiffs and one federal district judge can dictate abortion policy for the whole country based on a somewhat evanescent, ephemeral concern about the speculative possibility that they might someday see some patient.

And to say that all women across America should be banned from taking mifepristone—which is essentially the relief the plaintiffs are asking for—merely to ward off this very speculative risk that one woman somewhere in the country will take the drug, have a reaction, randomly switch doctors, randomly show up in the emergency room, and therefore, one of these doctors will see them, and then their attention will be diverted from some other patient, it just doesn't strike me as the way to make abortion policy for this nation.

And it just seems to me that separation of powers, principles in Article III are designed to prevent that type of court order from taking over national policymaking. And let me just say one more word about the merits.

There are some important issues about the reopening doctrine that Thomas raised. But actually, the Fifth Circuit stayed the portions of the order that relate to the reopening doctrine. So I don't want to take up too much time here. Let me turn to some of the merits issues because the Fifth Circuit concluded that the plaintiffs had sufficiently a likelihood of success on their claim that certain decisions made by the FDA in 2016 were arbitrary and capricious.

So in 2000, the FDA approved mifepristone period, and in 2016, the FDA loosened certain restrictions on the use of it. Specifically, it increased the gestational age limit from 49 to 70 days, reduced the number of required in-person clinics visits to one—so you can take the second drug at home—and then allowed non-doctors to prescribe it.

So the Fifth Circuit said, basically, that the FDA just didn't consider safety enough. But if you actually look at the FDA's order, it's extremely extensive. On the first question involving 70 days gestation, it analyzed studies with over 30,000 women. On the second question regarding the number of in-person visits, it analyzed 11 studies with over 30,000 participants. On the third question about non-doctors, it analyzed 4 separate studies with 3,200 women in randomized controlled clinical trials.

The FDA also recognized that some of the changes were interrelated. So it specifically used data from certain studies for evidence on multiple changes. It's an extremely thorough analysis. And there's a concern that if that's not enough, if that's arbitrary and capricious, then, really, the Court's decision does jeopardize other safety decisions because the FDA's decision is very thorough, and it's typical of the types of thorough decision making it makes in other contexts.

So either the courts were applying an abortion-specific rule that this is not safe enough for an abortion drug—even though it would be safe in other contexts, which it shouldn't do in a case about administrative law—or the court was jeopardizing lots of FDA decisions if all these studies really weren't enough to get over the APA. And let me wrap up there and turn it over to the next stage of the webinar.

Jennie Bradley Lichter:  Thank you both. As we said at the outset, there's a lot to get into here. So these both very thorough openings gave us an orientation to a lot of the issues. There's actually a lot more left to talk about.

So we'll continue to dig into the Texas litigation. But let's pivot first so that we're fulfilling our assignment by The Federalist Society to talk about the dueling decision so called—the dueling decision being the Washington decision that Tom did discuss briefly: the district court decision coming out of Washington State that was issued on the same day as the Texas District Court decision within just a few hours of each other.

As Tom said, the cases are being sort of paired, if not conflated, in the public narrative because they are both about the FDA's approval of mifepristone and conditions on use. But the plaintiffs and the questions presented are quite different.

Adam, do you want to add anything about the Washington case to what Tom said earlier, just to make sure it's thoroughly on the table as we continue the conversation?

Adam Unikowsky:  Sure, yeah. So I think it's quite natural that they'd be paired together in the public attention. I mean, they're on the same topic. These decisions came out the same day. It's hard not to treat them as a unit. The Washington case involved arguments that were sort of almost the exact opposite of the arguments in the AHM case.

Essentially, the Washington case said that the restrictions were too severe. And so, not to get too technical here, but the FDA has this REMS program for certain types of particularly dangerous drugs. It stands for Risk Evaluation Mitigation Strategies. So only a fairly small percentage of drugs are subject to the REMS, such as fentanyl, certain antipsychotic drugs, and others. And mifepristone is one of those.

And the plaintiffs, in that case, basically say that mifepristone is really safe, and REMS is unnecessary. So, in one case, they're saying that the safety restrictions aren't enough, and in the other, they're saying it's too much.

And so, in the second case, the district judge issued an order basically freezing the status quo the same day that the Texas judge issued an order that altered the status quo. So everyone was a bit confused about that, which is one of the reasons it went to the Supreme Court so quickly. That case also presents some challenging issues in terms of questions like exhaustion.

There's a good argument—at least that the government made—that the FDA didn't -- that the plaintiffs didn't exhaust. Standing also is a complex issue. Washington was relying on its own expenditures, which raises issues that are also in a Supreme Court case this year. I think the interesting thing about that case is that the FDA actually really did defend against the preliminary injunction motion. I mean, the FDA wrote a pretty strong brief saying Washington claims didn't have merit. So the FDA is, I think, fighting both cases pretty hard.

The administrative law issues in that case are difficult, and they're just very different from the Texas case. But it is the case that if Texas loses its case, that case will still be litigated as well, and that'll present a host of other interesting administrative law issues.

Jennie Bradley Lichter:  Great, thank you. Next question. I'm going to direct this one to Tom, if you want to speak to it. Adam talked a little bit about the merits and then the remedy in Texas.

And Adam, per your framing—if I'm getting this correct—it's one single district judge shouldn't be permitted to set abortion policy for the entire country on the basis of these sort of hypothetical harms presented by this particular group of plaintiffs? This, in my mind, of course, raises the question of what is sometimes referred to as “nationwide injunctions” as the kind of broad term used for this issue set. But the question of what is the right scope for a remedy in an APA action, right?

When we're talking about agency action, what is a court to do? What is a district court to do, essentially, when faced with what the Court is determining to be a flawed process that violated the APA in some ways?

Tom, do you want to talk to that at all? I know this is an issue that's not -- it's specific to this case in a sense that I think it comes up in the context of this case, but, of course, also relevant in many, many other cases in the last few years too.

Thomas Jipping:  Well, nationwide injunctions are controversial. And we've had events here at the Heritage Foundation looking at that. And it is a significant degree of power where a district judge, whose technical jurisdiction is one state or part of one state, and the effect of that then reaches nationwide. And the judge in Washington did not grant a nationwide injunction there. It was more limited.

At the same time, that's what the appellate process is for. And this, of course, has already been now the second time in the Fifth Circuit, will very likely go to the Supreme Court. So Judge Kacsmaryk will not have the last word on that nationwide injunction. But they are controversial.

I mean, at different points of the ideological spectrum, when litigators are pursuing their cause in court, depending on whether they think they'll have an advantage or not, they either like or dislike nationwide injunctions. But that is one aspect of this that we'll have to get a final verdict on from the appeals courts.

Jennie Bradley Lichter:  Absolutely, right. And the Supreme Court hasn't spoken directly yet, I believe, to the validity of a so-called nationwide injunction, right?

Thomas Jipping:  Yeah, and not in general across the board.

Jennie Bradley Lichter:  Exactly, exactly. A really interesting question. Adam, do you want to say anything else about the remedy, the scope of remedy, or are you good on that?

Adam Unikowsky:  Sure, yeah. So the question of nationwide injunctions and vacatur of agency actions is actually a very, very difficult question. Actually, there's a pending Supreme Court right now, United States v. Texas.

We're going to get a decision potentially this week or next week in which one of the issues that was litigated was whether a court has the power to vacate a rule or whether it only has the power to enjoin the parties. It's part of a technical question, but it's actually quite related to what exactly the court has the power to do in an administrative law case.

I completely agree with you, Thomas, that hostility or love of nationwide injunctions completely depends on who the president is. I mean, we've seen that the immediate -- the day the administration shifted in 2021, suddenly, people started going from loving to hating nationwide injunctions and vice versa.

I agree that Judge Kacsmaryk’s opinion eventually is going to be in the past. It's going to reach the Fifth Circuit and ultimately the Supreme Court. So the concern about one judge dictating policy is maybe a little overstated, but I think that it’s -- they're still concerned about a small set of plaintiffs in some sense dictating nationwide policy with sort of a small, seemingly not the most important interest in the debate, dictating the outcome.

And, to me, that's why the standing issue is of particular significance. Article III, as the Supreme Court has always said, is an important portion of the aspect of the separation of powers. And one of the reasons we require standing is, in some sense, not to allow plaintiffs with a high degree of ideological interest, but a low actual stake to bring cases to court and sort of force decisions out of courts. And so that's why I think standing is one of the concerns in this case.

Jennie Bradley Lichter:  Great, thank you. All right. Now, I'm going to ask you both to go out on a limb and make a prediction here, if you're comfortable assuming, as I think we safely can, that the Texas case, at least, will certainly make its way back to the Supreme Court after the Fifth Circuit rules and that this case will be on the regular docket presumably in the next term. What do you think?

I'd love to hear from you both about what you think the outcome will be when the case gets back to the Supreme Court in the normal course. And here, I think we're probing, or you could speak to both what you think the correct legal outcome is and what you think this particular Supreme Court will decide. And those might be the same thing, but they might not, depending on your perspective, right. So, Tom, do you want to go first?

Thomas Jipping:  Well, if I could confidently predict such things, I'd probably have a different job. And I've always had a little trouble distinguishing what I hope will happen from what I actually think will.

Some of the things that would be beneficial in a final ruling—the issue we were just touching on about national injunctions and clarification about some of these standing issues in this kind of a context—I think the right decision and what I hope will happen is that the problems that have occurred -- and I know, Adam, you were referring to some of the numbers of studies and so on.

It's not so much the number of studies or the number of participants but what those studies were about. And here, there are real questions about whether there was evidence for safety and effectiveness in the circumstances for which this drug was proposed to work. And I think it would be beneficial for the FDA to do it right. If everything that the FDA and advocates on that side of the question are saying is true, doing it right will end up with approval of this drug.

But there are many, many questions about whether—not just whether the Supreme Court is political. There are polls that show people are kind of skeptical about that—but whether these executive branch agencies are politicized and are making decisions to further an agenda. And I think maybe it would help if we said, “Look, these are real problems and real questions and real doubts. And the FDA ought to go back and do it carefully and do it right this time.”

Adam Unikowsky:  So I guess it's my turn to make a prediction, is that right?

Jennie Bradley Lichter:  That’s right.

Adam Unikowsky:  So, as they say, predictions are always hard, especially about the future. And if I was better at making predictions, I also would certainly have a different job. I'd probably be retired at this point. Plus, people ask me to make predictions, and I'm almost always wrong. So just keep that in mind.

We do have some tea leaves that are worth something, which is the Supreme Court's stay order. There are no opinions. We don't know what they actually thought. However, the applicable legal standard requires consideration both of the likelihood of success in terms of getting cert granted and the likelihood of success on the merits.

And so we see a majority of the Court, at least five -- there's only two public dissenters. In principle, there could have been other silent dissenters. But at least five members of the Court did vote to stay.

My best guess—although I have no insider knowledge whatsoever—is that the Court -- the justices felt there's likelihood of success that the plaintiffs wouldn't have a standing because that issue was fully and thoroughly litigated and erred in the briefing. And if they think that, I guess it's possible more further briefing would change their views. But I think the issues were pretty aired pretty well.

So if I had to guess, I'd say that the Supreme Court would stick with its initial tentative view that there isn't standing and not resolve any of the merits’ issues and the administrative law issues at all. But that said, again, there's no opinion from the Supreme Court. It's a stay order, and so one cannot be confident in that prediction.

Jennie Bradley Lichter:  I think it'll be fascinating to see if and when the Texas case does get back to the Court, as you both said, what specifically are they going to focus on, right? And does it ultimately turn into a standing case, and the rest is all sort of secondary?

Is the timeliness issue -- the timeliness, as I think Tom mentioned, is really the one main thing in which the district court in Texas and the Fifth Circuit parted ways, right? What does that end up looking like later on in the litigation? So it'll be very interesting to see what happens when it gets up there.

We would welcome questions from viewers at this point—particularly questions in the form of questions would be most welcome—and I'd be happy to pass those on to the panelists. But in the meantime, Adam, question for you.

I'm going to put you back on the hot seat to respond to something that Tom mentioned in his opening, I believe, which was among other allegedly bad acts by the FDA or improper, arbitrary, and capricious actions, was this a 14 -- I believe it's a 14-year delay in responding to one of the citizen petitions that becomes kind of teed up the litigation, so to speak.

And you'll have to remind me what the law requires. Is it a six-month response? Is it 180 days? I think that the law said -- right. Okay, 180, right. So the law tells the FDA, “You have X amount of time to respond to a citizen petition.” The FDA, at least in this case—maybe all the time. I don't know but just blows past -- way blows past that—how -- what is the remedy for that?

If you are a citizen who's waiting for 14 years for a response to your citizen petition—which is an important step in exhausting your administrative remedies—how do we hold the FDA accountable for letting 14 years go by without responding?

Adam Unikowsky:  Yeah, so I'm not familiar with the circumstances of the delay. It sounds really long. I mean, I can't defend 14 years, and I don't know why it happened. I don't have personal knowledge of that.

If an agency is delaying, I think that you can bring an APA claim while the delay is pending saying something like, “You've waited too long. You have to act right now.” Sometimes, a mandamus action saying, “You have a statutory deadline. You've got to follow it.” I agree. Agencies who delay inordinately should be held accountable in court. I completely agree.

But what happened was, after the 14 years—this epic delay—that actually started the 6-year clock to start the -- to challenge the 2000 action. And the plaintiffs actually didn't even sue in the six-year clock. So they had from March. I think it was ’14 until March of ’20 to file their suit, and they actually didn't file in that deadline.

That's why, in my view at least, the suit was time barred. I agree they shouldn't be punished for the FDA's own delays. But if the clock is delayed until 14 and they don't sue in the 6 years after that, that's the basis of dismissing the suit. But I agree that long delays -- I mean, I can't defend that.

Jennie Bradley Lichter:  Right.

Thomas Jipping:  And the FDA actually had two of those, not only the 14 years following the first citizens’ petition, which was filed in 2002. But then when the FDA dropped safety rules in 2016, some of these same groups filed a citizen petition in 2019. And the FDA waited 2 more years—which is multiple times greater than 180 days—to respond to that as well.

Now, I mean, as we discussed already, that timeliness issue involves that reopening doctrine. So you have to look at the substance of this agency's subsequent actions to see whether that constructively or effectively reopened the original -- either the original approval or the 2016 action. So that kind of affects the analysis of that particular issue.

But one of the ways that you deal with it is the way the Court -- the Fifth Circuit is dealing with it, which is the FDA's decision to wait a total of almost 17 years to respond to citizens’ petitions in these cases has consequences because the Fifth Circuit said that exhausting administrative remedies, there's an exception to that when the agency itself has abused its own process and has not followed its own rules.

So one of the things that the courts can do—which looks like they're doing here—is to say, “Look, you can't take whatever time you want to respond to this and then turn around and say, ‘Whoops, the windows closed. You can't sue us on this now.’” So I don't know what the explanation is for that. They didn't miss it by a week or two. They missed it by a decade or two, and that ought to have consequences.

Jennie Bradley Lichter:  Thank you. All right, let's circle back to standing, which we've talked about a few times. Great question from a viewer. “If standing is the fatal flaw in this case, who would have proper standing to sue?” Adam, I think you think that the plaintiffs, as you've said, don't have standing.

Tom, I imagine you would agree with the Court so far that they do. But imagine that it turns out the Supreme Court says they don't have standing. Can either of you speak to who would be the proper plaintiffs in this case?

Thomas Jipping:  Well, I wanted to clarify just a little bit what that -- what their standing argument is. It's not simply some women will switch doctors. In fact, the Fifth Circuit was quite firm in saying that it was certain that the number of women—especially as the FDA is dropping their safety rules—it is certain that the number of women who would have to seek emergency care for complications will go up.

The Court asked if non-doctors are prescribing this and then there's complications, who's a woman supposed to go to? The non-doctor? No, they'll go to the emergency room. And that members of these doctor associations are emergency room doctors. So it wasn't just a statistical probability or a likelihood—at least according to the Fifth Circuit. It was a certainty that that was going to happen.

So I think it was firmer than what Adam was describing, and not just they might switch doctors and that doctor might be one member of this association. So I think clarifying that standing argument is very important.

Jennie Bradley Lichter:  Okay. And Tom, so you do think they do have standing, that the courts have been correct?

Thomas Jipping:  Well, they had, I think, four different theories of standing. We don't have time here to discuss all of them. But the Fifth Circuit found that the individual doctors had standing, that there's associational standing, there's organizational standing. So yeah. One or more of those theories, I think, is legit.

Jennie Bradley Lichter:  Great, thank you. Adam, who would be your proper plaintiffs?

Adam Unikowsky:  There might not be one in this case. It seems counterintuitive. And it's so interesting how the polarity of these issues has changed. I'm not that old, but I'm old enough to remember when it was a Democratic leaning or liberal-leaning organizations who would have these very expansive views of standing.

Thomas Jipping:  I am.

[Laughter]

Adam Unikowsky:  Often, it was in establishment clause cases back when views on the establishment laws were different. And the argument was made that, “Well, someone has to challenge this improper expenditure of tax expenditures and things like that to religious organizations. And so it's got to be us, a taxpayer, who's morally opposed to spending money on religious schools and things like that.”

And there's some Supreme Court cases saying, “Not necessarily.” Judges are supposed to resolve cases or controversies that come in front of them. And if there's no one that has standing, then the issue will just be left to the political process. It's possible someone has a standing that I haven't thought of because there's lots of people who are more creative than me, but no one immediately comes to mind.

A woman who was allegedly injured by the drug wouldn't have a standing because they're seeking only forward-looking relief. They can't seek damages from the FDA. And so it's quite speculative that they use it again. So that person probably wouldn't have a standing to challenge the approval.

I don't think these plaintiffs do. It's not obvious who does, in my personal judgment. And that just may mean that the legislative and executive process are what solves the problems that are asserted.

Jennie Bradley Lichter:  Adam, do you think that could be relevant to a possible Supreme Court analysis of standing, either explicitly or implicitly, this looming sense that, “Well, maybe there isn't anyone else”?

Adam Unikowsky:  It could be. Well, I actually don't think it should be explicitly important at all. Actually, my personal view is that it's just irrelevant who else might have a standing. I mean, the Court has to resolve the facts in front of it. If this plaintiff doesn't have standing, that's the end of the story—regardless of other hypothetical plaintiffs. If the Court feels that it needs to rule on this and doesn't think it's going to do any better in terms of a plaintiff, it could affect the judgment, but I don't think it should.

Thomas Jipping:  I agree with Adam that “if not us, who?” is probably not the right rule for establishing standing. And that is what courts do is they decide the legal dispute in front of them with regard to the parties, the issues, and the facts that are in that case.

Jennie Bradley Lichter:  Good, thank you. All right, I'm going to take another audience question that came in for Adam, but I'll ask you again to both speak to it. This is circling back to the Comstock Act, which Tom mentioned at the top, and maybe we haven't spent enough time probing because it's an interesting wrinkle in thinking through the use of mifepristone.

Question: “Assuming that the courts can ultimately reach the merits in this case, was it arbitrary and capricious for the FDA to not consider the Comstock Act in making these approvals? And if the answer is not—in other words, it was not arbitrary and capricious—perhaps because Comstock was not enforceable prior to the Dobbs decision, were the FDA to reconsider mifepristone or the existing REMS, would the FDA be obligated to consider the Comstock Act now?”

Adam Unikowsky:  So I don't think it was arbitrary and capricious because I think there's an exhaustion problem. Perhaps because of the then state of constitutional law, no one ever raised the Comstock Act issue to the agency. So I don't think that the agency was obliged to respond -- to consider this legal issue. Even in the challenge to the 2016 decision, again, the Comstock Act issue was not raised.

There's an agency regulation requiring exhaustion, which wasn't satisfied. So that's my somewhat boring answer. Hypothetically, if the issue were raised, I think an agency is required to answer questions that are raised to it. I think there's a number of ways the agency could have resolved it.

It could say, “Okay, well, our bailiwick is not to consider federal criminal laws. All we have to do is consider health and safety,” or it could say, “Fine. We'll approve it, but it just can't go through the mail or common carriers, which is what's regulated by the Comstock Act.”

Or the agency could say that we agree with the Biden administration's OLC's view that, in fact, sending the drugs doesn't violate the Comstock Act, which is a debatable proposition as well. And then whatever rationale the agency uses could be challenged in court. I agree under the APA.

Jennie Bradley Lichter:  Tom, do you want to say anything more about that?

Thomas Jipping:  Well, one of the possible answers by the FDA that Adam mentioned that they're only responsible for the laws that they themselves enforce. The Supreme Court clearly has foreclosed that. The precedent that I referred to, it's called “NextWave Personal Communications [inaudible 47:00].

From 2003, they said that the Administrative Procedures Act requires federal courts to set aside federal agency action that is not in accord with the law—which means, of course, any law—and not merely those laws that the agency itself is charged with administering. The applicability of the Comstock Act, I think, is an important issue.

Along with whether you like or dislike nationwide injunctions, if you like or dislike a statute, you'll call it either “on the books” or “arcane,” I suppose. But that is an important issue. The Office of Legal Counsel of Justice did put out an opinion earlier this year. I wrote a paper on that which the Heritage Foundation published. OLC didn't even attempt to interpret the Comstock Act. They simply made a case for why they think the Comstock Act should mean something other than what it says.

So I think it's an opportunity to address a statute like that, which is -- and I worked in the Congress for 15 years. I saw a lot of badly written statutes. This one's pretty straightforward. And so I think that issue is important as well. And the plaintiffs here did raise it in the district court and in the court of appeals.

Jennie Bradley Lichter:  Great, thank you. All right. Let's talk about a question that goes to -- an audience question that goes to the arbitrary and capricious analysis, I believe, is what this is getting to. Circling back, Tom, to, again, to your discussion in your opening about problems with the studies that the FDA focused on in its judgment about the safety and effectiveness of administering mifepristone.

So the viewer says, “You have said several times it was problematic for the FDA to make a judgment about safety and effectiveness in situations that had not been studied.” In other words, Tom, as I think you explained, the FDA was looking at studies about safety and effectiveness with certain parameters in place—certain conditions of use in place. Based on those studies, it decided to remove the parameters moving forward.

The viewer says, “Doesn't this misstate the relevant standard under the APA? The law does not require studies that examine counterfactual. And if it did, this would preclude agencies from ever being able to relax regulatory restrictions on any technology because it's just not possible to study the use of a technology without existing the regulations -- without relaxing the existing regulations around it.” Does that make sense? A little bit of a circuitous question.

Thomas Jipping:  I think that characterizes the issue in a particular way that maybe this supports this viewer's opinion. But that doesn't mean that the FDA can approve a drug -- and this is an initial approval. This isn't a subsequent review or something along that line.

I mean, if you want to look at subsequent decisions, 2016, the FDA says that doctors no longer have to report non-fatal medical complications. And then 2021, they dropped the in-person dispensing requirement, in part, because there's no evidence of non-fatal adverse events. But the original application --

There, the burden is on the manufacturer to show that that drug is safe and effective for the intended use under those proposed circumstances. They can't just have nothing. They can't simply, “Well, we sort of extrapolated something.” And I gave the example of the drug was approved for, at that time, up to seven weeks of pregnancy, but there was no evidence of its impact on minors who get pregnant and would presumably use the drug.

So it can't be nothing. And in this case, there are just these glaring kind of empty spaces where there was just simply no evidence where, given the standard that the FDA has to follow, you think they would have to.

Jennie Bradley Lichter:  Adam, do you want to say anything else about the type of evidence that you think is appropriate or required?

Adam Unikowsky:  Sure. So first of all, in the 2016 decision, the FDA actually did look at quite a lot of studies involving the relaxed conditions from foreign countries. So, of course, it couldn't look at American studies because it was illegal to do those things in the U.S. So most of the studies it looked at were maybe almost all of them were foreign.

And so it actually did have a fairly abundant body of evidence regarding the effects of these changes. So I think it's just hard to say that it was arbitrary and capricious to make these changes in view of the evidence before the FDA. More generally, I mean, the FDA is given a lot of flexibility in how it makes decisions.

There's a statute that says something like it can consider any information in making its decisions. Of course, it has to act rationally. But there's no strict rule saying it has to consider evidence that's exactly the same as what's on the label, and it ultimately has to make inferences on the basis of the data before it.

And one of the concerns about the case is that the Fifth Circuit was requiring, basically, the perfect study—which will absolutely never exist—and saying that the FDA can't act without it. And it's not clear to me it would have applied such a rule outside of an abortion case, which is one of the concerns that many people had about the case.

Thomas Jipping:  Right. And I don't think they were talking about the perfect study. But questions about whether research or data from other countries under other conditions in other regulatory circumstances, I think there's a real question as to how applicable that is. It's one thing to make inferences about research that's done here for purposes of our regulatory process. It's another to go elsewhere in the world.

And the Fifth Circuit did address this. They said, “It's one thing to talk about just one little issue in isolation, but you have to look at it in the context of all of the REMS, all of the safety rules in combination.” And you really can't come to a conclusion about that by looking at a study from another country.

Jennie Bradley Lichter:  All right. We have just a few minutes left. Before we wind down, would either of you like to say a final word, any final point that we haven't circled to, or following up on something the other panelist said? Adam, you can go first.

Adam Unikowsky:  Well, again, first, let me thank you for the very important discussion that was today. I guess I'll turn it over to you, Thomas. I think I said what I had to say. I'm not sure I have anything that comes to mind.

Jennie Bradley Lichter:  Thank you. Yeah, that’s great. Any final words, Tom?

Thomas Jipping:  Well, thanks for letting me participate. I did intend it at the top -- I did want to thank Adam for -- I read some of his really thorough blogs on this, and he made a point of saying—particularly with regard to Judge Kacsmaryk, some of the attacks that have been made on him personally.

And it goes to the phenomenon that I was talking about at the top, I think. People want the decision to come out a certain way. So if you have a judge who, at least personally, they believe, “Oh, he's pro-life. Well then, he's got to be wrong on this issue” or something. But those kinds of attacks—and there have been a lot of them—that have been inappropriate. And I wanted to thank Adam for pointing that out because that really is something I hope we would all agree on.

There are good judges on all the points of the ideological spectrum. It's how they interpret and apply the law to the facts, not what some of their personal opinions are. And so, anyway, I just wanted to say that to Adam. I really appreciated that in what he's been writing.

Jennie Bradley Lichter:  Wonderful. Thank you both. And I will just add my own note of thanks to both of our panelists and to The Federalist Society for facilitating -- for really modeling how to have a reasoned discourse focused on the law and the facts about an abortion-adjacent issue, which is difficult to do, as I think our country has learned in the past year in particular. So it's a pleasure to be a part of this conversation.

I think it's a really fascinating case. This has been informative for me. I hope it has been for our viewers as well. I'll be watching with interest to see what happens over the course of the litigation.

I think we can safely let our viewers know that Tom and Adam will presumably both be commenting on later stages of this case, so you could keep an eye on both of them to follow their unfolding thoughts as the case continues to develop. And I think we are finished. Chayila, over to you to take us out.

Chayila Kleist:  Absolutely. On behalf of The Federalist Society, I want to thank our experts for the benefit of their valuable time and expertise today. We really appreciate you joining us. And thank you to our audience for participating.

We welcome listener feedback at [email protected]. And as always, keep an eye on our website and your emails for announcements about other upcoming virtual events. With that, thank you all for joining us today. We're adjourned.

 

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