You the case for this sitting is 2023 10362. Alliance for Hippocratic medicine at all, versus US Food and Drug Administration at all, versus Dan co laboratories, LLC. We'll hear first today from Ms. Harrington from the DOJ, the FDA and the FDA on behalf of the FDA.
Thank you, Your Honor, and may it please the Court Sara Harrington on behalf of the federal defendants, the district court's order is an unprecedented and unjustified attack on FDA scientific expertise. This court should vacate the order because plaintiffs are unlikely to prevail on any of their claims. And because the balance of equities tips decidedly against preliminary relief. No, I
hate to cut you off so early, but you've said unprecedented. We had a challenge to the FDA. Just yesterday.
You had a challenge to the FDA. Yes. But I don't think there's ever been any court that has vacated, FDA is determination that a drug is safe to be on the market and the
FDA just withdraw support each drug just last month,
FDA can make that determination based on exercising its own scientific expertise. But it's not a courts role to come in and second guessed that expertise. And no court has ever done that.
So I'm just wondering, why not just focus on the facts of this case. Rather than have this sort of FDA can do no wrong theme.
I'm happy to focus on the facts of this case. I think it's important to understand the case in context, though. In our view, the most straightforward way to resolve this appeal is on threshold grounds. Because the plaintiffs have not even come close to establishing standing on any of their many theories of standing. And because their central claims are time barred. I'm going to start if I can with their theories of individual and associational standing, plaintiffs and their members are not regulated parties. FDA approval of mifepristone does not require them to do anything at all. They claim injury from speculative downstream effects of choices made by a chain of other people who are not parties to this lawsuit. They alleged that they have treated occasional patients who present to the emergency room with complications from taking mifepristone, but even they do not argue that simply treating a patient injures a doctor. Instead, they offer four theories of injury, none of which is a cognizable Article Three injury that is traceable to any action of FDA. First, they assert that they and their members will be forced to complete abortions in violation of their religious beliefs. That assertion fails for multiple reasons. First, none of them not even one of their declarants alleges that he or she has been compelled in the past to perform any procedure in violation of his or her religious beliefs. They're carefully worded declarations refer to experiences of other people who are not plaintiffs. They describe having provided care without saying that they objected to it or considered it to be an abortion. And this make unsupported allegations that they will in the future be required to do things that they've never in the past been required to do. It seems
that some of the declarations allude to possible surgeries and that sort of thing.
Well, none of them none of their declarant says that he or she has in fact been forced to participate in any procedure that they would consider to be an abortion
that says surgeries in post abortion care.
I'm not sure any of them said that they have actually done it. They refer to other people having done it. Dr. Scott says that she has cared for patients who have needed procedures after taking me for Christine, she doesn't say that she actually provided those procedures. She doesn't say that she objected to them, even if she did provide them, which again, she doesn't say she doesn't say that she objected to them on religious grounds. And none of the
oppose with her colleague or one of the other doctors colleagues who performed a D and C would that count?
No, because that person is not a plaintiff to this case. Right? You need to have an identified plaintiff in the case who can say that they are imminently going to be injured, and none of them have said that they've been injured in this
audience said that they were either plaintiffs or members of a plaintiff organization.
But plaintiff organizations need to identify specific members. This is the Supreme Court has held us and summers and clapper and other cases
when the affidavits be that specification, are you saying there has to be something more than that?
Yes. But none of the affidavits even alleges that they themselves have had to participate in an abortion against their religious beliefs. They're very carefully worded, but they none of them actually says that. And you can't read that critical piece of that critical fact into the allegation into the declarations Excuse me. They all say what you need
to have standing is an expression of an objection of conscience.
What I'm saying is you need to prove that there's you're an imminent risk of being injured. One of their theories of injuries is that they will be forced to do things against their religious beliefs. But they've never alleged that they've ever happened in the past. And there's no reason to think it would happen in the future.
They say religious belief or conscience. But either one,
I think they could say either one. But neither thing has never alleged that any identified plaintiff has been required to perform an abortion against their religious or conscience beliefs in the past. And they also ignore conscience protections in federal and state law.
Because I want to make sure I understand the argument, looking at the Francis declaration, paragraph 15. Members are opposed to being forced to end the life of a human being in the womb for no medical reason, including by having to complete an incomplete elective chemical abortion. So that's certainly an expression of a conscious objection on behalf of members.
Absolutely. We don't dispute their sincerely held beliefs, or their objections to engaging in those activities. But the point is, they're not an imminent risk of being forced to do that. And they've never they don't allege that they've ever been forced to do it in the past. And it would be surprising if they could allege that because they have robust conscience protections in federal and state law. They ignore those protections and they blatantly mischaracterize the position that the government took in a different case about EMTALA.
What is the government's position about EMTALA does physicians objection based upon conscious reasons, Trump in EMTALA
for the the obligations of EMTALA run to the hospital that accepts federal funds, but it doesn't require any particular individual plaintiffs or excuse me doctor to perform any particular procedures that he or she has a religious objection to
what about one doctor emergency rooms?
Again, the obligation runs to the hospital and so the hospital would need to ensure that there's someone on staff if they have accepted the federal funds and agreed to the conditions of EMTALA, who can perform whatever perform excuse me whatever emergency care is needed, as required under EMTALA. But plaintiffs have robust parties excuse me objecting doctors have robust protections under RiFRA. These plaintiffs and none of their declarants explain what about
the assertion that this violates the Hippocratic Oath? Is that covered by RiFRA?
I know I think referred just covers religious objections. Exactly.
I mean, your your argument is I ascertain. It is sort of that that RiFRA is coterminous with conscience objections, but conscience objections could go a lot farther than just religious based objections, right?
There are conscience but there are conscience protections in place and federal and state law that aren't necessarily tied to religious objections. And HHS and all of its years of enforcing EMTALA is not aware of any instance in which a doctor has been forced to engage in any procedure against his or her conscience beliefs. And
the declarant. To your said, they've seen these patients, they've cared for them. I take that to mean they treated them and that they expect to see more in the future. How's that? Not enough for standing? If the doctor also has a conscience? objection to doing so
because they very carefully don't say that they've ever had to do something that they have a conscience objective differential,
are we to the declarations at this stage? I mean, this isn't this isn't summary judgment where we would take everything in the light most favorable to the nonmovant. We're at a preliminary injunction phase. So how much should we scrutinize and split words of what are in those declarations?
Well, Your Honor, it's not splitting words, we have to take what they say in the declarations. That's true. But they haven't actually said that they've had to do the thing that they fear will happen in the future that that's happened to them in the past. We can't read that into it. They they understand what they need to do to allege standing. They understand what they need to do to allege a past injury. They have very carefully not alleged that specific
question record on the ROA 277 to 279. She says she's performed surgery on at least a dozen of women after a failed chemical abortion sometimes including removing the embryo or fetus. Is that not akin enough? Removing the embryo or fetus in a surgical proceeding?
She doesn't ever say that she was compelled to do that against her religious beliefs. And it would be again surprising if she had been compelled to do that, because there's protections for conscience
for that same starting her up and it specifically says harms my conscience rights.
But she doesn't explain how why she didn't raise her conscience rights in in attempting to avoid that duty in
emergency conduct. Different
point, though, that's not that you didn't swear to it is that she screwed up by not actually invoking her legal rights?
No. Well, we don't know that she was compelled to do anything against her conscience rights. She claims she's done things. She doesn't claim that she was forced to do it against her conscience rights. It's not an injury to do things if you don't if you don't have an objection that you raised at the time to doing them. And they're certain certainly even if you thought that there had even if you thought there were allegations that there had actually been a violation that someone had been compelled to complete an abortion or perform an abortion against their conscience or religious beliefs, which I think if you look carefully, you'll find that there isn't. It's pure speculation.
Well, in my practice, I often treat patients She admitted to the emergency department I'm paraphrasing with complications from chemical abortions. Paragraph 13. In my practice, I've cared for several dozen women in the emergency who were totally unprepared for the pain and bleeding experience due to chemical abortion, but none of those 17 Paragraph 18 Paragraph 21. I mean, it's
but none of the things you just read say that she that this person was compelled to complete an abortion. caring for a patient who's admitted to the emergency room after after taking mifepristone isn't the same thing,
point that you have to perform the abortion, you can't do other things related to that practice, that would not count as a conscious violation.
What I'm saying is they haven't said that they have been forced to do things against their conscience. And even if they had said it, which I again, I don't think they have but I don't we don't need to get bogged down in it. If if we have a disagreement about that. It's purely speculative, whether it would happen in the future. They have these robust conscience and protections and religious belief protections. There's no reason to think that it would happen imminently. Supreme Court cases like clapper and summers and Luhan and lions all say you need to have you need to have an identified plaintiff who was an imminent risk, occasionally
referred cases like clapper and summers, there was no real serious way to try. Let's talk with Moe clapper and summers both involve no real past injury of any kind.
Summers did involve past injuries, there were identified plaintiffs who had suffered injuries. There was in fact there was a specific project that had been challenged that the court wasn't even part of the case. Right. That was that had that had settled. Right. But the plaintiffs but but still, the plaintiff said that they alleged the Supreme Court agreed that they had been injured in the past. And they said that wasn't enough, even though it was almost certain that some member of the association would be injured in the future by some forest service project going
to have standing for what was left in the case.
But that's all that this case is it's about seeking prospective relief.
Right. So I'm sorry,
if Dr. Scott is already done this and dozens of times, and she says that I'm going to continue to be doing this. What What more does she need under the existing case law?
I don't think I can, I don't think she says she's done it. She's done anything against her conscience or been compelled to do it dozens of times. But even if she had she, we need to show that it's imminent, that it's going to happen in the future and that that that injury is traceable to something that FDA has done. Here you have a chain of, you know, five or six people in between the FDA approval or more of the drug and anything that could happen to any of these doctors, you're
not disputing the idea that in the future because of the FDA sanctions, more women will will turn up in emergency rooms needing emergency care. What you're saying is it's not imminently pinned impending that anybody will have to be forced to violate their conscience objections
that were absolutely disputing that many women will show up in emergency rooms, or that more will show up in emergency rooms meeting emergency care from taking mifepristone. All of the evidence establishes that Mr. Persona is an extremely safe drug, the rate of serious complications is well under 1%. So there's it's extremely statistically unlikely that any woman will need to go to the emergency room to seek care after taking me for personal growth. The
Wozniak real quick, the Wozniak affidavit says, and last six months, I had this experience. That's at paragraph 23. And then paragraph 29. In my experience, I expect to see and treat more.
Again, seeing and treating patients isn't itself an injury. I'm sorry to interrupt you, please. So seeing and treating patients on its own isn't an injured themselves with complications from chemical abortion. But that's but just treating patients isn't an injury, right? It's you have their theories of injury or that they violates their religious beliefs, that it will increase their liability and insurance costs. But it will take time and attention away from other patients in that it causes them stress. Okay, but the first three of those, they don't actually allege it's happened. But if you're talking about the liability and insurance costs, again, they're carefully ready. Declarations never say that any of the plaintiffs has faced any liability in connection with mifepristone or has suffered any increase in insurance costs. And there's no reason to think that would happen. You might recall
in the SBA case, there was essentially one past incident. And the assurance that SBA was going to continue to engage in its activities. And so expected future courses one past expectation of future and that was enough, but an SBA was a directly regulated party. Yes, that was, I know, you're going to distinguish it. But am I correct about the fact Yes, the directly
regulated party had had one experience in the past? Yes, but these are not directly regulated parties. And the Supreme Court and Luhan in this case, in cases like ET versus Paxton, have made clear that it's much harder to establish standing, when you're not the directly regulated party, when you're saying you have suggesting
that it's going to be a different metric, based on whether the injury has direct regulation versus conscience.
That's what the Supreme Court has said. That's what this Court has said it's much harder to show that you face an imminent risk of injury in the future. If you're not the directly regulated party. It's much harder to show traceability because there are other people's Establishment
Clause cases there are which are basically conscience cases were seeing at once and wanting to go back again, is enough.
It is true that the First Amendment does have sort of a laxer. Sometimes it's applied in a more relaxed way. And Susan B Anthony is arguably First Amendment sort of speech rights right? And petitioning rights. But again, there is a directly regulated party who face criminal potential criminal liability administrative sanctions,
typical Establishment Clause cases certainly not regulated party. That's a pure conscience. Right? I don't want to see the 10 commandments monument, but
there are no First Amendment claims. In this case. This is an APA case. We're talking
about conscience just I feel like you're pushing back with I'm trying to deal with the underlying principle the underlying principles of the conscience, right? How much of a conscience right is enough to establish the standing for PII purposes, in cases like lion and lions? And sorry, SBA.
But I don't we don't dispute that they have conscience objections, the question is, is it traceable to anything that FDA has done, and that's where you get into this. That's why it's important that they're not regulated parties. Because what you have between FDA and any of these doctors, is independent choices by many other people who are not parties to this case,
we have a lot of cases, environmental cases where a environmental group, not a regulated party will sue the regulator, because they are allowing some private entity to engage in some sort of commercial development activity, what have you that result? environmental harm?
That's summer is essential, right? I mean, that's similar to summers. There are a lot of cases, right. But those people are forced, those people are required to establish standing, and they're required to show imminence of an injury. You know, generally what they're doing is challenging an ongoing activity. And so, like Laidlaw is an example of that, right, where there were discharges into
freedom, the fact that it's a third party is not a problem.
But they were there, they were showing a direct injury from the activity that was being allowed. Here. Again, it's from the activity that was being checked from the agency action, that was that's being challenged. Here you have approval of a drug, FDA is approval of a drug doesn't require anyone to do anything. The manufacturer doesn't have to make it, nobody has to ship it, nobody has to prescribe it, and nobody has to take it. Okay, you have to have all of those things happen, and then have a very rare incidence of serious side effects. Before any of those patients are former
of commerce case, where it seems to be a discussion about how once the government engages in activity, there's predictable third party responses, there will be women who will take this right. But
there you had there you had speculation I was it wasn't speculation, but there you first of all, there it was. You had there, the plaintiffs were states. And so they were the effects on them happened at a population level, a population wide level. And so if there was sort of, you know, 2% Fewer people who responded to the census, they would get 2%. Less money, right? 2% fewer dollars. Here, there's nothing like that you're talking about you need to show injury to individual plaintiffs. You can't rely on population wide statistics and probabilities to establish imminence,
could you so it's not the number of instances. Right, is that it? You're saying? It's that whether it's certainly impending, that one doctor will be forced to perform one abortion against their conscience?
That's what that Supreme Court has said, yes. So no, that is that, yes. That's what I'm saying. But I'm saying I'm not making it up. I'm just No.
So so if it was only one, that's good enough, but you're just saying it's not sufficiently certain.
Right? It's absolutely uncertain that this is going to happen, right. So in summary, I think of a statistic
uncertain, because people are not going to go to the hospital where they are in these rural areas, and there's only one emergency doctor who happens to be in this group.
So I think it's very unlikely that that's going to happen. And again, we don't know that it's ever happened to these plaintiffs or to anyone else. Because when a patient when a provider prescribes mifepristone to a patient, he has to say, yes, he signs a piece of paper saying I have plans to provide any follow up surgical care that's needed. And if I'm not able to do that, then I have designated someone else who's going to do it. That's, that's
very puzzling to me, I have to say, because it's my understanding that most of these cases, the dispenser, the prescriber is not the person who provides the care in the follow up care, and especially whenever it says if you have an emergency, on the form, it will say, Go immediately to the nearest emergency room, that will be the provision that they make, most often. And, you know, that was certainly an issue and all of those cases involving emergency admitting privileges and that sort of thing, the idea that the provider is not the doctor who is giving, and this is not a criticism of them, but they are not usually at a full ambulatory services center. Many times even if it is in person, certainly not if it's a mail business thing on the computer. So they're not going to be the person carrying it's going to be there. In fact, they're going to be referred to the emergency room. Isn't that the more common situation and dispensing of medication abortion is not
at all the more common situation and so one thing I think in your question, you're conflating two Things which is the need for follow up care and the need for emergency care, it is true that if there's a need for emergency care, then a patient is probably very likely to go to the emergency room. That's what her doctor will tell her to do. But again, that happens in less than 1% of all cases, people will take me for prestone. Now the state panel relied on the patient agreement form, which reveals that something between two and 7% of patients in those in that population, the drug won't work. But that what that means is that it won't successfully terminate the pregnancy in the usual 14 day treatment period. But those people will go back to their doctor and discuss with their doctor out if they
didn't get it from a doctor. I mean, the FDA is relaxed the requirement that the provider even be
back to their provider and discuss with their provider who does midwife, yes, and discuss with their provider the next step. But even in that small population pharmacy, that metal mailer in a pharmacy is not the prescriber, I mean,
it just strikes me that what the FDA has done in making this more available and doing it by mail order and removing the doctor visits, as well as the requirement that the prescriber be a doctor is you've made it much more likely that that patients are going to go to emergency care or a medical clinic where one of these doctors is a member, I don't see how you square that circle.
I don't think any of that is right. And that hasn't been borne out by the evidence. So
speaking of the evidence, did you want to answer more fulsomely?
If I may, yes. So you have to get the you have to have a prescription to get the drug. Just like all other prescription drugs, you can get that from someone who's authorized by state law to prescribe the drug. The FDA requires that that person be able to date gestational age of a pregnancy and assess for ectopic pregnancy. So that again decreases the number of people who can actually prescribe the drug. It's true that you can get the prescription from a pharmacy now, just like you get all your other prescriptions. But that doesn't mean that the person who prescribed the drug your provider isn't there to do to talk with you about the follow up care involved. No doctor has to be involved. That's true. But but most of the women who for whom the drug doesn't end their pregnancy in the first 14 days don't need surgical intervention. They talk to their provider, they either do a wait and see they take a second dose of misoprostol and that the secondary atomizer crystal works in something like 95% of those cases. So it's very rare that they need actual surgical follow up. And when their provider is someone who's not equipped to provide that care, they are required by FDA to have put in place a plan before doing the prescription to allow those women to identify for those women someone that they can go to to get that care.
I just wanted to ask quickly about the record, we don't seem to have the administrative record in this case is, is we have certain exhibits that were admitted at in front of the District Court. But we don't have the official administrative record, as far as I know and check with the clerk's office today is if maybe I'm wrong, but that's what I understand. You absolutely do not have administrative rights. Why don't we in? What's the situation on that? And do we need it or not at all?
absolutely needed. In an APA case, you're supposed to judge the agency's actions based on the administrative right, where is it? And how do we get it? Well, we would love to produce it. And we are in the process of producing it. But the district court acted before it was able to be produced, how long will it take you to get it to us, I can't give you an estimate of time, what we're told is it's going to be hundreds of 1000s of pages, because the plaintiffs are challenging actions that took place almost a quarter century ago.
So you've been working on it this whole time for us since the inception of the district court matter, or what when did you start working on it?
FDA is working hard on that. And I don't have an estimate for when it's gonna you know, when
you started working on it,
I think they started working on and as soon as the case got going, I can't tell you I cannot give you an exact date. But it's because
Okay, so you want us to wait till we have the record.
We want you to wait, the plaintiffs asked the district court to wait, the plaintiff said please don't enter a preliminary relief. Let's get the administrative record and have a trial on the merits. And then we can determine relief. Okay,
so how soon can we get the record?
I don't know. I know. It's frustrating. But I don't have a date I can give you Well, can
Can we supplement that
the 28 J letter the tell us when we could have the record? And if that's something we could feasibly wait for? I'm not saying we should wait. I don't know whether we need to. But to let us know when we'll have the record. But I think it's like something we would want to know about.
Yes, I can I can go back and talk to my clients and give you whatever answer we can give you. I don't think it's going to be imminent, because again, this is hundreds of 1000s of pages. These are actions that took place a quarter century ago. And so there and
you produce it in stages. If you can't produce it all at once.
I can talk to my clients. But
is it a secret? I mean, it's the record, right? It's not a
secret. It's like in cold storage somewhere because these are things that happened a long time ago.
I mean, but you'll probably have brought it out of storage by now because you got a big national case going on about it
agency has recovered. I know it's frustrating. I don't have anything more specific to tell you about that. Okay,
well, let's move on because I think Judge had a question.
Three questions, if that's all right. I want to talk about the adjuster affidavit. Because you've been challenging the notion that any of these doctors either have objections or have been involved. I don't
I don't challenge that they have objections to whoreson and providing abortions. We take that as given.
Oh, okay, fair enough, then then maybe I don't need to, but I'll just go through real quick anyway. Joe Juster paragraph 17 I treated a woman Planned Parenthood New Mexico, chemical abortion, heavy bleeding 10 weeks gestation, your uterine infection. I provided her with antibiotics and performed DNC paragraph 26 I am opposed to chemical abortions. I think they are more than
that. But he doesn't say that I viewed the performing the DNC as performing an abortion. He doesn't say objected to that procedure. He doesn't say I was forced against my conscience rights to execute the procedure. And so I think it's, again, very speculative that any doctor any any identified plaintiff is going to be forced to do anything against their conscious or religious beliefs going
forward. We even talked about third party standing. Can we agree that the Dobbs case, obviously reached the merits? Right, right. So third party standing, still existence
thing? Yes. But but in order to invoke third party standing, you have to first establish your own Article Three standing. And in the in cases where abortion providers are allowed to assert the rights of third parties invoke third party standing, they are challenging laws that operate on them by requiring them or preventing them from doing something here. So if you know if if doctors who oppose abortion, wanted to challenge a law that required them to
resign funny, Rob, I thought the whole theory of third party standing in the abortion context is that it's the woman who has the privacy, right, not the doctor.
It's the woman who has the rights that are being asserted, but the doctor has to have his own injury in order to bring the claim. So the Supreme Court's been very clear about that the plaintiff has to establish independently as to establish Article Three standing, and then can raise the rights of a third party.
My last question anyway, Justice Alito, in his recent dissent, or whatever you call it, in this case, the emergency stay sort of alludes to sort of some public chatter about FDA perhaps might not follow court orders. So I just wanted to give the same opportunity to clarify that I think Chief Justice Roberts gave to the state of Texas, in the SBA case, SBA case. Is the FDA intending to follow whatever this Court decides obviously subject to Supreme Court review?
Absolutely. Right. So whatever this court decide that decides maybe continued to be stayed pending Supreme Court
subject to Supreme Court, right, but the FDA will oblige.
Yes. And secretly from the Supreme Court, we submitted an affidavit from Dr. Woodcock explaining all the things that the FDA would need to do to comply with the state panel's decision in this case, I think that's good evidence that we're planning to comply with any court orders. Yes,
I'm going to give you five more minutes and give everybody five more minutes because we haven't gotten off of standing. And we've been appreciate your helpful argument here today. We've kind of thrown a lot at you, and we appreciate it. So it's helpful. I have a couple of questions about how this works with regard to the telemedicine situation can can you help because you were saying that the people providing the telemedicine have to be licensed in the jurisdiction? Or that they have to be appropriate provider so that they're not violating the state law? How does that work with? With it? Also, I want to know how does it worked? Do they have to is video on Zoom, so they observe the person to see what the gestational stages how it is all? Can you walk us through how this actually works?
Absolutely. So the REMS, that are in place now put in place by the FDA require that anyone who's prescribing this drug, any provider, whether they be a doctor, nurse, midwife, physician's assistant, be able to assess gestational age and be able to assess for ectopic pregnancy. How
do they do that? Practically speaking,
so they do it in by exercising their medical judgment. And FDA defers to them. I had to do that. And so sometimes they
see the people or do they cannot see the face even or do they have to look? I mean, how did they decide?
Just looking at someone normally you can in that early stage of pregnancy, you can't assess either of those things, right. But you can assess it by asking questions. And so this has been true for the entire life of mythic plus, can
this be done via email where I say my last period was X date, and this is my and therefore this far along, and therefore I'm within the rent, and you asked me a follow up if I have complications, diabetes or something, I don't know what the complication would be and then you and I say no, I don't have any of that. And then it's all just an email exchange. Is that all that's required? How does this work?
FDA does not dictate the practice of medicine. And so it requires that these doctors have these skills. It requires that they go over all of the risks of serious adverse events. They it requires that doctors discuss all the side effects expected side effects, and that they assess for gestational age and ectopic pregnancy and doctors then practice medicine according to or other providers or other providers, right but these are providers who are licensed by law, to by state law to proceed Dr. Drugs,
are they in their own in the state where the person is? Or are they in a different state? And how does that work? Because we have some some of the affidavits. I mean, not that the the amicus brief say that people are using like intermediary addresses, and having people using a drop box, basically. And having that been sent to a different state that might not allow it, how does it work?
None of that is dictated by the FDA. And none of that is relevant to whether the FDA is determination that this drug is safe and effective with these conditions and that this drug is safe and effective with these conditions in place. Right. There's a whole event,
isn't it to whether or not there should be an injunction? Because if it's violating other law, which we have to determine perhaps that then we have to decide whether or not it's appropriate to enter an injunction or not. And that's one of the factors we would consider?
Absolutely not, because if if people are using the drug in ways that violate state law, and we don't know that there's no evidence of that, in this case, there are some sort of unsupported allegations and amicus briefs. But none of that has anything to do with what the FDA has done. This is again, an APA challenge to actually get decisions that the FDA has made. And whatever happens with drugs, once they get into people's hands has nothing to do with whether the drug is safe and effective. So
that are crossing state lines or telemedicine across state lines or intermediaries, anything like that, when it revoked the in person visits or the in person prescription requirements
Congress charged the FDA with considering whether a drug is safe and whether it's effective or not with the to consider
the things that Judge Elrod was asking about in terms of the safety of the drug, without with a mail order regime,
they considered the safety of the drug with a mail order machine. But again, you don't just
consider crossing state lines or the idea that someone in California would prescribe things for someone in Mississippi, and that there would be go arounds, workarounds or whatever may happen?
No, because those things are not relevant to safety relate to the safety of the use of the drug? I don't think it does. I think FDA is charged with determining what was relevant for safety and efficacy. And it's certainly not up to lawyers and judges to come in and say, well,
the FDA didn't consider an important part of the problem. It is our role correct to go behind the FDA and determine whether what they did was arbitrary and capricious. There's no reason
to think that's actually part of the problem, let alone an important part of the problem. The FDA considered who can prescribe the drug under what conditions and they authorize those conditions that makes the drug safe and effective?
Are we do only consider the FDA or is this, you know, a unitary executive sort of situation where we also consider the White House statements that we're going to get these to everybody, no matter where they live? Is that part of our inquiry? Or is that something we should ignore?
I think two answers first, I want to resist your premise that FDA did not excuse me, the White House did not say we're gonna get these drugs to everybody, no matter what it said the important caveat was there it was in there that they can they can be used where it's legal to use them. Okay. So I think there's certainly no indication that anyone's trying to do anything unlawful. But the challenge, is
it or the White House? If that's that's to be considered what? No, because the unitary executive coming here is part of the FDA. Are you? Are you at odds with the White House's approach? Or is it is it irrelevant? What's
relevant? Because this is an APA challenge to decisions that FDA has made? Right? So decisions they made in 2020 16? I'll just say if I can, I know my time is up the tooth out. I mean, any challenge of the 2000 action is clearly time barred. They waited eight months passed or statute of limitations. And so the state panel was right, that that the
I have a couple of questions. If you need to submit if Dan co needed to submit an S NDA or whatever you would properly call that. How long would that take? According to your your folks? And am I allowed to consider affidavit submitted after the fact in determining that
you're talking about if like the state panel regime were put into place? Assume yes,
that the 10 we don't go on just for the sake of argument. It's not a foreshadowing. But we're having to deal with whether or not the 16 regulations could be.
So first, I would just put in a plug for saying that the plaintiffs have not made any effort to show how the 2016 changes on their own have caused them injury, and they need to do that you can't dispense standing and gross. But you know, I think you can look at the Woodcock declaration that was submitted in the Supreme Court. It wasn't submitted before because no one we didn't have any reason to think that they would be in order to put the 2016 regime back in place. And I think it would take probably a matter of months in order to get a new labeling and a new regime set up. But I think it's important to note that if you put the 2016 regime back in place like the state panel wanted to do, that would require women to take four times as much for prestone as they take under the current regime. Now FDA we think was right that it was safe and effective to do that. But if the main thrust of the plaintiffs argument is that they shouldn't be taking this drug at all. It's a pretty strange remedy to then require women to take four times as much pending the outcome of the ultimate outcome of the case. Ace,
I thought that part of the argument is that they should be taking it only under the supervision of a doctor who visits them three times. And that the number of other factors. I didn't know it was just on that they shouldn't be taking the drug.
I mean, the plaintiffs have multiple claims, right. They want to take the drug off the market entirely. But they also have various challenges to the changes that were made in 2016. It nets, but I'm saying they would need to so
I'm sorry, what that would be relevant to that would be relevant
to that, but they would need to show why those changes injured them, and they certainly haven't done that. Why, assuming that the drug is on the market, those changes have caused them some cognizable injury that's traceable to FDA.
Okay. Does anyone have any further questions? Thank you very much.
Good afternoon, your honors and may it please the Court Jessica Ellsworth on behalf of Danko. District Court and the state panel did not focus on exactly which doctor they concluded had standing to challenge which FDA action this panel is questions suggest that it is focused on trying to figure out the answer to that question. There must be a specific doctor whose declaration has facts showing a personally and cognizable injury from each challenged FDA action, and that this injury is certainly impending. They can't do this. That declarants specified next to no actual treatment of any patient with any level of detail. And in the few cases they give detail. Its care that someone else provided it's drugs that came from India, those are not FDA approved drugs. And its patients who had contra indications that again, is not traceable in any way to FDA. From there, the declarants offer nonspecific statements that are untethered to actual facts about what drug A patient took. They often say the patients can't tell me what they took. So we don't know even that it was FDA approved mifepristone, they don't identify the circumstances under which they took it. Was it the FDA approved regimen? Or was it something else? They don't describe the care that the doctor actually personally provided? Or when the event occurred? Was this something in 2003? Or was this something in 2016? Or was this something in 2020? It was the plaintiffs burden to show standing. And they didn't do that. The state panel, I think, recognized that no declarant did this, which is why the state panel looked to the patient agreement form and the blackbox warning and said, Well, those tell us complications from if a prestone must be certain to happen to someone somewhere. And that's enough. But that asked the wrong question. The question is not about whether someone will be injured by myth a prestone. somewhere sometime it's about whether any of the doctor declarants face certainly impending injury, the state panel used false math to claim this certainty, which our brief walks through exactly why that math does not in any way relate to the 2016 or the 2021 changes.
You don't mean false, necessarily. You You mean was mistaken, don't you?
False in the sense of inaccurate? Yes, that's right. The math was actually correct. As in, if you calculate two to 7%, times the number of women who have taken Mefa prestone. That would give you the number of women who the label suggests have had an incomplete treatment. But what is false is to equate incomplete treatment with a trip to the ER, there is no declarant who says that there is nothing in the record that says that. And so that's where the inaccuracies come in. There's no link to these doctors. I have studied the declarations and it certainly sounds like this panel has as well. There are two declarants, who I think identify any specific care they gave to a patient with enough facts that might show that it was an FDA approved mifepristone, taken in accordance with FDA approves regimen. And that's paragraph 23 of Dr. scops declaration, and paragraph 17 of Dr. jesters Declaration, which which you referenced judge hoe, of course, those two declarants practice in Texas and in Indiana. So even if they alleged one patient that they actually cared for at some time in the past, we now live in a world where the availability of abortion in Texas and Indiana is quite different than it was prior to jobs that matters when what this Court is tasked with doing is determining whether there is a certainly impending injury. There are three other Clarence to offer specifics about a patient who took a drug, Dr. Francis identifies a patient who took a drug from India. That doesn't help. Dr. Wozniak and paragraph 24 identifies a patient who was told she could not have a medication abortion because she was on blood thinners and obtained myth a pristine anyway, that doesn't help them. And Dr. Johnson says that some patient took an unidentified abortion pill and then needed a blood transfusion. And once a patient had severe pain, but didn't know what she had taken. That's it. Those are the only specifics you have the remaining declaration paragraphs, and you've identified some of them in the discussion this morning, offer only generalized statements. There are no time details, there are no details about a conscious objection that the doctor tried to make and was prevented from making and there's no acknowledgement of the changed law. This particularly matters when we think about the fact that the 2000 approval challenge is time barred. The state panel, I think was exactly right on that. And the appellees say next to nothing to refute the state panels analysis about why reopener does not apply and why equitable tolling does not apply. So that leaves a need for a declarant to identify certainly impending harm from a 2016 change
to the reopening discussion for a moment. I'm assuming you're familiar with the Sierra Club, DC Circuit case?
Yes, sir. Right. Yes, Your Honor.
The theory there being that you restart the clock, the six year clock, if the regulations have changed in a way that alter the financial incentive altered the incentives, significantly altered the stakes of judicial review, changes the calculus for for a plaintiff. Why is that not the case here?
I think it's for exactly the reason the state panel identified these plaintiffs already filed a citizen petition in 2000. The stakes were sufficient
plaintiffs after that, aren't there? You're right that some of them carry forward. But there were some participants in the remember my dates here, some in the 2019 round who did not appear in the 20 Sorry, 2002. Round. That is doesn't apply to that group.
So So I don't think it changes the question about whether there was a sufficient stake. There was a change to the stakes, right, a change in the stakes, because
like the male issue is not a dramatic change. You don't think the going from seven to 10 weeks is direct change, you don't think going from three visits to just one without a doctor.
So your honor, is I understand the appellees argument about Sierra Club, it only relates to the 2016 changes their argument about 2021 is simply based on this reference to a full review of them if a pristine rems that occurred in 2021. And of course,
the stakes have changed dramatically.
Your Honor, I don't know that that's true. If you read through these declarants. Their statements in all of the declarations, they're real,
big difference between the 2000 regime, the 2016 regime. Why did y'all go to the Supreme Court? I think there's a big deal, right? There's a lot at stake. What whoever is right, we can't deny this is a big stakes issue. So I'm not I'm not really understanding how this is a small states. Now,
the question is whether any of these declarants would have seen it as a different question about whether to sue FDA over the fact that a non physician prescriber can prescribe the drug or that an inpatient appointment is not required when they would have otherwise said, Oh, well, now we need to challenge this 2000 approval, these declarants all make very clear they are opposed to abortion drugs, period. In fact, they're opposed to abortion period. There is nothing that any of them have identified, that shows that they found a different calculus when they got to 2016 or 2021. And I think time sort of is a is an indicator of this. After the 2016 changes, they waited three years to file a citizen petition.
Is it your position that going back to the 25 2015 regime, whether when the 2015 regime or in the post 2016 regime? No big deal? Either way, it's not much of a difference.
So No, Your Honor, you're not saying that? No, I'm not. I'm not saying that at all. I think there's a very significant difference in Yes, very significant. And yes, I think it's a very significant difference. But the question is about whether the stakes for these plaintiffs somehow changed in a way and they have not identified any way in which the stakes for them changed.
I think it'll have to do this more often. Because the with the lack of safety guard's to make sure that the person gets the proper care or doesn't take it when it's ill advised that they that they will have to just do it more often is something they say between the 16th and the 10. Isn't that an allegation that the plaintiffs make?
I think they make three allegations, Your Honor, about the difference is that one of them, one of them is that there's a later gestational age that's wrapped in post 2016. And that that could lead to additional instances of an incomplete treatment. But what that ignores is that what FDA found, and this is documented repeatedly through the hundreds of pages that are in the record, before you about FDA review, is that with the new dosing regimen that was put in place in 2016, even for those later stages, between 49 days and 70 days, the rate of complete treatment was higher than the rate of complete treatment originally approved in 2000. In other words, it got safer.
ask you a question about that. Is there any difference? You know, because your clients drug is the nutrition element, the progesterone element, that for the for the fetus? And that that's what's cut off before? The other drug is, is is the one that causes the fetus to be expelled. Given the fact that the nutrition is not, it's not being as high as 400 200 difference? Is that causing any difference in the whether the fetus is already demised? Before the pushing the expelling have that have they shown any differences in the results from that? And does that if they shown absolutely none? It doesn't matter whether it's 200 or 400?
I'm not aware of anything in the record that addresses that particular question. Or or that FDA looked at that particular question. I think the question before FDA was whether this new dosing regimen was safe and effective. And what FDA did was look at the complete treatment rates that occurred using this and it an analyzed dozens of studies involving 10s of 1000s of women, and found that the rates of complete treatment were were even higher than they had been originally. The other thing in 2016, that they found was that an additional dose of misoprostol would resolve 90% of the situations for women where they didn't have a complete treatment in that first 14 day period
rested the tissue or whatever. That's right, it would avoid that
it would avoid the need to go to an emergency room, it would avoid the need for surgical follow up care.
And you do you agree with the FDA that it would just take a few months to get your situation? To make sure that you got your labeling correct.
It would take a number of months, I think to view
but I mean, wouldn't it take that long while there's a stay in effect, while the all the briefing keeps going on in this case? So you could get that all ready to go? And so you're how would you have an injury? And the reason I'm the reason I ask is because we have to consider this injunctive relief question. And whether you're harmed because you're out of business, which is certainly a harm if you're out of business, or whether you can just pivot to something that's already been approved. And you're not really affected because the whole thing is stayed in the meantime and gives you enough time to get it all pivoted.
Your Honor, it's very tricky to determine how we would go back to FDA with an snda that says you should here's all first of all that clinical data that would support making all of these changes,
and it was already approved. So in the labels already exist?
Well, there is a label that was used during that time period. That is correct. But it is not a label that is on Eighth during
that to unsafe during that time period. Of course you don't. That's right.
But the process of going back to FDA, this is not like a light switch that you can flip off and flip on.
And if you have several months probably.
Yes, Your Honor.
How can you show that I'm trying to decide on if we were to get to that and I'm not foreshadowing again, whether or not you're going to be out of business, which would be a big, big harm on your side of the ledger, or whether you're just inconvenient slightly while you get some work done.
Your Honor, I do want to be clear that because we are here now on the merits as opposed to a stay. Danko does not need to show irreparable harm. The question is simply whether we are harmed. It is the plaintiffs who have the obligation to show irreparable harm, and particularly where their declarants are in Texas and Indiana. It is very difficult to see how the situation on the grounds that
are harmed to the other parties also.
Yes, Your Honor. harm to the skidding. Yes, and I agree. And I think the Danko duck coloration that was submitted in the Supreme Court alongside the one from FDA documents that essentially this would remove mifepristone from lawful distribution in the United States for for a period of months, even properly
before us to consider under the rules. So, Your Honor, I think submitted it to a different court that's higher in every way than us. Or can we go say, go look in their record and say, well, we don't have it here, but we can borrow it.
I think at a minimum, this Court could take judicial notice of it. But in any event, it grew out of the state panels, I think, correct determination that the 2000 approval was time barred. And so the only question at that point became a different one than had been the situation in the district court when the 2000 approval was on the table. If I could just one more
question. I'll give you a little bit time. But I do have a question about Jin bio pro, you may not have a comment on it. But I'm very confused as to why they're not intervene or in the party. If they say that it affects them in lockstep, like it affects you or your client because of the same approvals. That's what the amicus brief. But that's a very odd amicus brief, because they seem to be actually saying they're having concrete injuries in this case. So that Do you have any comment on that? Or how we're supposed to figure that out and what to do about the generic situation?
I do not have a comment on what their litigation strategy may or not, may or may not have been? No, they are not my client. I can tell you,
can we whatever we do we just do. Is that what you're? I mean,
I can tell you that Danko intervened in this case, because we view this case as essentially existential to our continued existence.
Your client. You're sure your client is Danko, not Population Council.
I'm curious, then maybe this is not necessarily directly attributable to you all, but Population Council is the one who originally sought the application. That's correct. What do you make of the fact that Population Council seems to have agreed that subpart H is the wrong way to go?
Your Honor, I think the subpart H question in this case is a purely academic one, and has been since 2011. When FDA approved the rams that all the use restrictions currently operated between
approving restrictions on an approved drug and approving the drug. Right. subpart H as I understand it, I'm not an FDA expert, but I want to hear your argument. subpart H is the is one way to get approval from the FDA. It's an accelerated less rigorous format as I understand it, and population counsel who's maybe not your client, but who brought Benko in I thought said that subpart h would be unlawful, unnecessary undesirable. We asked FDA to consider subpart H I'm sure you know requires that only for serious deadly illnesses. As Population Council rightly says pregnancy is not an illness. So,
Your Honor, may I correct a couple of things about your understanding of FDA law. And approval is under Section 355. And 355 D in particular sets out when FDA should approve a new drug application, FDA regulation had promulgated a rule for subpart H for drugs that allowed it to approve a drug under 355. But please use restrictions on that drug. Congress
ID I think it's very understandable idea when you have cancer, AIDS, deadly diseases. And you want to give people the chance to take drugs sooner rather than later. You have an accelerated process. So there are two parts two separate pieces. Why does this? Why do you need to use that process here does even fit given that pregnancies, almost certainly not an illness.
There are two parts to subpart H one is acceleration that was not used at all in this case. So the accelerated part of subpart H is irrelevant. The other part of subpart H relates to use restrictions. That use restriction authority was subsequently codified by Congress. In the statutory section 355 dash one, it gave FDA what's called rems authority for set for drugs that previously had had restrictions through subpart H for Biologics that had had restrictions through subpart E for other manufacturers who had simply agreed to impose restrictions in something called risk maps. This is set out in the Federal Register Notice talking about FDA adopting this the REMS for these for these products after Congress's enactment. And so since 2011 When dichos rems submission was approved by FDA. We know that FDA used the 355 approval 355 D. And it has now coupled that with use restrictions under its rems authority that just makes this subpart H question. I think an academic one at this
point stand because there's an important point on merits. I want to make sure I understand it. You're referring to the 2011. FDA letter. The 2011. FDA letter refers to the approval being under subpart. H. The 2016. Subsequent state by the FDA, we're projecting the 2002 petition says the same thing, that the approval of ru 46 was based on subpart H. I think they said the same thing. And 2021 I think they said that same thing in the brief to this court. It's all about subpart H. So rams are I totally agree do the REMS are subject to the 2007 legislation? enactment. Right and the only issue is very much still part of this case.
I disagree, Your Honor. And I think the FDA counsel can correct that as well in the rebuttal to explain that 355 D is the statutory mechanism for approval. And that is the only statutory mechanism for approval of a new drug application. I would note that the
statements, I mean, maybe the FDA just was sloppy in its language. Maybe that's the theory, but I'm looking at the language, multiple 2011 2016 2021, the brief in this court all say the 2000 approval was based under subpart. H. And I
think that references the fact that there were use restrictions through subpart H that were imposed as part of the approval but but the approval itself, you
still have to ask the question does subpart H is this drug eligible for subpart? H treatment given that subpart H as I understand it is limited to serious illnesses. C is not a serious illness?
So your honor, again, I think there are very good arguments and we walk through them and FDA walks through them as to why subpart H was correctly used. But but it is truly irrelevant, serious illness. So in the preamble to the subpart H regulation Mother's Day that we will be celebrating illness. No, Your Honor, but FDA used the words illness, condition disease interchangeably, and it's subpart H regulation when it was promulgating it. And the size to that are in the brief.
I'm sorry. What do you mean interchangeable?
Use the words as though they refer to the same thing and disease illness and condition and pregnancy. And I don't think the plaintiffs have disputed this.
We want CFR 314 Dash sorry, doc for 500 serious or life threatening illnesses, the term illnesses.
I agree, Your Honor, that is the language that is used in the regulation itself. But as I said in the preamble, and in the discussion of the comments that were submitted in conjunction with that rulemaking, there is discussion about it applying to conditions and it has applied to other things that I think would you would not typically think of as a serious illness like like acne and infertility and, and other drugs that the agency again, all prior to 2008 that the agency decided should have use restrictions when they came on the market. Do you
have something you wanted to add? Because I have been asking you quite a few questions.
I have just two points I want to make and they relate to questions that you asked Judge Elrod, the first is on the record and the question about how long it will take the record to be produced. One thing that I think is important about how this court answers this question is that the scope of the record here will turn on significant insignificant part on what actions these plaintiffs have standing to assert. And were timely asserted. So if, for example, this court can get
the record first and then answer the question. I mean, that's normal, you send us the record with the agencies, we get that at the beginning of the case, or else we pre terminate the record. If it's a case, it's not, you know, in some immigration cases, we don't ever get the record. But if we need the record, we need the record.
So I don't think the record bears on standing and timeliness. And in a typical APA case, Judge Elrod, what usually happens is that the government or the government and an intervene or file a motion to dismiss on these threshold issues, and the record only gets produced as to whatever portion of the case
you don't think we necessarily need anything else than what we have
not to decide what's before you right now. Something else. Yes, the other. The other very quick point I wanted to make was that you had asked a couple of questions about both telemedicine and about a rural patient who might go to the ER and I wanted to point out on that, again, this relates to standing none of these declarant there is not a single statement in any of the declarations before you that identifies a declarant who treated a patient after that patient received FDA approved missa prestone through a telemedicine appointment, there is not a single declarant who identifies a patient they treated because they had to because it was a rural patient who had no other option other than to go to an ER. So it all comes back to what's in these declarations. The court needs to read them carefully. And when it does, I think it will conclude that there is no standing, at least as the panel concluded as to the 2016 and 2021. And that there is no timely assertion. I
have one more question is Ellsworth. And you've been extremely helpful. And I want to just say we have read the declarations as you already acknowledged, but we will read them again. That you don't you know, I know this case was briefed and argued under really an extremely expedited timeline, it was very difficult for everybody involved, and we appreciate the hard work, everyone's done. Your filings have been excellent. However, I am concerned about some rather unusual remarks in the filings. And I'm wondering that and these are marks that I don't normally see, or we don't normally see in briefing from various steam counsel. That talk about the district court, where there's comments at the district court defied long standing precedent. The court's injunction was an unprecedented judicial assault, the courts relentless one sided narrative, the non expert court, equally groundless, bending every settled rule, this is much more kind of remarks towards the district court that we normally don't see from learned counsel. And I'm wondering if you would have had more time and not been under a rush and probably exhausted from this whole process? Would those have been statements that would have been included in your brief? Or do you want to say anything about that?
Your Honor, I think those statements reflect our view that the district court court was very far outside the bounds of
appropriate to attack the district court personally in the case in that way, Your Honor, than just the rulings?
I don't think that those remarks any of them were intended as any sort of personal attack. They were an attack on the analysis. And you can say
we disagree with the analysis. We think it's all wrong for these reasons. But normally, you don't say the court ruling is an unprecedented judicial assault. That's an unusual remark, don't you think?
It says has been an unusual case for for reasons that you identify
with? And I just wanted to give you a chance to comment on that.
I certainly think with more time we may have ratcheted down some of that, and I appreciate your honors comment on that very much. This is a case that has been litigated at breakneck speed.
And I understand that and that's why I've that's what I thought originally, but I'm hearing from you that maybe you think that was appropriate. And
let me follow up on that, given that you're saying it's appropriate. I'm going to focus on a slightly different part of it, that the language that we're talking about is unprecedented judicial assault on a careful regulatory process. This is echoing some of the comments we heard earlier from FDA counsel. I don't understand this theme. The FDA can do no wrong. First of all, you'll agree that is basically the narrative you're putting forth. Nobody should ever question the FDA. This is unprecedented. The FDA just last month in response to litigation about the the drug, a subpart H drug for pregnant women Makina, FDA withdrew it. In response to a New York Times headline, FDA rushed a drug for preterm births. Did FDA put speed over science. Just last year, Senator Murray, chairman of the Chair of the Senate Health Committee, criticizes the FDA for quote, unacceptable, long standing food safety failures. FDA is being blamed for the opioid crisis, Your Honor, and a journal of ethics article how FDA failures contributed to the opioid crisis. None of this has anything to do with this case. What I'm trying to say is, why are we it's a thing that you all are putting forth, that is completely unnecessary. We are allowed to look at the FDA just like we're allowed to look at any agency. That's the role of the courts.
Absolutely, Your Honor. I think some of that may have been prompted by the district court itself saying that it was second guessing FDA. And so to the extent that part of our theme is that a CT is not to second guessed, FDA that is established, and I think every type of agency APA review. It's
FDA approved this drug in 2000. According to the AMA journal, you tell me if it's correct or not, but the quarter the AMA journal article, of all the novel novel therapeutics approved by the FDA that decade 1/3 of them have had safety issues. I don't have to meet This breaks from the US Medical Association and the Association of American Physicians detailing numerous FDA problems with numerous problems with FDA approved drugs. Do you know how many FDA drugs have been recalled in the history of the agency?
I do not know the answer to that question. I know that we have a number of briefs from former FDA officials from seven former FDA commissioners who served under both Democratic and Republican administrations documenting the very significant harms to FDA that would
come from Yes.
They talk about the harms that would come from a
GPS, which was approved by the FDA for five decades, prescribed, approved for prescription to pregnant women for decades. Turns out it's carcinogenic.
And, Your Honor, that's exactly why there is adverse event reporting and FDA monitors that this
route of adverse reporting that non fatal ones. But,
Your Honor, that is, well, we'll do a lot of problems here. If I could just mention one thing on the adverse event reporting judge Elrod, and I promise to be very brief, because I think that is a tremendously inaccurate statement to make NIFA prestone remains subject to the exact same adverse event reporting regimen that every other drug from FDA is subject to plus, it still has some mandatory reporting. So it is wildly inaccurate to say that there
certainly it's more moderate. Right for the non fatal adverse events and only annual or periodic rather than before. Why would you do that? Right, when you were expanding its use to potentially maybe it's not more dangerous, but I'm touching more dangerous. Certainly the plaintiffs think it's more dangerous. Why deprive the world of that information at that very moment? Because what are the pro science pro information, pro intellectual curiosity position?
In the hundreds of pages where FDA explained exactly why it was doing that that are in this record? What we see is that FDA looked at each one of those changes and said, there is zero difference to patient safety based on many clinical studies involving 10s of 1000s of people. So if if you as FDA have, I believe there are 90 citations in the sight or clinical review that's in the record 90 different references? Well, at least it looked at all of them in Toto. There was never a request from the plaintiffs
that looked at all of these changes in toto The cumulative effect together.
There are a number of studies that look at multiple aspects of changes in Toto. There is no requirement for a rems modification to do that. And for what I asked you,
I asked, Are there any studies that looked at these changes in Toto?
And the answer to that is no. But there is no legal requirement to do that under the under 355 dash one, which sets out FTAs rams authority. In fact, you don't even need clinical data at all to make a rems modification. Thank you very much, Your Honor. Thank
May it please the Court My name is Aaron Holly and I represent appellees. The FDA has talked a lot this morning about deference, but courts do not defer to agencies when they ignore congressional commands, nor when they put politics above women's health. And that's precisely what happened here. Confronted with a drug that could not otherwise be approved, FDA marketed myth of prestone by labeling pregnancy and illness than FDA strip this drug of virtually every safeguard it had wants to be necessary in order to sell the drug, despite zero studies showing that this complete deregulation was safe. Finally, FDA allowed for bail order abortions, contrary to federal law and common sense and an end run around the promise of jobs that states may protect their legitimate interest in unborn life and women's health by regulating abortion. For at least three reasons plaintiffs in this case have standing to challenge his actions. First because of FDA, unlawful approval and deregulation in Biffa prestone. Plaintiff doctors have been forced to participate in and complete elective abortions contrary to their consciences.
What's your best excerpt for that proposition?
Yes, Your Honor. I think we have several if we look at the conscience harms at a high level. Let's take Dr. Francis's declaration at page ROA 269 Dr. Francis says that plaintiff swith debt plaintiff doctors with ethical medical and conscious objections to abortion will quote be forced to participate in completing unfinished elective a chemical abortions. They've done that in the past. So Dr. Francis herself talks about a specific example. That example is also at 269 and 270. But Dr. Scott talks about completing 12 surgeries as Your Honor noted that we're required her to take embryos fetuses as well as against tissue from the mother's womb. I think that the disconnect,
go into your sentence. But I do want to follow up on.
Sure. Sure. I think the disconnect here Your Honors really comes down to the way that FDA, and Danko are defining the conscience harm. If you look at the declarations here, declared our are not alleging a harm because they're forced to provide an abortion. Certainly they would consider that a harm, but their conscience harm is much broader. They allege that they feel complicit in an elective abortion by being forced to complete that procedure. Danko and FDA says it doesn't quibble with the sincerity of these conscience harms but they are mystifying it. It's not just the abortion, it doesn't matter to plaintiff doctors for the child has died 30 minutes before or 30 minutes after that doctor has to provide a DNC that makes them feel complicit and violates their conscience.
Fair enough. I get the complicity point. But just so I understand the debate that we're having today. Yes, sir. A fair amount of time has been spent on Scott, paragraph 17. Yes, Your Honor. If I understand opposing counsels argument, and hopefully we'll hear more on reply to make sure I've not misunderstood it. I think they're basically making a passive voice. Point. Right, which is, I have cared for at least a dozen women who have required surgery. I think their notion is that was sort of deliberate passive voice on on Dr. Scott's part. Can you clarify this for us?
Absolutely not, your honor. Dr. Scott's not a lawyer. She's an emergency room physician who testified that she has often treated women suffering from chemical abortions. She testified that she has treated dozens of women. And she also testified that she has cared for and treated as well as at performing herself. Those DNC abortions.
She has performed them. Yes, absolutely.
Where where's this testimony?
So I think we have to look at a record that paragraph 17 It does say care for. But again, Dr. Scott's not a lawyer. It's sort of passenger. Did
you said you just told Judge ho that she's testified all this Where Where would we find that? Well, I mean, I don't?
Absolutely, Your Honor. It's in her declaration. So her declaration notes, a few key things. Her declaration notes, it says that she's often treated women suffering complications for Kim, chemical abortion gone wrong. It notes that she's treated dozens of women. It also notes that she has cared for as well as dawn herself. Doesn't DNC or suction aspiration abortions, requiring her to remove fetuses, embryos, and pregnancy tissue. If we're going to parse her words, that last phrase guarantees that that she herself performed, though she wouldn't know what was involved in those procedures. If you were just talking about some colleague. In addition, she testifies that in five instances, she was required to either perform blood transfusions or intravenous antibiotics, sometimes both. If we're talking about summers or clapper or New York versus Department of Commerce, or this Court's Case in et versus Paxton, there is no question that there's a substantial risk of harm, that that might occur again.
But what if what if the opposite counsels point that she nowhere says I was forced to do this in contravention of my conscience? In other words, did she lodge an objection? Was she required to lodge an objection before invoking this? Or did she just do it? Because it was an emergent situation where the patient needed care? That's different, isn't it?
So So, Your Honor, I think the state panel correctly noted that these doctors are not supposed to choose between their livelihood and their conscious objections. As you noted, these are emergency room doctors face with emergent situations, a doctor spot notes that this the emergency situation may force her to in the life of a human child in the womb,
but what about handing it off to another doctor who doesn't have the same objection?
I'm not sure, Your Honor. That so I think that that the doctors here feel compelled to treat women. They also have a sincere, conscious objection. And I don't think the nature of a conscious objection would require them to say, I'm not going to do this. I think that they can still complain about the treatment and say it violates my conscience rights to be forced to be complicit in an elective abortion.
The approval of any drug that triggers a conscience concern in the part of a doctor gives that doctor standing to bring a suit and challenge the approval.
No, Your Honor, I think there are you draw the line. So I think there are a number of things that really differentiate this case from defendants parade of horribles. First, as dogs recognize abortion is different. The talking about ending the life of an unborn child a second, this case is much different from a doctor who claims a harm from treating an asthmatic child or a gunshot victim. Because here the actions are directly traceable to the FDA unlawful actions in approving and deregulating Mr. Press down. In fact, Your Honor, these harms are far from unexpected. If you look at the record on pay Age 1592. This is the initial approval, the FDA acknowledges that emergency room doctors are going to be part of the solution in cleaning up the messes left. For women suffering consequences of chemical abortion, they acknowledge this because they say we're not requiring at that point doctors that that requirements even been removed. But at that point, we're not going to require doctors to have surgical ability. And we're not going to require them to have admitting privileges. Instead, we're going to allow them to refer to emergency rooms. And that brings up another point that my friends on the other side mentioned that the adverse events here is less than 1%. I'm not sure where they're getting that number, maybe it's from FERS, which there's all sorts of problems with. But if you look at the current medication guide for Mr. prestone, the current one updated in January of 2023. What that medication guide says at table two is that between 2.6 and 4.9% of women will present to the emergency room, those numbers match on to the numbers found by the state panel. And they as the state panel reasonably found, it makes it reasonably certain that these plaintiffs will end up with women suffering from chemical abortion gone wrong. I standing does not require that an additional woman show up on the emergency room door, especially when so many women already have it doesn't
matter if it's for an emergency life threatening situation or if they've gone just because they're they don't know what to do or they're confused. Does that matter in any way?
So it might, Your Honor, in the prior circumstance, you might be able to call in another doctor. But these women there's testimony in the record about a doctor who treated a patient who had gone out of state to obtain chemical abortion drugs passed out on the in the Uber on the way home and was unconscious by the time she arrived at the emergency room.
Is it accurate that none of these? None of these doctors refer to any telemedicine problems?
Absolutely not. You're on Earth. There's testimony after testimony that talks about how the FDA is deregulatory efforts have increased the number of women they're seeing. In fact, if you look at Dr. Francis declaration, what she says is that during the time period, when a federal judge has stayed enforcement of the in person dispensing requirement, she saw emergency room visits go up, but that I believe that ROA 267
You're making a predictable argument, the predictable under Department of Commerce, government policy change certain responses are predictable the population. Yes, Your Honor.
But I would distinguish that from summers all Summers is about is it says reasonably that you can't assert.
I said summers I'm gonna depart department commerce. Is
this correct? And indeed, you know, more than predictable. I think it's expected. The FDA itself expected these emergency doctors would as the state panel found have to clean up the aftermath. And for the records.
I'm sorry. Do you agree with counsel opposite that to show third party standing, the doctors have to demonstrate Article Three standing independently?
I think that's an open question for the Supreme Court's decision in June medical, I think they clearly do that here. And they also clearly satisfy the other requirements for third party standing. And as Justice Alito pointed out, in his dissent in that case, abortion providers usually spend two to three minutes with a patient, the declarations here, detail hours I spent with individual patients, caring for them. In addition, if abortion providers can challenge regulations that are meant to protect women from abortion providers, certainly a bore the pain, excuse me, the doctors who care for these patients should have third party standing as well.
You disagree with the state panels? Footnote four?
I think so, Your Honor, when you look at that footnote in dogs are the cases that are cited, the new Dell case and others really concern the situation in which there's a conflict of interest. And I would probably agree with that dissent that there are there is a conflict of interest when abortion providers say we don't need surgical Adams ambulatory requirements. You know, Louisiana and Texas both said that was necessary to protect women's health. abortion providers came in and said No, it's not. I think that's a conflict of interest. In this case, however, we do not have a conflict of interest because the women injured by Mithra prestone, as well as the doctors who treat them are all suffering the harm caused by that drug.
We've been talking mostly about 2016. But what about 2021? Is that not moot?
That's a great question, your honor. And no, when you look closely at Danko and FDA sprigs, what they say is that the 2021 non enforcement decision is moved. We would agree with that that the pandemic ended I think it was on May 11. And and so that just not entitled
to any relief on the 2021 non enforcement decision in December. 2021 is that correct?
I think that is likely what is not, Your Honor, is our challenge to the 2021 petition decision and the petition decision opposite
time. month in December? I'll go ahead. I'm sorry. No worries,
Your Honor. So the petition decision is clearly has a live issue with the case. In this case. mootness occurs when there's not a live controversy, just like a defendant cannot cease conduct voluntarily, in order to trigger the Buddhist doctrine, neither can the FDA pass a subsequent regulation in 2000, or, excuse me, subsequent rims requirements in 2023, which effectuates the 2021 final determination
actually argue much about 2023? You know, I know that it's in the panel, motions panel opinion and a footnote there with a citation to the MPP case, I believe, you're sure, but it's but did you plead or argue anything about 2023? And should we be relying on that in any way?
So No, Your Honor, what I'm saying is that the 2021 petition decision, so in 2019, plaintiffs challenge the 2016 rims major changes. They also asked the FDA to retain in person dispensing I think advocates has been saying, you know, we should take this away. So they asked the FDA to retain in person dispensing into December of 2021. The FDA denied that part of the petition, and then that that claim is absolutely live. We are challenging FTS determination of allowing mail order abortions, and the 2023 rims effectuates that final decision, it was required by that 20 Not
the blanket COVID. But the denial of the 2019, which occurred in 2021.
Absolutely, Your Honor. So that claim is very much alive, but not faltered.
I would think the voluntary cessation doctrine totally takes care of this right. Absolutely. Your Honor, not only not promising you this is not going to recur. They've codified it permanently.
Absolutely, Your Honor. I would forever, it would be like an agency saying you can't do X, someone challenging it. The agency promulgating a new regulation saying you can't do x which still governs individual conduct. Absolutely.
I just want to have the floor. I want to ask about the subpart. H because there was some discussion earlier about how the accelerated approval was not used. Do you want to respond to that?
My understanding of the record, Your Honor, is that's completely incorrect. In the letter that the FDA sent the Population Council, they said that the drug could not be approved, but for subpart H. So my understanding of the entire record is that because the drug was a serious life threatening illness, which FDA itself was not prepared to approve without postmarketing restrictions, the only avenue available to it was subpart. H, and you're already absolutely correct that that subpart H approval is still at play section 355. One is only a rems provision, the FDA triple A amendments grandfathered those subpart H approvals in but but the postmarketing restrictions, not the approval. So the relevant approval is still 2000.
Just to be clear, I think what they were suggesting is not that they didn't use subpart H at all, but that they used a different a different part of support age, not the accelerated approval part. And you're saying that's incorrect.
So it no you're in, I think it's a true that I don't think they actually did accelerate approval, even though subpart H was intended to do that for cancer and HIV drugs and the like. But it's absolutely true that they use the part of subpart H that required them to find it was an illness. But it took
four years. It wasn't one of these several month ones like the Hodgkin's, non Hodgkins and leukemia, etc.
Correct? Your Honor, none of our argument relies on that the long term, you know how long it took, rather than they used a procedure probably incorrectly. Because it because it was the only thing available to them in order to find build a pregnancy with an illness. The second problem with that, of course, is there were no studies that looked to see whether medication abortion or chemical abortion had therapeutic benefits over surgical abortion. And
I do have a question, though, that goes to it's about what Giotto has been talking about with you. I am confused. But why FTAs formal approval in 2011 with a new risk management strategy didn't cure any error as to subpart h two. And so why wasn't that good enough?
Because, Your Honor, I think it would be I think FDA is argument here is that Congress codified the approval of Mr. prestone. And I think there's no way to glean that sort of specific detail saying that the Congress itself actually approved Mint for precedent that what what Congress did instead was Congress say that we are grandfathering in Are these other these other subpart H things? They gave the agency 180 days to submit a new rims. So it was just a stopgap measure for all of the drugs this this general stop gap grandfathering provision in no way approved any particular remedy, FDA
did not formally approve MUFA prestone with a new risk mitigation strategy in 2011. The FDA did not formally do that.
I don't believe so, Your Honor. I think what they did is approved rims that they didn't the the approval and the rims are are different three ones under 355 and ones under 355 dash one
object to record. Thank you.
Sure. I was your challenge to the 2000 approval timely.
So through the reopening doctrine that this Court recognized in Texas versus Biden and the DC Circuit has recognized in a number of cases.
So on the reopening doctrine, is it untimely?
So let me convince you on the reopening doctrine when we look at 2016.
And I'll ask the same question again when you're done.
So when we look at 2016, the agency itself labeled those changes major, it also at ROA 703 labeled those changes interrelated. So it strips away all of those changes. And under the statutory section 355. One, each and every one of those nine stripped away changes was required for the FDA to determine whether it was safe.
Well, but so I get that. But they also have 1516 years of safety data use data. It's more widespread post approval. So is every time the FDA going to relax some prior restriction or requirement or safeguard, based on history of performance? Does that then mean we're here on a reopening issue? I mean, how do you draw that line?
Absolutely not, your honor. There are only 76 drugs that are subject to rems. And I think if you look at them, we'd be
here 75 more times, possibly.
But so but if I could convince you on another thing, the DC circuit's also says to look at context, and this would be something that was not true of the other 75 drugs, when you look at the
approval of the underlying approval of the drug in 2000. So I 16 or 19, or 21, or 23, did they
so your honor, on the very same day that they stripped away the changes made the major changes. They also denied the citizen petition, which they said they'd been quote carefully considering for 14 years. That was made by the very same decision maker definit Woodcock signed the petition decision, the signatures are redacted for the major changes, but the day buffet. You know,
I know it's an interesting factoid, perhaps. But what difference does it make if it's the very same day by the very same person? What is the is that something legal significance or factual significance in the case?
Absolutely, Your Honor, it shows that the context that the FDA was absolutely reconsidering the 2000 approval and whether Mr. President was state, at the very same time it was stripping away the 2016 requirements. They were all sort of the same silo, the left hand knew what the right hand was doing. And as a matter of context, I just I just think that the the same day makes a tremendous amount of difference, assuming
that arguendo that we do not agree with you on the reopening doctrine. As Judge Wilson asked you earlier, do you lose on the 2010 2010? Your Honor?
I mean, the 2000 approval? Yes.
Yes, we did. We're stuck with the 2016 and the 2021. Right.
So I think that's correct, Your Honor. But if I can try one last time to convince you on the reopening in 2021, the agency says that it fully considered the REMS. Now, again, the statute 355 One, as well as the regulations require that each and every one of those safeguards was determined to be safe. It would be like for example, if you had a toddler, and you tested a bar stool and it has three legs and you said the the bar stool is safe, you toddler can climb on this bar stool, um, then you strip away one of the legs or maybe two, you're going to reevaluate your determination as to whether that barstool is safe. I think that's what the reopening doctrine gets at. Um, with respect to judge hos question to my friends on the other side, there was no opportunity for plaintiffs here to challenge in court, the 2000 approval before 2016. And the reason being is that the 2000 approval was not final until 2016. Was that petition denials? What triggers under 21 CFR 1045? Ad Agency determination is not final the FDA determination until the FDA act on a citizen petition. So that finality requirement isn't triggered until 2016.
Okay, let's talk About the generic version, is there any specific evidence in the record that your client sustained injury from the generic version as separate from the from the other version?
So I'm not aware of any specific evidence, Your Honor. But on the other hand, neither is there any specific evidence that they have not here, if you look,
for plaintiffs bear the burden of showing standing? I mean, in other words, they'd have to be injured by the by the generic version of the name brand.
Yes, Your Honor. But
it's not in the record. No standing?
I'm not sure that's correct.
Under the fair system, as we've noticed, nothing is required to be reported unless there is a fatality. The fair system actually is quite onerous process 48 pages of exclamatory decision pages on how to fill out a FERS form. But part of that is including the dosage and the manufacturer, but we don't have that information.
If you don't have the information isn't that fatal? Mean? In other words, we're going to find standing based on the possibility that there might have been data if it were reported.
So I think one way Your Honors, absolutely can find standing is organizational standing. Plaintiffs here associational painters fit within all four corners of both OCA greater from this court, as well as a havens relatie, plaintiffs apologue. The rest of the organizational plaintiffs have clearly expended considerable time, energy and resources in a number of specific and concrete ways. There was a 92 page petition devoted to challenging the 2000 approval along with a 30 page response. There's testimony that that took considerable time and effort, there had been independent studies performed to show the dangers of MyFord prestone. There have been analyses of the existing data from the FDA Eric
weren't there? And I mean, and they're not here, either. So should we not do anything with regard to that?
So I think I think your honor to come back to the initial question. I think, if you look at the 2021 mill order abortion mandate, what this Court can do under Section 705, or section 706, is act upon the FDA, or what the FDA did was unlawful. And so I think plaintiffs have standing I'm certainly organizational standing, I think also standing as individuals and associations. But even as an organization or standing case, this Court would be empowered under the Administrative Procedure Act to either stay the effective date of any of these challenge actions, or, on the other hand, as the District Court did, or excuse me, or under Section 706 to vacate those decisions.
Okay, well, let's talk about the balance of the equities. Yes, Your Honor. You believe you bear the burden of showing irreparable harm?
Your Honor, yes, I believe we have shown irreparable harm defendants or excuse me, defendants on the other side, all of their arguments boil down to a merits based argument. But if we look at the record here, again, I'd point you to right ROA 2368. That is the current medication guide. And it says that between 2.6 and 4.9% of women will end up in the emergency room, excuse me, 2.9 and 4.6 will end up in the emergency room because of Misbah prestone. This causes severe harm to women. As the medication guide indicates there can be sepsis, you can lose your life. There are a number of harms caused to women by men for prestone as well as to plaintiff doctors in this case,
plaintiff doctors irreparably harmed.
And I believe your honor, being forced to be complicit in completing an elective chemical abortion would be an irreparable harm. In addition, there are a number of other harms that are plaintiffs advanced here, and they map advanced emotional harms. The doctors talk about the heartbreaking toll that treating post abortive women suffering, grief and complication causes under Spokeo and TransUnion. Those constitute that emotional harm in combination with the constitutional harm of conscience is enough. There's a lot of evidence in the record about medical that the harm to their medical practice. They talk about emergency and chaos in the emergency room. Again, something that is expected under the very approval regime countenanced by FDA. Let's,
let's talk a little bit more about this harm situation. It seems that it's the first thing we would look at are the parties to the case and the FDA would have an interest if it is indeed a lawful action that it has a lawful action go into in come into being and not be thwarted, that would be their interest, the Dan co people would want to not be put out of business that would be their interest is it so and yours, your your your clients interest would be to, to not have to perform more, more of after effect abortion type proceedings for a variety of conscience and emotional issues that fair enough. And in being concerned about the health of the women who might be harmed. We have stacks and stacks of all of these friends who have filed these briefs. And they're on every side of the aisle and lane. And this is not uncommon in these days. And so you have the people that are the people who and this is not, I don't minimize their situation, people who are in sexually abusive relationships. And they file briefs on both sides of this. There's one group who says, Well, if you can't see the doctor, you're not going to get away from the being abused or human trafficked. And there's the other group who says, If you don't give them the pill, by mail, then they will never get away because they will be trapped by by the abuser. And I am not minimizing the situations on either side of this. That's just one example. And these are serious societal issues. Or do those. Do we have to figure out which way to which way that goes? Do we take that into consent consideration at all, in deciding the the balance of equities here? And how do we decide that?
So I think, your honor that might fit within the the public interest prong, but the FTAs job here was to ensure that Mr. prestone is safe and effective. There are other methods of obtaining abortion that are available to people in the tragic circumstances you detailed, but that doesn't mean that the FDA is justified in approving a drug that sends between 2.9 and 4.6% of women to the emergency room,
just kind of extra out there. But they don't cut particularly either way, because they're on both sides of it. And we need to just look at whether or not the FDA erred.
I don't think so, Your Honor. I think that the briefs saying that, that removing chemical abortion are overlooking the fact that surgical abortion is available. This way, this case is not about ending abortion, it's about ending a particularly dangerous type of abortion. So So I think the availability of other abortion procedures would mitigate much of that harm you were talking about. On the other side. In addition, make sure
we're doing the right analysis. Yes, Your Honor. Any help the other side has on this appreciate as well.
Yes, your honor and respect to the interests of the parties here. There simply is no interest in the perpetuation of unlawful agency action. The FDA didn't even argue that it was harmed until it's brief in this court. In addition, Your Honor, Dan Coats hands had been complicit from the very beginning. They urge the FDA not to require ultrasounds, if we're going to talk for instance about ultrasounds and the harm from each of the particular decisions. If you look at the 2021 decision approving the absence of an in person, doctor visit any in person doctor visit, you can get it through the mail. Now, the studies that the FDA relied on, ironically required ultrasounds, you'd go to a doctor, you'd get an ultrasound, and then the abortion provider would mail you the chemical abortion drugs. In addition to this, those studies showed that complications doubled from the emergency room that we've been talking about 2.6 to 4.9. There were two studies. One of them the Raman study showed it rose to 7%. The Chong study showed that emergency room visits rose to 6%.
The we consider all of these studies, are we supposed to only consider the studies that the FDA considered Are we allowed to be roaming through the literature. You know, Your Honor, these are I mean, and I'm not saying we're not I'm just wondering to know, you know, I saw in one of the amicus briefs it said 590 Women in an emergency department in England go every month, and that there are three times more likely to seek emergency ambulance ambulatory complications, because since the since this, this type of thing went into effect. But am I allowed to consider that or do I save the FDA already took that into account or maybe they didn't use that particular study or it's not a good study? So, Your Honor, what you're absolutely
allowed to do is look at the studies the FDA did these are the two studies the two US studies that they relied upon in order to remove the in person visit. They admitted that the studies do not themselves. This is ROA 834 that the studies themselves do not remove support removing in person, they acknowledged that removing in person would increase ER visits. The only other thing they looked at was the fair's data. But as we've discussed, an estate panel athlete laid out, it's an ostrich in the head asteroids in the sand head approach to say that we're going to eliminate reporting requirements, and then justify removing even more requirements based on the absence of data. So I think if you look at the 2021 decision, not only is there clear harm flowing from that decision, we've got an increase, essentially doubling of emergency room visits from the two studies that the FDA itself relied on. In addition, that decision is absolutely unsupported by the record. At a minimum, the FDA has to explain its decisions. Here, it relied on the three things as our brief laid out, none of those are are persuasive. The first eight is not persuasive. The reporting from Damco is not persuasive because it was based on the FERS data. And these two studies were not persuasive. If we're going to talk specifically about the 2016 procedure. And the 2016 major changes affirmatively harmed plaintiffs here in a number of ways to begin, there's no dispute that with each increasing week of gestation, there are more complications, again, to turn to the current medication guide. And this is in the record. And at table four of the current medication guide. There is a 5% increase from week seven to week 10. In incomplete abortions, there's nearly a 3% jump in surgical procedures, point three to 3.1. This definitively shows that the 2006 major changes, harm plaintiff doctors, as well as the patients they chose they treat, get them
a major change. 2016. That's correct, Your Honor. What FDA actions forced you to your clients to divert resources? This is an organizational standing question.
Absolutely. Your Honor. I think each each one of them. In particular, if you look at the 2000 decision, plaintiffs have diverted resources from their usual activities. If it were not for the FTAs, approval of Mr. prestone, then they would be engaging in other activities they've testified to, such as protecting the value of life at every stage of development, advocating for greater conscience protections and arguing against surgical abortion. Is
there anything in the record indicate what specific activities your clients were unable to do because of a diversion of resources? A Yes, Your Honor. I think those are the three I just listed. Those are specifics they were unable to do because of the diversion of resources or reduce
them and this Court's decision and OCA greater says that it is not required to list to identify specific projects. That's one way to show organizational harm. But it was not a heightening of the Luhan standard. The courts prior language, I believe was in city of Kyle that talked about specific projects. What OCA greater says is sure that's one way to show it. But we didn't intend to heighten the Luhan standard, as long as you have a diversion of resources away from ordinary activities. That suffices.
You have anything
further? Yes, Your Honor, I would like to mention as well, the specific problems with the 2016 approval. Judge Wilson alluded to this. But in the 2016 approval, the FDA stripped away nearly every safeguard that did not have a reasoned explanation for doing so it did not have a single study that looked at all of these changes that on ROA 703, the FDA acknowledged were interrelated. This would be as the state panel noted a like having a car with airbags and roll bars and seat belts and side mirrors and a rearview mirror and a backup camera and sorts of other safety things and then taking them all away without ever having a study that looked at that. And while a one to one match may not be required. What is certainly required, especially when the FDA says that the changes are interrelated is an explanation for why that study doesn't exist, or why it can cobble together different studies in order to support those changes. That's completely absent from the record here. In addition, Your Honor, when you look at Section 355 D it requires a few things section 355 requires adequate testing. It requires sufficient information and it requires substantial evidence. The FDA erred both in 2000 as well as in 2016 by relying on studies that included included crucial safeguards, like ultrasounds law Like the 14 day follow up visit, and it doesn't explain why those things are necessary. Again, this would be like, you know, telling your toddler you can climb on something, but then taking away that safeguard, so the Population Council, as Judge has noted, even thought that ultrasounds might be a good idea. If you look at the studies from 2021. Those studies had ultrasounds, even though the abortion provider was going to mill the drugs out. So it's an unreasoned decision to have studies with safeguards, and yet turn around and approve the drug. Without those necessary safeguards.
FDA and Dan co say that in joining the use of myth, Pistone would put miscarriage management at risk. And some several the Miki also does that way against in the injunction? No, Your Honor. I
believe that 85% of OBGYN ins I do not they're not certified abortion providers. So the vast majority of abortions are of excuse me of miscarriage management would be undertaken by a second drug at the second drug in this regimen, de missa. Pro stole, because most it will be do not use me for prestone. In addition, Your Honor, I'm not aware of any case that would uphold an unlawful approval based on an off label use. So I don't think that that would be an appropriate basis or an appropriate consideration to uphold FDA approval here.
Thank you, I believe we have your argument.
Thank you, Your Honor.
And we appreciate it just as we've appreciated everybody else's argument.
Thank you, Your Honor. Just a few points if I might and then happy to answer any questions. You have Giotto. If I could go back to subpart H with you. We say in our brief on page 45 of our opening brief that the approval of the drug was directly under the statute under Section 355 D 355. The author was also authorizes FDA to approve conditions on the use of a drug. Of course, an agency could not promulgate a regulation that gave itself more authority than the Congress had given it in the statute. And so everything Congress excuse me, I think FDA did in 2000, was pursuant to its statutory authority. Also, I want to say, again, that any challenge to the use of the subpart H regulation would be time barred because that any invocation of the of the regime and subpart H of the framework is relevant only to the 2000 approval. Nothing in the 2016 changes reopened the 2000 approval, FDA did not look again, at the three studies that had relied on for the 2000 approval, it didn't go back and ask the question whether the drug was safe for use under the conditions that were currently in place. What it asked was whether a different set of conditions would also ensure safety. That's what was under review in 2016. The denial of the citizen petition in 2016 doesn't also wasn't a reopening. And the denial of that citizen petition in 2019 did not reopen the approval question, because the plaintiffs didn't even ask for the approval to be withdrawn in their 2019. Petition.
Go briefly back to the subpart H issue. I definitely saw what you saw said on page 45. But on page 10, do you make the point that FDA, I believe this out of the 2016. This is your procedural history part of your brief, you note that in 2016. Deputy his position back then at least was if a person was approved under subpart. H noting that pregnancy can be a serious medical condition.
It's true that yes,
you can argue an alternative. There's nothing wrong with that. But just to be clear,
right? What I'm saying is that right? I'm sorry to interrupt. Yes. What I'm saying is that the subpart H regulation was not a necessary predicate to the approval of the drug with conditions. That Authority came from the statute itself. It's true that FDA used the framework that's in subpart. H And as my co counsel my friend from representing Danko explained, FDA viewed the subpart H regulation as applicable to serious conditions. It used subpart H to approve drugs for pain management for high blood pressure and low blood pressure, other things that are conditions but not illnesses. It explained this in responding to the in its 2016 response to the original citizen petition. But again, it wasn't a necessary predicate for the action that was taken in 2000.
A quick question about the Comstock Act act. I understand that part of your argument is that the circuit courts in the early 1900s interpreted the ACT prohibit only unlawful abortions. And that Congress acquiesced to that interpretation when it amended the Act and other drug laws that's kind of a synopsis. Has the Supreme Court or even a circuit court ever applied the recodification Canon to circuit court decisions?
So in the Inclusive Communities case that cited in our, in our briefs that's about whether there's a disparate impact cause of action under the Fair Housing Act. This is a case from 2015, I think from the Supreme Court there. The Supreme Court said, you know, looked at the fact that all of the courts of appeals that had addressed the issue under the original Fair Housing Act had viewed it as having a disparate impact cause of action, those decisions had been called to the attention of Congress. And when Congress amended the statute, it hadn't changed the operative language. And the court viewed that as a signal that Congress believe that that interpretation was correct. And so whether you view that as acquiescing in those decisions or not, it certainly was viewed as evidence that that was the correct decision. And the Supreme Court in 2015, held that, in fact, the statute does have a disparate impact cause of action. And so it's a similar situation here, where you have all the courts of appeals that have looked at this thing. It doesn't prohibit the mailing of things that are unless the sender intends that they be used unlawfully. Well, there's some
disagreement of whether that's true whether all the Court of Appeals says we don't have time,
right. But those those decisions were brought to the Congress's attention. And and so that's how that was our main argument on CommSec is that Congress did not charge FDA with doing a survey of all civil and criminal laws when making decisions about whether drugs are safe and effective. And so it just wasn't, FDA is full of scientists, not prosecutors, it's just not part of their charge, their statutory duty to figure out if other things that people do with drugs that are that they get approved, would violate any other laws. So I just want to note, I understood my friend on the other side to have abandoned any equitable tolling argument. And so we think reopening is the only theory under which they could get at the initial approval for the reasons I've explained that decision was not reopened in 2016. If I can briefly just touch on the ultrasound argument, although I see my time is running low. I just want to note that FDA has never required ultrasounds, FDA explains that ultrasounds are not an effective safety measure in the studies that they relied on that they are that they were, in fact, a data gathering tool. I wonder if the panel would indulge me?
Because I take it you agree that the safety issues do change dramatically based on gestational age?
I don't think they changed dramatically know what the what the evidence that my friend pointed to was that the
White House these limits? Why have seven weeks in the original and then 10 weeks?
Well, they might I mean, because I think it goes to effectiveness, right. And so the difference that Miss Holly pointed to was the difference in the percentage of times that the abortion is completed. And it may be true that it has a lower completion rate at hires weeks in some studies and other studies that showed a greater success rate at higher, I'm sorry, please, please finish it at a higher gestational age. So
your position then the FDA position is seven weeks, 10 weeks, 15 weeks, 20 weeks, it's always fine to use this drug. The only question is whether we're going to work to be a successful abortion after possession.
No, what I'm saying is that FDA has determined that it's safe and effective up to 10 weeks, it has not made any decision about anything that could happen after 10 weeks. That's been the data that was submitted to FDA. That's what the scientists,
but implicit in that statement is that it could very well be very unsafe after 10 weeks.
It could be or it could not be That's not a question that FDA has made a decision about.
But the point is under the FDA is rems and whatever you call it before the rounds system. Age mattered. So I took your question to be on the way to figure an age as well as the ectopic pregnancy problem.
So it is not the only way. And so even in the studies that were that FDA relied on for the original 2000 approval, the French studies did not require ultrasounds because there are lots of ways to determine gestational age. Pardon me, you can ask the patients, right, there's the same is true is true with ectopic pregnancies. And in fact, if you
I'm sorry to interrupt, but we just had a case yesterday, and I'm not holding you responsible for yesterday's case. But yesterday's case was literally about how important it is to the FDA to find out issues of age that that's in the context of vaping. But the point is FDA was very, very aggressive about making sure that vaping products are used only by adults and not by children.
Right. Okay, but here, what they're doing is they're deferring to doctors to medical people to make that medical determination about gestational age, and they say to doctors, you should determine gestational age you should assess for atopic pregnancy before you prescribe this drug, but they leave it to doctors to practice medicine to determine how to do that. And if you look, this is important. If you look at the rate of ectopic pregnancies, in people in women who have taken me for prestone. It's a tiny fraction of the percent of ectopic pregnancies in all women who have who are pregnant. So 2% of pregnancies for
ectopic pregnancy. Pardon me, how would you assess without doing some sort of examination? Or you ask
questions that you asked if the patient was interested in? Would
you answer that would tell I would say
are you experiencing, you know, certain kinds of pain. I do experience shoulder pain, which is referred pain from abdominal trauma. Are you feeling you know, Dizzy, there's all kinds of things that you can ask. And in fact, if you look at the data that's on on women who've had ectopic pregnancies who took me for prestone and half of those cases there was an ultrasound performed, and I think 60% of those ultrasounds, there was no evidence of the ectopic pregnancy that was seen. Right. And so but I think the fact that the rate of ectopic pregnancies is much, much lower and women who take me for pisto than it is in pregnant women generally shows that in fact, ectopic pregnancies are often being found by doctors before they prescribe me for prestone. And so there's certainly no sense in which, and I think there's no allegation that the drug causes ectopic pregnancies or makes the exact perfect pregnancy. Worse, it just doesn't work to end the ectopic pregnancy
when there's already a gap. Do you acknowledge that there's a gap between reported complications and actual complications, because different measures have wildly different numbers reported of complications do acknowledge that there's a we don't have great information on complications?
I don't believe that I don't agree that we don't have good information about complications, the reporting requirements are this a bit Apply now to me for persoane are the same, a little bit stricter, but generally the same as those that apply to all other drugs or most other drugs that have been approved by FDA. The sponsors are required to submit adverse and adverse event data to FDA on an annual basis, they have a very serious market incentive to do that. Because if the labeling is not kept up to any adverse event, for any adverse event, yes, they're required to report that data.
And they get that information if they, if the people don't go back to the, to the prescriber. And most states don't require people to they don't report from the emergency room or they. You know, God forbid the morgue? How do you get that information? That to know that it's reliable enough to say we don't need it in a more robust fashion.
So I'll just say the most women have taken this person do follow up with their own doctors. And so those doctors who are certified by Danko and done by a pro to prescribe the drug, have the ability to collect that information. But I think more generally, the sponsors collect that information the same way that all drug sponsors collect the information and I can just complete the sentence I was about to say, which is that they have a strong market incentive to do that, because at the labeling is not kept up to date in terms of expected outcomes and risks. Then they face serious tort liability and so that sponsors take very seriously their duty to collect information. They have to survey the medical literature, they survey studies, they survey all the post marking data they can find and they are required to report that information, all that information to FDA on a regular basis.
Thank you. We have your argument. Thank you. We appreciate all the arguments today in this case is submitted.