No interruptions and completely unfiltered. Cspan, your unfeltered view of government. And now, a u. S. Appeals court panel based in new orleans heres oral argument in a occasion involving an abortion case. The case was previously heard in texas where the judge stopped the ruling. Afterwards it was appealed and temporarily halted. This is two hours. The case for this sitting is 202310362. Alliance for hippocratic medicine et al vs. Food and Drug Administration et al, vs. Food anDrug Administration ffc. Well hear first from mrs. Harrington on behalf of the f. D. A. Fda can make that determines but no courtas ever questioned that expertise. I wonder if we c do that rather than ha thisort of f. D. A can do fro wrong they think. Im happy to do that but i think its important to undeta the case involved. The f. Dsentral claims are time barred. Ill start with their series of individual and associational standing. Aintiffs and their members are not rulated parties. F. A proval does not require them to do anything at all. They claim downstream effect of chans de by other people who are not parties to is lawsuit. They present with complications fr taking a medication but even theare that simply treating a patientnjes a doctor. Instead their offer four series of injury, none that is acble to any action of the f. D. A. First they report that they and their administration will be forced to complete abortions in violation of their religious beliefs. No allege that hor she has be compelled in the past to do anything in objective to their religious believes and they make unsupportedding a allegations that they will in the future be required to do things in the past theyve never been required to do. It seemso allude to possible surgeries and that sort of thing. New has been forced to participant in any procedure they would consider to be an abortion. Surgeries in postabortion care. They refer to other people havent having done it. Dr. Scott says she has cared for patients afterward,ot that she provide those procedures and she doesnt say she objected to themven if she did provide them. Would her colleague or one of the otr doctors colleagues who performed a d and c, would that count . No, you need to have an identified laugh in the case tock say that theyre intimaty going to be injurered. Said they were either plaintiffs or member of a plaintiff organization. A match Organization Needs to identify specifi members. Wouldnt affidavits be that cls occasion . Yes, but none of the actually says that and you cant proceed that critical fact into the declarations. Youre saying what you need toave standing is an expression of an objectable corks. You need to prove that youre at imminent risk of being injured. One of their theories ishat theyll be forced to do things against they are reline of scrimmage beliefs. Do theyay religious belief or conscience . They can say either one but never h it been allegedhat anyone has done this in the past and they also ignore conscious protections in federal and state la i want to make sure i undersnd the argument, looking at the francis, paragraph 15. Members are opposed to for no medical reason, including having to complete an incomplete medical abortion. Thats ctaly a an objection. Aolutely, we dont dispute their objections to engaging in these activities t the points is theyve never been forced to do that. It would be surprising if they could allege at because they have robusconscience protections in federal and state law. They ignore nose protections. What is the governments position about. The obligationn of emtala what about one doctor Emergency Rooms . Again, the obligation ru t the hospital so the hospital would need to ensure that theres someone on staff whoan perform whenever Emergency Care is needed. Doctors have protections. What about the objection that this violates the hippocratic oath. Does is that covered no. Conscience objections could go a lot further than just religious bad, right . There are consciee objections placed in federal and state law that arent necessarily tried to religious objections and were n aware of any instance in whi a doctor has had to engage in anything against his or her religious beliefs. They cared for this patients. I take thato believe they treated th and that they expect them to see more in the future. How is that not enough for standing . Because they carefully dont satheya ever had to do so. This isnt Summary Judgment where he would we would take everything in the light ofhe mismovement or the preliminary judgment phase. How much should we split words of what are in those declarations . Your honor, its foot sptting word. We have to take what they say is true. But they understd what they need to do so allege standing and allege a pastnjy. The r. A. 77 to 79. She says shes performed surgery on a dozen women after a clinical abortio including sometimes removing the eringo or fetus. Is that not enough . She doesnt ever say that she was compelled to do that against her relines belief and there are protection for sorry to interrupt you but it specifically says harmed by conscious right. She doesnt say she specifically thats a different point. Thats foot that she didnt swear tot but that she screwed up by not invoking her legal rights. She claims she has done ing. Its not an injury to do things if you dont have an objection that you raise at the time to doing them and even if you thought there were allegations that there has bn a violation. That someone had been compeled to perform a an abortion against their religious beliefs, which i think you find that there isnt. In my practice, i also treat patits that are admitted to the emergency deparent for clinical abortion. But none of this paragraph7,8, 1. But none of these things say that the person was compelled to completing a abortion. Your point that you have to perform the abortion, you cant do other things represented to that practice . That would not count as a conscience violation . Theyre not sayinghe havent done anyin against their conscience. Which, even if they had said9, its purely smith selective on whether it would happen in the future. Supreme courts cas le clapper and summers and luh and lyons all say you need to have an identifiedatient who was at imminent ring in a case like clapper and summers, both involve no real past injury of any kind. Summers did. They identified matches who had suffered injuries. There was a specific project that hasee challenged the plaintiff wasnt even part of the case. But still, thelaintiffs and the Supreme Court agreed that they had been injured in the past and they said that wasnt enough. To have standing for what was left in the case. But thats all this cases. Seeking reef. Im sorry. Dr. Scott has already done this dozens of times and she says that im going to continuing to be doing this. What more does she need under the existing case law . Again, i dont think shes done anythin against her conscience o being been compeled to do it dozens of times. But even if she had shed have to prove it was imminent to heal again. Youre not disputing the idea that in the future because of the f. D. As actions, re women will turn up at emergcy rooms needing Emergency Care. What youre saying is thaits not eminently pending that anyone will have to go against thei conscious conscience objectio. All of the evidence establishes nash it a extremely safe drug. The rate oferus complication is well under 1 . So statisticallynlely that any woman mr. Need to go to the emergency room to seek tear. Is wozniak case admits in the last sixens in, i had this experience and in paragraph 29, i expect to seend treat more. Again, treating and seeing patients suspect on its own isnt an injy. With complications fm chemical abortion. Treating patients is an not an injury. Their fear is that it vials religious beliefs, that it will increase the liability in insurance costs, that will take timewa from other parents and that it causes them stress. They dont actually allege it haens. Their carefully worded declarations ner say that any of the plaintiffs vs. Has faced any liability or suffered any increase in insurance costs. As i recall in the s. B. A. Casehere was essentiallyne hatch incident and the assurance that s. B. A. Was going to coinue to engage in its activities. One past expectation of future and that was enough. Am i correct about the fact . Yes, the party had had one experience in the past, yes, be you these are not directly regulated parties and its much harder to establish standing when youe not the directly laterred party. Are you suggesting that its going to be a different metc based on whether the injury is direct correlation vs. Conscience . Thats the what the Supreme Court has said. In the establishment cases there are, which are eventually conscience cases. Where seeing it once is eugh. Sometimes its applied in a northerly, lax way. There a directly regulated party who says potential violated party thats a purconscience right. I dont want to see the 10 commandments monument. But this is an efforp. A. Case. Ok, but were talking about conscience. Im trying to deal with the underlying principle. Thats the conscience right. Homuch of a conscience right is enoh to establish the standing for p. I. Purpes in cases lightly eyitness and sorry, s. B. We dont dispute that they have conscience objections. The question is whether its related to anything f. D. Aas done. We have a lot of cases, environmental cases, where the environmental group, not a regulated party, will sue the regulator because theyre allowing some private enty to engage in some sort of commercial activity, watch you, that results in environmental harm. Thats summers, essentially or similar to summers. Right, those people are required to establish standing. Required to show imminen of an injury. Basically show an ongoing activity. We agree but the fact that its a third party is not a problem. There they were showing a direct injury from the activity that was being allowed. From the Agency Action that was being challenged. Here you have approval. And f. D. As approval of a dg doesnt require anyone to do anything. You have to have all of these things happen and then have a very rare incident of serious side effects before any how about the department of commerce case . There seems to be a discussion about once the government sis in activity, theres predictable third party response. There will beomen who will take this. There y had the the plaintiffs were states so the effect on them happened at a populationwide level so there were 2 fewer people who spded to the sentence, they would get 2 less money. Here theres nothing like that. You need toho injury to individual plaintiffs. You cant rely on atistics and probabilities. So its not the number o instances, right . Youre saying its whether its certainly imending that one doctor will be forced to perform one abortion against their corks . Has what the Supreme Court has said, yes. Yeah, but is that yes, thats what im saying. Im not making it up. So if it was only one, thats good enough but youre just saying its not sufficiently certain. Right, its absolutely uncertain that it is going to happen. Uncertain because people are t going to go to the hospital inural areas and theres only one emergency doctor whhappens to be in this group . I think thats very unlikely it happens. When provider dribs price it to a patient, he signs a piece of paper saying i have plans to provide any followup Surgical Care thats needed and if im not able to do that, i have provided someone else whos going to do it. Thats very zzng to me. Its my understanding that most of these caseses, the prescriber is not the person who provide the care in the followup care. Especiallyhenever 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 that was certnlan issue in all of those cases iolving emergency admitting privileges and that sort of thing. The idea that the provider is not the doctor who is giving its not a criticism of them but they are not usually at a full butory svis Center Center many times even if it is in pern. Certainly if its a male business thing on the computer so theyre not going to be the person caring. In fact, theyre going to be referredo the emergency room. Isnt that the more common situatn dispensing of medication abortion . It is not at all the more common situation. One thing in your question, the ed for followup care and the need for Emergency Care. Its ue that if theres a need for energy care, the patient is likely to go tohe emergency room but that happens in less of of all cases. The state reveal that is something between 2 and of patient in that populatn,he drug wont wk. But those people wilgoack to their doctor and discuss with their doctor what if they didnt get it from a doctor . The f. D. A has relaxed that provider. Yes, discuss with their provider is the next step. The pharmacy . T pharmacy is not the describer. What the f. D. A. Has done by removing the doctovisits as well as the requirement that the prescriber be a doct is youve made it much more likely that patients are gng to go to Emergency Care or a medical facility where the doctor is a member. Thats not drawn out by the evidence. Speaking of the evidenc did you want to answer . If i may. Just like all other prescription drugs, you get that by someone authoredy state law to prescribe the drug. That law states that that perm be able to assess ectopic pregnancy. Its true that you can get the precition from a pharmacy now but that doesnt meayo provider isnt there to talk about followup care. So no doctor has to be involved . Thats true but most of the women for whom the drug doesnt end their pgnancy in the first 14 days doesnt need pregnancy interception. They take a second dose and that works in Something Like 95 of ose cases so its very rare athey need actual surgical followup and they are required by f. D. A to have put i place a plan to identify for thoseomen someone they can go to get that care. I wanted to ask quickly about the record. We dont seem to have the administrative record in this case. We have certain exhibits that were admitted ifront of the District Court but we dont have the official administrative record as far as i know, a i execked checked with the Clerks Office today. Thats what i understand. Why dont we and wasp whats the situation on that and do we need it or not at all . Absolutely need it. Youre supposed to judge bas on the administrative record. How dwe get it and the where is it . We would le to produce it. How longould it take you to get it to us . I cant tell you because were told its going to be hundreds of thousands of pages. So youve been working on it this whole time since the inception of the District Court matter or when did you start working on it . The f. D. A is working on it and i dont know when its going to happen. Do you know when they started workingn it. Ihi as soon as the case got going. But i cant give you a exact te. So you want us to wait until we have the district roare they said lets get the administrative record and get it on the later. So h soon can we get the record . I dont have a date i can give you. Can you supplement the 28 record that tells us when he could we could have the record . M not sure we have to wait but to let us know when well have the record. Yes, i can gback and talk to any clientsnd give you whatever information we can. I dont think its going to be imminent because these are hundreds of thousands of pages. This took a quarter of a century ago. C y produce it in stages if you can produce it all once . I can tk to my client. I it a srete . No, its like inold storage somewhere. Youll probably have brought out of cold storm by now because theres a National Case going on it. Lets move on. I think judge ho has a question. 6 three questions. Youve been channeling th notion that any of these doctors either have objections or have been involved. I dont challenge that they have oks t providing abortion. We take that a given. Ok. Paragraph 1, i treated a woman, transferred her to mexico. Chemical aboion. Heavy bleeding. Erine infection. I provided her with antibiots and performed a d and c. Paragraph 26. I am opposed to chemical abortions. But he doesnt say tt i view performing a d. And c. As performing an abortion. He doesnt say i was forced against my conscience to execute the procedure. I think its very splat active that any identified plaintiff is going to be forced to do anhing against their conscience or religioubeliefs going forward. C we agree that e dobbs case obviously reached the merits, right . Right. But in order tinke thirdparty standing you have to first eablish your own article ii standing and in cases where abortionroders are allowed to do that, they are challenging on law that is operate on that and by requiring them or preventing them from doing something in doctors who parten me but i thought the whole tory of thirdparty standing in the abortion context is that its the woman who that has the privacy right, not the doctor. But the doctor has to have his own injury in oer to bring the claim. The plaintiff has to independently establish article iii standing. My last queion, anyway. Justice is a ledo in his recent atever you call it in this case sort of alludes to some public chatter about the f. D. A perhaps might not follow court orders so i just wt to give the same opportuny to clarify that i think chief Justice Roberts gave the state of texas in the s. B. A. Case. If the f. D. A intending to follow whatever in Court Decides . Absolutely. Whatever this Court Decides pending Supreme Court he court, right. But the f. D. A will abide . Yes, particularly fm e Supreme Court. We sent in an affidavit explaining all the things that e d. A would need to do to comply with the state everyday in this case. Give you five more minutes and give everybody five more minutes because we havent gotten off of standing anwe appreciate your helpful argument here today. Weve thrown a lot at you a we appreciate it so its helpful. I have a couple of questions about how this works will regard to the tell ned situation. Can you help . Because you were saying that the people providing the tele medicine have to be licensed in jurisdiction or they have to be appropriate providers so that eyre not violating the state law. How does th work with and also, i want to ow how does it work is it video on zoom so they observe the person to see what the gestational stage is . Can you walk us through how this actually works . Absolutely. The requirements now require that anyone prodewhos prescribing this drug. Doctor, nur, middle wife, assistant be able to assess gestational age and assess for right, how do they do that practically speaking . By assessing their judgment. Do they see the people or not see their face them . How do they decide . Jt lookingt someone in those early stages of pregnancy, you cant assess either of those things but you can assess pregnay. Can this done by email to say my last period was x at a time and therefore im this far lon and you ask me a followup, if i haveomplications, diabetes or something and you say, no, i dont have any of that and its all just an email exchange, is that all thats required . F. D. A does not dictate the practice of medicine. It requires that the doctors have the skills, it reires that they go over e sks of its required that doctors discuss all the expected side effects and that they discuss for gestational age in pregnancy or other providers. Rht, these are providers who are licensed by state law to prescribe drugs. Is they in the state where the person is or in a different state . How does that work. Some say people are using, like, intermediatery addresses and having people using a drop box and hangt sent to a diert state that might work. How does that work . None of that is relevant to the f. D. A or that this drug is safe and effective with these conditions in place. If its violating other law which we have to detein perhaps, that then we have to dede whether or not its appropriate to interan injunction or not and thats one of the factors we would consider. As a result not. In people are using the dru this ways that assignment invite state law and we dont know that. There are some unsupported allegations but this is, fen, an effort p. A. Challenge and whatever happens with drugs once gay get into peoples hands have nothing to do witwhether the drug is safe and effective. Crossing state lines or anything likehat without the precipitation requirements . The f. D. A was consiri whether its safe and effective did the f. D. A consider the things judge elrod was talking about . They considered the safet with the mail order regime. Did they already consider crossing state rnds and that there would be work around, go arnd or whatever might hatch. Doesnt that relate to the relevance of the use of the drug . I dont think it does. I think the f. D. A determines that and itno up for lawyers and judges to if the f. D. A didnt consider it important, it is our role to determine what are iorder their and capricus the path considered who canning prescribe the drug, dewhat conditions. Are we considering the f. D. A or is in a you know tarry executive situation where we also conder the white house statements that were going to get these to erybody, no matter where they live. Two answers. First, the wte house dead not say were going to get these drugs to everybody no matter away the important caveat is that they can be used wherev its legal to use them. There are certainly no indications that anying anyone is trying to do anything nashville. A you at odds with the white houses approach or sit i were relevant . Its irrecommend havent. This is an challen to be decisions they have made. Any challenge to the 2000 action is clearly time barred. They waited eight impacts past theirtatute of eliminations. I have a couple of questions. If danco needed to summit an s. N. D. A. Or whatever u would probably approialy call, that how long would that take, according to your folks and am i allowed to consider after davis submitted after the fact in determining that . Yr talking like if a state panel we are puinto place . Yes. Just for the sake of argument. Its not a foreshadowing but were having to deal with whether or not the 16 regulations coulde at first i would say the plaintiffsast made any tempt show how the exhibithaes on their own have helped. But you can look at the calculation submitted in the Supreme Court. And i think it would take probably a mter of months in order to get aew labeling and new setup in man. But its important to note that they would take four times as much as under the current regime. If the main thus of the plaintiff sergeant that they shouldnt be taken nip at all. Its a trophy make sure women are taking four times as much. I thought they should before taking this under the supervision of a doctor who visits them three times and a number of other factor. The plaintiffhave multiple claims. They want to take the drug off the market entirely but they have challenges to the chaes made in 2016. Right. Th wld be relevant to that. It would be relevant but they would need to show that changes injured them an they havent done that. Ok, ds yone have any further questions . Thank you very much. Good evening, your honor. Im here on behalf of danco. The declare ants specifyify next to no explanation of any patient with detail and in the instance of detail, its care someone else proded, drugs from india, not f. D. Aapproved trugs and its parents who had contra indications. From there they offer nonspecific statements that are untethered actual fact about what drug a patient too they often say the patients cant tell me what they took. So we dont know if it was f. D. Aapproved. Was it the f. D. Aapproved regimen or Something Else . They dont describe the care at the doctor actually personally provided but when the event occurred, was this something in 2003 or something in 2016 or somethi in 2020 . It was the pintiffs burden to show standing and they didnt do that. The state panel, i think, recognized that no declare ant did this, which is why they looked at the patient form and id this must be certain to happen to someone somewherend thats enough but that ask the wrong question. The question is not about onest someone will be injured by the drug at some time. The state panel used false math to claim this certainty. Ich our brief walked thugh exactly why that mask is not related to the changes. You dont need false necessarily. You meanas mistaken, dont u . False in the sense of inaccurate. Thats right. The mask was actuallyorrect, as in, if you calculat2 to 7 times the number of wen who have taken the drug. That would give you the number of women who t label suggests have had an incomplete treatment but that the walls what is false is to equate incomplete dream with a trip to the n. R. So thats where the inaccuracies come in. Theres no linko these doctors. I have stued the declarations and it certainly sous like this panel has as well. There are two declarence who i think stiff niche instructions to a patient be enough facts to show that it was taken with their action. Of course, those two declarant practice in texas and in indiana. Even if they allege one patient that th actually cared for at se time in the past, we now live that a world where the availability o abortion in texas and indiana is quite different than it was prior to dobb that matters with what this court is tasked with doing is dermining whether there was an impending injury. There are three other stas to describe specifics about someone who took a drib. One from india, that doesnt help. Dr. Woznia identified a patient who wod, told she couldnt have an abortn because of blood thinners and octobered the drug anythg and dr. Johnson said some patient took an unidentified abortion pill. And once a patient had severe pain they didnt know what they had taken. Th remaining declaration perhaps are for only generalized statements. There are no time detls. No details about a conscious objection that theoctor tried to make and was prevented in making and theres no outof the changed law. The 2,000 approval challen is time barred. The state i think was exactly right on that and the apeees stay next to nothing to roosevelt the state analysis on why reopening does not apply. So tt leaves a need for a declarant to identify send impending harm from a 2016 chge. Back to the reopening discussion for a ment. Im aim schuming youre familiar with the c. R. Cb d. R. Skirt case . Yes, your honor. Theory there being that you restarted the clock. If the regulations have changed in a way that altar significantly amounts war the stakes, changes it for the laugh. Why that not the case here . I think for exactly the reasonhe state pebble itched. These manufaures already filed a petition in 2000. Youre right that some of them carried forward but there were some participants in the 2019 round whoid not appear in the 2002 round. That argument doesnt apply to that group. I donthink it changes the question about will be there was a circuit skate a change in the stakes. You dont they the male issue is not a dramatic change . You dont thinkoing from six to 10 weeks is a change . You dont think going three visits to one . As i understand, it only real estate to the fifth changes. The stakes have changed dramatically. Your honor, i dont know that thats true. If you made these throughout statements in all of declarations theres no big difference between the 2,000 regime and the 2016 regime. I think there is a big deal. Whoever the right, we cant deny this i a big stakes issue. The question is whether any of these declarant would hav seen it as a different question about whether to sue f. D. A. Over the fact that a night they would have otherwise would have said, no now we need to they are opposed to abortion drugs period. In fact, theyre opposed to apportion, period. Nothing shows that they found a different allege russ when they got to 2016 and 2021. After the 2016 changes they waited thee years to file a citizen petition. Already in e 2015 regime or post 2016 regime, no big deal any way. Im not saying that at all. I think theres a very significant dference in ut the question is about whether the state for these plaintiffs somehow changed in a way and theyve not identified in any way in which the stakes for hem changed. I think well have to do this more often because with the lack of safeguards to make sure the proper bern gets the proper care or doesnt take it when thre imviced and something say against the is that the allegations they make . I think naymick three. Is that one of them . One of them is that theres a later gestational age thats watched in post 26. But what that ignores is that what f. D. A found, and this is documented repeatly for the runs of pings that are in the tournament is that with the new dosing regimen put in place in 2016. Ev for those later stages, the te of complete treatment was higher. In other words, it got safer. Can i ask you a queion about that . Is there any difference you know, because your clients drug is theew tradition element. The progesterone element for the feet us and that thats whats cut up before t other drug is the one that cases the feet us to be expelled. Givenhe fact that nutrition is not being its 200, 400 difference is, that causing any difference i whether the fetus is already demised before the expellin have they shown nip differences in the results on that. On if theyre shown none. It doesnt matter whether its00 or 400 im not awear of anything in the order that addresses that particular question or that f. D. A looked a that question. I think the where he before fast break was where whether this new dosing regimen was safe and effective and f. D. A looked at the complete rates that secure saturday kinked using this and found that the rates of complete trement were higher than they had been originally. The other things they found was that anadditional dose of would resolve 0 of the 790 of the situation for rim. Iwould avoid the rest of the tissue or whatever 1. Thats right. Ed if avoid the need to go to e energy rare. Contrary. Do you agree with the nba that it coul just take aew months to get your situation correct . It might ke that long. You could t that all ready to go and how would youave an injury and the only reason i ask is because we have to consider this ajunkettive reef questi and whether youan just pivot to something thats already been approved and youre not really affected because the whole thing has stayed in the mean team. Its very tricky to determine how we would go back to n. D. A. Here first of all, is klein c cata that would support making all of these changes but its already approved and the labels loves already exist. There is a label that was used during time period, that is correct but the process of going back to f. D. A. This is not like a light switch that you can flip off and trip on. You have several month probably. I remember trying decide that, if we were going to get no thatability whether or not youre going to get out of businessnd whether youre just inconvenienced slightly while you get some work done. Diengo does not danco does not need to show whether we were harped but whether we were irreparably hard. What we could consider harm to the otherarties also . Yes, and i grew and i think the danes to declaration was streeting in t Supreme Court, along with the one from the f. D. A. That socially we would remove which drug in the United States r a period of months. Is that everyone proper for us to consider under the rules . I think if you submitted to a Different Court thats liger higher at any level season that us . I think this court should take judicial notice out of it but in the end, direct determineshat the prow approval was time bars. Sohe only question at that point became a digits one. If i could just just one more question. Ill give you little bit of time but i do have question abt general bio pro. Im very cfused as to why theyre not in the party in it affect them in lockstep like it affect you, your clients, but thats a very odd amicus brief. Theyre saying they have concrete injuries in this case. Do you have any commt on that . I do n have a extent comment and what their litigation strategiy may or may not not been 1. Whatever we do, we just do. Diengo intervened in ts case. Speaking of our clients your client is diengo, not population counselor . Counsel . Thats right. M so secures. Population counsel is the one who originally sought the application . Thats right. What do you make of the fact that theyvesomedded to agree that sub part h is the way to go . I think the sub part eight estion in this case is a pure my academic one and that be since 2011 theres a difference between approving restrictions on an approved crutch drug and approving the drug. Sub part h and one way to get appral from the f. D. A. Its an cented, less rigorous format. And population, who bught diengo from has been that sub part h would be un it requires that only for serious, debtly illnses. As pop layers rightly says. Pregnancy is not an ill inns. Youre honor. May i correct a couple of things about your understanding of f. D. A law . An approvals under section 355 and 355d in particular sets out en first degree should approve new drug regulion. They had program gated a rule that allowed it to approve a drug urns 355 but place youth restrictions on that drug. Its a very understandable idea. Whether you you have cancer, aids, deadly disses, you have an accelerated process. The question is why do you need to use that process here . There are two parts to sub part a. One is acceleration, thats no was t used tall in this case. The other part ofub part eight lates to use restrictions. That was codified by conference in the statutory section 35 ix1. It gave f. D. A wt you say called recommends for judgment. Previous live had had restrictions but floyd lollics. For those who have agreed to caus problem. Talkg about the f. D. A, adopting the rems for these products after dgs adam. Soince 2011, we know that f. D. Used the 355d approval and it has now customed that with youth reductions, under its rim authority. That majors this question an academic one. Youre referring to the 2011 f. D. Letter. That refers to the approval being under sub part h. It says the same thing, that the approval because based on subpar age h. I think they said the same tng in 2021 and the same thing to this court. Its all about sub part h. I totally agree, the recommends with subject to the leslation. I disagree, your honor, and i think the f. D. A council can correct that as well. 355d seventh statutory recognize anymore for approval of a new drug anally applicatio. Maybe was just low presre in its hangs but im looking at multiple, 2007, 2021. The breach in this court all say the 200 approval was basedn sub part h. I think there use retrillions th were imposed. We still have to ask the question, does u. P. S. Suck pt h this is drug available given thathis drug as i understandivity, is limitedded to serious ill cbs. Illness. It is truly irrelevant in the preamble to the. Ts is mothers day, are we celebring illness . No, your honor but f. D. A used the word illness, disease in its program gays when it was providing it. Im sorry, whado you mean interchangeable . It use is the words as though it revealed to be the same something. Serious or life threatening illnesses determines illnesses. I agree, that is the language usinged in the regulation itsf but in the preamablend in it hass you were not typically think of as a serious illness, like acne, infertility and other drugs all prior to 2008 that the agency dided should have use rerictions when they came on the rket. Do you have something y wanted to add . I have two points. The first is on th record and the questionbout how long it will take the record to be produce. One thing that is important about w this core insert this question is the scope of the cord will turn a significant part on what actions these plaintiffs have standing to assert. If for example you send us the rord at the beginning of the case or we preadmit the record. If we need the record, we need the record i do not think the record bears on standard and timeline. What usually happens is the government files a motion to dismiss on the threshold issues and the record only gets oduced as to so you do not think we need anything else tn what we have . You had asked about telemedicine and aboutoing to the er. This relates to standing. None of these, there is not a sile statement that identifies a declarant that treated a patient after that patient received fda approval mifepristone. They treated because they had to because he was a rule patient who had no other option. It all comes back to the declaration. I think the court will conclude there is no standing, at least as the panel concluded as to the 2016 and 2021 ive one more question. We have read the declaration but we will read them again. I know this case was argued under an eedited timeline. It was difficult for everybody involved. Your filings have been excellent, however, i am concerned about some raer unusual remarks. These are remarks i do not normly see in briefing from esteemed counsel that talked about the distri cou, where there isomments that the District Court defied longstandg precedent. The Court Injunction was an unprecedented judicial assault. The courtsnesided narrative, the nonexpert court, equally groundless, bending every settled rule. These are remarks we do not normally see. I am wondering if you had more time and not bee under a rush come up with those have been included in your brief . I think those statements reflect our view that the District Court was very far outside the bounds was it appropriate to attack the District Court personally . I do not think those remarks were intended as any sort of personal attack. They were an attack on the analysis we dagree with the analysis, you can said that. Normally you do not say the courts ruling is an unprecedented judicial assault. This has been an unusual case i just wanted to give you a chance to commenon that. With more time, we may have ratcheted dn some of that. This is the case that has been litigated at breakneck speed. That is what i thought originally, but i am hearing maybe you thought that was apprriate and going to focus on a slightly different part of it. I do not understand the statement the fda can do no wrong. Nobody suld ever question the a. The fda just last month withdrew it in response to a New York Times headline that they rushed a drug for preterm births. Just last year, senator murray, chair of the Senate Health committee, criticized the fda for unacceptable longstanding fo safety failures. The fda is being blamed for the opioid crisis. None of this has anything to do with this ca. It is a theme y are putting forth that is completely unnessary. We arellowed to look at the fda. I think some of that may have been prompted by the District Court itself saying it was secondguessing fda and so to the extent that part of our theme is that al khor is not to seconduess fda, that is established and i think in every type of review. The fda approd this drug in 2000. Of all the therapeutics approved that dece, one third of them have had safety sues. I do not have any comments on that, your honor. Numerous fda problems numerous problems with fda approved drugs. Do know how many fda drugs have been recalled . I do not know. I know we have a number of briefsrom former fda officials who served under democratic and republican administrations documenting the significant harms to fda it was approved for the day five decades. It waspproved by the fda for decades. I think that is an inaccurate statement to make. Mifepristone remains subje to the exact same rorting regimen that every drug is subject t plus it has mandatory reporting. It is wildly inaccurate to say certainly, for thnonfatal adverse effects, why did you do that right when you were expanding s u. Certainly the plaintiffs think is more dangerous. Why depart the world of that information at that moment . In the hundreds of pages where fda expined, what we see is the fda looked at each one of those changes and said there is zero participation safety. If you as fda hav90 citations in the clinical review that is in the record they looked at all of them . There was never a request the cumulative effect together all of them. There is no requiremento do that. Not what i asked you. Are there any studies that looked at the changes in toto . There is no legal requirement to do that. U do not need Clinical Data at all. Thank you very much, yr honor. May it please the court. The fda has talked a lot this morning aboudifference. Courts do not defer to the agency when they nor congressional demand nor when theyut politics above womens healthnd that is what happened here. Fda marketed mifepristone and then stripped the druof virtually every safeguard. Fda allowed abortions country to federal law and common sense. For at least three reasons plaintiffs have [indiscernib] first because of fdas unlawful approval, plaintiff doctors have been forced to participate in elective abortions. What isou best excerpt for that proposition . E have several. Lets take dr. Franciss declaration. Dr. Francis says that plaintiff doctors with ethical, medical objeions to abortion will be forced to participate in completing chemical abortions where is evidencehehave done that in the past . Dr. Francis herself tops about a specific example. Talksbout a specific example. Doctors got talks about completing 12 surgeries that required her to take fetuses and pregnancy tissue from the womb. I think the dconnect comes down to the way that fda and danc laboratories are defying [indiscernible] declarantss are not alleging a harm because they are forced to ovide an abortion. Their conscience harm is broader. They allege they feel complicit in elective abortions by being forced to complete at procedure. It is not just the abortion. That makeshem feel complicit. I get the complicity point. Fairmont of time has been spent on 17. A fair amount of timeas been spent onumber 17. I have cared for at least a dozen women who ha required surgery. There notion was that was deliberate passive voice. Can you clarify this . She is an Emergency Room Physician w testified she had often treated women suffering from chemical abtis. She has treated dozensf women and she has caredornd treated as well as rforming herself this dnc abortion. Here is this testimony . I think we have to look at paragraph 17, it does say care for. But again, she is not a lawyer. You just said she is testifying on this. Where would we find that . It is in her declaratn. Her declaration notes she has often treated me sufring complications fromhemical abortions. She has treated dozens of women. She has cared for as well as done herself a dozen dnc abortions requiring her to remove fetuses, embryos and pregnancy tissue. She testified that in five instances she was require to perform bloodransfusions. There is no questn ere is a substantial risk of harm that might occur. Wt about the point that she no worse as i was forced to do this she does not y was forced to do this. Did she justo it because it was an emergency and the patient needed care . That is dfent, is it not . These are emergency room doctors faced with emergent situations. The doctor notes the emergency situation may rce her to end the life of a human child wet what about handing it off to otr doctor . I am not sure. I think the doctors here felt compelled to treat women. They also have a sincere jection. I do n think it would require th to say i am not going to do this. I think they can still complain about treatment. That it violates the rights to be forced to be complic in an elected abortion. It gives that dr. Standing to challenge the approval echo to challenge the approval . They are talking about and in the life of an unborn child. This case is different from a doctor who treats a gunshot victim becse the actio are traceable to the fdas unlawful acons in a proven and deregulating mifepristone. If you look at the recoron page 1592, the fda acknowledges that emergency room doctors are gointo be part of the solution in cleaning up the mess left for women suffering consequences of medical aborti. Theyckwledge it. We are not going to require cts to have surgical ability or admitting priles. We are going to allow them to rer to Emergency Rooms. That brings up another point that the adverse event here is less tn. I am not sure where they are getting that number. If you look at the current medicaon guide for mifepristone updated in 2023, it says that between 2. 6 and 4. 9 of women prent to the emergency room or those numbers the emergency room. A anding room does not require an additional woman showp on the regency room door. Emergency room door. Does that matter in any way . In the priors circumstance, you mighte le to call in another doctor. Eres testimony about a doctor who treated patients who had gone not of state, passed out in the number, it was unconscious by the time sharrived in the emergency room. Ith accurate none of these doctors refer to any telemedicine problems . Absolutely not. There is testimony that talks about how the fda deregulatory efforts have increased the number of women they have seen. During the time perio, she saw emergency room visits go up. You are making a predictable argument. I would distinguish that from summers. I meant department of commerce. I thinkt is expected. These emergency doctors would k to be cleaning up the aftermath. Do you agree to show thirdparty standing doctors have to demonstraterticle three independently . I thi it is an open question. They clearly dth here. They clearly satisfied the other reirements for thirdparty standing Justice Alito pointed out abortion providers spend two or three minutes with the patient. The dearion here he tells ours snt with individual patients. If abortion providers can challenge regulation that are meant to prove protec women from abortion providers, certainly the doctors who care for these patients should have thirdparty standing. Do you disagree with the state pane when you look at that footnote, the cases cited really concerned the situation in which there is a conflict of interest. There is a conflict of interest when abortion providers say we do not need that. Louisiana and texas said that was necessary to protect women health. Abortion providers said no it is not. In this case we do not have a conflict of interest becau the women injured by mifepristone and the ctors who treat them are all suffering the harm caused by that drug. We have been talking mtly about 2016, but what about 2021 . That is a great question. When you look closely, they say the 2021 nonenforcement decision is a moo is moot. Not entitled to any relief on the 2021 nonenforcement decision . Think that is likely. The petion decision gahead. The petition decisionlearly was the issue in thicase. Mootness occurs when there is not a live controversy. Neither can the fda pass a regulation a requirement in 23 which effectuate the 2021 but you do not actually argue much about 2023 and i know it is in the opinion in the footnote with the citation. Did you plead or argue anything about 2023 . Should we be relying on that . What i am sang is the 2021 decision in 2019 plaintiffs jane lynch the 2016 changes. Theylso asked the fda to retain in person dispensing. In december of 2021 the fda denied thapa of the petition. We are challenging fdas determinatn of allowing mailorder abortions. That fin decision was required t denial of the 2019 which occurred in 2021. Absolutely. I would think [indiscernible] totally takes care of this. Absolutely, your honor. It would be like an agency saying you cannot do x, someone challenging it. Absolutely. I want to ask about sub part h because there was a discussion abouhow the accelerated appral was not used. That correct in the letter the fda sent, they said therug could not be approved but for sub part h. Because drug was a lifethreatening illness, which the fda was not approved prepared to approveth only avenue available to itas sub part h. That sub part h approval is stilat play. The amendments grandfathered the sub part h approvals in. The relevant approl is still 2000. I think what they were suggesting is not that they ud sub part h at all. Your saying that is incorrect. No, your honor. It is tr they used a part of sub part h. But it took four years. It was not one of the several months once. Correct your honor. E use the procedure probably incorrectly because it was the only thing available to them. The second problem is that there were no studies that looked to sewhether medication abortion had therapeutic benefits over surgical abortion. I am confused why fda formal approval in 2011 with the new Risk Management strategy did not ensure any mistake as to sub part h. Why was that not good enough . Fdas argument is that congress codified thapproval of mifepristone. There is no way to glean tha specific detailhacongress itself actually approved mifepristone. What congress did instead was say we are grandfathering in these other sub part h things. They gave the agency [iiscernible] he fda did not formally approve mifepristone in 2011 . I do not believe so. Wl check the record. Thank you. How is your challenge to the 2000 approval timely . Whewe look at 2016 i will ask the same question again when you are done. The agency labeled those anges major. It strips away all of tse changes. Under the statutory section, each and eve one of those changes was requiredor the fda to determine whether it was safe. I get that, but they also have 15 years of data, iis more widespread, postapproval. His er time the fda going to relax someafeguard or restriction based on history of oup performance, does that mean we are here on an reopeni issue . Absolutely not. The are only 76 drugs subject to that. The c. Circuit judge also said to look at contacts. The underlying approval of the drug in 2000. The very same day they stripped away the changes, they also dend the petition where they we considering for 14 years. That was made by the same decisionmaker. They signed the decisn, the signatures are redacted forhe major changes, i know it is an interesting fact, but what diffence does it make if it is the very same day by the same person . Does that have legal significan . It shows the contact was reconsidering the approval and i think the same day mak a tremendous amount of difference. Assuming we do not agree with you in the reopening, do you lose on the 2010 . 2010,our honor . O you mean the 2000 approval . Yes. If i cant try one if i can try to recvince you on the reopening. The statue as we as the regulation required that those safeguards was determined to be safe. It would be like if you had a toddler and you tested a barstool and you said it was safe. The teller can climb on the barstool. The time in climb on the batool. I think tt is what the reopening gets at. There was no opportunity for plaintiff here to challenge in court the 2000 approval before 2016. The reon is because the 2000 approval was not final until 2016. Lets talk about the generic version. Is there edence that your client stain injury from the generic version as separate from the of their version . From the other rsn . I am not aware of any specific example. The plaintiff bears the burden of standing. Yes, your honor, but that is not in the record. I am not sure that is correct. Nothing is ruired to be reported unless there is a fatality. Part of it is including the dosage and the manufacture but we do not have the information. Isnt that fat . I thi o way you can find standing is organizational standi. Plaintiffs sit at all four corners. Theyav expended te d resources in a number of specific ways. There s a 92 page petition devoted to challenge in the 2000 approval. There is testimony that took time andffort. There were independent studies rformed to show dangers of mifeprisne. There had been analyses the existing data. They e not here. Should we not do anything with regard to that . If you look at the 2021 mailorder abortio mdate, what this court can do is act upon the fda. That what the fda did was unlawful i think plaintiffs have standing, certainly organizational standing. But even as a organization, this court would be empowered to stay the Effective Date or on the other hand vacate those decisions. Lets talk about the balance of the equity. Do you believe you bear the burden of showing irreparable harm . Yes, believe we have shown irreparable harm. Defendants on the underside all of their arguments boil down to a [indiscernible] argument. The current medication guide says between 2. 6 and. 9 of women will end up in the emergency room because of mifepristone. This causes a severe harm to women. You can lose your life. There are a number of harms caus to women by mifepristone as well as tolaintiff doctors. How were the doctors harmed . By being forced to be complicit in completg an elective chemical abortion. There are a number of other harms. They advanced emotional harms. The doctors talk about the heartbreaking ld that treating postabortive women suffering grf d complication causes. Th emotional harm is enough. There is a lotf evidence about e harm to their medical practice. They talk about ks in the emergency room. About ks chaos in the emergency room. Lets talk about the harm situation. The firsthing we would look at are e parties. If it is indeed a lawful action that it has a lawful election go into that co into being. The danco loratories people would not want to be put out of business. That would be their interest. Your clients interest wod be not to have to perform more aftereffect abortions f a variety of emotional and conscience issues. Is that fair enough, and being concerned about the heth of the women. We have stacks of these briefs anth are on every side of the aisle. So you have the people i do not minimize their situation. People in sexually abusive relationships and they file briefs on both sides of this. There is one group who says that yocannot see the doctor you are not going to get away fm being abused. There is the other grp who says if you do not give them the pilly mail, they will never get ay cause of then they will be trapped by the abuser. I am not minimizing these situations. That is just one example. These are serious societal issues. Do we have to figure out whi way that goes . Do we take that into nsideration at all in deciding the lance of equities here . How do we decide that . I think that might fit within the public interest, but the fdajob was to ensure that mifepristone is safe and effective. There e there methods of obtaing abortion that are ailable to people in the tragic circumstances y detail. That does not mean the fdas justified in approving a drug that sends women to the emergency room. Do we need to just look at whether or not the fda erred . I do not think so. The briefs are overlooking the fact that surgical abortion is aible. This case is not about ending abortion, it is about ending a dangerous type of abortion. The availability of other abortion procedurewould mitigate that. I want to make sure were doing the right analysis. Es, your honor. In respect to the interest of the parties here, there is no interest in the perpetuation of unlawful Agency Action. The fda did not argue it was harmed until this brief in this cour dao laboratories has been complicit. They urged the fda not to use ulasounds. If you look at the 2021 decion approving the absence of an in person doctor vit, the studies that the fda relied on ironically required ultrasounds. And then the ortion provider would mill you the chemical abortion drugs. Those sties showed complications double from the ergency room. One of the studies showed it rose to 7 . The other study showed emergcy room visits rose to 6 . A we supposed to only consider the studies that the fda considers . Are allowed to be roaming through the literature . I not saying we are not. I saw you the amicus briefs, is sup 590 women in an Emergency Department in lingo every month and they are three mes more likely to seek emeen bulatory complications. But am i allowed to consider that or do i said the fda already took that into account . What you are alloweto do is look at the studs e fda did. These are the two stueshey relied upon. They admitted the studies do not thsees support removing in person. They acknowledge removing in person would increase er visits. As we discussed, it is an ostrich ithe sand approach to say we would require that and justify removing even more requirements based on the absence of data. If you look at the 2021 desion not only is there clear harm, we have an increase eenally doubling emergency room visits from the two sdies that the relied on. That decision is not supported by the record. The fda has to explain its decisions. Reliedn ree things. The reporting from dancos not persuasive. And these two studs re not persuasive. The 2016 major changes afrmatively harmed plaintiffs in a number of ways. To begin, with each increasing week of gestation, there are more complications. This is in the record. In the current mication guide there is a 5 increase from week seven to week 10 of complete abortions. Th shows the 2006 major changes harmed plaintiff doctors as well ashe patients. 2016 . That correct. What fda actions forced your clients to divert resources . At think each one of them. If you look at the 2001 decision, plaintiff had diverted resources omheir usual elective buddies. If it were not for the fdas approval, they would be engaging in other activities, such as protecting the value of life, advocating for greater protections and arguing against surgical abortions. Does anything to kate what activiti your clients were unable too because of the diversion of resources . Yes, your honor. This courts decision says it was not required to enfy specific products. Th ione way to show organizational harm. The courts partly which talked about specific projects. Ha as long as youav a diversion of resources that suffes. Do you have anything further . I would like to mentionhe specific problem with the 2016 approval the fda stripped away nearly every safeguard. They did not have reasoned explanation for doing so. They did not have a single study that looked at all of these changes. The fda. What is certainly required is an explanation for why that does not exist that is completely absent from the record here. In addition, it requirea w things. It requires adequate testing, and a require bstantial evidence. The fda aired in 2000 and 2016 by relying on studies that included crucial safeguards like ultrasounds, likehe4 day followup visits. It does not explain why those things are not necessary. This would be like telling your teller you can climb on somethg t then taking away that safeguard. Th even thought that ultrasounds might be a good ea if you look at the studies from 2000 one those studies had ultrasounds. It is an unreasoned decision to have studies witsafeguards and turn around and approve th drug without those necessary safeguards. Fda says in joining the use mepristone would put [indiscernible] at risk. I believe 85 of ob gyns are not certified abortion providers. The vast majority of abortions of miscarrd management would be undtang by a second drug. Because most do not use mifepristone. I am not aware of any case that would uphold an unlawful approval based on an off label use. Do not think that would b an appropriate conseration to hold fdas approval here. Thank you. I believe we have your argen thank you, your honor. We appreciate it. Just a few points if i may. If i could go back to sub part h , the approval of the drug was der the statute. It authorizes fda to approve conditions on the use of the drug. Everytng fda did in 2000 was pursuant to its statutory authory. Any challenge to the sub part h will be timebarred. It is relevant only to the 2000 approval. Nothing in the 2016 changes reopen 2000 approval. Reopened 2000 approval. It asked whether a different set of conditions would also ensure safety. That was under review in 2016. The denial of the petitn was also not the reopening. The denial in 2019 did not reopen the approval question. Lets go back to the sub part h issue. I saw what you sa on page 45. On page 10 you make the point that fda in 2016, their position was that mifepristone was approved under sub part h. You can argue the alternative. Theres is nothing wrongith that. That authority came from the statute itself. Fda viewed the sub part h regulation as applicae. It was not a necessary pdite for the action taken in 2000. I understand part of your argument is that the courts in the early 1900s interpreteth act prohibit only unlawful abortions and congress acquiesc to that interpretation in other drug laws. Has the Supreme Court or even a Circuit Court of her applied that to Circuit Court decisions . In Inclusive Communities cas our briefs, the Supreme Court said all ofheourts of appeals that address the issue haviewed that as having a spirit cause of action disparate cause of action. The court viewed that as a signal back congress didot believe that interpretation was correct. It was viewed as evidence that that washe correct decision. The Supreme Court held that it does have a disparate cause of tion. It does t ohibit the mailing unless the sender intends they be used unlawfully. Those decisions were brought to the congress attention. Congress did not chae fda with doing a survey of all civil and iminal ls. It is not part of thr charge to figure out if othe drugs would viotether lows. I thinkeopening is the only thing they could get at the initial approval. For reasons i explained that decisionas not reopened in 2016. Fda has never required ultrasounds. Fda explains ultrasounds are not a safety measure in studies they relied on. Ey work a data gathering tool. I take it you agree the safety issues do chae dramatically based on gestational age. I do t think that, no. Hy have these limits . Wife seven weeks in the original and then 10 weeks . I think it goes to effectiveness. The difference was the difference in the percentage of times the abortion was completed. The fdas position is seven weeks, 10 weeks, weeks, it is always fine to use this drug. Thenly question is whether it will work. If there position . No. Implicit in that statement is that it could very well be unsafe. Tt is not a decision the fda has made. H mattered. A mattered. Ge mattered. There are lots of ways to determine gestational age. We just had aase yesterday. Yesterds case was how important it was too the fda to find out issues of age. The fda was very aggressive about making sure that they were used by adults, not children. They were referring to doctorso make that medical determination. Doctors should determine gestational age before u prescribe this drug. If you look at the rate of the totwo pregncies, it is a tiny fraction in all women. How wouldou assess without doing some sort of examination . Are you experiencing certain kinds of pain . Do you experience shoulder pain . Are you feeling dizzy . There are all kindsf things you can ask. Ifou look at the datainalf of those cases an ultrasound performed. In 60 there was no evidence of those egncies seen. It shows generally ectopic pregnancies are generally ing found before ty prescribe mifepristone. When there is already a gap do you would knowledge there is a gap between reported complications and actual complications . I do not agree that we do not have great information about complications. The reporting requirements that apply to mifepristone are the same as those at apply to most other drugs aroved by fda. Sponsors are required to submit data to fda on an annual basis. They hava rious market incentive to do that. For any adverse event . Es. How do they get that information if the people do not go back to the prescriber and most states do not require people if they do not report from the emergency room, god forbidhe morgue, how do you get that information and to know that it is reliable enough to say we do not need it in a more robust fashion. Adapters certified by think a laboratories the doctors certified by think a laboratories collect that informatio they have strong market incentive to do that because at the labeling is not kept up to date, they face serious liability. They take very seriously their duty to collect information. They are required to report that information to fda. Thank you. We have your argument. We appreciate all the arguments today. This case is submitted. Cspans washington journal. Everyday we are taking your calls live on the air on the news of the day and we will discuss policy issues that impact you. Thursday morning, we will discuss the debate about that sitting and all the congressional news of the day with pennsylvanian democratic congressman Brandon Doyle and Michigan Republican congresswoman lisa mcclain. Watch live at 7 00 eastern on thursday morning on cspan, or on cspan now, our free mobile app. Join the discussion with phone calls, facebook comments, Text Messages and tweets. Cspan is your unfiltered view of government. We are funded by these Television Companies and more, including charter communications. Charter is proud to be recognized as one of the best internet providers and we are just getting started, building 100,000 miles of new infrastructure to reach those who need it most. 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