parents, ronald and nancy reagan. watch it on c-span, c-span now, or online at c-span.org. >> coming up tonight on c-span, the supreme court heard oral argument in a consolidated cas'l for expanded use for the abortion pill mess up her stone. eholders reprenting alliance for hippocratic medicine spoke to the press after the supreme court heard or in a case regarding access to the abortion pill, mifepristone. later, pete buttigieg, president biden, and national transportation safety board chair jennifer homendy, spoke about the collapse of the bridge in baltimore after being rammed by a container ship. that and more tonight on c-span.

>> c-span has your unfiltered view of government. we are funded by these television companiesnd>> the grs a place you call home. at sparklight, it is our home, too. right now, we are all facing our greatest challenge. that is why sparklight is working around the clock to keep you connected. we are doing our part so it is a little easier to do yours. >> spalight supports c-span as a public service along with these other television providers, giving you a front row seat tdemocracy. >> the supre court heard oral argument in fda versus alliance for hippocratic medicine, consolidated case challenging the fda's approval for expanded e for the abortion pill mifepristone. the medication, approved by the fda in 2000, is part of a two-pill rinatinearly.

the nation's highest court now has until june to make a ruling in this case. >> we will hear argument this morning in the food and drug administration versus alliance for hippocratic medicine and the consolidatedas >>ay it please the court, fda approved mifepristone placed on the agency's scientific judgment that the drug is safe and effective. it has maintained that judgment across five presidential administrations a mlionof americans have used mifepristone to safely end there pregnancies. at the outset, respondents lk standing. they cannot rely on a statistical theory of injury like the lower crtdid.

instead, they have to identify a specific doctor who faces imminent harm t their theories rest on a lgcin of remote contingencies. only an exceptionally small number of women suffer the kinds of serious competitionth for emergency treatment. it is speculativth any would seek care from the two doctors and even if that hapne federal cautions protections would guard against the injuries. and there is no sito conclude that any of that would beraceable to the incremental changes that the fda made in 2016nd021 as to the availability of mifepristone in general.

they are too attenuated as a matter of law and the court should say so and put an end to is case. if the court reaches the merits that the fda was lawl e agency relied on dozens of studies including tens of thousands of women. they do not identify any evidence that thagcy overlooked and they just disagree with the analysis of the data, but that does not provide an office -- a license ahorize second-guessing. finally on the remedy, the release enrebelow would severely disrupt the federal system for developinan improving drugs harming the agency and pharmaceutical industry and inflict great harm on women across the nation. llg back these changes would unnecessarily restrict access witho stification. some women could be forced to undergo surgical artns and others might not be able to access the drug at all and all of this woulhaen at the no certain injury of their own. the cot ould reject that profoundly inequitable result. i welcome questions. justice thomas: if we agree witu give us an example of who would have standintohallenge these fda actions? as a general matter we have seen wsuits brought by for example prescribing physicians or patients who want greater access. sometimes we have seen theories of competitor standing where competindr manufacturer

ghsue and claim that the fda approval creates a competitive harm or injury in that sense. ishether there would bequestion individuals who oppose aboio who would have standing and went to challenge the actions the answer is no. the reason is becae ose people are not regulated in any relevant way under the fda here. they do not presibor take the fda is not requiring them to refrain from doing anything, they are not required to treat women who take mifepristone, and the fda is not requiring that they seek out scare from these ecic doctors so they stand at a deficit -- at a distance from the actioth are challenging and the court said in many cases that in a situation kehat when you are not the direct object of regulation it can be more dit

justicthas: isn't that a criticism of some of our association and standing cases and organizational stain cases? >> i do not think it is. with respect to associational standings this courtasaid that the association needs to identify a specific member ffing a concrete harm and an injury that is nonspeculate. i do not take issue with that fact, they are agreeing it would be necessary to identify a specific doctor. the probm th the asciional standing theory is that it rests on this chain of remoteosbility with so many steps in the process that would ve to occur laying one speculative remote odds of chance of inrycross another toet to the ultimate harm on ■$■.behalf of esdoctors. >> you associate the remote nature and it affects the

likelihood that thtients will go to the emergency room and so on. re a number of which your argument would change, the of an ergency room visit, doctors who spend more time in the erncy room, at some point does this analysis lead to the other su? ms. prelogar: it is rd to agine that it could for a couple of different reasons. i takeheoint you will pick out different links and suggest that trere ways to depart and say that maybe h aonorwo cod be more likely to occur. but we have an objection to the underlyinghey has a legal matter because it rests on so ma dferent things that would happen one on top of another and turn on independent decisions made by third parties who are strangers and not partf e suit. that brings the case like

klapper orumrs where the court has recognized that when the theory of injury turns on ma intervening events separated by independent decisions it cou mn that there is an insurmountable hurdle to establishing standing. >> could you provide a more specific answer to the first question that justice thomas you,s there anybody who could challenge in court the lawf of what the fda did? ms. prelogar: in this case i think the sw was no. justice kavanaugh: is therep anody that could do that? let us start with the states that intervened. will you say that in that litigation fine, you can challengitnd let us get the meri othis issue and what the lawfulness of the fda did? ms. prelogar: the states lacked standing, they a aerting indirect injuries and could result in the states alway suing the united states government.

justice kavanaugh: how about a doctor who opposes abortion,e is on duty when won who comes in with complications from taken mifepristone, anth doctor is the only one on duty who can attend to the woman's problem and as a result in order to save her life she has to abort the viable fet. with that doctor then have standing to seek injunctive relief? or would you say this is too speculative. this is like being struck by lightning and it is not sufficiently likely that ts will happen to this doctor again? ms. prelogar: atould represent past harm and we are not dispinthat conscious violation would be cognizable. we think that situation has neveco to pass and respondents have not identified an incident in more than 20 yes at mifepristone has been available that resembles that siation. so our view would be it is su you have to think about the events that would ha t transpire. justice alito:owbout a woman

who suffers adverse consequences from havg ken mifepristone, would she sue for damages or wod u say that is barred by sovereign immunity? msprelogar: i expect that we would have those arguments and i recognize that with respect to traceabityhat is harder for us. justice alito: is there anybody who can so and get a judicial lawful. and maybe what they did was perfectly lawful, but shouldn't somebody be able to challenge that in court d o? who would have standing to bring the suit ms. prelogar: with respect to these regulatory changes it hard to argue that anyone has standing but the court has said sndg does not have a basis to depart from article reprinciples, so i think it is clear that even if there

alternative person who could sue, that does not mean that the court should dispense with the requirements of article three. justice alito article three is matter if the fda flagrant violated the law it did not do what it should have do a endanger the health of women it is too bad that nobody can sue in court? there is no remedy, the american op have no remedy. ms. prelogar: i think it would be wrong to suesthat if the fda had made a mistake and a drug was producing safety consequences that there istoe n. i do not think these respondents could invoke article thr t have the court step in. the fdtas seriously its responsibility to ensure the fe of drugs and conductsan make adjustments as safety situations emerge. drug sponsors remain responsible at all times and we have a court system that can su that there -- that if there aren't safety problems the sponsors

will take action. if the premise is that unsafe drugs could remain on the market, that is incorrect. >> your argument here i said, i have great rpeanll dwe have to comply with it. your argument is that even if the fda unlawfully, nobody can che that in court, and yomade last week, we shouldent not get to the question whet the white house and others violed the right to freedom of speech and we shouldhat the aintiffs cannot bring suit? ms. prelogar: we are lki at the specific respondents and we do not think they come in 100 miles of the circumstances thisw

court has identified of nonspeculative harm that can ea the injuries for forward-looking relief. >> i am assuming that if there were -- if this had been unsafe arossly visible way, you know, 40 percent more incrse hospitalizations that some doctor would've challenged th lack of an in person? ms. prelogar: no doctor is requedo dispense other things. justice sotomayor: but they want to, but we have said if they are regulations that stop them from doing it, i guess that dr. could come in and say this is unsafe by not having people visit me befoha, we are not warning them and etc. ms. prelogar: certainly those kis of distinct safety concerns emerge there are steps at the anclevel. there is nothing like that here. conjuring a hypothetical. ms. prelogar: thfd regulations do not require doctors to not grant an in person visit. they think that is the best way to provide a standard of care. they are not directly required to dispense mifepristone through a ital arrangement. >> can i ask you a question out the roadblocks that you identified in a chain becae you said a doctor could invoke conscious protection to refuse to complete an abortion when the

embryor tus was still alive. so i want to be clear, the federal gover's position is he dtor what have conscious objections but it is your position that such doctors would have recourse for the protecti federal law? ms. prelogar: let me be clear because i think that the circuit misunderstood the arguments and respondents have repeated misunderstanding.■" we never t override conscious objections. he said the opposite. if you look at the texas litigation wdisclaimed that undetaing and made clear that we understand that nsous detection should continue to apply and shie a doctor who does not nto provide care. >> with that be true ia health-care desert haswell? ms. prelogar: we do not think it protectis d imposes obligations on hospitals and hospitals have plans in place to

address these contingencie they have staffing plans and it is a matter of best practices anthey often asked for doctors to articulate the objections in advance so they can take account of that. eyave cross staffing agreements and in the government's experience, almostf any situation where there has been that kind of direct nfct. >> one last question about the soation standing.■■4 its own standing and its own

right that id on injury to one of its members. so, the injuries that the association is argui fnd in the associational standing and they are the kind of allocations that we see in advocacgrps, increased expenses, that results from the complicatnsf having to address and explain the new changes. i am notalng about expenses of filing the petition. let us just talk about resources. can you distinguish that? msprogar: i think havens was trying to distinguish between two types of organizational jues and they said in that case the organization had come forward with decand concrete injury to itself and they had a coract to provide low income housing or search to secure it for ies and the practices directly interfered with that and made imo difficult for the organization to carry out its obligations t ven said it was not in a standing that would allow the organiti to describe a setback. that is the court trying to distinguish between demonstrable

harm and that kind of abstract setback on the other hand. i recognize and your question toucs it that some lower courts have seemed to read it as far broar andings. the government has been resisting standi bause that would essentially mean that any advocacy organiziocould say it opposes what the federal government is doing an th if that were enough every organization would have standing it would be an expansion of ordinary article three principles we would welcome an eventual standing, but i think thetional assertion of injury falls into cket of the abstract setback and does not come close to the drable harm that was the issue in haven. >> that is aul

clarification. on a similar clarification. thank you. respect to individuals, i have heard and listen to your argument and read the ie and i think i understand it. how does it fit yr mind with offended observers standing under the esblhment cause or some injuries about -- i access a park and i like to look i in a certain way, and those kind of injuries at the court has sometimes recognizednd sometimes cast doubt on. ms. prelogar: there are different strandofrecedent and i would puth establishmentprecedent and first amendment in its own bucket. the court has recognized different theories. ste gorsuch: standing is standing at it is article three. we have to find some way to stitch it together and a looking for guidcerom you. >> i think the way to approach this is if you are going to regnize an offense or stress

injury to recognized -- no, i represent the government so i think that kind of theory of injury would go far too much in e direction of allowing article three courts to igin paste on generaledrievances. to distinguish the acacias -- situation where there is a direct governmental action producing that type of injury. here the argument is that the fda actions in approving isto in 2016 and 2021, which was an incremental change, it iar upstream of the downstream assertion of harm that the respo are lat cannot suffice for article three. >> thank you. justice alito? justice alito: you said that the sixth cidid not give any reason to think that the changes wod be more dangerous in combination than individually, buisn't that obvious that three things that might be

innocus not excessively dangerous if engaged in by themselves might become very daerous when they are all done together? and why shouldn't e fda have address that? ms. prelogar: the only way that would be true ithe three changes are interconnected and■h mutually reinforcing, gudi against the same kind of risk. if there was reason to think that the reason why feistone is up to safe up to 10 weeks is because its ing prescribed by doctors instead of nurse practitioners then those changes would be interconnected because one change would be the safety nefor another. there is nothing like that the studies at the fda examined demonstrated with eaustive examination that the changes were safe not because there were other safeguar tguard against risk because if you go up to 10 weeks there is no en no matter who is prescribing. in the absence of that effect of the changes do not tnkou can

fault the agency for not giving more explicit attention to this issue and it did. it citedulple studies i combin■ in multiple changes because a standard of care had evolved over the 1yes it had been approved and many of the changes were being deployed together safely. justice alito: shouldn'the fda considered the application of the comstock provisions? ms. prelogar: i think it does not fall under that lane. the fda can maintain restrictnsf it is necessary to ensure safe use. in 2020 one what they determined it ith you do not need in person dispensing so the ftca did not reirthat restriction and it could not be imposed. the fda was not approving, mailing in violation of comstock even if you interpreth and we do not think it means what the respondents suggested means. but i don't t was the fda's responsibility to consider that. justice alito: it did not say anything autt and this is a prominent provision. its t some obscure

subsection of a complicated obscure law. they knew about it, everybody in the field knew about it, shouldn't eyddress it. you have answers to the argumentma on the others, should the fda said we have considered that and provide some sort of an explanation? msprogar: let me give two responses, it would not have been permissible for the fda to consider maintaining that restriction cae of comstock. if you look at the relative statutorcoeption, this is reproduced on fdcatake into account for restrictions are safe a efficacy concerns in deciding to maintain a program. the other thing i would say is athe agency did have a memorandum on comstock at ja535, which ishedvice conveying the interpretation. justice alito: they got the advice but it did not refer to that? ms. prog: in the 2021 desi, no, but it was modified in 2023 and this is rt of the administrative■4

justice alito: thelatiffs to say that the studies that they relied on sa tt mail order mifepristone suggests more frequent trips to the emergency om now, this is what i see as the fda's response. "although the litetu suggests that there might be more frequent emergency room care visits related to the use of mifeprionwhen dispensed by mail, there are no impairment increases and other serious adverse events related to fepristone use." does that really count as explanation to the suggestion that the data shows th tre are going to bmo emergency room visits? this is the increase of emergey om visits are of no coeqnce and it does not merit some comments? ms. prelogar: that is reoned explanation of what they were observing. although it acknleed that some of the studies reported

additional visits, did not eqte to additional serious adverse events. one of the studies, lfhe women who went to the emergency room did not get treatment many might go because they are experiencing heavy bleedg which mimics a miscarriage and they need to know whether or no@ they are having colication. in that circumstance the woman is not having a serious adverse event from mifepristone, which does not call into account the safety determinations. thfdparsed those studies and it made specific determinations abouthresults with respect to safety and efficacy. it fully explained its desi-making and falls well into the zone of reasonableness. justice sotomayor: on the last question the reality iev if there is some increase in emergency room visits, the question of when that rises to a suicient safety risk is up to the fda, correct? ms. prelogar: that is right and. it did not overlook it. i want to emphasize that the studiewe far from the only evidence that the fda consulted. at the timitcted it had real-world experience during the covid-19 pandemic, a period of time when the in person

dispensing requirement was not enforced and the fda started by looking at a comparati analysis the two periods when you had in persodiensing and when you didotnd saw that there was no serious increase of e evt -- events or the difference. that there are complications in virtually all of them. at what level the cost benefit analysis tells you to stop prescribing something is a very difficult questi, n't ? entrusted to the fda. justice sotoyo whatever the increase was, lee fda determined under thstdard that it was not sufficient to create a risk that counterbalanced the need for access, correct? ms. prelogar: because the fda is instructed to take into accot burdens on the health care stem as well and looked at a variety of sources to colu that the burden suggested that it was not necessary to keep this restriction iple to ensure safe use. justice kagan: if i could take you back to the discussion with justice barretabt the conscious objection and i'm sure that you have read the declaratio cefully and im thin tsay about this. as you read those declarations, what is the conscious objection? wh are the doctors objecting to exactly? ms. prelogar: i think the clarations are specific. there are only seven doctorsho

regularly practice and submitted evidence and they ar relatively short. this isja 150-20beuse there are only two who provide any informioabout their specific objections. osare dr. scope and francis. the others do not prove specific detail about exactly what care would viattheir conscience. dr. francis is ja155 and the other at j57 they object to ending the life in t wb. justice kagan: they do not object to providing whatever aes from taking mifepristone, in other words supposed somebody has bled significantlyn ed a transfusion or any of a number of oer things that might happen, as you understand th is not objection to that?

ms. prelogar: i think the fairest reading is that they are not objecting to that. i acknowledge that respondents suggested that the ia broader conscious injury and there might be other doctors who have aroer concern about providing care, and even if that injury had been in this clation we think as a matter that they have a nonspeculative injury. in part because of all the things that woulhave to happen in a woman going to the specific doctors and the fact that the adderall conscious protections e signed to deal with this issue and they would cover the range of objections that existne obviously es of all kinds and wajust asking about these particular declarations.

ms. prelogar: i think they havew not asserted a broader injury, buev if they could come forward with other doctors or adjust the decraon still that would not suffice. juickagan a quick question about the merits. you open your brief with the date mea, t with the statement and it starts with the

government's knowdgand since then i am sure that you have had lots of time to think about this case and get all of the background information on it. i will read you the sentence and ask you whether it is still■a■s true.

to the government's knowledge. "this case mkshe first time" and i'm going to say is at the first time or only time "any"4 court has restricted access to the f's drug by second-g is it stilthonly time? ms. prelogar: still to our knowdg and we have seen a trend of c fda's judgment to grant greater access to drugs. and whatever direction you, at those kind of judgments.

justice kavanaugh: just confirm on the standing issue, under federal law no doctors can be forced against their conscious is to perform or assist in an abortion, correct? . s provide broad coverage and there are some triggering requirements on receiving federal funding. we cited the relevant provisions on page five. the church amendments ha t c ain the kind of injury and there are state law precons that often apply. justice barrett: would that be tr if the declarations were interpreted that they regard any paication such as transfusion as after otherwise complete as tiss bng removed? ms. prelogar: the most relevant churchmement provision is 42a-7d that said that doctors shall not beeqred to perform or assist in any part of the health care prograth would violate the doctors' religious or moral beliefs which are td

to the nature of beliefs than procur. stice barrett: this goes to the merits. as i understand , e serious consequences that have to be reportedr at the fda considers risks are death and he data bears it out thato the elimination of the in peon spensing requirement or visit at the outset would lead mistakes in gestational aging, which could increase the need for a dnc or the amount of bleeding but that does not count as an adverse event? ms. prelogar: there is a list of serious events and i am not sure that i he l of them down to be able to recite them although they are in the reco. i think the prisis wrong the idea that they changed in person

dispensing would increase the risk. that was n rlected in the data that the fda consulted and wod point you to a particular section in particul where the fda explains that even in person you are not geinan ultrasound, that has never been required. the relevant questn ght be is your provider is going to ask you a number of's straining questions and there is no reason why ifference would lead to different safety outputs. justice barrett: i thought there was a small percentage increase wrong about that? ms. prelogar: i think that with respt the er visits there were increasedouvisits although as i explained that was not actually correlated with an increase in serious advers events. i do not want to represent all they varied a little bit but the ultimate conclusiowathat mifepristone could be prescribed without in-pern sits. there have been no contrary evenbaet there was no requirement of an ultrasound or detecting a fetal heart beats or

anything like that evebere the doctor could go based on when the last menstrual period was. ms. prelogar: that dates back to the initial appral it has not been required used to have an ultrasound. is of course necessary for providers to diagnose and date genal age which remains true. they still have to have that capability and deployed whatever mechanismshebelieve would accurately allow them to identify contraindications. but it iwrg to suggest that if the court was versus changes that every woman will get a tetf play. justice barrett:owven under that was iible to detect anctopic pregnan uesti with pla? ms. prelogar: there is a set of questis ch as did you become

pregnant with an iud or after tubal ligation. are you experiencing unusual bleeding or ask if ty ve had a prior pregnancy. if the woman has that kind of risk factors imaging might be necessary but that remains true as well that the prescriber has to be confident that it has excluded tho kds of conditions before prescribing. the standard of care around the rl most medication abortion occurs without an ultrasound. justice jackson: good morning. i am worried that there is a significant mismatch in this case between the claimed injury and the remedy that is being sought. and that that might or should matter for standing purposes. i do not know that the doctrines caurthis. i guess i see it that the injuries that the respondents our conscience injury that they are being forcedrticipate in a medical procedure that they object to. and obvious commonsense remedy would be to provide them

with an exemption that they not have to participate in this and you said several times that federal law alreadgis him that. so i guess then what they are asking for in this lawsuit is mo than that. they are saying because we object to having to be forced to participate inhiprocedure we are seeking an order preventing anyone from having access to these drugs at all. d guess i am trying to understand how they could possibly be entl to that given the injury they have alled?■ ms. prelogar: i agree and i think its levant to standi. there is a mismatch between the claimed injury and the remedy

they were seeking. you could think of this as a type of nef interest analysis. if the doctors have a conscious inryhere are statutes designed to deal witit specifically to guard against the injury occurring and instead they are reaching t d rhtunder a different statute that does not regulate them at allr ke them do or not do anything and the relief that they are seeking would dramatically alter the improved conditions for use ■ fect women all around the nation simply because of this injury already directly addressed. justice jackson: if it was not addressed the remedy would be to exempt them, right? ms. prelogar: one of the hard

things arying to tailor relief is they are asserting such a diffuse theory so that the only option was to grant a tionwide remedy and it runs counter to ordinary principles ofar specific relief. wrong with the theory of injuryg in the first place because it is so attenuated and claim that they would need so mal the coun. justice jackson: in addition to the challengeswe have here, the respondents below challenge the initial desi to approve mifepristone in the of course, tha challenge was not timely because of the statute of limita in the context of another case that this court is continuing, the statute of limitations issue. setting aside standing, have you thought about how a ruling on the statute of limitations in either direction might impact what happens in ■fthese nds of cases wi tse kinds of challenges? ms. prelogar: it just reflects thstakes of the corner post

case and provides the mostiv example of the way it ulbe possible if this court were to approve the reesfor the broader series of the statute of limitations t way it could op tng bame a doctor later or started working in emergency room later and wouldryo unsettle long-standing actions that occurred decades previously. i understand to suggest that there might be equab defenses that the government could raise and we would certainly want to raise that type of defense with the approval of mifepristone and has proven to be safe and effective. >> thank you counsel. >> mr. chief justice and may it plea court, in 2016 and 2021, the fda made certain changes to the labeling and use restrictions. the decision below stops them from selling it in line with that scientific judgment based on a highly attenuated claim that an unknown doctor could be called someday to an unknown emgey room after a series of decisions by third-party is. no facts link that possible future encounter to a specific change that the a de in 2016

or 2021. respdents view of the food, otnl upend this but viral every drug approval or modification that the fda has made for decades. rers is required for two reasons. academic exercise and what is conceivable. they lacked standing under every prong of the analysis. on t mits, fda exhaustively consider the evidence and explained s nclusions, which is what is required to do. i welcome questions. ste thomas: the solicitor general points out it would not be susceptible to a comsto a problem. but in your seyou would be. so howo u respond to an argume tt mailing your product and advertising it would violate the comstock act?

ms. ellsworth: we agree with the gornment that the fda's charge under the food, drug andcoet aco looking at safety and ats true for new drug approvals andg modicaons. the fda routinely approves drugs that are restricted by oer ws such as environmental laws, customs laws and so on. i think this court should think hard about the mischief it would invitef allowed agencies to start taking action based on statutory responsibiliti tt congress has assigned to other

agencies. on the merits, this issue is not ruled on below, and in any event i would point out that in 2021, the decision allows the use of brick-and-mortar pharmacies in addition to mail order justice thomas: my problem is that you are private. the government, unrstand the government's argument.f fe harbor that you are suggesting. and it is fairly broad. and it specifically covers drugs such as yours. ms. ellsworth:ouhonor, we disagree that that is the correct interpretation oth statute. we think in order to address the correct interpretation they would need to be a situation in which this situation is to do. this has not beeenrced for 100 years and i do not believe that this case presents an oppouny for the court to inon the reach of the >> counsel, i would likeo k you the same questions i was posing to the solicitor general. klapper and susan b. anthony bout requiring a

substantial risk that harm will you argue that that is not present. how are we supposeind a spot at which the risk becomes substantial? ms. ellsworth: i think this court has always thought about the standing inquiries as a you are trying to evaluate whether something is actual and. and these terms, substantial sk and pending which has been used to dating back to 1923 that we are a claim falls in the spectrum. >> and we toss around a lot aboudeils, but as a

practical matter, how do you figure out? atercentage would be enough and what percentage of emergen room visits would be enough? ms. ellsworth: i thinkt e way klapper got at this question is to really think about whether there is an attenuated chain and contingencieth have to happen. in sittis where there is th chain of circumstances involving third-party decisions that have to play out and hear the chain is quig. if that puts atiff's theory on the side of conjecor hypothetical and not impending injury. >> how i comny aggrieved byheca i gather that this is your ion of mifepristone is the only product you are mng? ms. ellsworth: that is correct. justice alito: the fifth circuit decision does not prohibit you from continuing to produce and

sell that product, correct? ms. ellsworth: that is correct. justice alito: i gather your injury is that you think you will sell more if the restrictions that previously were in place were lifted. so you will make more money. ms. ellsworth: the injury is that we are preventefr selling our product in line with fda's scientific judgmenabt the safe use of the drug. justice alito and you will be harmed because he will sell more? ms. ellsworth: a company's ability to market its product is how it considers the revaty scheme that governs it product. justice alito: during the questioning of the solicitor general statement was made that no course has ever previously second-guessed the fda's judgment about access to a drug, correct? it has never second-guesse that. ms. ellsworth: that is correct. juice alito: do you think the

fda is infallible? ms. elwoh: wdo not and we■m do not think that is t-ed up in any way. justice alito has the fda ever created a drug and then pulled it after experience showed it d adverse consequences? ms. ellsworth: it has done that and i think that underscores why the advee ent reporting and the post-market surveillance and the abilitth these plaintiffs have, even if they do not have standing, cerin if they are seeing patients presenting with adverse events and doing studies that show that there is some unknown safety mponent that the fda should acknowledge, they can take signifansteps to bring that to the agency's attention and justice alito: do you think th the fda should've continued reporting nonfatal consequences? ms. ellsworth: they decided not to in 2016 based on more than 15 years of a well established safety profile when that reporting was required. eris no drug on the market today under any rem that requires any reporting that the plaintiffs said should be reimposed. justice alito: one. be a bad thing? you do not wantoell a product that causes harm to the f's tests, wouldn't you want that data?

ms. ellsworth: that data is certainly somethinth we are lookg r all the time. it is part of the reporting ligations for a manufacturer to be aware of any datbeming available through any means. we have a one 800 nuer and a one 800 number on the labeling. i think that gets atoncern that i have heard the early questioning on who would have standing if these aiiffs do not. drug manufacturers are varies frequently subject to tort ligation, product liability suits and failure to warn suits, deceptive adrting suits when soone is claiming harm fm a product. what is so i think revolutiona really about the arguments here th on standing and mer■tit on

the y at they attempt by individuals who do not use this odt and do not prescribe this product and have the conscious right not to treat anyone who has taken the product, they wanto event anyone else from using it in line with fda's nsidered scientific judgment. justice alito: just one more■ pot ong sort of the same lines. does your company think what the fda has done preempts state ws that prohibit the dispensation of mifepristone within those borders? ms. ellsworth: we have not taken a stance on the issue. justice alito:hat is youought a? ms. ellsworth: there are lawsuits brought by the genec company that do make that

argunt and i think that is for later courts to sort out. our position in this case has been that this is about fda scientific judgments reached in 2016 and 2021. justice alito: you do not want to answer? ms. ellsworth: we do not have a position prepared to say today. >> could you go cko the reporting and said you would bjt your product to higher standards and now we are being brought down to the regular, ulyou talk about that a little bit, what are the normal standards for adverse event reporting and why e ey there?

what instead where you subct to in the past? what changed was not danco's adverse event reporting responsibility. it has been the same throughout this period. what change was from 2000 until 2016 prescribers were reported to report evtso danco and then we had a separate lition. in 2016 the rems were aligned be more consistent with the reporting requiremt at applies to all 20,000 plus fda approved drugs. there are only today seven that continue to have even the limited higher adverse event reporting for debts then applied to mifepristone. it is only one of seven that ha tba justice jackson? justckson: you are asked if the agency is infallible and ess i am wondering if you specialized scientific knowledge with respect to pharmaceuticals and as a company that has pharmaceuticals, you haveéd

concerns about judges parsing medical anscntific studies? ms. ellsworth: yes. i think we have signict concerns and there are two amicus briefs from the pharmaceutical industry that expands on why exactly that is so concerning for pharmaceutical coanies who depend on fda's gold standard review proce t approve their drugs and be able to sell their prodtsn line with that considered judgment. justice jackson: can you say what they y? ms. lsrth: i am happy to. i think the reality is and this decision allow is a good example of. you haveieonne study that was an analysis of anonymous blog pts you have another set of studies that he reli othat were not in the administrative record and would not be bau they postdateheecisions. they have been retracted for a lack of scientific rigor and misleading presentations of data. those sorts of errors can in fact judicial analyses precisely because judges are not experts

in statistics or the methodology used for scientific studies and clinical trials. that is why the fda has many hundreds of pages of analysis in the record of what the scientific data showed and courts are not in a position to parse through d cond-guess that. >> thank you. >> ms. hawley. >> mr. chief j and may it please the court. fda approved was not adequate. that violates the apa. the lower court's decision

reor long-standing and crucial protections under whh millions of women used abortion drugs. we have heard a loth morning about standing. article three is satisfied because the fda relies on hospitals to care for women haed by aborti9 d 4.6% of women will end up in the emergency room and three the fda acknowledges that women are more likely to need surgical intervention and other medical ca without an in person visit. nearly 650,000 women take mifepristone every single year. it is no surprise that respondents experienced an increase in emergency room visits and treated women suffering from abortion drug harms tens othsands of -- dozens of times. men's have suffered tens of thousands of times. the respondent doctors will be forced to manage harm is not a bug in the system but part of

its design. ruling against respondents on standing will allow federal encies to constrict -- conscript nonregulated policies from sng other harm without judicial recourse.áiç r rmits this. e outsourcing of abortion drug responding to resp doctors forces them to choose between a woman with a life threatening condition anates their conscience. this choice is intolerable. the fda failed to comply with basic requirements and in 2021 it e rs visit based on data that it says elsewhere is unreliae and in 2016 it failed to explain e cumulative effects of the wholesale removal of safeguards. these actions are fasht of what was requires and this court shldffirm. i welcome their questions. >> council, you assert an injury part of the alliance of diverted time and resoceu]

isn't that just the cost of litigating and psug this litigation? ms. hawley: i do not think so r couple of reasons. first what respondent doctors have done ishon their practice as well as structured the medical practice tbrg life into the world. and they are cald om the labor and delivery floor down to the operating ro ttreat a woman suffering om drug harm that is opposed to why they enteredheedical profession and it comes along with emotional harm. dr. sct lks about them being heartbreaking situations and some of the most stressful work heas had to deal with.

said that the nature of the harm was "non-economic" and did not prevent the cou fm finding an injury. the court looked atwthings. whetr ere was an impairment as the organization's mission and whether there wasn expenditure of resources. both of those are satisfied here. if you look at how our organizations have been harmed they have been forced to diver resources from advocating for their pro-life mission generally to explaining the dangers of the rmrom abortion drugs. one of the primary reasons that that is because in 2016, the fda took away the providers report adverse events. >>hat would be anyone o is

aggrsi or vigilant about bringing lawsuits. st simply by using resources to advocate their positi i court. you say w,t uses an injury which seems easy to manufacture. >> don't think that is true, justicthas. i acknowledge they had havens where you had preludto litigation types of activities. to resource justifications don't count. in thica, if you look at respondent dlarations, they perform studies, analyzed stud several■ú of thosthey are . they come through medicaid data ook at the true nature of adverse events and all those sorts ofudto litigio nor would they have heard about fda's unlawful conduct. >> the line you quoted about

economic crimes had to do with the fact that they did not contend to so there was no economic loss or gain to them renting the apartmt. at tnk you are pointing to is that they pvid services on their own. ita't just the member services they were relying on. they were providing services to people to help them rent apartments. so that is a very important distinction from here. separate from the individual attendancelaims of standing based on wasted resources, their resources. the organizations areotosing anything. their job is to do extl what you are talking about and they are doing it. th are investigating certain problems but that is not an

injury that is her address above by this by vacating this rule. >> a couple of things, your honor. where the court system did not economic nature of the interested housing, again, you have to look t underlying embrace. thespect to our injury. if the regulations are put back place, the protections whereby individual abortion providers would provide o organizations with more accurate information. >> council, can i ask you about the remedy?

blto object for two reasons. one is the emergency nature. many womgo to the emergency room and if wenk about what that might look like, take dr. francis. she is on the labor and delivery fl>> i don't wantpothesize. tell me in her declaration which healks about not able to object or post a conscientious

obctn. when she talks about -- can you point me to any place in the claration where they attempted to object but were unable to? >> no. fotwreasons. dto don't necessarily know until they scrub into that operating room whether this may omanot b in operation. it could ba it could be an elece abortion. the government simply cannot get story straight. we jt ard that the church amendment applies. they called the district court. >> let me askou -- if we were to find that there were content just objections■ and these doctors do have a way to deal with these kin oprocedures, should we in this case on that basis? >> no.

because these are ougency situations. they can't waive process -- prious moments. >> assuming we have a world in which they canio say they have. my que is isn't that enough to remedy their iss? do we have to also entertain your argument that no one else in the world can have thg or no one else in america should have this drug in order to protect your clients? >> it is not possible given the emergency naturofhe situation. am sry. i think justice jackson is a -- is sanget's get rid of all that. we should provide a remedy sufficnt and go no further.

have a individuals. normally we would allow equitable relief to address them . recently i think what justice jackson is colluded to -- we had what one might call a ras of unersal injunctions. this seems like a prime example of what could be tni a small sword into a nationwide legislative assembly on an fda ruler other federal government action. >> yes. i think it is impractical. i think the district court medy was appprte under section 705. it grants reviewing court's the

ability. when the parties before the court are nonregulated pares the only avenue inhi they could possibly g release is wh the parties before the court get. that is for a state issue or in her cases, of a culture. >> why can't the court specify that this relief runhe parties before the court? as opposed to looking to the agency in general and think the agency can't do this anywhere? >> i think that might be imactical. if we are thinki about the situation with regards to . francis -- is what she does day in and dayut and so it

seems to say that the wld run -- these two particular plaiifwould be missing. that the rulions would still be in place. they would permit things like mail-order abortions. if we look at the merits of what they did in 2021, they relied on two things. rst on the data. >> understand your impulse there. there are exactly zero universal injunctions. pretty consequential ones. and over the last four years or so, e mber is something like 60 and mey are relatively new t. to ask us to pursue this new remedial force which this court

has never adopted. lower court's kind of run with this. i just want to give you one more shot at that. >> sur divorcencsulates equitable me a they have fed from the beginning of the 19th century that thees before the court get release. in this instance, we have noegulatedares, the party could fmers, ranchers, they are -- the only availily for police is if the court does something to theregulation issu. otherwise these parties are simply out of luck. >>e ask you about your basically -- your basic theory standing. when you did your 123 your opening statement, isoded very probablstk to me. i don'remember exactly what

the 123 let's say it is something along the of representing the doctors and the re a lot of women out there. argoing to have adverse events. to come to the emergency room and sthe is some probability of the like that one of our doctors who has a content is objection is going to come face-to-face with one of these women who has an adverse event. is that your theory? >> no. what we think really sho t report -- the respondent have danny here is■& that the fda had not acknleed. in regulating them, they have continually said emergencies from doctors and ob/gyn hospitals are critical. >> you are just saying that en the fda admits they are going to

see some adverse events. people are going to showp people are going to come face-to-face with one of our doctors who objects to some aspect of the treatment. that is the theory. >> recentlthk all of that is true. we don't think it is proem with probabilistic stain here we have seven named plaintiffs in addition. e>> does your they ally depend on you having at least one rs? i take them toay these probability theories based on very nice. eyave nothing to do with our article three requiremts you need a person to be able to come in and meet the court's regular stanngequirements. you agree wi tt. so whos urer y had to pick one y go read that and that

declaration is going to tellwhyp here. >> dr. francis and doctors gone. >> what about those twooctors gives you the nd of imminent injury let alone the traceability. request to speak to dr. francis at the beginning, there has been some confusion about t pcise nature of the conscious part. if you look at 155 paragraph 15, she is talking about objecting to not only taking the lifof child but also completi tt process. echoes this decoration at 142 and 143. >> i read th d

what actual emgey treatment has she participated in that she objects to and that she has stated an objection to? >>he prior page talks about what she was required to perform due to a life-threatening emergency. quick she herself performed that. >> that is correct. quick did he have an opportunity tobjt? >>o. these are life-threatening situations to scrub out d find something else or treat the woman. qukly when the people with cocis objections to this is th make those objections known. it may be harder, it may be &8 context but both hospitals have mechanismsn place to ensure the doctors who are allowed to do this in advance and a allowed to do it at the moment.

th s so and when i looked at . francis and dr. scott, ere's just nothing you have there thatko there are other requirements. this happened to d't think you r either one of those doctor i think we do. given the emergency nature. it is impractical to have an objection launched prior to understand whaisoing on in that operating room. this is to the disic crt fifth circuit brief where the government set the church nor any of the other intended them to apply -- and liti this with the federalovnment saying they don't have consciousrotection. >> is it true i decisions have

not relied on probabilistic determination? the court said they were anng bechere was a cluded on the questionnaire. they would not fill out the census at all. it was probable that there was some risk that your state would risk losing a representativer would risk losing moneynd this f probabilities. >> absolut we agree with that. you can look athe case. it is certainly true that the

data is appropriate to considerw in determining-x■qhether there s substantialis e a admits this is a 533. this is at 5:42. seven women lleed serve -- will need surgical intervention. wh ty talk about there being no incasin adverse events from t increased gestational age, the only way they can say ignoring surgical intervention. that is because -- >> what we do with the fact that two ry on the scope the indiana and texas have abolished abortions and abolished them by pills or otherwise. into whether other people are illegally breaking the law- what does that do infiy

small beusthere are thousands of hospitals in the country. thousandan thousands of places where pregnant women may be sufri from miscarriages or otherwise to know or even imagine how one is going to ever actually sea patient that he or she is going to be forced to intervene on their balbut then add to ithat this is ille the states. >> i think the b answer is a prologue. emples.

when you go out of the state, that is a highly like the -- gher likelihood. this turns es into those follow-up visits. a woman went t mexico and retu t texas as well as dr. johnson where one went t illinois and returned to indiana. one in five abortions take ple like new mexico.third states the border states in which our doctors reside. >> can i take you back to affidavits? >> you were talking about dr. francis. and as i read her allegations, she said her partn w forced ving fetus.$ e said she performed a d&c on a woman who was suffering serious applications but the fact that she performed that do not necessarilyeathere is no living embryo or fetus becae u can have one after a miscarriage.

if that is right, i think the ffulty here is that these affidavits do read more le conscientious objection as opposeto actlly participating in the abortion to end the life. -- and the lengtof the embryo or fetus. do you want to address that? >> sure. i think dr. francis can be read for the broader conscious harm. it is beyond sibley requiring ending and unborn life with respect to evennarrow conscious arms whether a doctor may need to end a life, we think there is still a ssttial risk.

that mns 3.1% of pregnancies ll ongoing, requing d&c. 55% of those occur in the emergency room. there is a substantial number of women suffering abortion ug harm. >> not all those will iol the privacy that will otherwise be via you can have complicat or excessive bleeding even after the abortion is completed in that respect whether the i question.1s ongoing and the fda says they will need surgeries to stop bleeding or ongoing pregnancies or failures. >> you have a broad number of doctors in your organization that are dentists andrs that are retired.

how many members of your ospitals who might be -- >> there are hundreds of them. i think in particular, the named plaintiff our ob/gyn hospitalists who spent time on delivery floors. >> can you clarify the broader conscious harm from the narrow one? as justice barrett does but you suggest there is a broad one. what is that? >> in a district court, understand the conscious harm be either taking the le an unborn child which would sometimes require a partner in an emergency situation. ple processthe

that takes a number such as on. it is not that hard3a■y to -- >> complicit like i work ith emergencym erthis is going on? i amamring -- i am handing them a water bottle? what do you mean complicit in the process? >> this -- whatar our doctors is being involved in completing and the terms of our declaration an ecve abortion. it is not that hard to see why if you think about what is harm involved. >> is being involved in completed an elective aborti. i took that to be a conscientious objection. i think what justice jackson is asking herhai asked before of justice barrett is if there is any broeronscious objection that appears and i am

no sure i care all that much about thdirict court but it appears in the declarations. >> in this instancecoleting elective abortion means removing an embryo, fetus -- dr. ans talks about being required to pform a d&c. >> whether or not there is any live tissue. >> yes, your honor. i would t u to paragraph 115. ey also describe the complicity of harm from being elected -- involveinlective abortion. these doctors stgree about a woman's uterus of a fus in cases like little sisters of the poor.

>> it is my understanding that sometimes completion doesn't involve surgical intervention. do you have a sense of how oft ? we mayll the way down the chn to the person having the emergency procedure. my understanding with some these chemical abortion scenarios is the completion occurs by describing additional medicatis. could it be done by another phician? that the dose has been since 2016. i think all the way back to 01. it has been approve since 2016. the best memrse have are so consistent with that. that mns it will be ongoing. i encourage you to look at j for

a five and this explains these risks go up. >> and just trying to get at -- i'm still working on howan circumstances or how often it would be your clients actually ve to complete the procedure in the wayre describing. >> the doctors talk about doing this at leasa zen times. removing embryos, fetuses. if you thinkbout.1% at 10 weeks -- this has only gone up. the in person visit w bh necessary and minimally burdenme- minimally burdensome these sorts of situations occur less frequentl. >> thank you.

answers of the solicitor general and counselor for danco wit respect to this act. i would like you to comment on their answers. >> for sure. we don't think there is any case in this court that empowers the fda to ignore otderal law with respect to the comstock act aselant here. s drugs should not be mailed either through e mail or through common carriers. so we think the plaintext is very clear. >> when did you first raise the comstock act >> i think it s rst raised in district court. we think exhaustion ds t apply for two reasons. first it would be legallyile . this is a whole another kettle of fish.

if you look at section 704, haustion is only required in two instce this isonstent. the lower court have taken opinns there is no oen required or ency will that stays the precedin >> pi ask about the traceability of it all? i want you to tell me if you agree with this understanding. even beyond provg atever injury you are part -- whatever ju you are trying to pro, you have to shift that injury is traceable to the 2016 and 2021 fda actions that you are challenging and of course that means showing that these incidents you are talking about

in the emergency room are caused by wter incremental increase and risk there is as a result. i guess my first question is do u agree with that statement? what do you need to show? and ifou do, how do you satisfy that? why do you satisfy that? icwe believe that we need to show the 2016 and 2020 on action increase the risk of harm. >> i gsse are saying you have to link whatever and for your members he two that increased do you agree with that? >> we do and we agree with that for a couple of ass. we are not in tortogtion. you look at the 2021 action within traceability status is as j 845- without that in person

visit, er and other medical care question might be some dispu between the two of you about how big the increase -- increased risk is. w do you connect that risk to particular actions that your members have to particular injuries thayo members have undergone or willndgo? >> t oginal risk. think the declarations are really quickly on this. if you look at dr. francis's declaration. she thought shsaan increase in emergency visits from dr. johnson, dr. scott said the same thing. it is entilyonsistent with

fda numbers. in 20,he fda sd the emperor visit was necessary to preserve women's health because the impression visit is the best opportunity to examine things like -- things to observe pregnancy and age of consent. because the g said that initial impression visit that had no requirement of an ultrasoundr y effort to detect fetal heartbeat except it inaccurate read on gestation age. so i would not necessarily be eliminated? >> i think the fda's undate if you look at t study, it shows a nearly threefold increase when you have -- when you removed it.

it was about 2.1 without. >> when they remove this, it took away the opportunity to do that. i think a cog -- medical organizations th cated that are best practice. what is allowed under this is a couple of screening questions. i do think that is nearly as good aann-person exam. quest let's say that -- let's this -arve out and put aside explain to me what additional costs you might have incurred or what your resources had diverted

in a way that wod t aside havens. >> putting aside the onc this and present -- one citizen petition, it was che respondent organization cod studies and analyzed studies including going through the meca data. it included going to theffrs data. course iou do one of them at roa five. sorry roa 70. those are pretty comprehensive stie quest at the end of the ligation or were they to the end of? >> to accurately assess the harm from artn drugs. getting absolutely separate from the negation. that is the only way i which anyone can rse a concern to the these proceedings go on behind closed doors. the first time is a citizens

prediction. >> what difference if a do court of the opinions of the expert agency concerning the safety and efficacy of drugs? >> under this cou's administrative procedure, a peer review is no toothless. instead,n is case, we are not asking that urt second-guess the agency at all buer look at what the fbi said it did so based on their data. >> iue i don't understand how that isot second-guessing the agency. u e saying the court can look at studies maybe different studies. e the same studies. and critique theironusions about them.

what difference do we owe them at all with respect to their assessment that these studies establish what it is they say they do about safety and efficacy? >> and think that is inaccurate to portray. the reas being is we are oking at what fta said. it says you have t have adequate tests. >> did the lower court's go representations were major today. they have since been found removed. they are obviously looking at not just what the fda was oking at. are you asking us to just look at the fda and nothing else? >> that claim is not even before this court but with respect to the two claims before the court, the 2015 and02 we think theda is arbitrary.

what the fda said is we are going to loo at individual studies and even the we say they are interrelated, we are going to take precons away. that is arbitrary. thank you. >> youounsel. >> thank you. on the associati standing, get the impending injury?ne to what's wanting to look at is whether that harm has materialized ithe past and how often. there is no guarantee there will be a future injury but what is soelng is that respondents don't have a specific example of any doctor ever having to ole this care in violation of their conscience. this is for the declarations that never specifically say here how the care is provided.

the fact that they don't have a doctor willing to submit that i think demonstrates the past time as it happened and the reason that happened because it is speculative. the e so many links in the chain that would have to occur. it would be about having the federal in play. they said that they voluntarily conducted studies. if that is enough, every organization in this country has standing to challenge y federal policy th dlike. havens reay uld not possibly say that. he does at the outeralce. remedy, justice courses, justice jackson, you plan out the ring anomaly here of the nationwide nate this remedy. maybe mo tailored remedy to the party.

the problem here is they sued the fda. thfda has nothing to do with it -- with the enforcement of protection. that is all happening far downstream. and the only way to prida remedy therefore was to grant this kind nationwide release that is so far remod om the regulatory authorities that it is ultimately requirentll women everywhere to chae for this drug. i think it isor stepping back and thinking about the profound mismatch between that injuryndhe remedy of the response obtained. they said the fear that there might be some emergency room doctors who may be presented with irebly rare applications and the doctor may have to prove treme -- we don't think thatarm has materialized but with the court date is entered sweeping nationwide belief that restricts access for every single woman in th country a