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 t consolidated case. >> may it please the court, fda approv mepristone placed on the agency's scientific judgment that the drug is safe and effective. it has maintained that judgment across five presidential administration and millions of americans have used mifepristone to saly end there pregnancies. at theutset, respondents lack standing.

they cannot rely on a statistical theory of injury like the lower courts did. instead, they have to identify a specific doctor who faces imminent harm but their theories rest on a longchain of remote contingencies. onlyn exceptionally small number of women suffer the kinds of serious competitions that could trigger any need for emergency treatment. it is speculative that any would seek care from the two doctors and even if that happened, federal cautions protections would aragainst the injuries. and there is no basis to conclude that anofhat would be traceable to the incremental changes that the f me in 2016 and 2021 as to the availability of mifepristone in general.

they are too attenuat aa matter of law and the court should say so d t an end to this case. if the court reaches the merits that the fda was lawful the agency relied on dozens of studieinuding tens of thousands of women. they do not identify any evidence that the agency overlooked and they just disagreeitthe analysis of the data, but that does not provide an offic-- license to authorize second-guessing. finally on the remedy,he release entered below would severely disrupt the federal system for developing and improving drugs harming the agencyndharmaceutical industry and inflict great harm on women acrosthnation. rolling back these changes would unnecessarily restri aess with no justification. some women could be forced to undergo surgical abortions and others might not be able to access the drug at all and all of this would happen at the request of plati's who have no certain injury of their own. the court should reject that profoundly inequitable result. weome questions. justice thomas: if we agrewi you on the standing could you give us an example of o uld have standing to challenge these fda actions? as a general mtewe have seen lawsuits brought by for example prescribing physicians or patients who want greater

access. sometimes we havse theories of competitor standing where competing drug manufacturer might sue and claim that the fda approval creates a competitive harm or injury ith sense. justice thomas, if the question is whether there would be diduals who oppose abortion who would have standing and nt to challenge the actions the answer is no. the reason is because those people are not regulat iany relevant way under the fda here. they do not prescribe or take mifepristone. the fda is not requiring them to refrain from dngnything, they are not required to treat women who take mifepristone, a the fda is not requiring that they seek out sce om these specific doctors so they stand at a deficit -- at a distance from the action they are challenging and the court said my cases that in a situation like that when you are not the direct object of regulation it can be more

difficult to establish standing. justice thomas: isn't that a criticism se of our association and standing cases d organizational standing cases? >> i do not think it is. with respect to associational standings this court has said that the association needs to identify a specific member suffering a concrete harm and an ju that is nonspeculative. i do not take issue with that fact, they are agreeg would be necessary to identify a specific doctor. the problem with the associational standing theory is that it rests on this aiof remote possibility with so many steps in the process that ul have to occur laying one speculative remote odds chance of injury across another to get to the ultimate haron behalf of these doctors.

>> you associate tote likelihood that these patients will go to the emergency room d so on. is there a number of which your argument would change, the significant number of consequences, higher likelihood of an emergency room visit, doctors who spend more te in the emergency room, at some point does this analysis leato the other result? ms. prelogar: it is hard to imagine that it could for a couple of different ass. i take the point you will pick out different links and ggt that there are ways to depart and say that maybe has a specific matter one or two could be more likely to occur. but we have an objection to the underlying theory has a legal matter because it rests on so many different things that would happennen top of another and turn on independent decisions made by third parties who are

rangers and not part of the suit. that brings the ca le klapper or summers where the court s cognized that when the theory of injury turns on many intervening events separated by independent decisions it could mean that there is an insurmountable hurdle to establishing standing. >> could you provide a more specific answer toirst question that e thomas asked you, is there anybody who could challenge in che lawfulness of what the fda did? ms. prelogar: inhicase i think the answer was no. justice kavaug is there anybody that could do that? let us start with the states that intervened. will you say thainhat litigation fine, you can challenge it and let us get the merits of this issue and what

the wfness of the fda did? ms. prelogar: the states lacked standing, they are asserting indirect injuries and could su in the states always suing the united states government. justice kavanaugh: howbo a doctor who opposes abortion, he is on duty when a woman who comes in with complications from ken mifepristone, and the doctor is the only one on duty who n tend to the woman's problem and as a result in order to save her life she has to abort the viable fetus. with that doctor then have standing to seek iunive relief? or would you say this is too speculative. this is like being struck by lightning and it is not ffiently likely that this will happen to this doctor again? ms. prelogar: that would represent past haranwe are not disputing that conscious violation ulbe cognizable. we think that situation has never come to pass and respondes ve not identified an incident in more than 20 years that mifepristone has been available that resembles that situation. o view would be it is unduly speculative.

you have to think about the events that would have to transpire. justice alito: how about a woman who suffers adverse consequences from having taken mifepristone, would shsufor damages or would you say that is barred by soveigimmunity? ms. prelogar: i expect that we would have those arguments and i recognize that with respt traceability that is harder for us. justice alito: is there anybody who can so and get a judicial ruling on athe fda did was lawf. and maybe what they did was perfectly lawful, bushldn't somebody be able to challenge that in court and who? who would have sndg to bring the suit? ms. prelog: th respect to the gulatory changes it is hard to argue that anyone has standing but the court has said that the fact that no one would

have standing does not have a basis to depart from article three principles, so i think it isle that even if there is no alternative person who could sue, that does not mean thathe court should dispense with the requirements of articlthe. justice alito article three is important. your argenthat it does not tt if the fda flagrantly violated the law it did not do at it should have done and endanger the health wen it is too bad that nobody can sue in court? there is no remedythamerican people have no remedy. ms. prelogar: i think it would be wrong to suggest that if the fda had made a mistake and a drug was producing safety consequences that eris nothing to be done. i do not think these respondents cod invoke article three to have the court step in. the fda takes seriously its responsibility to ensure the safety of drugs and conducts oninsurveillance and can make adjustments as safety situations emerge. drug sponsors remain responsible at all times and we have crt

system that can ensure that there -- that if there aren't safety probls e sponsors will take action. if therese is that unsafe drugs cod remain on the market, that is incorrect. your argument here and as i article three and we all do we have to comply with your argument is that even if the fda acted unlawfully, nobody can challenge that in court, and that is lly the argument you made last week, we should noto the question whether the white house and others violated the right to freedom of speech and we should say that these plaintiffs cannot bring su? . prelogar: we are looking at the specific respondents and we

do not they come in 100 miles of the circumstances thi court has identified of nonspeculative harm that can create the injuries for forward-looking relief. >> i am assuming that if there were -- if this had be unsafe in a grossly visible way, you ow40 percent more increased hospitalizations that some doctor wl've challenged the lack of an in person? ms. prelogar: noocr is required to dispense other things. justice somar: but they want to, but we have said if they are regulations attop them from doing it, i guess that dr. could come in and sath is unsafe by not having people visit me beforehand, we are not warning them a e. ms. prelogar: certainly those kinds of distinct safety concerns emerge there are ep at the agency level. there is nothing like that here. justice sotomayor: i am conjuring a hypothetical. ms. prelogar: the fda regulations do not require doctors to not grant ain person visit. they think that is the best way to provide a standard of care. they are not dectly required to dispense mifepristone through a critical arrangement. >> can i ask you a question

about the roadblocks that you enfied in a chain because you said a doctor could inke conscious protection to refuse to complete anboion when the embryo or fetus was still alive. so i want to be clear, the federal government's position is that the doctor what have conscious objections but iis your position that such doctors would have recourse for the protections of federal law? ms. prelogar: let me be clear because i think athe circuit misunderstood the arguments and spdents have repeated that misunderstanng we never thought that this would override conscious objtis. he said the opposite. if you look at the texas litigation we disclaimed that understanding and made clear that we understand that conscious detection should ntue to apply and shield a doctor who does not want to provide care. with that be true in a health-care desert haswell? ms. prelarwe do not think it would overrideonious

protections and imposes obligationonospitals and hospitals have plans in place to drs these contingencies. they have staffing plans and i is a matter ofespractices and they often asked for doctors to articulate the jeions in advance ty can take account of tha they have cross staffing agreements and in the government's experience, almost four decades we are not aware of any situation where there has been that ndf direct conflict. >> one last question about the association standing.

its own standing andtswn right that is based on injury to one of its members. so, the injuries that the association is arguing found in the associational standing and they are the kind of allocations at we see in advocacy groups, increased expenses, thatests from the complications of having to address and explainheew changes. i am not talking about expenses of filing the petition. let us just talk about resources. can you distinguish that? ms. prelogar: i think havens was tryi tdistinguish between two types of organizational injuries and they said in that case the organization haco forward with direct and concrete injury to itselfndhey had a contract to provide low income housing or search toece it for clients and the practices

directly interfered with tt and made it more difficult for the organization to carry out its obligations but haven said it was not in a standing that uld allow the organization to describe a setback. thats e court trying to distinguish between demonstrable harm and tt nd of abstract setback on the other hand. i recognize and yourueion touches on it that some lower courts have seemed to readt far broader standings. the government has been resisting standing because that would essentially mean that any advocacy organization could say it opposes what the federal vernment is doing and therefore has to devote resources tohepposition. if ere enough every organization would have standing and it would be an expansion of ordinary article t principles. we would welcome an eventual

clarificat organizational standing, but i think the assertion of injlls into the bucket of the abstract setback and does not come to the demonstrable harm that was the issue in haven. >> that is a helpful clarific on a similar clarification. ank you. with respect to individuals, i have heard and listen to your gument and read the briefs and i think i understand it. how does it fit in your mind with offended obseerstanding under the establishment cause or some injuries ou-- i access pa and i like to look at it in a certain way, and those kind of injuries at the court has sometimes recognized and sometimes cast doubt on. ms. prelogar: there are different strands of precedent and i would put the establishmentprecedent and first amendment in its own bucket. the court has recognized different theories. justice gorsuch: standing is standing at it is articlthe. we have to find some way to itch it together and i am looking for guidance from you. >> i think the way to approach

this is if you are going to recognize an offense or stress injury to regned -- no, i represt e government so i thk at kind of theory of injury would go far too much in the direction of allowing arcle three courts to weigh in paste on generalized grievances. to distinguish thecaas -- the cases,enally it is in a situation where there is a dictovernmental action producing that type of injury. here the argument is that the fda actions in approving mifepristone in 2016 and 2021, which was an incrementnge, it is so far upstream of the downstream assertion of harm that the respondents are asserting that as a matter of w and a attenuated link that cannot suffice for article three. >> thank you. justice alito?

justice alito: you said th sixth circuit did not give any reason to think that the changes would be more dangerous in combination than individually, but isn't that obvious that three things that ghbe innocuous or not excessively dangerouifngaged in by themselves might become very dangerous when they are all done together? and why shouldn't the fda have address that? ms. prelogar: the only way that would be true is if the three changes are inteoncted and mually reinforcing, guarding against the same kind of rk. if there was reason to think that the reason why mifepristone is up to safe up to 10 weeks is because it is being prescribed by doctors instead of nurse practitioners then those changes would ierconnected because one change would be the safety net for another. eris nothing like that. the studies at the fda examined demonstrated with an exhaustive examination that the cng were safe not because there were other safeguards to guard against risk becsef you go up to 10 weeks there is no observab irease in adverse events no matter who is

prescribing. in the absence of that effect of the changes do not think you can fault the agen f not giving more explicit attention to this issue and it did. it cited multiple studies i combinedn ltiple changes because a standard of care had evolved over the 15 years it had been appved and many of the changes were being deployed together safely. juice alito: shouldn't the fda considered the applicationf the comstock provisions? ms. prelogar: i think ds not fall under that lane. the fda can maintain restrictions if it is necessary to ensure fese. in 2020 one what they determined it is that you do not need in person dispensing so the fa did not require that restriction and it could not be imposed. the fda was not approving, mailing in violation of comstock even if you interpret that and we do not think it mea wt the respondents suggested means. but i don't not it was the fda's

responsibility to nser that. justice alito: it did not say anything about it and this is a prominent prisn. it is not some obscure substi of a complicated obscure law. they knew about it, everybodin the field knew about it, shouldn't they address it. you have answers to the arguments made on the others, should thedaaid we have considered that and provide some sort of an explanation? ms. prelogar: let me give two responses, it would not ve been permissible for the fda to consider maintaining that restriction because of comstock. if you look at the relative statutory conception, this is reproduced on page 6a, the onl thing the fda can take into account for restrictions are safety and efficacy concerns in decidi tmaintain a program. the other thing i would say is that the agency did have a memorandum on comstock at 53 which is the advice conveying the interpretation. justice alito: ty t the advice but idinot refer to that? ms. prelogar: in the 2021

decision, no, but it was modified in 2023 and this is part of the administrative rerd for that. justice alito: the plaintiffs to say that the studieshathey relied on said that mail order mifepristone sges more frequent trips to the emergency room. now, this is what i see as the a's response. "although the literature suggests that there might be more frequent emergency room care visits related to the use of mifepristone when dispensed by mail, there are no impairment increases and other serious adverse events related to mifepristone use." eshat really count as an explanation to the suggestion at the data shows that there are going to be more emergency room visits? this is the increase of emergency room visits are of no consequence and it does not met some comments? . prelogar: that is a reasoned explanation of what theyer observing. although it acknowledged that some of the studiererted

additional visits, did not equate to additional serious adverse events. one of the studies, half the women who went to the emergency omid not get treatment. many might go because they are exriencing heavy bleeding which mimics a miscarriage and they need to know whether or not they are having a complication. in that circumstan t woman is not having a serious adverse evenfr mifepristone, which does not call into account the safety detmitions. the fda parsed those studies and it made specific deternaons about the results with respect to safety d ficacy. it fully explained its decision-making and falls well into the zone of reasonablenes justice sotomayor: on the last estion the reality is even if there is some increase in emergency room visits, the question of whenharises to a sufficient safety risk is up to the fda, correct? ms. prelogar: thats ght and the fda acknowledges this. it did not orlk it. i want to emphasize that the studies were far from the only

evidence that the fda consuld. at the time it acted it had real-world experience during the covi19andemic, a period of time when the in person dispensing requirement was not enforced and the fda started by oking at a comparative analysis the two periods wn you had in person dispensing and when you did not and saw that there was no serious increase of adverse event -- events or the difference. justice soto the problem is that there are complications in virtually all of them. at what level the cost benefit analysis tells you to st prescribing something is a very difficult question, isn't it? ms. prelogar: thats question entrusted to the fda. justice sotomayor: whatever the increase was, lefddetermined under the standard that it was not sufficient to create a risk that counterlanced the need for access, correct? ms. prelogar: because the fda is inrued to take into account burdens on the health care system as well and looked at a vaety of sources to conclude that the burden suggesteth it was not necessary to keep this restriction in place to ensure safe use. justice kagan:f could take you back to the discussion with justice barrett about the conscious objectn d i'm sure that you have read the declarations carefully and i am sure that mshoy will have things to say about this. as youeathose declarations,

what is the conscious objection? what are the doctors objecting to ect? ms. prelogar: i think the declarations are specific. the e only seven doctors who regularly practice and submitted evidence and they are relatively short. this isja 150-200 because there are only two who provide any information about their specific objections those are dr. scope and francis. e others do not provide specific detail about exactly what care would violate their conscience. dr. francis is ja155anthe other at ja157. they object to ending the life in the womb. justice kagan: they do not object to providing whatever re is necessary to a person who might have complications from takinmipristone, in other words supposed somebody s bled significantly in need a

transfusion or any of a number of other things that might haas you understand there 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 there is a broader conscious injury and there might be other doctors who have a broader concern about providing ca, and even if that injury had been in this declaration we think as a matter of law it could not demonstrat that they have a nonspeculative injury. in part because of all the things that would have to happen in a woman gngo the specific doctors and the fact that the adderall conscious protections are designed to deal with this issuanthey would cover the range of objections that exist. justice kagan: there are obviously ones of all kinds and

i was just asking about these rtular declarations. ms. prelogar: i think they have not asserted a broernjury, but even if they could come forward with other doctors or adjust the declaration still that wouldotuffice. justice kagan a quick question abouthmerits. you open your brief with the

date meant, but with the statement d starts with the vernment's knowledge and 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 e ntence and ask you whether it is still

true. to the government's knowledge. "this case marks the first time" and i'm gointoay is at the first time or only time "any court has restct access to the fda's drug by second-guessing the safe use." is it still the only time? ms. prelogar: still to our knowledge, and we have seen a trend of courts overwriting fda's judgment to granter access to drugs. and whatever directi, at

it from we believe that the courts have no authority to ke those kind of judgments. justice kavanaugh: just confirm on the standing issue,nd federal law no doctors can be forced agastheir conscious is to perform or assist in an abortion, corrt? ms. prelogar: we think that fedel nscious protections provide broad coverage and there are some triggering requirements on receiving federal funding. we cited the relevant provisions on page five. the church amendments have the most comprehensive instructions and they guard against the kind of injury and there arste law protections that often apply. justice barret wld that be true if the declarations were interpreted that thererd any participation such as transfusion as after otherwise complete as tissue being removed? ms. prelogar: the most revt church amendment provision is 42a-7d that said that doctor shall not be required to perform or assist in any part of the health care program that would violate the doctors' religious

oror beliefs which are tied to the nature of beliefs than procedures. justice barrett: this goes to the merits. as i understand it, the serious consequences that have to be reported or that the fda considerris are death and transfusion but it seems to me that the data bears it out that thelination of the in person dispensing requirement or visit athe outset would lead to mistakes in gestational in which could increase the need for a dnc or the amount of bleeding but that does not count as an adverse event? ms. prelogar: eris a list of serious events and i am not sure that i have all of them down to

be able to recite them although they are in the record. i think the premise is wrong the idea that they cng in person dispensing would increase the risk that was not reflected in the data that the fda consulted and i would point you to a partul section in particular where the fda explains that even inerson you are not getting an ultrasound, that has nev bn required. the relevant question might be is your provider is into ask you a number of's straining questions and there is no reason why that difference would lead toifrent safety outputs. justice barrett: i thought there was a small percentage increase about tracking which i might be wrong about that? ms. prelogar: i think atith respect to the er visits there were increased four visits although as i explained that was not actually correlated with an crse in serious adverse events. i do not want rresent all of the different studies bau they varied a little bit but the ultimate conclusion was that mifepristone could be esibed

without in-person visits. there have been no contrary evidence introduced. justice barrett: there was no requirement of an ultrasound or detecting a fetal heart beats or ything like that even before the doctor could go based on whenheast menstrual period was. ms. prelogar: that dates back to the initial approval. it has not been required used to ha aultrasound. it is of course necessary for providers to diagne d date gestational age which remains true. they sllave to have that capability and deployed whatever mechanisms they believe would accurately all tm to identify contraindications. but it is wrong to suggest that if the court was versus changes th ery woman will get a note for sound. at has never been the state of play. justice barrett: how even under that was it possible to detect an ectopic pregnancy unless the woman was presenting with plane? ms. prelogar: there is a set of questions such as did you become

pregnant with i or after tubal ligation. are you experiencing unusual bleeding or ask if they have had a prior pregnancy. if the wom h that kind of risk factors imaging might be necessary t at remains true as well that the prerir has to be confident that it has excluded those kinds of conditions befe escribing. the standard of care around the world, 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 sought. remedy that is being and that that mighorhould matter fortaing purposes. i do not know that the doctrines capture this. i guess i see it that the injuries that the respondents allege as you articulatehe our conscience injury that they are being forced to participate

in a medical pcere that they object to. and so the obvious commonsense remedyou be to provide them wiexemption that they do not have to participate in thi procedure. and you said several times that federal law already gives him that. so iue then what they are asking for in this lawsuit is more than that. they are saying because we object to having to be forced to participate in this procedure we are seeking an oerreventing anyone from having access to these ugat all. and i guess i am trying to understand how they could possibly be entitled to that given the injury they have alleged? ms. prelogar: i agree and i think it is relevant to standing. there aismatch between the claimed injury and the remedy

they were seeking. you could think ofhias a type of zone of interest analysis. if the doctors have a conscious injury there are statutes designed to deal with it specifically to guard ait the injury occurring and instead they are reaching out and invoking rights under a different statute that does not regulate them at all or make them do or not do anything and the relief that they are seeking would dramatically alter the im conditions for use and affect women all around the nation simplbeuse of this injury already directly addressed. justice jackson: if it was not addressed the remedy would bto exempt them, right?

ms. prelogar: one of the hard things about trying to tailor relief is eyre asserting such a diffuse theory so that the only option was to grant a nationwide remedy and it runs counter to ordinarprciples of party specific relief. it shows that there is somhi wrong with the theory of injury in the firstla because it is so attenuated and claim that they would need so mucrelief all over the country. justice jackson: in addition to the challenges that we have here, the respondents below chlenge the initial decision to approve mifepristone in the year 2000. of course, that occurred a long time ago a ty said that challenge was not timely because ofhe statute of limitations. in the context of another case thatcourt is continuing, the statute of limitations issue. setting aside standing, have you thought about how a ruling on the ate of limitations in either direction might impt what happens in these kinds of cases with these kinds of

challenges ms. prelarit just reflects the stakes of the corner post send provides the most vivid ample of the way it would be possible if this court were to approve the request for the broader series of the statute of limitations in the way it could open the door to plaintiffs saying i became a doctor later or started working in emergency room later and would try to unsettle long-standing actions th ourred decades previously. i understand to suggest that there might be equitable defenses that the government cod raise and we would certainly want to raise that type of defee th the approval of mifepristone and has proven to be safe and effective. >> thank you counsel. >> mr. chief justice and may it please the court, in 2016 and 2021, a made certain changes to the labeling and use restrictions. the decision below stops the from selling it in line with that scientific judgme bed on a highly attenuated claim that an unowdoctor could be called someday to an unknown emergency room after a series of desis by third-party is.

no facts link that possible future encounter to a specific change that the fda made in 2016 or 2021. respondents vi othe food, drug and cosmetic act is so flexible it will not only upend this but virtually every drug approval or modicion that the fda has made for decades. reversal is required for two reasons. article three standing inoan academic exercise and what is conceivable. they lacked standing under every prong of thenasis. on the merits, fda exhaustively consider the evidence an explained its conclusions, which is what iseqred to do. i welcomqutions. justice thomas: the solicitor general points out it would not sceptible to a comstock act problem. but in your case, you would be.

so how do you respond to an argument that mailing your product d vertising it would violate the comstock act? ms. ellsworth: wage with the government that the fda's charge undethfood, drug and cosmetic act is minted to oking at safety and that is true for new drug approvs d modifications. the fda routinely approves drugs th are restricted by other laws such as environmental laws, custs ws and so on. i think this court should think hard about the mischieitould invite if it allowed agencies to start taking action based on

stutory responsibilities that congress has assigned toth encies. on the merits, this ise not ruled on below, d any event i would point out that in 2021, the decision allows the use of brick-and-mortar pharmacies in dition to mail order. justice thomas: my problem is that yourerivate. the government, i understand the government's gunt. you are private and the statute esot have the sort of safe harbor that you are suggesting. and ifairly broad. and it specifically covers drugs such as yours. ms. ellsworth: your honor, we disagree that that is the coect interpretation of the ate. we think in order to address t correct interpretation they would need to be a situaonn which this situation is to do. this has not been enforced for 100 years and i dootelieve that this case presents an opportunity for the court to opine on the reach of the statute. >>ounsel, i would like to ask you the same questions i was posing to the solitogeneral.

klapper and susan b. anthony talk about requiring a substantial risk that harm w occur. you argue that that is not how are we supposed to find a spot at which the riskes substantial? ms. ellsworth: i think this court has always thought about the standing inquiries as a eson of degree. you are trying to evaluate whether something aual and imminent or whether it is conjectural or hypothetical. and these rms, substantial risk and pending which has been used to dating back to 1923 that

we are a claim falls in the spectrum. >> and we to aund a lot about details, but as a practil tter, how do you figure out? what percentage would be enough and atercentage of emergency room visits would be enough? . ellsworth: i think it the way klapper got at this quti is to really think about whether there is an attenuated chain and contingencies that have to happen. in situations where there is this chain of circumstances involving third-party decision the chain is quite long.d hear if that puts a plaintiff's theory on the f conjectural or hypothetical and not impending injury. >> how is your company aggrieved by the challenge that is bro in this case? i gather that this is your version of mifepristone is the ly product you are marketing? ms. ellsworth: thaorrect. justice alito: the fifth circuit

decision does not prohibit you from ctiing to produce and sell that product, correct? ms. ellsworth: that is correct. justice alito: i gather your injury is that you think you wi sl more if the restrictions that previously were in place were lifted. so y wl make more money. ms. ellsworth: the injury is that we are prevented from selling our product in line with f's scientific judgment about 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 hoit considers the revelatory scheme that governs it product. ste alito: during the

questioning of the solicitor general statenwas made that no course has ever previously second-guessed the fda's judgment about access to a drug, correct? it has never second-guessed that. ms. ellsworth: tt correct. justice alito: do you think the fda is infallible? ms. ellsworth: we do not and we do not thi tt is t-ed up in any way. justice alito has the fda ever created a drug and then pulled it after experience showed it had adverse consequences? ms. ellsworth: it has nehat and i think that underscor w the adverse event reporting and the post-market surveillancend the ability that these plaintiffs have, even if they do t have standing, certainly if they are seeing patients presenngith adverse events and doing studies that show that there is se known safety component that the fda should acknowledge, they n ke significant steps to bring that to the agency's attentn d our attention. juste ito: do you think that the fda should've connu reporting nonfatal conseens? ms. ellsworth: they decided not to in 2016 based on more than 15 years of a well established safety prolehen that reporting was required. there is no drug on the market today under any rem that requires any reporting that th plaintiffs said should be imposed. justice alito: one. be aad thing? you do not want to sell a product that caus rm to the people who take the product

relying onoutests and the fda's tests, wouldn't you want thatat ms. ellsworth: that data is certainly something that we are looking for all the time. it ipa of the reporting obligations for a manufacturer be aware of any data becoming available through any means. we have a one 800 number and a one 800 number on the labeling. i think that gets that concern that i have heard the early questioning on who would have standing if these plaintiffs do not. drug manufacturers are varies frequentlyubct to tort litigation, product liability suits and failure to warn suits, deceptive advertising suits when someone is clainharm from a product. whats i think revolutionary really about the arguments here both on standing and merit on

the way that they attempt by individuals who do not use this product and do not prescribe isroduct and have the conscious right not to treat anyone who has taken the product, they want to prevent anyone else from using iin line with fda's considered scientific judgment. justice alito: jt e more point along sort of the same lines. does your company think what the fda has done preempts state laws that prohibit the dispensation of mifepristone with tse borders? ms. ellsworth: we have not taken a stance on the issue. justice alito: what is your issue on it, and you have not thought about it?

ms. ellsworth: there are laui brought by the generic company that dma that argument. and i inthat is for later courts to sort out. our position in this case has been that this is 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 tod. >> could you go back to the questions about adverse event reporting and idou would subject your product to higher standards and now we a bng brought wno the regular, could you talk about that a little bit, what are the nma standards for adverse event reporting and why are they

there? atnstead where you subject to in the past? >> what changed was not danco's adrse event reporting responsibility. it has been the samehrghout this period. what change was from 20 until 2016 prescribers were reported to report events to danco and then we had a separate obligation. in 26 e rems were aligned to be more consistent with the reporting requirement that applies to all 20,000 plus fda approved drugs. there are only today seven that continue tha even the limited higher adverse event reporting for debts then applied to mifepristone. it is only one of sen that have that. >> any further? justice barrett? justice ja justice jackson: you are asked if the agency is infallible and i guess i am wondering if you think that the courts have specialized scientific knowledge with respect to pharmaceuticals and as a company that s

pharmaceuticals, you have concerns about judges pars medical and scientific studies? ms. ellsworth: yes. i think we have significant concerns and there are two amicus briefs from the pharmaceutical industry that expandonhy exactly that is so concerning for pharmaceutical companies who depend on fda's ldtandard review process to approve their drugs and be ae to sell their products in line with that consideredudent. justice jackson: can you say what they say? ms. ellsworth: i am happy to. i think the reality is and this decision allow is a good example of a. you have a district court that amg other things relied on one study that was an analysisf anonymous blog posts. you have another set of studies that he relied on that were not in the administrative record and would not be because they postdate the decisions. they have been retracted for a lackf ientific rigor and misleading presentations of data.

those sorts of errors can in fact judicial analesrecisely because judges are n eerts in statistics t methodology used for scientific studies and clinicalris. that is why the fda has many hundreds of pages of analysis e record of what the scientific data showed and courts are not in a position to parse through and second-guess that. >> thank you counsel. >> thank you. >> ms. hawley. >> mr. chief justice and may it please the court. fda approved was not adequate.

that violas e apa. the lower court's decision restored long-standing and criaprotections under which millions of women used aboio drugs. we have heard a lot this morning about standing. article three is satisfied becausthfda relies on hospitals to care for women harmed by abortion drugs and nces that between 2.9 and 4.6% of women will end up t emergency roomndhree the fda acknowledges that women are more likely tne surgical intervention and other medical care without an in person visit. ar 650,000 women take mifepristone every single ar it is no surprise that respondents experiencean increase in emergency room visits and treatedom suffering from abortion drug harms tens of thousands of times. -- dozs times. women's have suffered tens of thsands 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 wl low federal agencies to constrict -- conscript nonregulated pics from suffering other harm without dial recourse. article three neither demands nor permits this. the outsourcing of abortion drug responding to responsive doctors forces them to choose twn a woman with a life threatening condition and violates their conscience. this choice is intolerable. the fda faedo comply with basic requirements and in 2021 it eliminated the initial in person visit based on data that itayelsewhere is unreliable and in 2016 it failed to expla the cumulative effects of the wholesale removal of safeguards. these actions are far short of what was requires and this court should affirm. i welce eir questions. >> council, you assert an injury on the part of the alliance of

verted time and resources. isn't that just the cost of litigating and pursuing this litigation? ms. hawley: i doothink so for a couple of reasons. first what respondent doctor have done is chosen their practice as well as structured e medical practice to bring life into the world. and they are called from the labor and delivery floor down to the operating room to treat a woman suffering fr artion drug harm that is opposed to why they entered the medical profession a icomes along with emotional harm. dr. scott talks about them being heartbreaking situations and some of the most stressful work he has had to deal with.

>> this cot se specifically said that the nature o the harm was "non-economic and did not prevent the court from finding an injury. the court looked at two things. whether there was an impairment as the organatn's mission and whether there was an expenditure of resources. bo of those are satisfied here. you look at how our orgazaons have been harmed, they have been forced to divert resources from advocating for their pro-life missionenally to explaing e dangers of the harm from abortion drugs. onof the primary reasons that that isequired is because in 16the fda took away the

requirement that abortion providers reportdvse events. >> that would be anyone who is aggressive or vigilant about bringing lawsuits. just simply by using resources todvocate their position in court. you say now, it causes an injury which seems easy mufacture. >> i don't think that is te, justice thomas. i acknowledge they had havens where you had prelude to litigation types of activities. to resource justifications don't count. in this case, if you look at respondent declarations, they perform studies,nazed studies in several of those are in t rord. they are not short. they come through medicaid data to look at the true nature of adverse events and allho sorts of things are itr prelude to litigation nor

woey have heard about for fda's unlawful conduct. >> the line you quoted about economic crimes had to do with thfa that they did not contend to rent an apartme so there was nocomic loss or gain to them rentg e apartment. what i think you are pointing to is that they provided services on their own. it wasn't just the member services they were relyi o they were providing rves to people to help them rent aptments. so that is a very important distinction omere. separaterothe individual attean claims of standing bad on wasted resources, their resources. the organizations are not losing anything. their job is to do exactly what u are talking about and they

are dog . they are investigating certain problems but that is not an inry that is her address above by this -- by vacating this rule. >> a couple of things, you honor. where the court system did not economic nature of the interested housing, again, you have to look to the underlying embrace. with respect to ournjy. if the regulationsreut back in place, the protections whereby individual abortion providers would provi our organizations with more accurate information. ouncil, can i ask you about the remedy?

are able to object for two reasons. one is the emergency nature. many women do go to the emergency room and if we think about what that might lookik take dr. francis. she is on the labor and delivery floor. >> i don't want to hypothesize.

tell me in her dlation which he talks about not being able to object or post a cocitious objection. when she talks about -- can you point me tonylace in the declaration where they attempted tobject but were unable to? >> no. for two reasons. respondent doctors don't necessarily kn uil they scrub into that operating room whether this may or may not be in operation. it could be a miscarriage. it could be an elective abortion. the governmentimy cannot get it story straight. we just heard that the church amendment applies. they cald the district court. l me ask you -- if we were to find that there were contt just objections and these doctors do have a way to deal

with these kinds of procedures, should we in this case on th basis? >> no. because these are our emergency situations. they can't waiverocess -- precious moments. >> assuming we have a world i which they can actually watch the objections you say they have. my question is isn'that enough to remedy their issue? do wha to alsonttain your argument that no one else inhe world can have this drug or no one else in america should ha this drug in order to protect your clients >> it is not possible given the emergency nature of the situation. >> letterrupt there. i am sorry. i think justice jackson is a ass spot all that. -- is saying let's get rid of all that.

we should prida remedy sufficient and go no further. we have a handle individuals. normally we would allow equitae lief to address them . recently i think what justice jackson cluded to -- we had what one might call a rash of universal injunctions. this seemsike a prime example of what could be turning a small sword into a nationwide legislative assembly on an fda rule or other federal government action. >> yes i think it is impractical. i think e strict court remedy was appropriate under

section 705. it grants reviewing court's the ability. when the parties before the urare nonregulated parties, the only avenue in which they could possibly get release is what the parties before the court get. that is for a statessue or in otr ses, of a culture. >> why cant the court specify that this relief runs to the parties before the court? as opposed to looking t the agency in general and think the agency can't do this anywhere? >> i think that migh be impractical. if we are thinking about the situation with regards to dr. francis --hi is what she does

dainnd day out and so it seems to say that these would run -- these two rtular plaintiff would be missing. that the regulations would still be in place. they would permit things like il-order abortions. if we look at the merits of what they d in 2021, they relied on two things. they relied first on the data. >> i can understand your impulse there. there are exactly zero universal injunctions. pretty consequential ones. and over the lt ur years or so, the number is something like 60 and may be than that. they are relatively new things.

tosk us to pursue this new remedial force which this court s never adopted. lower court's kind of run with this. i just wantoive you one more shot at that. >> sure. divorce encapsulates equitable remedies and they he fed from e ginning of the 19th century that the parties before the court get release in this itae, we have nonregulated parties, t pty could be farmers, ranchers, they are -- the only availability for police is if the cou ds something to the fda order or regulation issue. otherwise these parties are siut of luck. >> let me ask you about your basi-- your basic theory standing. when you did your 123 your

opening statement, it sounded very probably stick to me. i don't remember exactly what the 123 let's say it is sothing along the lin of representing theocrs and there were a lot of women out the. they are going to have -- they are going to have adverse events. to come to the emergency room and so there is some probability of t le 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 yo tory? >> no. what we inreally shows the report -- the respondent have danny here is that the f h not acknowledged. in regulating them, they hav continually said emergencies from doctors and ob/gyn hospitals arcrical.

>> you are just saying tt even the fda admits they are going to see some adverse events. pele are going to show up in emergency rooms. 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. >> recently think all of that is true. we don't thk it is problem th probabilistic standing. here we have seven named plaintiffs in addition. >> does your theory really depend on you havingt ast one person? i take them to say these probability theories based on ry nice. they have nothing to do with our ticle three requirements. you need a person to be ableo come in and meet the court' regular standing requirements. you agree with that.

so who is your person? if you had to pick one anday go read thatnd that declariois going to tell you why we are entitled to be up here. >> dr. francis and doctors gone. >>ha abo tse two doctors gives you the kind of imminent inryet alone the traceability. request to speak to . francis at the beginning, there has been some confusion about the precise nature of the conscious part. you look at 5 paragraph 15, she isalngbo objecting to not only taking the life of a child but also completing that process. that echoes this decoration at 142 and 143

>> i read that declaration pretty clearly. what actual emergency treatment has she participated in that she objects to and that she has stated aobction to? >> theri 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 anpptunity to object? >> no. these are life-threatening situations to scrub out and find something else or treat the ma quickly when theeoe with conscious objections to this is they make those objections known. it may be harder, it may be eaer in a particular context but both hospitals he mechanisms in place to ensure

the doctors who are allowed to do this in advance and are allowed to do it at the moment. they say so and when i looked at dr. francis and dr. scott, there's just nothing you ha there that suggests there are other requiremes. this happened to them in the past. i don't think you have it for th one of those doctors. >> i think we do. vethe emergency nature. is impractical to have an objection launched prior to understand what is going on in that operating room. this is to the district court fifth circuit brief where the gornntet the church nor any of t other intended them to apply -- and litigating this with the

federal government saying they don't hav conscious protection. is it true i decisions have not relied on probabilistic determination? the court idhey were standing because there was a question abo cizenship included on the qstionnaire. they would not fill out the ceust all. it was probable that there was some risk that your state would risk losing a rresentative or wod sk losing money under some federal program. you put together this chain of probabilities. >> absolutely. we agree with that. you can lo a the case.

it is certainly true that the data is appropriate to consider in determining whether there i substantial risk. the fda admits this is a 5. this is at 5:42. seven women will need serve -- will need surgical inrvtion. when they talk about there being no increase in adverse events from the increased gestational age,henly way they can say that is by ignoring surgical intervention. that is because -- >> what would we do with the fact that these two rely on the scope the indiana and texas have olished abortions and abolished them by pills or otherwise.

when you get into whether other peop a illegally breaking the law -- what does that do -- its already infinitesimally small because there are thousands of hospitals in the country. thousands and thousds of places where pregnan wenay be suffering from miscarriages or otherwise to know or even imagine how one dr. is going to ever actually see a patient that he or she is going to fced to intervene on their behalf but then add to it that ts is illegal in the states. >> i think the best answer is a prologue.

we have two examples. when you go out of the state, that is a highly like the -- higher likelihood. this turns er rooms into those llow-up visits. a woman nt to micand return to texas as well as dr. joson where one went to ilnois and returned to indiana. one in five abortions take place out of state in third states like new mexico. the border states in which our s reside. i take you back to the affidavits? >> you were talking about dr. francis. and as i read her allegations, she said her partner was forced to perform a d&chethere was a living fetus. she said she pformed a d&c on a womanho was suffering serious applications but the fact that she peord that

does not necessarily mean there is no living embryoretus because you can have one after a miscarriage. if that is righti ink the difficulty here is tha these affidavits do adore like conscientious objection as opposed to actually particatg in the abortion to end the life. -- and the length of the embryo or fetus. do you wantoddress that? >> sure. i think dr.rancis can be read for the broader consciouha. ibeyond sibley requiring ding and unborn life. with respect to even more narrow conscious arms whether a doctor may need to end a life, we think there is still a substantial risk.

that means 3.1% of pregnancies will be ongoing, requiring a d&c. 55of those occur in the emergency room. there is a substantial number of women suffering abortion drug harm. >> n a those will involve the privacy that will otherwise be viable aembryo or fetus. u can have complications or excessiv bleeding even after the abortion is coled in that respect whether there is pregnancy tissue remaining. question 3.1 is ongoing and the fda says they will need surgeries to stop bleeding or ongoing pregnancies or faire >> you have a broanuer of

doctors in your organization that are dentis and doctors that a rired. how many members of your organization are a bch i went to hospitals 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 hom the narrow one? unrstood it as justice barrett does but you suggest there is a broad one. what is that? >> in a distri crt, understand the conscious harm to be either taking the life of an unborn child which would sometimes require a partner in an emergency situation. reest that is what i understood the narrow want to

be. participating in arodure that is ending the life. so what is t bader one? being complicit in the process that takes a number life such as abortion. it is not that hard to -- cplicit like i work in the emergency room where this is going on? i am hammering -- i ahaing them a water bottle? wh do you mean complicit in the process? >> this -- what harms our doctors is being involved in completing and the terms of our dlation an elective abortion. it is not that hard to see why there mit a conscious harm if you think about what is voed. >> is being involved in completed an elective abortion. i took that to be a conscientious objection. i think what justice jacksons

asking her what i asked before of justice barrett is if the is any broader conscious objection that appea a i am not sure i care all thatuc about the district court but it appears in the declarations. >> in this instance, completing elective abortion means removing an embryo, fetus -- dr. francis talks aboutei required to perform a d&c. >> whether or not there is any live tissue. >> yes, your honor. i would put you to paragra 115. they also dcre the complicity of harm from being elected -- involved in elective abortion. these doctors must agree about a woman's uterus of a fetus.

in cases like little sisters of ther. >> it is my tanding that sometimes the completion doesn't involve surgical intervention. have a sense of how often ? we may get all the way down the chain to the person having the emergency procedure. uerstanding with some of these chemical abortion scenarios is the cometn occurs by describing addion medications. could it be done by another physician? that the dose has been since 2016. i think althway back to 2001. it has been approved since 2016. the best members we have are so consistent with that.

th means 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 how many circumstances or how often it would be youclnts actually have to complete the procedure in the way you are describing. >> the doctors talk about doing this at least a dozen times. removing ery, fetuses. if you tnk about 3.1% at 10 weeks -- ts has only gone up. the in person visit was both necessary and minimally burdensome -- minimly burdensome. these sorts of situations occur

less frequently than. hank you. >> i am sure you heard the answers of the solicitor general and counselor for danco with respect to this act. i would like you to comment on thr answers. >> for sure. we don't think there is any case inhi court that emporshe fda to ignore other federal law th respect to the msck act as relevant here. it says drugs should not be iled either through the mail or through common carriers. so we think the plaintext is very clear. >> when did you first raise t comstock act? >> i think it was first raised district court. we think exhaustion does not apply for two reasons. firsitould be legally futile

. this is a whole another kettle of fish. if you look at section 704, exhaustion is only requid two instances. this is consistent. the lower court haveaken opinions. there is no is often required or agency will that stays the preceding. >> pi ask about the traceability of it all? i want you to tell me if you agree with ts derstanding. even beyond proving whatever injury you are par--hatever injury you are trying to prove, you have to shift that injury is traceable to the 2016 and 2021 fdactions that you are challenging and of course at

means showing that these incidents you are talkin about in the emergency room are caused by whatever incremental increase and risk there is as rult. i guess my first question is do you agree with that statement? what do you need tsh? and if you do, how do you satisfy that? why do you satisfy that? twice we bie that we need to sh the 2016 and 2020 one action increase the risk of harm. >> i guess we are saying you have to link whatever and for your members have two tt increased risk. do you agree with that? >> we do and we agree with that for a couple of reasons. we are not in tort cognition. you look at the 2021 action within traceability status is as

j 845 -- without that in person visit, er and other medicalar question might be some dispute between the two of you about how big th increase -- increased risk i how do you connect that risk to particular actions that your members have to particular injuries that your members have undergone or will undergo? >> the original risk. >> i tnkhe declarations are really quickly on this. if you look at dr. francis's declaration. she thought she saw an increase

inmergency visits from dr. hnn, dr. scott said the same thing. it is entirely consistent with a numbers. in 2020, the fda said the emperor visit was necessary to preserveom's health bau the impression vis i the best opportunity to examine things like -- things to observe pregnancy and age of consent. because the general said that initial impression visit that had no reqrent oan ultrasound or any effort to detect fetal heartbeat except it wod t necessarily give inaccurate read on gestational age. so i would not necessarily be eliminated? >> i tnkhe fda's undated shows thara didn't go up. if you look at the study, it shows a nearly threefold increasehen you have -- when

you removed it. it was about 2.1 without. >> when they rove this, it took awathopportunity to do that. i think a cog -- medical organizations that created that are best practice. what is allowed under this is a couple of screening questions. i do think that is nrlas good as an in-person exam. quest let's say that -- l's just carve out and put aside this -- explain to mehat additional

costs you might have incurred or what your resources had diverted in a way that would set aside havens. >> putting aside the once this and present -- one citizen petition, it was clear the respondent organization conducted studies and analyzed studies including goinghrgh the medicaid data. itncluded going to the affairs data. course i would do one of them at roa five. sorry roa 70. those are pretty comprenve studies. quest at the end of the litigationr were they to the d of? >> to accurately assess e rm from abortion drugs. getting absolute sarate from the negation. that is the only way in whi anyone can raise a cce to the fda. these proceedings gon behind closed drs

the first time is a citizens prediction. >> what difference if any do court of the opinions of the expert agency concerning the fety and efficacy of drugs? >> under this court's administrative procedure, a peer review is not toothless. instead, in this case, we are not asking that the court second-guess the agency at all but rather look at wh t fbi said. it did so basedn their data. >> i guess i don't understd how that is not second-guessing the agen. you are saying the court can look at studies.

maybe different studies. maybe the same studies. and critique their conclusions about them. what difference do we owe them at all with reec to their establish what it is they say they do about safety an efficacy? >> and think that is inaccurate to portray. the reason being is we are looking at what fta said. it says you have to have adequatees. >> did the lower court's go beyond that? representations were major today. they have since been found removed. they are obviously looking at not juswh the fda was looking at. are you asking us to just ok at the fda and nothing else? >> that claim is not even before this court. but with respect to e o claims before the court, the 2015 and 2021, we think the fda

is arbitrary. at the fda said is we ar going to look at individual studies and even the we say they are interrelated, wargoing to take protections away. that is arbitra. >> you. >> thank you counsel. >> thank you. on the associational standing, e do you cross the line to get the impeinjury? what's wanting to look at is whether that harm has materialized in the past and how often. there is nouarantee there will be a future injury but what is so telling is that respondents don't have a specif example of any doctor er ving to violate this care in violation of theironience. this is for the declaratio th never specifically say here

is how the care is provided. the fact that they do't have a doctor willing to submit that i think demonstrates the past time as it happened and the reason that happened is because it is ecative. there are so many links in the chain that would have tocc. it would be about having the federal in pl. theyaithat they voluntarily coucd studies. if that is enough, every organization in th country has anding to challenge any federal policy they dislike. havens realty could not possibly say that. he does at the outer balance. on remedy, justice courses, justice jackson, you plan out the striking anomaly here of the nationwide nature of this remedy.

maybe a more tailored remedy to the party. the problem here is they sued the fda. the fda has nothing to do with it -- with the enforcement of protection. that is all happening far downstream. d the only way to provide a remedy therefore was to grt this kind of nationwide release that is so far removed from the regulatory authorities that it is ultimaty requirement all women everywherto change for this drug. i think it is worth stepping ba a thinking about the profoundistch between tt injury and the remedy of the response obtained. they said the fear that there might be se ergency room doors who may be presented with incredibly rare applications and the doctor ma have to provide treatment -- we don't think that harm has materializedutith the court date is entered sweeping

nationwide belief that restricts access for everyine woman in this country and that causes profound harm. harm the agenc it harms the part of it -- it harms the pharmaceutical industry saying that this would be -- destabilize the system for approving and regulatingrugs. the court should reverse instructions to dis