you can watchheilms at studentcam.org. this evening on q&a, patty davis discusses her book "dear mom and dad," a memoir written as a letter to her late parent, rona watch q&a today and every day this week at 7:00 p.m. eastern on c-span, c-span now, our free mobile video app, or online at >> the supreme court heard ora argument in f.d.a.v. alliance for hippocratic medicine. a consolidated case challenging the f.d.a.'s approval for expanded use for the abortion pill. the medication approved by the f.d.a. in 2000 isart of a two-pill regimt for terminating early pregnancies. the nion's highest court now has until june to issue a ruling in this case. 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 medicin and the consolidat ce. may it please the placed on the agency's scientific judgment that the drug is safe and effective. it has maintained that judgment across five presidential administrations and millis americans have used mifepristone to safely end there pregnancies. at the outset, respondentsac standing. they cannot rely on a statistical theory of injury like the lowerous did. instead, they have to identify a specific doctor who faces imminent harbu their theories rest on aonhain of remote contingencies. only an exceptionally small women suffer the kinds of serious competitis at could trigger any need for

emergency treatment. it is speculate at any would seek c hped, federal cautions protections would guard against the injuries. and there is nbas to conclude that any of that would traceable to the incremental changes that the fda made in 20 a 2021 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 this lfuthe agency relied on dozens of studies including tens of thousands of women. they do not identify any evidence that e ency overlooked and they just disagree with the analysis of

the data, but that does not provide an office -- a license touthorize second-guessing. finally on the remedy, the release ted below would severely disrupt the federal system for developg d improving drugs harming the agency and pharmaceutical industry and inflict great harm on women across the nation. roing back these changes would unnecessarily restrict access wi njustification. some women could be forced to undergo surgicalboions and others might not be able to access the drug at all and all of this wod ppen at the request of plaintiff's who have no certain injury of their own. the urshould reject that profoundly inequitable result. i welcome estions. you on the standing could you give us an example of who would have standg challenge these fda actions? as a general matter we have seen lawsuits brought by for example prescribing physicians or■ó■1 patients who want greater access. sometimes we have seen theories of competitor standing where competg ug manufacturer■ mit sue and claim that the fda approval creates a competitive harm or injury in that sense.

justice thomas, if the question whether there would be individuals who oppose artn who would have standing and went to challenge the actions the answer is no. the reason is beusthose relevant way under the fda here. they do not prcre or take mifepristone. 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 spific doctors so they stand at a deficit -- at a distance from the actn ey are challenging and the court said in many cases that in a situatioli that when you are not the direct object of regulation it can be more fficult to establish standing. juste omas: isn't that a criticism of some of our association and standing cases and organizational sndg cases? >> i do not think it is. with respect to associational standings this cou h said■b

suering a concrete harm and an injury that is nonspeculiv i do not take issue with that fact, they are agreeing it would be necessary to identify a specific doctor. the prlewith the soational standing theory is that it rests on this chain of remo psibility with so many steps in the process that d have to occur laying one speculative remote odds of chance of ju across another to get to the ultimate harm on behalf othe doctors. >> you associate the remote nature and it affects the likelihood that patients will go to the emergency room and so on. here a number of which your argument would change, the significant number of consequences, higher likelihood of an emergency room visit, doctors who spend more time in thgency room, at some point does this analysis lead to the otherelt?

ms. prelogar: it ihard to imagine that it could for a couple of different reasons. i ta t point you will pick out different links and suggest thathe are ways to depart and say that maybe has a specific matter e two could be more likely to occur.yi toryl matter because it rests on so nyifferent things that would happen one on top of another a made by third parties who are strangers and not pa othe suit. that brings the case like klapper smers where the court has recognized that when the theory of injury turns on ny intervening events separated by independent decisions it cldean that hurdle to establishing standing. >> could you provide a more specific answer to the first

question that justice thomas d you, is there anybody who could challenge in court the lass owhat the fda did? ms. prelogar: in this case i think thaner was no. justice kavanaugh: is there ybody that could do that? let us start with the states that intervened. will you say that in that litigation fine, you can challee and let us get the metsf this issue and what the lawfulness of the fda di ms. prelogar: the states lacked standing, theyresserting indirect injuries and could result in the states alws suing the united states government. doctor who opposes abortion, he is on duty whea man who comes in with complications from taken mifepristone, d e doctor is the only one on duty who can attend to the woman' problem and as a result in order

to save her life she has to abort the viable fus with that doctor then have standing to seek injunctive relief? or would you say this is too speculative. this is like being struck byn6 lightning and it is not sufficiently likely that■ will happen to this doctor again? ms. prelogarth would represent past harm and we are not diutg that conscious violation would be cognizable. we think that situation has ner me to pass and respondents have not identified an incident in more than 20 arthat mifepristone has been available that resembles that tuation. so our view would be it unduly speculative. you have to think about the events that would veo transpire. justice alit h about who suffers adverse consequences from hintaken mifepristone, would she sue for damages or ulyou say that is barred by sovereign immunity? . prelogar: i expect that we would have those arguments and i recognize that with respect to traceali that is harder for us. justice alito: is there anybody

who can so and get a judicial ruling on what the fda did was lawful. and maybe what they did was perfectly lawful, but shouldn't somebody be able to challenge that in couranwho? who would have standing to bring the su? ms. prelogar: with respect to these regulatory changes iis hard to argue that anyone has standing but the court has said that the fact that no one would havetaing does not have a basis to depart from article the principles, so i think it is clear that even if theris no 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 impoan your argument that it does not matter if the fda flagraly

violated the law what it should have nend endanger the health of women it is too bad that nobody can sue in court? there is no remedy, the american pele have no remedy. ms. prelogar: i think it would be wrong to ggt that if the fda had made a mistake and a drug was producing safety consequences that there is nothing bdone. i do not think these respondents could invoke article teeo have the court step in. the a kes seriously its responsility to enre saty of drugs and conducts ongoing surveillance and c make adjustments as safety situations emerge. drug sponsors remain responsible at all times and we have a court system that caenre 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. eras i said, i have great respect for article three all do we have to comply with it.

fdd unlawfully, nobody can nge that in court, and u made last week, we shouldent not get to the question wh violated the right to freedom of speech and we shou that esplaintiffs cannot bring suit? ms. prelogar: we areoong at thsp do not think they come in 100 miles of the circumstances this court has identified of nonspeculative harm that can crte the injuries for forward-looking relief. >> i am assuming that if there were -- if this had been unsafe

grossly visible way, you know, 40 percent more inead hospitalizations that some doctor would've challenged e lack of an in person? ms. prelogar: no doctor is reir to 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 berend, we are not warning them and etc. ms. prelogar: certainly those nds of dishegey level. there is nothing like that here. justice sotomayor: i am conjuring a hypothetical. ms. prelogar: e a 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 crical arrangement. >> can i ask you a question about the roadblocks that you identified in a chain beus you said a doctor could invoke conscious protection to refuse to complete rt embrfetus was still alive. so i want to be clear, the the doctor what have conscious objections but it is your position that such doctors would have recourse for the protections of federal law? ms. prelogar: let me be clear

because i think that the circuit misunderstood the arguments and respondents have repeateth misunderstanding. we never thought that this would he said the opposite. if you look at the texas litigatione disclaimed that unrsnding and made clear that we understand that cocious detection should continue to apply and shld doctor who does nowa to provide care. uen health-care desert haswell? ms. prelogar: we do not think it would override conscious proteconand imposes obligations on hospitals and hospitals have plans in place to

address these contingencs. they have staffing plans and it is a matter of best practices d they often asked for doctors to articulate the objections in advance so they can take account of that. th have cross staffing agreements and in the government's experience, almost four decad ware not aware of any situation where there has been that kind of direct asciation standing. its own standing and its own right thats sed on injury to one of its members. so, the injuries that the association is argngound in the associational standing and they are the kind of allocations that we see in advocoups, increased expenses, that results from the complic of ha

changes. i am n tking about expenses of filing the petition. let us just talk about resources. can you distinguish that? inries and they said in that case the organization had comete injury to itself and they had a ntract to provide low income housing or search to secure it foclnts and the practices directly interfered with that and madet re difficult for the organization to carry out its obligationbuhaven said it was not in a standing that would allow the orgazaon 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 toheon it that some lower courts have seemed to read it as far brdestandings. the government has been resisting stanngecause that would essentially meanhat anyany it opposes what the federal government is doing d therefore has to devote resources to the opposition. gv

if that were enough every organization would have standing d it would be an expansion of ordinary article three principl we would welcome an eventual clarification on organizational standing, but i think the assertion of injury falls into bucket of the abstract setback and does not come close to thestrable harm that was the issue in haven. >> that ispful clarification. on a similar clarification. thank you. with respect to individuals, i have heard and listen to your argument and read thbrfs and i think i understand it. how does it fiinour mind with offended observers standinr

some injuries about -- i access a park and i like to looatt in a certain way, and those kind of injuries at the court has sometimes recogniz a sometimes cast doubt on. ms. prelogar: there are dienras precedent and i would t e establishmentprecedent and first amendment in its own bucket. the court has recognized■ different theories. juice gorsuch: standing is standing at it is article three. we have to find some way to stitch it together a im looking for guan from you. >> i think the way to approach this is if you are going to cognize an offense or stress injury to recognized -- no, i represent the government so i

think that kind of theory injury would go far too much in the direction of allowing article three courts tweh in paste on generiz grievances. the cases, generally it is in a situation where there is a direct governmental action producing that type of injury. here the argument is that the fda actions in approving ests aren 2016 and 2021, asserting that as a matter of law and a attenuatedthat cannot suffice for article three. >> thank you justice alito? justice alito: you said that the sixth circuit did not give any reason to think that the changes would be me ng t isn't that obvious that three things that might be innoouor not excessively dangerous if engaged in by themselves might become very ngerous when they are all done together? and why shouldn'the fda have address that? ms. prelogar: the only way thate

changes are interconnected and mutually reinforcing, arng against the same kind of risk. if there was reason to think that the reason whmipristone is up to safe up to 10 weeks is because ibeing prescribed by doctors instead of nurse practitioners then those changes would be interconnected becaus one change would be the safety t for another. there is nothing like th. the studies at the fda examined demonstrated witanxhaustive examination that the changes were safe not because there were other safeguo guard up to 10 weeks there is no observable increase in adverse evts no matter who is prescribing. in the absence of that effect of the changes do nothi you can fault the agency for not giving more explicit attention to this issue and it did. it cit mtiple studies i combined in multiple changes because a standard of care had evolved over the5 ars it had been approved and many of th changes were being deployed together safely.d't the fda

considered the application of the comstock provisions? ms. prelogar: i think it does not fall under that lane. the fda can maintain restriio if it is necessary to ensure safe use. in 2020 one what they determined its at you do not need in person dispensing so the ftca did not reque that restriction and it could not be imposed. the fda was not approving,■ mailing in violation of comstock even if you interpt at and we do not think it means what the respondents suggested means. but i don'noit was the fda's responsibility to consider that. justice alito: it did not say anythingbo it and this is a prominent provision. inot some obscure subsection of a complicated obscure law. the field knew about it, shouldn'th address it. you have answers to the argumes de on considered that and provide some

sort of an explanation? . elogar: let me give two responses, it would not have been permissible for the fda to consider maintaining that restrictiobeuse of comstock. if you look at the relative statuty nception, this is reproduced on page 6a, the only thing the a n take into account for restrictions are satynd efficacy concerns in deciding to maintain a program the other thing i would say is thhe agency did hah t advice cg the interpretation. justice alito: they got the advice but it did not refer to that? ms. elar: in the 2021 cion, no, but it was modified in 2023 and this is part of the administrative record for that. justice alito: t pintiffs to say that the studies that theynr mifepristone suggests more frequent trips to the emergency ro. now, this is what i see as the

fda's response. "although the lirare suggests that there might be more frequent emergency room care visits related to the u increases and other serious adverse events related to mifepristone use." does that really count aan that the data shows athere are going toe re emergency room visits? this is the increase of emerncroom visits are of no nsuence and it does not merit some comments? ms. prelogar: that ia asoned explanation of what they were observing. although it acowdged that some of the studies reported additional visits, did not uate to additional serious adverse events. one of the studiesha the women who went to the emergency room did not get treatme. many might go because they are experiencing heavy blein which mimics a miscarriage and

they need to know whether or not they are havina mplication. in that circumstance the woman is not having a serious adverse event from mifepristone, whi does not call into account the safety determinations. e a parsed those studies and it made specific determinations abt e results with respect to safety and efficacy. it fully explained its cion-making and falls well into the zone of reasonableness. justice sotomayor: on the last question the realitys en if there is some increase in emergency room visits, the question of when that rises to a fficient safety risk is up to the fda, corre the fda knledges this. it did not overlook it. i want to emphasize that the studs re far from the only evidence that the fda consulted. at the t covid-19 pandemic, a period time when the in person dispensing requirement was not enforced and the fda started by looking at a comparave analysis the two periods when you had in pern spensing and when you d n and saw that rse ent -- events or therease of

difference. justice sotomayor: the problem is that there are complications in virtually all of them. at what level the cost benefit prescribing something is a very difficult quesonisn't it? ms. prelogar: that is a question entrusted to the fda. justice somar: whatever the increase was, lee fda determined under e andard 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 acun burdens on the health ca system as well and looked at a variety of sources to ncde that the burden suggested that it was not necessary to keep this restrictionn ace to ensure safe use. justice kagan: if i could take you back to the discussion with justice barrt out th■e that you have read the declaratnsarefully and i am sure that ms. holly will have thgso say about this. as you read those declarations what is the conscious objection? at are the doctors objecting to exactly? ms. prelogar: i think the declarations are specific. there are only seven docto w regularly practice and submitted evidence and they e relatively short. this isja 150-200 cause there are only two who provide any infoatn about their specific the are dr. scope and francis.

the others do not provide d ole their conscience. dr. francis is ja155 and theat. they object to ending the life inheomb. justice kagan: they do not object to providing whatever care is necessary to pson who mit ve complications from taking mifepristone, in other words supposed somebody has bled significant ineed a transfusion or any of a number ofther things that might happen, as you understand is not objection to that? ms. prelogar: i think the fairest reading is that they are not objecting to that. tres a broader conscious injury and there might be other doctors who have bader concern about providing care, and even if that injury had been in this dearation we think as a matter

of law it could not demonstrate that they have a nonspeculative injury. in part because of all the things thawod have to happen in a woman going to the specific ardesigned to deal with thise issue and they would cover t range of objections that exist. justice kaga tre are i s just asking about these■l particular declarations. ms. prelogar: i think they have(

t en if they could come forward with other doctors or adjust the dlation still that would not suffice. ste kagan a quick question you open your brief with the date mntbut with the statement and it starts with the government's knlee 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 the sentence and ask you whether it is still true. to the government's knowledge. "this casear the first time" and i'm going to say is at the0= first time or only time "any

court has restricted access to the a's drug by second-guessing the safe use." is it stl e only time? ms. prelog trend of courts overwriting fda's judgment to grant greater access to drugs. it from we believe that the courts have no authority to make 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?■■ú msprelogar: we think that federal conscious protection

provide broad coverage and there are some triggering requirements on receiving federal funding.ans on page five. the church amendments vehe most comprehensive instructions and they guardgast the kind of injury and there are state law ottions that often apply. justice barrett: would that be ue if the declarations were interpreted that they regard any rtipation such as transfusion as after otherwise complete as tiueeing removed? ms. prelogar: the most relevant chur andment provision is 42a-7d that said that doctors shall not ruired to perform or assist in any part of the health care progm at would violate the doctors' religious or moral beliefs which areiepre.

justice barrett: this goes to the merits. as i understanitthe serious consequences that have to bert a transfusion but it seems to me th the data bears it out that the elimination of the in rs dispensing requirement or visit at the outset would le t 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 iavall of them down to be able to recite them although they are in the rerd i think the eme is wrong the idea that they changed in person dispensing would increase the risk. that wasoteflected in the data that the fda consulted and i uld point you to a particular section in particar where the fda explains that even in person you are not ttg an ultrasound, that has never been required. the relevant queiomight be

is your provider is going to ask you a number of's straining questions and there is no reason whth difference would leadut justice barrett: i thought there was a small percentage increase about tracking which i might be wrong about that? ms. prelogar: i think that with reecto the er visits there were increas fr visits although as i explained that was not actually correlated with an increase in serious advee events. i do not want to represent all of the different studies because they varied a little bit but the ultimate conclusn s that mifepristone could be prescribed without in-psovisits. there have been no contrary evidence introduced. justice rrt: there was no requirement of an ultrasound or detecting a fetal heart beats or anything like that efore the doctor could go based on when the last menstrual peri was. ms. prelogar: that dates back to the initial apov. it has not been required used to have an ultrasound. it is of course necessary for providers to diagnose and date stional age which remains true. they still have to have that capability and deployed whatever

mechanis ty believe would accurately allow them to identify contraindications. but its ong to suggest that if the court was versus changes that every woman will get no for sound. that has never been e ate of play. justice barrett: how even under that wasssible to detect an ectopic pregnancy unless the woman was prenng with plane? ms. prelogar: there is a set of quesonsuch as did you become pregnant with an iud or after tubal ligation. are you experiencing unusual bleeding or ask ifhehave 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 tseinds of conditions before prescribing. the standard of care around the wod, most medication abortion occu w stice 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 and that that might or should matter for standing purposes. i do not know that the doctrines pte this. i guess i see it that the injuries that the respondents allege as you articulate them our conscience injury that they are being forc tparticipate object to. anhe obvious commonsense remedy would be to provide the with an exemption that the not have to procedure. and you said several times that federal law alreves him that. so i guess then what they ar asking for in this lawsuit is

re than that. object to having to be forced to participate ts procedure we are seeking an order preventing anyone from having access to these drugs at all. i ess i ame tied to that given the injury they have al ms. prelogar: i agree and i think irelevant to stanng there is a mismatch between th claimed injury and the remedy they were seeking. you could think of this as a type ozo of interest analysis. if the doctors have a conscious ju there are statutes

designed to deal wh specifically to guard against the injury occurring and insinod invokingigs under a different statute that does not regulate them at a omake them do or not do anything and the relief that they are seeking would dramatically alter the improved conditions for us affect women all around the nation simply because of this injury already directly addressed. justice jackso if it was n■ot addressed the remedy would be to exempt them, right? ms. prelogar: one of the hard things such a diffuse theory so that the only option was to grant a nationwide remedy and it runs counter to ordinary principles pty specific relief. it shows that there is somhing so attenuated and claim that they would need so much relief l er the country. justice jackson: in addition to the challengt we have here, the respondents below

challenge the initial cion to approve mifepristone in the year 2000. of course, that occurred a long time ago and they said that challenge was not timely because of the statute of limitis. in the context of another case that this court is continuin the statute of limitations issue. setting aside standing, have you thought about how a ruling on the statute of limitations i either direction might impact what happens in these kinds of cases thhese kinds of challenges? ms. prelogar: it just reflects e stakes of the corner post case and provis mo vid example of the way iwod be possible if this court were to approve the qut for the oninhe way it could open the door to plaintiffs sayi iecame a doctor later or started working in emergency

room later and wou t to unsettle long-standing actions that occurred decades previously. i understand to suggest that there might be eitle defenses that the government could raise and we wou certainly want to raise that type of defense with the approval of mifepristone and has proven to be safe and effective. >> thank you counsel.plhe courtd 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 erncy room after a series of decisions by third-party i no facts link that possible future encounter to a specific change that thfd or 2021. respondents view of the food, drug and cosmetic act is so inflexible it will n oy

upend this but vtuly every drug approval or modification that the fda has made for decades. veal is required for two reasons. article three standing is not an academic exercise and what is conceivable. they lacked standing under every prong of the analysis. onheneitconclusions, which is what is required to do. i welcome questions. juice thomas: the solicitor general points out it would not be susceptible to a comsckct problem.ouca, you would be. so h dyou respond to an argunthat mailing your product and advertising it would vernment that the fda's charge under the food, drug and

smic act is minted to looking at safety an mofitions. the fda routinely approves drugs that are restricted byth laws such as environmental laws, customs laws and so on. i think this court should think hard about the mischief it would invi iit allowed a start taking action based on statutory responsibilieshat 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 ord. justice thomas: my problem is

that you are private. the governmenti derstand the government's argument. you are private and the statute does not have the sort osa harbor that you are suggesting. and it is fairly broad. and it specifically covers drugs such as yours. ms. ellswort yr honor, we disagree that that is the correct interpretationf e 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 bn forced for 100 years and i do not believe that this case presents an ope on the reach of theo statute. >> counsel, i would li task you the same questions i was posing to the solicitor general. klapper and susan b. anthony about requiring a substantial risk that harm will occur. you argue that that is not present. how are we suppo■■sind a spot at which the risk becomes substantial? ms. ellsworth: i think this

court has ■úalways thought about the standing inquiries as a$o question of degree. you are trying to evaluate whether something is actual andq imminent or whether it is conjectural or hypothetical. and these terms, substantial risk 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 figure out? wh percentage would be enough and what percentage of emergcy room visits would be enough? ms. ellsworth: i thi ithe way klapper got at this question is to really think about whether there is an attenuated chain and contingencs at have to happen.

in suaons where there is is chain of circumstances involving third-party decisions that have to play out and hear the chain is qong. if that putsintiff's theory on the side of conjl or hypothetical and not impending injury. >> howur company aggrieved by the challenge that is brought in this i gather that this is your only product you areting? msells justice alito: the fifth circuit decision does not prohibit yound 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 prevend om selling our product in line with fda's scientific judgmt out■k the safe use of the drug. justice alito and you will be harmed because he will sell ability to market its product is how it considers the relory scheme that governs it product. justice alito: during th 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-guesd that. ms. ellsworth: that is correct. stice alito: do you think the fda is infallible? ms. lsrth: we do not and we 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 had adverse consequences? ms. ellsworth: it has done that and i think that underscores why the adrsevent reporting and the post-market surveillance and the abily at these plaintiffs have, even if they do not have standing, ctaly if they are seeing patients presenting with adverse events d doing studs gnict steps to brt

to the agency's attention and our teion. justice alito: do you think at 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. the is no drug on the market requires any reporting that the plaintiffs said should be reimposed. justice alito: one. be a bad thing? you do not wt sell a product that causes harm to the people who take the product relying on your tests and the a's tests, wouldn't you want that data? ms. ellsworth: that data is certainly something at we are loinfor all the time. it is part of the reporting

obligations for a manufacturer to be aware of any da coming available through any means. we have a one 800 mber and a one 800 number on the labeling. i think that getth concern that i have heard the early■i■eo not. drug manufacturers are varies frequently subject to tort tigation, product liability suits and failure to warn suits, deceptive veising suits when someone is claiming harm from a product. what is so i think revolutiory really about the arguments here both on standing and merit on thwathat they attempt by individuals who do not use this prth conscious right not to treat anyone who has taken the product, they wa tprevent anyone else from using it in line with fda'considered scientific judgment.

justice alito: just one more inalong sort of the same lines. does your company think what the fda has done preempts state laws that prohibit the dispensation of mifepristone within those borders? ms. ellsworth: we have not taken a stance on the issue. justice alito: what is your issue on it, and you have not thoughabout it? ms. ellsworth: there are lawsuits brought by the geri company that do make that■" arme. 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 justice alito: you do not want to answer? ms. ellsworth: we do not have a position prepared to say today. >> could you gba to the questions about adverse event reporting and said you would suect your product to higher standards and now we are being could you talk about that a standards for adverse event reporting and wharthey there? what instead where you sje to in the past? >> what changed was not danco's adverse event reportin responsibility. it has been the same throughout this period. 2016 prescribers were reported

to report en to danco and then we had a separate obgation. in 2016 the rems were aligneto be more consistent with the reporting requirenthat 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 vehat. >> any further? justice t? justice jackson? jujackson: youre asked if the agency is infallible and guess i am wondering if you specialized scientific knowledge with respect to pharce and as a company that has pharmaceuticals, you have concerns about judges parsing medical d ientifictusiifant concerns and there are two amicus briefs from the pharmaceutical industry that

expands on why exactly that is so concerning for pharmaceutical mpanies who depend on fda's gold standard review prosso approve their drugs and be able to sell their pr justice jackson: can you say what thesa mselworth: i am happy to. i think the reality is and this decision allow is a od a. you have a district court that among other things reld one study that was an analysis of anonymous blogos. you have another set of studies that he reedn that were not in the administrative record and would not beecse they postda t decisions. they have been retracted for a lack of scientific rigor and misleading presentations of data. those sorts of errors can in fact judic because judges are not experts in statistics or the methodology used for scientific studies and that is why the fda has many hundreds of pages of analysis in the record of what t scientific data showed and

courts are not in a position to parse througansecond-guess that. >> thank you counsel. >> thank you. >> ms. hawley. >> mr. chiefce and may it please the court. fda approved was not adequate. that violates the apa. the lower court's decision sted long-standing and crucial protections under ic millions of women used abortion drugs. we have heard a is morning about standing. article three is satisfied because the fda relies on

hospitals to care for women rmed by abortion drugs and concedes that between 2.an 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 re without an in person visit. nearly 650,000 women tak it is no surprise thatgle year. respondents experienced an increase in emergency room visits and treated women suffering from abortion drug harms tensousands of times. women'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 agencies to constrict -- conscript nonregulated policies fromufring other harm without judicial recourse. article three neither demands nopermits this. the outsourcing of aboion dr

responding to reonve doctors forces them to choose between a woman with a life threatening condition d olates their conscience. this choicis intolerable. the fda failed to comply with basic requirements and in 2021 itlinated the initial in on visit based on data that it says elsewhere is unrelbl and in 2016 it failed to explain the cumulative effects of the wholesale removal of safeguards. e e ou affirm.equires and this court i welcome their questions. >> council, you assert an injury onhe part of the alliance of diverted time and reurs.

isn't that just the cost of litigating anduring this litigation? ms. hawley: i do not think so foa couple of reasons. first what respondent doctors have done csen their practice as well as structured the medical practiceo ing life into the world. and they are cfrom the labor and delivery floor down to the operating omo treat a woman suffering from abortion drug harm that is opposed to why they enter t medical profession and it comes along with emotional harm. dr. ottalks about them being heartbreaking situations and so has had to deal with. >> this court case specifically said that the nature of the harm

was "non-economic" and did not prevent the crtrom finding an injury. the court lookedo things. whhethere was an impairment and an organization's mission expenditure of resources. both of those are satisfied here. if you look at how our organizations have been harm, they have been forced to divt resources from advocating for their pro-life mission generally to explaining the dangers of the ha from abortion drugs. one of the primary reasons that that is required is because in 2016, the fda took away the requirement that abortion providers report adverse events. that would be anyonwh is agesve or vigilant about bringing lawsuits. just simply by using resources to advocate their posionn court.

you say now, icauses an injury which seems easy to mantu true, juste omas. i acknowledge they had havens where you had prele of activities. to resource justifications don't count. in tse, if you look at respondenteclarations, they perform studies, analyzed stiein several of those are in the record. they are not short. they come through medicaid data look at the true nature of adverse events and all those sorts things are neither prele litatn■m nor would they have heard abou fda's unlawful conduct. >> the line you quoted about economic crimes had to do with the fact that they did not contend to rent an apartment so there was no economic loss or gain to them renting the aparen

wh i think you are pointing to is that theyroded services on their own. wn'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 attendance claims of standing based on wasted resources, their resources. a n losing anything. their job is to do acy what you are talking about and they are doing it. ey are investigating certain problems but that is not an injury that is her address above rule.is -- by vacating this >> a couple of things, your honor. it

where the court system did not economic nature ofyo have to lootohe underlying embrace. wi respect to our injury. if the regulations are put back in place, the protectionwherebyn providers would provideur organizations with more accurate information. >> council, can i ask you about the remedy? ■ ■

are ae object for two reasons. one is the emergency nature. many weno go to the emergency room and if wehink about what that might look like, take dr. francis. she is on the labor and delivery floor. >> i don't wahypothesize. tell me in her declaration whic) talks about n bng able to object or post a conscientious jeion. when she talks -- can you should talks about,ted to object but were unable to? >> no. r o reasons.

respondentocrs don't necessarily know until they scrub into that operating room whether this mayr y note in operation. it could be a miscarriage. it could be an elective abortion. the government simply cannot get it story straight. weheard that the church amendment applies. they called the district court. >> let me ask you -- if we were to find that there were content just objections and the doctors do have a way to■96! del with these kdsf procedures, should we in this case on that basis? >> no. because these are r ergency situations. they can't waive process -- ecious moments. >> assuming we have a world in which they can actually watch

the objectou say they have. my qstn is isn't that enough to remedy their i do we have to also entertain your argument that no one else in the world can have is drug io protect your clients? >> it is not possible given the emergency nat the situation. i am sorry.errupt there. i think justice jacont. -- is we should provide a remedy suffie and go no further. we have a handle individuals. normally we would allow equitable relief to address them

. recently i think what justice jackson is colluded had what one might call a rh of iversal injunctions. this seems like a prime exampl of what could beurng 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 the district court remedy was aroiate under section 705. it grants reviewing court's the ability. when the parties befor the court are nonregulated pti, the only■ e wch they could possiblyet release is

at the parties before the court get. that is for a state issue or in other cases, of a culture. >> why can't the court speci that this relief r the parties before the court? to the agency in general and think the agency can't do this anywhere? ■ú>> i think that might be practical. if we are thinking about the situation with regards tdr francis -- this is what she does day in and day out and so it to say that tseould run -- these two particular plntf would be missing. that theegationsthey would perme

mail-order abortions if we look at the merits of what they did in 2021, they relied on two things. they relied first on the data. an understand your impulse there. there are exactly zero universal injunctions. pretty consequential ones. and over the last four years or sothnumber is something like 60 and may be than tt. they are relatively new things. to ask us to pursue this new remedial force which this court has neverlower court's kind of h this. i just want to give you one more shot at that. >> s divorce eapsulates equitable remediesnd they have fed from

the beginning of the 19t century that t■ pties before the court get release. in this instance, we have ul pties, the party coulbearmers, ranchers, they are -- the only avaabity for police is if the court does something to the fda order or regulation issue. otherwise these parties are simply out of luc me ask you about your basically -- your basic theory standing. when you did your 123 your opening statement,t unded very probay ick to me. i do't remember exactly what the 123 let's say it is something along the lines of representing the doctors and erwere a lot of women out there. they are going to have -- they e going to have adverse events.

to come to the emergency room ando ere 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 swshe report -- the respondent have danny here i that the fda had not acdged. in regulating them, they have continuall said emergencie from doctors and ob/gyn hospitals are critical. >> you are just saying thatven the fda admits they are going to see some adverse events. people are going to sh uin 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.

>> recenink all of that is true. we don't think it is p with probabilistic sndg. here we have seven named plaintiffs in addition. >> does your torreally depend on you having at least onpeon? i tak them to say these probability theories based on very nice. th haveiren. you need a person to be able to come in and meet the court's regular stdi requirements. you agree thhat. so w iyour person? ifou had to pick one and say go read that and that declaration is going to tell you re>> dr. francis and doctors go. >> what about those two doctors

gives you thki of imminent injury let alone the traceability. at the beginning, there has been some confusion aboutherecise nature of the conscious part. if you look paragraph 15, she is talking about objecting to not only taking the l a child but also complenghat process. that echoes this decoration at 142 and 143. >> i read that declaration pretty clearly. l erncy treatment has she participated in that sh objects to and that she has stated an objection to? the 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 oect? n these are life-threatening situations to scrub ouand find someickly when the people with nsous objections to this is ey make those objections known. it may be harder, it may be easier in a particular context 5 ensure the doctors who are allowed to do this advance andre al moment. eyay so and when i looked at dr. francis and dr. scott, there's just nothing you have there that suggests there are

other■j requirements. this happened to them in the past. ion't think you have it for either one of those docts. >> think we . emergency nature. it is impractical to have an objection launched prior to understand wt going on in that operating room. this is to the district fifth circuit brief where the government s nor any of the other intended them to apply -- litigating this with the federal gernment saying they don't have conscious protection. >> is it true i decisions have not relied on probabilistic determination? the court said they were stding bau there was a question about citizenship included on the questionnaire.

4they would not fill out the census at all. it was probable that there w some risk that your state would risk losing a representative o would risk losing money under some federal program. you put together this chain of probabilities. >> absolel we agree with that. you can look at the case. it is certainly true that the data is appropriate to consider in determining whether there is substantiak. will need surgical intervention.

enhey talk about there being no iree in adverse events fromhe increased gestational age, the only way they can s that is by ignoring surgical intervention. that isau -- >> whad we do with the fact that two rely■ñ on the scope the indiana and texas have abolished abortions and abolished them by pills or otherwise. when you get into whether other people are illegally breakin the law -- what does that do -- it is already infinitesimally small cae ther hospitals in the country. thousas d thousands of

places where pregnant women may be sfeng from miscarriages or o to know or even imagine how one dr. is going to ever actually e patient that he or she is going to be forced to intervene on theirehf but then add to it that this is ilgain the states. >> i think the best answer is a prologue. we have twoxamples. when you go out of the state, that is a highly like the -- higher likelihood. this turnsr oms into those a woman wento mexico and rerno texas as well as dr. johnson where one wento

illinoisnd returned indiana. one in five abortions take ac out of state in third states like newthe border states in whr doctors reside. >> can i take you back t affidavits? >> you were talking about dr. francis. and as i read her allegations, she said her■ear pform a d&c whs living fetus. she said she performed a d&c ong serious applications but the fact that she performed that not necessari mn there is no living embryo or fetus beyou can have one after miscarriage. if that is right, i think the diiculty here is that these affidavits do read moreike conscientious objection as opposed to actually participating in the abortion end the life. -- and the len the embryo

or fetus. do you want to address that? >> sure. i think dr. francis can be read for the broader conscious harm. ■d requiring ending and unborn li. with respect to ev me narrow conscious■ life, we think there is still aubantial risk. that 3.1% of pregnancies will be ongoing, reqri a ■u55% of those occur in the emergency room. there is a suntiodr

harm. >> not all those willnvve the privacy that will otherwise be viable in an embryo or fetus. you can have complicio or excessive bleeding even after the abortion is completed in th respect whether tres pregnancy tissue remaining. questi is 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 thatre a],nw dtors that are retired. how many members of your organization are a beach i went hospitals who might be -- >> there are h of them. i think in particular, the named plaintiff our ob/gy

hospitalists who spent time on delivery floors. >> can you clarify the broader conscious harm from the narrow one? i understood it as justice rrthere is a broad one. what is that? >> in a district court, understand the conscious harto be either taking theifof an unborn child which would sometimes require a partner in an emergency situation. request that is what i understood the narrow want to be. participating in a procedure that is endi tso what is the br? being comic in the process that takes a number life such as abtion. it is not that hard to -- >> complicit like i workn e

emergency roowhe this is going on? i am hmering -- i am handing th a water bottle? what>> this -- whms our doctors is being involved in completing and t terms of our declaration an eltive abortion. it is not that hard to see why there might be a conscious harm if you think about what is involved. >> is being involved in completed an■óoron i took that to be a conscientious objection. i think what justice jackson is asking h wt i asked before of justice barrett is if there is any bad conscious objection that appears and i am t sure i care all that much about e strict court but it appears in the declarations. >> in this instan, mpleting elective abortion means removing an embryo, fetus --

drfrcis talks about being required toerform a d&c. >> whether or not there is any live tissue. >> yes, your honor. i woulyou to paragraph 115. they also describe the complicity of harm from being elected -- invold elective abortion. these doctormu agree about a woman's uterus of aet. in cases like little sisters of the poor. >> it is my undetanding at sometime completion doesn't involve surgical intervention. do you have a sense of h o m g e

ain to the person having the emergency procedure. my understanding with so these chemical aborti scenarios is the completion occurs by describing additional medica ■écould it be done by another ysicianthat the dose has been se 2016. i think all the way back to 2001. it has been approd since 2016. the best mbe we have are so consistent with that. thateansi encourage you to lookr a five and this explains and ju- i'm still working on h my circumstances or how often it would be your clients actually

have to complete the procedure in the w y are describing. >> the doctors talk about doing this at ledozen times. removing embryos, fetuses. if you think about 3.1% at 10 weeks -- this has only gone■nza. the in person visitasoth necessary and minimally burdso -- minimally burdenso. these sorts of situations occur less frequenan. >> thank you. >> i am sure you heard the answers of the solicitor gener and counselor for danco wh respect to this act. i would like you to comment on their answers.

we don't think there is any case in this court that empowers the fda to ignore hefederal respectt revant here. ays drugs should notugth mail or through common carriers. so we think the plaintext is very clear. >> when did you first raise the comstock a? >> i think iwafirst raised in district court. we think exhaustionnot apply for two reasons. first it would be legallyutile . .this is a whole another kettle of fish. if you look at section 704, exhaustion is only required in two inans. this issistent.the lower court n

opio. there is nisften r agency will that stays the precedg. >> pi ask about the traceability of it all? i want you to tell me if you agree wi this undeta beyond prir injury you are part -- whatever inry you are trying to pve you have to shift that injury is to the 2016 and 2021 fda actions that you ar challenging and of course that means showing that these incidents you are talking about in the emergency room are caused byhaver incremental increase and risk there is as a result. i guess my first question is do you that statement? what do you need to show?

and y do, how do you satisfy that? why do you satisfy that? twe we believe that we need to show the 2016 and 2020 one action increase the risk of harm. >> iue we are saying you have to link whatever and for your membersavseri. do you agree with that? >> we do and we agree with that for a couple oreons. we are not in to cnition. you look at the 2021 action within traceability status is as j 845 -- without that in person visit, er and other medical

question might be some diste between the two of you about how big the increase -- increased risk is. how do you connect that risk to particular actions that your members to particular injuries tt ur members have undergone or wi uergo? >>heriginal risk. think the declarations ar really quickly on this. if you look at dr. francis's declaration. she thought e w an increase in emergency visits dr. johnson, dr. scott said the same thing. it is en consistent with fda numbers. in02 theaid the emperor visit was necessary to preserve women's health because the impression visit is the best opportunity to examine things like -- things to obser

pregnancy and age of consent. because theenal said that initial impression visit that had no requirement of an ultrasou oany effort heartbeat t would not necessarily give inaccurate read on gestati age. so i would not necessarily be eliminated? >> i think the fda's undad shs that race didn't go up. if you look athe 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 reatedwhat is alla couple of screening question i do think that is nearly as goods in-person exam. quest let's sayju carve out ande this explain to me what additional costs you might have incurred or what your resources had diverted in a way that ulset aside havens. >> putting oe this and present -- one citizen petition, it wasle the respondent organization ndted studs e id data.

it included going to tairs data. course wld do one of them at roa five. sorry roa 70. those are pretty comprehensive uds. quest at the end of the tigation or were they to the end of? >> to accurately assess the harm fromboion drug getting absolutely separate from the negation. that is the only wayn which anyone canaise a concern to thfd these proceedings go on behind closed doors. the first time is a citizens prediction. >> what difference ifny do court of the opinions of the expert agency concerning the safety efficacy of drugs? >> under this cot's administrative procedure, a peer

review is t toothless. instea ithis case, we are not asking thacourt second-guess the agency at all t ther look at what the fbi sa. ■>it did so based on their data. >> gss i don't understand how that second-guessing the agency. are saying the court can look at studies. maybe different studies. ybe the same studies. and critique the cclusions about them. what difference do we owe them at all with respect their assessment that these studies establish what i is they say they do about safety and efficacy >> and think that is inaccurate to portray. the reon being is we are

looking at what fta said. veo have adequate tests. >> did the lower court's go beyond that? representatis rethey have sinced removed. they are obviously looking a not just what the fda was looking at. are you asking us to just look at the fda and nothing else? >> that claim is not even before this cou. but with respect to the two clai before the court, the 2015 a 21,e the f is arbitrary. what the fda said is we are going to lk at individual studies and even the we say they are interrelated, we are going to take ottions away. that is arbitrary.

thank you. nk you counsel. on the associa standing, get the impending injury?ne to what's wanting to look at is whether that harm has materializedn the past and how often. there is no guarantee there wil be a future injury but what is tling is that respondents don't have a specific example of any doctor ever having to vie this cinthis is for the decs that never specifically say here is how the care is provided. the fact that they don't have doctor willing to submit that i think demonstrates the past time as it happened and the reason that happeneis becauspeculative. erare 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 challengan federal policy eyislike. havens rltcould not possibly say that. he does at the out bance. on remedy, justice courses, justice jackson, you plan out thstking anomaly here of the nationwide nurof this remedy. mayba re tailored remedy to the party. the problem here is they sued the fda. e fda has nothing too it -- witf protection. that is all happening far downstream. and the only way to ove a therefore was to grant this kinof nationwide release

that is so far revefrom the regulatory authorities that it is ultimately requime all women everywhere to cng for this drug. i think it is wth stepping about the profound mismatch between that inju a the remedy of the response obtained. they said the fear that ther might be some emergency room doctors who may be presented withncdibly rare applications and the doctor may have to prid tatnt -- we don't think that harm has materialized but with the court date isf that restricts access for every single woman in is countryndhat causes profound harm. jo]rmhe agency. it harms the part of it -- it harms the pharmaceutical industry saying that this would be -- destabilize the system for

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