will get through this together. thank you. >> good morning again. paul wiedefeld, secretary of transportation. a few updates since our meeting this morning. the crew that was out there working was basically repairing potholes, so you understand that had nothing to do with a structural issue at all with the facility. at this time, one person has been rescued. and so far, and our efforts continue in terms of that. engineers are on site right now determining both the structural issues, obviously the debris field and we'll start to work that, but we'll work hand and hand with the ntsb before we take any further action in that area. with that, i do want to introduce the fbi for a few comments as well. >> hello. my name is bill delvano, the

special agent in charge of the baltimore field office. first and foremost, i want to say that our hearts go out to everyone that is impacted by this tragedy. especially the victims and their families. on behalf of the fbi, i would like to say that we are with you, we are with baltimore, and we're with the partners every step of the way. the fbi, when very first looking at and assessing this matter from an investigative standpoint, i want to be clear that there is no specific or credible information to suggest that there are ties to terrorism in this incident. the fbi has been part of this response from the beginning. we came within one hour to the command post, and quickly latched up with our very strong partners, all along the way.

we will bring whatever resources that the fbi has to bear. we have already brought our crisis response, our victim services, and just recently our underwater search evidence recovery teams are on site. and we will continue to provide all those resources as long as it takes. and as the investigation goes on, we will take it to its logical conclusion along with our partners. to the people of baltimore, to the public, i ask you to be patient as we go through this and as information becomes available to us. and lastly, i want to say thank you, thank you to our partners, thank you to everyone who in the fbi and counts on the fbi, we will always bring what we need to the people of baltimore and we are with you. next i'd like to introduce the coast guard.

>> good morning. the coast guard is still actively searching at this time. we are using response boat crews from two of our local coast guard stations, one of our helo crews and also one of our cutter crews on one of our 87 foot patrol boats. we will continue to work with our local, state and fell partners during this tragedy. thank you. >> governor, as far as you are aware, was the collapse of that bridge -- as that ship hit that part of the bridge? >> we're still in the process of investigating what happened. so we don't have any further details whether or not it was inevitable or not. >> but no structural issue with the bridge. >> the bridge was fully up to code. we have no further information about what happened during that

time. >> is all shipping in and out of the port now stopped completely and do you have any estimate very early on as to how long it will be before shipping can be resumed to the port of baltimore? >> we don't have any estimates on timeline because right now our exclusive focus is on saving lives. ur exclusive focus is on search and rescue. >> could you give us a better sense for the number, we heard i know mr. wiedefeld said one rescued, but earlier we heard that two had been rescued. can you tell us the total numbers we're talking about that may be -- that you're searching for and how many have been rescued? >> well -- >> there are eight individuals, six are being searched for right now. one is at -- was taken to the hospital. and one is not in the hospital that we're speaking to. >> so six unaccounted for? >> yes. >> and does that involve individuals that may have been in vehicles that are in the water? >> we believe it is the

construction crew. >> so we don't think there is anyone in vehicles in the water? >> no, we do not believe so. >> we'll take questions right here. >> governor, two questions. quickly, how quickly did you find out about what happened here and what was your reaction when you heard the scale of what occurred today? >> it was -- i think it was probably within minutes of everything, less than an hour, when i know that my phone first rang. and, you know, first when the mayor of baltimore and our chief of staff. and it was -- we know the key bridge. i've ridden over the key bridge countless times, so many of us know the key bridge because it is our normal commute. this is a place that is a normal commute route for over 30,000 marylanders every single day. and so to hear the words that the key bridge has collapsed, it's shocking.

and heart breaking. and immediately our -- the first thought and first idea you go back to what happened to the people, what was the impact on human life. but for every single one of us who are marylanders, the words that the key bridge is gone, it still shakes us because for over -- 47 years, that's all we have known. and so this is -- this is not just unprecedented from what we're seeing and what we're looking at today. it is heart breaking. >> governor, can you confirm that the crew on the ship alerted authorities that it had lost propulsion? >> we can confirm that the crew notified authorities of a power issue, yes. >> that they had lost power on the ship? >> yes. >> was there any --

[ inaudible ] >> excuse me. total of eight. one rescued in the hospital. one not in the hospital. we have communicated with that person. and then six that we are searching for. >> and all the construction workers were -- [ inaudible ] >> the -- yes, they were all related to the construction program, yes. >> we heard that multiple vehicles went into the water. any word on how many vehicles went into the water and the condition of those people that were in the vehicles? >> not at this time. >> was there any way to shut down the bridge? was there enough time for that distress call to trigger something like that? >> the thing that we know is that, you know, even as the boat was coming in, you know, we had a ship that was coming in at

eight knots, coming in at a very rapid speed. we do know that the investigation is currently going on. but i have to say i'm thankful for the folks who once the warning came up, and once notification came up, that there was a may day who literally by being able to stop cars from coming over the bridge, these people are heroes. they saved lives last night. >> the focus is on rescue now? but looking forward, is there any vision for how long it could possibly take to move the wreckage, to rebuild, how it could possibly be done? can you look ahead to the future at all at this point? >> this is going to be a long-term build. it is going to be a build that is going to require every facet and every aspect of our society. it is something that i can tell you we are going to get this done. we are going to make sure that this is not just -- not just

rebuilt, but that we are going to rebuild in a way that remembers the people who this tragedy has impacted and also do it in a way that honors the community that it serves, but right now i could not give you any form of estimate on timing or cost right now. my and all of our exclusive focus is we're just trying to save lives. >> can the mayor talk about the state of emergency locally, please? >> yes, thank you. listen, we know the governor issued a state of emergency, but we at the local level felt the need to do that too because there may be some things that we have to encumber with fire department and other agencies that will be able to pull down support for as we all work together, again, as we are focused right now on saving lives and working through this unspeakable tragedy. >> in the interim, i know there is obviously the focus is on the rescue and the recovery. but this is such an important thorough fare here in baltimore for drivers, people trying to get around, how are they going to be able to manage while that

is also going on? >> yeah, so we also already have been in touch with people about alternative routes and ways people can navigate now that this tragedy has happened. i don't know if, secretary -- >> a sense of scale, roughly about 35,000 people in a day use that facility. about double that use the harbor tunnel and double that again use the fort mchenry tunnel. so basically we have two other options. we'll make sure that we have as much personnel out there to deal with any incidents because as you know that can cause backups very quickly and we will basically put a lot of communication on different alternatives. we're looking at transit alternatives as well. >> what role will the legislature play in this response? are there any policies, any funds that will be freed up? >> we're -- we have our senate president here, we have members of legislature here. the legislature is going to have a role in all of this as well our local elected officials, as

will state officials, as will the federal government. everybody will have a role in terms of how we think about the rebuild. >> how long do you expect shipping to be closed down through the port? do you have any estimate in terms of the port here? >> we don't at this point. we don't at this point. >> no ships going in or out at this point? >> good morning. i'm jose diaz-balart. we have been listening to a news conference out of baltimore this morning where active search and rescue efforts are under way for at least seven people following the collapse of the francis scott key bridge after a container ship crashed into the bridge overnight. i want to bring in nbc's correspondent ryan nobles, he's in baltimore, as is nbc news investigative correspondent tom winter. what do we know about what happened just a little over 1:30 in the morning? >> reporter: well, jose, we learned a lot from this press conference that just took place. a lot of questions that we had this morning that are finally getting answers. and the first being how many

victims we think are a part of this terrible accident. and the first responders and public officials telling us that they believe that there were eight victims total. two of which have already been rescued. one of them taken to the hospital. one of them not injured, not needing treatment. but the other six still unaccounted for. they believe those six were part of a construction crew that were working on this bridge at the time of the collapse. miraculously, it appears at this point at least from what we garnered from this press conference that officials do not believe that there were cars on the bridge at the time. at least they don't believe there was a need to rescue anyone from a car that was on the bridge at that time. and that probably has something to do with the fact that it happened at 1:30 in the morning. and to back track into that, to explain to our viewers, that may be tuning in for the first time as to what happened, it was a massive container ship, a thousand feet long, that we're now learning appeared to have lost power, smashed into the

base of the francis scott key bridge and collapsed leading to this big accident that happened here today. jose? >> and, tom, you've been looking into details of the crash and the boat. what is the latest on the investigation? >> more details are coming in to view here, jose, as we review the video, some of which you just saw. take a look back at it, for the moment it first enters the frame, as well as the data traffic on board that vessel there is about -- think of it like a large shoe box size transmitter, that puts out the vessel's speed, longitude, latitude, that can be helpful for other vessels. the vessel appears to be headed right through the channel where it needs to be in the river there before it deviates to the right and appears to hit the bridge or moments before it hits the bridge at approximately 7.6 knots. we know there were two instances starting at 1:24:33, according

to the video where the lights go out on the vessel. approximately a minute later 1:25:32, the lights come back on, visible exhaust is coming from the smokestack, the rear of the ship. and then a minute later, 1:26:36, some lights appear to go out and at 1:27:11 they come back on, within a minute or two of that, jose, this ends up happening and the bridge, the container ship goes into the bridge. no manufacturer here, very reliable one, known engine manufacturer here, a very reliable here, this seems to be a catastrophic failure of the propulsion system. a lot more questions to be answered in the coming days as far as exactly what happened. >> ryan nobles and tom winter, thank you. we are also watching another breaking news story this morning at the supreme court where right now justices are hearing a case on the abortion pill mifepristone. these arguments going on right now. the justices are questioning the

u.s. solicitor general. let's go right in and listen. >> -- somebody be able to challenge that in court? who in your view? who would have standing to bring that suit? >> i think that with respect to these regulatory changes it is hard to identify anyone who would have standing to sue, but the court has said time and again that the fact that no one would have standing doesn't provide a basis to depart from article 3 principles. richardson, valley ford, clapper, it doesn't mean that the court should dispense with the indispensable requirements of article 3. >> okay. i understand that. article 3 is important. so your argument is that it doesn't matter if fda flagrantly violated the law, didn't do what it should have done, endangered the health of women, it is just too bad, nobody can sue in court? >> certainly we think that -- >> there is no remedy the american people have no remedy for that? >> well, i think that it would be wrong to suggest that if fda had made a mistake and a drug were actually producing safety consequences that there would be

nothing to be done. i don't think that these respondents could invoke article 3 jurisdiction to have the courts step in. but fda takes very seriously its responsibility to ensure the safety of drugs. it conducts ongoing surveillance and can make adjustments to the regulatory regime of safety situations emerge. the drug sponsors themselves remain responsible at all times. we have a tort system in this country. and that can help ensure that if there are safety problems that come to pass, the sponsors will take action and reaction to that. so if the premise here is that unsafe drugs could somehow remain on the market, i think that's incorrect. >> so your argument here is, and as i said, i have great respect for article 3, we all do. we have to comply with it. but your argument here is that even if the fda acted unlawfully, nobody can challenge that in court? that's basically the argument you made last week, right, in the murphy case, we shouldn't get to the question whether the white house and others violated the right to freedom of speech, we should just say, well, these

plaintiffs can't bring suit, right? >> we are looking at the specific respondents in this case and their theories of standing. we don't think they come within 100 miles of the kind of circumstances this court has previously identified of nonspeculative harm that can create the kind of injury for forward-looking relief. >> i'm assuming that if there were an -- if this had been unsafe in a grossly visible way, you know, 40% more increase hospitalizations, that some doctor who was prescribing it would have challenged the lack of an in person. >> no doctor is required, justice sotomayor, to dispense -- >> no, but if a doctor who wants to, just like a doctor who wants to do abortion, we have said if there is regulations that stop them from doing it, i guess that doctor would come in and say, this is unsafe, i can't -- by not having people visit me, beforehand, we're not warning

them et cetera, et cetera. >> certainly i think if those kinds of distinct safety concerns emerge there would be steps taken at the agency level. there is nothing like that here. there is no evidence to suggest it. >> i'm pondering a hypothetical. >> i want to be clear that fda's regulations here don't require doctors to not grant an in person visit if they think that is the best way to provide a standard of care here. they're not directly required to dispense mifepristone through any particular arrangement. >> counsel, can i ask you a question about the conscience injury. i want to be clear, the federal government's position is that their doctor would have conscience objections, and if a circuit criticized the government's inconsistent positions, but it is your

position that such doctors would have recourse to the conscience protections of federal law? >> yes, absolutely. and let me be clear about this. because i think that the 5th circuit did misunderstand our argument. the federal government has never taken the position that mtala would override a doctor's conscience objective. we disclaimed that understanding and made clear that we understand that conscience protections to continue to apply and shield the doctor who doesn't want to provide care in violation of those protections. >> would that be true in a healthcare desert as well? >> yes, we don't think it would override conscience protctions for an individual doctor and hospitals have all kinds of plans in place to address these kinds of contingencies. staffing plans, i understand as a matter of best practices they often ask for doctors to articulate their conscience objections in advance. they have cross staffing agreements with other hospitals and in the government's

experience, this is almost four decades of experience, we are not aware of any situation where there has been that kind of direct conflict between mtala and conscience protection. >> this is about the association standing. its own standing, its own right, based on injury to one of its members, the injuries that the association is arguing sound in the havens realty associational standing, there are kinds of allegations we see by immigration advocacy groups, division of resources, increased expenses, that result from the complications of having to address and explain the new changes. and i'm not talking about the expenses of filing a petition. that's not what i'm talking about. let's just talk about the division of resources. can you distinguish that from haves realty. >> what haven said is that in that case the organization had come forward with direct and

concrete demonstrable injury to itself. and they had a contract to provide low income housing and the racial steering practices directly interfered with that, made it more difficult for the organization to carry out its contractible obligations. havens itself said it was not blessing a theory of standing that would allow an organization to assert a setback to its abstract social interests. so i think that reflects the court trying to distinguish between more concrete direct demonstrable harms on the one hand and that kind of abstract setback on the other hand. and i recognize and your question touches on it that some lower courts in particular have seem to read havens to endorse far broader theories of standing including in the immigration context, the government has been routinely resisting standing because we think that that would essentially mean that any advocacy organization could say it opposes what the federal government is doing and therefore has to devote resources to at opposition.

we would welcome an eventual clarification from the court on organizational standing, but here i think that the organization's assertion of injury falls in the bucket of the abstract setback and doesn't come close to the kind of demonstrable harm that was at issue in havens. >> i'm sorry. >> i'm done. >> that's a helpful clarification. i would like a similar clarification. thank you. with respect to individuals. i've heard and listened to your argument and read the briefs and i think i understand it. but how does it fit in your mind with offended observers standing under the establishment clause or some injuries about i access a park and i like to look at it in a certain way and those kinds of injuries that the court has sometimes recognized and other times has cast doubt on. >> so it is true, i think that there are different strands of this court's precedent. and i would put the establishment clause precedent

and first amendment precedent generally in its own bucket because the court has sometimes recognized different theories of the first amendment context. >> let me push back on that a little bit. standing is standing. it is article 3, right, that we're interpreting here. and so i think it has got -- we have to find some way to stitch it all together. >> i think the way to approach this is to if you're going to recognize some kind of offense or distress type of injury, that to recognize -- >> should we -- this is a preliminary -- >> no, i represent the government, so i think that that kind of theory of injury would likely go far too much in the direction of allowing article 3 courts to weigh in based on generalized grievances. but i guess what i would say to distinguish the cases for the court has sometimes found that type of injury cognizable, here our argument is that the fda's actions in approving mifepristone in 2016 and 2021 if you're look at that, an incremental change, is so far

upstream of the downstream assertion of harm or distress that the respondents are asserting that there is just as a matter of law an attenuated link here that cannot suffice for article 3 jurisdiction. >> thank you. >> thank you, counsel. justice thomas, anything further? justice alito? >> when you say that the 5th circuit didn't give any reason to think that the three changes made in 2016 would be more dangerous in combination than they were individually, but isn't that obvious that three things that may be innocuous or not excessively dangerous, if engaged in by themselves, may become very dangerous when they're all done together. why shouldn't the fda have addressed that? >> i think the only way that that would be true would be if the three changes are interconnected and mutually reinforcing, guarding against the same kind of safety risk. so, i agree that if there were

reason to think that the reason why mifepristone is safe up to ten weeks gestation is because it is being prescribed by doctors instead of nurse practitioners, for example, then those changes would be interconnected because one change would effectively by the safety net for another. there was nothing like that in this record. it demonstrated the changes, an exhaustive examination, were safe, not because there were other different safe guards in place to guard against risks, but rather because if you go up to ten weeks of gestation there is no observable increase in serious adverse events, no matter who is prescribing. in the absence of that kind of effect, it cited multiple studies that combined multiple changes because the standard of care evolved over the 15 years mifepristone had been approved and many changes were already being deployed together safely. >> shouldn't the fda have at least considered the application

of 18 u.s. c 1461? >> i think that the com stack provisions don't fall within fda's lane. fda under the fdca can only maintain restrictions under the rems program if it is necessary to ensure safe use. in 2021, what fda determined is you don't need in person dispensing for safe use, so the fdca did not independently require that rems restriction and couldn't be imposed once fda made that determination. that doesn't affect other sources of law. fda was not affirmatively approving, mailing in violation ofinterpreted it that way. but at the very least i don't think it was the fda's responsibility to consider that nor could they consider it under the statute. >> it didn't say anything about it. this is a prominent provision. not some obscure subsection of complicated obscure law. they knew about it. everybody in this field knew about it.

shouldn't they have at least addressed it? you have answers to the arguments made on the other side. shouldn't the fda have at least said we have considered those and provide some kind of an explanation? >> let me give two responses. one is that i don't think it would have even been permissible for fda to consider maintaining this restriction because of comstock. if you look at the relevant statutory section here, 355-1 g 4. this is reproduced at page 6a of the appendix to our brief, it is clear the only thing fda can take into account for restrictions are safety and efficacy concerns in deciding whether to maintain a rems program. the other thing i would say is that the agency did have a memorandum on comstock at ja 535, that was the advice that fda received conveying the interpretation of comstock. >> got the advice, but didn't refer to that, did it? >> in the 2021 decision, no. but the rems was modified in 2023 and this was part of the administrative record for that.

>> okay. one last question. the plaintiffs say that the studies that the fda relied on for the 2021 amendment say that mail order mifepristone suggests more frequent trips to the emergency room. now, this is what i see as the fda's response to that. quote, though the literature suggests there may be more frequent emergency room care visits related to the use of mifepristone when dispensed by mail, from the clinic there are no apparent increases in other serious adverse events related to mifepristone use. does that really count as a reasoned explanation to the suggestion that the data shows there are going to be more emergency room visits? this is -- the increase in emergency room visits is just of no consequence? it doesn't even merit some comment? >> that is a reasoned explanation. what fda was observing, is though it acknowledged the fact that some of the studies reported additional emergency

room visits, that didn't equate to additional serious adverse events. half of the women that went to the emergency room didn't get any treatment at all. many women might go because they're experiencing heavy bleeding, which mimics a miscarriage and they might need to know if they're having a complication. so it doesn't call into question the safety determinations regarding the drug. at the end of the day, fda carefully parsed the studies and it made specific determinations about the results to be gleaned with respect to safety and efficacy and i think it falls well within the zone of reasonableness under arbitrary and capricious review. >> thank you. >> on the last question, that did trouble me, but the reality is even if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the fda, correct?

>> that's right. and fda acknowledged it. so it is not like it overlooked this aspect of the studies. i also want to emphasize that the studies were far from the only evidence fda consulted. at the time it acted in 2021, it had real world experience during the covid-19 pandemic, a period of time when the in person dispensing requirement was not enforced, and fda started by looking at as a comparative analysis the two periods of time when you had in person dispensing and you didn't. and saw there was no relevant increase in serious adverse events or difference between the two time frames. that further supported the safety. >> the problem with all drugs is there are complications and virtually in all of them. >> yes. >> and at what level the cost benefit analysis tells you to stop prescribing something is a very difficult question, isn't it? >> and that's a question that congress has entrusted to fda. >> but putting that aside, here, whatever the statistical increase was, fda determined under the rems standard it

wasn't sufficient to create a risk that counterbalanced the need for access, correct? >> correct. because fda is instructed to take into account burdens on the healthcare delivery systems as well and it looked at a variety of sorts of data to conclude on balance the burdens were suggested that it was not necessary to keep this restriction in place to ensure safe use. >> thank you. >> justice kagan? >> if i could take you back to the discussion you were having with justice barrett about the conscience objection, and just ask you, i'm sure you read the declarations carefully and i'm sure miss holly will have things to say about this too, but as you read those declarations, what is the conscience objection? what are the doctors objecting to exactly? >> i think the declarations are specific on this point. there are only seven doctors who regularly practice and submitted evidence and the declarations are short. this is ja 150 to 200.

i encourage reading them because there are only two doctors out of the seven who even provide any information about their specific conscience objections. >> those two are who? >> dr. scott and dr. francis. the relevant language for -- >> the other five don't refer to conscience objections. >> or provide any specific detail about exactly what care would violate their conscience. dr. francis at ja 155, dr. scott ja 167, both describe the injury in the same terms, they object to ending the life of a human being in the womb and fear they might have to complete an abortion for a woman who has an ongoing pregnancy. >> as you understand those declarations, they do not object to providing whatever care is necessary to a person who may have complications from taking mifepristone. in other words, for example, suppose somebody has bled significantly and needs a transfusion, or, you know, any of a number of other things that might happen. as you understand the declarations, there is not an

objection to that? >> i think the fairest reading of the declarations is they are not objecting to that. i acknowledge there is a broader conscience injury at play here and there may be other doctors who have a broader concern about providing any care, even if that broader conscience injury had been in this declaration, we think still as a matter of law they could not demonstrate they had a nonspeculative injury because of the upstream, things that would have to happen, going to specific doctors, but also the fact that the federal conscience protections are specifically designed to deal with this issue, and they would cover the range of conscience objections that exist in this context. >> right there are obviously conscience objects of all kinds. i was asking about the particular declarations of these particular members of the organization. >> i think on these declarations, we have not asserted a broader injury. if they could come forward with other doctors or try to adjust their declarations in some way still that would not suffice. >> can i ask a quick question

about the merits. you opened your brief with a somewhat arresting statement, but it starts with to government's knowledge, and this was written a few months ago, and since then i'm sure that you had lots of time to thing about this case and to get all background information on it, i'll read you this sentence and ask you whether it is still true to the government's knowledge. to the government's knowledge, this case marks the first time and i'm going to say is it the first time, the only time, any court has restricted access to an fda approved drug by second guessing fda's expert judgment about the conditions required to assure that drug's safe use. is it still the only time? >> that is still to our knowledge the only time a court has done that. we have seen a disturbing trend of courts sometimes also overriding fda's judgment to try to grant greater access to drugs when that overrides fda's expert judgment to ensure safe use and no matter what direction you

come at it from, we on behalf of fda think courts have no business in making those judgments in the absence of the kind of arbitrary and capricious error that could satisfy the apa. >> thank you. >> justice gorsuch, justice kavanaugh. >> just to confirm on the standing issue, under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct? >> yes, we think that federal conscience protections provide broad coverage here, just to be super precise, there are some triggering requirements of receiving federal funding and so forth. we cited the relevant provisions at page 5 of our reply brief. the church amendments have the most comprehensive protection here and we think those amendments guard against the injury that are asserted. >> justice barrett. >> would that be true to say they regard any participation, even transfusions or dncs after

the abortion is otherwise complete because tissue needs to be removed? >> yes, i think that would be true. so, the most relevant church amendment provision is 42 u.s. c 300 a-7d and the language says that doctors shall not be required to perform or assist in any part of the healthcare program that would violate the doctor's religious or moral beliefs, tied to the nature of the doctor's belief rather than particular procedures. >> one other question and this goes to the merits. as i understand it, the serious adverse consequences that have to be reported or that fda considers risks are death in transfusion, but not, say -- it seems to me, i think the data bears this out, that the elimination of the in person dispensing requirement or the in person visit at the outset would lead to mistakes in gestational aging, which could increase the need for a dnc or the amount of

bleeding, et cetera. but that does not count, correct, as an adverse event? >> so, i want to be careful because there is a list of serious adverse events and i'm not sure i have all of them down to recite them to you. but they're in the record. the premise of the question is wrong, the change to in person dispensing would necessarily increase the risk of those events. that was not reflected in the data that fda consulted. fda explained that even in person you're not necessarily getting an ultrasound, that's never been required, and, so the relevant question might be is your provider going to ask you a series of screening questions like when was your last menstrual period in person or via telemedicine and there is no evident reason why that difference would lead to different safety outcomes. >> there was not a -- i thought there was a small percentage increase in the tracking? i'm wrong about that? which i may well be. >> i think that with respect to

the er visits, there was evidence there was increased er visits, though as i explained that wasn't actually correlated with an increase in serious adverse events. they varied a little bit, but fda's ultimate conclusion was that mifepristone could safely be dispensed without in person visits. it had evidence to support that conclusion in 2021 and there has been no contrary evidence introduced. >> so there was no requirement of either an ultrasound or detecting fetal heart beat or anything like that, even before the doctor could just go based on the woman's recounting when her last menstrual period was? >> that's right. and that dates back to the initial approval of the drug in 2000. it has never been a required condition of use to have a ultrasound. it is necessary for providers to be able to diagnose ectopic pregnancy and date gestational age, that remains true under the rems now. they have to deploy whatever mechanisms they believe would

accurately allow them to counterindications for the use of miss priss tone. mifepristone. pristone >> under the pre2021 rems was it possible to detect an ectopic pregnancy without an ultrasound unless the woman was presenting with pain? >> there are a set of questions deployed, do you have unilateral pelvic pain, did you become pregnant while you had an iud in, are you experiencing unusual bleeding, if the woman had a prior ectopic pregnancy and imaging may be necessary. but that remains true under the 2021 rems as well. the prescriber has to be confident it excluded those kinds of conditions before prescribing this drug. the standard of care around the world, most medication abortion occurs without an ultrasound. >> justice jackson? >> good morning.

i'm worried there is a significant mismatch in this case between the claimed injury and the remedy that is being sought. and that that might or should matter for standing purposes. i don't know that our doctrines capture this, but i guess i see it that the injuries that the respondents allege as you articulated them are conscience injury, they are being forced to participate in a medical procedure that they object to. and so the obvious common sense remedy would be to provide them with an exemption that they don't have to participate in this procedure and you say, you said here several times, that federal law already gives them that. i guess what they're asking for in this lawsuit is more than that. they're saying because we object to having -- to be forced to participate in this procedure, we're seeking an order preventing anyone from having

access to these drugs at all. and i guess i'm just trying to understand how they could possibly be entitled to that, given the injury they have alleged? >> i agree, justice jackson. and i do think it is relevant to standing. there is a profound mismatch here between the claimed injury and the remedy they were seeking, and you can almost think of this as a type of zone of interest kind of analysis. if the doctors have a conscience injury, there is a specific statute designed to deal with it, to specifically tailor made guard against the risk of that injury occurring. instead, they're reaching out and seeking to invoke rights under a different statute, the fdca, that doesn't regulate them at all, that doesn't make them do or not do anything and the relief that they're seeking would dramatically alter the approved conditions of use for mifepristone and affect women all around the nation because of this conscience injury that is already directly addressed by other -- >> if it wasn't addressed, we would see this lawsuit and the remedy would be to exempt them, right? >> yes, i think that one of the

hard things about trying to tailor relief here is they're asserting such a diffuse theory of injury that it seems like the only option that runs counter to party specific relief. it shows there is something wrong with the theory of injury in the first place because it is so attenuated and because they claim they would need so much relief all over the country. >> let me ask you another question. in addition to the challenges that we have here, the respondents below challenged the fda's initial decision to approve mifepristone in the year 2000. of course, that occurred very long time ago, the 5th circuit found that challenge wasn't timely because of the statute of limitations as you're aware in the context of another case we heard this term, the court is currently considering the statute of limitations issues. have you thought about how a ruling from this court on the statute of limitations, in

either direction, might impact what happens in these kinds of cases with these kinds of challenges? >> yes, i think that it just reflects the stakes of the corner post case. and provides a vivid example of the way that it might be possible if this court were to approve the request for a broader theory of the statute of limitations this that case, the way it could open the door to plaintiffs coming in and saying i only became a doctor later or only started working in an emergency room later and would try to unsettle long-standing agency actions that maybe occurred decades previously. i understand the corner post petitioner to have suggested there would be equitable defenses the government could raise in those kind of cases. we would want to raise that kind of defense with respect to mifepristone, which is proven to be safe and effective over decades of use. thank you. >> thank you, counsel.

>> mr. chief justice, and may it please the court, in 2016 and 2021, fda made certain changes to the labeling and use restrictions for danco's drug. the decision below stops danco from selling it in line with the scientific judgment based on a highly attenuated claim that an unknown doctor could be called some day to an unknown emergency room after a series of decisions by third parties. no facts link that potential future encounter to a specific change fda made in 2016 or 2021. respondents view of the food, drug and cosmetic act is so inflexible it would up end not just mifeprix. reversal is required for two reasons. first, article 3 standing is not an academic exercise in what is conceivable. respondents lack standing under every prong of the analysis. second, on the merits, fda

exhaustively considered the evidence and reasonably explained its conclusions, which is what it is required to do. i welcome the court's questions. >> the government -- the solicitor general points out would not be susceptible to a comstock act problem. but in your case, you would be. so how do you respond to an argument that mailing your product and advertising it would violate the comstock act? >> justice thomas, we agree very much with the government that fda's charge under the food, drug and cosmetic act is limited to looking at safety and efficacy considerations. that's true for new drug approvals, also true for rems modifications. fda routinely approves drugs whose manufacturer and distribution is restricted by other laws, like the controlled

substances act, environmental laws, customs laws and so on. we think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that congress has assigned to other agencies. on the merits, this issue is not presented -- not ruled on below. and in any event i would also point out that in 2021, fda's decision allows use of brick and mort are pharmacies in addition to mail order pharmacies. >> well, my problem is that you're private. the government, i understand the government's argument. but you're private and the statute doesn't have the sort of safe harbor that you're suggesting. and it is fairly broad, and it specifically covers drugs such as yours. >> your honor, we disagree that that's the correct

interpretation of the statute. but we think that in order to address the correct interpretation there would need to be a situation in which that issue was actually teed up. this statute has not been enforced for nearly 100 years. and i don't believe that this case presents an opportunity for this court to opine on the reach of the statute. >> counsel, i'd like to ask you the same questions i was posing to the solicitor general. our precedence clapper and susan b. anthony list talk about requiring a substantial risk that harm will occur and you argued that's not present here. how are we supposed to find the spot at which the risk becomes substantial? >> your honor, i think this court has always thought about these standing inquiries as a question of degree and you're trying to evaluate whether something is actual and imminent or whether it is conjectural and hypothetical and these terms substantial risk certainly impending which has been used

dating back to 1923 get at where a claim falls in this spectrum. >> right. we toss around a lot of adjectives, but i'm trying as a practical matter how do you figure out? what percentage of adverse consequences would be enough? what percentage of emergency room visits would be enough? >> i think the way clapper got at that question and you can see this in footnote 5 of the opinion is to think about whether there is an attenuated chain of contingencies that have to happen. in situations where there is this kind of attenuated chain of circumstances involving third party decisions that have to play out in a particular way, and here that chain is quite long, that that squarely puts a plaintiff's theory on the side of the conjectural or hypothetical and not the certainly impending injury. >> how is your company aggrieved by the challenge that is brought in this case? i gather this is your version of

mifepristone is the only product you're currently marketing, is that right? >> that's correct, justice alito. >> and the 5th circuit decision does not prohibit you from continuing to produce and sell that product, right? >> that is correct. >> all right. and so i gather your injury is that you think you're going to sell more if the restrictions that previously were in place were lifted? >> yes. >> you're going to make more money? >> the injury is that we are prevented from selling our product in line with fda's scientific judgment about the safe and efficacious use of the drug. >> and you're going to be harmed because you're going to sell more? >> i think that certainly a company's ability to market its product is a part of how it considers the regulatory scheme that governs its conduct. >> during the questioning of the solicitor general, the statement was made that no court has ever

previously second guessed the fda's judgment about access to a drug, right? and it never second guessed that. >> that's correct. >> you think the fda is infallible? >> no, your honor. we don't think that at all. we don't think that question is really teed up in any way in this case. >> has the fda ever approved a drug and then pulled it after experience showed that it had a lot of really serious adverse consequences? >> it has certainly done that. and, your honor, i think that underscores why the adverse event your honor, that underscos why the adverse events, the ability that these plaintiffs have, and even if they don't have standing, certainly if they are seeing patients presenting with adverse events, and if they are doing studies that show there's some unknown safety component the fda should acknowledge, they can take

significant steps to bring that to the agency's attention and dan go's attention. >> but don't you think they should have been reporting of the nonfatal consequences? >> it was based on more than 15 years of a well-established safety profile when that reporting was required. there's no drug on the market today that requires the kind of reporting that the plaintiffs are saying should be reimposed here. >> why would that be a bad thing? you don't want to sell a product that causes harm, and take your product relying on your tests, and wouldn't you want that? >> that data is something that we are looking for all the time. it's part of the reporting obligations for a manufacturer to be aware of any data that is

becoming available through any means. we have a 1-800 number on our website, and a 1-800 number on the labeling. one of the things i want to note, drug manufacturers are frequently subject to tort litigation, product liability suit, failure to warn suits, and deceptive advertising suits when somebody is claiming harm from a pharmaceutical manufacturer's product, and what is revolutionary about the arguments here on standing and the merits, that they attempt by individuals that do not use the product or prescribe the product, and those individuals want to prevent anybody else from using it -- >> just one more point along the same sort -- sort of along the same lines. does your company think that

what the fda has done preempts state laws that prohibit the dispensation of mifepristone? >> our position in this case has been that this is about fda scientific judgments. >> you don't want to answer that question? >> i am not prepared to speak to that today. >> could you talk a little bit

about what are the normal standards for adverse event reporting, as you understand them? why were they there and what were you subject to in the past? >> may i answer the question? what changed was not denco's reporting responsibility has been the same, but what changed from 2000 to 2016, prescribers were asked to report to dango, and in 2016, there was a reporting requirement that applied to all fda approved drugs, and there are seven that are limited to the higher adverse reporting to deaths to

mifepristone. >> anything further? justice jackson -- >> yeah, i have one quick question. you were asked if the agency is infallible, and i am wondering about the flip side, which is do you think that courts have specialized scientific knowledge with respect to pharmaceuticals and as a company that has pharmaceuticals, do you have concerns about judges parsing medical and scientific studies? >> yes, your honor, i think we have significant concerns about that, and there are two am acuss briefs that expand on why that's concerning for pharmaceutical companies that do depend on the fda's gold standard process to approve their drugs and then sell those drugs.

>> can you say a little about what they say? >> i am happy to. the reality in this court, this decision below is a good example of it. you have a district court that among other things relied on one study that was an analysis of an anonymous blog post, and another set of studies he relied on that were not in the administrative record and never would be, and they have since been retracted for lack of scientific rigor and misleading information and data, and that's precisely because judges are not experts in statistics or the methodology used in the studies for clinical trials, and that's why the fda has many hundreds of pages in the analysis of what the data showed and courts are not in a position to parse through and

second guess that. >> thank you. >> thank you, counsel. >> thank you. >> ms. holly. >> fda approved abortion by mail admitted was not adequate and that violated the apa. the lower court's decision restore long-standing and crucial protections under which millions of women use abortion drugs, and we heard a lot this morning about standing. article 3 is satisfied here because the fda relies on hospitalists to care for women harmed by abortion drugs, and 2.9 and 4.6 women will end up in the emergency room, and the fda acknowledges women are more likely to need surgical

intervention, and it's no surprise that respondents have been treated, and women have suffered tens of thousands of times. the respondent doctors forced to manage the abortion drug harm, and ruling against respondents here, article 3, neither demands nor permits this. fda's outsourcing of abortion drug harm to outsourcing doctors forces them to choose between helping women with abortion and their conscious. in 2021, it eliminated the

initial in-person visit and based on data, it says elsewhere, and these actions fall far short of what the apa acquires, and this court should affirm. i welcome the court's questions. >> counsel, you assert an injury on the part of the alliance of diverted time and resources. isn't that just the cost of litigating, of pursuing this litigation? >> i don't think so your honor, for a couple of reasons. first, what respondent doctors have done here is chosen their particular practice and structured that practice to bring life into the world, and when they are called down to the operating room to treat a woman

for abortion drug harm, and that comes along with emotional harm. one doctor talks about these being some of the most stressful work she's had to deal with, your honor. >> i understand that. i am talking about the injury of having to divert resources to litigate this? >> with respect to the organizational standing. >> the alliance? >> the best evidence is the fda's reply brief. the government resorts to the underlying briefs in the case to say there was a contract and economic harm, but this court case specifically said the fact that the nature of the harm was, quote, noneconomic, did not prevent the court from finding an injury, and they looked for two things, when there was an impairment of the mission or expenditure of resources, and both things are satisfied here. if you look at how the