>> hello. >> my name is >> bill delano on 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 >> clear that there is no specific or credible information to suggest that there are ties to terrorism in this incident they're bi has been part of this response from the beginning >> we >> came within one hour to the command post and quickly lashed up with are very strong partners all along the way. we will bring whatever resources that the fbi has to bear we've already brought our crisis response or victim services and just recently are 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 people of baltimore >> 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. >> and we will always >> bring what we need to the people of baltimore. and we are with you next 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 halo crews from an air station at atlantic city and also one of our cutter cruise on one of our 87 foot patrol we will continue to work with our local state, and federal apart. there's during this tragedy. thank you >> governor governor >> and it out of the harbor stop >> as far as the collapse of that bridge, inevitable as that bridge >> know where we're still in the process of investigating exactly what happened. so we don't have any further details about whether or not it was inevitable or not. >> no structural issue now, there were indicted. the bridge was actually fully up to code, so we have no further information about what was what happened or that the governor is there's all shipping in and out of the board now stopped completely and you having any estimate very early on as to how long it will be before shipping can resume for the portfolio? >> yeah. we don't have we don't have any estimates on timeline because right now, our exclusive focus is on saving lives. are exclusive focuses on search and rescue >> could you give us a better sense for the number because we'd heard mr. we'd have built one of the rescue, but earlier for baltimore, we heard that jupiter can you tell us the total numbers we're talking about? it maybe that you're searching for and how many have been rescued? >> well they're eight individuals six per been search for right now one is it was taken to the hospital and one is not in the hospital that we're speaking to. >> so six unaccounted for? yes, it does that involve individuals that may have been vehicles that water that we believe is a construction crew but we don't think there's anyone in vehicles. >> no, we do not believe so right here >> this question here >> governor two questions. quick. how quickly did you find out about what happened here and what was your reaction? would you heard the scale of what does the current event bridge earlier >> well hey, it was i think it was probably within minutes of everything less than an hour when i know that my phone for shrine and first from the merit baltimore also from our chief of staff >> and it was we know the key bridge i've written over the key bridge countless times so many of us know the key bridge because it is our normal community. 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 heartbreaking. and immediately are the first thought and the first idea is go back to what happened to the people where are we? 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 >> it's still shakes us because four over for 47 years, that's all we've known and so this is this is, this is not just, not just unprecedented from what we're seeing and what we're looking at today it's heartbreaking. donor. can you confirm that the crew on the ship alerting authorities that it was propelled >> we can we can confirm that the crew notified notify authorities of a power issue that they had lost power on the shut down >> total bay excuse me a total of eight rescued little hospital 1, not in hospital, but it is we have communicated with that person and then six that we are searching for yes, they were all related to the construction program? yes. >> multiple vehicles went into the water. word on how many vehicles went into the water and the condition of those people that were in the mutant, not at this time >> was there any way to shut down? the range? was there enough time for that distress calls to turn or something like that? >> now, the thing that we know is that even as the boat was coming in we had a ship that was coming in at eight knots so coming at, at, at a, at a very, 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 who once the note, 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 live lesson. they saved lives last night >> focuses on rescue. now looking forward, is there vision for how long it they take possibly be done. you look into the future. >> this is going to be a long-term built it's going to be a bill that's going to require every facet and every aspect of our society. it is something that i can tell you. we're 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 is impacted, and also do it in a way that honors the community that it serves. but but right now, i could not give you any form investment on timing or cost right now. my and all of our exclusive focus is we're just trying to save lives >> state of emergency yes. >> thank you listen, we know the governor issued a state of emergency, but we have the local level. i 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'll focused right now on saving lives and works in through this unspeakable tragedy >> in the interim, i know that there's obviously the focus is on the rescue and recovery but this is such an important thoroughfare here all the more for drivers, people trying to get around, how are they going to hold a man while that is also going on? >> yeah. so we've also already been in touch. people by alternative route and ways people can navigate now, this tragedy has happened. i don't know sector if you want to suggest just give you a sense of scale, roughly about 35,000 people, you know, they use that facility about double that use the harvard tonal and double that again, use the fort mchenry tunnel so basically we don't have at those two other options. we will make sure that we have as much personnel out there to deal with any incidents. because as you know, that can cause the backups very quickly and we will basically put a lot of communications or david alternatives. we're also looking at transit alternatives as well. >> in this response i'll go all the legislature plane is respond. are there any policies and going to be freed up? it's one so yeah we are. in fact, you know, we have our senate president here. we have members of legislature here. the legislature is going to have a role in all this as will our local elected officials as well. state officials, as will the federal government everybody is going to have a role in terms of how we think about the rebuilt >> respect shipping to be closed down are the ports you have any estimate in terms of the work here, we don't at this point, we don't just want are going we're out at this time, correct? yeah, we are. but when we do, we don't have it. we don't have an estimated timeline as of yet our focus really is right now and just make sure we're saving are they able to get out and i'm sorry currently, dr. or they are now >> you don't want the one that's that's catch it under the being guided out by firstly and secondly, did you just say that it issued a may day in enough time that you were able to stop all traffic entering both sides so that the only the casualties we expect. another workers on the bridge? >> yes, ma'am. so the investigation is still going on, so we're going to have all the full details. and also all the full details about the timeline and the tiktok that took place. but we're thankful that between the mayday and collapse that we had officials who were able to to begin to stop the flow of traffic so more cars would not up on the bridge. and i can just sum on the bridge were there during the collapse >> yeah. well, there's someone that bridge there have been reports that have been sonar that have detected vehicles at the bottom of the water as well as eight people. there could still be people trapped inside or potentially have died vehicles. is that correct? >> i think while the investigation is still going on to find out exactly exactly how many people and what was situation. but the thing that we do know is that, is that many of the vehicles were stopped before they got onto the bridge, which which which saved lives in a very, very heroic way. >> thank you all right. >> hello, i'm another update later. thank you. >> we don't know >> crispy. all right. that was maryland governor wes moore along with other state and federal officials briefing the public on the situation with this massive calamity in baltimore, the collapse of the francis scott key bridge. i want to go to cnn's pete muntean and gabe cohen as we're following this breaking news out of baltimore at this hour pete, let me start this coverage from you >> what >> what stood out to you? i mean, i do think we got some answers to some outstanding questions. from earlier this morning, the governor at one point in telling a reporter right there at the end of the news conference at another point during the news conference that there was a power outage. it sounds like on this vessel that that outage was reported to the bridge and it sounds as though the government were saying right there at the end of the news conference that they were able to shut down the bridge to traffic and that may have saved lives. and so they're looking for what about six people right now as the search and rescue efforts are still underway, what can you tell us, pete? >> we're learning some really interesting key new details that we have not heard before, jim. one is that there was a heroic effort by those who are on the bridge of this 950 foot-long container ship out of failing to sri lanka that they were able to issue a mayday call when it apparently became a to them that they were going to collide with the bridge, which maryland governor wes moore says may have saved lives that kept more cars from going across the key bridge here between the east side of the punjab's go river in dundalk, where we are to the west side of the potassium river and the continuation of interstate 695, which was the baltimore belt one by that is really critical. we also learned some other new details. this boat was going at about eight knots, which is very slow, but consider the fact that this boat is about 100, a hundreds of tons. so a lot of inertia, a lot of mass as it hit this piling of the key bridge, which you can see over my shoulder there, essentially the remainder of the bridge as a bridge to nowhere and the suspension portion of the bridge. now submerged in the potassium sco river was more also said, very interestingly that this boat what's more also said that this bridge was up to code, that there was no real issue up with a bridge before this collision we've also heard a little more specifics on the numbers of those who are missing. eight people, according to maryland transportation secretary paul, we'd have feld were working on the key bridge doing deck work, repairing potholes at the time of this collision at 01:28 in the morning six of them are now missing unaccounted for 200 been accounted for. 1 is in the hospital right now. one is not in the hospital, did not need further treatment. so the search is continuing according to the coast guard, which we heard from here with helicopters and with boats of the banks of the potassium sco river and curtis bay to try and find those six missing people now unaccounted for the focus right now is still on a rescue operation, not a recovery operation as they try and find these unaccounted wanted four workers who were on the key bridge at the time. some other really interesting details here also from the fbi and for maryland governor wes more, he underscores that this is not an act of terrorism, that this wasn't a parent accident which is a question that many people had as they saw this video, servicing a line of this container ship veering for the big piling there in the pedantic over every here really, really critical new details just coming to light. jim >> yeah, absolutely. pete muntean. thank you very much. gabe cohen, if you can stand by for just one moment, i want to bring in the fire chief, james wallace of the baltimore city fire department. chief wallace, thank you for being on the line with us. i've driven over this bridge many times over the years. i know how critical it is to the baltimore area marylanders who travel around. this region and that shipping and industrial sector of the economy over there. it's just, it's just a vital artery of that area but i guess the more pressing concern right now is that you have a rescue mission underway. where does that stand right now, if you can tell our viewers >> yes, sir. thank you. and good morning. >> so we received this call around o1, 40 hours. this morning. and by o1 50 hours, we had resources on this scene and we began to deploy resources onto the water we've had boats, multiple boats out since then. we continue to have additional resources arrive we also were able to quickly deploy via the maryland state police air assets. so it was it's very important to get infrared technology not only on the water, but also in the air above the scene. as far as where we are now, we have as of about an hour ago and i suspect this number's probably increase a little bit. we had eight dive teams that we're deploying out onto the incidents scene itself, which encompasses about 50 divers those dive teams continued to be supported by air resources, but they've, they've been able to map the area and develop a dive plan and then deploy out and they're beginning the search in a subsurface manner, if you will >> and chief, if you can just help us kind of walk through the timeline of events as best as you understand them because we heard the governor, there are a few moments ago. tell reporters that his understanding is that there were people on onboard that ship who experienced this power outage. they call all that in too, i guess authorities who run the bridge is that correct? and alerted them to this power outage and that the ship was heading towards the bridge. and then the bridge was shut down. do you have any information that can help us fill in the blanks? as to that timeline, there >> yeah, i really can't add anything to it. it appears as though with the position of the vessel, it was outbound baltimore harbor obviously, it did strike the bridge. the bloody events that have led up to this actual incident i've been just laser-focused on the search and rescue operation, right. of really not had time to be briefed on those type of details, sir. >> i understand. so, chief, let me ask you about the rescue part of this earlier in the de we had heard that there were cars spotted in the water can you tell us about that part >> yeah. the last brief i got on that and that's that's been almost two hours ago we've in addition to the technologies i spoke about with infrared we're also using side scan sonar technology. we have that available now, so multiple vessels that are out right now actively searching. >> what >> i'm told is we've been able to mark what they believe to be three passenger vehicles. they've also been able to mark a cement truck and we believe we've marked a fifth vehicle. i don't know the nature of the vehicle, whether it's a passenger vehicle or work vehicle? but right now, we believe we've marked five vehicles >> and tell us about the challenging conditions that you're rescuers encountered or earlier this morning, i understand the water temperature is about 48 degrees. i mean, this this must have been a very difficult mission for your teams >> water temperature was 48 degrees >> we >> were we were in probably the low the low, maybe mid '40s with regard to air temperature it got very wendy after about an hour down here but i think the one factor that in when any type of operation that search and rescue, but especially on the water. the one factor that we were really battling was nightfall. it was obviously very dark. so when we deploy people onto the water, we were we were the lucky that we had clear skies overhead and we were able to give them aircraft reconnaissance above us. and that overwatch factor when we put people out, we didn't dive in darkness our search in and of itself was a, was a surface search as opposed to subserve if it's where we are now, but it's very challenging given the amount of wreckage and just those, those factors. >> yeah. i mean, chief, i was going to ask you about that. i mean, we're we're your cruise pulling people out of the water under the wreckage. was the wreckage. >> all >> all around them when they were doing this conducting this operation. i mean, that must have been absolutely harrowing >> so they >> those search around the records to the best of their ability. but this incident and of itself, all really present presented a potential per secondary collapse there are already been a catastrophic collapse. there's still certain elements of the bridge that are up as well as the bridge on the bow of the boat >> so >> it's a dynamic of an incident like this operating in a space of uncertainty. that just makes things very difficult. add darkness to it. >> it becomes dangerous all right, absolutely. >> and hats off to your teams for all the heroic work that they do chief waltz. thank you very much for your time this morning. we appreciate it 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medication, abortions, and treatments for miscarriage. just last year, research shows it was used in 63% of all abortions nationwide the supreme court, which has a conservative supermajority, now has to decide if the fda overstepped its authority by making it easier to access this drug, are going to listen into oral arguments right now. let's go to that now. >> is 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 they're gonna be more emergency room visits. this is the increase in emergency room visits is just no consequence. it doesn't even merit some calm, some comment >> that is a reason explanation would at da was observing in that passage is that although it acknowledged the fact that some of the studies reported additional emergency room visits, that didn't equate to additional serious adverse events. and in fact, one of the study's half of the women who 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 just he to know whether or not they're having a complication. but in that kind of circumstance, the woman is not having a serious adverse event for mifepristone. and so it doesn't call into question the safety determinations regarding the drug. and you know, at the end of the day, fda carefully parsed those studies. it made specific determinations about the results to be gleaned with respect to safety and efficacy it fully explain us decision-making. and i think it falls well within the zone of reasonableness under arbitrary and capricious review. all right. thank you. >> justice sotomayor >> on that last question, because that the 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's not like it overlooked at this aspect of the studies. i also want to emphasize justice sotomayor, that the studies were far from the only evidence fda consultant at the time and 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 when you didn't and saw that there was no relevant increase in serious address? verse events or difference between those two timeframe. so that further supported the safety control been with all drugs. is there are complications and virtually all of them >> yes. >> what level the cost-benefit analysis tells you to stop prescribing something is a very difficult question, isn't it? >> that's a question that congress has entrusted to de, >> but putting that aside here, whatever the statistical increase was fda determined under the rim standard that it wasn't sufficient to create a risk that counterbalanced the need for access, correct? correct. because fda has instructed to take into account burdens on the health care delivery system as well. and it looked at a variety of sources of data to conclude that 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 >> general, if i could take you back to the discussion that you were having with justice barrett about the conscience objection. and just ask you, i'm sure that you've read the declarations carefully and i'm sure ms holly will have things to say about this too but as you read those declarations what is the conscience objection. what 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 relatively short. this hasn't j hey, 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? >> those are dr. scott and dr. francis. the relevant language for the other five don't refer to conscience objection. they don't refer to their own conscience objections or provide any specific detail about exactly what care would violate their conscience. dr. francis is at ja 155. dr. scopus at ja 167, both described the injury in the same terms. they object to ending the life of a human being in the womb and fear that they might have to complete an abortion for a woman who has an ongoing pregnancy. >> so as you understand, those declarations, they do not object to providing whatever care is necessary to a person who may have complications from taking that for prison stone. and other words, for example, suppose somebody has led significantly needs a transfusion or any of a number of other things that might happen as you understand the durations, there's not an objection to that. >> i think that the ferris reading of the declarations is they are not objecting to that. now, i acknowledged that respondents in their red brief have suggested there's a broader conscience injury in play here and that there might 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 is a matter of law. they could not demonstrate that they have a non-speculative injury, in part because of all of the upstream things that would have to happen in terms of a woman having the serious event going to be specific the pick doctors, but also the fact that 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 >> obviously, conscience objections tens of all kinds. i was just asking about the particular declarations of these particular members of birth, and i think on these declarations, they have not asserted a broader injury, but even if they could conceivably come forward with other doctors or try to adjust their declarations in some ways still that would not suffice. >> okay. can i just ask a quick question? sen. about the merits you open your brief with the somewhat arresting statement, but it starts with to the government's knowledge and this was written a few months ago. and since then, i'm sure that you've had lots of time to think about this case. to get all background information on it. so i just read you this sentence and ask you whether it's 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 isn't the first time is that 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 court sometimes also overriding fda's judgment to try to grant greater access to drugs when that overrides fda's experts judgment about what's necessary to ensure safe use and no matter which direction you come at it from we on behalf of fda, think that courts have no business making those judgments in the absence of the kind of arbitrary and capricious error that would satisfy the apa thank you >> justice gorsuch, justice camera, just to confirm on the standing issue under federal law, no doctors can be forced against their conscience is 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've cited the relevant provisions at page five of our reply brief the church amendments have the most comprehensive protection here, and we think that those amendments guard against to the kind of injury that respondents are asserting there are also state law protections that often apply in this context. >> thank you >> justice barrett, would that be true even if the declarations were interpreted as respondents do to say that they regard any participation, even in transfusions or dnc's 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 usc three 108 dash seven d, and its language says that dr. shall not be required to perform or as or assist in any part of the health care program that would violate the doctors religious or moral beliefs. so it's tied to the nature of the doctors beliefs rather than particular there procedures. >> and 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? our deaths and transfusion. but not say, i mean, it's to me and 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 de and the need for a d&c 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's a list of serious adverse events that i'm not sure that i have all of them down to be able to recite them to you all though they're in the record, but i do think the premise of the question is wrong. this idea that the change to in-person dispensing would necessarily increase the risk of those events that was not reflected in the data that fda consulted. and i would point you to j3 83 to 384, in particular, were update fda explained that even in person you're not necessarily getting an ultrasound that it'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? there's no evident reason why that difference would actually lead to different safety out. so there was not even a i thought there was a small percentage increase in the tracking. i'm wrong about that, which i may well be the dj a way better than i am. so i think that with three respect to the er visits, there was some evidence that there were increased er visits, although as i explained to justice alito, that wasn't actually correlated with an increase in serious adverse events i don't want to represent all of the different findings of the different studies because they varied a little bit. but fda's ultimate conclusion question was that mifepristone could safely be dispensed without in-person visits. it had voluminous evidence, i think to support that conclusion in 2021 and there's been no contrary evidence that's been introduced so there was no requirement of either an ultrasound or detecting a fetal heartbeat or anything like that even before the dr. could just >> go based on the woman's recounting when her last menstrual period that's right. and that dates all the way back to the initial approval of this drug in 2000. it has never been a required condition of use to have an ultrasound. fda has always left that up to medical judgment. now what it's of course necessary for providers to be able to diagnose ectopic pregnancy date gestational age? that remains true under the rems. now, prescribers still have to have that capability and they have to deploy whatever mechanisms they believe would accurately allow them to identify contra-indications since for use of mifepristone, but it's wrong to suggest that if the court reverses 2021 changes than every woman's going to get an ultrasound. that's never been that the state of play in how this drug has been administered how even under the pre 2021 rams was it possible to detect an ectopic pregnancy without an ultrasound unless the woman was presented pain. >> so there's a set of screening questions >> that are often deployed. you can ask things like do you have unilateral pelvic pain? did you become pregnant while you had an iud in or after a tubal ligation? he shen are you experiencing unusual bleeding? you could ask whether the woman has had a prior ectopic pregnancy. if the woman has those kinds of risk factors, then imaging may be necessary, but that remains true so under the 2021 rems as well, the prescriber has to be confident that it has excluded those kinds of conditions before prescribing this drug. and the standard of care around the world, most medication abortion occurs without an ultrasound. >> thinks >> justice jackson good morning general >> i'm i'm worried that there >> is a significant mismatch in this case between the claimed injury and the remedy that's being sought, and that that might or should matter for standing purposes. i don't know that our doctrines sort of capture this, but i guess i see it that the injuries that the respondents allege, as you've articulated them, are conscience injury that 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 and you've said here several times that federal law already gives them that i guess then what they're asking for in this lawsuit is this 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 i'm 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 that they have alleged. >> i agree. justice jackson and i do think it's relevant to standing. there's 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 dr. have a conscience injury there's a specific statutes designed to deal with it too specifically tailor-made guard against the risk of that injury occurring. and instead, they're reaching out and seeking to invoke rights under a different status shoot the feca 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 condition prince of youth for mifepristone and effect women all around the nation simply because of this conscience injury that's already directly addressed by other providing if it wasn't law, if it wasn't addressed, than we would see this lawsuit and the remedy would be to exempt them, right? yes. >> yes. i mean, i think that one of the hard things about trying to tailor relief here is that they're asserting such a diffuse theory of injury that it's almost as though the only option was to grant a nationwide remedy of the kind the lower courts issued. and that runs counter to ordinary article three principles of party specific relief. but i just think shows that there's something wrong with the theory of injury in the first place because it's so attenuated and because they claim they would need so much relief all over the country. >> let me ask you another question. addition to the challenges that we have here, the respondents below challenge the fda's initial decision to prove mifepristone in the year 2000 of course, that occurred a very long time ago the fifth circuit found that 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 issue. so setting aside standing, have you thought about how a ruling from the 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 stake 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 in that case, the weight it could open the door to plaintiffs coming in and saying, well, i only became a dr. later or i only started working in an emergency room later and we'll try to unsettle longstanding agency actions that may be the occurred decades previously, i do want to say that i understand the corner post petitioner to have suggested maybe there would be equitable defenses that the government could raise in those kinds of cases. we would certainly we want to raise that type of defense with respect to the approval of mifepristone, which i think has generated tremendous reliance interests and proven to be safe and effective over decades of use. >> thank you. >> thank you, counsel >> ellsworth >> mr. chief justice, and may it please the court? in 2,016.20 21 fda made certain changes to the labeling and use restrictions for dan goes drug mifeprex the decision below stops danko from selling mifeprex in line with that scientific judgment? based on a highly attenuated claim in an unknown dr. could be called someday to an unknown emergency room after a series of decisions by third parties no facts causally linked that possible 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 append not just mifeprex but virtually every drug approval and rams modification fda has made for decades. reversal is required for two reasons first, article three standing is not an academic exercise in what's conceivable respondents lack standing ending under every prong of the analysis second, on the merits, fda exhaustively considered the evidence and reasonably explained its conclusions, which is what 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 you in your case, you would be so how do you respond to an argument that mailing your product and advertising it would violate the common stock 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 >> fsb considerations. that's true for new drug approvals. it's also true for rams modifications fda routinely approves drugs whose manufacture and distribution is restricted by other laws, like the controlled substances act, environmental laws, customs laws, and so on. i think this court should think hard about the mischief it would invite if it aloud agencies to start taking action based on statutory responsibilities that congress has assigned to other agencies on the merits. this issue was not presented below extent it was not ruled on below and in any event, i would also point out that in 2021 fda's decision allows use of brick-and-mortar pharmacies in addition, and to mail-order pharmacies >> well, my problem is that your private the government. i understand the government's argument but your private and the statute doesn't have the sort of safe harbor that you're suggesting and it's fairly broad and it's 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 >> council. >> i'd like to ask you the same questions i was posing to the solicitor general. you are precedents, class mapper and susan b. anthony list. talk about requiring a substantial risk that arm will recur and you argue that is not present here. how are we supposed to find the spot at which risk becomes substantial >> your honor, i think this core has always thought about these standing inquiries as really a question of degree. and you're trying to evaluate whether something is actual an imminent or whether it's conjectural and hypothetical. and these terms substantial risk. certainly impending, which has been used dating all the way back to 1923, get at where a claim falls in this spectrum, right? >> i mean, we tossed around a lot of adjectives, but i'm just 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 that the way clapper got at that question and you can see this in footnote five of the opinion in is to really 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. but that's 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 in that >> is brought in this case, i gather this is your version of mifepristone is the only product you are currently marketing, is that right? >> that's correct. justice alito and the fifth 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 going to sell more if the restrictions that previously were in place were lifted >> you're going to >> make more money >> the injury is that we are prevented from selling our product in line with fda scientific judgment about the same if an efficacious use of drugs and you're going to be harmed because you're going to sell more >> i >> think that certainly accompanies 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 guest the fda's judgment about excess two to a drug, right? and it's never second guess that that's correct >> you think the >> fda is infallible >> no your honor. we don't think that it'll and we don't think that question is really teed up in any way in this case. >> that's the fda ever approved the drug. and then pulled it after appearance 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 reporting, the post-market surveillance that fda does. the ability that these plaintiffs have, even if they don't have standing, certainly if there are if they are seeing patients who are presenting with adverse events, if they are doing studies that show there is some unknown safe 50 component that fda should acknowledge. they can take significant steps to bring that to the agency's attention, to bring that to dan goes intention, but don't you think the fda should have continued? two require reporting of non-fatal consequences >> your honor, the fda decided not to continue that reporting requirement in 2016 based on more than 15 years of a well established safety profile when that report being wise required, there is no drug on the market today under any rams that requires the kind of reporting that the plaintiffs are saying should be reimposed here. >> so why would that be a bad thing? wouldn't your company, you don't want to solve product that that causes very serious harm to the people who take your product, relying on your tests at the fda's tests wouldn't you? want that that data? >> your honor, that data is certainly something that we are looking for all the time. it is part of the reporting obligations for manufacturer to be aware of any data that's becoming available through any means. we have a when 800 number on our website. there's a 1800 number on the labeling. i think, your honor's question though, gets that concern i heard in some of the earlier questioning about who would have standing if these plaintiffs don't have standing. and one of the things i want to note is that drug manufacturers are very frequently subject to tort litigation a product liability suit, failure to warn suits deceptive advertising suits when someone is claiming harm from pharmaceutical manufacturers, product what is so i think revolutionary really about the arguments here, both on standing ending in the merits, or the way that they attempt by individuals who do not use this product do not prescribe this product and have a conscience right not to treat anyone who has taken this product those individuals want to prevent anyone else from using it? it in line with fda's considered scientific judgment. >> you go, does your company just one more point along the same sort of along the same lines. does your company think that what the fda has done preempts state laws that prohibit the dispensation of myth within their borders we have not taken a position on that issue and it has not been teed up in this what is your what is your company's position on it? you have even thought about it one of your competitors made that argument, right? >> that's right. there are some lawsuits that have been brought by the generic company that do make that argument. and i think that is for later courts to sort out our position in this case has been that this is about fda's scientific judgments reached in 2,016.20, 21, you don't want to answer that question? i don't think we have a position that's on that that i'm prepared to say today. >> could you go back to justice alito's questions about adverse event reporting and you said you were subject your product to hire standards and now we're being brought down to the sort of regular at could you talk about that a little bit? what are the normal standards for adverse event? reporting, as you understand them, why are they there what instead we use subject to in the past >> may i answer the question >> justice kagan, what changed was not danko those adverse event reporting responsibility. danko is adverse event reporting responsibility has been the same throughout this period. what changed was that from 2000 until 2016, prescribers were obligated to report adverse events to danko and then danko then had it's separate reporting obligation to fda so what in 2016 is hearing a case that could radically affect access to the abortion pill medication, abortion in the united states want to talk about this with our panel. we've been listening to all of those i'm joined now by our cnn medical correspondent, meg tirrell, scene and chief legal analysts, laura so cnn legal analyst and former federal prosecutor le williams and professor at george washington university law school. sonya suitor guys, thank you very much, ladies and gentlemen. thank you for being with this i'm laura, your sense of these arguments and how they're playing out right now. i mean, not a big shocker there playing out pretty much along the lines of this conservative super majority on the supreme court right now conservative justices sort of poking holes in the arguments that the fda is infallible. we heard justice alito say this just a few moments ago to one of the attorneys, i think for the the drug maker asking, what do you think that the fda is infallible i mean, the arguments have kind of gone along those lines. you're sensitive. >> well, let's just take a step back as to why we're here. we obviously know that since the dobbs decision, the overturning of roe he weighed all eyes have been on politically, what different dates want to do now that it's returned to the states this is a case about mifepristone, one and a two-step drug regimen, excuse me to perform a medication abortion, nearly half or more are performed in this way using this drug. the whole point of this is that there was a lower court ruling that said, hold on. the fda should never have granted access to this judge jug in the first place. and if they did, they should roll it back to four. you could have telemedicine or even having a brick-and-mortar retailer dispensing the whole crux these arguments now is whether one, the people who brought this, the anti-abortion activists divisions have agi standing to be here. do you have an injury before me or is this prospective? objective in some way about your conscience. the other side of it is if they were to decide that the fda suddenly has to change their rules only with respect to abortion related medication. it could have a huge domino effect down the line for all drugs that are prescribed in this country. and so the big question for them now is, well, which we favor is the idea of trying to avoid this case entirely, or is it leaning into further this idea that we want to regulate abortion in ways that they're dobbs decision said ought to be left to the states. >> yeah. meg, i mean, there were some suggestions are in the arguments that mifepristone is somehow unsafe. it is one of the safest drugs out there yeah. >> and what's really interesting, i mean, this has been around since 2000. there's been a lot of studies done about the safety and what they've found is that severe adverse events happen and 0.3% of cases of folks using this, the efficacy rate they find it's 95 to 98% in super interesting lee, because this drug is increasingly being used via telehealth they find that the safety is the same regardless of whether you're getting this through telemedicine or you're getting this in-person at a clinic and sania this i mean, this flows out of the dobbs decision that's the reason why we're listening to this today. absolutely, it does. so when dobbs said that there was no constitutional right to abortion that left it to the states. but what is happening is that even if abortion is banned in certain states phase 14 states have banned on people can still access medication, abortion through telehealth and through the mail. and so i think this case is really about trying to i'm control who has access to abortion and reach the people who were able to evade those bands. >> elliott, your sense of these arguments, how they've, they've broken down. we've heard the conservative justices trying to poke holes in what is something that is widely accepted across the country is normal report reproductive care. yeah, absolutely. it's picking up on exactly what laura was saying there's two big things happening in this case and it's playing out very clearly in the arguments number one, it's about the world post dobbs and post roe v. wade abortion specifically. and what does it mean? in american life? number one, number two is the role of the administrative state. what power do agencies have to regulate and make decisions on things like drugs or food, or air or water, and a goal, quite frankly of the conservative movement, legal moves meant for the last half century has been the dismantling of the administrative state. and particularly justice gorsuch is one that deepen his bones, believes that agencies have too much power, even the fda ought not to have the juice that it has two regular, so whatever they write here, i would think is going to touch on some of those issues, however, because the justices are free to write concurrency's or dissents or whatever else. and what power agencies have to make decisions is a critical issue and it's going to come up >> and laura, this really has the potential to chip away further abortion rights in this country. that's the big implication of this because if you think that the prior cases are about whether it's an incision in your dr. in yourself as a woman deciding whether or not to seek out of wash-related services. now, this is a question whether the supreme court has a right to dictate what the fda is able to do in terms so regulations in doling things out, remember the consequences are very big. it's not, it would not just be mifepristone if they challenge and say that the fda ought to cite, have to have a new way of examining and evaluating drugs and how they have to go down the line to figure out whether there available and how they should regulate that. >> that >> just not just this drug, it should be all of them. think of it, all those that meant then would leave the marketplace, not just for women reproductive rights, but everyone that's really the crux of this issue. why alito was saying, well, hold on as the fda and fallible. he believed in me even further the thing will hold on is he leaning in that direction to suggest that the fda somehow is fatally undermining their credibility. that'd be very sweeping where nobody is saying the fda is infallible think anybody he's made that argument, but or you could here where the justice was going there when he made that comment. all right. laura meg elliott, sonya, thank you very much. we'll of course, get back to you. a busy morning here in the cnn newsroom. stay with us so we'll be back in just a few moments. what's that guy's we're gonna go to the next hour or we're going to go to the top of the hour that thank you for staying with us. you were alive at the cnn newsroom. i'm jim acosta and in washington, as i was saying a few moments ago, i thought we might be going to break, but we're not we've got a lot of moving parts this morning we're going to begin this hour with the disaster unfolding right now in baltimore, a massive one mile