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find the full schedule on your program guide or watch online anytime at the tv.org. >> the house will be in order. >> celebrating 45 years of congress like no oth primary source for capitol hill. providing balce unfiltered golfer -- coverage of goveren taking you to where theebated and c. c-span, 45 years and counting. powered by cable. >> the supreme court ruled unanimously to preserve nationwide access to the abortion pill. the case was brought forward by antiabortion groups onhe claim thathe va wch approved the drug in the year 2000 overlooks safety issues in its decision. this caseas argued before the court in march. it is about 90 minutes■■j.

>> we will hear argument ts morning in case 23235 the food and drug admisation. and the consolidated case. please the court.ice may have fda approved based on thegey scientific judgment that the drug is se and effective. it is maintained that judgment against five presidential administrations and millions of americans hav ud it to safely and their pregnancies. that choice, but that does not them article three standing or legal basis to upend the regulatory scheme. dents lack standing. we now concede they cannot rely on the lower courts and instead they he to identify a specific doctor who fes internet harm. their theories rest on the long chain of remote contici only an exceptionally small number of womenuffer the kind of serious complications that

could trigger any need f emergency treatment. it is speculative that any of thatou seek care from the doctors whoted injuries and even if that happened the protections would guard against inju ty would face. ther i no basis to conclude that anyf that would be treae to what fda made in 2016 and 2021. matter of law.eories are a the court should say sond put an end to this case. if the court reaches the merits fd aion was lawful. they relied on dozens of studies allowing tens of thousands of women. respon do not identify any evidence that the anc overlooks. they just disagree with the agency's analysis with the data befo it did that does not provide aicense to authorize second-guessing of the agenc second judgments. finally on remedy. the relief entered below with severely disrupting the federal po for developing.

arming the agency and pharmaceutical industry. it would reflect gra farm on women across the nation. lling back fds chang with unnecessarily restricting access with no safety jusfition. some women could be forced to undergo more invasivetishile ott be able to access the drug at all. all of this would happen at the request of plaintiffs who he no certain injury of their own. thourt should reject that profoundly inequitable resul. i welcome the courts questions. >> general, if we agree with you on standing, could you give us an example of who wou cllenge, o challenge these fda actions? .... ....

the rest on this chain of remote possibilities in so many different steps that would have to occur each one remote that the chance of injury on top with another to get to e ultimate harm they are claiming on behalf o these doctors. mchugh emphasized the remote adverse effects had the likelihood patience will go to the emergency-room and so on. is there a number which are arguments would change a significant number of consequences a highelihood of an emergency-room visit,

doctors who spen time in the emergency-room could at some point as this analysis lead to the results? >> it's hard for meagine that itou and there are a couple of different reasons for that. i take tnt you might take out different links in the chain and suggest their ws to depart from the facts here an suggest maybe one or twof ose events could b probable and it would more likely to carpet we have an objection to the underlying theory of the matter because it rests on so many different things that would have to happen on top ofnoer and to turn on independent decisions made by parties who are strangers ts litigation who are part of the say. we that brings the case with an those like r or summers for this court is recognized in a serious injury turns on so many different intervening events separated by independent decisions it can mean there's an insurmountable hurdle■z establishing it.

>> could you provide a more specific answer to the first question that justice thomas asked you? is there anybody who could challenge in court the lawfulness of whathe fda did hear? >> in isarticular case i think the answer is no no. nd that wasn't my question. is there anybody who can do that? let's start with the state to intervene a lot. litigation fine you can challenge it and let's g to the merits of this issue, the lawfulness of what the fda did? >> know think the state's standing in their indirect injuries and states could only sue the federal fer government anacor caution against that result in united states versus texas. opses abortions as she's on duty in emergency-rm when a woman comes in with complications from having taken

mr. press downndhe doctors the only one there on duty who can attend to this woman's problem problem and has resulted in order to save her life to dooras two aboard a viable fetus. would that doctor then h standing to seek injunctat spulative? this is like being struck by lightning and it's not likely this is going to happen again. >> wd agreehat represents conscious violation providing care in violation of one conscience but i guess we think that situation has never comeo pass and response haven't ideifd any incident ore than 20 years that mifepristone has been available in a market in that hypothetical situation so ouriew would be it's unduly spelave and you have to think abo the offensive have to transpire to get to that. >> i understand th aument. how about a woman who suffers verse consequences from having

>> i expect we'd have sovereign muty arguments in that type of with respect to traceability tt's a harder argument for us. >> is there anybody who can sue and gett judicial warning on what are the fda did was lawful maybe what they did was perfectly lawful shouldn't somebody be ultra-challenge that in court and who in your view would have standing to do that? >> withesct to these regular tire changes it's hard to idenfynyone who would have standing but the court has time and again the fact that no one would have standing doesn't provide standing. it's in richardson and clapper so it' clear even if there's no alternative person who could sue thatoe't mean the court should dispense with the ensable arguments of tie iii. >> i understhat in article iii is important so your argument it doesn't matter if

fda flagrant vlated the law didn't do what it sho have should have nendangered the bad that nobody can sue in too court. there is noemedy and the american people have no remedy for that? >> i think it would be wrong to suggest the fda had made a mistake in the drugs were prucg safety consequences and nothing could be done. i don't think the court should step in the fda take seriously the responsibility to enrehe safety of drugs and a convex on going surveillance and make adjustments and safety situations emerge. the drug sponsor remains responsible at all times that can help ensure their saty problem to come to pass the sponsors will take action and reaction to thato the premise here is unsafe drugs could remain on the market, i think that's incorrect. you argument here and i have great respect for article iii and we all do. we h to comply with it but

the majority hears even if the fda acted unlawfullyobody can challenge that inrt? that's basically the argent you made last week in the m case. he shouldn't get the question whether the white house and others vio their right to freedom of speech, we should pls can't -- >> we are looking at the specific correspondence in this ca. we don't think they come with 100 miles of the circumstances this court is previously identified if n speculative injury or forward-looking relief. >> i'mssumg if this had been unsafe or in a visible way of 40% mark increased hospitaliz that some doctor who is prescribing it would have challenged the lack of in person. no doctor is required justice

sotomayor t dispense -- >> just like a doctor who wants to do an an and a set of there's regulations that stop them from doing itss that doctor could come in and say this is unsafe.■■> i by not having people visit m beforehand we are not warning them etc. etc.. >> certainly thoseds of distinct safety concerns emee there would be steps taken at the agency level. there's nothing like that here. >> i'mring a hypothetical. >> i want te clear that fda's regulations don't require doctors tontn person visit. that's a standard of care here so they are not directly required to dispense mifepristone or any pri arrangement. say council can ask the questions about the -- one of the roadblocks you identified identified as they go to chain

because a doctor couldn't invoked protections to rto complete an abortion where a embryo or fetus was still alive. they just want to be clear the federal government's position their doctor would have possible objections in the entire tigation but it is your position that such doctors would have recourse in the protection of the federal law? >> absolutely tt let me be clear because the rpoents have repeated that misunderstanngere but the federal government has never taken a position that it would override an individual■" doctors conscious perception if you look at the attempts arligation we disclaim theerstanding and make clear the winter stand detections continu to apply and shield an officer did so want to provide fair in violation of those prons. >> we don'thi he it would

override conscious protections ofndidual doctor. hospitalsave all kinds of contingencies. theyft ask for doctors t articulate articulate their conscious is the objection in advance. the governments experienced for decades of experience we are not aware of any situation where there has been that kind of direct conflict between cos protection. >> one last question. talking about based injury to one of it's members. the injuries that the of allegations received by kinds immigration. diversion of resources increased expenses there resn a complication to have to addressa

tion. that's not what i'm talking about. can you distinguish that? >> i think havens itself was trying to distinguish between two types of potential organizational injuries and whitehaven sai in that case the organizationad come forward with directndoncrete demonstrable injury to itself. the organization had■p a contrat to provide long-term housing for ie and practicesnd made it mordiicult for to carry out a contractual obligation. havens itself that was not blessing the standing tould allow an organization to assert a setback with abstract social interests. trying to distinguish between more the on the oneld not abstract every hand. she just to spirit some lower cotsn particular have seemed to rest havens to a far broader

theory of standing including immigration context for the government has been routinely resisting standing because h thinks that would essentially mean any advocacy organization could say it opposes what the federal government is doing so therefeave to devote resources to an opposition. if that were enough than every organization would havetaing it would be a vast expansion of article iii. we wou bk him an eventual arication from the score on organizational standing here i think the organization's bucket of the abstractlls in the and doesn't come close to the demonstrable harm that's an issu haven >> alarifica, thank you. with rpect to individuals i've heard anened to you argument and i think i understand it but how does it fit in your mind with an observer standing under the establishment clause for some

injuries. i access the park and i looks to look at it in a certain way a those kinds of injuries at the court metimes is recognizing and other times cast out. >> i think they are differe strands of thisou's president and i would put the and a precedent generally innt it's own bucket. >> i'd push back on a little bit e standing is standing. it'srtle iii that we are interpreting here so we have got to find a way to-it all together >> i think it would approach ishis is to recognize some kind of distress type o injury. as a >> i ghat i would say thi

court has sometimes found that situation where there is at's a direct governmental action and you've seen that type ofury and hear our argument is athe fda's actions in improving mifepristone specifically in 2016 and 2021 t a incremental change is so far stam of the downstream assertion of harm distress the respondents are asserting it's a matter of law in an attenuated way can't -- say thank you council. justice thomas, justice alito? >> you say the fifth circuit didn't give any reason to think that the three changes made in 2016 would be more dangerous in combination than they re indily. isn't thaobvious that three things that be innocuous or not exely dangerous if engaged in by may

become very dangerous when th are all done together? why shouldn't the fda have >> i think the onlyay that would be true would bef e three changes are interconnected and mutually reinforcing auing at the same kind of safety risk but i agree there's aean to think the reason why mifepristone is safe up tecset's being prescribed by doctors or practitioners for example and those changes will be interconnected because one an would be a safety net for another but there was nothi like that and a recdor the studies fda examined and demonstrated these changes a it was an exhaustive examination were safe not because ther were he safeties. ere's no increase inus adverse events to matter who's prescribing is so the absence of that effect of the changes i don't think you can call the

expert attention to the issue and it did. multiple studies combine muip changes precisely because t standard of care had evolved over the 50 years miss the press don't have been approved in many of the changes were being deployed safely. >> should the fda have at considered the application of 1461 >> the comstock provisions don't fall whi fda or the fda under the ftca can only maintain restrictions under the program essary to insure safety pin 2021 what they determined if you don't need dispensing for safe use of the ftc did not independently require that recent prescription and can be imseonce that determinn made. fda was not of mstock even if you interpreted it that w and at the very

least i don't think it was fda's responsibility to consider that or could it have under that statute. didn't do anything about it and this i prominent provision and not some obscure subsection of a complicated ocu lot. they knew abo iand everybody knew about it. shouldn't they have the least address to? to have answers to the air currtsade on the other side and shouldn't the fda at least and we considered those and provide some kind of an exclamation? >> let me give two responses one permissible for fta t maintain the restriction because of comstock pretty odook at the statutoryection herehi is reproduced on page 6a in the appendix to her breathe. it's clear the only thing they can take in account o safety and concerns in deciding whether ken from maintain the program but t other thing of maintain the agencyidave a memory and

among comstocky 35 and that was the advice that fda received containing the interpretation of comstock. >> it didn't revert to that. >> into 2021 decision no. it was modified in 2023 and this is part of the administrative record for that. >> one last questor the plaintiffs say the study the fda relied on for the 2021ment miprtone suggest more frequent trips to the emergency-room. this is i see is the fda's response to tt quote although the literature suggests there may be more frequent emerroom care visits related to the use of mifepristone by mailha the clinic there no parent increases and other serious adverse events related to mifepristone. does that count as a reasonhe sn

that the data shows there will be more emergency-room visits, the increased emergency-room visits is justquence and doesn't merit some compliments quicksand that's a reason asked the nation. what fda was obsvi the passage although they acknowledge the studies reported in additional emergency-room visits a didn't equate to additional serious adver events and back on the studies for woman went to the emergency-room didn't get treatment ate all. women may have been experiencing heavy bleeding during a were having compliciobut in that circumstance the woman is not having a serious advse even fm mifepristone so safety determinations regarding the drug. into drug. the day-to-day end of the day fda has carefully paed the studies and made specific determinations about the results of the lanes with safety and efficacy and i think it falls well within reasonableness unde.

snake justice sotomayor. >> on the last question the reality is even if there is some increase in emergency-room visits the question up when that rises to a sufficient safety risk is up to the fda, correct? >> that's right in fda acknowledges it. it's not like it overlooks the ct of the study but i want to emphasize justice sotomayor the studies were far from the only evidence. athe time of 2021 it had real-wor expernc during a covid 19 pandemic of period of time when an person dispensing require require most not in rce in fda started by looking at is a comparative comparave analysis for two periods of time end mifepristone when you didn't insult the w no relevant increase in serious adverse events related to the timeframe s >> the problem with all drugs is their art comp -- complications

and virtllall of them. at what level the cost benefit analysis tells you to stop prescribing something? at the very difficult question. >> that the question that congress has had trusted with the fda. utting that aside here whatevertatistical increase was fda deter under the standard wasn't sufficient to create a risk that counterbalanced the need for access. >> a correct because fda is instructed to take intont alth care delivery system has some looks at a variety of urs that on ballots the burdens it was sgeed it was not necessary to put a restction in place to ensure safety. >> if i could takeou back to thecussion you are having with just disparate about the conscious objection i just ask an i'm sure you've read the declaration carefully and i'm sure ms. hawley will have things

say about the as you read those decorations what is the conscience objection? wh a the doctors objecting to exactly? >> i think the decorations are specific on this point that they are only seven doc to practice and submitted evidence at decorations are relatively short. i encourage r them because they are only two doctors out of seven who provide any information about their specific conscientious objection. those the start dr. skop and dr. francis. spend the other five don't ction president they don't don't provide any ecic detail about exactly what care would violate their conscience. those described iury in the same terms and the terms and the object and in the life of t human being in the womb and they might have toete an abortion for woman who has an ongoing ncy. >> as you understand those decorations do you not object to

providing wts their care is necessary to person who may have colications from taking him mifeprto? in other words for example suppose somebody has bled significantly ands a transfusionr any of the number of other things that might happen. you understand the declarations is not an objection to that? >> the reangf the decorations as they are not objecting t that pitted knowledge respondents suggested there's a broader conscious injury in here there might be other doctors who ever have a broader ncn about providing any care even if the broader conscious injury had been in the declaration as a matter of law and eyan't demonstrate that they have a non-speculative injury becse of all the things who would have to happen in tf the woman of having a series of but also fact that the federal conscious protections are specifically designed to do with is issue and cover the range of conscientioection.

>> they are obviously conscientious objs of all time but i was just asking about that particular declarations of these par members. >> on theeclarations they have not asserted a broader injury if they come forward with other doctors who try to object the declaration in someays >> and i just ask a question about the merits? you open your briefitthe somewhat■hesting statement but it starts with to t government's knowledge and this is written at few monthsgo and since then i'm sure you he had lots of time to think about this ca and to get all the background inforti on it so i will just read y this sentence and ask you whether it's still true to the government's knowledge. to the government's knowledge this case marks first time and i'm going to say is at the first ti o the 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

safety. it is still the only time? >> that's still to our kno the only time and we have seen a disturbing trend of the courts overridingt grant greater access to drugs andha overrides what's necessary t ensure safe use in a matter which dictn you come at it from wthe fda think courts ha no business making those judgments in the absence of a kind of arbitrary capricious air that would satisfy the apa. >> thank you. >> just to score shoots. is to confirm on the standing issue under federal lw ors can be forced against their consc to perform or assist in an abortion correct? >> we think federal conscious protections pridbroad coverage here into the super precise error triggering requirements that receive ferafunding and so forth. we cited page five of ourep brief. the amendment of the most

comprehensive protection and we think those amendments guard against the kind of injury the dents are starting. there also ptections that apply in this context. >> just disparate. >> up would that be true even if the decorations were the response to view that they were ening for suspicion even transfusion or a dnc because tissue ndso be removed? >> i think that would be true most relevant provision is 42 usc 300a -- 70 and the lanag■o says that doctor sha not be required to perform or assist in an part of t health care program that violates the doctorgious or moral beliefs >> one other question as i understand it the serious adverse consequences that have to be reported o considers a risk our death andfusion

i mean itms to me the elimination of the in person dispensing requireme or the visit at the owould lead to mistakes in gestational aging which could increase the need for a dnc oamount of bleeding etc.. that does not count current correct? there's a list of seriousecause adrs events and i'm not sure that i have all of them down to recite them tough theyem the qus idea of that it would increase e risk of those events. that's not reflected in the data cannot point you to create a fo particular. fda explained even in person you aren't necessarily getting an ultrasound but that's never been required so the relevant question might be fischer provider going tosk screening

questions and there's no evident reason why that difference would lead to different safety outcomes. >> i thought there a small percentage increase, and i'm wrong about that which i may we be. >> i think with respect to the er visit there werencased er visits although as i explained to justice alito correlate wh an increase in seriousdvse events, don't want because they buried that the ultimate conclusion was that had voluminous evidence. there is then no contrary idence. >> there was no requirement of either ultrasound were detecting a feartbeat or anything likeeven before the doctor is based on when the woman's steriodas

>> it has never been a required position. e fda has led the that up to the medical judgment. is important for them to diagnose ectopic pregnancy. they he to deploy whatever meod they believed would allow them tidtify■k■j contraindications for use of subs -- mifeprion but every woman to get an ultrasound that's never been in play. >> how it even uhe pre 2021 round with it impossible to discover neck tom: -- ectopic pregnancy without an ultrasound expand their questions that are often deployed and you ofteneployed things do you have unilatalelvic pain or did you become pregnant while you had an iud and are y experiencing unusual bleeding and whether the woman is at a prr ectopic pregnancy and if

she has those risk factorsnd may beecessary but that remains true under the 2021 event itself great she is to be competent excluded those cons before providing in the stanf care around the rld st occurs without an ultrasound. >> justice jac morning general. i'm worried that is a significant mismatch in this case between the claimed injury and the remedy thaseing sought. that might or should matter. i'm nure that our doctors have captured this but i guess i e it that the injuries that theespondent alleges are conscious injury that they are being forced to participate in a medical procedure th ty object to. so the obvious commonsense remedy would be tode them with an exemption that they

t have to participate in this procedure and you say here several time faw r&d does that but i guess them what they are askin for is mor than that. they are saying because we ject to having to be forced to particip the procedure we are seeking an order preventing anyone from having access to these at all. s 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 think it's relevant there's a profound mismatch betweenhe claimed injury in the redy they are receiving. you nlmost think of this as a type of zone o ierest analysis. if you're doctors have the conscious injury there's a spectatute to specifically tailor made guard against that inju occurring. they are reaching outnd seeking to invoke rights under different statute. it ftc doesn't regulate them all

and doesn't make them do or no do anything but the relief that they are seeking would dramatically alter the conditions of use of them mifepristone and affect women alaround the nation simply becauset's our addressed already. it wasn't addressed we would see this lawsuit in the remedy would be to defend them. >> one of the hard things abo trying to deal with this is there such a diffuse theory of ju it's almost as though the only option was to grant a nationwide remedy of the kind issued in that counter to ordinary article iii pncipals on specific relief butt shows there's something wrong with the theory of injury because it's so attenuated and the claimed there would be so much relief all over the country. >> let me nother question but in addition to the challeng that we have here the respondents challenge the fda's initial decision topp year 2000. a course ccurred a ry

long time ago and was that challenge timely echoes of the ute of limitations? as you are aware in the context another case the court is currently considering the statute of limitations so setting aside standing have you thabout how ruling in this court on the statute of limitations in either directioin these kinds of cases with these kinds ofenges? i think it reflects the stake at the corner post case and provide apecific specific example of the way it might be possible if th crt were to theory of the statute limitation and open the door to them coming in and saying i only became a doctor later only started working in emergency rooms than and i do want to say kinder stand maybe there would be a total defense that the

government could raise in those kinds of cases amount to raise that type of defen wh respect to the appralf mifepristone which has prono be safe and effectivever y thank you.se. >> thank you council. ms. ellsworth. saint meese -- mr. chief justice may it please the court in 2016 and and fda made certain changes to the labeling and use prescriptions for metal bricks. it stops them from selling it in ne with the scientific judgment based on a highly attenuated claim and an unknown doould be called sunday to an unknown emergency-room after series of decisions by a third party. no facts costly link that featuring countero specific change fda made in 2016 or 2021. spdents to the cosmetic act

as on flexible it would not only stopetroparks any drug pral fda has made decades. verso is required ror two reasons. article iii standing is not an academic exeis in what conceivable. respondents standing under every oduct analysis. second on thts a ta exhaustively consideredhe evidence in recent explained it's conclusions with us -- which is whatt's required to do and i welcome the court's questions. >> the gent for solicitor ra points out would notrr be susceptible to a comstock act problem. but in your seou would be so how you respond to an argume that mailing your product and advertising it would viole the comstock act?

stice thomas we agree very much wit government that fda's charge under the boot having cosmetic act as limited at looking at safety and efficacy considerations and that's new -- true for new drug approval and brands my vacation. d.a. routinely approves drugs and is restricted by oths like the controlled substances act environmental ls stoms laws in se ssions on. i think the court should think hard about the mchf he would have would have invited that allowed agency to take action based on statutory responsibilities that congress has assigned to other agencies but on the merits this is presented or ruled on below ny event i would point out in 2021 fda'secision allows use of brick and mortar pharmacies in mail order pharmacies. private and i just than there

government's argument that you are private and e atute doesn't have the sort of safe harbor that you are suggest it's fairly broad and specifically covers drugs such as yours. >> your honor we disagree but that's the correct interpretatithe statute that we think in order to address the interpret and would need be a situation which that issue was teed up for the statute hasoteen enforced for nearly 100 years and i don't believe this case presents an opportunity for the court to opinon the recent statute. >> council is like to ask you th same questions i waing to the solicitor general. the susan b. anthst talks about acquiring risk that may occurring you argue that's not principled here but how are we supposed to find the spot at

which the risk would become substantial? >> your honor i think this court has always thought about inquiries is a question of degree. you are trying to alte whether something is eminent or conjectul d hypothetical. these terms substantial risk intending ichas been used dating back to 1923 get it where claim falls within the spectrum. >> we tossed around a lot of adjectives. i'm just trying as a practical matter how do you figure o what percentage of adverse consequences would be enough in what percentage of emergency-room visits would be engh? the way the clapper credit that question and you could see it is tk about whether there is an attenuated change of contingencies that have to happen in situations wor ts kind of aenuated change of circumstances involvg third-party decisions that have to play out in a particular way and hear that change is quite

long that's squarel p the plaintiffs very on the side of the conjectural for hypothetical and not the impending injury. hows yr c agreed by the challenge by the challenge brought in this case. mifepriss thonly product you are currently -- and this does notbit u from continuing to produce and sell that product, right? >> that is correct. i gather you're in inquiries you believe you'll somewhere think reions that were in place were left there? so you're going to make more money to expand juries we are prevented from selling a product in the fda's scientific judgment of this safety and efficacy end

use of the drug. speaking you will bed because you wil sell more.pa ability to market his product is a part of a at covers mist. during the questioning of the solicitor general the statement was made that no coas ever eviously second-guessed the fda's judgment about acces a drug, right? >> that is correct. do you think the fda's infallible? >> know your honor and we don't think that question is keyed u in any way in this case. >> has the fda er proved the drug in and pulledt after experience showed a catalog of ally serious adverse consequences? >> is certainly ne it in your andr that underscores what the adverse event reporting the post

market surveillancehafda do the abity that these plaintiffsaveven if they don't have standing certainly ey are seeing patients who are presenting with adverse events and if are doing studies that show there is some unknown safety component tt fda should acknowledge they can take significant steps to bring that to the agency's attention. >> don't you think the fda should have continued to require reporting of a nonfatal consequence? thk your fheif you decided not to continue the reporting requirement in 2016 based on more than 15 years of the welllished safety profile for not reporting was required. the is no drug on the market they enter any round that requires the reporting that thee reimpose. >> why would that be a bad winch company, you don't want to sell a p that causes very serious harm toheeople who take your product and

relying on your test. wouldn't you want tta? >> your honor that data certainly something we are looking for the time. obligations bind the manufacture to be aware of a da that's becoming available. we have a 1-8ber on our b site and the 1-800-number on -- your honor's question gets to that concern i heard an earlier question about who would have standing to these plaintiffs don't have stain to one of the things i want t noteug manufacturers are very frequently subject to tort litigation product library will they -- advertising seats when someone is claiming harm from me pharmaceutical manufacturing process. what is so revolutionarybo the arguments here both on standi ithe merits are the way they attempt by individuals who do notse it'srocts do

not prescribe the product and have it conscious r not to treat anyone who has used the product is individual want to prevent anyone from using it in line with the fda's judgment. say just one more point along the same lines. is yourompany think that what the fda has done preamps state law that prohibit the dispensation of mifepristone with tir borders? >> wave not taken a position on this issue and it's not been keyeup >> what isr company's position on the? have you had any thought about it and what if your competitors ve an argument? there some lawsuits have been brought a company that ma that argument and i think that's r later courts to sort out. our position in this case has been tt is is about fda's scientific judgment reached in 2016 and 21.

>> you don't want to answer that question? we don't have aion on that. i'm prepad to say. the can you getusti alito's question, couldoualk about that a little bit and what adverse event reporting and what instead were you subject to the past? >> may answer the question? just a cave in -- just as kagan the adverse event reporting it habe the same. drivers obligated to report016 adverse events and then they had a separate reporting application to the fda. in 2016 it was more consistent

with the reporequirement that applies to all 20,000 plus approved drugs. ey are only today seven continued to have even a limited higher adverse event recording for death that applies to isto so there's only seven that have that. >> thank you. >> justice jackson. >> i just have one question. you say the agency is infallible and i'm just wondering do you thin courts have specialized scientific knowledge with respect to pharmacls and that the company that has pharmaceutical do you h ieific and medical studies? we have significant concerns

about denver to amicus brief from the pharmaceutical indtr that expand on why exactly that so concerning for pharmaceutical companies who do depend on f's full standard review process to approve their drugs and to be able to sell their products in line with that cred judgment. >> can you say a ltl bit out what they?ap to. the reality is and thicot, decision below is a good example of it. you have a dtrict court that among other things relied on one study that was an analysis of anonymous posts and another set of studies tt relied on that were not in the adminirave record and would never be because they postdate it and it's been since retracted for misleading presentation at fema. those o errors and judicial analyses precisely because judges are not experts

in statistics and not experts in th methodology used for scientific studies or clic trials. that is why fda hasany hundreds of pages of analysis in the record of what the scientific dat shows and crts are just not in a position to parse through decd-guessed that. thank you. >> thank you council >> misms. hawley? >> may it please the court. the dn nearly restored long-standing and crucial protections under which millions of women used abortion drugs. we talked a lot about standing. article iii i cited here because when the fda rel th of harm i abortion

drugs and to cup fda concedes between 2.94.6% of mewill end up in emergency rooms and three the fda acknowledg as women arev morey to need surgical intervention of their medical care without an in person visit. according to -- nearly 650,000 women take mifepristone every it's no surprise respondents have experienced an increase in emergency rooms visits and deed treated women suffering from abortion drugs harm tens of ousands of times. dozens of time women have suffered tens of thousands of responded doctors is not a b in the ft system the partm the party that ver design. ruling against again respondent authenic you wou allow fed agency to conscript nonrelad parties in the filing their consciousness and suffering other harms without judic recourse. article iii neither demands nor

permits this. fda's outsourcing of abortion drugs h doctors forces them to chotween a healthier woman with a life-threatening condition and violating their conscience. this choice is intolerable. on the merits if he failed to comply with requirements. in 2021 it eliminated the init person visit based on data and elsewhere it's.j! in 2016 it had failed to considerxpin the humility of removal safeguard. wholesale of what the fda requires.ar shot i welcome trt's questions. >> council you assert an injury he part of the line of veed time and resources. n't that just the cost of litigating and pursuing this litigation? first what responded doctorse o.

particular practice asell a structure that medical practice ng life into the wor they are called from their labor and delivery court to truman that is diametrically opposed to why they ent medical profession and comes along with emotional harm as dr. scott talks about these being heartbreaking situations and in the stressful work she's h deal with your honor. >> i understand that i'm talking about the injury of having to >> with respect to the. organization? alliance. >> we think havens the best evidence of s the fda's reply brief. underlying brief in the case and there was economic harm to this cot'case specifically says the fact i'm part the nature of the harm was non-economic did

not prevent the court from finding inj havens whether there was an impa of the organn's missionnd second whether there was an expenditure of ces. both things are iede. taking a look at how our organizations have been harmed they've been for use did resources and advocating for their pro-life mission to explaining the dangers of the harm from abortion drugs. one of primary reasons that is required is because in 2016 fda took awa requirement that abortion providers report >> but that would be anyone who is aggressive or vigilant a bringing lawsuits, just s by using resources to advocate your position in court. you say now causes an injury

seems easy to manufacture. >>'t think that's true in this case justice thomas. acknowledgeouave a prelude litigation type of activity. in thoseases those resource justificaton't count but in this case if you look at respon declarations they know tey have analyze studies and several are in the record and they are short. they come through medicaid data and to get the truth nature of adverse events and although search of things are neither a prelude tohe negation nor would they have occurred but for fda's conduct. >> council in the line you put about economic -- that had to do with the fact that they gen -- sohe was no economic lawsuit orto renting the apartment but was i think they provided

servesn their own. it wasn't just the member services that they provided they were providing services to people to help them with the departments but that's an important distinction from separate from the individual defendants claim of standing based on their resources. the ornitions are not losing anything. their job is toactlyhat you are talking about and they are doing it. they are investigating certain proble that's not an injury that's rre of the bike vacating this rule. >> a couple of things your honor this court in havens did not rely an econom nature. i would point y were the court

said that non-akamai nature of housing they were speaking broadly. again you'd have to dig throu the underlying brief to fin the ic interest of the court injury it's reversible.r our own for example if the regulations protections whereby thehe individual abortion providers ed to provide information about adverse events that would provide a respondent organizations with more accurate information about the harm of aboron drugs. >> council counselor can i ask you about the remedy and the way i was talking with the a.g. but it makes perfect sense for individual doco for a -- what they are askr here in order to prevent them from possibly ever having to these kinds of procedures

everyone knows should prevented from getting access to this mion so why isn't that plainlyverbroad the remedy in the end of this case? up with the premise of that question just as jackson i don't think her doctors necessarily able to object. with one is the emergency nature of the procedures. sap acknowledges many women go to the emergency-room and if we just think authat that might like. report.n the labor in livery >> i'm sorry ion't want to esize. tell me in her declaration where she talks about nog able to object or pe a consciousness objectio >> she talks aboutou honor udent can you point me to anyplace in the declaration whe a declarant states that they attempted to object x. they knr honor for twosons.

responded doctors don't necessknow until they scrubbed and at the opera and whet may or may not be abortion harm. could be an elective abortion. ddition the government simply cannot get his story straight if you look at the district court in that case we we would love for this court to adopt thisosition. >> let me ask you this. if we were to find there are conscientiou objec that say hospitals taken iccount in these doctors do have a way, shoulde in the case on that basis? >> we would welcome tt t it's not broad enough to include ouredy. because they are emergencies situations they can't precious moments sng in. >> i'm saying assuming we have a the objections that you say that

the paid my question is isn't that e to remedy issue text do we have to also entertain your arguments that know one else in the world have this drug for no one else in ame should have this drug i order to protect your ? >> in your honor it's not possible gen the emergency nature of the situation >> council let me interrupt there, i'm sorry. i think just as jack i saying with respect to client normally in article iii the judicial equitable remy the issue and we say over and over again provide a remedy sufficient to address the plaintiffs asserted injuries and go no further. we have before us a handful of individuals who havesserted a normally they would allow an eqe relief to address them.

recently and i think what just as jackson is alluding to wha we might call a rush of universal injunctions and in this case seems a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an fda rule for any other feral government action. >> yes, your honor. i think it's an practicable praise aious objection. nk that district court remedy was perfectly appropria under section 705. section 705 granted dripping courts authority to issue all necessary and apate relief and thenment acknowledged argument when the parties before the court nregulated parties. the onl avenue in which they could posset relie+5in the

course the parties before the court get it and that's in this case an issue or another various parties before the court won't get it. >> why can't the court specified this relief belongs to the before the court as opposed to looking at the agency and general and saying agency you can't do this anywhere. >> i think your honor that might be impracticable. in the emergency-room situation she'd have to know w she's in emergency-room and whether it's in a miage and ectopic pregnancy o an elective abortion. this is whe does day in and day out so it seems t plaintiffd ns would still be in place and permit thing mail-order abortion. they would ever met th reporting reqrents and if

you look at the merits of what two things.2021 fda relied on they relied first on the data. >> counselor before you back to the mi went back and looked and there exactly zero univers injunctions that were issued during franklin delano roosevelt's 12 years in office. pretty consequential ones and over the lt ur years or so the number is something like 60. maybe more than that. it's a relativelnething in your asking us to pursue this relatively new remedial course. th courtas never adopted itself with this and i just want t give you one more st that. >> sure your honor. agai the apa encapsulates equitable remedies and in pomeroy and others have said to

ng at the 19th century requires the parties before t court get this#■ instance wheree non-graded parties at those parties co farmers or seed farms but they are only availabilityelief is if the court does something to the fda. otheise the parties are out of . may i ask ms. holly about your basic standing and this is a clear occasion. when you did your one, two, three it sounded problematic to me. ing along the lines of we represent a lot doctors and their a lot of wut there fraction of them will have verse events in some fraction of those are going to come t

the emergency-room and so there's some probability or likelihood that one of our objection is going to comes face-to-face with one of these women who has an adverse event. is that your theory? >> no, your hor but we think shows respondents standing here is fda's own acknowledgment so i'd point y to j. a3 inform regulatingonly saidency-room doctors hospi critical to the safety. >> les satish or theory. even fda admits that they are going to be adverse eve and people are going to show up in emergency rooms. le are going to come face-to-face with one of our s objects to some aspect of the treatment. but we don't think it's as true

problem withstanding as was the case under sumrs for summers involved unidentified numbers. here we seven named plaintiffs. no one in summers -- the sure theory depends on your having at least one person bau summers to be saying these probability theories sound and have nothing to d with article iii requirements. you need a psoto fail to come in and meet the court's regular st requirement >> do believe that's co i believe that's correct your honor. >> if you had to pick one in sayed go read that declaration t clation is going to te you why we are entitled to be here. >> dr. francis and doctors >> what about tse two doctors

gives you the kind of eminent injury let alone the trans ability that we lly require? speaking to f at the beginning there has been confusion about the precise conscious unpredicted look at ab other m whoraph 15 she talks object not only to taking the life of an unborn child during an elective abortion but also completing that process. it's cent with. >> i read that declaration pret carefully. what actual emergency treatment but she partid in that she objects to and that she is stated in objection to? >> the prior page talks the d which he was required to

life-threatening injury. >> she herself performed that? >> that is correct. >> tichy have an opportunity to object image objec made your honor these are life-threatening situations where a choice for the doctor is to either scrap out and try to find someone else or treat a woman. >> usually conscious objections thpeople with conscious objections to this as they make those objections known and that be harder and it may be easier in a particular context at most hospitalsave mechanisms in place and routines lace to eure doctors who in advance and they are allowed to do it at the moment. they say so and when i looked at . ancis' and doctors scott, there's nothing u ve there that suggests tha know this is the other requirement that

you need but at the very least to be upo say what this happenedo em in the past, i either one of those doctors. >> i thi we d honor given emergencye. it's simply impracticalave an objection law. understawhat's going on in i point to the district court where the government saysneithef the sponsors■l of those consci protections apply in emergency situat it's a lot to ask our doctors that the top one litigate this th the general counsel. >> is it true that our standing decisions have not relied on problem unless determinations like the deptmt of commerce case who said they were standing because the question about

the questionnaire a certain percentage an unknown percentage of residents would then not fill out the censall and therefore it is pr there was some risk that new york state would ris losing a representatives and risk losing money under some federal program and put together this chain of probability and efficient to establish standing. >> absolutely we agree with that justicelito. in particular you can look at the seed farm case which involve nonregulated parties in this court looked at the distance and it's appropriate to consider in determining the substantial risa fda commits an 533 between 2.9 m4 .6% of women will g to the emergency-room. it acknowledged us542 that

up to 7% of women will need surgical intervention. when the fta talks about there events from the increasedr gestational age the only way an say that is by ignoring surgicervention. >> but what do we do with the fact that these two people rely on the scope that indiana and texas have abolished abortions and abolished them by pills or otherwise. we can get into whether other people are illegally breaking theaw what ds e duty of probability which is ihe are thf hospitals in the cntry, 50 states and i don't know homany territories, thousands and

thousands of places where pregnant women go who may be suffering from miscarriages or otherwise to know or toow one de a patient that he or she is going to be forced to intervene on their behalf but then addo states. thislegal in the >> the best answe justice somar in our declaration we have three doctors that it should b to abortion drugs a dozen times ande e examples where women went out-of-state and if you bought a state there's a higher have a follow-up visit.oing to would the fda's regime has done is er brooms into follow-up visits. we have had that happen with the where a woman went to illinoison

and was followed up in indiana.d illinois their border states which doctors decide. >> ms. hawley can iake you to justice kagan's question? were talking about ■"dr. francis and as i read your allegation as her affidavit reads she said that her partner wa p a dnc and she said she performed a dnc and woman who was suffering lications but the fact that she performed a dnc doesn't necessarily mean players a living embryo or fetuss because you can at have a dnc after misce. if that's right, i think the difficulty here at least to me the conscious objections at two participating in abortion and the lifehe embryo or the

fetus and i don't need either scott or fra to say they have indicated that so do you want to address that? >> first just disparate dr. fr can be read from the broader conscious. that's how the dt court understood it and that's how the state panel and e fth ciunderstood it to extend beyond simply requiring ending up in unburned life and with■% respect to whether a docr maneed to end-of-lifehe think they are still a substantial risk of th occurring. if you look at the numbers in the increase of seven to 10 s and just is not age that means 3.1% of pregnancies will ongoing requiring a dnc. we know in our oa 7055%■■ of the dnc's occur in the emergency-room. it's a substantial number of

woffering abortion drug harm and again 650,000 women. involve pregnancy that would otherwise be viable or an embryo or fetus. there could be complications or excessive bleeding even after abortion is completed in >> up to 7% will need surgery to stop either bleeding or ongoing pregnancy. >> how many members of your organization, you abductors in your organizat and dentists. many members of your organization or ob/gyn who prti hospitals? that they are hundf them your h i thinkn particular the plaintiffs are hospitals who

spend most of their time on the labor and delivery floor but are called to do or to treat certain emergencies. >> ms. hawley can you clarify broader conscious harm and i interested the conscious harm is just disparate dead but you suggest it's a broader one. >> i pointbe pages 78 of the diri court patisso court understands the conscious harm to be either t the life of an unborn child which testify through partner required to do that because it's an gency situation. >> i am participating in a procedure that's ending a life. what is the broader one? the broader one is being complicit inherocess that unnecessarily takes an unborn life such as reforming a dnc abortion and is t that hard. i work in emergency-room and

this is going on? i'm giving tm a water bottle? o you mean complicit in the process? >> this court takes -- what harmshe doctors as being involved in completing in terms of our declaration and elective abortion and it's really not that hard to see why that might be a conscious harm could he thinkbo what's involved in it. >> again it's being involved in completing and ee abortion. i took that mean the conscious objection i think what justi jkson is asking her what i asked before whatus disparate is, is there any broader conscious objection that appears and i'm not se i care that much about the district court b appears in the decla. >> guesser honor in this instance completing an abortion

drcis talks about being required to perform a didr or nt live tissue. i would point t paragraph 15 where she talks about completing an abortion. the declaration on 142 and 143 describe complicity harm. being involved in an elective abortion and these doctors performing a dnc mcrape out a woman's uterus and the emperor and the fetus or tissue in this court is recognized harms like that. >> sorry. it's mind standingtg sometimes the completion does not involve cervical intervtion. we may get all the way down the

chain tohe doctors in their persons having the emergency procedure annderstanding is for some of these chemical completion occurs by prescribing additional medications. do you have a sense of how many times the completion is that raven could be done by another doing a medicalosed to your procedure? the second mstone is an parte regimen. all the way back to 2001 but it's been approved by since 2015. the best numbers we have are still consistent with that and that means 3.1% of pregnancies will be ongoing. i enure you to look at j.a. 40507 for this explains these risks go i'd guess i'm trying to get at i'm still working on how many circumstances and ten it would be that clients have

to complete the procedure in a way that you are describing. >> dr. scott talks about doing this a least a tusd times easier dnc or section aspiration abtion of the placental tissue. in additior honor if he think aboutumbers again to 3.1% at 10 wee and this is only gone up. in 2020 fda told this court than person visit would be cessarily verdant sum on a woman's health >> thank you council. justice thomas. >> ms. hawley i'm sure you have heard the answers of thed the counsel for danco with respect to comstock. i'd like you to comment on their answers.

>> sure justice thomas. we don't think there any cases with respect to the comstock act that's relevant here the comstock act says the drug we think the plain text of thatl is pretty clear. >> when did you raise the comstock act? >> i believe the comstt was first raised in the district court but wehi exhaustion does not apply for two reasons. first it was futile as fda's adoption goes. this is a whole other kettle of fish if you look at section 704 adoptions, excuse me adoption is only required in some instances eithstatute or agency rule with pending litigation. this is consistent withase of derby the lower court give

soliciting opinion we think a better reading at 704 is that there's no exhaustion required unless the statute or agency rules are preceding during judicial review. >> justice and? may i ask your view of traceability and one understanding i want you to tell if you agree with this. beyond proving whatever injury you are tryingo prove that you have to show that the injury is traceabltohe 2016 and fda actions that you are challenging. of course data showing that these incidents that you are talking ab the emergency-room are caused by whatever incremental increase and risk there is as a result of the 2016 a0ction.thfit questionu agree with that statement and what y nd to sou

do how do you satisfy that and why do you satisfy that? we believe justice and under case flowing to show it increases the risk of >> i guess what i'm saying is you haveo link whatever injury your members have tubet increased risk. do >> we do and for a couple of reasons. traceability we are not in a polygraph sort of the world. we lookhe 2021 action we think traceability as satisfi by ellsworth and so j.a. 405 the study without that in person visit other medical care is likely to increase. these ar the same sort of questions that harm responding clients. spirit that might bdiute between the two of you which is

how big the increased risk is let's even take your view that therome measurable increased risk. how do you connect that risk to particular actions that your member have two particular injuries that your members have undergone or undergo? it could be original risk. >> i think the declarations are quite clear if you look at dr. francis' declaration when it was joined by federal dist court she saw increas emergency-room visits. this is entirely consistent wit in 2020 fda told court in person visit wessary to preserve women's health because and in per visit is the best opportunity to examine for things like accurately

addressing gestational age and thank you. >> ju gorsuch, just disparate? >> general prelogar said there's no -- you wouldn't necessarily give an accurate occupational pregnancies so why would that the elimination of those visits necessarily increase the >> your honor fda's own data shows that those risks did go up. if you look at the correct study it shows a nearly threefold increase emergency-room ts when you have it. it was 5.8% was also about 2.1 without. because surgeons voluntarily said this would be good idea to have have a filter sound t detected fetal heartbeat wt? >> when they removed the in person visit took away the

opportunity to do that. local organizations created tha best practice info woman comes into doctors offer she's likely get an ultrasound to access both econom - at tom: pregnancy -- at topic pregnancy. you have to be able to order these on line with a coue ening questions. >> let me to the organizational standing question.s y i'm just going to carve out them put aside the cost of filing a petition or litigation andlying to your organization is help explain to me what it additional cost tto me that the incurred or how your resources were deferred. the decoration is clear that rentrganizations conducted studies in and lay studiethis included going through the medicaidata into

the data to the extent it was ailable and i would point to roa 870 and before-and-after. the circumference of studies. >> are they at the end of litigation or were they -- state to assess the harm from abortion ugs your honor. that's separate from the litigation and wanting to know what this institution is that is the only way anyone can raise a concern to the fda. proceedings go on between danco behind closed doors. the best way to raise these is throughetition. >> justice jackson. >> what difference if an support the opinion on the expert agency concerning the safety and efficacy of drugs? under the court's administrativerodure

precedence in this case we are asking the courts that can grasp the determination a a but look at what fda says. when fda took ay pression visited did so based on data and said it cannot be used to calculatan adverse event and studies hav said j.a. 407 are not adequate. >> i guess i don't understand how that scope of review is not second-gg the agency. they are looking studies and are saying the courts can look at studies a may be different studies and maybe the same studies and proceed t their conclusions about them so what deference dwe them at all with respecheirt is that thy say they do abo safety and efficacy? >> i don't think an accurate portrayal is at issue here.

the reason being is a discussing the court to look at whatda said. they said you have to have ad test. >> did the lower courts go beyond that? have since been found discdnd removed sohe were obviously looking at not just with e a was looking not in ord tmake their assessment. are you askg to just look at the fda and not anything else? >> that claim is note this court buckworth -- with resp to the claims b the court in 2016 and 2020 and wthe fda's own statements are arbitrary. in 2016 let%g t are to look at individual studies and even though they are interrelated when you're going to take athe protections away at once. that was arbitrary and state farm it would be arbitrary

as well. buttal geral prelogar? >> mr. chiefustice u.s. where you cr get in to impending injury wanted accords but that is whether the harm is materialized in east doesn't always guarantee they will be future injuries and hear what is telling respondents don't have a specific examplef any doctor having violated the scare iniolation of their cons. instead respondents have pointed to the declarations that specify one of their identified membs here's the care i provided and here's how a of my conscience and here's why conscious protections were unavailable to me. they don't have the doctors willing to take that sworn declaration in court demonstrates pastrm hasn't happened in the reaor that is because it's so itould if in so many links chain occurring at the end would have federal

protections and play. myrid is pointed to the facts they invested time of preparing at citizen petitioned and th vuntarily conducted studs. if that is enough every organization in th cntry has federal policy dates lere havens cannot possibly do that for the court should say some clarify produce at the out of bounds and respondents don't qualify unde standard. >> oth remedy justice gorsuch and justice jackson you point out a siking anomaly. justice jackson you suggested maybe re tailored remedy is thearties. they sued the fda. fda has nothing to do with enforcemen othe conscious otection but that's happening far dowm at the hospital level and the only way to prida remedy based on this injuryaso grant this nationwide relief that is so far

removed from fda's regulatory authory 's ultimately requiring all women everywhere to change the use of this drug. it's worth stepping back finally and taking the profoun mh between a serious injury in a remedy thaondents obtained. they have said that theyr that there might be some emergency-room doctor somewhere someye might be presented with some woman who is suffering anncredibly rare complication at the doctor might have to provide tatment notwithstanding the conscious protection. materialized to what the court did is to guard against at rete risk and nationwide relief for sticks access to mifepristone to every single minus country thataus harm. it harms the pharmaceutical industry whichsounding alarm bells in this sen saying this wouldestabilize improving and regulating drugs and it

harms women who need access to medication abortion and truth conditions the fda determines are safe and effective. the court should reverse the instructions to dismiss inconclusively in this litigation. >> thank you council. the case is submitted. ..

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