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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
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...
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Mar 26, 2024
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all things the fda decides. it's been making these decisions for the last few years that have loosened the rules to make it more accessible. so the central question today, does the food and drug administration have the last say on how drugs are prescribed and what drugs are allowed, or do the courts have some kind of authority as well? antiabortion groups say the court should have a say, that the fda should not have the last word. but drug companies say if the courts got into the pharmaceutical business, that would allow all kind of things, for instance, what if the fda denied approval for some new cancer drug because it was ineffective. could that drug company get the denial overturned by going to the courts? >> it could have the effect of really undermining the fda and essentially saying anybody who has an idealogical concern about a certain medication could try to go to court after the fda's experts have reviewed the evidence and determined that it's safe and effective enough to be approved. >> if the supreme
all things the fda decides. it's been making these decisions for the last few years that have loosened the rules to make it more accessible. so the central question today, does the food and drug administration have the last say on how drugs are prescribed and what drugs are allowed, or do the courts have some kind of authority as well? antiabortion groups say the court should have a say, that the fda should not have the last word. but drug companies say if the courts got into the pharmaceutical...
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the fda extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies to their business. this is the voice of justice neil gorsuch. and this case seems like a prime example of turning what could be a small lawsuit. >> into a nationwide legislative assembly on an fda rule or any other federal government action. >> a decision on the case is expected this summer in washington. i'm maddie beer-temple. governor gavin newsom pushing back on the latest attempt to ban abortion in the united states. he released a statement. >> just in the past hour stating quote, republicans want a national abortion ban full stop. they'll do whatever it takes, including trying to strip away fda approval for a drug that's been
the fda extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies to their business. this is the voice of justice neil gorsuch. and this case seems like a prime example...
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the fda extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies to their business. this is the voice of justice neil gorsuch. and this case seems like a prime example of turning what could be a small lawsuit. >> into a nationwide legislative assembly on an fda % rule or any other federal government action. >> a decision on the case is expected this summer in washington. i'm maddie beer-temple. >> governor newsom released this statement saying, quote, republicans won a national abortion ban full stop and they'll do whatever it takes, including trying to strip away fda approval for a drug that has been proven to be safe and effective for decades. these hostile actions are not just on popular. they
the fda extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies to their business. this is the voice of justice neil gorsuch. and this case seems like a prime example...
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steven: speaking of the fda, i want to talk about the regular -- the ai. in particular, ai is only as good as the data driving it. you have to acquire a lot of data, and in the case of health care, a lot of personal data, and companies like verily are being entrusted with the information, some protected by hepa and other privacy regulation, but some not, so i'm wondering what regulation might be missing that is needed as ai becomes the norm? great question. certainly after the biden white house put forwardhe exetider ont was showing ai touches every aspect of life, and there is the potential for us as a society to recognize where is the most individual and how is it we might be able to protect this, but not as a hurdle getting us to that utopia where perhallctos and have better diagnosis, faster care, cheaper care. that is the promise that we bee ai can get us to. steven: the vision we are working towards. dr. trister: right, but to get there, we have to understand where people feel comfortable today, and understanding what data could they contribute, what
steven: speaking of the fda, i want to talk about the regular -- the ai. in particular, ai is only as good as the data driving it. you have to acquire a lot of data, and in the case of health care, a lot of personal data, and companies like verily are being entrusted with the information, some protected by hepa and other privacy regulation, but some not, so i'm wondering what regulation might be missing that is needed as ai becomes the norm? great question. certainly after the biden white house...
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guidance for its 2016 updates and second guessing the fda's medical advice. it would limit access to the abortion pill, even in states where abortion is legal. every box would need to be pulled and labels updated. a decision in support of abortion opponents could jeopardize every fda approval on all other drugs, potentially extending to certain vaccines and birth control. this is the first major challenge to abortion access since the court's conservative majority overturned roe v. wade two years ago in the dobbs decision. a decision is expected by june at the height of the presidential campaign. with all that, joining us now is yamiche alcindor, andrew weissmann and dr. patel. yamiche, to you. what are the questions in the court? what are the crowds saying in this first test of an abortion -- certainly, abortion-related procedure since dobbs? >> that's right. this is really the most consequential abortion case to come before the supreme court since this court overturned roe v. wade in 2022. we have been outside all day. there's a large crowd. mostly people wh
guidance for its 2016 updates and second guessing the fda's medical advice. it would limit access to the abortion pill, even in states where abortion is legal. every box would need to be pulled and labels updated. a decision in support of abortion opponents could jeopardize every fda approval on all other drugs, potentially extending to certain vaccines and birth control. this is the first major challenge to abortion access since the court's conservative majority overturned roe v. wade two...
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Mar 4, 2024
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the fda are highly skewed towards avoiding risks. so there's a tendency us to have drugs that are safer, but not to have drugs that are effective. now i've heard remarkable statements from some of these committees in considering drugs. one has seen the statement. there are not enough patients with disease of this severity to warrant marketing. this drug for general use. now, that's fine if what you're trying to do is to minimize drug toxicity for the whole population. but if you happen to be one of these, not enough patients and you have a disease that is of high severity or disease, that's very rare, then that's just tough on you. for ten years. mrs. estero dean suffered from severe asthma. the medication she received serious side effects. her condition was getting worse, but the drug her doctor preferred was prohibited by the fda. so twice a year mrs. usdin had to out on a journey. i had been very sick. i had been in and out of the hospital several times. and they couldn't seem. to find a way to control the asthma. and i had to cha
the fda are highly skewed towards avoiding risks. so there's a tendency us to have drugs that are safer, but not to have drugs that are effective. now i've heard remarkable statements from some of these committees in considering drugs. one has seen the statement. there are not enough patients with disease of this severity to warrant marketing. this drug for general use. now, that's fine if what you're trying to do is to minimize drug toxicity for the whole population. but if you happen to be...
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Mar 19, 2024
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of fda medication is far safer and allows you to live a happier, healthier life than, you know, using fentanyl several times aitude that remains pervasive throughout american society. host: lev facher, who report addiction in the united states for stat news, you can find it online. (202) 748-8000astern and central time zones, (202) 748-8001 mountain and pacific. for those of you with a speci. paul, you are on with our guest, go ahead. caller: thank you for take my call. i had a couple of questions. i currently take opioids and i have for quite a few years. i've got five major third test had five major surgeries, arthritis. you haveindtion. is there a government formula that says x amount of milligrams is safe forguest: yeah, i figurd get some from patients with pain, it's a huge subplot in my opinion. for those who may not know, you know, in t mand, you know, aboue ago, there was of course a huge prescription opioid oversupply problem driv large part by companies like purdue pharma and the medication oxycontin. of course, the government respon to that was to really restrict opioid pre
of fda medication is far safer and allows you to live a happier, healthier life than, you know, using fentanyl several times aitude that remains pervasive throughout american society. host: lev facher, who report addiction in the united states for stat news, you can find it online. (202) 748-8000astern and central time zones, (202) 748-8001 mountain and pacific. for those of you with a speci. paul, you are on with our guest, go ahead. caller: thank you for take my call. i had a couple of...
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the fda are highly skewed towards avoiding risks. so there's a tendency us to have drugs that are safer, but not to have drugs that are effective. now i've heard remarkable statements from some of these committees in considering drugs. one has seen the statement. there are not enough patients with disease of this severity to warrant marketing. this drug for general use. now, that's fine if what you're trying to do is to minimize drug toxicity for the whole population. but if you happen to be one of these, not enough patients and you have a disease that is of high severity or disease, that's very rare, then that's just tough on you. for ten years. mrs. estero dean suffered from severe asthma. the medication she received serious side effects. her condition was getting worse, but the drug her doctor preferred was prohibited by the fda. so twice a year mrs. usdin had to out on a journey. i had been very sick. i had been in and out of the hospital several times. and they couldn't seem. to find a way to control the asthma. and i had to cha
the fda are highly skewed towards avoiding risks. so there's a tendency us to have drugs that are safer, but not to have drugs that are effective. now i've heard remarkable statements from some of these committees in considering drugs. one has seen the statement. there are not enough patients with disease of this severity to warrant marketing. this drug for general use. now, that's fine if what you're trying to do is to minimize drug toxicity for the whole population. but if you happen to be...
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wade was overturned and you had an one side the fda as well who was represented by the u.s. solicitor general and a lawyer for danco, the maker of mifepristone. they were arguing the fda should have the regulatory rights to continue to regulate and to have the approvals processes and approval authority over this mifepristone medication and they were arguing that the fda used science-based evidence to continue to not only approve this pill and continue to allow it to be accessible, but also to make it more accessible in recent years. they were arguing on the other side they were arguing that there were hypotheticals and all the different things pitching back against the fda authority to do what they did in recent years was really not based in actual fact. on the other side, you had antiabortion groups who -- and their lawyers arguing that the fda did -- that the fda in expanding the access to this pill, but they made women unsafe and that they did so in a way that would hurt the ability of women to get critical care. they also argued in many ways that doctors including emerge
wade was overturned and you had an one side the fda as well who was represented by the u.s. solicitor general and a lawyer for danco, the maker of mifepristone. they were arguing the fda should have the regulatory rights to continue to regulate and to have the approvals processes and approval authority over this mifepristone medication and they were arguing that the fda used science-based evidence to continue to not only approve this pill and continue to allow it to be accessible, but also to...
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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 interstate bridge has collap
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...
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this includes officials from the cdc and the fda. you are watching live coverage on >> i advised members and remind them of all the rows of corn. the issues we are debating are important. the members feel deeply about. i understand that. while vigorous disagreement is part of the legislative process, members are reminded that we must adhere to established standards of decorum and debate. this is a reminder that is a violation of house rules and the rules of this committee to engage in personalities regarding other members or to question the motives of a colleague. remarks about type are not permitted by the rules and are not in keeping with the best traditions of our committee. this is a very serious matter. of the courtroom at all times and urge all members to be mindful of their remarks today. if the chair finds the member to be in violation, remember will be suspended of speaking for the remainder of the hearing but i never organize myself for the purpose of making an opening statement. good morning. vaccines are crucial public he
this includes officials from the cdc and the fda. you are watching live coverage on >> i advised members and remind them of all the rows of corn. the issues we are debating are important. the members feel deeply about. i understand that. while vigorous disagreement is part of the legislative process, members are reminded that we must adhere to established standards of decorum and debate. this is a reminder that is a violation of house rules and the rules of this committee to engage in...
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numerous studies show that mifepristone, which was first approved by the fda in 2000, is safe. a study in the medical journaljama found that the number of self—managed abortions obtained using pills has soared with more than 26,000 americans using pills to induce at—home abortions after the overturing of roe v wade injune 2022. one of the things the justices spent a lot of time on today was not what we think of is the heart of the case, which was the fda's decision to expand access to mifepristone in 2016 and 2021, but instead on whether or not the challenges in this case, who are doctors and physicians groups whose members are opposed to abortion, have a legal right to come to court at all to challenge the fda's approval. you know, on two levels. first of all, whether or not someone can come to court to sue is sort of a bipartisan issue. it is something that justices of all ideological transfer attention to. it would also offerjustices and offramp to send this case back, to throw it out, without having to get to the heart of the case, the tougher question about the fda's a
numerous studies show that mifepristone, which was first approved by the fda in 2000, is safe. a study in the medical journaljama found that the number of self—managed abortions obtained using pills has soared with more than 26,000 americans using pills to induce at—home abortions after the overturing of roe v wade injune 2022. one of the things the justices spent a lot of time on today was not what we think of is the heart of the case, which was the fda's decision to expand access to...
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i mean, the fda says, look, we've followed our regulations. here are the way we always do. we had a system for collecting data about complications from this drug called adverse events for 15 years, we collected extra data we saw that the drug was very safe overwhelmingly safe, and based on the reports we were receiving and lots of studies that mounted over the years, we decided to loosen the rules that is the standard process that the agency follows. and if you think about this from the perspective of other drug companies, they're saying, well, wait a second if we can show that a drug is more safe over time, than when it was first approved. that's important for our ability to market the drug we want the fda to be able to update its determinations right? >> there's also an, another aspect to this and that is how the court interprets harm. right. because the question of whether the plaintiffs actually have standing came up over and over again today, and if the court rules that they do it's quite possible that we'll see more cases where let's say that the standard of proving h
i mean, the fda says, look, we've followed our regulations. here are the way we always do. we had a system for collecting data about complications from this drug called adverse events for 15 years, we collected extra data we saw that the drug was very safe overwhelmingly safe, and based on the reports we were receiving and lots of studies that mounted over the years, we decided to loosen the rules that is the standard process that the agency follows. and if you think about this from the...
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did the fda think of science and safety. much of the argument as you highlighted was about standing. and, basically, they said there are these seven doctors that have conscientious objections and it might be the case that at some point one of the doctors' patients will take mifepristone and it might be that might cause a side effect like a headache and that might cause that person to go to the emergency room. and if that person goes to the emergency room, it might be that that person will need to be treated and if that treatment is necessary, it might be that one of these seven doctors is the person treating it. that is a ridiculous chain of causation. i don't think it worked in the supreme court today. justices on both the left and the right wings of the court just expressed massive skepticism about this. and so i think that is where the case will be decided. >> to the second part, the issue of judges and science. mr. is an exchange on this. and i want to play for our viewers this exchange that begins. begins with justice k
did the fda think of science and safety. much of the argument as you highlighted was about standing. and, basically, they said there are these seven doctors that have conscientious objections and it might be the case that at some point one of the doctors' patients will take mifepristone and it might be that might cause a side effect like a headache and that might cause that person to go to the emergency room. and if that person goes to the emergency room, it might be that that person will need...
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back in january, the fda announced that buprenorphine was causing people to lose their teeth. this was on the heels of that other lawsuit where they were lying to people about the pills nond trying to force them to take the film. i'm starting to wonder, because of what's happening with people losing their teeth is that why doctors are not prescribing buprenorphine instead of the other opioid pain medicines? guest: i'm not aware of active change in prescriber behavior. it's true that one side effect of some forms of buprenorphine are dental decay. that is certainly something to of. while we are on the topic methadone is also a serious medication with potential side effects. first of does cause overdose. in much smaller numbers than fentanyl or a more powerful, licit opioid. but methadone can also cause heavy sweating, weight sexual dysfunction. these medications are, like a previous caller said, not a panacea. they are medications like any other with because it is, gatives, side effects and benefits. the bottom line is that people who take them are less likely to die, but there
back in january, the fda announced that buprenorphine was causing people to lose their teeth. this was on the heels of that other lawsuit where they were lying to people about the pills nond trying to force them to take the film. i'm starting to wonder, because of what's happening with people losing their teeth is that why doctors are not prescribing buprenorphine instead of the other opioid pain medicines? guest: i'm not aware of active change in prescriber behavior. it's true that one side...
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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 that a court has done that. >> there's a lot to get to. the former acting us solicitor general who has argued 50 cases in front of the supreme court, and be a legal analyst and host of the podcast courtside. thank you for being here. there are a couple of very interesting legal issues. one is standing. why is that issue-- let's start with that. what is the issue around standing? because it doesn't speak to anything underlying about mifepristone or abortion necessarily and it's about whether this case is valid. >> good to see you and before answering that i just want to disclose that i am unabashedly against this lawsuit and indeed, my law partner argued the case brilliantly today. the one great thing about the oral argument today is that all of the applicants were women, all three of them doing-- for the religious doctors. there are two issues. one is thi
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 that a court has done that. >> there's a lot to get to. the former acting us solicitor general who has argued 50 cases in front of the supreme court, and be a legal analyst and host of the podcast courtside. thank you for being here. there are a couple...
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challengers say the fda disregarded important safety issues when it expanded access. experts in the pharmaceutical industry warn the ruling could open up other medicines to new litigation. >> potentially what is at stake is the future of the existence of the fda and the ability of people with the capacity for pregnancy to regulate their pregnancies at all. what is at stake is the legality of contraception, what is at stake is the legality of abortion, even if you live in a state where abortion is legal. >> the biden administration is siding with the fda. >>> now to decision 2024, and in just a few hours robert kennedy jr. plans to announce his vice presidential pick in oakland. now, a few names to be floating around and his potential vp running mate, including nfl quarterback aaron rodgers, jessie ventura and california-based attorney nicole shanahan. shanahan is the ex-wife of google's founder. the announcement is scheduled for 11:00 this morning at the henry j. kaiser center. >>> family members are responding for the first time after two brothers were attacked over
challengers say the fda disregarded important safety issues when it expanded access. experts in the pharmaceutical industry warn the ruling could open up other medicines to new litigation. >> potentially what is at stake is the future of the existence of the fda and the ability of people with the capacity for pregnancy to regulate their pregnancies at all. what is at stake is the legality of contraception, what is at stake is the legality of abortion, even if you live in a state where...
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. >> reporter: the fda has approved the drug for use at up to ten weeks of pregnancy and under current rules, allows for providers to prescribe it via telehealth and send to it patients in the mail that's exactly how podcast host erin gallagher was able to access the abortion pill >> it arrived in my mailbox, and from there, it was up to me to decide when and if i wanted to take it. and as i made the decision to do it, it removed so many barriers. >> reporter: but all that could soon change because of case before the supreme court that could restrict the mailing of abortion pills, require that the drug be provided in-person at a doctor's office, and limit its use up to seven weeks' of pregnancy. >> most of our patients are finding out that they're pregnant around seven or eight weeks. >> reporter: the group behind the lawsuit, alliance for hypocratic medicine, which is against abortion rights believes the fda exceeded its authority when it made the drug more accessible. what do you intend to argue before the supreme court next week >> we're going explain to the court and show how the f
. >> reporter: the fda has approved the drug for use at up to ten weeks of pregnancy and under current rules, allows for providers to prescribe it via telehealth and send to it patients in the mail that's exactly how podcast host erin gallagher was able to access the abortion pill >> it arrived in my mailbox, and from there, it was up to me to decide when and if i wanted to take it. and as i made the decision to do it, it removed so many barriers. >> reporter: but all that...
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Mar 25, 2024
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they're fighting about fda rules. >> yeah. i mean, so obviously if the supreme court, for example, was to say that, the fda didn't have the authority to allow telehealth abortions in 2021 or didn't have the authority to lift other restrictions on mifepristone in 2016, the enforcement authority, the fda would be the one to say if someone was violating the new rules, we're going to impose a civil penalty or we're going to impose a criminal penalty, but the discretion about what to do that, when to do that, or whether to do that at all, would depend on who's in the white house. who is in that executive branch agency? it's reasonable to assume that enforcing mifepristone rules that the biden administration doesn't agree with wouldn't be a priority for biden in the same way it might be if trump is in the white house and someone is in hhs who feels differently about mifepristone, potentially even though some f itself feel very differently about mifepristone. john: the heritage foundation actually has a whole project of, of things th
they're fighting about fda rules. >> yeah. i mean, so obviously if the supreme court, for example, was to say that, the fda didn't have the authority to allow telehealth abortions in 2021 or didn't have the authority to lift other restrictions on mifepristone in 2016, the enforcement authority, the fda would be the one to say if someone was violating the new rules, we're going to impose a civil penalty or we're going to impose a criminal penalty, but the discretion about what to do that,...
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the fda acted extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies to their business. this is the voice of justice neil gorsuch. and this case seems like a prime example of turning what could be a small lawsuit. >> into a nationwide legislative assembly on an fda rule or any other federal government action. >> a decision on the case is expected this summer in washington. i'm maddie beer-temple. and governor gavin newsom pushing back on the latest attempt to ban abortion in the united states releasing the statement. >> republicans want a national abortion ban full stop and they'll do whatever it takes, including tried to strip away fda approval for a drug that has been proven to be safe and effectiv
the fda acted extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies to their business. this is the voice of justice neil gorsuch. and this case seems like a prime...
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one thing we should note, this was not about the fda's initial approval of mifepristone. this was about subsequent changes that the fda made during the pandemic and otherwise to expand who could get it, when they can get it, and who could prescribe it. what was being argued, in essence, by the challenges to this? marcia: well, if you focus only on the merits, which had to do with the changes that were made in 2016 and 2021, the challengers believed that those changes have created significant risk of harm to the women who take the pills, as well as are injuring doctors who have conscience objections, especially emergency room doctors, who may be forced to deal with the complications of the drug if it goes wrong for women. but really, william, the focus of the argument, that they were dominated actually, by this question of standing, whether the challengers themselves, which is an umbrella organization for anti-abortion, doctors and dentists, whether those challengers really had the legal right to bring this challenge to the fda in the first instance. william: the issue of
one thing we should note, this was not about the fda's initial approval of mifepristone. this was about subsequent changes that the fda made during the pandemic and otherwise to expand who could get it, when they can get it, and who could prescribe it. what was being argued, in essence, by the challenges to this? marcia: well, if you focus only on the merits, which had to do with the changes that were made in 2016 and 2021, the challengers believed that those changes have created significant...
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the fda acted extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies do their business. this is the voice of justice neil gorsuch. and this case seems like a prime example of turning what could be a small lawsuit. >> into a nationwide legislative assembly on an fda rule or any other federal government action. >> a decision on the case is expected this summer in washington. i'm maddie beer-temple. we also have a statement now from governor gavin newsom pushing back on the latest attempt to ban abortion in the united states. here's part of it. >> republicans want a national abortion ban. full stop. they'll do whatever it takes, including trying to strip away fda approval for drugs that have been proven
the fda acted extensive body of evidence. the biden administration defended the fda in court saying opponents lacked legal standing to bring the case because they aren't harmed by the fda's rules. we don't think they come within 100 miles of the kind of circumstances court has previously identified. the court seemed concerned that the case could have broader impacts on how many government agencies do their business. this is the voice of justice neil gorsuch. and this case seems like a prime...
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so look, i mean the fda mifepristone. this is the top takeaway, is incredibly safe safe for the tylenol. it's been authorized for 20 plus years. >> and >> we know it has recently been introduced in brick-and-mortar pharmacies. it's more critical than ever that we have this access in the wake of dobbs and i thought justice jackson, kentucky brown jackson had the right retort to that question, right? she said, has the supreme is the supreme court ever fallible? and i think the answer is from us. absolutely. and it's recent and they have to be cautious there at the lowest approval ratings in this country that they've ever had. >> it's a very important point. there's already been adjustments anticipated by medical providers about taking away this one part of a two drug regimen. and then you've got other issues that dr. talking about in terms of what it could do for even miscarriage treatment and beyond. ladies, thank you so much for being or tiffany write many time mirage you. thank you. >> both. >> well, rfk junior, he's got
so look, i mean the fda mifepristone. this is the top takeaway, is incredibly safe safe for the tylenol. it's been authorized for 20 plus years. >> and >> we know it has recently been introduced in brick-and-mortar pharmacies. it's more critical than ever that we have this access in the wake of dobbs and i thought justice jackson, kentucky brown jackson had the right retort to that question, right? she said, has the supreme is the supreme court ever fallible? and i think the answer...
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the fda has approved that as safe and effective. and that's what's on the line, among other things in this case that will be argued tomorrow in the supreme court. >> i know this is folly to ask, and you don't have to answer if you want, but what are you expecting the court to do here? everything i have read is that the underlying ruling, the district court ruling is so bananas that it would be unthinkable for them to side with that district court judge. that said, the appeals court did uphold some of what he was trying to do. so that makes it a little bit more of a wild card. what are you actually expecting? >> i don't want to predict what the supreme court is going to do, but i want to make really clear to your viewers that there was no basis in law and fact, use pointed out in the district court's opinion, and there was no basis in law and fact in the very conservative fifth circuit decision. so there is only one right outcome on the facts of the law in the supreme court, and that is to uphold all of the agency decision making. th
the fda has approved that as safe and effective. and that's what's on the line, among other things in this case that will be argued tomorrow in the supreme court. >> i know this is folly to ask, and you don't have to answer if you want, but what are you expecting the court to do here? everything i have read is that the underlying ruling, the district court ruling is so bananas that it would be unthinkable for them to side with that district court judge. that said, the appeals court did...
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so the fda stance was you look, we followed the proper procedures. there's really no great harm in this and that's why this drug has been out there since 2000. but the supreme court here might not even get to that broader issue. they might end up tossing this this case on the standing is shared will see what happens. >> jessica schneider. thank you very, very much for more on today's arguments. i want to bring in our senior supreme court analyst, joan biskupic, joan reading between the lines on the questioning, but that we all heard today, how do you expect the justices eventually to handle this? >> sure. wolf and it really was a compelling set of arguments at the court they were asking really piercing questions to all three of the electors who lawyers who took the lectern, one of them was a woman by the name of erin hawley who happens to be a very active anti-abortion advocate, who's married to josh hawley. he was there in the courtroom as four other officials, including the attorney general of new york, letitia james just shows the stakes of this f
so the fda stance was you look, we followed the proper procedures. there's really no great harm in this and that's why this drug has been out there since 2000. but the supreme court here might not even get to that broader issue. they might end up tossing this this case on the standing is shared will see what happens. >> jessica schneider. thank you very, very much for more on today's arguments. i want to bring in our senior supreme court analyst, joan biskupic, joan reading between the...
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she filed an amicus brief in support of the fda. >> this case really crystallizes what's always been the politicization of science in the abortion regulation area. but, the stakes are getting higher as we have courts strip federal agencies of their ability to make expert decisions. sarah: the case also contains what scholars say is a bold legal strategy. anti-abortion lawyers claim that a long dormant federal law passed in 1873, the comstock act, prohibits the mailing of any supplies used for abortions. so, that can be not just abortion pills, but also hospital beds and medical gloves, anything. >> anything. sarah: it would essentially shut down abortion across the united states. >> because everything is mailed. sarah: for activists like kristan hawkins, that is the aim. >> you make it illegal for doctors, for abortion vendors, for pharmacies to distribute drugs with the intention to end human life. that is a direct abortion. that is what the pro-life movement seeks to stop. >> no one will be targeting these precincts. sarah: hawkins runs students for life, one of the largest anti-ab
she filed an amicus brief in support of the fda. >> this case really crystallizes what's always been the politicization of science in the abortion regulation area. but, the stakes are getting higher as we have courts strip federal agencies of their ability to make expert decisions. sarah: the case also contains what scholars say is a bold legal strategy. anti-abortion lawyers claim that a long dormant federal law passed in 1873, the comstock act, prohibits the mailing of any supplies used...
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in 2016 and 2021 the fda allowed doctors to prescribe the drug remotely and send it through the mail. expanded eligibility to ten weeks. the administration argues the fda relied on medical evidence to initiate the changes and reversing them or banning the drug will have sweeping consequences for women. >> administration will continue to stand by fda's independent approval and regulation of mifepristone as safe and effective. we will continue to fight back against unprecedented attacks on women's freedom to make their own health decisions. >> anti-abortion groups and doctors sued the restricted drug saying the fda dangerously abused its discretion to push on demand abortion. a federal judge in texas invalidated the ruling. pulled the drug off the market. appeals court said the drug is legal but restricted access to it and here we are to sort it out. alliance defending freedom is arguing to restrict the drug saying quote the fda recklessly removed its original safeguards like in person doctor visits leaving women to suffer serious complications alone. women deserve better. the court is
in 2016 and 2021 the fda allowed doctors to prescribe the drug remotely and send it through the mail. expanded eligibility to ten weeks. the administration argues the fda relied on medical evidence to initiate the changes and reversing them or banning the drug will have sweeping consequences for women. >> administration will continue to stand by fda's independent approval and regulation of mifepristone as safe and effective. we will continue to fight back against unprecedented attacks on...
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Mar 26, 2024
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mississippi republican senator cindy hyde smith says the fda should be protecting women from the drug. they are breaking the law in doing this. they're endangering lives by doing this. the food and drug administration insists mifepristone is safe and its safety and effectiveness are closely monitored. health and human services secretary xavier becerra says restricting access to the drug would be harmful. more women would probably >> place themselves in. >> further danger trying to access the care that they need. have confidence in our arguments before the court. the white house says it will keep pushing for nationwide protections for reproductive rights. >> the court should wall on the case by the end of june in washington. i'm anna wiernicki. >> arrival of spring filling up your car may hurt your wallet. a little bit more. according to triple a rising oil prices are contributing to increases the gas station, including here in the bay area. the highest is in san mateo, a county that is at 5.16, san francisco and marin sonoma and napa counties not too far behind east bay. you can expec
mississippi republican senator cindy hyde smith says the fda should be protecting women from the drug. they are breaking the law in doing this. they're endangering lives by doing this. the food and drug administration insists mifepristone is safe and its safety and effectiveness are closely monitored. health and human services secretary xavier becerra says restricting access to the drug would be harmful. more women would probably >> place themselves in. >> further danger trying to...
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the justices heard arguments today from one side, really arguing about whether or not the fda should have the authority to continue to have approval over this abortion pill and should have the ability to expand that access. on the other side, they heard from antiabortion groups through their lawyer arguing that this, that the moves by the fda here to expand access to this abortion pill, that it really put women's lives at risk. and also put doctors in a situation where they would have to go against their conscious. >> without question, the fda's actions have made taking chemical abortion drugs less safe. today, i argue before the united states supreme court on behalf of doctors and medical associations who have witnessed these harms firsthand. the fda violated federal law in its ability to keep women safe. >> second guessing the scientific data-driven judgments of an independent agency is an extreme position that could inject uncertainty across american life. >> reporter: so there you really heard both sides laying out their arguments. the stakes here are the access to mifepristone.
the justices heard arguments today from one side, really arguing about whether or not the fda should have the authority to continue to have approval over this abortion pill and should have the ability to expand that access. on the other side, they heard from antiabortion groups through their lawyer arguing that this, that the moves by the fda here to expand access to this abortion pill, that it really put women's lives at risk. and also put doctors in a situation where they would have to go...
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and that's because of some of the arguments from the fda lawyers that government lawyers and also the drug manufacturers, lawyers they really said, look the doctors are bringing this case because they believe that they might at some point maybe have to treat women who appear in the emergency room because of potential complications from mifepristone, the justices seemed to indicate that maybe that sort of injury was just far too hypothetical to bring a suit and then we saw interesting comments from i'm the chief justice and also neil gorsuch talking about the fact that, you know, why did they did a handful of doctors have the power really to get a lower court opinion that would've banned this pill nationwide or at least taken back some of the restrictions on it. and here are the justices this case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on on, on an fda rule or any other federal government action >> thoughts. >> i guess, your honor hi again, i have to say that i think it's impracticable. to raise a conscious objection,
and that's because of some of the arguments from the fda lawyers that government lawyers and also the drug manufacturers, lawyers they really said, look the doctors are bringing this case because they believe that they might at some point maybe have to treat women who appear in the emergency room because of potential complications from mifepristone, the justices seemed to indicate that maybe that sort of injury was just far too hypothetical to bring a suit and then we saw interesting comments...
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accountable for violating the law to the detriment of women's health. >> reporter: they claim the fda did not adequately evaluate the safety risks and wants the high court to limit access even in states where abortion remains legal. >> risks are extremely minimal and it's extremely safe. >> reporter: they say it's been safe since its approval in 2000. a >> it would upend not just mifepristone but every drug approval. >> reporter: justices appeared skeptical of the challenge the anti-abortion doctors made. >> they're saying because we object to having to participate in this procedure, we're seeking an order preventing anyone from having access to these drugs at all. >> reporter: the supreme court is allowing full access to the drug while legal proceedings play out. >>> former president donald trump now under a new partial gag order in his criminal hush money case. the presiding judge ordered trump not to talk about witnesses or court staff in the upcoming case. the judge said the order was necessary, because past trump statements included threatening and inflammatory language that go,
accountable for violating the law to the detriment of women's health. >> reporter: they claim the fda did not adequately evaluate the safety risks and wants the high court to limit access even in states where abortion remains legal. >> risks are extremely minimal and it's extremely safe. >> reporter: they say it's been safe since its approval in 2000. a >> it would upend not just mifepristone but every drug approval. >> reporter: justices appeared skeptical of the...
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it was first approved by the fda more than two decades ago. this texas judge, a trumpet appointee, a lifelong antiabortion activist, he ruled the fda was wrong to approve this drug. i have to tell you, his ruling was not a monument to intellectual heft. i'm not a lawyer but i know it is a bad thing when you're ruling relies on two studies that have since been retracted by their publisher. also, another "study" that pulled its data from anonymous blog posts posted on an antiabortion website. also, according to a brief filed by the aclu, the ruling also cited testimony from a person purporting to be a doctor who is not actually a doctor, unless you are okay to make people call you dr. because you have a masters degree in theological studies. like i said, not exactly a model ruling. nevertheless, a republican heavy appeals court upheld that texas ruling. we don't know what the supreme court is going to do in response. today, in a post roe v. wade world, two thirds of abortion are done through medication and in this case, the court will deliberate
it was first approved by the fda more than two decades ago. this texas judge, a trumpet appointee, a lifelong antiabortion activist, he ruled the fda was wrong to approve this drug. i have to tell you, his ruling was not a monument to intellectual heft. i'm not a lawyer but i know it is a bad thing when you're ruling relies on two studies that have since been retracted by their publisher. also, another "study" that pulled its data from anonymous blog posts posted on an antiabortion...
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. >> fda is not requiring them to do or refrain from doing anything. they aren't required to treat women who take mifepristone. fda is not directing the women who take the drug to go seek out care from these specific doctors. >> reporter: and today, a majority of justices seemed deeply skeptical of the effort to further restrict the drug. >> i'm worried that there is a significant mismatch in this case between the claimed injury and the remedy that's being sought. what they're asking for here is that, in order to prevent them from possibly ever having to do these kinds of procedures, everyone else should be prevented from getting access to this medication. >> reporter: even conservative justices like neil gorsuch -- nominated by donald trump -- also sounding uneasy with limiting access to the pill. >> in this case, seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an fda rule or any other federal government action. >> reporter: the only two justices who seemed inclined to side with the anti-ab
. >> fda is not requiring them to do or refrain from doing anything. they aren't required to treat women who take mifepristone. fda is not directing the women who take the drug to go seek out care from these specific doctors. >> reporter: and today, a majority of justices seemed deeply skeptical of the effort to further restrict the drug. >> i'm worried that there is a significant mismatch in this case between the claimed injury and the remedy that's being sought. what they're...
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>> i'm going to try not to speak directly for the fda because the fda did this assessment analysis independently from hhs. they are the agency that has been tasked with that job with their scientists and i won't try to speak for them but what these conclusions was based on the science of the evidence they had before them. >> didy development or mental health consequences or impact on pregnant women? >> i'm sure they took into consideration all the information out there on both of the facts and evidence that there is on cannabis use. >> you are saying that for a >> i don't want to try to speak for the fda scientists because i didn't do the actual assessment but i am pretty -- >> you announced the recommendation. i assumed you would take into account impact on adolesct egn. >> i am sure fda would have taken into account all of the erent circumstances involved. i didn't make the recommendation was it was made by fda. >> i'm going to follow up on some of the questions senator meneez a s asked. your department is responsible for the administration of the office of refugee resettlementa correct? that
>> i'm going to try not to speak directly for the fda because the fda did this assessment analysis independently from hhs. they are the agency that has been tasked with that job with their scientists and i won't try to speak for them but what these conclusions was based on the science of the evidence they had before them. >> didy development or mental health consequences or impact on pregnant women? >> i'm sure they took into consideration all the information out there on both...
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the fda acknowledges that. i also want to emphasize that the studies were far from the evidence that was consulted. it had a real world experience during the 19 pandemic, a period of time when the person dispensing requirement was not enforced. they started looking at the two periods of time and saw that there was no relevantbetween the frames. >> the problem is that there are complications with virtually all drugs. at what level it tells you to stop prescribing something is a diicult question, is not it? >> that is interested fda. host: talking of the abortion pill. we are taking your calls about abortion access in thedo you the expanded? do you think it should be restricted? and stay the same? on our line for expanding is mark. good good morning and thank you for c-span. i think that abortion rights should be expanded. abortion is a human right and it is also health care. i do not understand why six justices with law degrees are going to decide what women can do when they have medical issues . it is just ridi
the fda acknowledges that. i also want to emphasize that the studies were far from the evidence that was consulted. it had a real world experience during the 19 pandemic, a period of time when the person dispensing requirement was not enforced. they started looking at the two periods of time and saw that there was no relevantbetween the frames. >> the problem is that there are complications with virtually all drugs. at what level it tells you to stop prescribing something is a diicult...
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compare that to now, the second guessing of the fda's decisions and the fda's decision to either evaluate or approved different drugs. that was really stunning to me. and thinking about where we are today that the supreme court might, if standing is met be in a position to decide this >> and that is such a great point, laura, because what's going on here, if they decided to allow this case to go forward. and in fact, they cited i'm throwing out the fda rules. this could happen to any drug. it could happen to anything hiv drugs, it could up until control because basically a few doctors that have a different ideological view are able to come forward and say, hey, we might have to do something here when in fact they're protected by law from this conscience provision. but in fact, if you let this case go, it could undermine in all safety rules for drugs and basically remember, it's the same kind of thing from the beginning and it is joe biden's belief, my belief that women should be able to make their own decisions about their health care. >> i do want to bring into our conversation what this
compare that to now, the second guessing of the fda's decisions and the fda's decision to either evaluate or approved different drugs. that was really stunning to me. and thinking about where we are today that the supreme court might, if standing is met be in a position to decide this >> and that is such a great point, laura, because what's going on here, if they decided to allow this case to go forward. and in fact, they cited i'm throwing out the fda rules. this could happen to any...
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over its approval of mifepristone and the case now focuses on fda approval of expanded access to the drug but during the hearing, justices from across the ideological spectrum press the group challenging the drug as to whether it had standing or the right to bring the case, asking their lawyer about what harm group faced. >> may i ask ms holly about your basic theory of standing i mean, you're just saying even fda admits that they are going to be sunnah adverse events. people are going to show up in emergency rooms. people are going to come face-to-face with one of our doctors who objects to some aspect of the treatment just to confirm >> on the >> standing issue under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct? >> justice ketanji brown jackson pressed on why the group believes restricting everyone's access to the drug is necessary given the doctors can raise religious objections under federal law. >> i mean, it makes perfect sense for the individual doctors to seek an exemption but as i understand it, they already hav
over its approval of mifepristone and the case now focuses on fda approval of expanded access to the drug but during the hearing, justices from across the ideological spectrum press the group challenging the drug as to whether it had standing or the right to bring the case, asking their lawyer about what harm group faced. >> may i ask ms holly about your basic theory of standing i mean, you're just saying even fda admits that they are going to be sunnah adverse events. people are going to...
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this comes after a rule change by the fda in january 2023. the fda says food makers can advertise that regularly eating yogurt may reduce the risk of type 2 diabetes. the decision comes after a 2018 petition from danon yogurt's parent company. the fda says language to consumers must note that evidence is limited and eating three servings per week is the threshold for reducing risks. >>> traders joe's is recalling steamed chicken dump llings because the product may contain plastic. >>> cleveland police chased a pair of horses down interstate 90 after they escaped during a routine exercise. cars had to come to a complete stop while the animals stampeded down the highway. police say mounted officers recovered both horses safely. ckrit today" will be gh ba. ead and shoulders, right? only when i see flakes. then i switch back to my regular shampoo. you should use it every wash, otherwise the flakes will come back. tiny troy: he's right, you know. is that tiny troy? the ingredients in head and shoulders keep the microbes that cause flakes at bay. m
this comes after a rule change by the fda in january 2023. the fda says food makers can advertise that regularly eating yogurt may reduce the risk of type 2 diabetes. the decision comes after a 2018 petition from danon yogurt's parent company. the fda says language to consumers must note that evidence is limited and eating three servings per week is the threshold for reducing risks. >>> traders joe's is recalling steamed chicken dump llings because the product may contain plastic....
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i'm going to try not to speak directly for the fda because the fda did this assemethey are the agency that s been passed with that job. i won't try to speak for them. i will say that the rigorous work that was done to come to these conclusions was based on the science of the evidence they had before. >> did they do additional research on brain development or mental health consequences or impact on pregnant women? se sure they took into consideration all the information out there on both the effects and the evidence that there is on cannabis use. >> you are saying that for a fact? sec. becerra: i'm saying i don't want to try to speak for the fda and the scientists because i did not do the actual assessment. >> but you announced a recommendation. i assumed you would take into account impact on adolescent brain development and mental health consequences or pregnant women. sec. becerra: as i said, i'm sure the fda would have taken into ant all the different circumstances involved. i did not make the recommendation, it was made by the fda. >> i want to follow up on some that senator menend
i'm going to try not to speak directly for the fda because the fda did this assemethey are the agency that s been passed with that job. i won't try to speak for them. i will say that the rigorous work that was done to come to these conclusions was based on the science of the evidence they had before. >> did they do additional research on brain development or mental health consequences or impact on pregnant women? se sure they took into consideration all the information out there on both...
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we have the algorithm, it's fda approved. and what we found in the clinical studies is that surgeons were missing 26% of the polyps. and again, it's not that they're doing something wrong. other than being human. when they're doing eight procedures a day, in some cases ten, their eyes get tired and they miss things. and some things are almost impossible to see with the naked eye. and the ai picks it up and it doesn't get tired. >> we keep learning how ai is better than humans. they don't get tired. they don't make these mistakes that can be life-threatening. you guys are doing some incredible hypertension stuff that could make it for -- now fda approved that could make it so people who don't like to take their pmedicine because they can't see that they have hypertension you save their lives for them. >> right. i think, jim, this new hypertension procedure we call simplicity could be the biggest thing that we've ever done. we've been working on it for 15 years. as you mentioned, just got the fda approval. and what it is, it's
we have the algorithm, it's fda approved. and what we found in the clinical studies is that surgeons were missing 26% of the polyps. and again, it's not that they're doing something wrong. other than being human. when they're doing eight procedures a day, in some cases ten, their eyes get tired and they miss things. and some things are almost impossible to see with the naked eye. and the ai picks it up and it doesn't get tired. >> we keep learning how ai is better than humans. they don't...
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but abortion opponents say the fda disregarded safety concerns over the drug. those putting pregnant women at risk. a ruling in favor of the abortion opponents bringing the case well, not only severely restrict access to the drug, but could upend the fda regulatory process for any drug. the biden administration says that would lead to chaos and is arguing for the court to lead the status quo in place. >> rolling back fda changes would unnecessarily restrict access to mifepristone with no safety justification. some woman could be forced to undergo more invasive surgical abortions. others might not be able to access the drug at all. and all of this could happen at the request of plaintiffs who have no certain injury of their own. the court should reject that profoundly inequitable result. fdc outsourcing of abortion drug harm to respondent, doctors forces them to choose between helping a woman with a life-threatening condition and violating their conscience. >> and the court will likely release its final ruling on the case later this spring reporting in washingto
but abortion opponents say the fda disregarded safety concerns over the drug. those putting pregnant women at risk. a ruling in favor of the abortion opponents bringing the case well, not only severely restrict access to the drug, but could upend the fda regulatory process for any drug. the biden administration says that would lead to chaos and is arguing for the court to lead the status quo in place. >> rolling back fda changes would unnecessarily restrict access to mifepristone with no...
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is it the only time any court restricted access to an fda approved drug by second guessing fda expert judgment. >> no doctors can be forced against their consciouses to perform or assist in an abortion, correct? >> hey, hey, abortion pill has got to go. >> i had understand the conscious harm as justice barrett does but you suggest a broaded one. >> while some new supreme court justices may be weary whatever their reasons, he is running floating a national abortion ban that would kick in at 15 weeks. if you are listening in a blue state or a place that has consecrated the rights, kansas, this would override that if there is a federal ban if he is elected. politically democrats welcome the topic and the clear stance. biden is leading into a campaign strategy hammering this in the general election in the months ahead. they see it but the biden campaign is a clear contrast and way to mobilize women and younger voters. this is a strategy biden was touting on the roads yesterday. democrats think they can flip the state as same gop positions collide with extreme candidates. there are voters
is it the only time any court restricted access to an fda approved drug by second guessing fda expert judgment. >> no doctors can be forced against their consciouses to perform or assist in an abortion, correct? >> hey, hey, abortion pill has got to go. >> i had understand the conscious harm as justice barrett does but you suggest a broaded one. >> while some new supreme court justices may be weary whatever their reasons, he is running floating a national abortion ban...