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May 17, 2024
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that fda -- that equilibrium is not set by the fda. the quality issue that we need to work on and we are trying to help us best we. but your main question value -- the manufacturers is, we work every day with them and they are required to give us more information. they resisted as giving up the crucial information that we need. when there is a shortage, we are finding they are cooperative to work together to try to fix it, but it would be better if we had all the data we needed to put together a predictive algorithm to allow us to intervene preemptively and prevent this shortage. you will have a copy of the list with the correct information that would make a difference. i also want to point out that while there is a shortage, the biggest shortages are occurring and energetic generic drugs, the less expensive the drug, the more likely this shortage because of the way the market is not succeeding in rewarding high-quality manufacturing. that's the point i think we need to address over the next few years. any >> guess as to what factors a
that fda -- that equilibrium is not set by the fda. the quality issue that we need to work on and we are trying to help us best we. but your main question value -- the manufacturers is, we work every day with them and they are required to give us more information. they resisted as giving up the crucial information that we need. when there is a shortage, we are finding they are cooperative to work together to try to fix it, but it would be better if we had all the data we needed to put together...
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Mar 31, 2024
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the fda is only able -- the fda has shown a disregard for what women and girls go through when taking abortion drugs alone. every american should be concerned by what the da has done. women deserve better. regardless of one's views about abortion, we should all agree that women's health matters. women deserve for the fda to do its job and for the -- the federal government to look out for health and safety. thank you. quest good afternoon. my name is dr. christina francis and i am a board-certified ob/gyn who practiced medicine for over two decades. i am also the ceo of the american association. one of the four medical associations that are plaintiffs in the case against the fda that are argued for the court this morning. regardless of one's views about abortion, we should all agree that women deserve to have the doctors in person ongoing care when taking high-risk drugs. we should all agree that women's health matters. and we should all agree that the fd has job is to keep people safe. but the fda has violated its duty to women. after requiring critical safety standards for the use of
the fda is only able -- the fda has shown a disregard for what women and girls go through when taking abortion drugs alone. every american should be concerned by what the da has done. women deserve better. regardless of one's views about abortion, we should all agree that women's health matters. women deserve for the fda to do its job and for the -- the federal government to look out for health and safety. thank you. quest good afternoon. my name is dr. christina francis and i am a...
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Mar 26, 2024
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why shouldn't the fda have addressed that? >> i think the only way that that would be true would be if the three changes are interconnected and mutually reinforcing, guarding against the same kind of safety risk. so, i agree that if there were reason to think that the reason why mifepristone is safe up to ten weeks gestation is because it is being prescribed by doctors instead of nurse practitioners, for example, then those changes would be interconnected because one change would effectively by the safety net for another. there was nothing like that in this record. it demonstrated the changes, an exhaustive examination, were safe, not because there were other different safe guards in place to guard against risks, but rather because if you go up to ten weeks of gestation there is no observable increase in serious adverse events, no matter who is prescribing. in the absence of that kind of effect, it cited multiple studies that combined multiple changes because the standard of care evolved over the 15 years mifepristone had been
why shouldn't the fda have addressed that? >> i think the only way that that would be true would be if the three changes are interconnected and mutually reinforcing, guarding against the same kind of safety risk. so, i agree that if there were reason to think that the reason why mifepristone is safe up to ten weeks gestation is because it is being prescribed by doctors instead of nurse practitioners, for example, then those changes would be interconnected because one change would...
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Mar 27, 2024
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entrusted to the fda. justice sotoyo whatever the increase was, lee fda determined under thstdard that it was not sufficient to create a risk that counterbalanced the need for access, correct? ms. prelogar: because the fda is instructed to take into accot burdens on the health care stem as well and looked at a variety of sources to colu that the burden suggested that it was not necessary to keep this restriction iple to ensure safe use. justice kagan: if i could take you back to the discussion with justice barretabt the conscious objection and i'm sure that you have read the declaratio cefully and im thin tsay about this. as you read those declarations, what is the conscious objection? wh are the doctors objecting to exactly? ms. prelogar: i think the clarations are specific. there are only seven doctorsho regularly practice and submitted evidence and they ar relatively short. this isja 150-20beuse there are only two who provide any informioabout their specific objections. osare dr. scope and francis. the
entrusted to the fda. justice sotoyo whatever the increase was, lee fda determined under thstdard that it was not sufficient to create a risk that counterbalanced the need for access, correct? ms. prelogar: because the fda is instructed to take into accot burdens on the health care stem as well and looked at a variety of sources to colu that the burden suggested that it was not necessary to keep this restriction iple to ensure safe use. justice kagan: if i could take you back to the discussion...
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Mar 26, 2024
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if we look at the merits of what the fda did in 2021, the fda relied on two things. they relied first on the -- >> i can understand your impulse there, and i went back and looked and there are zero universal injunctions issued during franklin roosevelt's time in office, and pretty consequential ones, and over the last year or so the number is something like 60, and maybe more than that. it's a relatively new thing, and you are asking us to extend and pursue this remedial course, and this court never adopted that itself, and lower courts run with this and i want to give you one more shot at that? >> the fda incapsulates inequitable equities, and in you have nonregulated parties, those parties could be farmers or ranchers, and their only availability for relief is if the court does something to the fda order or regulation at issue, otherwise the parties are out of luck and that's inconsistent with equity. >> may i ask you about your basic theory of standing, and just as a clarification question as much as it is anything, when you did your 1, 2, 3 in your opening statem
if we look at the merits of what the fda did in 2021, the fda relied on two things. they relied first on the -- >> i can understand your impulse there, and i went back and looked and there are zero universal injunctions issued during franklin roosevelt's time in office, and pretty consequential ones, and over the last year or so the number is something like 60, and maybe more than that. it's a relatively new thing, and you are asking us to extend and pursue this remedial course, and this...
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Mar 26, 2024
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is is consistent with the fda so numbers. in person visit was necessary to preserve women's health because the visit is the best opportunity to examine ectopic pregnancy's and gestational age. justice barrett: that in person visit had no reqnts of an ultrasound or effort to detect the fetal heart beat so it would not give a r gestational age so why would that eliminate the risk? ms hawley: those risks did go up. it shows a threefold increase dy emergency room visits when you removed it. it was 5.8 witthe in person visit and 2.1 without. is that because doctors thought it was a good idea to ms h it took away thed? opportunito that. medical organizations agree that this practice if a woman comes into a doctor's office and assess gestational age but what is allowed under the fda rules is to be able to or■)der these online lines with screening questions and thus not nearly as >> let'say i will carve out and put aside an online petition as harms to your organization. explained toe the additional cost you incurred or your resourc
is is consistent with the fda so numbers. in person visit was necessary to preserve women's health because the visit is the best opportunity to examine ectopic pregnancy's and gestational age. justice barrett: that in person visit had no reqnts of an ultrasound or effort to detect the fetal heart beat so it would not give a r gestational age so why would that eliminate the risk? ms hawley: those risks did go up. it shows a threefold increase dy emergency room visits when you removed it. it was...
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Mar 27, 2024
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but the fda has violated its duty to women. after requiring critalstandardsf chemical abortion drugs for 16 years including the necessary in person doctor visitcheck for life-threatening conditions, the fda tragically removed them. without even adequately evaluating the impact women's health. ■x reckless action has endangered the safety and well-being of men and girls across the industry. my colleagues and i are on the front linesg and treating women harmed by the fda's shameful actions. we knew we had no choice but to sue theas physicians who care dy about our patients, it is appalling that the fda no longer requires doctors to provide in person ongoing care to women using high-risk drugs. these in person doctor visits are vital to check women for severe bleeding and life-threatening infections. no woman should ever be left abortion at home alone. without even one in person example the doctor. yet that is precisely what the e despite its own label stated that one in 25 women who take these drugs will end up in the i hope the
but the fda has violated its duty to women. after requiring critalstandardsf chemical abortion drugs for 16 years including the necessary in person doctor visitcheck for life-threatening conditions, the fda tragically removed them. without even adequately evaluating the impact women's health. ■x reckless action has endangered the safety and well-being of men and girls across the industry. my colleagues and i are on the front linesg and treating women harmed by the fda's shameful actions. we...
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Mar 27, 2024
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the problem here is they sued the fda. e fda has nothing too it -- witf protection. that is all happening far downstream. and the only way to ove a therefore was to grant this kinof nationwide release that is so far revefrom the regulatory authorities that it is ultimately requime all women everywhere to cng for this drug. i think it is wth stepping about the profound mismatch between that inju a the remedy of the response obtained. they said the fear that ther might be some emergency room doctors who may be presented withncdibly rare applications and the doctor may have to prid tatnt -- we don't think that harm has materialized but with the court date isf that restricts access for every single woman in is countryndhat causes profound harm. jo]rmhe agency. it harms the part of it -- it harms the pharmaceutical industry saying that this would be -- destabilize the system for approving and regulating drugs. the court should reverse instructions to announcer: this evening, patti davis discusses her book "dear mom and dad." a memoir lit -- written as a letter to herspotl
the problem here is they sued the fda. e fda has nothing too it -- witf protection. that is all happening far downstream. and the only way to ove a therefore was to grant this kinof nationwide release that is so far revefrom the regulatory authorities that it is ultimately requime all women everywhere to cng for this drug. i think it is wth stepping about the profound mismatch between that inju a the remedy of the response obtained. they said the fear that ther might be some emergency room...
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Mar 31, 2024
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its entirely consistent with fda number in 2020, the fda said the emperor visit was necessary to preserve women's al because the impression visit is the best opportunity to examine things like -- thingbserve pregnancy and age of consent. because the general said that initial impression visit that had no requirement of an ulasound or any effort to detect fetal heartbe except it would not necessgive inaccurate read gtational age. so i would not necessarily be eliminated? >> i think the fda'undated shows that race didn' up. if you look at the study, it shows a nearly threefold increa when you have -- when you removed it. it was about 2.1 without. >> when they remove this, it took away the opportuny do that. i think a cog -- medical orgazaons that created that are best practice. what is allowed under this a couple of screening questions. i do think that is nearly as good as an in-person exam. quest let's say that -- let's just carve out and putside this -- explain to me what addion costs you might have incurred or what your resources had diverted in aayhat would set aside havens. >> putting a
its entirely consistent with fda number in 2020, the fda said the emperor visit was necessary to preserve women's al because the impression visit is the best opportunity to examine things like -- thingbserve pregnancy and age of consent. because the general said that initial impression visit that had no requirement of an ulasound or any effort to detect fetal heartbe except it would not necessgive inaccurate read gtational age. so i would not necessarily be eliminated? >> i think the...
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Mar 26, 2024
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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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May 17, 2024
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why is the fda enabling these chinese products? >> i would not use the term enabling but i would say this is a huge production issue coming out of china into our ports. we need to stop the use of illegal products. >> this administration has proven it is unable to do anything at the border with respect to security. but, wouldn't the foreign manufacturing -- >> as we said many times today, we are the referees but you make the rules. if you choose to do that you may. i would also say that a lot of promises are being made in the vaping industry. if they have user fees -- >> are these chinese companies paying the user fees? >> whoever makes the product has to pay those. >> what do you foresee from the next 12 months with respect to cbd? you mentioned that you are closing communication -- communicating but what about shifting gears with cbd oil, industrial hemp? >> i think it is the decision of congress so we would look forward to working with you all as quickly as possible to come up with a regulatory pathway that you think is really --
why is the fda enabling these chinese products? >> i would not use the term enabling but i would say this is a huge production issue coming out of china into our ports. we need to stop the use of illegal products. >> this administration has proven it is unable to do anything at the border with respect to security. but, wouldn't the foreign manufacturing -- >> as we said many times today, we are the referees but you make the rules. if you choose to do that you may. i would also...
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Feb 15, 2024
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the public health community is very frustrated with the fda. a lot of this comes from regulatory tobacco policies and a sense that the agency is focused on talk as opposed to action and, dr. yagi talked about if they have -- we are probably not operating from a space of success. what you think we can do to push the fda towards action and what do you see as key levers and key barriers? >> one of the things we need to do in public health is moved from the mindset of implementing policy at a snails pace. to a more urgent approach. as you know, i trained in internal medicine and i always had the experience of being contemplative and dealing with disease on what i know but i spent a lot of it practicing emergency medicine which often means acting before you know what you need and just taking care of the patient. there is a regulatory mindset that we need to move to. it's not just the fda. it's really all of our regulative agencies. to dealing with the urgency of the problem. boris pointed out that 480,000 people is a big number but, you get a bigger
the public health community is very frustrated with the fda. a lot of this comes from regulatory tobacco policies and a sense that the agency is focused on talk as opposed to action and, dr. yagi talked about if they have -- we are probably not operating from a space of success. what you think we can do to push the fda towards action and what do you see as key levers and key barriers? >> one of the things we need to do in public health is moved from the mindset of implementing policy at a...
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Jan 13, 2024
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so what do you think we can do to push the fda towards action? what do you see is the key levers and key barriers? >> or things in public health he got to do is to move fromxç the mindset of implementing a policy and many ways at a snails pace to a more urgent approach. as you know ice trained in internal medicine. of being contemplative and dealing with disease based on a diagnosis that we know. i spent most my time practicing emergency medic means acting before you have all the information that you need. enough to take care of the a regulatory mindset we need to move to it's not just the fda. it's really all of our relatively agencies. to dealing with the urgency of an urgent problem. pointed out 480,000eople is a big number. when you think about affect these are preventable deaths and so i think we needehave. the regulatory speed of not doing this in due course. the regulatory process moves at a snail's pace but many people involved in that process. so it's not just the agency that has a speed up the activity but every aspect of that. and tha
so what do you think we can do to push the fda towards action? what do you see is the key levers and key barriers? >> or things in public health he got to do is to move fromxç the mindset of implementing a policy and many ways at a snails pace to a more urgent approach. as you know ice trained in internal medicine. of being contemplative and dealing with disease based on a diagnosis that we know. i spent most my time practicing emergency medic means acting before you have all the...
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Feb 16, 2024
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that the fda covered. my friend and colleague is the dean at the university of maryland is also the former acting surgeon general and served 27 years in the u.s. public health service as a commissioned officer and trained in dermatology family medicine and occupational medicine. and then lastly the public was executive director of the american public health association. this health secretary he has experienced it as a clinician. were going to continue our discussion we start with doctor bush on. i want to start with you. you oversell the 50th anniversary of the surgeon general's report on smoking. you are both an idealist and a realist. what steps do you think we should take to lower the overall burdens of tobacco products used in the u.s. while protecting youth? >> but to acknowledge the facts and made incredible progress in this arena but let's pat ourselves on the back. public health is an incredible things. as you mentioned it was just 10 years ago in january that we issued the 50th anniversary report
that the fda covered. my friend and colleague is the dean at the university of maryland is also the former acting surgeon general and served 27 years in the u.s. public health service as a commissioned officer and trained in dermatology family medicine and occupational medicine. and then lastly the public was executive director of the american public health association. this health secretary he has experienced it as a clinician. were going to continue our discussion we start with doctor bush...
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Mar 14, 2024
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fda modernization act 2.0 topic, animal testing. the law called on fda to certain requirements that biopharma and pharma companies test their product on animals, my question, what is your reaction to that? goal or that the f.d.a. is needing to work through? >> our requirement is that sponsors, entitiede products the approaches that that they show the safety of the products going certain models need to be used for this. they need to show that. this clarifies the alternative methods can be process. we are very interested in advancing innovation in that space. alternative methods are non- animal -based appro■aches. some as well pre-clinical testing for things like chips or silicone -based approaches. we do internal work in those areas we havern research others and understanding how they can be used iner instances. there's also work going on ai -based approaches. the science are not at a placeat to fully be able to replace animal testing for instance if you want to understand them clinically made whole organism to do that per not at a
fda modernization act 2.0 topic, animal testing. the law called on fda to certain requirements that biopharma and pharma companies test their product on animals, my question, what is your reaction to that? goal or that the f.d.a. is needing to work through? >> our requirement is that sponsors, entitiede products the approaches that that they show the safety of the products going certain models need to be used for this. they need to show that. this clarifies the alternative methods can be...
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Mar 4, 2024
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we introduce the fda modernization 3.0 act. that would establish a program the fda to qualify the group testing methods to reduce or place animal models. it builds on fda modernization act 2.0. as the next step. we are trying to do is really make sure can these models and make sure we are doing investigational drugs. i know how important it is to make sure improving market and polo a short time after. before not you agree fda author : and non- animal investments when it comes to evaluating safety spoke about in your testimony? >> i mentioned earlier it's a complex question because new platform technologies clearly testing because models don't capitulate every organ of the bodyut adduced there are indications where a small increment on an existing treatment using the same warmth or substitution these models that have these should take this this. >> can you share your observation how it can better peed up the development of these drugs? >> for example described is cystic fibrosis referred to earlier were approved in the earlier p
we introduce the fda modernization 3.0 act. that would establish a program the fda to qualify the group testing methods to reduce or place animal models. it builds on fda modernization act 2.0. as the next step. we are trying to do is really make sure can these models and make sure we are doing investigational drugs. i know how important it is to make sure improving market and polo a short time after. before not you agree fda author : and non- animal investments when it comes to evaluating...
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Jan 13, 2024
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i do think youg about fda and avoiding and not addressing this is a mistake. it may take years for us to mitigate and get there. >> a big fan of taking a poster not taking action. something passive aggressive it's a regulatory strategy for tobacco is not a good regulatory strategy needs to be proactive the communications question i agree with you it's going to be a massive educational undertaking. probably needs to a variety of sources the fda needs to be a part of it they can't do it all by themselves. some people trust the fda others don't trust after allowed theallowthe strike we have had. having a public education campaign for physicians about the risk continuumnonpartisan thing that we all should agree on and the agencies should be doing they not doing a the product center. >> i've enjoyed having you here i am sure you have a lot of places to go we have taken more than allotted. >> is fun though. >> will skim around of applause.
i do think youg about fda and avoiding and not addressing this is a mistake. it may take years for us to mitigate and get there. >> a big fan of taking a poster not taking action. something passive aggressive it's a regulatory strategy for tobacco is not a good regulatory strategy needs to be proactive the communications question i agree with you it's going to be a massive educational undertaking. probably needs to a variety of sources the fda needs to be a part of it they can't do it all...
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Mar 24, 2024
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so this is a very technical case about the fda. when it decided to expand access to mifepristone, what it did or didn't look at in terms of evidence about the safety of these changes is changes like making mifepristone available through the 10th week of pregnancy instead of the seventh, allowing it to be prescribed by telehealth appointments and then allowing health care providers who aren't physicians to prescribe the drug. and so the the fifth circuit said that when it made these changes in 2016, the fda didn't cite a study t that looked at the cumulative effect of all of these changes and whether or not it would still be safe to to take mifepristone. in light of all of these changes, the biden administration and danco, which is the manufacturer of mifepristone, said, you know, first of all, that we did cite such a study, but more broadly that the fda reasonably concluded that there were no safety problems based on all of the evidence that it had before this is not a constitutional question. this is a very technical question abou
so this is a very technical case about the fda. when it decided to expand access to mifepristone, what it did or didn't look at in terms of evidence about the safety of these changes is changes like making mifepristone available through the 10th week of pregnancy instead of the seventh, allowing it to be prescribed by telehealth appointments and then allowing health care providers who aren't physicians to prescribe the drug. and so the the fifth circuit said that when it made these changes in...
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Feb 13, 2024
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we studied one before and after fda warnings and found dosages increased in the products after fda warnings. the fda's actions are inadequate to date. they need to do more because it is not just these three products, tianeptine, kratom, phenibut, but others. >> thank you so much for joining us. >> my pleasure. amna: last week el salvador's president bukele was reelected. he first came into power in 2019 and for nearly two years has overseen a vast and brutal crackdown on gangs, transforming the nation from one of the deadliest in the world one of the safest in latin america, but that peace has come at a cost, thousands of innocent people jailed and and undermined democracy. i traveled to two cities north of the capital san salvador to file this report. reporter: for two years, patricia has prayed for her partner's return. victor was imprisoned in the el salvador's war on gangs. >> i do not know anything about him and that hurts because we were a very united family. reporter: his absence is felt in every room and at every meal. in 2022, victor and patricia's son roderigo were arrested, witho
we studied one before and after fda warnings and found dosages increased in the products after fda warnings. the fda's actions are inadequate to date. they need to do more because it is not just these three products, tianeptine, kratom, phenibut, but others. >> thank you so much for joining us. >> my pleasure. amna: last week el salvador's president bukele was reelected. he first came into power in 2019 and for nearly two years has overseen a vast and brutal crackdown on gangs,...
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. >> do you think the fda is infallible? that was justice samuel alito's question today in the supreme court case that could determine the future of medication abortion and also the future of drug approval in this country. the fda after all is the federal regulatory agencies that approves new drugs in the united states, and this case calls into question whether the courts should believe the fda when it says a drug is safe. justice alito's skepticism there tells us a lot about the court's conservatives, and it suggests that they may be thinking about something much bigger than even abortion, mainly whether conservatives are going after the regulatory state on whole. right now right-wing judicial activists have brought a series of cases that threaten to upend 40 years of supreme court precedent and hobble the federal government's basic ability to enforce laws. those lawsuits are trying to limit regulators ability to enforce everything from laws on insider trading to laws that protect the food we eat and the air we breathe. bac
. >> do you think the fda is infallible? that was justice samuel alito's question today in the supreme court case that could determine the future of medication abortion and also the future of drug approval in this country. the fda after all is the federal regulatory agencies that approves new drugs in the united states, and this case calls into question whether the courts should believe the fda when it says a drug is safe. justice alito's skepticism there tells us a lot about the court's...
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Feb 14, 2024
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products after fda warnings. the fda's actions are inadequate to date. they need to do a lot more because it is not just these three products -- tianeptine, kratom, phenibut, but others. more than a dozen foreign drugs being sold currently as dietary supplements in the united states. ali: dr. peter cohen, associate professor of medicine at harvard medical school, thank you for joining us. >> my pleasure. amna: last week el salvador's president bukele was reelected. you landslide win. he first came into power in 2019 and for nearly two years has overseen a vast and brutal crackdown on gangs, transforming the nation from one of the deadliest in the world to one of the safest in latin america, but that peace has come at a cost, thousands of innocent people jailed and, critics say, undermined democracy. i traveled with a producer to two cities north of the capital san salvador to file this report. for two years, patricia has prayed for her partner's return. victor was one of the more than 75,000 people imprisoned in
products after fda warnings. the fda's actions are inadequate to date. they need to do a lot more because it is not just these three products -- tianeptine, kratom, phenibut, but others. more than a dozen foreign drugs being sold currently as dietary supplements in the united states. ali: dr. peter cohen, associate professor of medicine at harvard medical school, thank you for joining us. >> my pleasure. amna: last week el salvador's president bukele was reelected. you landslide win. he...
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Mar 26, 2024
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we're asking this court to look at what fda said. the fdca says you have to have -- >> didn't the lower courts go beyond that? representations were made that the lower courts relied on studies that have been found discredited and removed. so they were obviously look at not just what the fda was looking a t. >> that wasn't quite the right sound bite. that was jackson arguing why should the courts get into this. mark joseph stern, how did that go? >> very poorly for the anti abortion advocates here represented by erin hawley. she said we've proved time and again it poses a threat to women but as judge brown pointed out, it's a very safe drug. safer than viagra and tylenol. they sited these studies that purported to show it was actually dangerous and caused excessive bleeding but in between those decisions and today, those studies were retracted for being insufficiently rigorous and sponsored by abortion groups that had an ax to grind against abortion. i think when the justices did reach the merits, there was very little that erin could
we're asking this court to look at what fda said. the fdca says you have to have -- >> didn't the lower courts go beyond that? representations were made that the lower courts relied on studies that have been found discredited and removed. so they were obviously look at not just what the fda was looking a t. >> that wasn't quite the right sound bite. that was jackson arguing why should the courts get into this. mark joseph stern, how did that go? >> very poorly for the anti...
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Mar 26, 2024
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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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Mar 26, 2024
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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 26, 2024
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numerous studies have shown that the drug, first approved by the fda in 2000, is safe. they also argue its members, which include doctors, might suffer harm my having to treat patients who use them to end a pregnancy because it would be in opposition to their own religious police. the bite in the ministration argued that doctors cannot show that the fda's decisions directly harmed them and that the ruling in favor of the antiabortion group would severely disrupt the federal system for developing and improving drugs and would inflict great harm on women across the country. a research organization that doesn't support abortion rights reported that there were approximately 642,000 medication abortions in 2023, about 60% of all abortions in the u.s., a 10% increase since the year 2020. for more on this story, we can turn to our supreme court reporter. great to have you back. can you explain why some justices appear skeptical of the antiabortion arguments, including some of the justices appointed by republican presidents? >> one of the things the justices spent a lot of time
numerous studies have shown that the drug, first approved by the fda in 2000, is safe. they also argue its members, which include doctors, might suffer harm my having to treat patients who use them to end a pregnancy because it would be in opposition to their own religious police. the bite in the ministration argued that doctors cannot show that the fda's decisions directly harmed them and that the ruling in favor of the antiabortion group would severely disrupt the federal system for...
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Mar 27, 2024
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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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by second- guessing the fda's expert judgment? >> we have had a rash of universal injunctions. this case seems like a prime example of turning what could be a small loss into a nationwide legislative assembly on an fda rule or any other federal government action. >> it makes sense for the individual doctors to seek an exemption, but as i understand it, they already have that. so what they are 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. >> the court is expected to rule on the case by the end of this term, likely late june or early july. >>> while that was going on in d.c., president biden and vice president harris were in north carolina to highlight the administration's efforts to expand access to healthcare. biden spoke out about today's supreme court hearing and called out trumped by name for his role in overturning federal abortion right. >> trump probably says "after 50 years, i was able to
by second- guessing the fda's expert judgment? >> we have had a rash of universal injunctions. this case seems like a prime example of turning what could be a small loss into a nationwide legislative assembly on an fda rule or any other federal government action. >> it makes sense for the individual doctors to seek an exemption, but as i understand it, they already have that. so what they are asking for, here, is that in order to prevent them from possibly ever having to do these...
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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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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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this isn't me saying it is what the fda has said. what they say in court now is very different than what their own data tells you. >> i mean, it's a widely used pill. it's quite safe, but on the not even on that in and of itself, the question was whether or not they have this standing to bring this in. dr. justice, amy coney barrett herself seemed especially skeptical of that. she pointed to what you had submitted in particular, basically saying that you weren't able hello, to show that you've suffered the harm to actually bring this case to have a legal standing, to bring it. do you still think that she'll ultimately rule on your side and the end of this well, i certainly hope that the justices will hear what we have presented, which is that those of us again, who are on the front lines taking >> care of these women women that have been abandoned by the fda, women that had been abandoned by those who are giving the abortion drug's who are not performing any follow-up those of us who are taking care of them are seeing the harms that
this isn't me saying it is what the fda has said. what they say in court now is very different than what their own data tells you. >> i mean, it's a widely used pill. it's quite safe, but on the not even on that in and of itself, the question was whether or not they have this standing to bring this in. dr. justice, amy coney barrett herself seemed especially skeptical of that. she pointed to what you had submitted in particular, basically saying that you weren't able hello, to show that...
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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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the fda's plan to ban menthol cigarettes. some say that decision could cost lives and self checkout stands. a thing of the past will not. everybody in favor of getting rid of them. we'll explain. the governor newsom announcing the tourism in california has reached record levels, but that's not the case in san francisco. >> some appear on the iconic golden gate bridge, a testament to america's greatness. california's greatest. we could be more proud to announce today. record breaking tourism numbers in the state of california over 150 billion dollars tourism. spend unprecedented in our state's history. >> governor newsom heading to the top, the gate bridge, the town of huge tourism boost in california. and the governor announcing that tourists have spent more than 150 billion dollars in california in the past year. surpassing the 144 billion that that was a record set in 2019. governor newsom says that not only is the state retaining its title as the world's 5th largest economy. it's also growing in population for the first ti
the fda's plan to ban menthol cigarettes. some say that decision could cost lives and self checkout stands. a thing of the past will not. everybody in favor of getting rid of them. we'll explain. the governor newsom announcing the tourism in california has reached record levels, but that's not the case in san francisco. >> some appear on the iconic golden gate bridge, a testament to america's greatness. california's greatest. we could be more proud to announce today. record breaking...
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watch this. >> the fda violated federal law to keep it safe. they are not left to receive these drugs in the mail or at their dorm room without ever having been checked by a doctor for life-threatening conditions. that is reckless. >> on its face if one did not know any better they could say that sounds a scary. young girls getting this drug that gives you and abortion. getting into their dorm room. what is your reaction? how does this actually work and how dangerous is it really? you actually know. you are not a dentist. >> i am prescribing this drug and i have been through the different phases of what they have done. 24 years ago it was approved by the fda. at that time we had to go through rigorous standards. you have to put in a lot of detailed reporting on talking to women about adverse effects and side effects and we could not even dispense it for a pharmacy. we had to have an office dispensing of the drug. it was as hard as possible to get one of the most safe and effective drugs. it has less adverse side effects than tylenol. fast-forwa
watch this. >> the fda violated federal law to keep it safe. they are not left to receive these drugs in the mail or at their dorm room without ever having been checked by a doctor for life-threatening conditions. that is reckless. >> on its face if one did not know any better they could say that sounds a scary. young girls getting this drug that gives you and abortion. getting into their dorm room. what is your reaction? how does this actually work and how dangerous is it really?...
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Apr 11, 2024
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this includes officials from the cdc and the fda. you are watching live coverage on c-span3 . >> 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. the chair will enforce these roles 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.
this includes officials from the cdc and the fda. you are watching live coverage on c-span3 . >> 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...
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airsupra is the only rescue fda-approved to do both. airsupra is an as-needed rescue inhaler and should not be used as a maintenance treatment for asthma. get medical help right away if your breathing does not improve, continues to worsen, or for serious allergic reactions. using airsupra more than prescribed could be life threatening. serious side effects include heart problems, increased risk of thrush or infections. welcome to the modern age of dual-action asthma rescue. ask your doctor if airsupra is right for you. wanna know a secret? more than just my armpits stink. that's why i use secret whole body deodorant... everywhere. 4 out of 5 gynecologists would recommend whole body deodorant, which gives you 72 hour odor protection from your pits to your- (sfx: deoderant being sprayed) secret whole body deodorant. my name's dan and i live here in san antonio, texas. i ran my own hvac business and now i'm retired. i'm not good being retired. i'm a pain in the neck. i like to be able to have a purpose. about three or four years ago, i was
airsupra is the only rescue fda-approved to do both. airsupra is an as-needed rescue inhaler and should not be used as a maintenance treatment for asthma. get medical help right away if your breathing does not improve, continues to worsen, or for serious allergic reactions. using airsupra more than prescribed could be life threatening. serious side effects include heart problems, increased risk of thrush or infections. welcome to the modern age of dual-action asthma rescue. ask your doctor if...