an fda ms. raider went to the plant in 2008 and actually found the plant was not investigating them. these in the active ingredient which showed up and recommended to the fda official action indicated which would have restrict did those drugs from coming into the u.s.. the fda determined that the pharmacy's response was adequate as a concerned the action pertaining to the chromatogram's and demonstrated the peaks did not impact the product so did not impose an import alert. guess than a year later that plan was under worldwide restriction because the drugs contained impurities. in closing i would suggest that the fda needs to overhaul its foreign drug inspection program. needs a go to highly trained well-funded cadre of inspectors with the clear career path. they should perform short notice or no notice inspection as opposed to announcing the month in advance as they do now and they should rarely overrule the recommended sanctions of its own inspectors which happens all too often now. thank you

inspections to achieve the fda reduce their u.s. inspection. all of the plans we are talking about are supposed to be inspected roughly every two years. >> what you're describing is maybe to do, reviewed by congress to make sure flowing through the inspections are happening on a regular basis without the diplomatic -- >> right. to be clear, the inspections are happening but what we are talking about is the quality. >> certain protocols about wanting certain protocols, unannounced on an x basis by individuals who speak the language. we have the existing mechanism, it's just improving it in some way. >> overhauling the inspection program and making it less on her face and making it rigorous and making sure the standards are verifiable, i think i'm maybe not enough of a tiny expert but they certainly want into our market. they do have a political and image problem at home about appearing to be regulating things. some of the investigators i is something where china's domestic ambitions in terms of securing public safety and its role in being the gl

other things go through the fda as well. devices, so one of the things that juul has the advantage is that they now have the backing that altria, the and no not beoro, as hard for them. but it may be harder for the smaller vaping companies that we have not heard of, more like mom-and-pop institutions. it will be tougher for them. they could possibly go out of business. that is kind of the way that we see a lot of things working with the food and drug administration, but there is the balance to make sure that companies claiming their products is doing is actually what they are doing and doing it safely. host: what is the level of nicotine between a juul product versus a combustible cigarette? guest: juul pod is equal to the amount of nicotine in a pack of cigarettes. i have talked to younger adults d per day, same nicotine as a pack of cigarettes. host: a caller from california, gabby. caller: it is abby. i vape. it is the same as greg. i had been smoking for a lot of years and i just quit recently, juul -- aot use a differen

inspections to achieve the fda reduce their u.s. inspection. all of the plans we are talking about are supposed to be inspected roughly every two years. >> what you're describing is maybe to do, reviewed by congress to make sure flowing through the inspections are happening on a regular basis without the diplomatic -- >> right. to be clear, the inspections are happening but what we are talking about is the quality. >> certain protocols about wanting certain protocols, unannounced on an x basis by individuals who speak the language. we have the existing mechanism, it's just improving it in some way. >> overhauling the inspection program and making it less on her face and making it rigorous and making sure the standards re verifiable, i think i'm maybe not enough of a tiny expert but they certainly want into our market. they do have a political and image problem at home about appearing to be regulating hings. some of the investigators i is something where china's domestic ambitions in terms of securing public safety and its role in being the glob

served as that when he commissioner of the fda -- 23rd commissioner of the fda, joining us this morning to discuss federal regulation of cannabidiol, cbd as it is better known as. explain what cbd is. guest: it is a derivative of the cannabis plant. it is an oil extract, previously only available from the plant you grow marijuana from. 2018 farm bill legalized the growing of hemp, which is a form of cannabis that has low concentrations of thc. hemp become seeing a much more prominent agricultural crop. it can grow in poor quality soil, so you see it grown in lower quality soils. it could be a real opportunity for american farmers to develop a new crop. being able to derive cbd from hemp and market it, there's a hemp. pharmacies growing host: what is cbd used for? guest: right now, it is only used for one purpose. it is approved in a concentrated form for the treatment of certain seizure disorders. a lot of companies want to put cbd into dietary supplements and food. the way the law is constructed right now, that is not legal. all the cbd being put in pet food or different foods for huma

next at 5 the fda is proposing new the fda is proposing new graphic warning labels ...6, 7, 8 the fda is proposing new graphic warning labels ♪ ♪ ♪ big dreams start with small steps... ...but dedication can get you there. so just start small... start saving. easily set, track and control your goals right from the chase mobile® app. ♪ ♪ chase. make more of what's yours®. just between us, you know what's better than mopping? anything! at the end of a long day, it's the last thing i want to do. well i switched to swiffer wet jet and its awesome. it's an all-in-one so it's ready towhen im. the cleaning solution actually breaks down dirt and grime. and the pad absorbs it deep inside. so, it prevents streaks and haze better than my old mop. plus, it's safe to use on all my floors, even wood. glad i got that off my chest and the day off my floor. try wet jet with a moneyback guarantee >>here's what the cdc says despite years of campaigning to stop smoking cigarettes are still killing 480,000 americans every year so federal health officials want to add more vivid warning labels bu

what exactly is the fda investigating? anna: they have gotten reports from people that this has happened to who say they have had seizures and that juul was one of the e-cigarettes that some of these people putting reports in used. they said recently, the fda, that there have been 127 reports of seizures possibly linked to e-cigarettes. what they have not said is what devices were used in this, and what we found out is that to start this investigation, the reports they were looking at were linked to the juul devices. emily: obviously, this is coming at an interesting time. we've got not just the fda investigating, but also the ftc reportedly investigating. what does this mean for juul? anna: this is the latest in a series of scrutiny of this company. the cdc just came out with the damaging report showing 193 cases of serious lung disease and one death that vaping cause. -- had caused. that they were investigating that. we've got the cdc, fda, and the federal trade commission all looking closely at this product which until

what is the fda investigating? >> they have gotten reports from people that this has happened to who say they have had seizures of thet juul was one e-cigarettes that some of these .eople putting reports in used they said recently, the fda, that there have been 120 seven reports of seizures possibly linked to e-cigarettes. what they have not said is what devices were used in this, and what we found out is that to start this investigation, the reports they were looking at were linked to the juul devices. emily: obviously this is coming at an interesting time. investigating,a but the ftc. what does this mean for juul? >> this is the latest in a series of scrutiny of this company. with theust came out damaging report showing 190 three cases of serious lung disease and one death that they vaping cause. ftcave the cdc, fda, and looking closely at this product which until now has gone largely unregulated, with deadlines being pushed year to year. this comes one week before a bunch of new devices will hit the market. emil

avoid fda regulation. explain what it means for product to be on the market before that date. >> you are talking about -- >> with selling pot in one single store be sufficient? >> would it be sufficient to run a business? i am not sure. >> i don't want you -- under the fda rule, vaping product on the market prior to august 8, 2016, the date they went into effect could avoid fda regulations. can you explain what it means for a product to be on the market before that? what does it mean? >> my best recollection of the standard, offered for commercial sale is effectively the definition. >> did you rush any products onto the market before the august 8th grandfather date in order to beat that effective date? >> we did. that is a fair way of putting it. effectively every product in the category that the deadline did, none of those products. >> reclaiming my time. screens aren't working. i can recite well here. february 2, 2016, internal email 6 months before this grandfather date from sarah richardson, including

in the words of the fda of vaping epidemic. last year alone 80% increase of high school students vaping, 50% increase in middle school students using e-cigarettes, today because of devices like juul are accompanied kids friendly flavors or million children nationwide rvp. juul another e-cigarette companies like to claim that their products are only meant for adults looking to quit cigarette but a look at the facts dispelled that notion. there is no clinical trial program that will devices help them quit smoking to rest. none. despite all the marking claims there's no evidence of jewels most fundamental marketing claims. compared to less than 3% battles. juul knows exactly where the money can be found in a stock from adult to quit smoking, it is kids. today's youth vaping epidemic is a new version in an old bottle that i personally familiar with. i will not go into the details. but on friday the 13th 1959, one week before my 15th birthday i said in my father's hospital bedside as he died. he died from lung cancer. two packs of c

how are the fda and e-cigarette companies reacting to the study? >> this just came out last week so i have not talked to any e-cigarette companies or the fda. the nih is aware of it. as far as you understand it, how is the industry reacting? is doing that juul there on studies on this. and they have to submit their own study to the fda by next year. they are looking at a lot of this because they have to weigh the risks and the benefit and prove to the fda that these products are more beneficial than they are harmful. i think we will see some of their research which i imagine will attempt to contradict smooth is coming out over several months. and be included in what they sent to the fda. emily: more to come. thank you so much for joining us. fitbit is pushing beyond hardware and into services. the cofounder and ceo tells us how the news description model will help the company take on a petition from apple and amazon. this is bloomberg. ♪ emily: the u.s. justice forrtment is opposing a bid internet cable between u.s. and hong kong. it is intended

you are dependent on the fda inspection process. you do not have anything of your own, do you? you do not test any pharmaceuticals? >> that is correct. >> what is the anecdotal anyence, if you have it, of of the drugs administered to our war fighters being inadequate, counterfeit, or not effective? >> i do not know that we have any specific data on that. i do think there has been a recent experience that may illustrate the risk. i think that is an illustration, a little bit of a wake-up call, and i think there are others concern from my the health delivery standpoint is trying to communicate a beneficiary and it was a bit of an eye-opener that normally, when we have the fda post those notice, it is one and done. but we have continuing ongoing issues not limited to one source, but multiple sources. china?hat india and >> what you are pointing to is the second order risk. india just exacerbates the risk. that is an interesting case study on the potential risk that we have on relying on those sources. >> thank you very much. >> thank you very much. thank you for testifying today a

the fda would approve it any day. when he was done, caleb and his friend phillip, dorian's son went up to him and ali repeated it was for adults and not kids, and took out the sleek looking juul, showed how it it worked and called the iphone of vapes. and that's when we moms decided to fight back. we discovered a couple months before our kids were juuling under our noses which is common, it doesn't mean you're a bad parents if your kids are juuling, it's stealth by design. we knew that nicotine was harmful to our kids' brains and as we researched and put pieces together we learned that juul's deceptive behavior seemed to be part of the marketing strategy. >> a retired super was offering people in his state and massachusetts money if they'd implement the anti-juul, and came across the stanford medical prevention tool kit with an odd disclaimer we immediately realized was a reference to juul taking information it shouldn't have. none of this is surprising. as i said, juul is stealth by design. juul says it no longer res

fda and china fda and hope to help accelerate the process of adopting the consistent best practice. capacity building environmental regulatory science similar to that for the global health professionals is in urgent need in china. finally, since we are talking about the defense in china's drug apology, i would like to point out to successful cases in the past. and see what we can learn from them, one is china's tobacco control for many years chinese governments are reluctant to work to act on the tobacco control because of the worry of the lost revenues from the tobacco industry. who framework convention on tobacco control eventually change the government's attitude. what i think we can learn here is if we can frame fentanyl crisis not just as a u.s. problem or u.s. china problem but as a global issue on synthetic drugs. similar to the methamphetamine epidemic in asia and codeine and tramadol in africa. it will be easier to engage chinese government if we invite them to be a part of alliance to fight against the synthetic drug crisis. finally, on building a surveillance system and d

, theriest: as you stated fda has primary responsibility, the department of commerce as well. mr. lewis: we heard that budget restraints are stopping them from doing things that need to be done. i. priest: yes, but again, think that responsibility within the administration falls on those departments. perspective, we don't have the ability put -- ability to procure or test. but i would agree with you that the risks you stated are accurate. mr. lewis: are there alternative sources, even if the price is higher? mr. priest: yes, and i think i commented on that in the statement. my understanding, again, not being a procurement specialist, but if i can paraphrase from the know ist, what we also the process we have to manage by exception, the department cannot find -- if the department cannot insufficient -- find quality and quantity's to buy thatneeds, we must from elsewhere. once a manufacturer meets the demands, nonavailability determination will be issued, opening the availability to noncompliant projects. what that indicates from our partners is that they can exhaust whatever source

there is not yet any fda approved treatment for this kind of teen nicotine addiction. i will share very briefly just one or two stories because they are heartbreaking and they come from every state representative here on the panel and probably every state of people in this room. for massachusetts, our payback kristin speaking about her son a hockey player, he's developed a cough and complain he was not able to breathe while skating. he became distant moody and irritable. at extreme bouts of anger, a very common thing that people report. the home environment is toxic. it turns out that he has restrictive lung disease, he has inhalers in oral steroids. he's been smoking upon the day. the equivalent of more than a pack a day for three years. another one from north carolina from her son look at his addiction was so severe, he spent 39 days as an inpatient rehab in california. we've began living with a stranger. are straight a student grades dropped to f. it was the extreme anger, it turned out our 14 -year-old had a substance abuse problem and that's was juul. now i want t

. >>> earlier, the fda announced it was investigating 120 cases of people suffering from seizures after vaping. joining us is dr. scott got leeb on the board pfizer. we know vaping is safer than smoking cigarettes, but this is a relative situation where do you come down on this how safe is it to vape >> right, there's no question if you can get a currently addicted adult smoker, it's going to be less harmful, but less harmful doesn't mean safe, and we can't allow these products to be on the market at the expense of addicting a whole generation of kids on nicotine and onto these products there are going to be direct effects of these products on people's health and lungs. we have animal data and now human data that the vaping products do have an impact on health and the lungs. >> what do you think the ceo of juul saying his product wasn't intended for teenagers and apologizing to parents of teenagers who are addicted to this >> i think the product was positioned in the early years in a way where it was appealing to youth. if you look back at some of the early marketing campaigns and socia

to the fda, go drugs, medical devices. hasof the things that juul an advantage would be that they now have the backing and the money out for you -- south korea ia has to offer and it will not be as hard for them but may be harder for the smaller vaping companies we have not heard of or more like mom-and-pop kind of institutions. it will be tougher for them. they could possibly go out of business. the way we see a lot of things working with the fda, but there is the balance to make sure companies claim their products is what they are doing and they are doing it safely. host: what is the level of nicotine between a juul product and a combustible cigarette? pod is equal to the nicotine and a pack of cigarettes. i have talked to younger adults who use one pod per day, same nicotine as a pack of cigarettes. host: a caller from california, gabby. caller: it is abby. i vape. it is the same as greg. i have been smoking cigarettes for a lot of years and i just quit recently. i do not use a juul but a different device. my question i

it is a study we helped design with the fda. the study was conducted under a special protocol assessment agreement. we thought we might receive notice of the advisory committee earlier. why we did, we do not know. we were prepared earlier and will be prepared in november. david: how long does this take? john: is typically a one-day affair. it is an opportunity to talk about the child design and the resultedresult, which in a 20% reduction in debt. people think about and if yoular risk match your cholesterol your 30%. your risk by 25% to being able to talk about that and the safety profile of our were similarents between our drug into placebo is an opportunity we are looking forward to. hopefully that will lead to prompt action by the fda and we are preparing for approval of the syndication and then a robust launch starting late the .ear david: if all goes as you hoped, you will have final approval by the end of the year? reps we have added sales with the idea of doubling our sales force to be trained to december with a robust la

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the fda wants to finalize the rule in the spring. they are almost certain to face a challenge in court. >>> santa rosa doctor faces murder charges for allegedly overprescribing painkillers to his patients. a state attorney general's office charged doctor thomas keller with second-degree murder for allegedly prescribing dangerously high levels of addicted we always narcotics the for patients. he is charged with elder abuse causing the death of one patient. and issuing prescriptions without legitimate purpose. the complaint alleges keller drastically increased prescriptions for vicodin oxycodone oxycontin percocet and morphine. those levels well outside accepted medical practice. he is being held without bail. >>> across the country hundreds of writers are killed in traffic collisions every year. that is cost to install more protected by claims. researchers find that all bike lanes are created equal. protected bike lane separate writers from traffic with areas like parked cars. insurance institute for highway safety finds lanes like th

morning, thenesday former head of the fda on why he thinks the fda needs to take more action on cbd. national alliance on mental illness senior policy advisor talks about red flag was. -- laws. and as part of the podcast week, we talked to the head of the global dispatches podcast. journal, 7 a.m. eastern. be sure to catch podcast week. on thursday, our guest is the code test -- cohost of a podcast, and on friday, the host of congressional dish. >> here is look at live coverage wednesday. on c-span, montana governor presidential candidate steve the pressll speak at club about the 2020 presidential race and policy issues like gun violence and campaign finance. elijah followed by cummings on his committee's investigations of the trump administration. on c-span two at 9:30 a.m., a discussion about the importance of maintaining military air superiority globally. noon, a discussion of congressional war powers and whether the 2001 authorization for the use of military force can be applied to future conflicts. and the heritage foundation takes a look at japanese-korean trade relations and h

por su parte, la fda reconociÓ que se han reportado mÁs de 90 sÍntomas relacionados a la condiciÓn y afirma que si bien la fda no tiene pruebas definitivas que demuestren que los implantes de seno causan estos sÍntomas, respaldan la teorÍa de que algunas mujeres experimentan sÍntomas sistÉmicos que pueden desaparecer al extraerlos. ademÁs, esta agencia ordenÓ a un fabricante el retiro a nivel mundial de implantes y expansores que estÁn asociados al rezo de un tipo de linfoma como medida de precauciÓn. a soÑarlo no les pagaron sus implantes luego de que sintiera su vida amenazada. >> tenÍa muchas cosas en mi cuerpo, pÉrdida de memoria, me faltaba el aire, no podÍa respirar. sentÍa que los senos estaban sÚper calientes. cuando empecÉ a leer los testimonios de cada una yo lloraba como un bebÉ. lloraba porque decÍa esta soy yo. >> de hecho, cientas de mujeres han participado en audiencias de las fda con sus testimonios. no obstante, el experto indica que es un camino largo. >> estamos trabajando en ciertos estudios para poder definir y confirmar que ciertos sÍntomas est

i found our hospital does not carry many antibiotics that were just approved by the fda. your hospital almost certainly doesn't either. this is part of what the book is about. why is that? we hear about drug-resistant bacteria and fungi and then we find success with the fda approving a new drug. that doesn't go to the shelves of your hospital or your doctor knows how to prescriber it ort that it will ever reach you. i was flabbergasted. why? what is the reason? more importantly, what is this mean for future drug development? one thing that people don't recognize there is a formulary committee at each hospital they decide what drugs to add or which ones they will not use. they are able to buy in bulk based on making specific deals. at my hospital we use love for ofloxacin but not its sister drug but some coming out are so expensive that the farmers loan - - the pharmacies in the hospitals cannot afford to useim them.. i thought this was a fascinating conundrum and my book is about a new antibiotic that was approved by the fda may 2014 and did not go anywhere. i didn't go t

asÍ que estamos viendo de 100 a 200,000 mujeres y eso es sÓlo en estados unidos. >> segÚn la misma fda, algunos estudios relacionados con la silicona presentan problemas con enfermedades del sistema inmune o de las articulaciones y mÁs recientemente ha aceptado que puede haber una relaciÓn entre algunos implantes y un tipo de cÁncer llamado linfoma anaplÁsico de cÉlulas grandes. marÍa en california, quien inicialmente recibiÓ implantes de agua salinadice que desconocÍa los peligros cuando su mÉdico le recomendÓ un cambio para entonces estaba libre de cÁncer, pero no de dolencias. >> me dolÍa la espalda, el cuello, diferentes lugares en el cuerpo cerca de los senos. y fui a platicar con el cirujano. sabes? creo que quizÁs deba ayudar si te cambiamos los implantes. y ahora si vamos a ponerte de silicona. >> los implantes en infectaron y tuvo mÚltiples complicaciones que legaron el proceso de reconstrucciÓn de sus senos por varios aÑos. simultÁneamente los sÍntomas se agonizaban. >> la Última vez completamos todo en enero del 2015 y ya para mayo junio del 2015 sentÍa q

the fda says that claim his faults for today's health minute. i mandy gaither. >>tyson foods is announcing a recall of one of its chicken products. the usda says more than 39,000 pounds of the company's. weaver brand frozen chicken patty product is under the recall the fully cooked chicken could be contaminated was extraneous materials potentially affected chicken product was produced on january 31th of this year the recall covers 26 out resealable plastic bags of the chicken with a best if used by date of january 31th 2020. so far no illnesses or injuries have been reported if you have the product in your fridge or freezer you're urged to toss them out or return it to the store. and dolls in one town are causing some confusion. and a 103 year-old skydiver shows is never too late coming up in today's take a look at this and if you are streaming us on kron on the news continue oh thaphenomenal!, that's unfair. that's so unfair. c'mon jay-bo. let's go. let's go. woahh! try my $4.99 bbq bacon double cheeseburger combo. only at jack in the box. ♪ try my $4.99 barb

this is nine years after the fda proposed similar labels. tobacco companies killed the effort in court and the final ruling on the proposal is expected next march. >>> on the heels of the world cup victory, the u.s. women's soccer team takes their fight for equal pay to court. talks between the team and the u.s. soccer federation have broken down after just one day. they plan to move their gender discrimination lawsuit forward. the women won their fourth world cup last month in france but earned less than one quarter of what the u.s. men's team would have been paid for the same thing. >>> we continue back-to-school coverage in west contra costa county with a jefferson award winner on a mission to stop violence on the streets of richmond. the reverend created a program and it is a swahili word that means achievement and is designed to get parents engaged sukit home t itat they need to teaches students to focus, pay attention and follow instructions. >> we don't have this for the students in the district, then what? what would be available to

others are wondering if the fda thinks it is more of a replacement. does that debate have a place as we look at philip morris and altria, some of the regulatory pressure that you see? anna: i think it does have a place in this debate. there has been this balancing act that the government has been trying to keep up with. maybe these e-cigarettes can help smokers quit. at the same time, they are seeing teens use them more and more. which they don't want, because the centers for disease control and prevention has said that nicotine can have harmful effects on a developing brain. next year, there will be a deadline in may where these companies like juul will have to submit applications to the fda to get approval for their product. they have a really big milestone coming up that they will have to meet. taylor: wonderful analysis. thank you. bloomberg news reporter anna edney and bloomberg intelligence analyst ken shea. coming up, we sit down with a silicon valley legend. steve wozniak shares his thoughts on the trade war, facebook, and of course the compan

the #1 prescribed fda-approved oral combination treatment for hr+/her2- mbc. but allstate helps you. with drivewise. feedback that helps you drive safer. and that can lower your cost now that you know the truth... are you in good hands? ♪ >>> welcome back to "gma." who will run the world? beyonce runs the world. that's right. we saw the superstar grace t ♪ >>> welcome back to "gma." who will run the world? beyonce runs the world. that's right. we saw the superstar grace the cover of "vogue's" september issue last year and one of the photos from that issue has been acquired by the national portrait gallery. it is one of the most coveted magazines of the year and just ahead we'll reveal who is on the new september 2019 cover and that's an exclusive that's only on "gma." >> that is coming up in a few minutes. >>> we have a lot of headlines we're following this morning including the midwest and northeast bracing for another blast of severe weather. it comes on the heels of that flash flooding overnight and a tornado that touched down in new jersey. >>> there's

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in april, the fda began investigating dozens of reports of seizures potentially related to vaping. and this week illinois health officials warned that e-cigarettes "can be dangerous" after an adult who had been vaping died from severe respiratory illness. >> we've had the twenty two cases in illinois, and then all of those cases they all reportee of those 22 cases resulted in a death. >> the c-d-c is also investigating nearly 200 cases of severe pulmonary illness in an effort to determine if the use of e-cigarettes is to blame. >> health officials suspect an association between vaping and lung problems. however a direct causation hasn't been proven at this time. >> vaping has been assumed to be a safer practice than say smoking cigarettes. at this point we are unclear whether this injury we are seeing is related to the device itself, whether it is related to a substance that these teens are vaping, or one of the agents oils or solvents with it. >> among those who have been hospitalized is 20- year old alexander mitchell from utah. >> i would hit my vape easily 40 times in an hour.

the fda looking into new reports of people having seizures after vaping. >>> the things people do for a selfie. a woman's painful lesson after posing with an octopus. >>> coming up at 6 pm a species on the brink of extinction is about to make a comeback. the extensive program that will help them thrive at a popular bay area trail. >>> >>> all across the country you were hearing this. you can hear the crowd chanting do something about stricter gun laws. a group called the minnesota moms demand action. they gathered with state representatives and other supporters. they join thousands of others nationwide who are demanding action after the recent surge in mass shootings. the governor. >>> i will tell you what. i am not waiting on mitch mcconnell. i trust minnesotans to fix this. let's have the votes on red flags and background checks. with this pen we will sign it into law. we can do it this week and finish this. >>> hearing the same thing across the country from governors and other legislators. he went on to say he is counting on minnesota congressman dean phillips to help the state ach

jae: creo que a nivel de los fabricantes y de la fda la información debe ser más clara... que algunas mujeres enferman y ese mensaje debe prevalecer al que se ha estado diciendo de que los implantes son seguros. tifani: mujeres como alejandra levantaron su voz para hacerse escuchar. en marzo de 2019 la agencia reguladora fda llevó a cabo audiencias en washington para escuchar testimonios tanto de médicos como de pacientes. alejandra: y entonces me doy cuenta que los implantes que supuestamente yo pagué más por ellos, porque eran la última tecnología, que eran implantes texturizados, ahora estaban ligados a un nuevo tipo de cáncer que era--que es directo. que es un link directo que tienen además. tifani: en julio de 2019 la fda le pidió a allergan, que fabrica implantes, que hiciera un retiro voluntario de un tipo de implante conocido como "texturizados". la decisión se basa en un estudio mundial que relaciona este producto con cáncer linfático. la recomendación es que, si la paciente ya tiene implante y no tiene síntomas, no debe preocuparse, pero la mayoría

in the last congress in a bipartisan i think unanimously we reauthorize fda and give agency new tools and resources to get generic drugs into market faster. we've already seen the positive effects of that legislation played out. we've seen last year the fda approved a record number of generic drugs driving competition and giving consumers more choices. just last month this committee unanimously approved a number of fda policies site increase transparency in the supply chain and bring down prescription drug prices. i hope we can continue to work across the aisle on commonsense policies to address the rising drug cost and in doing so we will rely on the testimony and it set of witnesses like those before us today. again i would say having been involved in these efforts for years, we need to look from one into the other of everything related to healthcare, madam chair, not just drugs, notches pbms, not just insurers. we need to get this right for our constituents, for our country. i don't think that the country on the face of the planet that does more innovation in health care than the u

others are wondering if the fda thinks it is more of a replacement. some of the regulatory pressure that you see? anna: i think it does have a place in this debate. there has been this balancing act that the government has been trying to keep up with. maybe e-cigarettes can help people quit. they are seeing teens use them more and more. nicotineas said that can have harmful roof -- harmful effects on the brain. next year, there will be a deadline in may where these companies like juul will have to submit applications to the fda to get approval for their product. taylor: wonderful analysis. thank you. bloomberg news reporter anna ed ney and bloomberg intelligence analyst ken shea. coming up, we sit down with a silicon valley legend. steve wozniak on the trade war and the company he cofounded, apple. if you like bloomberg news, check us out on the radio, the bloomberg app, bloomberg.com, and in the u.s., on sirius xm. this is bloomberg. ♪ taylor: we are getting some late news on tuesday. telecom has filed for -- pelaton has filed for its ipo. it filed

scott gottlieb served as that when he commissioner of the fda -- 23rd commissioner of the fda, joining us this morning to discuss federal regulation of cannabidiol, cbd as it is better known as. explain what cbd is. guest: it is a derivative of the cannabis plant. it is an oil extract, previously only available from the plant you grow marijuana from. 2018 farm bill legalized the growing of hemp, which is a form of cannabis that has low concentrations of thc. hemp become seeing a much more prominent agricultural crop. it can grow in poor quality soil, so you see it grown in lower quality soils. it could be a real opportunity for american farmers to develop a new crop. being able to derive cbd from hemp and market it, there's a hemp. pharmacies growing host: what is cbd used for? guest: right now, it is only used for one purpose. it is approved in a concentrated form for the treatment of certain seizure disorders. a lot of companies want to put cbd into dietary supplements and food. the way the law is constructed right now, that is not legal. all the cbd being put in pet food or differen

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the fda reiterated their warning about the products. saying ingesting them is the same as drinking bleach and it can have serious health consequences. jon: 20 texas cities have been hit by a ransomware attack. in a press release. texas says it will deploy resources to the most of critically affected jurisdictions. stay tuned for a new episode of. "watters' world." jesse: donald trump considering buying greenland. comedian pauly shore is here to discuss. jon: it's a cool day to be a cat if you are one with a certain fur color. we'll dig our clause into that one next -- our claws into that next. liberty mutual customizes your car insurance, so you only pay for what you need. i wish i could shake your hand. granted. only pay for what you need. ♪ liberty. liberty. liberty. liberty. ♪ since my dvt blood clot i was thinking... could there be another around the corner? or could it turn out differently? i wanted to help protect myself. my doctor recommended eliquis. eliquis is proven to treat and help prevent another dvt or pe blood clot...

and look up the ones approved by the fda last year. they almost certainly are not in your local hospital, and part of that is because it costs so much money. then the question is why does it cost so much money? it isn't simply that they are greedy, but to get a drug approved by the fda, typically take us ten years and a billion dollars to go through phase one, two and three clinical trials. if you are developing a drug for blood pressure, high blood pressure or four high cholesterol, it's going to be worth it because that is a drug that they will prescribe to patients and they take this every day for the rest of your life or some variation of that. think about an antibiotic they are prescribing and short courses, doctors are very stingy about prescribing them. there is a lot of talk now about how you fix it and that is what my book is about, addressing not only from the patient's perspective, but what about everyone else. you may not have a superbug infection that one day you were somebody in your family might come and where the pipeli

it's about running the fda as a more effective situation. that was the move until trump budget director mick mulvaney let the cat out of the bag while talking to republicans at a fund-raiser early this month. >> you've heard about drain the swamp. what you probably haven't heard is what we're actually doing. the usda tried to move or did move two offices out of washington, d.c. to kansas, missouri. guess what happened? guess what happened? more than half the people quit. now, it's nearly impossible to fire a federal worker. i know that because of a lot of them work for me and i've tried and you can't do it. by simply saying to people you know what, we're going to take you outside the bubble, outside the belt way and outside this liberal haven to other parts of the country and they yet. >> the trump administration was so excited to tell republican donors about this. you know how hard it is to get rid of these terrible pesky federal workers? finally we have figured out a way to shed that dead weight. we are so psyched to get rid of these feder

todos los rellenos faciales que se usan y estÁn a prueba de la fda que en un proceso de esterilizaciÓn. carolina: en pantalla se ven las imÁgenes de cÓmo le quedo a la joven en labio. es algo preocupante. ¿es comÚn esta sustancia? >> bueno, no es comÚn. lo que he visto en estados unidos. estÁn son complicaciones industriales aprobados en otros paÍses europeos. no manejan la esteralidad comÚn. al no tener garantÍa de la fda, al no haber pasado por el escrutinio mÉdico-- >> claro, doctor, me gustarÍa saber como pacientes quÉ es lo que tenemos que saber o preguntar al doctor ante esta realizar este tipo de procedimientos. >> dos preguntas principales, hay que verificar la autenticidad del material. les compartÍ un link a la cadena de visiÓn para que puedan compartir con la audiencia. y se puede ver si estaban aprobados. tÍpicamente esta persona debe tener estudios en cirugÍa plÁstica o dermatologÍa. y debe saber manejar, y hacer las inyecciones seguras. y saben que son poco probables. >> doctor rueda, excelentes recomendaciones. sea aquÍ en estados unidos o en otros pa�

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it said fda approved. there is no fda approval for children's toys. >> reporter: we reached out to amazon for comment and they told us they have reviewed and addressed all the items brought to our attention by "the wall street journal," adding they use artificial intelligence to scan the more than 5 billion daily changes to product detail pages and analyze the tens of millions of customer reviews that are submitted weekly. last year alone they say they invested over $400 million to ensure products offered are safe, compliant, and authentic. something its customers depend on. >> our thanks to becky worley there. and amazon also says if a customer ever has a concern about a product, to contact the site's support team and they will investigate. >>> coming up, the surprise for some girls heading back to school. >> where they'll be finding some unexpected words of encouragement. toxic chemicals and carcinogens are leaching into the environment. it's happening right where we live, work and play. everywhere. ciga

brush like a pro. >>> in 2005, the fda approved a new treatment for a rare genetic disease. it was a hard road to get there because the disease in question is rare, so finding enough patients to test it in clinical trials was a hard thing. doctors at ucsf's benioff's children's hospital found a young woman in guatemala named isabel bueso who was willing to participate. ms. bueso and her family have been told by the trump administration that they need to get out of this country within 33 days. that among other things will end her access to the drug that is still keeping her alive and that she helped developed for everyone else in the world who also has this rare genetic illness. joining us is dr. paul harmitz who has treated her since she was 7 years old and led the clinical trial to treat her disease. thank you very much for being with us tonight. >> thank you, rachel. it's really, this has been a devastating two-week feared and we appreciate your help trying to tell isabel's story. >> it's absolutely horrifying. i have to ask you basically if i have explained this accuratel

. >>> the fda has warped about pig ears. pet owners who them at home are advised to throw them out. >> the fda asks that anyone who handles pig ears, wash your hands when you're done touching it. >> 127 people have contracted sam untila in 33 states. if faa a -- fda is investigating. >>> popeyes chicken has been closed because of cockroaches. a notice on the window said the violations were immediate danger to public health or safety. the chain has been there for 30 years and popular with locals and tourist. >>> bart's new general manager was here to discuss service. robert powers talked about the uphill challenge. >> my highest three priorities bringing on a bart police chief is one of the three. we've hired 33 police officers in the last six months, that's more than we hired all of last year. >> are you stopping there. >> we're going to fully staff the police department. >> the bart board will discuss the efforts to combat fare evasions and the new dates at an upcoming meeting. >>> an under represented community creating ch

>> we have been very encouraged with our interactions with the fda so far. we also take encouragement that we have developed something similar in the past already and as far as w are aware, were able to follow a similar development pathway. deirdre: so dr. crystal, when the president tweets or talks about fentanyl coming from china, is that based on your research, that's the number one source of fentanyl coming here? >> it would appear so, in terms of the fentanyl that's being used obviously illegally and killing so many americans. significant amount coming from china. some is also coming from mexico. earlier in the year, there was a seizure of around 100 pounds of fentanyl. that's enough to kill over 50 million people. in fact -- deirdre: staggering. >> there is a division of hhs who is responsible for launching medical countermeasures against chemical attacks. they have supported some of this development work as well, because they are concerned about fentanyl being used in a chemical attack setting. deirdre: that's a sobering thought. let me ask you. you h

in moving adults away from cigarettes to these so i'm looking for members of congress to say if the fda isn't going to do anything and the doj won't stop them there coming together, we should start regulating the products again. so i think that congress could be looking to do things to made market by limiting the types of products that can be sold in the united states. >> and among the concerns, usually they decline because of concerns about pricing and that sort of thing. but in this case people are also asking what exactly the benefit is of philip morris getting altria with everything that stephanie described going on what do you think it is after? >> well, there was some confusion when the companies announced this morning that they were in talks because they described it as a merger of equals but as more details have emerged, we've learned that philip morris would control around 59% of the company. so that may explain some of that stock fall this morning. but there are concerns around the u.s. tobacco market. juul represents a risk in terms of litigation and a regulatory risk lawmake