>> so we had july the 17th, an fda meeting. that was our first meeting with the fda. we were able to introduce two new outcome measures for our trials. and the fda was quite positive that we can run a phase two trial in the u.s. and we have also got an approval by the european agencies in uk, spain and the netherlands which were quite enthusiastic in particular because this drug has an excellent safety profile. it's well tolerated. and by the way, hundreds of patients now take the drug worldwide, off label, of course, from the philippines, india, to latin america and also in the u.s. >> since i've already broken the rules and i know senator casey has to leave, do you want to interject a question? >> i'll wait for the testimony of the following. >> the next testimony will come from richard tsang, a partner and reporter in london. i'm grateful to discuss certain technical and regulatory issues relative to facilitating approval of new treatments to ensure their timely access by patients with rare diseases. my statement is drawn upon my experience as a medical scientist,

the fda published the draft method last month and the same day the fda also published guidance on this so-called master protocols which can allow a single clinical trial to evaluate multiple drug candidates, multiple disease types and more than one patient population under the same clinical trial structure, potentially reducing the time and cost of generating the necessary data for approvals, or approval. one of the common points we hear from the patient community and the companies working to develop new drugs is that patients are and understandably so, desperate for access to new drugs. that is hard to enroll them in clinical trials, congress is given the fda specific authority in the fda review act, the reauthorization act i should say, to consider ways to design clinical trials that can incorporate data from expanded access, use of investigational drugs. the fda is also learning from the adaptive trial designs employee during the able outbreak in 2014, and using those lessons to inform other clinical trials where the standard randomization -- randomized double blind placebo trial is

>> so, we had july 17th an fda meeting. that was our first meeting with the fda. we were able to introduce two new outcome measures for our trials and the fda was quite positive that we can run a phase 2 trial in the u.s., and we have also got an approval by the european agencies in uk, spain, and the netherlands, which we're quite enthusiastic, in particular since this drug has an excellent safety profile. it's well tolerated. and by the way, hundreds of patients take the drug now worldwide off label, of course, from the philippines, india, to latin america and also in the u.s. >> thank you. since i've already broken the rules and i know senator casey has to leave, do you want to interject with a question now before you leave. >> i'll wait for the testimony of the following -- >> that's fine. our next testimony will come from lincoln sang, a partner at arnold and porter in london. >> mr. chairman, ranking member and distinguished members of the committee, my name is lincoln tsang. i'm grateful to discuss certain technical and regulatory issues relative to facilit

so we need some assistance from the fda, we're hoping a non-hostile fda, so we can keep this industry around, grow it, and not just hand over in its entirety to large tobacco companies, which is the path we're on right now. >> so you're about to hear from the fda commissioner, dr. scott gottlieb. what do you agree with and disagree with in his approach to e-cigarettes? >> i think back. last night, there was an article that commissioner gottlieb wrote five years ago for forbes. and he talked about how the tobacco control act, the bill passed in 2009 by congress, that it was supposed to give a route, give a pathway for less harmful tobacco and nicotine products to come to market. and so i see that in his writing. when he spoke last year at the fda, july 26th, the last year and said, smokers smoke for the nicotine, but the nicotine is not the major cause of the death and disease, that is caused primarily by inhaling burning smoke. that kind of rhetoric, that kind of language is great. but in terms of what i disagree with him on, i think that the way that he is presenting this issue ignor

>> i look at it the same way the fda does. you have something called the population health assessment where you not only look at the users of the product, the adult users, what are they doing, but then luke at youth and how many of them are transitioning to cigarette smoking. how many of them are only experimenting versus using 20-plus days of the month? the acceptable level, it depends. are you talking about youth that are using one to two days a month, which was the case several years ago? or are we talking about increasingly the numbers where you have teens habitually using. those are two entirely different matters. >> when we were talking on the phone, you told me you quit using watermelons. you have to unpack that statement for me. >> sure. 2009 these products hit the market. the fda under former leadership tried to ban them, claimed them to be drugs. it turned out to be the best advertising this industry could have because made millions of smokers aware that the products existed. unfortunately, the products were junk. so

the fda is cracking down on the industry leader, juul. and as a o adidi roy, tells us that could have an unintended benefit for big tobacco. >> reporter: they'resleek, slim and stylish. that's one reason juul's vaping devices are so popular >> it's on of the products that just flies off the shelf. ar reporter: juul asferly 3/4 of the ecigarettet and now it's fighting copy cat companies. juul is asking regulators to order 1companies to stop selling lock alike e-cigarettes. the company filed a complaint with the u.s. international trade commission, alleging the companies, quote with, blatantly emated the distinctive design of juul's system. juul wants the agency to stop theng products from b imported, distributed, sold and u.s.ted in the the company alleges copy cat products include flavors byle bubb bubble, apple juice, and sour gummy. which seem to target underage user. juul itself is the focus of an investigation in ecigarette manufacturers and teen use o vaping devices. just last week fda officials showed up at juul headquaaners left wi

plus juul getting burned as the fda cracks down. could the smoking stocks be next we will explain, more "fast money" after this. thank you clients? well jd power did just rank them highest in investor satisfaction with full service brokerage firms...again. and online equity trades are only $4.95... i mean you can't have low cost and be full service. it's impossible. it's like having your cake and eating it too. ask your broker if they offer award-winning full service and low costs. how am i going to explain this? if you don't like their answer, ask again at schwab. schwab, a modern approach to wealth management. >>> welcome back to "fast money. shares of chipotle bucking the trend after key bank nishlgted the stock with a bullish overweight rating and set a $500 price target jim kramer set down with the ceo in an interview today. let's listen. >> the purpose of chipotle doing you know food with integrity and the mission of cultivating a better world, it never stopped resonating with millennials and genz and a lot of employees -- i t

we begin with fda commissioner dr. scott gottlieb. he talkeded to the online news publication, axios, about steps the agency is taking on children vaping. >> and next it's our honor to have the 23rd commissioner of food and drugs of the united states. he practiced medicine as a hospital physician. he was a residesident fellow at american enterprise institute. before that, residency internal medicine at mt. sinai medical center in new york. and studied econ at wesleyan university in it middletown, connecticut. we have some friends there. it's an honor to welcome to the axios stage the fda commissioner dr. scott gottlieb. welcome to axios. thank you so much for joining us. really appreciate it. what do you think of wa yhat yo heard so far? glad you got to meet brandon and jacqueline. >> we've said all along we think e-cigarettes could be a viable alternative for adult smokers. and help more people get off combustible tobacco. the issue isn't nicotine that causes the death and disease for smoking. it's the products of combustion. if you

the fda wants to know if it's targeting kids.orts. >> reporter: the fda requested information from juul in april. they dropped in unannounced. it is part of the agency's investigation into the epidemic of teen e-cigarette use. the xda wants to clear the air on what's driving teenage vaping and agency officials showed up without warning friday at juul's offices in san francisco. their goal? they say to gather information about juul's sales and marketing practices to determine whether the company is deliberately targeting minors. the company says it wants to be part of the solution in preventing under age use and has released over 50,000 pages of documents to the fda since april. >> vaping can deliver nicotine to your brain, reprogramming you to create more and more. >> reporter: the fda will also be looking at prior social media campaigns by juul that show young models in bright colors. the study published tuesday by the center for disease prevention found juul sales increased 600% last year. from 2.2 million in 2016 to 16.2 milli

as a defined substance versus an fda process. general, manyy things states are dealing with is election security, border security, and how that works for election laws and voting laws there. what does indiana face in november when it comes to voting laws? >> i think indiana is in great shape. we encourage satellite voting. recently we had a case we were that leftn controversy. a federal judge had stepped in. we had opposed the federal judge dictating what should happen because we believed the state statute is sufficient to provide communities with the opportunity to set their own standards. in the county were indianapolis have determiners the number of satellite voting sites. that encourages more people to get active and involved. it is necessary beef of -- up the number of people involved. anything we can do to promote that we will do. i read you had to settle something with the ridesharing company uber, and how those -- that affected those who use the surface -- service. could you explain? >> a number of states have been dealin

it's an honor to welcome the fda commissioner, dr. scott gottlieb. dr. gottlieb, welcome to axios. thank you so much for joining us. really appreciate it. what did you think of what you've heard so far? and by the way, i'm glad that you got to meet brandon and jacqueline. what have you thought so far? >> look, we've said all along that we think that e-cigarettes would be a viable alternative for adult smokers and help more people get off combustible tobacco. the issue isn't nicotine that causes all the death and disease from smoking. it's the products of combination. if you can migrate more adult smokers off of combustible products, hopefully off of nicotine altogether, and if not, on to nicotine replacement therapy, which is the safest form of nicotine delivery but perhaps on to e-cigarettes which we know presumably pose less risk to adults than combusting tobacco. the problem is the rising youth use and what we've said recently, you know, is that unfortunately, we think we're going to have to take steps that in order to close the off ramp to kids, we have to narrow the onramp for

>> we don't know exactly what the fda hasl. but i do think if you look at the history of tobacco companies and their marketing long before independent folks had data on marketing to use or the health implications of cigarettes the cigarette companies knew a lot and they hid that data. so i might expect that internal documents from juul might have important information about the marketing or the product that isn't available to the public. >> what is it overall when you see the numbers, the rising number of young people using these e-cigarette products. what is it that concerns you the most about that increasing rate of usage among young people? >> i think that we're concerned about young people using juul first of all because your brain is still developing until you're about 25-years old. and we do know the earlier you're exposed to nicotine the more likely it is you'll become addicted. so with young people experimenting with juul they may not not realize they're being exposed to very high levels of nicotine. as young people are

that is definitely not fda approved. we have connection against products making unproven claims particularly dietary supplements useful for opioid abuse disorder but there are tools that could be helpful in the context of a conference of approach to treatment coupling drug therapy. >> that may be useful in rural areas, there was not a lot of underserved areas with not enough providers to support. and move into a clinic and do something so they have a role. if i were to click on something that is not fda approved. you know what the internet is like. >> typically these would be fda cleared. lanny page, the medical device center with a collection of medical devices to be approved for treatment of opioid abuse disorder and 5 for 10k, we are talking about digital health tools. >> what are the tools, and the tools are rudimentary form. what to you and cms, and is a complicated epidemic, a black market component and overprescribing component and the sentinel, vaguely out there to pull into. >> the integration, they have good te

the dramatic action the fda is taking against san francisco-based juul. fda )s surprise inspection at te san francisco >>> welcome back, everyone. we are learning more about the fda surprise inspection at the san francisco headquarters of the popular e-cigarette maker juul. e-cigarette sales have been heating up with juul leading the way. >> now the company is under new scrutiny, the fda looking more closely at how they're marketing their products as the government works to keep the growing trend out of the hand of teens. here is nbc's morgan rap ert. >> reporter: e-cigarette maker juul is smoking the competition. new numbers out this week from the cdc show its sales are skyrocketing, increasing 641% from 2016 to 2017 when 16.2 million devices were sold. critics say the small, sleek device and friendly flavors like cream, cucumber and mint, are hooking a new generation on nicotine. >> it wasn't really a big thing in the high school, and then one day over a week period everything was juuling. >> reporter: juul's popularity may come with a price. the fda la

the fda for example. -- today's science. in the fda this year for example, they approved communication across tumor types based on genetic signature. i think with regard to artificial intelligence and the greater understanding of biology, we can reduce the cost ?f the regulatory period host: in many ways, when multinational companies say, look, we need innovation, we need the kind of income that comes with it, i think the u.s. is paying for the other countries. >> we pay 50% of the cost of research in our country. the rest of the world splits the other 50%. >> can i interject. >> yes. >> it is important to note that the initial price of a drug does not necessarily have that relationship to that cost of r&d. there is an article in the wall street journal from a couple of years ago that said, they basically figured out that this was how much oncologists would pay for medicine, and not be .ticker shocked it was quoted in the paper in the article that it had no relationship to the r&d. i would also point out that is not r and d,

, fda, lawmakers. they've released 50,000 of pages to the fda since april. >> reporter: we should point out, this is not the fab cracked down on juul. in september, they had 60 days to prove they could not get these in the hands of kids. live in san francisco, dion lim, abc 7 news. >>> dion, thank you. it can happen to anyone. getting a surprise medical bill that really puts you in serious debt. >> michael finney is here to talk about remedies. >> it's money that we're talking about here. bigger than that. more than 25% of people with health insurance have received a surprise medical bill. just big consequences on your credit score. >> there are ways to protect yourself. >> a ten-day hospital stay and heart condition in 2016 left him with medical bills popping $130,000. the 59-year-old comic bookstore owner thought his insurance would cover most of it. after months of trying to navigate the $76,000 gap between what his insurance company would pay and what the hospital billed him, he would turned over t

all this started from a lecture on the fda website.eir former gave a lecture about reducing nicotine exposure throughout society, talking about the potential for a 96% decline in the nicotine content in cigarettes. that is hitting stocks hard. but youot just altria saw this in shares in london. point.l, down 7% at one there was concern that the fda might be willing to crackdown on nicotine use. guy: is this just a tobacco related issue or is this also a vaping issue question mark -- issue? issue and a nicotine this is why the stocks are selling off. these companies has started to branch out into other things that were not cigarette use. the studies of the fta lecturer cited were about reducing nicotine consumption. there was concern this would not only hit cigarette sales but e-cigarette sales and smokeless tobacco products that do contain nicotine. getting a lot of hazing. keep in mind, there has been speculation about these companies trying to branch out away from cigarettes. there was a report that altria might be considering lookin

the fda has only approved one prescription cbd dg to tre form of childhood epilepsy. what's the risk >> the danger is, you don't know 100% if you'r what getting is what is on the label. it might be different ingredients. >> reporter: and beware of bogus claims. we went rundercover andan into one salesman who told us that cbd is produced by the university of maryl fd, completese. >> so, this is from the university of maryland, it's probably more lright? >> exactly. their business development side and research side. there's ver strict requirements, because they're affiliated with the university and they're registered with the fda. >> reporter: the fda has warned a number of companies to stop making misleading claims about cbd, but this is uncharted srritory. that's why it i important for you to do your own research and talk to a health professional you trust if you're thinking about buying cbd. sara wallace, news 4. >> aright. beautiful weather for all those or the ns heading out big celebration tonight. you were there, you -- >> my gosh. >> what a good ti. >> itas amaz

again, the eu company put into the fda, and the fda have an m.o.u. that if one inspects a plane in it if the other works at that inspection. it just seems logical we should have a global market for some of these drugs. so i like that, john. it's a great idea to go after these as an example. as regards to sickle cell that something where there needs to be a symbiosis between what research is an value-based purchasing. aside from just the tragedy of a sickle child it is expense of a single child. if you do gene therapy and find out one genome in a conversation wackadoo elegies egg victory over georgia, though -- [laughing] the doctor walk with me, this is hearsay, but there's a a very small gene that could be replace in the genome of a a sickle patient and make a huge difference. talk about something where compassion meets value-based purchasing. so the degree to which we can do that i think should be opportunities for that research. >> and that is being carried out, for sure. last question. short. >> my name is giorgio from vanderbilt university, and

the fda is calling the beeping by children and teenagers an epidemic. they have really sleet warned juul lab and other e-cigarette makers they must start -- stop marketing from minors. >>> the city of san francisco is offering a limited number of new less-expensive liquor licenses. the chronicle is reporting four out of the first five type lxxxvii licenses have been assigned. they cost $15,000 each. they are meant to bring business into the bayview, mission, outer sunset and other neighborhoods. regular liquor licenses can cost upwards of $100,000. the city will eventually end up 30 of the new licenses. >>> the cities. tuff shed community was revealed. today. oakland officials say the first two tuff shed villages have been a success. >> reporter: this man lives in a tent on an overpass -- under an overpass, he says he will still move -- soon moved here. >> i am excited. i can go back to school and go back to work. >> reporter: dexter gary is one of four people moving into oakland's third tuff shed development. >> there is a lot of people willing to walk

the fda seizing thousands of documents during an inspection of e-cigarette maker juul lapse. aditty roy has more on the story. >> reporter: hi there, julia the fda says it got more than 1,000 pages of documents here from juul headquarters as lawmakers are urging the government to restrict e-cigarette sales. all of this happening because the fda is looking into juul's sales and marketing practices and specifically teenage use of e-cigarettes which scott gottlieb calls an epidemic the number of high school students who have used e-cigarettes in the past 30 days has skyrocketed about 75% according to people familiar with preliminary data from the cdc. juul ceo kevin burns says it provided information about the company's online age verification protocols and calls meetings with the fda a constructive and transparent dialogue adding that it's released more than 50,000 pages of documents to the fda. meantime senators dick durbin and lisa murkowski sent a letter to the fda urging the agency to immediately ban kid-friendly e-cigarette flavorings and restrict online sales of nicotine

fda for approval.. >> yes, there is debate whether this product should be available to consumers. but like any other product category, the fee have a better product -- if you have a better product than the existing one, you make it available. rishaad: the fda did not give approval in january for iqos. you call this reduced risk products, which means it still has risks. which are those risks? the jury is still out, isn't it? currently is reviewing this product. the fda has taken a decision. least hopeful for at approval for the u.s. market very soon. these products are not zero risk. that's for sure. they do contain nicotine so they are addictive. but nicotine as part of the satisfaction. the objective here is to convince the people who smoke to switch to this product, 10 they have to have taste and satisfaction -- and they have to have taste and satisfaction. cigarettes, these products will have a positive impact on the individual and the population in general, so it will be beneficial for public healt

again the eu equivalent to the fda and the fda as an -- one will accept that inspection. it just seems logical that we should have a global market for some of these drugs i like that, john. it's a great idea to go after these. as regards to sickle cell, that something with the need to be a symbiosis between what research is in value-based purchasing. aside from the tragedy of a sickle child and his expense. if you did to gene therapy and find that one gene, the doctor walked in with news told me, this is little hearsay but there's a a small gene that cod be replaced in the genome of a sickle patient and make a huge difference. talk about something where compassion needs value-based purchasing. the degree to which we can do that should be opportunities for that direct research. >> that is being carried out. last question. george. short. >> my name is george ill from vanderbilt university, and i want to come back to what ken frazier said as we wrap up, and that is the patient. throughout today we talked a lot about and we've heard a lot about the disparity that occur with o

. >>> the fda makes a surprise visit to e-cigarette maker jewells. we have confirmed the fda seized thousands of documents related to the marketing of the wildly popular vaping device especially among teenagers. the cdc says the use of e- cigarettes has soared 75% in just the past year. juul controls 75% of the market. juul is cooperating saying they have released over 50,000 pages of documents to the fda since april. we want to be a part of the solution in preventing underage use. we believe it will take the industry and regulators working together to restrict youth access. >>> an update on the reopening of san francisco's transbay transit center. a cause of the cracks and two beams could be determined in had the next couple of weeks. today officials say fremont street could reopen next friday, october 12, at the earliest. once they begin a permanent fix, reopening the park is called a "definite possibility." while the rest of the center will remain closed. right now their focus is adding additional support to the section above fremont street. >> an

the fda's visit coming less than a month after the agency declared a crackdown on sales to teens. >> weust do more to stem what i see is epidemic of use of e-cigss. among te >> they have 60 days to keep it out of hands of young use or ce a ban. >> it's appealing. it's simple. the hejuul, pod, and it's so small and so convenient. >> beyond convenience, juul has something else that gives it be edge over many competitors. higher nicotine content. with an estimated 3 million regular high school students using juul and other e-cigarettes to get their fix.li >> e this year the fda first asked juul for documents to help the agency understand the use appeal of juul products. in t responsethe fda inspection, juul labs tell nbc news it has released more than 50,000 pages of documents to the government. wisconsining gears, a man is recovering from a rare infection that led to several amputations. the source from all this, licks from a dog. >> greg thought he had the flu this summer but doctors realized t was actually a bacterial infection transmitted from a dog. in this case the dog's saliva wa

new fda approved treatment called emgality. it's a self injectable drug. >> fifty to sixty percent of patients get a 50% reduction in migraines. this is a huge deal. this is one of the best migraine medicines we've had ever. >> not cheap either. the drug costs about $575 a month. the company is offering some sufferers their first year of doses for free. >>> coming up, new video of how rescuers got a leopard out of a 30-feet-deep well. >> didn't win last night's mega millions lottery? good news, you get another chance for one of the biggest jackpots. drowning in a nearly 30-foot- deep open well in india. first -- rescuers brought down a wooden step ladder for the animal to float on... then they lowered a cage for the big cat to enter... once it climbed in -- the team swiftly closed its doors and pulled it back to the surface. rescuers said the leopard was taken to a leopard rescue center to recover from the experience. the numbers are in for the mega- millions jackpot - but nobody won the big prize. it was estimated at 548-milli

i would say a lot of conversations we have been having with the fda and hhs, fda can keep approving products, and they are at record rates. if they are not just we are not getting it into the hands of people who needed, the -- if we are not getting it into the hands of people who need it, --. people are saying, i don't understand. you get approval and you launch the product, we do, but there is all this in the middle, everything that's controlling how you get your health care is dictating what you are getting. you, your physician, and your pharmacist anymore. >> give me a minute on the presidents tariffs. are they helping or hurting you? i don't mean you but the generic industry. >> i would say there is not a big impact on the generics industry right now from a tariffs perspective. we are making tens of billions of doses for pennies on the dose. that volume and efficiency and that access is at the core of a we do. >> china, india, -- >> all over the world. there is more raw material coming out of china than there is finished dosage form. >> why don't we make more of than the united states? >

. >> i've already said to the industry -- we've invited the main manufacturers in to the fda to have discussions with us about what steps they're willing to take, and we're scheduling those means right now. we've reached out to some of them. i've already said to them they need to contemplate what they're willing to do to address what we've seen. we haven't put all the data out yet. we'll be putting that out shortly sometime in november, the top line numbers. i think after people see that data, they'll understand why we're so alarmed. at that point we'll be ready to take action. i think the manufacturers have an opportunity now to come in and have a discussion with us. but it's not like i need another six months or another year to take action. we've been talking about this for a whole year. there is no surprise here that we were concerned about what we saw as a rising youth use of these products. now we have definitive data to demonstrate it. now we have to step in and take action. this is a public health emergency. we may have to announce something as early as november of action that

and clouded in smoke, the fda raiding headquarters of juul, seizing thousands of documents from the ecigarette maker. is the company targeting teens and is a crackdown coming? we are live at juul's headquarters power launch starts right now. >> yes, indeed, it does, everybody. welcome to "power lunch. i'm tyler mathisen the dow hitting a new record high, up for a fifth straight day. the s&p on track record close there. financials, tech, leading the way. this is a hot market and you, i suspect, may be getting a little richer bonds are on the move in the other way. the benchmark ten-year note, highest level for yields since 2011 caterpillar, apple, boeing, they are the leaders. ge, steady, despite reports it may cut its dividend lennar down despite an earnings boat, the company warning of higher costs courtney >> i'm courtney reagan hey, tyler, here's what's happening at this hour the sky falls on aston martin, shares of the luxury carmaker and james bond' choice of transportation hitting the skids on its debut, falling below its ipo price. and new clues about the job market ahead of friday's em

. >>> flu medicine breakthrough the brand new drug just approved by the fda that could help you get better faster after the deadliest flu season in decades. >>> feeling lucky? no powerball winner overnight. more than 700 million still up for grabs, plus, the small town holding a big secret. do they know who won that billion dollar jackpot? >>> good morning, america. want to get right to that breaking news, another suspicious package has been discovered here in new york city this morning. that is the scene in tribeca. it was addressed to robert de niro. not sure if it was his home or restaurant in downtown new york city, but you saw the device being taken away in a

the fda wants to clear the air on what's driving teenaged vaping.howed up without warning on friday at juul's operation in california. the company says it wants to be part of the solution in preventeding underage use and has released over 50,000 pages of documents to the fda since april. >> vaping can deliver nicotine to your brain, reprogramming you to create more and more. >> the fda will also be looking at prior magazine campaigns showing young models in groups with bright colors. the study found that juul sales in retail sores increased more than 600% last year, from 2.2 million devices in 2016 to 16.2 million devices in 2017. >> we believe that vaporization technology holds huge promise for public health. >> she said the product is intended for adult smokers to switch to something safer and healther this. >> it impedes our position. we don't want it at all. >> but aren't they going to loose a lot of market share and sales if they do man amg to stop kids from using their product? >> there are a billion smokers in this world. we don't want and we

this isn't the first time fda cracked down on juul. they were given 60 days to prove they can prevent these from getting into the hands of kids. dion lim, be abc 7 news. >>> home goods in the north bay has a lot of cleaning up to do after part of the roof cole lambsed yesterday morning. the cause is still under investigation. but it appears to be weather related. is san rafael had a lot of rain yesterday morning. the building is now red tagged. fortunately nobody got hurt. >>> it was nearly an inch and about 1500ths. it came down fast and furious in the north bay. we're not seeing that this morning. hi, everybody. engel side, heading towards the sunset, marina eventually, and the richmond district, that's where the live rain is. you can see on the peninsula, right over sfo, down 280 and also 101 all the way into the south bay. notice it's all green. you're not seeing the yellows, oranges and reds at the north bay. very light rain. but it will still be slick, nonetheless, as it may be the first time you have had rain in 130, 140 days. g

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what can you talk about -- >> beth: fda -- sure. well the fda allowed them to make this squishy claim that because of its time release mechanism that oxycontin first of all was the higher mill gram than its xeters that were immediate release, but the fda allowed them to say that because of the time-rerelease mechanism this high mill gram dosage drug was supposed to bleed out over 12 hours, and that it would give people in severe pain the miracle of uninterrupted sleep. that's a good thing. but what people quickly learned how to do was to do an end-run around the time-release mechanism, and put it in their mouth, get it soft and wipe off the coating which had the time release mechanism on their shirt sleeve, and then either crush it and either snort it and inject it, getting the full rush right away. there's a descrepancy on when perdue knew that was being done. they had said all along they didn't know until 2000. people like van zee were telling them they were seeing overdoses and then a new justice department set of documents that

the fda has warned of a nicotine epidemic among teens.ul says it's committed to preventing minors from using its products. >>> a new survey finds 37% of adults in the united states eat fast food on any given day. that's about 85 million people per day. >> wow. >> the study found higher income families eat more fast food than lower income families, and experts say more fast food advertising is influencing children. >>> well, cubs fans will need some comfort food right about now. the colorado rockies knocked off the cubs 2-1 in 13 innings in the wild card game. it was the longest win or go home playoff game in major league history. the rockies start the division series in milwaukee tomorrow night, so they don't have to travel too far. >> not too far. >>> well, coming up, the war on clapping. i have questions about this one. a new push to stop college students from putting their hands together. >>> but first if you need some motivation on this wednesday morning, wait till you meet this worker celebrating 65 years at the same job. >>> and a n

we would take the regulation of food away from the fda and move it back to back her culture so we areseeing more of that going on right now. and i hope we are able to send most of it off. >> you were talking about wanting better labeling on food and i'd just curious there is a lot of phobia about things not understanding the scientific names on food and maybe there's more familiar names you are used to so i am just curious about increasing transparency on food products but also the challenges that come with a lot of it. >> for a long time i used to rant about the phrase that is actually an impossibility and if you ever see chemical free shampoo you should roll your eyes because it is nothing but chemicals. it's a problem because we are afraid and don't understand chemistry and i blame some of that on the way we teach chemistry. i talked to a guy who said to me k-12 science education is a filter for the preset and it is if you are not rising to the higher level of science potential and i stole that from my own kids but through high school. we have to get back to teaching people chemist

gottlieb, fda can keep approving products and they are at record rates. if we're not getting it into the hands of the people who need it the continued approval will not mean more access, and i think people -- it's hard to make that practical. i don't understand. you get approval and we launched the product. >> right. >> we do, but there's all this in the middle, formularies and insurance and everything that's controlling how you get your healthcare is dictating what you're getting. it's not you, your physician and your pharmacist anymore give me a minute on the president's tariffs? are they helping you or hurting you and i don't mean you? >> i would say there's not a big impact on the generics industry right now from a tariff perspective because, you know, look, we are making tens of billions of pills for pennies on the dose, to have that volume and efficiency and provide that access. >> you have manufacturers in china, india. >> all over the world, and so it's not -- there's more raw material coming out of china than there is in those such form. >> why d

the fda announcing a raid of juul's headquarters the same day the cdc issued a scathing report abouth more. >> the fda took a look at more than 1,000 pages of documents from juul's headquarters telling abc news e-cigarettes are creating an epidemic of regular nicotine use among teenagers. >> reporter: this morning e-cigarette company juul is under fire. the fda raiding the company's headquarters seizing more than 1,000 pages of documents seeking information about juul's marketing practices. the agency warning of a nicotine epidemic among america's teenagers. >> don't give up. you'll find your perfect puff. >> reporter: this coming as from 2.2 million juul devices n sold in 2016 to 16.2 million in 2017. >> it's just a part of my life now. i know it's bad but i can't stop. >> reporter: this high-tech method of smoking sweeping across the nation's high schools. >> you see kids juul in class. >> kids are going to the bathroom, smoking it in stalls. >> reporter: part of its appeal, its liquid cartridges. coming in a wide variety of flavors like mango and cool mint. >> we think the fact th

. >>> the fda conducted a surprise inspection at an e get company in san francisco. juul dominates the market. the question of how it's getting the sales prompted take action. they say it appeals to high school and college-aged students. they are made to look like a usb drive and can easily be hidden and accused in class. >> it doesn't have the signal. it is associated more with something that you keep in your pocket. >> reporter: in a staple, juul says it is, quote, committed to preventing underage use and wants to engage with fda law phaeubg public health advocates and others to keep juul out of the hands of young people. adding, they have released 50,000 pages of documents to the fda since april. >>> you're never more than 7 minutes away from my act weather forecast. all the areas in sea foam green is a chance of thunderstorms today. good news you've worked so hard to (huachieve so much. perhaps it's time to partner with someone who knows you well enough to understand what your wealth is really for. monitor their blood glucose every day. which means they have to s

there is no fda definition. there are no regulations. >> reporter: the association has sued other companies for misleading natural advertising noting that consumers assign a meaning to natural. >> we found 81% of consumers think it means no artificial ingredients. >> reporter: she says that is really the case and points to the quote "natural flavoring" on the back of a lacroix can. >> they don't have to show up on the ingredients list. >> reporter: one concerning claim is it contains an ingredient found in cockroach insecticide. but it is a natural plan product used in flavoring agents and they say just because it is artificial does not mean it is harmful. consumer reports is now asking the fda to come up with a definition for natural that can be regulated. meanwhile, as for that insecticide ingredient experts say there is no reason to believe that your lacroix is unsafe to drink. >> the makers of lacroix tell us "natural beverage emphatically denies all these allegations." we conducted our own poll asking peopl

i also want to thank fda commissioner scott gottlieb. scott, stand up, scott. you've done such an incredible job. really, an incredible job. [applause] and cms administrator seema verma for joining us. seema, thank you very much. seema, great job. great job. [applause] i'm thrilled to be here at the department of health and human services, and i want to thank everybody. i understand that it's been decades since the last president came here. and i'm very surprised that president obama didn't come here for obamacare. explain that one to me. but he didn't. but it's a great honor to be here. you do an incredible job. you really do an incredible job. so i thank you. since the day i took office, i have made reducing drug prices one of my highest priorities. last year, the fda approved more than 1,000 low-cost generics, the most in the history of our country. this year we beat that record, approving even more generics. these new approvals are leading to cheaper competitive alternatives for lifesaving drugs like the epipen, saving americans almost $9 billion a year las

gottlieb, fda can keep approving products and they are at record rates. if we're not getting it into the hands of the people who need it, the continued approval is not going to mean more access. and i think people -- it's -- there's a -- it's hard to practice -- make that practical. people don't understand. they say, i don't understand, you get approval, and we launch the product. we do. but there's all this -- in the middle, there's formularies, your insurance, everything that's controlling how you get your health care is dictating what you're getting. it's not you, your physician, and your pharmacist anymore. >> give me a minute on the president's tariffs. are they helping you or hurting you? and i don't mean you. i mean the generics industry. >> there is not -- i would say there's not a big impact on the generics industry right now from a tariff perspective because, you know, look, we are making tens of billions of doses for pennies on the dose. i mean, as a selling price, so that ability to have volume and efficiency and provide that access is -- >> b

fda approved for over 19 years. hmm. [cell phone beeps] hey!police whistle blows] [horns honking] woman: hey! [bicycle bell rings] turn here. there. excuse me. uh. uh. [indistinct announcement on p.a. system] so, same time next week? well, of course. announcer: put away a few bucks. feel like a million bucks. for free tips to help you save, go to ♪ feed the pig martin luther king jr.: we hold these truths to be self-evident -- that all men are created equal. john f. kennedy: the torch has been passed to a new generation of americans. barbara jordan: the american dream need not forever be deferred. lyndon johnson: this is the richest and the most powerful country... we've been zipping along with these puzzles. let's keep it going with our third "toss up." "food & drink," that's the category. here we go. ♪ [ bell chimes ] - asha. - box of trail mix. no. no. jeffrey, might as well wait a bit. just don't all the lett-- don't let all the letters get up there. [ bell chimes ] - yeah? - bag of trail mix. yeah, that was-- [ chuckles ] [ cheers and appl

. >> the fda allowed them to make the switch of of the time release mechanism that first of all, the higher milligram than its competitors but the fda allowed them to say because of the time release mechanism the high milligram dosage drugs over 12 hours supposedly to give people in severe pain the miracle of uninterrupted sleep. but what people quickly learned was to do an end run over that time mechanism let it get soft then wipe off the coding on their shirtsleeve then crush it or snorted or injected getting the full rush right away. there is a discrepancy when purdue new that was being done but they said all along they did not know until 2000 that people were telling them they were seeing overdoses and then the justice department set of documents "the new york times" reported shows they knew months earlier than that it took me half an hour to find the police man who first saw that in the streets he said you can walk around town people with orange and green stains on their shirt where they wiped the coding off so it was clear to the police many of the pharmacies or the pharmacist

just because something is natural does not mean it is safe. >> reporter: consumer reports is asking fda to come up for a definition for natural. meanwhile the maker of lacroix tells us national beverage denies all allegations contained in the lawsuit. there are no sugars or artificial ingredients contained or added to the products." as for that insecticide ingredient experts say there is no reason to believe that your lacroix is unsafe. >>> we are asking people if they would still drink lacroix. you can see the results coming in. 40 8% they will -- 40 8% say they will continue to drink it. you can also go to the facebook page to vote. >>> the first lady with a close call with an elephant today. take a look. one of the elephants got pretty close forcing a member of the secret service to step in. this happened during a trip to an elephant orphanage. advocates say the visit could help the anals immensely. >> her coming here will create a lot of publicity to the elephants and people will know these elephants have a right to live and need to be prady also stories to children at an orphanage.

fda approved for over 19 years.that a top trump campaign official reached out to a foreign firm for proposaled to manipulate social media during the 2016 presidential election. the goals were influence and opposition research, but was it all legal? we have a washington investigator for the "new york times." he cowrote the article. he is a cnn security analysis. we are talking about rick gates. he pleaded guilty, he worked for the trump campaign, he worked for the trump campaign for a long, long time. what exactly was he discussing? with whom. >> this was in the spring of 2016 as donald trump was emerging out of the primary fight with his republican opponents looking toward the general election and immediately looking at the republican convention when we were worried about the possible defection of delegates away from trump towards the establishment. what rick gates heard in this washington hotel lobby was a proposal to basically manipulate the convention taking a proposal to use fake avatars, fake on line identities

we just had the head of the fda on and asked him about this new sort of sped up process.ere is what he said and i'll have you respond. >> well there's a lot of ways if we bring better science into the process we can modernize that process. some of the things are in development for a very long time we're trying to accelerate that. liz: talking about the epipen and the mylan situation but how do you feel about the fda and its new way of keeping things safe but hurrying up the process of getting things to market that are less expensive? >> scott gotley has been one of the great additions to our government. he is an unbelievable commissioner of the fda and he's working in multiple areas, both with patented products, drugs, that are innovative and novel in the field of gene therapy, in the field of biologics, in the field of medicines which are being made for orphan diseases, and he's moving those forward. scott's also moving generics forward much more quickly. liz: yes. >> but doing it intelligently making sure these drugs are safe for patients in america. liz: i want to talk

and discussing and then it reminds of your usb port, a personal electronic which is familiar. >> the fda says there were 2 million middle and high schoole hold a public hearing about banning the sale of most flavored tobacco products including all forms of tobacco including traditional and electronic cigarettes. chewing tobacco, hikes and poo cards and it would not include menthol cigarettes which adults like and they say this man is designed to protect children in seem -- children and there are more than 3 million high school and middle school students who smoke. under this proposal saratoga retailers that sell the band products to anyone under the age of 21 will face a $100 fine and lose th60 days. >>> there's a new study by the world health organization that says tobacco hurts the planet. the report says tobacco usage is partly to blame for d4 station ancigarette usage by one person over the course of their lifetime could lead to severe water shortages all over the world. >>> today is national coffee with a cup they meant to bring people and police officers together to talk about thei

time for people to be on record and in the meantime to put up bipartisan accomplishments and with that fda authorization and with that piece of legislation in a bipartisan product with both republicans and democrats with legislation to put in place the clear rules for operation of aviation industry dealing with protections for consumers and obviously providing safety and security measures so when the public travels they can do that in a safe way. integrating drones into the airspace and a whole range of other things. i am hoping that is a big vote that the majority here in the senate continues to work in a way addressing concerns of the american people. and with a separate set of rules there was the biden rule that says the presidential election that a seat should be held open if it comes open on the supreme court and the harry reid rule the 60 vote threshold and then the harry reid complaint when the republicans became the majority and now you have the schumer role to obstruct defeat or delay those politics of personal destruction no matter what they had to do that is what chuck schumer s