fda has no role in setting drug pricing. our actions serve to enhance competition, which has been shown to decrease drug prices. for example, i would like to go through some of the actions we do take that enhance competition. we often approve multiple drugs in a therapeutic class. they are separate drugs. for example, there are a lot of receive indianapolis born anti biotics. within a class, there may be a lot of drugs that compete in the market. also, we often approve different versions of the marketed drug once the patents have expired that are not exact copies under our 500 b 2 program, which is not generic but part of the legislation. these copies also can compete with the marketed drug. under the generics program, multiple, more less exact copies of a brand of drug can be approved once all exclustivety and patents expire. we frequently approve several copies at once. for example, recently, very recently, we approved eight crestors on the same day. so, there's a first generic, but there might be eight first generics. the

throckmorton here from the fda. one of my concerns based on the sole economics of it, right, basic economics, you have a generic product that's been on the market for 100 years and suddenly you see this massive rise in the cost, the price, to consumers. that would signal to entrepreneurs that there is an ability to make a profit. when you understand that the cost of goods for the juice is only $1, the delivery vehicle, which is unique and it's innovative, there is a cost to that, too, but when the juice is a dollar and they are selling it for $600 there's some room for some profit, but if new market entrance aren't able to submit an application and get it through the fda then, guess what, you have in this case mylan who is able to market a product quickly rise -- raise the price, bring whom an exorbitant amount of profit with no competition. it was actually my brother who said, hey, why are you trying to get in the business of some private entity and how they price it. i said because the market forces our network. c

what is the current fda backlog over all? what is the current backlog on drug approvals? >> currently there are 2300 new drug applications we are reviewing. that is not backlog. it is the product in the queue prior to 2012 prior to the passage, the number of products in the queue in 2012 that are unreviewed, less than 100. we have reviewed 90% of those to provide feedback to the sponsors. >> how many epinephrine products? >> can't answer that question. >> you know that number? >> i do not know that number. >> why are we having a hearing about this? >> you know that number. here is the thing. they may tell you had the fda we never talk about this, i don't care. congress doesn't care. i want to know how many epinephrine oriented products there are right now? >> i wish i could answer that. i can get back whatever information i can to you as quickly as i can. >> we you give back the answer i asked be change i will provide whatever information i can. >> are you going to answer the question i asked? >> is. >> will the gentleman agree, give them five minutes to get answers you.

i have fda questions here. how many abbreviated new drug applications are pending before the fda right now? >> 2300 actions are currently. is theaffetz: how long average wait time for an approval of a generic drug? >> i would like to get the information and get it back u.s. as i can. rep. chaffetz: can you define what, in fairness, what is a reasonable time before we start raising the red flags here? 10 days? >> 10 days sound like a, number, if that is good enough for you. rep. chaffetz: we would appreciate that. mentioned, as you you had some confidentiality agreements. that does not apply to congress, you know that, right? hello? ms. bresch: no, i did not know that. confidentiality. us.hat does not apply to i am sure your attorneys would work that through. i just want tot, go back and briefly, as i close, with what i said before, i have asked you every kind of way, with the prices come down, and you have basically made it , basically it falls in the , and the valiant people. the company the hearing and go thr

the fda banned a controversial chemical found in antibacterial soap. but it's still legal in toothpaste. consumerwatch reporter julie watts on what some say is a dangerous double standard. >> reporter: plain old soap and water that's now the official handwashing recommendation from the fda after essentially banning a common ingredient last week in antibacterial soaps. studies link triclosan to health concerns from hormone disruption to immune and reproductive concerns but despite the ban that same chemical remains in toothpaste. >> we are very worried about people being exposed to triclosan through their mouths through brushing their teeth. >> reporter: the natural resource defense council says it's also used to fight plaque and gingivitis in colgate total toothpaste. >> something we want the public to be aware of. >> reporter: the decision to ban triclosan in soap was a result of her group's lawsuit against the agency. when antibacterial soap manufacturers couldn't prove they were safe or worked better than regular soap, the fda essentially banned 19

throckmorton here from the fda. one of my concerns based on the sole economics of it, right, basic economics, you have a generic product that's been on the market for 100 years and suddenly you see this massive rise in the cost, the price to consumers. that would signal to entrepreneurs that there is an ability to make a profit. when you understand that the cost of goods for the juice is only $1, the delivery vehicle, which is unique and it's innovative, there is a cost to that, too, but when the juice is a dollar and they are selling it for $600 there's some room for some profit. but if new market entrance trants aren't able to submit an application and get it through the fda then, guess what, you have in this case mylan who is able to market a product quickly rise, raise the price, bring whom an exorbitant amount of profit with no competition. it was actually my brother who said, hey, why are you trying to get in the business of some private entity and how they price it? i said because the market forces our networ

throckmorton here from the fda. one of my concerns based on the sole economics of it, right, basic economics, you have a generic product that's been on the market for 100 years and suddenly you see this massive rise in the cost, the price, to consumers. that would signal to entrepreneurs that there is an ability to make a profit. when you understand that the cost of goods for the juice is only $1, the delivery vehicle, which is unique and it's innovative, there is a cost to that, too, but when the juice is a dollar and they are selling it for $600 there's some room for some profit, but if new market entrance aren't able to submit an application and get it through the fda then, guess what, you have in this case mylan who is able to market a product quickly rise -- raise the price, bring whom an exorbitant amount of profit with no competition. it was actually my brother who said, hey, why are you trying to get in the business of some private entity and how they price it. i said because the market forces our network. c

and this is an ongoing discussion with the fda. and remember, there is a lot of legislation that has changed for orphan diseases. and making sure that you could include all of the data. remember these are very small populations. they are complicates science and personalized genetic medicine and so i think the fda used the flexibility that is in the law to try to get this approved. so i think you're going to see in the future is many other companies like sarepta that are trying to push the envelope scientifically and to try to use the law as it was designed -- and really the purpose is to get therapy to patients as soon as possible. and so i think the fda followed the mandate that they were given and they worked very hard -- and i commend them on getting this done. >> and dr. kaye, last week one of your biggest critics on the fda resigned. did that provide the clear path for this drug -- is it a coincidence this guy resigns last week and the drug is approved this week? >> you know, we don't have really any insight into that whole pr

. >> that's what the fda said after banning anti-bacterial cream tries to blend in. cream tries to blend in. but the flavors we sent him here to fix it. but congressman joe heck became part of the problem. wall street invested over a half-million dollars in congressman heck's campaigns, ecurity, handing wall street billions in fees, but risking our retirement in the stock market, cutting benefits, putting wall street ahead of us. congressman heck -- what's wrong with washington. >>> if you are a frequent shipper, heads up. u.p.s. will be increasing rates. >> good news. the hike won't happen until after the holidays. they are not waiting long. right after the holidays, they average of 5%. the price takes effect december 26th. u.p.s. says this will support expansion as they try to maintain the high service levels expected by their customers. >>> a recall alert to tell you about on samsung's newest smartphone. two weeks after it went on sale, they stopped sales and recalled the flagship phone, the galaxy note 7 due to the potential of the battery exploding. the company

the fda is not suggesting throw out your anti-bacterials, just don't buy any more. the rule of thumb say hygienists about washing your hands, 20 seconds with soap and water, that's enough time, they say, to hum "happy birthday" twice, and we're not talking about hand sanitizers, we're only talking about anti-bacterial soaps. >>> the fbi took an unusual step today releasing its notes from hillary clinton's lengthy recent interview with agents about how she handled her emails while secretary of state. the release is certain to fuel the controversy that has hounded clinton for a year and a half. we get more this evening from andrea mitchell. >> reporter: hillary clinton's 3 1/2 hour fbi interview exactly one month ago, about a subject she seems to the fbi notes reveal that are things she actually didn't know about classified information, didn't recall being trained on how to handle it, relied on staff to use their judgment when emailing her, telling the fbi she didn't know the letter "c" on an email meant confidential, the lowest level of classification. speculating it

so we petitioned the fda again. and we got the institute of medicine to do a report on what should be done about excess sodium. not whether or not it's harmful. that had been settled, but what should be done. and the institute of medicine basically endorsed that 1978 petition saying the fda should limit sodium levels in cheeses, in breads, and different levels for these different categories of food. the fda immediately said it wouldn't limit the levels, but it might set voluntary targets. so it took another six years, earlier this year, well, for five years the fda didn't do anything. we sued the fda for inaction, public citizen represented us. and that got the fda to get off the dime and propose voluntary targets. so if we're lucky, those voluntary targets will be adopted as final voluntary targets, with two-year and ten-year goals. the ten-year goals would bring sodium down to safe levels. >> mike, i wanted to ask you, you have been pretty critical of the food and drug administration and u.s. department of agricul

see which mol >> plus, fda bans. how it affects more than 2100 products that you have in your home right now. >> plus, first pitch. you're gonna meet this amazing little boy who beat cancer and took the spotlight at progressive field tonight. he is incredible. >> good evening. between 60 to 100,000 people are expected tomorrow at the 2016 cleveland national air we'll talk about how the weather holds up coming up . combustible consumer alert. the world's largest smartphone maker is recalling its galaxy note 7. samsung is trying to keep the problem from blowing up. the battery is prone to exploding or catching fire. in a youtube video, a user claims his 2 week old phone went up in flames while it was charging. >> everyone rocking the new note y'all. >> 2.5 million galaxy note 7s. samsung said it conducted a thorough investigation and found a battery issue. hover boards have even caught fire. samsung said it's going to work for wireless carriers to get replacements out there now. >>> it's time to think again about antib

so the fda gets its budget from congress, they can put the leverage on the fda, and that' going to change and the person from the fda girl who is involved with this has said, we're doing better and will continue to do better. the medicare/medicaid fight is going to be a political battle roya royale best yea out, if it ever. but we saw the battle lines, and what happened today was the people who want medicare, medicaid authority, they got some ammunition from her testimony today. >> eric, always good to have you with us. thank you for joining us. >>hank you, sue. >> eric gordon from the university of michigan. >>> another drug maker raised the price of an acne medication to nearly $10,000 a tube. according to a report in the financial times, the privately held company called novum i am increased the price by 128%. the two main ingredients arin expensive. one an antibiotic that's been around for decades, and the other is a form of aloe, a generic form of the same crime costs less than $30. >>> the fed wasn't the only central bank to impact the markets today. policy makers at the bank of jap

now, the fda is making changes. susan hogan has been looking nt developing story. >> the fda not only says anti-bacterial is ineffective, it is banning the sale of those saying they may not be safe to use over longer periods. the fda says products containing certain active ingredients no longer will be marketed. 93% of liquid products that have the label anti-bacterial or antant anti-microbial. the agency says manufacturers did not provide them with scientific evidence that the anti-bacterial soaps are any better than plain old soap and water. >> soap is fantastic. soap is a detergent. it's very difficult to say why do you need >>> cleaning says antibacterial are safe and effective. in a statement, it says washing the hands with an anti-septic soap reduces the risk of infection. the fda ruling does not affect hand sanitizers, wipes and other products. >> thank you very much. >>> in d.c., detectives are looking for a person who shot and killed a teenager earlier this morning. it happened on 14th street in northeast.

when antibacterial soap manufactures couldn't prove it was safe, the fda banned 19 active ingredients, including the most common. the ban applies to antibacterial soap soap considered an o, this c. >> any chemical that's used in these kinds of products has to be safe and effective. >> the same standards don't necessarily apply to other products, like colgate toothpaste, submitted in the 1990s under a new drug application with new drugs, instead of safe and effective... >> they have to show the benefit outweigh the risks. >> it was shown to be effect t i have in reducing plaque. the balance of the benefit and risk has shown to be favorable for this product. however, they point to mounting safety concerns. >> we think the fda needs to revisit. >> colgate points to more than 100 studies, with the original application, and says they provide safety updates annually reviewed by the fda. the chemical remains in other products, including makeup, kitchen-wear and toys and pesticides. the long-term exposure to the chemical is higher than previously thought because it's in so many products. join

which the fda didn't do until 2015. another 10 year delay but trans fat really became a dirty word and so many companies started labeling their food no trans fat and it has been largely whist out of the food supply.90 percent or more of trans fat is gone, 7 to 7 and a half billion pounds a year and it really shows the impact starting with the scientific research because that really has been the foundation and years of advocacy, pressure on food companies not to use it, food companies told oil processors, give us better oils. oil processors went back to farmers and said grow better, different kinds of soy and canola and so on and we will pay you more money if you do so farmersgrew the stuff . the oil processors had more raw materials, they sold to food companies so this >> is a success story. >> huge success story. >> let'sturn to sugar. by the way, all those national tv programs , they are gone now.mike cannot get on any of these shows like phil donna show you show and all the other shows, you just look at what has repl

>> reporter: it did the fda introduced warning and rupptured tendons and nerve and joint and a family is coming forward with warnings. >> she was just and intelligent and tribrant and happily -- vibrant and happily married. >> he went to visit her mom. >> she loved life. >> and she lit up a room. >> yes she did. >> but months earlier it degan to unvalve. >> she -- it would begin to >> and tragically and she loses much more. >> my youngest daughter called and said i will be a few minutes late because there is an accident up ahead. >> up ahead another driver called 911. >> tupeered to be the person -- it supered to be a person -- is appeared a person was struck by a car. >> we knew she been late. >> she parked her carne car on the side of the -- parked her car on the side of the interstate and walked in front of somebody. >> how could that happen? >> it was not hurt, she would have never, ever, ever done something like that. and. >> could something four-months >> our original investigation shows they are associated with more than 200 thousands complaints. 3,000 deaths and ozozozresult t

fda makes it hard for approval for that. other companies that come up with alternate delivery devices, the bridge of bureaucracy stopped it and hillary clinton wants to create more bureaucracy and we have kids going to school with peanut allergies, corn nut allergies and it is tough because of the bureaucracy. liz: you see the epipen two pack costs 600 bucks. parents are sending their kids to school, they can't afford the $600 price for the epipen two pack, they can't, jeff. this expires after a year, so they have to buy new pax. do you think hillary clinton's new plan could work in any way? >> you know, i think that the role of any public official or anybody who has a public platform is really going to shine a light on the subject and let the marketplace determine what the price should be or what the correct price should be. >> if we're going to talk about shining a light on things, jeffrey manson, the west virginia democrat whose daughter has this thing up. >> heads mylan, right? >> mylan pushing to delay because it wants

several years ago the fda said, list listen, it's a warning shot. show us the data for us to allow these to be on the market and there really hasn't been any individual on using them. so, without that benefit, they're pushed off the market over the next year. >> you say several years, a reason to be concerned if you're using these soaps you might have some of these impacts? >> no, nobody knows of any direct human health issue with using these soaps. there's potential ones. so, no benefit of potential ones, we take a step back. nobody should panic but now when you go shopping and there's that claim, antibacterial, don't buy that one. >> what about hand wipes, the other products in this area? >> that's a great question. right now the fda said, hey, we'll look at data to see if there is benefit to them. again, a warning there. but there is no yet study tasy show there isn't benefit there or a harm there. the fda will look at that and learn more with regard to the hand sanitizers. >> two companies procter & gamble and johnson & johnson consumers look fo

once they become approved by the fda, doctors can then diagnose off of it and can actually authorize procedures off it or authorize any kind of whatever the next step is for the treatment of that illness. >> okay. what does it do for the -- i care about the patient. i don't care about the system. i know the system cares about itself and money. what does it do for the quality of life of the patient? >> yeah. so think about the application if you could actually have a patch that would actually be on your body -- i actually brought one. maybe i can show you that a little bit. anyway, just a patch that can actually sit on your body. you can see some of that in the background. that actually captures a bunch of data, and what kind of data would it capture? heart rate, skin temperature, posture. >> you're talking about blood pressure. you're talking about data that -- >> some of it might be captured by a wearable. >> yeah. >> too many false positives. >> there's two tricky things. in this particular device, this is vital connect that we work with. on this particular device, there's a couple

the fda says they could do more harm than good. companies have one year to remove the chemicals or take the product off the store shelves. our dr. david agus is in los angeles. good to see you. good morning. >> reporter: good morning to you. >> so what are these commonly used ingredients in these soaps and why is the fda taking this action now? >> so the two most common but 17 others. 9 total ingredients that were removed that represent about 40 of the soaps out there. the bottom line whenever a soap says anti-bacterial or a claim the endocrine in mice. at the same time, there hasn't been shown to be any benefit. so potential risk, i emphasize the word potential, and no benefits so the fda took a stand. >> and so, doctor, one of the leading trade groups here has pushed back, perhaps not unexpectedly, again the claim. the american cleaning institute released a statement that said in part, anti-bacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection. you mentioned risk

on this particular device, there's a couple of things that are in the works that aren't fda approved that includes like blood pressure and body temperature, but there's about eight different parameters that are already captured and already fda approved. so off those eight parameters you can actually now diagnose. what's interesting about that, what it does for the consumer, to get back to your question, is if you're in a hospital and you have something wrong with you, they will wake you up every hour or two hours. >> absolutely. >> to get all your vital signs. >> sometimes a million doctors and kids that come in. it's like a teaching hospital. >> poking you and pushing you and waking you up. it's kind of funny, the more they wake you up, depending ou sick you are, the more sick you are, the more they wake you up. it's kind of crazy. think about another really important application. now you can send the patient home, and if you had all this data where it was going into the cloud, it was going to your doctor, you can now allow the patient to come home and be at more peace. >> that's gr

. >> you think this is a problem with the fda? or you think this is a problem with the rules that congress has set up for the fda? >> both. the original rules to sort of create generic drugs, the hatch waxman act, is very old. it it envisioned small pills that you take out of a medicine cabinet that are easy to copy. more newer medicines of complex drugs that are harder to copy, it's not as simple as making a similar version of the drug that you're trying to copy. i think fda needs more flexibility to approve copies of some of these drugs. in the case of epipen, a classic example. >> hillary clinton just came out with a plan on friday for kind of checking out price controls when it came to drug hikes, drug increases. it's in response to what we've seen from so many of these companies that have hiked price with 500%, 800% or more. is that the right solution? >> unfortunately, i don't think it is. there is a self-correcting mechanism here. when these markets do become money none lighted the prices go up, that encourages competition

doctor holden said the fda banning of 19 different chemicals from consumer soaps as a result of years of study looking at the effects on humans and the environment. the most common chemicals don't work but the research says they do stick around. soil, food in our body. >>reporter: he has been looking at the risks since 2004. he testified thing that could affect hormone levels are created drug resistant bacteria. powerful chemicals have a place in labs and doctors offices soaps using on our hands and in all 2100 products will have to be taken off the shelves. to see if your soap has one of those chemicals look at the active ingredient found on the label had to see the full list of chemicals head to our website. back to you guys. >> samsung users holding brand- new phones tonight are upset. the company recalling 2 1/2 million of the galaxy note 7 phones catch fire. company blames the problem on a faulty battery. the galaxy note 7 was getting good reviews with an iris scanner that let your eyes a microphone. this recall comes days before apple is expected to announce have come out with b

the fda banning 19 chemicals answers to my own what exactly is getting the boot. >> this won't affect things like sanitizer in public places like the airport but the 75 the grocery store 40% of this chemical is found in all the so goodbye to the general public has been misled. antibacterial soaps are not really anti-anything. doctor holden said the fda banning of 19 different chemicals from consumer soaps as a result of years of study looking at the effects on humans and the environment. the most common chemicals don't >> they are in the air water, soil, food in our body. >>reporter: he has been looking at the risks since 2004. he testified thing that could affect hormone levels are created drug resistant bacteria. powerful chemicals have a place in labs and doctors offices faces multiple times a day. in all 2100 products will have to be taken off the shelves. to see if your soap has one of those chemicals look at the active ingredient found on the label had to see the full list of chemicals head to our website. back to you guys. >> samsung users holding brand- new phones tonight are

it is primarily the fault of the fda. i have read article, after article for many years we let the food and drug administration become so big and so bureaucrat i can, it is become almost impossible for a small company to get a drug or a medical device to market. and the costs of getting a drug or medical device to market on average become in many cases, most cases over a billion dollars to get a drug to market. and because of that, the drug industry has ended up in the hands of a few big giants. then i read article after article all these giant drug companies and pharmaceutical companies have hired many or most of the former fda commissioners and top level employees, just like the defense department, defense contractors have hired many so many retired admirals and generals. what they have done, in the drug industry, they have come in and they have manipulated the market. now, miss bresch, justifies all this saying that they only get $274 from the epipens. but this, these pens were selling by this other company, this germa

why does the fda move so slow? >> i don't know. that's a question i have too. they first came on the scene in 1978. it struck some concerns and some questions so the fda started looking into the dangers of these ingredients and it took until 2014 and i don't know why for them to say let's look at this in more detail and give these companies two years to prove to us that this is again tlees efficacy and it's safe and this year on friday they decided these ingredients have to go and they have to take them out. >> we as consumers should do what if we have these products in our home and we have may been using them. now we have to comply. >> again, it's up to each individual. i will say some of these products have been in other products for a very long time. a good example is toothpaste. it's proven in human studies to be safe and to decrease gum disease. >> are hand sanitizers safe. >> according to the fda yes. so as long as it's over 60% based in alcohol, which this one we have here is, then there is efficacy as far as cleaning but as good as soap and water. >> ba

that's how long the fda is giving companies to rework formulas and get rid of 19 active ingredients, calling >> i think it's a major de nice peggy thompson, the director of prevention feels so strong about the research. >> it was a big deal. it was quite an undertaking. >> reporter: nearly a year ago, when the hospital decided to switch to touchless dispensers, she also decided to get rid of antibacteria soap. the company she worked with told her she wasn't alone. >> she said their als were split about 50/50. so i felt confident that we weren't real limb by getting rid of the bacterial soapent that we have not made any change that would put patients at risk. >> reporter: experts say it's how you wash your hands that is important and not the ingredients. plain soap and water is just as effective. >> my advice would be to stop using antibacterial soaps. >> reporter: while some choose not to heed the advice, others proactive and taking a stance. >> reporter: the good news, no need to give up your hand sanitizers. most are alcohol based. the cdc recommending using that over the antibacte

the fda has got to get their act together and start working the process. i look forward to receiving the information that you said you would send. >> thank you. the gentleman from vermont. all, thank you for having this hearing. i find your own being statements at the right time. -- opening statements set the tone. he's asking about whether there is something we can do with the fda and the approval access processor and i'm all in. disclosure, mylan has an excellent production facility in vermont. many people work there and they are proud of it. third, what the drug companies do, i totally agree is widely important. my first wife had cancer. nine years and medication. it is important to get it right. here's the dilemma. by a letter.nt up my four year son has a severe peanut allergy. i'm a single mother working a low-wage job with little health care coverage. i can't afford to pay this much for epipen's and i can't afford not to because that cost is possibly his life. the heart of the matter here is that moms and dads are being given a choice. they can pay m

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the fda process. that is not what this is no matter if you closed it or left it with one condition listed on there. periods. >> if this were to pass would violent crime e erupt? >> it could. you're dealing with a cash business and criminal enthe ities. >> i've seen studies including one from ut dallas. showing in the eleven states that passed medical marijuana from 90-2006. >> i would argue that's incorrect and i would go through the law enforcement municipalities and look at the different laws in place in those states. that's not what we're looking at in the state of florida with the constitutional amendment. >> what are the health risks >> mirn affects the brain directly. there are obvious impairments to when you breathe things in. the only thing we're supposed to breathe in is oxygen, not smoke. >> to those that look at contradictions in drug policy. you have peo receiving joints curtesy of uncle sam, our federal government and others say i have a medical condition as well and i can't get this. you

th fda is not suggesting throw out your anti bacterials, just don't buy anymore. the rule of thumb about washing your hands, 20 seconds with soap and water, that's enough time they say to hum happy birthday twice, we're not talking about hand sanitizers, we're only talking about anti >>> the fbi took an unusual step today releasing its notes from hillary clinton's ngthy recent interview with agents abt how she handled her eils while secrary of ste. the release is certain fuelhe contrors that has hound cli for a yearnd a half. we get me this eng om andra tchell >> repor hillary fbi notes revealhere t are things she actually didn't know about classified inion.at didn't recall being train handle it. relied on staff to use their judgment when emailing her, telling the fbi she didn't know the letter c on an email meant confidential. the lowest leveling of classification. donald trump pouncing. >> that's a lye, unless she's . >> reporter: the fbi has said her emails had classified information, but she said she doesn't recall receiving any emails. hillary clinton says sh

we still have yet to apply to the fda and have approval, but this is a huge step on that journey. >> 225 people in the trial. how many do the fda need before they say we have got to give these children and their families the gw pharmaceutical? >> the good news is this is actually the third positive trial within the field of treatment-resistant child onset epilepsy that we've reported results for in the last six robust and, we believe, comprehensive body of data to file the nda submission with the fda and we are now on track to do that in the first half of 2017. >> so you mentioned that they take many different medicines. so in other words, these children have been taking, what -- you've got people, 16, 17, they've been taking medicines all their life and nothing's worked? >> well, unfortunately in the case of epilepsy, it's a very complex condition, and there are the currently available medications have limited efficacy or are not well tolerated. so this is something which is a hugely important, obviously to the company, but most importantly to the children and the families of those