you get to influence fda thinking. you get to sit at a small table with fda." >> one key person who sat on the steering committee for these meetings was doctor bob rappaport - the head of the fda division that regulates painkiller drugs. >> this is the voice of doctor rappaport at the fda hearing on the drug application for zohydro. >> throughout the hearing, rappaport repeatedly instructed the committee to focus narrowly on whether zohydro worked to relieve pain, rather than whether it would worsen the opioid epidemic. >> they did redirect us a few times when we were getting a little more concerned about individual safety. >> when the committee voted against approval, rappaport rebuked them for unfairly penalizing the drug company. >> it's hard not to learn from history. we're supposed to learn from history and try not to repeat our mistakes. >> there is not a legal basis by which fda can say we don't need another opioid because we've already had a lot of bad experience. >> doctor judith kramer voted against zohydro.

because fda -- because ebola is such a serious and often rapidly fatal disease, fda has approved such requests within a matter of a few hours and oftentimes in less than one hour. there are more than 250fda staff involved in this response. and without exception, everyone has been proactive, thoughtful and adaptive to the complex range of issue that his have emerged. we are fully committed to sustaining our deepen gauge. and aggressive activity to his support a robust response to the bola epidemic. thank you and i'll take your questions later. >> thank you. mr. wagner you are recognize today five minutes. >> thank you, chairman murphy. distinguished members of the subcommittee for the opportunity to discuss the efforts of u.s. just ups and border protection in deterring the spread of ebola by means of international travel. each day about 1 million travelers arrive in the united states. about 280,000 of them arrive at our international airports. cbp is responsible for securing our nations borders while securing the flow of legitimate travel and trade that is so vital our nation less eco

i was the beat reporter for the fda at the washington post.oing to spin you to the right, and you hope that by the end of it, you're walking down the middle. poussaint: the cigarette companies did their best to fight back. as did the tobacco growers. but in the end, the lies and deceptions of the cigarette companies had done irreparable harm. there needed to be public support for what we were doing, and one of the most important ways to get information out to the public, so that they could have a new understanding of the tobacco industry and tobacco products, was through the media. we really needed the media to help educate and inform the public. poussaint: and to help the media, the fda, like the insiders at the cigarette companies, sometimes gave reporters information and guidance that were invaluable. it was a far departure from the adversarial relationship that usually defines the media's relationship with official washington. we were all in search of the same thing, and what was critically important to fda's potential assertion of jurisdi

the fda -- because ebola rapidlya serious and fatal disease, the fda has approved such requests within a matter of a few hours and oftentimes in less than one hour. there are more than 250 fda staff involved in this response. and without intention, everyone has been proactive, thoughtful and adaptive to the complex range of issues that have emerged. committed to sustaining our deep engagement and aggressive activity to robust response to the ebola epidemic. thank you. and i'll take your questions later. >> thank you. mr. wagner, you're recognized for five minutes. andhank you, chairman distinguished members of the subcommittee for the opportunity efforts of u.s. customs and border protection. each day, about one million travelers arrive in the united states. about 280,000 arrive at our international airports. cbp is responsible for securing our nation's borders while facilitying the flow of legitimate and international trade so vital to our nation's economy. this broad responsibility, our mission remains to prevent terrorists united states.he however, we also play an limiting thee in i

because of fda longstanding collaboration with dod, fda was able to authorize use of ebola diagnostict emergency authorization within 24 hours of request. we authorize twoe use of additional diagnostic tests developed by the cdc and these tests are essential for a public health response. in addition we're supporting the world health organization. our scientists are providing technical advice to the w.h.o. as it works to assess the role of convalescent plasma of treating patients with ebola. i recently participate ain consult attention focusing on ebola vaccines in geneva which included dozens of experts from around the world and affected neighboring countries in west africa. participants agreed promising investigation of vaccines must be evaluated i scientifically valid clinical trials and a most urgent matter. fda is working closely with our government colleagues and vaccine developers to support this goal . it is import while note we all want access to immediate therapies to cure or prevent ebola the scientific fact is that these investigational products are in the earliest stages o

fda is working with our n.i.h. colleagues to develop a clinical trial protocol to allow companies and clinicians to evaluate multiple ebola products under a common protocol. the goal is to ensure interpretable data and generate actionable results in the most expeditious manner. it is important for the global community to know the risks and benefits of these products as soon as possible. until such trials are established, we'll continue to enable access to these products when available and requested by clinicians. we have mechanisms such as compassionate use which allow access to investigation of products outside of clinical trials when we assess that the expected benefits outweigh the potential risks for the patient. i can tell you that every ebola patient in the u.s. has been treated with at least one investigational product. because fda -- because ebola is a rapid and fatal disease, fda has approved such requests within a matter of a few hours and often times in less than one hour. there are more than 250 fda sta

fda when it comes to pharmaceuticals. and this is a very, very conservative safety sensitive organization. so much more. it's incredibly frustrating to deal with them. the reason for it is kind of obvious. here are a bunch of bureaucrats. and if they speed something to market, they maybe get a little pat on the back. it's not a really huge career advancing step for them. but if they allow something that turns out and we've seen it with the recall in the pharmaceutical industry which is common that, is career ending. it's going to be examined in a very detailed way. so the usual attack or feeling about our technology is actually the fda is extraordinarily conservative and resistant to allowing these sorts of things through. and, in fact, if i looked at the pressure that the pharmaceutical industry could bring to bear on the fda and sort of the heft of big pharma is far bigger than biotech like monsanto. it really surprises me that you think the fda is captured in the sense that it, you know, will allow junk science as you

now the fda looking out 168 weeks.are a lot of questions about the communication going on with the fda, why we're seeing one company move forward while the other company isn't. >> all right,ing meg tirell, t you so much. we asked people a question how much money do you think you'll need when you retire? then we gave each person a ribbon to show how many years that amount might last. i was trying to like, pull it a little further got me to 70 years old i'm going to have to rethink this thing it's hard to imagine how much we'll need for a retirement that could last 30 years or more. so maybe we need to approach things differently, if we want to be ready for a longer retirement. ♪ >>> the holiday shopping season is fast approaching and some are putting a target on the back of one well-known retailer. mike? >> it's common to see heavy options volume right before an earnings announcement. but today we saw heavy put buying in target, even though their earnings isn't going to be released until november 19th. these november 22

nih, fda, nci, cdc, cns, et cetera. it's impossible to build an organization or recruit the talent you need when on a year-to-year basis you don't know whether you can fund them. the probability of a young scientist today being funded is the lowest it's been in more than four decades. this golden age is in front of us. we think about the cost and to do no harm. but in many ways by lengthening time we are losing lives. by not providing access to the state of the art treatments today, by not incorporating science. in many ways, science today is running in the 21st century. but as dean has pointed out, it's running on tracks from the 19th and 20th century. we wonder why today in america that the average train, symbolic of science, travels at the exact same speed it traveled at 100 years ago. it has nothing to do with science or the ability of the train to move. it is running on tracks that cannot afford to have trains run at those speeds. we look at china and other countries around the world whose trains run two to three t

the fda was given instructions by the white house to promote bio technology. they created a position for him. his policy ignored the scientific consensus at the agency and then taylor became monsanto's vice president and chief lobbyist. now he's back at the fda as the u.s. food safety czar. now, is it true that gmos are dangerous? well, unfortunately, one of the scientists at the fda predicted correctly that, without required safety studies, the companies would not even do the normal studies that they would do because they're not on the fda list. so we have very few safety studies, but enough for the american academy of environmental medicine to evaluate and discover that the rats and that the mice that were fed gmos had gastrointestinal disorders, immune system problems, organ damage, accelerated aging, reproductive disorders and dysfunction of regulation of cholesterol and insulin. they said this information is not casual. it is a causal relationship based on standard scientific criteria. and on that basis all doctors should prescribe non-gmo diets to every

why do you believe fda approved zohydro, despite objection he and asking them to reconsider? >> the surge in heroin use is something a lot of people are talking about. it's estimated four out of five heroin users in the united states actually started by using painkiller opioid drugs. these are all derived from opium. it is a quick transition. we've spoken in our film with these addicts who have transitioned from taking these pills to shooting heroin. he started on these drugs when he was just a teenager by taking these pills. so it does seem to be something that is creating or factoring into the surge of heroin use. when you bring that back to the fda and you ask, well then why would you see putting another drug onto the market as the right step to take, i think the argument is that there is a perception that the people who abuse these drugs are people who are predisposed to taking narcotics. that is a big misconception. people who are prone to this epidemic are from all walks of life. we met a young lady in kennebunkport in the state of maine whose husband passed away from a

as was mentioned, you need to talk with fda. >> hoffman: the fda commissioner is margaret hamburg. why don't we have that information? i mean, antibiotics have been used on the farm for four, five decades. why don't we have it now? >> you know, for me, the question is, can we get it now? and that's what we're working on. i think it's really, it's a question of us all working together to identify what are the critical data needs and... >> hoffman: don't you know that now, though, 40 years? i mean, shouldn't you have a better handle on that, what data you need? >> well, you know, you're asking a very big question in terms of the overall picture. we are focused on certain aspects of this challenge. >> hoffman: last year, there were proposals in congress that would have required farmers to report in detail which antibiotics they're using on animals and how much. but industry groups like the national pork producers council opposed those efforts. did you lobby against those amendments? >> those amendments did not have a lot of support among congress. there was not really a need to active

because fda is -- ebola is a serious and offerly fatal disease, fda approved such requests within a matterf a few hours and less than one hour oftentimes. there's more than 225 staff involved in this response, and without exception, everyone has been proactive, thoughtful, and adaptive to the complex range of issues that emerged. we'll fully committed to sustaining deep engaugement and aggressive activities to support a response to the ebola epidemic. thank you, and i'll take questions later. >> thank you. mr. wagner, you are recognized for five minutes. >> thank you, ranking member, sub committee for the opportunity to discuss efforts of u.s. customs and border kut ms by der touring the spread of ebola by the means of travel. each day, 1 million arrive in the united states, 28 0,000 through the airports. cdc is responsible for securing borders and securing the flow of travel and trade vital to our nation's economy. within this broad responsibility, our priority mission remains to prevent terrorist and terrorist weaponing from entering the united states. however, we play an important role

there are more than 250 fda in this response. and without exception, everyone thoughtfuloactive, and adaptive to the complex issues that have emerged. fully committed to sustaining our deep engagement to support the robust response the ebola epidemic. thank you. >> thank you, chairman, of theuished members subcommittee, for the opportunity to discuss the efforts of u.s. customs and protection in deterring the spread of ebola by means of international travel. one millionout travelers arrive in the united states. about 280,000 arrive at our international airports. are responsible for securing our nation's borders while facilitating the flow of legitimate trade so vital to our nation's economy. our priority remains to prevent terrorists from entering the united states. however, we also play an important role in limiting the communicableious diseases from foreign countries. 100e had this role for over years. we've had modern protocols in place for over a decade. officers at all ports of entry traveler for overt illness. in close coll

the word you need to know from the fda so you're not tricked. >>> we want to hear from you about the stories you're interested in. first at 4. follow us on twitter and facebook. >>> in today's news for your health, have you noticed some of the largest restaurant chains are offering fewer drinks that have fewer calories. >> they noticed more items contained fewer calories than before. the trend is expected to continue now that consumers are demanding healthier food choices. researchers say if people would just consume 60 fewer calories every time they eat out it would put a huge dent in the country's obesity problem. >>> americans are living longer than before. >> a new government report is out showing life expectancy is at an all-time high. >> we break down the numbers. >> it's true. the life expectancy inched up from 48.8 years, a record high. there are differences between men and women. women are living longer. women live 81 years and men are living below the national average. life ec specktancy was nearly 6 1/2 years and not clear whether genetics plays a role in that but the lead

fda when it comes to pharmaceuticals. and this is a very, very conservative safety sensitive organization. so much more that it's incredibly frustrating to deal with them. the reason for it is kind of obvious. here are a bunch of bureaucrats. and if they speed something to market, they maybe get a little pat on the back. it's not a really huge career advancing step for them. but if they allowed something through that turns out, and we've seen it with a recall in the pharmaceutical industry, which is common, that is career ending. it's going to be examined in a very detailed way. so the usual attack or feeling about our technology is actually the fda is extraordinarily conservative and resistant to allowing these sorts of things through. and, in fact, if i looked at the pressure that the pharmaceutical industry could bring to bear on the fda and sort of the heft of big pharma is far bigger than biotech like monsanto. so it really surprises me that you think that the fda is captured in the sense that it, you know, will allo

recently, the fda approved self-injecting naloxone. nida is funding other user-friendly ways of administering naloxone. such as if the patient themselves can use it. also, since many of the overdoses occur when no one is around or the patient is asleep. nida is supporting the development of self-activated systems that initiate an emergency response when it's signaled that on overdose is occurring. finally research related to the treatment of opioid addiction. medication assisted therapies, methadone, naltrexone are all effective and they are effective in decreasing overdoses, but these medications are used in less than one-third of patients who need them. we are working to overcome the barriers that interfere with their adoption and we are doing research for alternative treatments such as vaccines against heroin addiction. we work closely with our partners, in implementing interventions towards preventing and treatment of this problem. i want to thank you again for organizing this meeting and for inviting us to participate. >> thank yo

>> we expect to get paid not from the fda. the fda doesn't fund these sorts of things. there are world government and non-government organizations who have lots of funds targets towards purchasing vaccines leak ours. >> how rapid can your manufacturing process be some of the development, you might have a potential vaccine or treatment, but it's only a few doses that can be used. so once you think you've got a vaccine that is viable, how quickly could you ramp up to have a lot of doses for potentially a lot of cases? >> let me ask you two way, one we did an example of last year, we took the new emergence in coin, within 91 days, we had scaled up manufacturing and special scaled and injected over 200 subjects and showed it protected people in terms of serial protect. so what our technology allows us to do in the case of ebola is two things that are important. one, we take the gene sequence from the current circulating strengths, or making a vaccine. we did that in september of this year. now it's october. we started scaled up manufacturing. we expect to be able to make do

fda when it comes to pharmaceuticals. and this is a very, very conservative safety sensitive organization. so much more. it's incredibly frustrating to deal with them. the reason for it is kind of obvious. here are a bunch of bureaucrats. and if they speed something to market, they maybe get a little pat on the back. it's not a really huge career advancing step for them. but if they allow something that turns out and we've seen it with the recall in the pharmaceutical industry which is common that, is career ending. it's going to be examined in a very detailed way. so the usual attack or feeling about our technology is actually the fda is extraordinarily conservative and resistant to allowing these sorts of things through. and, in fact, if i looked at the pressure that the pharmaceutical industry could bring to bear on the fda and sort of the heft of big pharma is far bigger than biotech like monsanto. it really surprises me that you think the fda is captured in the sense that it, you know, will allow junk science as you

the nuances of the fda's approach are more than i know. i will say to the degree that is true, that is a reasonable case to make. the fda has a mandate to make sure medical devices are safe. what they of eventually said is tell us about the approach you have taken to understand the risk that you have in these devices and security risks and what you have done to mitigate them. it is extremely light touch. we don't know yet. i don't think anybody knows how that will play out in practice. i think it is a very good way of giving direction, creating a north stars of the device makers know which direction of any to be heading and then letting them identify the best way to do it from the markets they are in and the risks they face. >> i will soon be opening up to the audience for questions and also online. question starting with -- we are hearing a lot about companies that offer security. it is not what you folks are doing. the companies are coming in to fix things after there is a problem. we hear that everybody is going to suffer incursion and

fda when it comes to pharmaceuticals. and this is a very, very conservative safety sensitive organization. so much more. it's incredibly frustrating to deal with them. the reason for it is kind of obvious. here are a bunch of bureaucrats. and if they speed something to market, they maybe get a little pat on the back. it's not a really huge career advancing step for them. but if they allow something that turns out and we've seen it with the recall

the fda trusts the companies to do the testing. >> so we're for the really being protected by the fdatected by the companies that are pushing the product that they actually want us to consume? >> it's big corporations are feeding us now. and a corporation asks corporate questions. >> and they are not partial? >> no. >> so what can we do about this? >> if we support organic farmers, community-supported agriculture, farmers who care with good seed and good soil, that make as huge difference. and we all need to get involved in labeling in our states. >> than)hváu for being here. >> thanks for having me on. >> for more info on how to take action, visit gmofilm.com. >>> up next, this week's "ask carol." want to know how hard it can be... ...to breathe with copd? it can feel like this. copd includes chronic bronchitis and emphysema. spiriva is a once-daily inhaled... ...copd maintenance treatment... ...that helps open my airways for a full 24 hours. you know, spiriva helps me breathe easier. spiriva handihaler tiotropium bromide inhalation powder does not replace rescue inhalers for sudden

the fda trusts the companies to do the testing. >> so we're for the really being protected by the fda, we're being protected by the companies that are pushing the product that they actually want us to consume? >> it's big corporations are feeding us now. and a corporation asks corporate questions. >> and they are not partial? >> no. >> so what can we do about this? >> if we support organic farmers, community-supported agriculture, farmers who care with good seed and good soil, that make as huge difference. and we all need to get involved in labeling in our states. >> thank you for being here. >> thanks for having me on. >> for more info on how to take action, visit gmofilm.com. >>> up next, this week's "ask carol." . with centurylink as your technology partner, our visionary cloud infrastructure, and dedicated support, free you to focus on what matters. centurylink. your link to what's next. ugh. heartburn. did someone say burn? try alka seltzer reliefchews. they work just as fast and are proven to taste better than tums smoothies assorted fruit. mmm. amazing. yeah, i get that a lot.

fda has taken steps to be proactive and flexible. they're leveraging on our authorities and working to expedite the government, manufacturing, and availability of safe and effective products for ebola. the provided fda advised companies to guide their submissions. we are reviewing data as it is received. these actions help advance the on ofopment of investigativ products as quickly as possible. result, the vaccine candidates being developed by the companies began phase one critical testings on september 2, and the vaccine candidates began similar setting on october 13 the er partnering with u.s. government agencies that support medical product development, including barda and the department of defense. fda was able to authorize the use of the ebola the agnostic test under our emergency authorization within 24 hours of request. of two authorize the use additional tests, and these tests are essential for an effective public health response. we are supporting the world health organization. we are providing technical advice to the who as

fda has taken steps to be proactive and flexible. they're leveraging on our authorities and working to expedite the government, manufacturing, and availability of safe and effective products for ebola. the provided fda advised companies to guide their submissions. we are reviewing data as it is received. these actions help advance the on ofopment of investigativ products as quickly as possible. result, the vaccine candidates being developed by the companies began phase one critical testings on september 2, and the vaccine candidates began similar setting on october 13 the er partnering with u.s. government agencies that support medical product development, including barda and the department of defense. fda was able to authorize the use of the ebola the agnostic test under our emergency authorization within 24 hours of request. of two authorize the use additional tests, and these tests are essential for an effective public health response. we are supporting the world health organization. we are providing technical advice to the who as

we heard from the nih, the fda.try and researchers. and we're really beginning to honey in on some areas that we can think about how we streamline the process so that we can get from the lab to the clinic. and that's very important to all of us. one of the things we talked about, for example, was the potential time and cost savings of a central irb process, which is something i have been working on for a long time. we also talked about the importance of sharing data and information among clinical registries. and these are just some of the topics that fall under this. today, what we're doing is we're looking for feedback from participants on what we've learned so far and where we could go. and i'm really happy to see so many members here. some of the common topics that we've seen are modernizing clinical trials, facilitating data collection and data sharing, incentivizing drug research for unmet need, incorporating the patient perspective into the research and regulatory process and developing young, emerging scienti

they studied the law of the fda and argued you don't need to take so long. you don't have to wait until the end result to show that a therapy is safe and effective. you can have markets and you can get these products out more quickly. i think the collaboration between the private sector where the market forces were pushed to move forward and we want government not to stand in their way by undermining them with less stability for their work. the private sector and the disease groups and most representatives of disease groups know more about the diseases than anybody else. they have worked so hard to try to understand what's at stake. pressing the government to be as flexible as possible. i think it's important for the infrastructure for the 21st century cures. i want to say i would be a little cautious about thinking we can solve big problems with legislation with all the unforeseen consequences that can sit inn at a panel here ten years from now and bemoan. i guess that's not a question, but comments. i thank the witnesses and particularly, my good friend an

that's a very difficult and delicate decision for the fda to make. you recall with the aids crisis, they had to make decisions like that. i think with their unmet needs, the fast -- if they believe it's safe -- will offer it to the patients on this compassionate use theerry. even n -- theory. even not having a bunch of human clinical trial data. and i think that's an appropriate thing to do. i think they know if the drug isn't safe and the safety profile isn't good, it's kind of pointless to give it to the patient. so no, i don't think that there are drugs that would kill the patients that otherwise would be available. and if it were, i think it's the fda's role to keep it off the market. >> you guys had a great quarter. i think this acquisition is the most important thing you've done so far. jim foster, chairman, president, and ceo of charles river labs. thank you for coming on "mad money." >> pleasure, jim. >> this is the company that's at the forefront of all that money that the biotech companies, a lot of it goes right to charles river and you ca

just this weekend, the fda announced they were going to allow emergency use authorization to screen for ebola in hospitals across the country, including in the tri-state area where there are quarantines. and it's going to give you a readout in about one hour. that suggests things will get more firm and understandable from here on out. >> patrick tucker, thank you for keeping us up to date on everything going on with the technology going on to fight this disease will stop -- this disease. is on the hunt in

. >> reporter: this doctor's battle against cancer drugs started in 2012 when the fda approved zaltrap for treating colon cancer. he compared that to another drug already on the mar kit, avastin. he said both target the same patient population work in essentially the same way, and when given as part of chemotherapy delivered the identical result extending median survival by 1.4 months or 42 days. >> they look to be about the same. to me it looked like a coke and pepsi sort of then. >> then discovered how much it would cost. $1,100 per month. more than twice that of avastin.

sobre las mamografÍas, tambiÉn cierto certificado en la fda tambiÉn informaciÓn sobre tratamiento dely buen consejo. > >> el dÍa comenzÓ con temperaturas frÍas, vamos a empezar con nuestro meteorÓlogo certificado. >> comenzamos la maÑana con temperaturas bastante frÍas, 30 grados, atlÁnti city, todo el área de la zona de la montaÑa de 25, esto estÁ por debajo de las temperaturas normales, gran parte de la zona desde filadelfia hacia el norte, hacia el sur, hemos alcanzado hasta 66, el fenÓmeno que viene es muy conocido en nuestra Área, el famoso nort wester, f aquÍ tenemos el primer ingrediente, toda la lluvia que viene adelante, ha estado ya lloviendo, lloviznas, chubascos, ambas se unen, se forma una sola, en torno a esa baja, tendremos tiempo de lloviznas, bastantes brisas, no tenemos nieve, porque las temperaturas no estÁn frÍas, nuestros modelos indicando ambas bajas, la posibilidad de lluvia en toda la zona, aquÍ en el golfo de mÉxico estamos vigilando, pudiera quedarse en esta Área, pudiera afectar la florida, 51 grados, nublados, la nubosidad no permite tanto frÍo, este es el

i am with the fda on this one. have a former colleague who was taking care of patients in africa who got an kneele stake. as you can imagine, everyone was very worried. he took one of the new therapeutics and got really, really help. and you see that a lot in anti in fact tense. you are trying to tweak the immune system, trying to trick the immune system into mastering its defenses against this budget, and the case of ebola, it's hold modus operandi is to turn off the immune system and sneak around into the organs . and you turn the immune system on in the wrong way and you can kill people. so we have to do safety trials. it is crazy to think about giving out, i think, vaccines or therapeutics, particularly therapeutics without safety trials. we do have test do this efficiently and effectively. but you do not want to just go giving people something untested. it could really backfire and cost you the confidence of the public without which you cannot contain this disease. >> i will build on that a little bit. you can

change the fda requirements single drug. instead prove a drug development process. these tools keep opening up and keep getting cheaper, there's nothing to stop people from actually just making their own drugs. today we see phenomenal amounts of creativity coming into the 3d printing space. all generally starting with one individual. i want to see every drug maker, you know, come from the maker community. i want to see it done fast and cheap. i want to see these best -- these amazing medicines be available for everyone. and i think if we do that, we'll actually beat cancer. we've been fighting it for so long, we actually forget we just might win. thank you. >> in nebraska, democrat faces pete ricketts for governor. the current governor is term limited. we'll have live coverage thursday evening at 8:00 p.m. eastern on c-span 2. here are some of the ads running in that race. >> you know, all across our state, i see people facing the same tough challenges. nebraskans want a fair shot. i stood up for family farmers and ranchers, and we helped 10,000 small businesses and

if you look at the fda guidance, it's high level. what it does is walk you through a risk management process. think about the threats. think about the impacts could be. and think about how you mitigate the resulting risk. it's a good approach to take. the same for the department of transportation's guidance for smart automobiles. that's one area. giving guidance to sectors who are new to thinking about this problem and helping them understand it's their problem now, too. that they have to be engaged in the solution. i think just to highlight another point i made, everything we can do to raise awareness, whether at the strategic level, making a ceo better understand that cyber security is imperative to the company or whether it's at the more operational leave egg he will, putting out threat information so that people who are on security engineering teams can understand what the bad guys are doing in the real world and how they can defend. that's a huge role for the government to play as well. >> i just wanted to follow up a little bit

the fda sauce is a medical device -- saw us as a medical device.ionng out for information purposes only, and now we are more medical natured. we are now working with the fda, and we are hoping to be on the market at some point. >> dealing with the government, it can be a long time. what is your timeframe? submitted an application for one of our former 250 reports. i think it will take some time. >> you have brought in executives with health care backgrounds, how's that changed your business? >> a massive change. ofdid not have a lot experience, we were a startup. as we started to grow we understood more and more that there is this whole world in the regular tour late -- regulatory landscape that we were getting into and that we needed people who really understood how to navigate that. >> d.c. that is a common problem for many of the disruptors in silicon valley who are disrupting industries where the new not have native experience? >> we are unique because health care is more regulated. i look at uber and youtube, the i see how consumer really tran

the fda saw us as a medical device.we launch the company, it was about giving you genetic information for education purposes only. as we have evolved, and has become more medical in nature. it makes sense that we are working with the fda and we have submitted an application for them. we are hoping to be back on the market at some point. >> when do you expect to be back on the market? >> we have submitted an application for one of our reports. i think setting expectations that it will take time is reasonable. >> you have brought in executives. how has that changed the landscape? >> a massive change. before we didn't have a lot of experience. we were a startup. as we grew, we started to understand that there is this whole world that we were getting into and that we need people who really understood how to navigate that. >> do see that as a common problem for many of these destructors who are disrupting industries where they do not have native experience? >> i think we are unique. health care is more regulated. i look at u

what would happen if the fda disagrees with the judge?five advocacy groups say the agency should not do away with the warning, instead they should strengthen it. >> they need to take chantix off the market. they need to take it off the market. >> tina hurst says her life is finally back to normal. she turned down a settlement offer from pfizer so she could keep speaking out against chantix. >> very forfei fortunate that iy and i'm living a great life. it could have been much different, like many other people who took chantix that killed themselves or hurt somebody else. >> pfizer declined to sit down with us in this story. in a statement the company said chantix is an important treatment option for adult smokers who want to quit. pfizer has had more than 9 million prescriptions of the drug in the ultimates. worldwide sales for the drug top $4 billion. james mee han wishehan wishes eg else would have turned out differently. >> i've had only two speeding tickets in my life. in one week, i changed my personality, lost my job. just about ruin

the fda has already approved one dod rapid screening test. this one -- biofire has asked the fda for consideration to allow hospitals to use this precisely for that. it will give you results in actually about an hour. one that can give you results in like ten minutes. that's probably two or three years away. but this one will give you results in an hour. and if biofire gets their way, then soon hospitals around the country will be able to use this for diagnostics and not just research. and then possibly airports as well. >> patrick, we've increased screenings at airports, but now there's concern about cruise ships, what about trains or buses, you think about being in a confined space for a long period of time. and that's quite concerning. but then you think, where do you draw the line here? >> the cdc drishgt, tom frieden, came out and said, travel bans won't work to keep the american population safe from this. and also we don't really like travel bans. we need to move as many people as we can that are trained and that are ready to deal with

recently, the fda approved self-injecting naloxone. nida is funding other user-friendly ways of administering naloxone. such as if the patient themselves can use it. also, since many of the overdoses occur when no one is around or the patient is asleep. nida is supporting the development of self-activated systems that initiate an emergency response when it's signaled that on overdose is occurring. finally research related to the treatment of opioid addiction. medication assisted therapies, methadone, naltrexone are all effective and they are effective in decreasing overdoses, but these medications are used in less than one-third of patients who need them. we are working to overcome the barriers that interfere with their adoption and we are doing research for alternative treatments such as vaccines against heroin addiction. we work closely with our partners, in implementing interventions towards preventing and treatment of this problem. i want to thank you again for organizing this meeting and for inviting us to participate. >> thank yo