but then, a shocking admission from the fda. >> the fda finally admitted that there had never been ady on this generic, never been tested in humans and that the information in that package insert was thejust made up. >> reporter: we went to see j someone at the fda to get an explanation. >> there was concern about testing the generics in normalÑ volunteers. we had had seizures reported and we were worried that we would be unethically exposing volunteers. >> they didn't want to do that test in healthy people, which seems ridiculous. i think they made a big mistake there. >> reporter: the fda did require testing in a lower dose of the drug and used those results to approve the 300 milliongram strength. finally, five years after the first complaint, the fda took that strength off the market in 2 2012. >> in fact, it was not equivalent enough to the brand drug. >> reporter: and so that's the reason why it was recalled? >> that's correct. >> tune in for the health news that matters. >> we felt vibd kated. after being told for so many years that we were totally wrong, that it was all in pe

and it doesn't involve the fda. what i understand from the community is anti-microbial discovers become hard. and i didn't know that until i talked to them. that they've screened like, large numbers of molecules and this pathways and so forth. and it's harder, it's hard to find the new generation. and so, that means a very robust scientific effort has to go on and a basic science of microbes and also in discovery of these new molecules. and do that, somebody has to have the faith that they're going to make money from that. 10, 15 years hence. okay. and they don't have that faith right now. i can tell you. so i don't think whatever has been done is enough. because you have to consider, if it's not commercial development, how is it going to happen? where is it going to happen? >> and would you help us as we go through this process, help us, this committee, identify ways to help innocentivise? >> absolutely. >> because you are helping with these people. and with this labelling debate, where i understand it, we also went

the antibiotic crisis. these funds are allocated across hhs, fda, dod and usda. sed for basic and applied research, with the rest directed towards stewardship and surveillance. currently have these berries agencies coordinate their efforts? >> well, there's been a long-standing antimicrobial task force at the agency level across the government that was headed at hhs, fda has been a part of that. the executive order directs the formation of a higher level task force in the government that will direct the implementation of the strategy that was announced. but there has long been coordination across the government agencies and doubly the pcast report discusses that. >> how is the u.s. coordinating with the world health organization? and other organization as well as other countries working to combat antibiotic resistance? >> we do have, fda, cdc and many others have relationships with world health. and i think the executive order yesterday and the strategy concedes as much tighter collaboration with heavyweight joe in a very concerted way -- of uh oh. >> thank you ve

john: but the drug company may say no, i don't want to get in trouble with the fda? >> they. my there is no guarantee with the laws. the whole show's topic is about choice. we're trying to give people who are dying the choice to try to save their own life without the government's permission. john: the fda says look, if you're dying, we have a compassionate use process, and they e-mailed us, we allow nearly every expanded request to proceed. >> sure, that's true. they do. except the problem with the compassionate use problem is it takes over 300 hours of bureaucratic paperwork and wrangling to get through the process, there have been a lot of documented cases of people actually dying while they're waiting for the fda to make a decision. john: it can take years, routinely takes years. >> routinely. john: they can say, we allow nearly every expanded access two, three years later. >> right, talking about terminally ill people here. they don't have 300 hours of bureaucratic wrangling time. what right to try let's them do is say okay, i'm going to the drug company that has experimen

the fda played a central role in this important effort and i think the agency for the work. we must all work together to ensure we have effective antibiotics for the future. in 1929 alexander fleming invented the process for the first antibiotic wonder drug penicillin. such discoveries for the 21st century can happen as well if we encourage greater investment and development of new novel antibiotic drugs. antibiotic saved millions of lives by treating infections caused by bacteria made through therapies like surgery, chemotherapy, neonatal entrance, by nature bacteria evolve and become resistant overtime. in addition miss use and inadequate diagnosis have contributed to antibiotic resistance and most antibiotics of less effective or ineffective against infections. antibiotic resistance must not be underestimated, more patients have no therapeutic options because of their resistance to available therapies. antibiotic resistance and development must be a high priority for this committee. i look forward to the hearing and thank my colleague congressman gingrey for partnering th

some people die because the fda will not approve. >> michaela knapp died two weeks ago. keith knapp lobbied members of congress and the media to save his wife, but ran out of time. >> ran out of time. she died in april, the drug approved just last week. in another indication, two ploer brothers have an illness that's causing their muscles to wither away until they die. there is no known cure but the other brother was lucky because the fda allowed him to try the drug. max is getting better, but his brother austin is not. >> my brother max can walk and i can only sit in my wheel chair and watch him. >> the government will not allow austin -- >> if austin is never given the chance to get on the drug, we know with 100% certainty that he will die. >> people die because government says no. but there are three states, colorado, louisiana and missouri recently passed laws that say if you're terminally ill, the choice is ours, sort of, you can try an experimental drug if you can prove that you're terminal, if the fd doesn't order the drug company not to give to it you. this small

we heard from the nih, the fda. we've heard from local universities and health centers and private investors, industry and researchers and we really are beginning to hone 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 r.i.b. process, something i've opinion 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 sharing, insent advising drug research, incorporating the patient perspective into the research and regulatory pr

i want to commend you and the fda on efforts to government gain act. i know of at least two drugs that have been released and also want to thank you for your expert on the adapt act legislation. i cosponsor with my colleague and good friend dr. gingrey. when dr. hamburg participate in last year's roundtable she spoke about the troubles of large clinical trial design in the antibiotic space. can you tell me your thoughts on how the unique nature and incentives or even disincentives inherent to the antibiotic space can sometimes make large clinical trials prohibited? >> certainly. not only is it kind of hard to discover new antibiotics, it's expensive to develop them. and the reason is it's really what dr. burgess was talking about. you have a patient before you with pneumonia. naked of all sorts of different organisms causing the pneumonia. without rapid diagnostics you don't know what is causing the pneumonia. so when you're trying to do an investigational drug, you have a sick person in front of you, you have a prolonged consent process where you have

what drives the cost of these investments post fda approval? >> it's a big -- what's the big cost drivers? >> i'm not sure what you mean but i am certainly happy to answer. there's an ongoing process after drug is approved so you actually understand the significance of use of the product in the real world. there are additional pediatric studies which are important, we believe -- >> let me shift just, i've got no time left but trying to come if you'll bear with me because i really -- and think you dr. hillan. i really wanted to address this question to dr. thomas. so if you could quickly respond, mr. chairman, if you'll bear with me. >> sure, and thank you for the question. getting approval is a start of a long process of paying for regulatory approval all over the world on a sequential basis of maybe over 100 countries. there's completion of commitments, unknown questions about basically that is 15 years of pediatric research. so if antibiotics that sometimes, started in a 15 year-old, proving that, drug safety reporting requirements. when you h

the fda has to be a limiting step. if i had breast cancer, stage four like that, god forbid, i would want to go wherever i thought i could be helped. >> that's a great point. dr. samadi, if the u.s., as we're told, has the best medical care in the world, why are they forced to go someplace else to go overseas, and is that safe? >> as a cancer surgeon, i wish her well. this is a tough cancer. she's fighting stage four. anyone that can help her to get to where she has to go, you have all of our support. u.s. has the best medical health care system and we believe that. the problem with medical tours and you see people go there -- the reverse is true, we have a lot of international patients that come and see us here, is because number one, cost is a huge issue. access to health care, we see the cost of health care is on the rise. maybe you don't have access to it. maybe the access is there but it's not available fast enough for you, the next available time for surgery or chemo could be six months from now. finally quality

what drives the cost of these investments post fda approval? >> it's a big -- what's the big cost drivers? >> i'm not sure what you mean but i am certainly happy to answer. there's an ongoing process after drug is approved so you actually understand the significance of use of the product in the real world. there are additional pediatric studies which are important, we believe -- >> let me shift just, i've got no time left but trying to come if you'll bear with me because i really -- and think you dr. hillan. i really wanted to address this question to dr. thomas. so if you could quickly respond, mr. chairman, if you'll bear with me. >> sure, and thank you for the question. getting approval is a start of a long process of paying for regulatory approval all over the world on a sequential basis of maybe over 100 countries. there's completion of commitments, unknown questions about basically that is 15 years of pediatric research. so if antibiotics that sometimes, started in a 15 year-old, proving that, drug safety reporting requirements. when you h

the government. government. john: fda said, we have a come patcompassion at use process, we allow nearly every expanded request to succeed. >> the problem with that program it takes over 300 hours are bureaucratic paperwork and wrangleing to get through the process there, have been a lot of documented cases of people dying while they are waiting for the fda to make a decision. john: it can take years, it routinely does. they allow them 3 years later? >> we're talking about terminaly ill people, they don't have 300 hours. i am going to the drug company with an expe experimental drug,y will give me an answer, i will have a choice to try. john: josh has als, his family initiateed this process. >> it took josh's family about 3 years, he has hired a law firm to get through the process, crazy thing about josh, his story, that drug that he wanted to try, was manufactureed in virginia by an american drug company, already legal in italy. he just topped try it three years, they gave it to him after he had lost the ability to walk u

over the past year the center for drugs at fda has been very busy on this issue. have issued many new or revised guidances on anti-microbial drug development. we approved three discussion designated under the gain act. we recently co-sponsored a workshop on this topic with the national institutes of health. and, of course, the center for biologics have been working on vaccines another way of addressing this problem and working on testing methods. despite all this progress, we must recognize that at that robust pipeline of new investigational anti-microbials does not currently exist. nor are there large number of drug discovery laboratories out there working to bring forth the next generation of candidate drugs. so, we don't have a robust pipeline. the reason for this apparently is primarily absence of commercial incentives to anti-microbial development. this problem must be solved one way or another if we're going to prevail in our fight against the ever changing microbes. we don't just need right now which we do need urgently new treatments for resistant organism

but the fda is warning there is no proof that it works. stin gray tells us some say the pills may be putting concussion victims at risk. >> reporter: a full battery of concussion tests. she took a shot to the head over the weekend. >> i was starting to get scared. but i decided to tough it out and went to work. by the end of the day i was a mess. >> toughing it out is a problem doctors say with teens and kids who want to keep playing after a head injury. >> they want to get back on the field, they want to play. they feel like they are missing something. >> reporter: that is why the fda is warning consumers about a rash of new supplements marketed as treatment for concussion. the claims are the pills will help you recover faster or help prevent one to start with. the fda says that is not true. >> there is no scientific evidence to back up the claims of faster recovery. >> reporter: doctors who specialize in treating concussions worry some people will look for a quick fix with the pills instead of going to a doctor. >> they may be tempted to

and it doesn't involve the fda. what i understand from the community is anti-microbial discovers become hard. and i didn't know that until i talked to them. that they've screened like, large numbers of molecules and this pathways and so forth. and it's harder, it's hard to find the new generation. and so, that means a very robust scientific effort has to go on and a basic science of microbes and also in discovery of these new molecules. and do that, somebody has to have the faith that they're going to make money from that. 10, 15 years hence. okay. and they don't have that faith right now. i can tell you. so i don't think whatever has been done is enough. because you have to consider, if it's not commercial development, how is it going to happen? where is it going to happen? >> and would you help us as we go through this process, help us, this committee, identify ways to help innocentivise? >> absolutely. >> because you are helping with these people. and with this labelling debate, where i understand it, we also went

the other brother was lucky because the fda allowed him to try an experimental drug. max is getting better but brother austin is not. >> he was sit in the wheelchair watching. >> it won't allow them to try something that helps max. here is his mom. >> if austin is never given the chance to get on we know with 100 percent certainty. he will die. >> people die because government says no. there is some good news. three states, colorado, louisiana, missouri recently passed laws that say if you are terminally ill the choice is yours. you may try a determinenal drug if it is if you are terminal. the small step towards sanity he works with this with cold water. am i characterizing this correctly? it might keep you alive. >> twls no guarantee with the law. the topic is about choice. we want to get people who are dying the choice to try to save their own life without the government's permission. >> the fda says look we have a compassionate use progress. >> the compassionate use program takes over 300 hours of bureaucratic paperwork. even though they may approve you there have b

it's the sense of the nih and fda having the ability to do the work in a new fashion. we gave fda a lot of authority to be more nimble and work more collaboratively with those who are developing pharmaceuticals and medical devices. i heard a lot of praise for that. with the nih, there is so clear how dependent the future is going to be on a stable and appropriate funding for biomedical research. if we had a 10-year decrease downhill in funding, it's not just the people who work at it. it's the whole health care system that pays a very heavy price. if we are determined to do anything and i think reflecting the will of the american people overwhelmingly, let's adequately fund nih research and the administrati administration. we have to fund the work through user fees. this is a government function. those who are trying to develop new breakthroughs have to figure out how to pay the user fees. to set up the user fees, we have to do what we have to do. we shouldn't see the constant decreasing or flattening out of the funds which erode over the years. i also am proud to have

and all of the west african regulatory counterparts. this is really crucial because fda is a leader in product development and regulatory authority so there's a lot of need to exchange information. we also have one of the most flexible regulatory frameworks in the world. we have a lot of authority to be able to make decisions based on the best available science and difficult to promote public health so oftentimes our framework is adopted by other regulatory agencies have to redo some consultations. i like to stress that this investigation of products, we are talking about to vaccine candidates and a handful of investigational drug therapies. they are in the earliest stages of development and for most only small amounts are available and that's natural when products are in the early stages of the moment. there's no impetus to manufactured in large scale so this constrains options for doing large-scale trials right now and to widely distribute a product. it's investigational and not to mention there needs to be efficacy and to do that we normally would do critical terms. t

in the united states, cannabis would have to go through rigorous testing, research and approval by the fdat, things start to get tricky. you see, marijuana also needs the approval of other governmental l agencies like the national institutes of health and the drug enforcement administration. this is, of course, difficult, if not impossible. why? because in the united states, marijuana is illegal and classified by the government as a schedule 1 controlled substance. that means it's considered to be among the most addictive drugs and not recognized as having any medicinal benefit. and that's why what i'm about to tell you is so ironic. >> the irony is that the federal government has patented one of the important chemicals in the plant. >> the government of the united states has a patent on a substance for medicinal purposes at the same time they say it has no medicinal purpose? >> exactly. >> this mayo clinic researcher is talking about patent number 6630507, held by the u.s. depth of health and human services for the exclusive use of cannabinoids for the use of certain treatments. >> i was

see create a atmosphere the safety so we have a lot of good news and this approved it's approved by the fda and yet fewer one thousand people in san francisco using prep why? because it is so limit but the most important reason is stigma we good frequently pamper the pill in people's sexual lives it's a way to protect one sever and foster human connection in the city the health care provider have not learned how to issue prep too much of our talks why cpr prep our doctors and nursing nurses are practical people they need to knows how so to new educational program how to talk about sex and sex you'll practices is one

and while they will likely continue, the fda says there's little evidence that testosterone boosting drugs taken by millions of american men are actually effective. but they add there's no real evidence to say they pose a serious risk either. the condition has been marketed as low "t" and the medications are offered to help with low sex drive and fatigue among some men. >>> still ahead for us tonight, in an emergency, lights and sirens when seconds count. tonight, why so many drivers don't move out of the way. >>> and later, a big surprise from one of the biggest names in music. tim mcgraw changing lives for american veterans and their families. lives for american veterans and their families. (announcer) are you dealing with hot flashes during menopause? why suffer more than you have to? you can do something different. because the landscape of options has changed. brisdelle is the only fda approved, non-hormonal option proven to reduce moderate to severe hot flashes during menopause. and the bedtime dose provides 24 hour relief. brisdelle is not for everyone. call your doctor if you h

the fda approves a diet drug, all that tonight and more on "nightly business report" for thursday, september 11th. >>> good evening, everyone, caution was the watch word of the day on wall street today. investors focused their attention on president obama's plan to combat islamic terrorists in the middle east. some tougher new sanctions against russia and the timing of the federal reserve's next interest move. the stocks began lower but closed at the high of the session getting a boost from rising oil prices, dow lost 19, nasdaq up by five and the s&p added a point by the close of the bell. >>> and despite the uncertainty there has been a trend in major weeks, many investors have stepped back in to buy. dominic shu looks at recent activity, what may happen next and what some professionals are buying right now. >> reporter: stocks go up and stocks go down, but with the overall market still near record highs many investors are wondering if now is the time to sell and take some of those profits off the table. certain stocks are getting hit worst than others, so far in september, the broader s&p

the fda is spending hundreds of millions of dollars. they are the most credible.le there is science on both sides of this issue let's let , the proper authorities come down on this. what i can tell you, this is a technology product. it can be modified if there is a component or aspect that the fda or the cdc feels needs to be changed. >> want to thank you very much for spending time with us. >> i really enjoyed it. >> any volume numbers for logic e-cig? >> we do about a quarter of our u.s. sales in c stores. >> thank you very much. miguel martin, the president of logic technology. coming up, more products. more details when it comes to technology. your listening to bloomberg radio and tv. ♪ >> this is "taking stock" on bloomberg. i am pimm fox. let's get a look at the market moving headlines with my radio cohost carol massar. >> russia and the ukraine are working on a deal to stop fighting in eastern ukraine. western leaders expect skepticism over the plan, noting earlier talks fail. president obama moscow's aggression in ukraine a threat to peace in europe. on th

see create a atmosphere the safety so we have a lot of good news and this approved it's approved by the fdand yet fewer one thousand people in san francisco using prep why? because it is so limit but the most important reason is stigma we good frequently pamper the pill in people's sexual lives it's a way to protect one sever and foster human connection in the city the health care provider have not learned how to issue prep too much of our talks why cpr prep our doctors and nursing nurses are practical people they need to knows how so to new educational program how to talk about sex and sex you'll practices is one barrier another barrier is health care coverage san francisco is a appearance and some people have to have access what are we doing as i said based on my informal discussions less than more like 8 hundred are receiving prep at this time based on the numbers needed to treat published this year by susan and extrapolateing we should be giving prepping to 6 thousand san franciscans and we might expect the number of new infections to drop to less than 50 those are informal calculations

they studied the law of fda and argued you don't need to take so long. you don't have to wait till the end result to show that a therapy is safe and effective. you can have markers, you can get these products out more quickly. so 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, the disease groups, most representatives of disease groups know more about those diseases than anybody else because they've worked so hard to try and 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. but i just 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 in a panel here years from now and bemoan. i guess that's not a question, but comments. i thank the witnesses and particularly my good friend and cons

. >>> a new weight loss drug gets the green light from the fda. we'll tell you who is approved to use the california-based product. >>> welcome back, everything. well, stocks are trading lower this afternoon. looking at the big board, the dow is down 30 points. nasdaq down 6 and the s&p is down a point. >>> google is now responding after millions of gmail addresses and passwords were posted online. in fact, 5 million gmail addresses and passwords were made public on a russian bitcoin forum. google says many are not current. google says it does not appear gmail was hacked and that the addresses and passwords were likely gathered from other hacked sites. >>> a bay area mixed martial arts fighter is expected to make a giant comeback this weekend and while the fight won't be easy, he's overcome a bigger challenge. matt major is homeless, living on the streets of san jose. he says despite doing well in the ultimate fighting championship several years ago, he fell into a depression after his sister's death and he ended up homeless. however, recently he b

this past year the fda approved paxle as a special indication. >> paxle? >> that's right. depressant paxle for night sweats and hot flashes. i see you shaking your head. >> i don't like medication. >> i want to say that, i believe in the natural way first. life-style altercation first. for women who are really suffering, you might consider that. >> if you don't have a uterus, most doctors take the benefit of hormones and give it to you. w should have with your doctor. september was prostate cancer month. i want to thank everyone for doing that. >> i want to make sure that every woman understands. i know everybody has a different set of symptoms and the way it affects them. just because i'm saying i don't want medications but i know people are going through it and going through it tough so i want to acknowledge that. >> point great. >>> it can be painful, sudden and deadly. coming up, the doctors will talk about deep vain thrombosis, what causes itnd what we can do about it. chantix (varenicline) is proven to help people quit smoking. chantix reduced the urge for me to smoke

, and achieving these goals will only occur through greater teamwork and collaboration among nih, the fda, industry, academics, medical professionals, and others, and it is unclear if the management and organizational structures to achieve this teamwork are in place today or can be improved. i think america must maintain its leadership role in this effort, and this effort to accelerate viewers will put the nation and our researchers on a trajectory to make the predominant diseases of today a thing of the past and provide hope for all. the initiator of this whole program is the chairman of our energy and commerce committee, and i am very pleased to ask our distinguished chairman, chairman upton am a from michigan, for any remarks he would like to make, and then i would like to thank him for taking time. mr. chairman? >> thank you, mr. chairman. it is truly a bipartisan effort. we formally unveiled it this past spring, and it will be bipartisan every step of the way. century cures initiative is, in fact, going to save lives. it is going to impact every family, not only in this country but p

now the next step is fda approval. let's get right to abc senior medical contributor, dr. jenn ashton. you were telling us this is a big deal. >> reporter: actually absolutely, this is the first drug of its kind in pill form to treat heart failure. this is a combination of two drugs and in this study which was the largest ever done for heart failure, it was found to reduce deaths from heart disease by 20% and improve quality of life. >> 20%, that's a staggering figure. how long will it take to get approval and get it out there? >> first it needs to be studied more in african-american patients and women. if the fda approves it, it could be available as early as 2015. highly significant and very optimistic. >> dr. ashton with us here. doctor, thank you. >>> as america heads back to work after labor day we're not heading back to a paycheck like this one. one of the biggest endorsement deals in sports history, nba star kevin durant, our partners at espn reporting that nike is offering durant $300 million over the next ten years to stay on. the deal negotiated by superstar jay-z

over the past year the center for drugs at fda has been very busy on this issue. we have issued many new or revised guidances on anti-microbial drug development. we approved three discussion designated under the gain act. we recently co-sponsored a workshop on this topic with the national institutes of health. and, of course, the center for biologics have been working on vaccines another way of addressing this problem and working on testing methods. despite all this progress, we must recognize that at that robust pipeline of new investigational anti-microbials does not currently exist. nor are there large number of drug discovery laboratories out there working to bring forth the next generation of candidate drugs. so, we don't have a robust pipeline. the reason for this apparently is primarily absence of commercial incentives to anti-microbial development. this problem must be solved one way or another if we're going to prevail in our fight against the ever changing microbes. we don't just need right now which we do need urgently new treatments for resistant organi

louis lewis instrument on the fda's response in 2009. he has also been very instrumental in more recent responses for examples to the middle east respiratory syndrome in the middle east and the recent bird flu that has become a major concern in east china and will be back soon in november and december as the weather gets cold. please welcome dr. lou borreo. [applause] >> thank you and thanks for inviting me today to discuss these actions to respond to the ebola epidemic in west africa. takes a special person to bear witness to these devastating diseases as you do and make a big impact in its management. needless to say this outbreak is the most heartbreaking and tragic we have witnessed. in recent history. there are many complex challenges we are facing. specifically the minimal health care and public health infrastructure within the countries have made this very difficult. as ben just mention the primary approach for containing epidemics like this is the standard tried-and-true public health measures. they are not working. it's just very

. >>> the fda gives a thumbs up to a new pill that could help dieters shed pounds. who will help and who it won't.  shannon: we'll take you live to the white house and look in on the 20th anniversary celebration for americorps. this you may remember was a program that president clinton started 20 years ago. plugs in volunteers at all kind of place, schools, non-profits, community service, giving them the chance to learn work skills and volunteer to help all different kinds of communities across the country. they're swearing in a new group that will embark on their service for americorps. we expect to hear from president obama and president clinton, the one who established and kicked off the program 20 years ago today. we'll check back in on that. if you want to watch this live it is streaming on foxnews.com. jon: right now a quick look what is still to dom this hour of "happening now." a massive fire at an industrial plant forces hundreds of people from their homes. it is hardly a sweet smell in the air as barrels of recycled perfume bottles go up in flames. >>> how

confident they will gain the fda approval they need. thank you for joining us.t you're working on, we were just baking h -- speaking about this whole ipo market. are you glad you came in in june and missed this route of the last few weeks? happy with the timing we got. this is just one step in the lifecycle of a company like ours which is developing a treatment that needs to be brought to patients. moreooner we do it with resources the quicker gets to patients. that is what drives us to do what we do. given all the finances that we the ipo, wed in have advanced our programs to more intensive types, and two more indication, and we hope to do it faster. >> hell out of you floyd that money? -- how have you deployed that money. ? >> initially we mentioned one implication per year. we are now working on five different types of cancer, working faster toward fda approval. mostat is it you are excited about? , yourre you working on biggest breakthrough? the talent of the people and the alliances. we have a line with the national cancer institute in developing jointly th

congress and the fda, with the medical device user fee act, and we're already seeing an acceleration of approvals. again it is working. fta and the industry are working together. it is also important to note the cooperation under the medical device innovation consortium under a doctor who is also working well, it is promising. and it is not enough, and we are hoping and willing to work with you to address these issues with all constituents to bring this cycle and this ecosystem back to work. there is a lot of work. and, oh, one thing i should not forget, another large threat to the medical device innovation. taking funds from small and large companies all over the country that they need to put into research and development to find the cures of tomorrow. and this will not show up tomorrow, ladies and gentlemen, but for years to come if these funds do not return to the industry and are put into work to find the cures for tomorrow. our help in any way we can. our organization and industry are conflict your initiative. >> thank you. and now we go to the physician and chief in charge of c

we have to look to the fda, work with the fda, how can we bring this development to the table sooner and better than we've ever done before. i'm excited about the possibility of helping to galvanize interest and get this drug to patients as soon as possible. >> you know some people are concerned that perhaps it's too quick. i mean i don't know what the medical ethics of it is when you have this kind of efficacy, when you want to get the drug out and help people, are there particular populations that haven't been studied enough? >> you know hari the answer is yes and yes. but it doesn't drop our interest or quell our enthusiasm. we need to move forward for heart disease that's clear. yes there are patients we wish we knew more about, like african american patients, like new patients with advanced heart failure. but there are ways using contemporary research philosophies, this is not about a company, this is about a brand-new way to take care of people that have a pretty compelling disease. if the disease wasn't so compelling sure we could slow down take more time get more data. but we