environment, energy, air, water, et cetera. and so we're of the dawn of the golden age, this enormous investment that the american public has made with the leadership both in the administration and the senate and the house, approving in '98 an increase in funding, which now exceeds over 200 billion. we're about to reap those benefits. whether those benefits will accrue to the united states of america or to some other country will be determined by the leadership and the commitment of this committee and others today. there are five easy lessons we could talk about today that we've seen over the last 30 or

40 years. one, putting the patients at the center of discovery, development and delivery process. more efficient clinical trials. meaningful working relationships between patients. and disease-specific organizations. one of the great advancements of the past two decades has been the strengthening and improvement of the disease recognition research group. two, incentivize collaboration across sectors in the r&d process. public/private partnership. look at history books and see those partnerships between ford and kaiser and the government that allowed us to have victory in world war ii as we moved our for-profit industrial companies quickly to produce ships and other products we needed during world war ii.

three, encourage novel financial solutions that address the riskiest r & d endeavors. change this risk/return ratio. as an example, mr. chairman, all we have to do is look at acid rain. a major issue in the latter part of the 1980s in america. movies, public hearings, et cetera, the loss of life to acid rain. the creation of a financial market for sulfur index that allowed people to reduce their emissions, get credits or for those to buy credits that in seven years eliminated 95% of all the acid rain in america. strengthening the basic translational research infrastructure depended heavily on the next generation of young scientists. today stem education is the rage for both men and women, boys and girls in america. after 15 years of studying,

ph.d.s, m.d.s, internships, residency, we have little to promise them in the future. and today, america is losing our best and brightest students to the rest of the world, and we run the risk of losing generations of young scientists either to other countries in the world or to other fields today. fifth ensure sustainable and predictable funding for our science agencies. 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 times faster than ours. it's not that they have

different technology. it's that they've alwed different infrastructure, 21st century infrastructure to allow those. one of the things i'm quite confident is that work on this committee will help us to build that 21st century infrastructure. >> i'm francis collins, director of the national institutes of health, and mike milken, i think, has wonderfully articulated the promise and the challenge of living up to that promise. i want to thank chairman upton and representative degette for convening this whole series of discussions and many members of

this committee who have participated by convening similar hearings and roundtables in various parts of the country. i was here for the first roundtable may 6th in this room. i was two weeks ago in lancaster, pennsylvania, when representative pitts convened a very interesting group of us around that table. it is enormously inspiring and encouraging to all of us involved in biomedical research to have this kind of focused attention on the opportunities that now lie in front of us for developing these 21st century cures. i live a paradoxical life because as director of the nih, i have the opportunity on a daily basis to see amazing science that is possible.

things that i would not have dreamed would happen in my own lifetime. at the same time i also preside over an effort, which, as mike has laid out, is under the greatest stress that it has seen in four decades. with young scientists who find it increasingly difficult to see a path forward to live out their visions. so it is welcomed indeed that this group has come together to try to see what could be done to cat ta liz greater progress and those cures that are still being waited for on those roughly 7,000 diseases, only 500 of which currently have a therapy that's available. the genome project helped us a lot in stepping into a new space here. now we now have technologies that allow us to look into the intricate details of how a cell does what it does and how things go wrong in the presence of disease. and yet we're not capitalizing on that opportunity at the level that we might. my own area of genomics, i can't help but point out that while we, the united states, led the human genome project and from that derived the return on that investment is 178-1 in terms of economic growth that derived from our leadership of that effort. yet if you ask me now where is the largest investment in genomics in the world, it is not in the united states. it is in xenjiang, dhin.

they read our playbook. saw an opportunity and took advantage of that. meanwhile we, over the 11 years since the genome project was completed in 2003 have seen a steady decrease in our ability to support research with a 23% cut in our purchasing power for biomedical research since 2003. and the results of that is the subsequent loss of the leadership that was basically clearly ours at that point. don't get me wrong. i celebrate what other countries are doing to contribute to biomedical research, but why would we, the united states, with all the talent and creativity and vision here decide to exit the stage just as it was getting interesting? we clearly have a critical role to play here. i really appreciate the way in

which this 21st century cures effort is asking very specific questions of what could be done by the congress in legislative terms that would assist us in terms of our ability to go faster. and we will be supplying -- i already mentioned in some of the other sessions, specific examples of that sort. it's getting to be quite a long list. some are big ideas and some of them seem kind of small, but they would help us a lot. they fall into three categories. one is how to enhance participant protection and increase transparency, to encourage participation by people in clinical trials and biomedical research but also make it clear we are transparent about how we do this. such things as providing privacy protections for individuals participating in research so that their private data doesn't find its way into unauthorized places, simply prohibiting, for instance unauthorized reidentification of individuals based on dna sequence would be an important step forward. second area is to facilitate collaborations and innovation. we've already heard some of those issues as relates to central irbs, something that we also feel quite strongly about and the common rule which is the way in which we have overseen human subjects research for 20 years is desperately in need of an upgrade. a lot of work has been done on that, but it has not come across the finish line. a simple area that, in one way,

is getting in our path, our new national center for advancing translational sciences. for reasons that i think reflect anxieties about whether this would be competitive with the private sector is legislatively prohibited from pursuing clinical trials beyond phase 2a. something which now at the present time really makes very little sense. i think almost nobody would support the rationale for that given that we have worked very hard to be sure that we are in no way competing with private sector efforts. and the third category, reduce administrative burden and increase efficiency. the famous paperwork reduction act has been for nih the source

of the greatest amount of paperwork that you can imagine when it comes to individuals who are trying to run simple studies where they wish to actually do a survey. this happens many times for trainees in our intramural program. you may not know that you can't run a survey to ask people about their opinions about precision medicine, for instance, if you're going to ask more than nine people, unless you go to the omb and get approval for that. that takes about nine months, at which point the trainee's about ready to leave. so clearly there are some helps we can use here. and all those reports, if you start adding up the reports that are congressionally required and which, as far as i can tell, nobody reads but which requires many hours of busy people's time, it would be great to sort of go down the list and throw out a lot of those that really have, if they once served a purpose, no longer do so. but again i just want to say how critical it is that we look at this issue from a holistic perspective of all the ways that our enterprise could be more vigorous and healthy. particularly as mike milken has said and others, diana degette

mentioned it as well, the need for a stable sort of support system. there's a great sense now of instability of insecurity, of a trajectory that nobody can be quite sure of. that's the worst thing you could do if you're trying to encourage innovation. to find that path forward would make a huge difference. it will make a difference in very concrete ways of saving lives. tell you one other story which is very much on my mind, and then i'll yield up. here we are, all of us, deeply troubled by what we see happening. the number of deaths from the ebola outbreak now over 2,000 and with no end in sight because of the way in which this terrible disorder is spreading rampantly like wildfire in liberia, sierra leone and begin pep the nih began working on a vaccine for ebola in 2001. we have steadily pursued that effort over these last 13 years. hoping that by the time a big outbreak occurred we would be ready for it. that vaccine has now been in animal trials shown to be highly

effective but as of this summer the outbreak really began to catch fire, had not quite reached the point of a phase one clinical trial. we worked in record time with enormous assistance from our colleagues at fda to speed up the process. and last week, the first volunteers at the nih clinical center were injected with this vaccine in a phase one trial to determine whether in fact it is going to be safe. and in another two or three months we'll know that and be in a position to do a phase 3 trial which it's most needed in africa. but i have to tell you if we had not undergone this ten-year decline in medical research support, we'd be a year or two ahead now. think about the difference that would make. had we been in 2014 been in position to distribute rapidly tens of thousands of doses with

our colleagues of this vaccine, how much different would this be and how many lives would have been saved? so the consequences of what's happened in the last ten years are not just that it's been tough on in scientific researchers, although it really has been. not just that it's damaged our ability to take advantage of economic growth that otherwise would have happened, it's also that lives are not being saved that could have been. the importance of this conversation could hardly be greater. i thank you for the chance to be part of it. >> thank you all. great experts in your fields. and i didn't mention at the beginning that, you know, not only is this committee united in working on this together, but we also have the commitment of leadership on both sides. steny hoyer was there and testified and kevin mccarthy our new majority leader is on board as well. let's open this up for discussion.

frank, first. >> thank you. again, i want to say to both you and diana how valuable i think that these roundtables have been. and we had one i guess it was -- was it only a week ago? it seems like two weeks ago with chairman pitts in his hometown in lancaster, pennsylvania, i thought was very good. i wanted to follow up on something that commissioner hamburg mentioned that day. you had talked about engaging patients, and i think you were responding to some extent to the woman who was from my district from medicine who was with the hydrocephalus foundation. and i just wanted you to talk a little bit more about that and how we can engage patients. and i was particularly referencing i know in the user fee bill we had a provision that allows patients to be part of the advisory panels. so that would be maybe one example of how we engage patients and maybe you can talk about that specifically, but i didn't want you to just limit it to that. it's just the idea of engaging patients. because a lot of times, as you know, the initiatives in terps of legislation that we pass on

the floor and, you know, some of the bills that we did last night on the floor actually come from these patient groups, if you will, who are so grass roots and involved and spent a lot of their life, you know, on some of these -- as part of these foundations like that. if you could elaborate more and mention more about the advisory panels and participation. >> thank you, such an important question. this is a critical time as we're really rethinking not just within the fda more broadly about how to really put patients at the center of what we're doing and really include the

patient perspective and reflect the patient needs in the work that we're doing. it goes far beyond engagement on an advisory panel if we do have patient representatives on advisory panels, but it really is to sit down with patients and patient groups in a systematic way to better understand their experience and their perspectives on the products that they're using, whether drugs or medical devices to better understand what they need and that they're experiencing their disease and what are the critical symptoms of their disease that they want addressed. and then how we can -- and what, of course, are the unmet needs. and then how can we actually incorporate that into both

product development and product review? for example, biomarkers were mentioned. but we want to use patient reported outcomes like biomarkers to ensure that we are both assessing the right measures of whether a product is having an impact and use those measures in a more fundamental way to define success. so i think that's really critically important. the other thing i would mention and, of course, mike milken in his various fillen tlop es and organizations have been leaders in this area but the role of patient specific philanthropies and organizations.

we increasingly work with them wls with the research community and product sponsors to really identify critical needs and opportunities and then together think about how to shape the in particular the clinical trials that need to be done, but other aspects of data collection so that the research and development and review process can be as accelerated as possible. one good example is the work that was done with the scientific community and the cystic fibrosis foundation to develop a new drug kaleidako which is for some people who have cystic fibrosis that have a particular genetic marker but the first that treats the not just the symptoms with the devastating and this has been

transform of a and provides the patients and the cystic fibrosis foundation made this work building on research on which francis collins did a while back. this has been transformative and the cystic fibrosis foundation for understanding the opportunity and moving forward quickly on it, and put up some critical resources, not just patients, but also dollar resources to help move the project forward, so there's a lot of important activity in this area, and i think that we need to look at what's being do done, and i think it can help us advance this work. >> thank you. mike bridges. >> thank you, chairman.

dr. collins, the offer still stands. i will be one of your test patients for the safety of the ebola vaccine. you rejected me on age criteria. i thought that was obviously discriminatory on your part. >> i had to reject myself on the same grounds. >> i still stand ready to offer my services. we had a good -- with manhattan institu institute, we had a very good round table. and i think faster cures was part of that up in boston. and the concept of adaptive licensing came up. currently, of course, through clinical trials. once it's approved, it's assumed to be safe and effective until proven otherwise. but the adaptive licensing pathway that some are using really did seem to have some appeal because we live in the information age. so the rapidity to which something could come to perhaps partial approval, to the rapid

learning that is now possible with the information systems that we have, it seems that this would be a reasonable direction in which to proceed. so i hope it's something we will consider, but also i see as administrator at the fda, is this something you all are looking into or would be receptive to in the realm of adaptive licensing? >> well, it's very much a topic of discussion. we have been involved deeply with counterpart regulatory authorities in other countries that are also looking at this as well as the scientific community to look at what are the opportunities to get robust scientific answers from a range of innovative approaches in terms of clinical trial design that can underelijah wolunderli. at the present time, the fda has quite an array of tools thanks

to our work with congress, including with the breakthrough designation. and in fact, our approaches are not binary. using again, going back to biomarkers, using biomarkers as surrogate end points, enables us to move a product with promise into the marketplace, but then collects data in a continuing way to actually then assure the final approval if the product really works and provides an overall benefit for patients. but this is an area that i think is ripe with opportunity to explore how can we streamline, modernize, and best adapt our regulatory pathways to make a difference. i think that secretary burwell mentioned that half of the recently approved drugs used

various methods for expedited approval, and that is making a huge difference. breakthrough designation is proving to be a real benefit. and i would have to tell you that i think one of the most important things to emerge in recent years in terms of all of this work is that what makes the most difference in actually reducing times from discovery to the bedside is really the ability for the researchers and the companies and fda to all work together early and in a continuing way to shape the development process to identify what is the data that's needed to move us as swiftly as possible over the finish line, and i think that is really where the most important work needs to

be done to make the most difference for patients. >> i have to add then the comment was made this morning about the 25% turnover. that someone is working with someone at the fda. they're getting to a point where perhaps the next steps are ready to be taken, and boom you've got to go back to square one. i mean, i hear this all the time. it's not new. >> well, that's a huge concern for us. and it reflects unfortunately that people are stretched too thin, work too hard, burn out, the conditions are challenging. and they're very competitive in other sectors. so i think we need to address those issues. the user fee legislation has enabled us to begin a process of hiring on more people and being able to really create the training and management systems that we are intending to help us do a better job at recruiting

and retaining people. but that is an essential issue, and it can undermine all of the best efforts, adaptive licensure will not fix that problem. we need to address the issue of recruitment and retainment i think in a very targeted and forceful way, because it is essential and has so many critical ramifications. >> and cross-training within the institutions was not up to one individual. thank you, mr. chairman. >> henry. >> thank you very much, mr. chairman. i want to commend these conferences, round table delaware discussions. they've been very valuable. what has come home to me in the number of meetings we've had is the promise of a lot of new innovations in the health care area. and it's an exciting time in medicine. i also have been struck by how dependent this whole future is

on the government in the sense of nih and fda having the ability to do their work in a new fashion. we gave fda a lot of authority to be more nimble, to be flexible, to work more collaboratively with those who are developing pharmaceuticals and medical devices. and i've heard a lot of praise for that. with the nih, they're just so clear how dependent this future is going to be on a stable and appropriate funding for biomedical research. if we've had a ten-year decrease downhill in funding for nih, it's not just the people that work at or for nih, it's the whole health care system that pays a very heavy price. so if we're determined to do anything, and i think reflecting the will of the american people

overwhelmingly is let's adequately fund nih research and the food and drug administration. i'm embarrassed, although i accept it already, that we have to fund the work of fda through user fees. this is a government function. and those who are trying to develop new breakthroughs have to figure out how to pay the user fees. it's just -- look, i authored the law to set up the user fees, but we have to do what we have to do. and we shouldn't see the constant decreasing or just flattening out of these funds, which erode over the years. but i also am proud to have my constituent and friend mike milken here, and i thank him for his presentation. the work of this whole panel has very much relied on the work that your organization has done,

particularly the 2011 discussions about barriers that prevent progress. and i was struck by the fact that you talked about the cap and trade program for the acid rain, to get rid of acid rain, which i authored. and it seems to me we need to do that for carbon as well, which is to unleash market forces. don't think the government can do it. we need to give the right incentives and then step aside and let market forces dictate the creation of the infrastructure to accomplish the goals we want. we need to do it more in the environmental area. we especially have to do it in the health area. but part of that infrastructure must be the maintaining and stable funding of the government in areas. to whomever on the panel that wants to address this,

legislation is a blunt instrument. we heard about the paperwork reduction act, which has caused more paperwork. the reports and all of the other things that we think are going to make things easier, instead they make them harder. i think we would welcome legislation to reform that area. but if we come in with a blunt instrument, suddenly recreating the fda authorities, or mandating things on the fda, or looking for the department of health and human services to do things that they're not equipped to do, and then of course we don't fund them to do it, i think we have to be cautious about some of the legislation that may be proposed. more than anything, we want government to be there to work collaboratively, and but we still have to recognize the safety and efficacy, which the american people and most people here would certainly think is

necessary for a new product. but we want those products out as quickly as possible. i remember the days when we had the first evidence of the aids epidemic, and the people that brought home the reform at fda to get some of these therapies out quickly were the group in the gay community. 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 and constituent mike milken for all that he has done. >> joe pitts. >> thank you, mr. chairman for convening this roundtable and thank you to the expert witnesses for your insights. every time we have one of these

hearings or roundtables, we learn a lot. we had an excellent roundtable with dr. collins, dr. hamburg, our chairman, dr. burgess, frank blum were there. it was very important and meaningful. dr. collins, you've forcefully made the case that it's imperative for congress to prioritize funding for nih. while i understand the importance of ensuring that funding for nih remains stable and predictable, congress is at a crossroads where federal dollars are already committed, particularly as they relate to federal entitlement and safety net programs. if we are going to find resources to stabilize and or potentially increase nih funding, congress is going to have to work hard at prioritizing resources that are focused on advancing science and research to spur the next

generation of cures. this is the question -- are there existing sources of research funding? that congress should examine as it attempts to find federal dollars to help advance the next generation of cures. your thoughts? >> i don't envy the position all of you members of congress are in with our nation in a very difficult fiscal deficit. circumstance trying to figure out how to balance the needs to support important government activities and i would submit that medical research is a very important government activity which, if not supported by the u.s. government, the basic science that nih done simply won't get done. at the same time i know you have to figure out how not to have a circumstance where we bury our heads in the sand as the deficit

grows, so you're faced with many difficult choices. one of the things we have been trying to do, and it has helped a bit, is to try to identify other ways to support medical research and other than the traditional nih appropriation. one that got started about six months ago is a partnership between nih and ten large pharmaceutical companies called the accelerating medicines partnership which is really unprecedented in its scope. the goal here is to try to identify that next generation of drug therapies that we know is waiting to be discovered given all breakthroughs that have happened in fields like genomics. by putting they will together, academic researchers and companies could be pretty exciting. the companies recognizing that, and much to their credit, are willing to engage in a partnership with nih where all of the data is immediately made accessible. it is not one of those where it

is hidden behind a curtain. and we would have a hard time participating if it were. this partnership which is being equally supported financially by both the companies and the nih, 50-50 split in an unprecedented way is moving forward on diabetes, on alzheimer's disease and on rheumatoid arthritis and lupus. my colleagues in big pharma and i watching personally over this closely wanting to be sure this doesn't run off the rails i think are quite gratified by seeing how far it's come in six months. that's an example of creative ways to try to do things. we are working in every way we can to identify partnerships in other parts of the governments. we have a number of very exciting initiatives including some that aim to put cells on a chip to allow you to investigate their behavior. i have a kidney here on the chip, by the way. i got a lung over here. these are basically amazing technologies, bringing together the engineering skills with the

biology skills of our nih investigators to move things forward in a fashion that could be great for identifying drug toxicities as well as effectiveness. you're asking about other places to go and look. i'm probably not in a great position to be able to say of all the various parts of government support of where are there opportunities. the board of governor includes the nih director. the patient-centered outcomes research institute is what that is. they are working hard to try to identify in a research/evidence based way what are the actual interventions that work and which ones don't work for patients in the real world. obviously issues that we really do need to know about. it is a hard working organization that's only been around for two or three years. i don't know how to balance those particular kinds of decisions that people are struggling to make. i want to promise the group that we are not just at nih saying give us money and we will keep doing things the way we have.

i get it. we have to be creative and make reforms in the way in which we administer our own funds that we through the public give to us. we are looking at every nook and cranny to come up with ways to be more efficient. i promise you this is not just researchers with their hands out saying leave us alone. we understand the obligation to be incredibly efficient and creative about what we do. and productive. we are willing to put ourselves under the microscope. >> mr. chairman, can i suggest a couple? one, i would say scoring. when we look at how things are scored, we need to totally re-evaluate that. i will quickly cite one example. fellow board member of mine and close friend for many years,

ward tripp cosells, was identified 13 years ago with advanced cancer and given a short period of time to live. he engaged in every known clinical trial, in this case for prostate cancer. he recovered and over 11 years, i would say ten extremely productive. he led two tours of duty to iraq where he led our medical efforts in iraq. one in afghanistan while he was taking chemotherapy. became the assistant secretary of defense in charge of the health of everyone in the dod. when we had issues at walter reed, he was called on to solve the problems at walter reed. founded two bioscience companies. was previously the doctor for both president bush as a cardiologist, and hired 2,000 employees. in the scoring, everything he accomplished in the 11 years, not the least of which was 11 years more that his young

children had with him who were very young -- 3, 4, 6 at the time. all of them will remember their father and their lives will be different and children's lives will be different. his score was zero. of any benefits of those treatments that he got. so we just count the cost, we don't count the benefits of this great american patriot. in the 11 additional years, he got every person and cancer dies approximately 16 years before their normal lifespan. i would say scorning. two international lives. the first gulf war supported by henry kissinger and others' efforts, the united states put up 20% of the money. other countries put up 80% of the money and the u.s. managed 100% of the money. there is an enormous opportunity

to drive research if we focus as part of the state department and other international efforts. other countries on a per capita basis are far wealthier than the united states today. norway, for example, many years ago set up a fund for the north sea. it's kind of a rainy day fund. their goal -- $500 million u.s. that fund today approaches $900 billion. they overshot that fund. in the united states, that would be like if you had a fund of $60 trillion sitting there. they can play as many other nations can an active role in activities if we had the structure here to get financial support from them today. third is the young scientists. many things have been created to encourage young people to work

in the field of teaching. and if you go and you get teaching degrees from universities, if you work in inner cities or difficult areas, we forgive their student loans that they've had. almost all nobel prizes have been issued for ideas within five years of school. you might have been 60 years old when you received the nobel prize, but the idea was generated when you are 25 and 30. today the average age i'm assuming is in the low 40s. 42, 43. of the first time an individual has received a grant. how discouraging can that be for a person with new ideas? today all of us who had children grow up and go to college and leave are intellectually challenged when our teenagers leave the house and go away to college as to how something works. this is the same technology that's available if science today, but we haven't found a way to encourage people to stay in science, to stay in research,

to stay with the nih. one of them might be easily to forgive their student loans that they've accrued being a doctor, a scientist, et cetera, if they work in these fields. there is benefit the same as a teacher in the inner cities. lastly matching to challenge the american public. challenge philanthropies. we have funded over 500 young scientists. it's amazing how little the money. 100 young sign ties for the fda. 100 young scientists for the nih and others around the country. let's challenge the american public where you need matching grants for those young scientists and i think we could accrue billions of dollars in matching grants here to keep young people and further their careers.

>> thank you. i have seven people on my list. gene. >> thank you all again for those of us who serve on the health subcommittee. doctor, thank you what you've done with our gain act that we passed last session. we have a follow-up -- the adapt act -- that would give some more authority and for the future of antibiotics and hopefully we'll do that. my main question, july 30th and 31st joint nih/fda meeting, you mentioned that the u.s. government should launch a public-private partnership. that would be to facilitate antibiotic development that would work to establish a master

clinical trial and protocol for antibiotics. they indicated that they have new drugs for bad bugs. in europe they like acronyms there, too. nd4bb were crucial to bringing together key stakeholders from the government, academia, industry to tackle the significant scientific challenges facing antibiotic development. they feel more about the u.s. public-private partnerships and the master trial protocol. >> certainly can and thank you for the question, congressman. the fda and nih and industry all got together at that meeting july 31-31, peggy hamburg and i worked closely through our joint leadership council to plan for

this. it's a very important issue, because when you see the way in which increasingly infections, particularly in hospitals, particularly in patients who are very sick if icus turn out to be from organisms that resist all known antibiotics, we are on a trajectory that's really quite frightening. the delivery of new antibiotics through the pipeline has been quite slow, for mostly financial reasons. that is the development of new antibiotic is not seen by most pharmaceutical companies as necessarily something that's going to be very profitable. you may have a small market, a short time the drug is delivered. a lot of liability concerns. here we are in a circumstance where the bacteria are increasingly through evolutionary processes after being exposed to way too much drug prescribing which is going on both in hospitals and in agriculture, are developing these resistances and we don't have at the present time a fully

effective strategy. one of the things that we need as part of that strategy -- this was the main topic of that meeting -- was to have a pre-existing network of clinical trial sites so that if a company says we now have a promising new antibiotic, you want to use that on people who are infected with these highly resistant organisms but you have to find them. fortunately, right now you don't find them everywhere. they tend to happen in outbreaks. when you don't have already a pre-existing network with staff on the ground, with consent forms, with irb approvals, then the company has their drug but there is no way to check it out and see if it works in less than many, many months. the idea is to have a master clinical protocol. nih, through our national institute of allergy and infectious disease is already invested already in making this happen in order to provide industry with that kind of a platform. it is a great example of a partnership where we all have a lot in common, a lot of needs

here. there will be, by the way, in the relatively near future a lot more information about plans that we've been cooking up over many months now about how to take a systematic look at this problem of antimicrobial resistance, perhaps even in the next week or two, there's going to be more about this coming from the president's council advisors and from a bunch of the rest of us. >> we hear a lot about ebola and the only two doctors who were able to get something. but mrsa is in every hospital in the country. hopefully we can move forward. >> 30 seconds.

>> that's good. bill. >> i had the opportunity to go through your wonderful facility a number of times this last year and see the advances of what you have done as it relates to animal testing that can help the drug industry. tell us a little bit about -- as we think about trains traveling at the same speed but the tracks are the same, let's talk about what you've been able do with those tracks and the science to improve the testing and expedite the approvals of what you are able to do. >> you were there, fred, when we launched or molecular imaging capabilities in preclinical work. while imaging is not new, its broad use is gaining momentum daily. in many cases on a regular tear basis, the regulations haven't

kept up with this science. that's not a criticism. believe me. it's not a criticism at all. no, but this isn't one. for example, there's no fda imaging approved for biomarkers for early stage. and yet when our clients and our sponsors go for approval, the fda in a great way talks about the old archaic ways of working through toxicology and whatnot and even some efficacy work. and then says we know that are you not required to do imaging, but do you have? of course we do. what that says to me it's our fault that we're not keeping pace with changing technology. and so i think in the case of the regulatory environment within which we live, that it's so hard for regulations to keep track -- keep pace. it's so hard for regulations to really help allow for if you innovative methods to be tested and used that maybe there's some way to have an emerging issues task force or something along those lines.

i'm sure you've thought of this before where when new technologies are available or being used, perhaps not in the mainstream of regulatory approval but are being used to supplement insight into drugs and imaging in particular for clinical trials. it's incredible what kind of insight has been achieved as a result of looking again at biomarkers and absorption, et cetera. so if there were emerging issues task force where in this case in a very collaborative way the sponsors in this case, researchers, innovators, could work with the regulators, could work with academia, the specialists, the subject matter experts, so that we could quickly allow some of this to happen. i know this is a litigious world that we live in but we're breaking new science and risk is part of it. you saw what you saw there is what is -- it's not -- there's a

lot more advanced technology an science than just imaging but it is coming of age today. it can clearly add significant insight, reduce costs, improve speed, as you saw and you know. and i would encourage that part of your legislation would allow us in a collaborative way to be able to work together to be able to allow to experiment and allow to work -- let these new technologies help us meet the goals and objectives that you define. >> just a quick comment about it. very important point. it raises sort of two different issues in my mind. one really speaks to i think a broader opportunity that built on this notion of the importance of public/private partnership and collaborative research in critical areas. there are things, biomarkers, various kinds of computer models or simulations, or other kinds of approaches where no one company is necessarily going to

want to take the risk of trying to develop it and characterize it and get it validated because there is a lot of risk and a lot of cost. but if these activities could be undertaken and we could identify these new research and regulatory review tools, whole classes of products would benefit and many companies would benefit and so we really need to be able to find ways to take some of those research dollars and make sure that they are targeted to these critical areas that are gaps in current research funding that require some of the kinds of new public-private partnership models as well so you get the best minds around the table working on these projects that often are really complicated and involve emerging technologies and how best to use them. we've seen the benefit already in the biomarkers area, for example, and the biomarkers consortium.

these are really underdeveloped models for public-private partnership and so-called precompetitive collaborative research and they're really under resourced in terms of research funding at present time. so i think there is a critical need and it is one where we know that if we develop it, it will make a huge difference. the other thing is that the regulatory process is really cumbersome and congressman waxman noted that congress recently gave us some new strategies and authorities to be more nimble and flexible. but putting regulations into place takes years and the notice and comments process is an important one for getting input. but it's lengthy, et cetera. so thinking about what are some of the models for how to work in more responsive, more collaborative and more flexible

ways in these kinds of situations where an emerging technology and an emerging opportunity is there i think is a challenge. i don't know if it could be fixed by legislation per se at the present time but i think it is an area that we need to delve more deeply into because it really matters. >> and in the end i know if my early years in the pharmaceutical industry that one of the major concerns was we have to do everything ourselves. it's our proprietary information. we're not going to share it with others. you don't see that anymore. there's not a drug that gets developed today that hasn't been developed by somebody, cross licensed with somebody else. there is that collaboration. so i think the movement is under foot. we just have to provide the framework that encourages it to happen so that we can indeed get these 21st century gears to the public much sooner than we currently do. i think it is all there, but collaboration is clearly the key. >> thank you.

good morning. thank you congressman upton and all might have colleagues focused on 21st century cures efforts. and to our expert panel, thank you for taking the time to be here. since this effort was launched, i've been hearing a great deal from academic research institutes across the state of florida, our great researchers at the moffitt cancer center, the robust and growing biomedical field in florida. and their top issue is congress provides sustained funding to the nih. that is the number one. when you begin to talk about what the congress should be doing. that is number one. it is followed closely on the shortage of physician residents and these young scientists. i've heard some great ideas here today but we have this issue, as well, with how medicare pays for

physician residents and there is a shortage in a number of states. we were supposed to go and look at nationwide the health workforce an we haven't done that yet. i think hopefully it could be incorporated into what we're doing. i'd like to follow on the last exchange on the biomarkers. because what i'm hearing at home after mapping of the human genome is that, boy, here comes some very cost-effective tests through biomarkers and others that would be -- they would give folks quicker information that they need on their health, they would be a substitute for a very expensive invasive type of test, and the folks want to know, well, why when we get these approved do i have to go back to cms and start all over again to

get something approved for medicare to pay for or, is this a problem that you all are hearing about? maybe you can talk about that. there seems to be these emerging cost-effective tests out there that would help us save money down the road and give patients quicker answers. >> well, thank you very much for that question. i think it is a really important issue and i think we're in the middle of three revolutions. when the genomics revolution, et cetera, when the big data revolution and then we're in the middle of a health care revolution. so i think i like to answer your question with two sort of two answers. one is that i think in terms of public and private partnerships,

i think we need to enhance the richness and the potential and the attractiveness of the data that the federal government provides to pharmaceutical partnerships by providing a coalesce data set of all clinical trials that are federally supported. that will make mining that day is a data set by companies and in the examples that dr. collins made would make the cooperation with the federal government a lot more attractive. that's how we can enhance things in terms of basically biomarker work, as well as industry government partnerships. the other issue that would facilitate these biomarkers is, as i was saying earlier, is to support often the smaller companies that cannot really afford to do clinical trials with biomarkers by expanding the coverage with evidence developed by the cd program and hhs. that's a good way to potentially

cover some of these biomarkers as we're gaining the knowledge through registries to see if they're effective. and also, as you probably know, moffitt has the concept total cancer care. we are about to launch a joint venture with them. so the concept that moving those kind of biomarkers through the orion system or the total cancer care where there is these large consortium that we'll all push together for the discovery markers, then the validation of that in these large data set. it comes down to really managing and leveraging big data across multiple institutions to not only develop new biomarkers but also to volume date them. -- validate them. part of that is the coverage

with evidence development. if that could be expanded, that would help a lot. as well as supporting a central repository for all federally funded clinical trials. that would also be a boon to industry partnerships and making those very attractive. thank you. >> bill cassidy. >> first, let me just thank you all for your good work. i am struck though, i think it is a little ironic because i think congress has created a lot of problems that we have here, at least the federal government has.

i'm struck, the 3% tax you speak of is obviously part of the affordable care act. an example. now i guess i have two questions. but along that theme. i'm a fellow that formerly did clinical research. i have gone through those 40-page documents. we wrote ours at 6th grade, not 8th grade. i was always told it was the office of human research protection which is part of hhs that required this. whenever i asked about centralized irb, i was always told, no, wait a second, we're required to have a local representative. although i know there is a central irb in denver, for whatever reason, my institution did not allow that because they felt like the federal government required. i'm looking at you, dr. hamburg, even though it is not under your office, fda is still involved with that. the first question, that 40-page document i've always been told is because washington, d.c. said you had to have it. secondly, dr. collins, you and i have spoken about this in committee but there is a report coming out of -- we've spoken out about nih needs more funding but there is an article out of ucsf, speaking about how there is a very poor correlation in nih funding between disease burden, however defined, and where nih puts its money. now this fellow wrote -- and he

said ten years ago this was a critique but as he reviewed data ten years after that, there had been no change. i think your interpretation has a little bit of wiggle room if terms of moving dollars around but what i'm most familiar with at cdc, at one point they were spending a billion on hiv and like $60,000 on hepatitis. even though the number of deaths related to liver disease was at least as great as that of hiv and disease burden was even greater. so there seems to be a really lousy correlation between where we're spending our dollar and disease burden. so two questions. one, have we met the enemy and he is us when it comes to the complexity of getting clinical trials approved. and secondly, to what degree is our federal agencies not taking this scarce dollar we have and moving it to things like alzheimer's dementia, neurologic diseases when that is our balloon note, if you will, away from things that, frankly, we've had a lot of success with.

>> first, i think that you have raised a set of really important issues that we're all working on and certainly frances and i have spent a lot of time discussing the value of central irbs and, more broadly, the importance of reducing the time, cost and cumbersomeness of doing clinical trials in this country. anything we can do to reduce that and make clinical trials more accessible to patients -- because that is another barrier to advancing clinical trials and ultimately the delivery of opportunity in science into a real world product. so i think that this is a really important issue. i think it is one that ultimately this effort, the 21st century cures, will likely take

on in some way or another. i applaud that. i think that it is an area where it has to be done right but where there are things that congress can do to actually make the situation better, not worse. big picture. there are many others than fda that need to be engaged in that discussion and you're right that there is a critical office in hhs that's involved in this. but work has been done. work needs to continue to be done but i think we're ready to do some things that will make a difference. on a much smaller scale with respect to fda, there's something that congress could do very quickly that i think would enable clinical trials in the device area to be more efficient and effective, and that is that the food, drug and cosmetic act actually has a requirement in it right now that mandates review of a clinical trial on a device by a local irb. and we think that if that could be amended and i think it is a

pretty simple fix, we could do some good. >> done. done. francis, go ahead. >> congressman, appreciate both of those questions. about what peggy said about human subjects review, there has been an effort under way now for about five years to revise the common rule and particularly to emphasize the need for central irbs instead of having every institution in a multi-site trial have their own irb tinkering with the consent form, adding another paragraph, changing the tense of the verb and all of that stuff that ends up costing you oftentimes a year of time and a lot of pages that get generated along the way. it is irrational. we need to stop in whole approach. actually nci, the cancer institute, for their large-scale cancer clinical trials is now using central irbs. there were some objections to that from institutions who were afraid they would be liable if their irb hadn't approved it, but those had been largely overcome.

we can do this and i appreciate you raising the issue. in terms of the correlation between funding support and specific diseases, we look at that a lot. that's certainly one of the jobs that i and the 27 institute and center directors at nih talk about almost every week when we gather around the table. actually, if you look at the current plot -- i'd be glad to send it to you -- it is not that wildly out of whack from what you might think. if you look at various measures of disease, whether you're talking about deaths or whether you're talking about such things as dailies and qualis, quality of life and disability, actually that curve is a reasonable approximation to what you might think would make sense from a public health perspective with a couple of outliers like aids. [ inaudible ]

>> i'm saying aids is an outlier in that graph. but i think there's scientific reasons why that has been the case, namely that this is not just a disease of this country, it is a threat to the entire global circumstance. [ inaudible ] >> thank you. your relative funding of alzheimer's relative to that is miniscule. again, my dad dies of it. we all have a parent. i got to say, when i look at your funding for alzheimer's, it seems miniscule relative to the disease burden and the future expense, the near future expense to medicare, medicaid, et cetera. >> i'm deeply concerned about alzheimer's, congressman. actually i spent some of my own personal efforts in an adjustment in the way our current portfolio supports that research because this is clearly a major threat to the future of

our nation and the world and an enormous burden upon individuals and their families who are stricken with this disease. there's probably nobody in this room that has not been touched by that. i take your point that we need to see that as a particularly high priority right now and that has been in fact what we have been trying to do at nih over the last two or three years. the other thing that i want to say without taking up too much more time, we have to be careful with the way in which science has developed over the last four or five years, particularly coming from the insights from the genome. we discover there are connections between diseases that we never knew about. it would not surprise me if the next breakthrough we are really waiting for in alzheimer's disease came from a researcher who at present time we would not say is working on that disease but is working on some other area. these connections between pathways continually surprise us so i think we do have to be careful not to be so targeted that we miss out on the unexpected where somebody working in one field actually comes up with -- >> except the billion dollars spent on aids has paid great

dividends. targeted research cannot be replaced with serendipity. some of us were hoping for serendipity. >> i think targeted research is critical when we can see a pathway toward finding a cure for a disease. but serendipity is one of the reasons america has been so successful for past 50 years. >> i want to thank all the members of the panel. you've done a fantastic job. i do apologize for coming in a little bit late and missing an important aspect of it. this 21st century cures initiative and these roundtable discussions i think have been absolutely invaluable.

there are a number of physicians of course on our committee. there are a number of people on our committee that have knowledge far beyond my limited medical knowledge, but it has been a great effort as we go forward in the 21st century. dr. hamburg, i'm going to address my question to you. representative green, my colleague on the committee from texas, and the co-author of the gain act, we are now, of course, as you know, working on the adapt act to take that a step further for limited population and antibacterial drugs. he diverted his question back to dr. collins so you didn't get a chance to discuss that but i would like you to spend a little bit of time talking about the adapt act and what that model maybe can be an example for other efforts in bringing other

drugs to market and medical devices in these highly specialized need areas, resistant antibiotics, limited populations. >> well, thank you for the question and thank you for your leadership on the critical issue of how can we ensure an adequate pipeline in terms of new drug development in the antibiotic arena which is ever more important as we are seeing drug distance spread. i think dr. collins did address a significant part of why the gain act was important in terms of needing to create new focus and incentives for drug development in this area. it has been a hard area in terms of companies wanting to really invest because market forces

don't make it just irresistible in terms of return on investment, especially when you have to take risks. i have to be honest and say that fda didn't make it irresistible either because we were really asking for very elaborate, large clinical trials that were timely, costly, and hard to recruit patients for all the reasons that we talk -- that dr. collins mentioned in terms of the complexity of doing these studies and being able to have the clinical trial ready to go when the patient appears sometimes deathly little with an infection that needs to be treated. so i think what we're trying to think about now is how especially in the context of antimicrobial resistance which is such an urgent problem.

how can we really design regulatory pathways that enable us to get meaningful answers as quickly as possible and reduce the risk for developers. a sort of special population approach enables us to sort of look at the highest risk end of a spectrum of patients that might be treated and really narrow the focus so that we can ask and answer questions where the risk/benefit falls out as quickly as possible and enables us to move forward more clearly, more swiftly. i think that's what we're really thinking about there. it applies in antimicrobial resistance in new microbial -- antimicrobial development. it applies in other areas that are important to public health as well, including a very heterogeneous disease category like obesity where if you can sort of narrow the indication, the development process can actually be sped.

>> joe barton. >> mr. chairman? >> he's brought his own expert with him. >> yeah. i didn't think we had enough firepower here with the head of nih and hhs and one of the billionaires who's put a lot of money into medical research. so i brought my own -- this is my volunteer staff assistant. dr. yamamoto, vice chancellor for research at university of california san francisco who calls dr. hamburg peggy. he said oh, peggy's down there. i want to go say hi to peggy. we were meeting -- >> you can call me peggy, too. >> but i am very impressed, mr. chairman, with the panel you've put together today. obviously to have these eminences here is just amazing. my question is going to be very similar to mr. pitts' but with a little different twist. we brought the deficit down from

$1.5 trillion to $.5 trillion, but it's still a half a trillion. with all the good intentions in the world, we've -- and i've introduced nih reform bills and doubled the funding of ni h-back in the gingrich era. i introduced authorization bill that increased funding for nih every year. but the reality is that you're going to get what you get, plus a little bit. that's just -- so given that, i want to ask mr. milken, is there anything we can do to incentivize the private sector to give more, to match some sort of a special tax break for medical research or perhaps even some sort of a government match if the private sector puts up so much, the government will match it dollar for dollar, or maybe one for two or something.

because we obviously -- and i think the chairman is with me on this. in a perfect world, we'd want an increase across the board. but in the real world, we're going to have to find ways to do better with what we have right now. so are there some things we could do next year in terms of giving incentives to the private sector that might actually result in measurable increases in private funding in these areas? >> thank you. i want to thank you for your work that you do. i'm excited to see my good friend, keith yamamoto with you today. as he is aware, there are a number of efforts right now on the potential for match. where you would go to private citizens, foundations, corporations, and the government would challenge them by offering to put up a dollar if they were matched for a dollar in the

philanthropy standpoint. one of the things, there are other countries in the world that allow you to have a higher deduction if you give money to medical research or bioscience. in the united states today, you are limited on your deductions to 30%. of your income for public foundations and 20% for private. in some countries they allow you to have a tax deduction of 50% if it is for medical research, science, et cetera. so i think as we saw in the efforts in acid rain and so2, that you can create incentives that would direct funds accordingly. one of the risks we run, i think we're all aware of, is that a number of the people who have accumulated grant wealth are not

as focused on inheritance taxes because they're planning to give their money when they pass away to foundations. and the opportunity to accelerate that. one example i might give you is, iras and 401(k)s, but particularly iras today when you're 70 1/2 you begin to drawn money out of those iras and are potentially taxed. i think many people, if forded the opportunity to give money to charity now, instead of wasting -- waiting 20 years or ten years, would give the money in their iras and 401ks. there was an experiment that was tried a few years ago where you could give up to $100,000 without tax out of your iras. it ran for two years and i think $140 million was given. but if you took the limit of $100,000 off and tried it for a couple years, you might be

surprised how much of private sector money is willing to go. and if you decided it needed to go into a medical philanthropy or whatever the decisions were, i think you could tap that. and if you decided it needed to go into a medical philanthropy or whatever the decisions were, i think you could tap that. third, i think today the issue of young scientists. i think if we had a formal program initiated, you would have a lot of funding from individuals, whether it's through their own academic institutions that they felt loyalty or they went to, to support these young scientists. we have spoken to dr. collins and also commissioner hamburg about the possibility through their private foundations could we help augment the funding. many years ago, i was touring

the nih and saw a young scientist. there wasn't going to be funding for the scientist and sent a collection to the nih to cover the funding for that scientist. nine months later, they figured out how to cash the check but told us not to ever do that again. and i told them there was another agency, the irs, that -- >> it's no good, it bounced. >> but they're getting better as dr. collins said. but i think we have not appealed to the american public enough to incentivize them. we see initiatives such as recently with als, and putting an ice bucket on your head, they raised $100 million and they used to raise two. in the area of men's cancers, the growing of a mustache in november, called movember worldwide now raises $150

million a year. so how do you communicate? and one of the challenges has been how do you get small amounts of money from larges numbers of people? and this has been a challenge and companies like safeway through their checkout program probably have raised a half a billion dollars for different diseases, breast cancer, prostate cancer, muscular dystrophy and others. average donation, $2. if you sent a check in to a medical research fountain, it probably costs us $15 to process it. notify it, et cetera. and so these other mechanisms which safeway did at the check out counter, rounding up, allow you to get millions of people involved with small contributions. and i think you can through some policy changes, run some tests here and maybe run them for a

year or two and see what happens. i think the risk is in an area i spoke of early, scoring. they're going to tell you that it's going to cost, you know, billions of dollars in future taxes in the next 40 years. but i come back to the statement that 50% of all economic growth has come from advances in extension of life and increasing the quality of life. and i think by accelerating the giving, we have young people in our country today that are in their 20s, that are worth $30 billion. should they wait until they're 70 or 80 years old? or should we try to tap in to both their intellect and their funds today by incentivizing it on a present value basis to support it today. so i think there's a number of areas that we could test. there's trillions of dollars in

these iras. should we wait, if you wait until you pass away, you can give it to your foundation tax free. no estate tax. why don't we encourage them today to participate? so i think there's a number of things we can do with private industry. i think there's another factor. we have surveyed cancer patients, we have set up so many regulations, and collection of data and accessing of data. we are protecting people that don't want to be protected. 600 million people on this planet go to facebook every day. they put information and secrets up online that anyone in the world can access that you can't even believe that they're saying that or putting it up on their website. more than 70% of all cancer survivors would be willing to make all their data public, all

their tests public, so that any graduate, ph.d. m.d. student, could access that data. how do you waive hipaa? how do you give up these rights to protect information you don't want to protect? i think there's a lot of work that could be done in data collection. when i was at berkeley in the 1960s and was focused on how do we access capital for small and medium businesses, as a student with little to no money, i was able to access free, the chris tapes which summarized financial transactions and markets, under the guidance of the university of chicago covering the previous 50 years at no cost. to try to create these data sets sometimes could cost $100 million. who has access to this data? we could provide enormous data, but i do think one of the elements is, how do you waive your privacy rights if you don't want that privacy?

>> that buzzer means that's 12:00. we're going to have a hard stop at 12:00 so we are. i want to really thank, you know, it's really thank everybody here that was involved in the thoughtful discussion. not only today, but in recent months as well. your ideas have in fact triggered us to move. i want to commend our staff. that's really -- [ applause ] but we're not done. this is the last formal meeting, you know, this month. we have another session, i think, next week, but during the next couple of weeks, i know this weekend i'm going to oregon and washington state and we're going to have an event in kalamazoo. i think there's going to be an

event or two in texas and florida and other states. i encourage our members to reach out and to continue to listen because when we do come back, we're going to start writing, we're going to try to do our best to do it right. as i said at the beginning, our goal is to move this early next year. have a draft proposal done early next year, and in all likelihood it won't be done this year. i don't want to set that. so we'll miss you dr. gingrich, because he's retiring from the congress. and some others, mr. waxman and others, but the ideas need to come in because we really do want to do this right. and lots of shoulders, we're going to be leaning on to make sure that it happens and we're most grateful for the administration's support too. peggy, you've done a good job, you realize constructively where

we need to go. silva burwell today, again, confirmed that the administration's support for this, reaching out to the senate, dr. collins has been a superstar not only in this room but traveling in different parts of the country, as well. and michael, your work again, we stole a lot from you over the last couple of years and just outstanding work that you have done and committed in the foundation and the organization that you have has truly helped us. great entrepreneurs bill parfitt and dean cameron, thank you for your work and two weeks ago in colorado, but now, we're very grateful for that assistance and we're going to turn the green light on in this green room. thank you. [ applause ]

in 2012, democrat cheri bustos defeated incumbent republican congressman bobby schilling in the 17th district

of illinois. this year he's challenging her to win the seat back. the two debated last week. here's a few minutes. >> congress as we start to close this debate we're starting with you cheri bustos. congress is to face more fiscal cliffs in the coming months. do you support an increase in the debt limit? and should sequestration cuts be permanent? >> my very first act in congress, my very first bill that i introduced is -- attacks government waste and abuse. and not in a small way. it identified $200 billion in wasteful government spending. i think that's the place we need to start before we do anything. my opponent voted not once, but twice, to end the medicare guarantee. that -- so that's looking at

balancing the budget on the backs of seniors in my opinion. where would cost seniors each $6,000 in out-of-pocket expenses. that's not the way we need to attack the budget problems that we have. on top of that, sequestration is a very, very dangerous place to go. my opponent voted for that. here's why. that impacted this economy right here in this area by $100 million. we had workers out at our arsenal who had to take paychecks home that were less than they're used to taking home. who their take-home pay was worse, they had to take time off, forced time off. and that's the vote that he cast for our number one employer in this area. >> mr. schilling? >> i find this very interesting because, the congresswoman went to washington, d.c. said that she was going to end the gridlock, dysfunction, and the very first opportunity that she got she voted no on all six budgets. and you know, when you go to congress, you've got to be able to compromise. our congress never had a

government shutdown. and the thing is that the big difference between the two of us is when i make promises to the people of the district, i kept every single one of them. the incoming congresswoman had promised to forego her pay during the government shutdown. we did some research and found out that she didn't do that. i think the key thing what we have to do at all costs is to try to avoid sequestration. there is so much waste out there that we could go and capture and we don't need to go in and start cutting our military so far back to where we can't defend our freedom as the united states of america. >> c-span's campaign 2014 is bringing you more than 100 debates for the control of congress. stay in touch with our coverage and engage, follow us on twitter @c-span and like us @facebook.com/cspan. tonight on c-span 3, selections from the homeland security and the airline pilots association conference. these annual events look at a host of issues including cyber security, surveillance programs,

space travel. it gets underway at 8:00 p.m. eastern. the house oversight committee last month looked at security and privacy on the online exchanges americans used to buy health insurance under the affordable care act. the administrator for medicare and medicaid testified that almost 7.5 million people have used the exchanges to sign up for insurance. >> the committee will come to order. without objection the chair is authorized to declare a recess of the committee at any time. the oversight committee exists to secure two fundamental principles. first, americans have a right to know that the money washington takes from them is well spent. second, americans determine efficient effective government that works for them. our duty on the oversight and government reform committee is to protect the rights. our solemn responsibility is to hold government, government

accountable to taxpayers, because taxpayers have a right to know what they get from their government. it's our job to work tirelessly in partnership with citizen watchdogs to deliver the facts to the american people, and bring genuine reform to the federal bureaucracy. over the past four years, the oversight and government reform committee conducted vigorous oversight of the implementation of the affordable care act called obamacare including the design and launch of healthcare.gov. today the committee focuses on the interconnected issues of security of the website and accountability within the administration and most of all transparency to the american people. the government accountability office released a report this week on security of healthcare.gov.

the gao found the administration failed to take appropriate and sufficient steps to protect healthcare.gov and associated systems against security and privacy risks. more importantly the gao reported strong -- report strongly asserts that security testing is not complete and security weaknesses continue to plague the website. one of the principle authors of the gao report will testify before us today. the committee released a report detailing several break downs in both accountability within the administration and transparency to the american people during the design and implementation of healthcare.gov. it is important to understand that with private sector high profile losses of information due to hackers, there huge repercussions to the companies and the government often comes

in and further victimizes the companies who have in fact been victimized by hackers. when the government fails to protect involuntarily taken personally identifiable information, there is nobody but people on this dais to try to hold government accountable. documents obtained show factions developed within the agency in charge of implementing obamacare, the center for medicare and medicaid services or cms, these factions fought over several issues including over website security. cms offense fought to keep information from their colleagues within the larger department of health and human services and additionally the administration endeavored to keep the truth and the true

nature of the website's problems out of the public eye. following the collapse of healthcare.gov, administration officials refused to admit to the public that the website was not on track to launch without significant functionality problems and substantial security risks. last month, cms denied the associated press access to security documents requested under the freedom of information act. even more recently, cms refused to provide the government accountability office documents related to the 13 incidents that we are going to hear about in vague detail here today. i want to make something very clear. refusal to cooperate with the gao, a nonpartisan government

created entity, refusal to allow access by the whistle-blowers under freedom of informationability, and refusal to cooperate with even the inspectors general, something we saw here just a few days ago, with 47 inspector generals out of 73 complaining with a lack of access, even within the executive branch, this is not the most transparent administration in history, and certainly the transparency we see here today was only done under subpoena. we will probably hear today that cms has offered to reach out on these 13 incidents. it is not acceptable after the public scrutiny reveals that they exist, and they've been denied, on the eve of a hearing, and only after an audit is completed, to then say we'd be glad to brief you. that's unacceptable. and quite frankly, one of the most disingenuous things i've ever seen. there were five months during the audit to comply with a

reasonable request by the general accountability office and it wasn't done. questions of security can no longer be easily dismissed by the administration. in late july healthcare.gov suffered a malicious attack from a hacker and it took nearly two months for cms to identify the intrusion. cms as mr. er marilyn tavenner who is with us today will testify and we will discuss that in addition to the gao report. i'm sure we will hear that there was no loss of data that this was not the main site and so on. that doesn't change the fact that security risk exists whenever you fail to secure, not just the main site, but back doors. too often back doors have been what we've discovered. in the case of another

investigation to this committee, we discovered that the back doors were something as simple in one case as a stolen laptop on which those who stole it later added peer-to-peer software, which then made information on that database available to the public, potentially. the federal trade commission opened an investigation and a plaintiff's trial lawyer sued and won money on behalf of people whose information was never actually released, but in fact both the government and plaintiff's bars thoroughly enjoyed going after a nonprofit aids clinic. i cannot and will not allow the government to put itself at a different standard of accountability. last month the center for medicare and medicaid services informed the committee that once again there were lost e-mails in response to the committee's subpoena and documents relative to healthcare.gov. this is not an uncommon pattern. this is a pattern of predictability. this administration has not complied with nor caused their key executives, including political appointees, to comply

with the federal records act. administrator tavenner admitted to deleting her own e-mails during the time period of obamacare implementation. madam, your actions hinder congress' investigation, and also prevent the public from accessing information under the freedom of information act. it appears as though this administration holds itself to a different level of compliance with historic federal documents and the last administration or any administration since the passage. we are also today joined by the department of homeland security u.s. computer emergency readiness tell or cert. the committee has concerns about the team's transparency reported earlier this month. the administration has already spent a billion dollars on a website that is still not fully

operational, and fully not secure. the same government officials responsible for the lack of transparency and accountability a year ago remain in the position of authority. questions of security, accountability and transparency go beyond whether or not you support the president's health care law. many of these issues are not limited to health care and mirror the transparency and accountability concerns raised again by 47 out of 73 inspector generals in an unprecedented letter to this and other committees of congress in august. minutes before hhs announced publicly on september 4th that healthcare.gov had experienced a malicious attack in july of this year, an hhs official contacted my office to give them limited details of the successful hack.

during the brief call hhs gave my staff the name and phone number of a contact at the department of homeland security, and suggested my staff contact dhs for more information about the hack itself and the government's response to the hack. my staff reached out to hhs's suggested contact at dhs on monday of last week. followed up on tuesday, and were told that dhs was running, parentheses, the request, back with hhs to see if we can all jointly get on the phone, seeing if -- seeing if tomorrow will work. however my staff followed up on wednesday and friday and then on monday and tuesday with no response from dhs. i would like to note that despite a week of persistent e-mails from my staff, dhs was unable to make time to brief our committee even by phone. however, two days ago, the minority staff notified me that

they were asking for our witness today to appear as a witness at today's hearing. i accepted it even though clearly this is a witness from an organization that has refused to answer questions or cooperate with the investigation. the minority staff reached out to see if dhs would appear as a witness. they were able to prepare in detail testimony before this hearing today. however dhs has still not arranged to properly brief our staff or to answer questions that we will be asking here today. i would like to introduce into the record at this time the correspondence between the staff and dhs as an example of what appears to be a very different treatment from this administration to a request from the majority staff, versus a request from the minority staff. without objection it will be

placed in the record. let's cut to the chase. i have with me three witnesses. two very clearly are not part of transparentsy in government. i have no doubt that your organizations have worked diligently with the minority to try to make this hearing good for you. it is not our job to try to make the hearing bad for you, but the american people deserve the truth, not a cozy relationship between the people of your president's party in covering up the ongoing failure to secure a website that cost over a billion dollars. with that i'm pleased to recognize the ranking member for his opening statement. >> thank you very much. first of all i want to apologize for running late. the speaker asked us to be at a joint session of congress to hear the president of the ukraine. and many of us were there. one of our most important jobs in congress is to help protect

the interests of the american people. they demand a government and private companies safeguard their personal information. safeguard their social security numbers. their credit cards, and their health information. nobody wants to get a call from a credit card company saying your personal information has been compromised. it can upend your entire life and it can cause serious financial problems for years. i believe they have the potential to perform a valuable function in the area. with our extremely broad jurisdiction over multiple federal agencies and entities, you can promote robust standards across the entire government and private sector. to date, however, we have not fulfilled this potential. today's hearing is our 29th on

the affordable care act, and our sixth on healthcare.gov. i completely agree that the aca website must be secure. that is why i'm so hardened that despite all of the challenges with the roll out last year, nobody's personal information has been compromised to date as a result of a malicious attack. nobody's. personal information has been compromised to date as a result of a malicious attack. now, that could change. so we have to remain vigilant after all, this is our watch. so far no attacks have been successful in that regard. there certainly have been attempts. last week the centers for medicare and medicaid services reported that hackers uploaded malware onto a server. there are several key facts to

know about the attack. first, it was not directed at healthcare.gov alone. but a much wider universe of targets. second, the server that was attacked was a test server and had no personal information on it. third, the most important, nobody's personal information was compromised as a result. that incident was investigated by the united states computer emergency readiness team into the department of homeland security. the rest of that team entered written testimony for today and reports and i quote, there is no indication that any data was compromised as a result of this intrusion, end of quote. although our committee has spent a tremendous amount of time focusing on the affordable care act and its website, no cyber

attacks have compromised anyone's personal information to date, we've been disregarding much more serious attacks that have actually compromised a massive amount of personal information. of our constituents. we are talking about hundreds of millions of people. hundreds of millions. for example on january 14th, more than eight months ago, i sent a letter requesting a bipartisan hearing with senior officials from target. as i wrote, up to 110 million americans were subjected to one of the most massive information technology breaches in history when their credit, debit and

other personal information reportedly was compromised, end of quote. on september 9th, i sent a letter requesting a bipartisan hearing on a major data security breach at community health systems, the nation's largest for-profit hospital chain. i explained that, quote, hackers broke in to its computers and stole data on 4.5 million patients, end of quote. as i noted, this was, quote, the largest hacking-related health information breach ever reported. end of quote. on september 11th i sent a letter requesting a bipartisan hearing to examine the recent security breach at home depot, where our constituents shop. i explained that home depot, quote, has more stores in the united states and a higher total annual sales volume than target. end of quote. and, quote, it appears to have experienced a data security breach for a longer period of time than the data security breach that occurred at target.

end of quote. and just this monday i sent a letter requesting a deposition with the ceo of usis, the company that conducts more background checks for the government than any other contractor, and which had its own breach this summer. and i wrote, and i quote, although press accounts have reported that the attack may have compromised the personal information of up to 27,000 federal employees, government cybersecurity experts now believe this number is a floor, not a ceiling. end of quote. i'm talking about the people who work on capitol hill. i'm talking about the people who work for the federal government. up to possibly 27,000. in response i received a letter back from the chairman yesterday, thanking me for my request over the past year, and

acknowledging, and i quote, these serious incidents merit further review. end of quote. chairman, i thank you for that. i hope we can start on this right away. after all, these are our constituents. let me close by highlighting that this is much broader than healthcare.gov. much broader. represented here today warn that the number of cyber attacks is increasing against target, across the federal government. obviously the same is true of the private sector. so oversight is certainly called for and i hope our committee seizes the opportunity and rises to the challenge. with that i yield back. >> i thank the gentlemen. at this time we would like to place on the record examples of state attorneys generals prosecution and relief on private sector and even public

sector entities, and the history of their going after entities for financial damages that allowed breaches. without objection, so ordered. >> mr. chairman, can i get a copy of that? >> we'll make copies available to all of you. it's all public information. and we did both include your massachusetts attorney general, vermont's attorney general, and maryland attorney general's actions on behalf of your constituents. >> i appreciate that. thank you. >> members may have seven days in which to submit opening statements for the record. we now welcome our witnesses. mr. gregory wilshusen is the director of information security issues at the government accountability office. and the subject obviously of some frustration before he got here today. miss marilyn tavenner is the

administrator for the center for medicare and medicaid services at the department of health and human services, hereafter called cms today. miss ann barron-decamillo is the director of the u.s. computer emergency readiness team at the department of homeland security. here after culled cert. according to committee rules all members are to be sworn. will you rise and raise your right hand. do you solemnly swear or affirm that the testimony you're about to give today will be the truth, the whole truth, and nothing but the truth? please be seated. let the record reflect that all witnesses answered in the affirmative. in order to allow sufficient time for your panel and what i suspect will be a robust series of questions, i would ask that you limit your opening statement to five minutes although your entire statements including the additional information that you may want to make available will be placed in the record.

mr. -- you know what happened, without my talking point it's really hard. mr. wilshusen, please continue. >> thank you, mr. chairman. chairman issa, ranking member cummings and members of the committee. i am pleased to be here as you examine the implementation of the patient protection and affordable care act. as you know the act requires the establishment of a health insurance market place to assist consumers and small businesses in comparing, selecting and enrolling in health benefit plans offered by participating, private insurers. cms is responsible for creating a federal marketplace for states that do not establish their own. this is supported by an array of systems including healthcare.gov the website that provides the consumer portal to the marketplace. my statement today will summarize the key findings from our recently issued work on the security and privacy protections of the systems supporting healthcare.gov. but before i proceed, mr. chairman, if i may, i would

like to recognize several members of my team who were instrumental in protecting and performing this work. with me today is john defer arie, marysol cruz, justin polk and mark kantor. in addition members from e-security lab also participated. lon chen, wes coyle, doug nell and michael stevens. >> could you all please stand so that we can at least for a moment realize your contribution? thank you. you may continue. >> thank you. healthcare.gov related systems, including the core systems of the federally facilitated marketplace, and federal data services hub, represent a complex system that interconnects a broad range of federal agency systems. state agencies, and their systems, and other entities such as contractors and issuers of health plans. the complexity and interconnectivity inherently introduces risk. assuring the security of such a

system poses a significant challenge. to meet that, cms has undertaken a number of activities to enhance the security and privacy of systems supporting healthcare.gov. for example cms has developed document security related policies and procedures. it's developed a process for remediating and identifying security weaknesses. cms also created interconnection security agreements with the federal agencies with which it exchanges information. and it instituted certain required privacy protections such as notifying the public of the types of information that will be maintained in the system. however cms did not fully or effectively implement key technical security controls to sufficiently safe if guard the confidentiality, integrity and availability of the federally facilitated marketplace and its information. for example, cms did not always require or enforce strong password control, did not sufficiently restrict systems

from accessing the internet, and did not consistently implement patches in a timely manner. cms also had shortcomings of its information security privacy management programs. for example, system security plans for the federal facilitated marketplace and data hub generally contained most required information. but each plan was missing key security information. cms had also undertaken a series of security-related testing activities that began in 2012. yet these control assessments did not fully identify and test all relevant controls prior to deploying the systems. in addition, cms did not fully assess privacy risk, and the privacy impact assessments, and had not fully established an alternate processing site for healthcare.gov systems to ensure that they could be recovered in the event of a disruption or disaster. to assist cms we made six

recommendations addressing the shortcomings with the information security and privacy program. and 22 recommendations to resolve technical security weaknesses related to access controls and configuration management. cms concurred or partially concurred with all 28 recommendations and noted that it was taking actions to address each of them. in conclusion, while cms has taken important steps to apply security and privatesy safeguards to healthcare.gov and its supporting systems, weaknesses remain that put these systems and the sensitive personal information they contain at an increased and unnecessary risk of compromise. mr. chairman, ranking member cummings, and members of this committee this concludes my opening statement. i'd be happy to answer your questions. >> thank you. mrs. tavenner? thank you. >> mr. chairman issa, ranking

member cummings, members of the committee, thank you for the opportunity to be here today and i want to make everyone aware that cms strives to be as responsive as possible. i understand we have provided over 140,000 pages of documents to this committee. transparency is important and that's why i am pleased to be here today and have the opportunity to answer your questions, and we will continue to produce documents. in the almost five years that i've had the privilege to work at cms, my focus has been on how we can best serve our beneficiaries, including seniors on medicare, adults and children on medicaid, and consumers enrolling in the marketplace. when i come to work each day, i work to expand coverage and competition, reduce cost, improve quality in ways that make a difference in people's lives. we are making real and important progress. as of august 15th this year, we have 7.3 million americans enrolled in the health insurance marketplace coverage. these are individuals who paid their premiums. we are encouraged by the numbers of consumers who've paid their