host: do you have numbers on that diversity? guest: i don't have individual diversity numbers, because the groups themselves don't typically keep that sort of information. what i was going to tell you there was a pullout last fall by gallup, the first real, meaningful poll data, 30,000 college students surveyed, what it demonstrated was that at five different facets of life joining a fraternity or sorority had a meaningful difference in the quality of life that you enjoyed long-term, be it financial, more likely to finish your college education, more likely to be actively -- academically engaged, more likely to be engaged as a community leader or volunteer. more likely to enjoy your work in your everyday experience. we are focused on that, that is one of the reason fraternity and

sorority membership is at an all-time high. there are folks that focus on this generation being lost in their ipads, phone, texting, the reality is there is a store nearly -- a store and or a demand for fraternities and sorties, because they provide an opportunity for students to grow and learn in a context that does not otherwise exist on campus. host: bart fraternities -- i am not ruling out a lawsuit said stephen jones, a lawyer hired by the sigma alpha epsilon chapter. we are wanting -- seeking someone other resolution to the matter in the face of the closing of that chapter being kicked off cap -- campus. two of the members being kicked off schools. independent line. guest: caller: a lot of these

campuses are microcosm of our country as a whole. to hear that someone has made a racial slur, it does not surprise me, it happens every day, whether it is publicly noted or not. i do not know why anyone is surprised. i know strides are being taken to have more diversity but, on campuses, you have black sororities and you have white sororities. the university of maryland, i don't think there's one black sorority. it does not surprise me, and it should not surprise anyone that racial slurs and stuff like this happen. it happens everyday. host: in today's "new york times," says the racist video is a window into a huge problem at fraternities on college campuses. he says greek life on campus is worth preserving, but before the next shocking video, schools must confront the inequality

that the greek system has managed to preserve. guest: there is probably a reason i use the "new york times" to read my fish every morning. i disagree strenuously. they provide minimum and for people to live and work together in a variety of contexts. for most of the 700,000 members spread across 12,000 chapters and more than 800 campuses, they are getting a chance to be involved in a diverse community that maybe they didn't have before in high school or growing up. i think they are part of the solution, this is the most diverse generation ever. the instances of racism they face remain challenging, that they have made significant strides over prior generations. this generation of students has said, like their fathers, they want to be part of the solution, fraternities and sororities are active in working in social justice issues every day.

that is especially true for african-american fraternities and sororities, which were founded to help that first generation of college graduates go back, get back, to those communities and help them move forward. host: flower mound, texas i'm a democrat line, george's waiting. -- george is waiting. caller: i have a different opinion about the chapter. we are eastern europeans. in eastern europe, soviet union, whatever, young students of organizations were very much dependent of the political life of the state. they were a submission of the government. here, i see an extreme -- here come a there is another extreme.

i don't know if this is that chapter prevents them from doing that. when they make mistakes or what is happened in oklahoma. which is clearly a bigger problem. when they make mistakes in taking an attitude, or political attitude that shows their concern for the future of this country, are there any limitations? host: are you saying you want to see more oversight of fraternities and sororities by outside groups? caller: yes, they have to show being more active in political life. guest: i think it is important glad to hear that you moved here

to the united states where we enjoy freedom of association and the opportunity to enjoy things like fraternities and sororities and exercise our right to be -- to be with people we want to be with an exercise our rights to free speech, usually means making people in the majority uncomfortable him otherwise that freedom of speech right without be worth very much at all. fraternities and sorties are highly regulated on college campuses. they are governed by state and federal law. we work together in partnership with the host institutions. they have professional staff who work closely with these organizations as they do with other student organizations. the vast majority of their activities are on file with the university oftentimes advance permission is required. most institutions would tell you that the vast majority of their leadership in other student organizations comes from members of fraternities and sororities. those tend to be the most engaged students, those folks

generally go on to have a much higher engagement in the political life and fabric of the united states then members that did not join fraternities and sororities. host: marilyn, independent line. you are on with kevin o'neill. go ahead. caller: i have three comments -- once you make about the kids. another to make about the fraternities in general and another about black people. those kids that -- they learned that once they joined the sorority, i don't know why they're trying to treat this as a racial incident, when the kids learn that song when they join their sorority. the africans that join the greek sorties, there are no black sorority, all of the sorties are

greek. i do not know why africans would want to join something greek and take it is progressive. in my opinion, about sororities, i look at them as men's colts -- cults. they do ritualistic practices that is based in satanism. host: i will let you respond. guest: let's take that in order there is no evidence at the university of oklahoma or any other case that any of these organizations are advocating or teaching their members to engage in acts that anyone would perceive as racist. that is a ridiculous assertion to make. you said there are no black sororities, i guess that is a misperception we can clear up quickly. there are nine predominantly

african-american fraternities and sororities all started around the beginning of the 20th century. they are all in the same association, many of the black fraternities, they have traditional african-american fraternities, and they are also members of the north american in a fraternity tousle. -- counsel. one of those sororities, delta sigma they are was just on capitol hill, they are couple thousand community leaders come to town. the vast majority of african-american members of congress are themselves alumni of one of those nine organizations. they are proud members and they think those organizations make a huge difference, not only in their communities, but in america as a whole. as for black magic and cu

lts, i do not think there is much to that. host: republican line in louisiana. caller: it is really sad that so many people are ill informed about what the greek system does. first of all it is a group of people that come together to live in unity any system stresses that fellowship, and also scholarship, and a community service. i was initiated into phi delta theta in 1968. i think it is so cool that the president of the phi delt chapter at okolona university --

oklahoma university is a really neat guy who happens to be black. opportunity chapters, they have their own unique personalities their own different -- the sae 's at ou screwed up, but that is not indicative of for trinity's and sororities at large. -- for turner these -- fraternities and sororities at large. host: one of our previous callers said that the more oversight of fraternities and sororities -- would you agree with that and -- if so how? caller: there is. at the university of arkansas,

they had behavior about three years ago, that chart -- that caused them to lose their charter. a national fraternity. they had to earn it back. it involved drinking. the national fraternities do have some very strict oversight. i would wager that sae, the national sae what have come down on these guys hard if president doran had not. guest: i want to make sure people understand that sigma alpha epsilon close that chapter at the university of oklahoma. independent of the president because of the accident -- because of the incident and they were not indicative of the organization. for trinity's and sororities had done a good job translating who they are, the largest value-based groups.

the largest providers of community service hours and expertise on college campuses today. the second largest landlord of college students housing a quarter of a million students across the country. and therefore reducing the tax burden on public universities that otherwise have to build facilities for those students. they are highly regulated. the reason we know that regulation is working is precisely because, when there is a problem, those problems are getting addressed. maybe privately, or in this case, publicly but there is an extraordinary accountability. i want to compare and contrast what is happening with university of oklahoma and at the university of virginia with other context. this is march madness this weekend, next weekend kicks off determined -- kicks off the tournament. you have had to members that

lost members of their team because of allegations of sexual assault. the universities did not close down the teams, they simply discipline the individuals. they do not discipline the women's track team because of what happened on the men's basketball team. but fraternities and sororities when these types of situations occur, a are being punished in a variety of fashions, not just as individuals, but the chapters are being closed, often by the impetus of the national organization. in the university virginia, thousands of students who were suspended by the university president for an allegation that eventually was proved meritless by an investigation i the "washington post," they were held accountable but something they had nothing to do with. most notable for that john, you had thousands of women leaders

sororities are the largest leadership organization for women on campus. they were held accountable and suspended for an allegation of sexual assault, which is a terrible message to send. host: pennsylvania is up next, line for democrats. caller: i'm sorry to hear you wrap your fish in the "new york times," but maybe that speaks to the gentle -- general intelligence level of fraternities and sororities. guest: maybe it does. i read it -- i read a great deal of publications. the caller is misinformed him and does not realize there is a strong correlation between the member of a fraternity and sorting and completing college. one of the reasons these host institutions are eager to partner with them. they help retain freshmen into

sophomore years and they a significant difference in making sure folks complete their college experience, earn that degree, and are capable of going out in the job market and getting a job that will help them pay the student debt they have incurred in the process. host: one of our colors but of a drinking issue at a fraternity i believe he said he attended, i want to run these numbers by you, this from a bloomberg story, 59 students died in incidents involving fraternities since 2005, that's 2005 to 2012, about half of them out of all related. i want to -- i what you to address the issue of drinking and wreaking deaths in fraternity houses -- drinking deaths. guest: the issue of alcohol on college campuses is complex. the government chose three decades ago to raise the drinking age to 21, and that has proved to be -- that has

transformed the way students use alcohol and are educated about it. before raising the drinking age it was very common for folks to drink in high school and to learn at home, under their parent supervision, how to handle our call and make responsible -- handle alcohol. folks are still drinking at that age, now they come to college campus and they are unsupervised , they have seen all the media depictions that they need to go crazy. efforts to control that are hemmed in, the universities are at a difficult position in trying to teach responsible behavior at the same time they are trying to kill 90% of the student body that they cannot engage in alcohol use. it sets up a difficult situation, where college students, the vast majority of them, are breaking the law regularly by dragging alcohol -- by drinking alcohol.

a lot about -- a lot of universities, if not turning a blind eye, are not enforcing it because it is difficult to enforce. eternities and sororities inherit a part of that problem. it is externally rare for a college students to arrive on campus and have their first ring on campus. they learn that behavior before they get there. colleges are dealing with the aftermath of that learned behavior. an environment -- host: is a lower drinking age something you would advocate for? guest: we do not have a position on whether or not the drinking age should be changed. we do have a commission on alcohol that is looking at ways they can continue to better educate members and students at large about how to make responsible choices, some of the

policy issues involved and how freaking occurs on college campuses -- drinking occurs on college campuses. college presidents would tell you that those issues concern them greatly. the weight the law is today, it encourages dangerous behavior. students know, if they will go to a bar, they will be carded, they now pregame, drink in the room, with illicitly obtain alcohol. by the time to get to their destination, that alcohol is in their blood system and it hits them at once and it can lead to dangerous situations. it is probably time for members of congress and others at the state level to have a discussion about how to address these issues. host: tennessee james, our line for democrats. you are on with kevin o'neill. caller: how are you doing this

morning? guest: good. caller: i want to know -- how can you sit there and say that it is regulated and it is not something that has been going on? everybody knows -- where i am from at least, the community i live in, not to do with race for turner these -- fraternities are more likely to do community service? we are kept out of that gate for life. you can't tell me, that i can do things.\ i can have a car in my yard. i can have a certain color, and i have to pay this and that. i've talked about you, the people that sit there and have the power -- you just sit there

and feed into it. guest: you bring up an important point about the history of fraternities and sororities. the article referenced in the interview, talking about they were founded as elitist when all universities were elitist. the history is vastly different. most of the women's organizations, some are as old as 150 years old those organizations were founded, in part, because women were having a difficult time having an access to higher education. sororities were a useful tool to make sure they had a handout the latter. -- up the ladder. national fraternities were

formed because they made an opportunity for different segments of the community to get into an organization of like-minded individuals who would support one another, learn to be community leaders and get engaged. i think it's very rare to have what the reviewer said, the system shuts anybody out, the system is inclusive, there is a place for everybody, it basically look for the right opportunity. the right place where they will feel comfortable with the values . if not, we incurred them to start a group that reflects their values. -- we encourage them. we would be happy to welcome them to our community. host: park hills, missouri, independent line. caller: good morning you don't mention about this bar -- the bar association they were under a flag in this country, how come

your not talking about that? host: we are talking about fraternities and sororities and the greek system. did you want to jump in? guest: i think shakespeare said it well, i will leave it at that. host: kevin o'neill is the executive director of the fraternities and sororities political action announcer: on the next washington journal bill richardson talks about congressional involvement in negotiations with iran over its nuclear program, president obama's request to use force against isis, and other foreign-policy issues. james hendel will talk about the potential 2016 presidential candidate spending time in new hampshire. and a roundtable discussion on legalizing marijuana, with the

founder and ceo of the medical marijuana advocates group. as always, we will take your calls and you can join the conversation on facebook and twitter. that is live at 7 a.m. eastern on c-span. monday night on the communicators, fcc commissioner minion cliburn on the recent net neutrality ruling and the subsidized broadband program lifeline. >> what i'm proposing that we do is overhaul the lifeline program making it concurrent and in sync with the information age. challenge them to give more to consumers. it should be for lifeline consumers.

get the providers out of the certification business. that is the number one problem we have seen with not so positive headlines. it is a vulnerability in the system. announcer: that is monday night on "the communicators" on c-span2. tuesday, there was a hearing on the benefits to patients. the nih director dr. francis collins and the fda commissioner margaret hamburg discussed with their respective agencies are going to advance the field of medicine. this is two hours. [captions copyright national cable satellite corp. 2015] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org] senator alexander: senator murray and i will have an opening statement. then senators will have five minutes for questions.

i have been looking forward to this day. this is in important hearing. i thank you for coming especially because that caused a change in plans. but we do not have two people who know more about what we're talking about than the two of you. this is in opportunity for us to discuss that. let me see if i can put this in context. we have a busy committee. in the last congress, senator harkin used to point out that we completed 25 pieces of legislation which became law and senator murray and i are working well together. and three major items that we intend to focus on in the next two years, among all the others, number one, fixing no child left behind. and we're working well together toward that. hope to have a markup on that after the recess.

second, we're working on simplifying and reauthorizing the federal government's supervision of higher education in america. we had a hearing on that recently, and it had an impressive report. senator mikulski, senator burr senator bennett, and i had asked for about simplifying regulations. and so that will be second. but the third topic is to deal with this exciting new era of medicine that we have. and take a look at what we can do as a congress working with the president to reduce the cost and the amount of time it takes to go from discovery of a medicine or a treatment or a medical device and take it all the way through to the medicine cabinet or the doctor's office. now, we know important work has been done in the congress on that not so long ago. but we have an opportunity this

year to make whatever contribution there is to make. and it's an area that we ought to succeed in because there's not really a political partisanship about this issue. in fact, the house of representatives is moving on a parallel track on something they call 21st century cures. president obama is extremely interested in precision medicine. i attended his announcement of that interest at the white house recently along with dr. collins and dr. hamburg. i've talked with him about it. and with secretary burwell. and suffice it to say that i believe every single member of this committee's interested in identifying what we can do to make it easier to move those drugs, treatments, and devices from discovery all the way through the medicine cabinet. we're not just talking about moving it through the fda. sometimes it takes two, four six, 10, 12 years to get to the fda's front door. so we're not just talking about

the fda. we're talking about the whole range of issues there. dr. collins has described it this way. he wrote in 2013, drugs exist for only about 250 of the more than 4400 conditions with defined molecular causes. it takes far too long and far too much money to get a new drug in to our medicine cabinets. this is an old problem that cries out for new and creative solutions. since dr. collins wrote, that the number of conditions with defined molecular causes has increased to more than 5400. the number of new drugs approved has not kept pace with these discoveries. dr. hamburg, who is here today has said that we are left relying on the 20th century approaches for the review of and oversight of the treatment president obama, in his

announcement of the new precision medicine initiative, said 21st century business will rely on american science technology, research, and development. i want the countries that eliminated polio and mapped the human genome to lead a new era of medicine, one that delivers the right treatment at the right time. in some patients with cystic fibrosis, this approach has reversed the disease once thought unstoppable. he introduced at that white house announcement a 27-year-old young man whose cystic fibrosis has been cured because he's one of the 4% of the sufferers with that disease caused by a mutated gene for which there's now a drug. and i think the legislation senator bennett, senator burr worked on may have helped to contribute to that opportunity. so this is the discussion that can affect nearly every american and in which we're going to take very seriously. senator burr identified a report that issued a white paper that we've been working on for some

time. it focused on the issues that we thought the committee ought to identify, and we've submitted that to senator murray and to the rest of the members of the committee for their consideration. costing too much to bring medical products through the discovery process and development process taking too long. whether fda's responsibilities include unrelated activities to what the focus should be. the disparity and scientific knowledge of the fda and the fast pace of biomedical innovation. those are some of the issues that we focused on. but what we hope to learn today from two distinguished leaders of our government is exactly what should we be focusing on? we don't want to waste our time. we can't do everything. this train is moving through the station in the next 12 months, and if our goal is to get from discovery to the medicine cabinet of the doctor's office what are the two or three things that we ought to spend our time

on? i believe we can do that working together. we're excited about it. it's a chance for your agencies and the rest of the government to let us help you get the obstacles out of the way that might be in the way of your getting your job done. some of them relate to money. some don't. some relate just to the pileup of administrative regulations at our hearing on higher education, there was talk about hiring a boston consulting group to assess the cost of rules and regulations to operate vanderbilt university for one year, and the answer was $150 million, $11,000 to every student's tuition at the university.

i thank you, dr. collins. i thank you, dr. hamburg. i'll now turn to senator murray and we'll then turn to the witnesses. senator murray: thank you very much, chairman alexander. dr. collins, dr. hamburg, great to have you both here. i have a lot of appreciation for the work that you do to encourage innovation and improved health and well-being. dr. hamburg, as you step down from your role at fda, i especially want to thank you for your many, many years of service and we're all very grateful for your leadership. so thank you very much from all of us. i'm very pleased to be working with chairman alexander and other members of the committee on ways that we can continue to advance biomedical innovation for patients. i believe that we are at a truly fascinating moment in medical innovation right now. we increasingly have the ability to move away from a one size fits all model of treatment. and instead treat patients according to their unique characteristics. we've seen enormous growth in life sciences as the source of economic strength and job creation. my home state of washington is a great example. life sciences are the fifth largest employment sector in my state, and it's growing. these are good jobs, in a industry with global reach, and our country needs more of them.

so it's critical we secure and build on the united states' leadership in medical innovation. to do this, i believe congress has to look at how we ramp up investment in the kind of research and development that helps drive this private-sector growth. that's something i will be very interested in exploring as part of our bipartisan efforts in the coming weeks and months. dr. collins, i know that you are very concerned about the impact of sequestration and what it has done to nih, and i am, as well and i hope that we can talk about that today, as well. i'm also eager to hear more about the many efforts at nih to ensure the united states remains the global leader in biomedical research and discovery. the fda drug and device approval process is another topic that i know we will receive a lot of focus. dr. hamburg, you recently announced that in 2014 the fda approved 51 new drugs, which is the most in almost 20 years. you should be very proud of what that means for patients and

families across the country. i look forward to hearing from you today about ways that we can build on that progress. another priority i will be focused on is the needs of women and young children in the research, development, and approval process. when we looked at the fda approval process back in 2005, senator kennedy reminded us that when patients open up their medicine cabinet, they deserve every assurance that the medicines they take are safe and effective. and that is just as true today. so as conversations about advancing medical innovation move forward, i'll be guided by his vision of upholding that assurance. in the weeks and months ahead, i hope we can reach an agreement on policies that help get us safe, effective treatments to patients more quickly. that would be good for our economy and could really make all the difference for so many families we represent. so thank you, again, to our witnesses for being here today. and thank you, chairman alexander, for holding this hearing. senator alexander: thank you senator murray. we have good attendance already of senators.

i would say that we've formed a working group of staff, a single working group, on this subject for the purpose of identifying how we'll proceed. and after this hearing, the next few weeks, the working group and senator murray and i will sit down and talk about how we can have a bipartisan process and take into account and focus our efforts in a way that gets a result. in that, we'll be aware of what the house is doing, and we'll work with secretary burwell and with the president, especially on their precision medicine initiative. each witness, i'll ask each of you to summarize, if you can, in about 10 minutes, your testimony so the senator also have a chance to have a conversation with you. i thank you both for coming. dr. collins first. thank you. he's the director of the national institutes of health, the largest supporter of biomedical research in the world. he's been director of nih since 2009. he's known for his leadership of the international human genome

project which led to the first completely sequenced human genome in 2003. next, we'll hear from dr. hamburg, commissioner of the food and drug administration. according to our staff, 25 cents of every consumer dollar that's spent in the united states you regulate when you regulate prescription drugs, medical devices, food, and tobacco products. dr. hamburg has been in this role for six years. we're glad she's retiring. i especially thank her for coming to this hearing -- [indiscernible] [laughter] senator alexander: i don't mean i'm glad she's retiring. i'll start that one over again. i'm glad she's here. and i'm glad she's here because she is retiring and she has this wealth of knowledge accumulated over the last six years, and i especially asked her to come for that purpose because i knew the

committee would want to hear from her. dr. hamburg, thank you very much for your service to our country. and even though you may be retired, we hope you'll continue to advise us, especially during this next year as we work through -- as we work through these issues, and i thank senator murray and senator mikulski for keeping me straight on my comments. right. dr. collins? dr. collins: well, good morning, chairman alexander, ranking member murray, members of this important committee, it is an honor to appear before you alongside my friend and colleague fda commissioner peggy hamburg. our agencies have much to gain by working to the, and we have been doing so and we're committed to that effort. in fact, peggy and i spent a productive three hours just yesterday afternoon along with senior leaders from both of our agencies who make up the nih/fda leadership council discussing a wide range of projects we are working on together. i'd like to, on behalf of the

nih, our employees, grantees and patient community, to thank members of this committee for your continued support and for holding this bipartisan hearing today. i appreciate the opportunity to discuss how we as a nation can drive innovation through federal investments and scientific research. breakthroughs generated by nih research -- and i'm going to show you a few visuals here if you can see the screen -- are behind many of the gains our country has enjoyed in health and longevity. for example, over the past 60 years, deaths from cardiovascular disease have fallen by more than 70%. meanwhile, cancer death rates have been dropping, about 1% annually for the last 20 years. likewise, hiv/aids treatments have greatly extended lives and prevention strategies are enabling us to envision the first aids-free generation. today i want to share with you a few of the many promising opportunities for biomedical research innovation. i can assure you the potential

of scientific research has never been brighter than it is today. nih remains strongly committed to basic science. fundamental research that serves as the foundation for discoveries that have long made america the world leader in biomedicine and accounts for no less than 145 nobel prizes that have been awarded to our scientists that we support through nih grants and through our intramural program. one exciting example in basic science is the brain initiative. this bold, multiagency multiyear effort is enabling development of innovative technologies to provide a clearer, more dynamic picture of how individual brain cells and neural circuits interact in time and space. this initiative will ultimately give us the tools for major advances in brain diseases. from alzheimer's and autism to schizophrenia and traumatic brain injury. nih is also innovating in translational science for basic science findings are developed in clinical benefits.

let me give you a few examples. recent advances in technology have led to the discovery of more than 1,000 risk factors for disease. but drug development is a terribly difficult and failure-prone business. a major reason for failures is that scientists often just don't know how to choose the right pathways to target for the next generation of drugs that they want to develop. so with this in mind, we were excited just a year ago to launch the accelerating medicines partnership, or amp. this is an unprecedented precompetitive, public-private partnership using cutting-edge scientific approaches to choose the most promising targets for therapeutic intervention. besides nih, amp partners include importantly the fda, ten biopharmaceutical firms and a number of nonprofits, including patient advocacy groups. initially, amp is focusing on three disease areas that are ripe for discovery at the next

generation of drug therapies alzheimer's disease, type ii diabetes, and the autoimmune disorders rheumatoid arthritis and lupus. through this approach we believe we can learn how to treat and cure disease faster, and we can do it together across this whole ecosystem. nih is also working to streamline the therapeutic development pipeline through effort at our newest center. more than 30% of promising medications fail in human clinical trials because they're bound to have unacceptable toxicity despite promising preclinical studies. could we do better? well the tissue chip for drug screening initiative is developing 3-d human tissue biochips that model the structure and function of organs, such as the lungs, liver, and heart. these organoid chips, and you can see the heart chip is beating in real time because the cells that are on that chip are cardiac muscle cells that are synchronized to beat just as they would if they were in a heart.

these give us the opportunity to mimic complex functions of the human body without putting humans at risk. enabling scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies, eliminating toxic or ineffective drugs earlier in the development process. scientific advances are also accelerating progress toward a new era of precision medicine. historically, doctors have been forced to base their recommendations for treatment on the expected response of the average patient. but recent advances, including the plummeting costs of dna sequencing, are now made possible a more precise approach to disease management and prevention that takes into account individual differences in genes, environment, and lifestyle. with this in mind, nih is thrilled to take a lead role in the multiagency precision medicine initiative that you all have already mentioned in the opening statements and which we at nih are very excited about.

in the near term, this initiative will focus on cancer, to accelerate efforts, this project will support research aimed at understanding why cancers develop drug resistance, using noninvasive methods to track therapeutic responses, the so-called liquid biopsies, and exploring new treatments including combination therapies targeted to the genetic profiles of a wide range of adult and pediatric cancers. as a longer-term and very bold goal of this initiative, nih will launch a national research cohort of 1 million or more volunteers who will play an active role in how their genetic and environmental information is used to prevent and manage a broad array of diseases. a project of this magnitude will lay the groundwork for new prevention strategies and novel therapeutics. there's no better time than now to embark on this enterprise, to revolutionize medicine, and move this precise personal approach into everyday clinical practice. in closing, to make this clear

in terms of its impact on human health, allow me to share a story that highlights the early promise of precision medicine. when maki was diagnosed with stage 3-b carcinoma of the lung in 2008, it was completely unexpected. she was 36 years old, never smoked a day in her life. yet her tumor was very large. almost seven centimeters with a very low likelihood of survival beyond a year or two. as maki began the recommended standard chemotherapy her doctors, who were ahead of their time in precision medicine suspected she might have a particular mutation in a gene called the epidermal growth factor receptor, or egfr. genetic testing confirmed their hunch. she was prescribed a drug that precisely blocks egfr's signal. and after three months of treatment, maki's large tumor shrunk dramatically, as you can

see. this was followed by surgery to remove cancerous tissue plus retreatment with the drug. today, seven years after her diagnosis, her doctors can detect no signs of cancer. what's more, maki has now completed a triathlon, landed her dream job as a biology professor at ithaca college, and welcomed a healthy baby girl. maki is the face of scientific innovation, made possible by sustained investments in biomedical research. with your support, we can realize the vision of accelerating discovery across the vast landscape of biomedicine, from basic science inquiries to more precise personalized approaches to treatments and cures. so thank you, mr. chairman. my colleagues and i welcome your questions. senator alexander: thank you dr. collins. dr. hamburg? dr. hamburg: thank you, mr. chairman, and members of the committee. i'm very pleased to be here

today to discuss our shared goal of speeding innovative treatment to patients. i look forward to working with you on this important effort. as you have noted, this will be my last appearance before the committee, as i'm stepping down. but i want to thank you for your support over the years, and our constructive engagement with this committee to advance fda's public health mission. i came to the agency at a time of considerable uncertainty and change in the biomedical product industry, a time when dramatic advances in science and technology, some that my colleague dr. collins just outlined, demanded new models, and approaches. in turn, we took a very serious look at our role in advancing biomedical product innovation to ensure that we would be a gateway, not a barrier, to the delivery of better, safer, and more effective treatments and cures. and, in fact, this has been a

high priority for me throughout my tenure, and i'm very pleased that as senator murray noted last year we approved the most new drugs in almost 20 years and more orphan drugs than ever before, and 41% of these new approvals were first-in-class products, resulting in a breathtaking array of truly innovative new therapies for patients. today, fda approves drugs faster on average than all other advanced nations 40 days faster than japan, 70 days faster than canada, and 174 days faster than europe. and fda has made substantial improvements in the efficiency of medical device reviews, as well. moreover, we've accomplished this while remaining the gold standard around the world for safety and effectiveness. yet despite these successes, too many diseases still await treatments and cures. serious public health needs such as treatments for alzheimer's disease are not being met. and rising r&d expenditures are

not matched by a proportionate discovery of new treatments. in this context, i want to address concerns raised by some that fda regulation is the principal obstacle to the development of innovative treatments and suggestions that fda's authority for procedures must be fundamentally restructured. as a physician, i know that if you incorrectly diagnose a patient's condition, the treatment that you'll prescribe is unlikely to work. unless we correctly diagnose why cures are still lacking for many diseases, we're unlikely to find the solutions that will actually deliver us those cures. so let me give you three examples of misconceptions. first is the incorrect but commonly repeated assertion that fda's approval of new drugs lags behind other countries. the reality is starkly different. over 75% of the new drugs approved by japan, e.u., canada, australia, switzerland, and fda,

between 2014 to 2013. were approved first by the fda according to a recent report by the british-based center for innovation and regulatory science. and the result is that americans are in fact far more likely to get first access to new medicines. second, fda is said to be rigid and inflexible in its approach to requesting and using data for approval of a new drug. in fact, fda's clinical trial requirements have been steadily increasing in flexibility. 45% of new drugs are approved based on a surrogate end point. 1/3 are approved based on a single clinical trial. last year we used expedited approval processing for more drugs than ever before about 66%. and thanks in part to the new authority that you gave us, 74 drugs have received the new breakthrough designation. my final example is a concern that investment in biotechnology

has dropped precipitously in the united states and that the fda is to blame. but in the words of the national venture capital association, biotechnology investment dollars rose 29% in 2014 to $6 billion placing it as the second largest investment sector for the year in terms of dollars invested. and jonathan leff, the leading biotechnology investor affiliated with nvca, said that one of the two reasons for the increased investment in biotechnology is the improved regulatory climate in recent years at fda. i cite these examples to suggest not that the world of biomedical research and product development is all fine, but to urge that we start with the right diagnosis. we do not want solutions based on inaccurate diagnoses. i caution against solutions that seek to lower the safety and effectiveness standards for approval of the medical products on which americans rely.

remember that the great leaps forward in evidence-based medicine of the last 50 years have come in part because of the high standards for product approval that congress put in place after a series of disasters involving unsafe and ineffective medical product. those standards have also boosted the confidence that americans place in medical product and that the world places in the american biomedical product industry. together, we can build on the progress that has been made in recent years to further advance biomedical science and improve the lives of patients. and there are some areas from the fda perspective that i believe we can all agree need to be improved. first, patients are uniquely positioned to inform medical product development. treatments can better meet their needs if we can capture science-based disease-specific patient input to incorporate in the development and review process. second, more attention needs to be given to the development of biomarkers and surrogate end

points. these can help scientists identify and target successful medical treatments and shorten drug development times, as dr. collins was noting in his remarks. fda has accepted hundreds of biomarkers and surrogates such as blood pressure changes, blood sugar reduction, and tumor shrinkage, yet biomarkers are still lacking for many diseases such as alzheimer's. the biggest obstacle is that scientists do not sufficiently understand the causes of alzheimer's and other diseases. to identify drug targets or identify which patients will benefit from certain drugs. to solve this problem, we must support the establishment of strong public-private partnerships, bringing the best minds together to develop the science that we need. third, real world data provides a vital tool to monitor medical product in use in the marketplace. fda sentinel initiative with more than 170 million lives is one of the largest uses of big data in health care and proving vital for monitoring safety in

emerging safety concerns. the science of using big data to establish product effectiveness is still in its infancy. real progress demands we develop the methodologies needed to harness the promise of real world data. and, fourth, fda and industry agree that the agency must be able to attract and retain talented scientists to review cutting-edge products. and we look forward to working with you to improve our ability to hire and retain these experts. so let me close by underscoring that speeding innovation, while maintaining standards for safety and efficacy, serves patients well. supports the needs of our health care system and has enabled the medical product industry in this country to thrive. and so i thank you for your support, for our efforts at fda, the work that you're going to be doing going forward, to advance that work and the work of all of our colleagues in the biomedical research community so that we can deliver on the promise of science for patients. thank you.

senator alexander: thank you dr. hamburg. we'll now have a round of five-minute questions. i'll start. i only have two questions. i've got a short one, which i hope to get a short response from dr. collins so each of you will have a chance to answer the second question. the first one is this -- the national academies have done a couple of studies that show that 42% of an investigator's time is spent on administrative tasks. the taxpayer spends about $30 billion through nih. 80% of that goes in to research. a conversation they had at national academy said about 10% would be a reasonable amount of time for an investigator although it would vary depending upon the investigation. what are the opportunities for reducing that 42% down more toward 10% or 12% or 15% for saving money so that we could have more multiyear investigations?

dr. collins: we are concerned that investigators are using more of their time. part of that survey that shows the number had not change from 2005 to 2012. we are doing what we can do to eliminate oversight, but it comes from other directions. things that we have done our to standardize the biographical sketch, something that can be done is the revision of the common rule involving human subjects, which has not gone through a revision in 20 years

and does not take into account the risk involved in study and applies a great deal of oversight to some studies that are truly don't risk. >> would you be willing to work with us so that during the next several months, we can make changes in the law and we can help with that. i want to asked you and dr. hamburg this question, we don't want to waste our time and we can't do everything. could you say now, and if you want to submit it later in addition to your statement what are one or two or three things that we should focus on. in order to make the greatest contribution to the goal of moving medicines, devices, and treatments, to the doctor's office.

>> i appreciate that question. i very much look forward to talking to you. if you want me to name to ring -- thuman inamed to the current very rigorous oversight in attendance of scientist at meetings. we are currently spending $15 million using hundreds of employees to go through a process, which as far as i can say is relatively little to added value. this triggers of misadventures by other industries who are having conferences in las vegas. a scientist going to conference is a critical part of how we move things forward. it is being inhibited by this heavy-handed oversight. in sf and the department of energy, and their scientific

budget that happens every year they are allowed to carry funds over. we are not. we come to september where the money goes away. we could be more flexible in how we spend the taxpayers money. >> thank you. i agree with what he said. are you looking for administrative issues, or broader question mark >> i was sure we don't waste of time. whatever you think. >> let me go to a higher level of what i think are two related needs. one is, i do believe we need to invest or money and regulatory science, to develop knowledge tools, approaches and strategies he -- strategies that enable us

to assess an effective and efficient way the performance of a product. it has been an underappreciated, under develop, and under do best -- invested area of our enterprise. it is proving to be essential as we are trying to take that last step from research and development, into a pulp -- product that would make a difference in people's lives. we have laid out an important and exciting search agenda. i think the other areas to recognize, the fda and scientists have a huge amount to conjure you to the overall process of roddick development as well as responsibilities for reviews. certainly for us to be a little engage in a consistent way earlier, as recent plans are being shaped so that the return

on investment in moneys can drive towards a product that works. >> thank you. >> thank you. dr. hamburg, before i could abroad topics i want to ascii about the recent outbreak of drug-resistant bacteria. one of the largest outbreaks in washington, there were 32 patients infected, although it is not what -- clear what caused their deaths, 11 have died. fda was supposed to be regulating the scopes. can you explain how this could have happened, and what steps the fda could taken. >> a lot of those scopes are important medical devices that show a critical role in patient care and diagnosing a series of important props. there are in fact used in more

than 500,000 procedures a year in this country, usually with great benefits. it allows an approach that is less invasive than open surgery. it overall has less risk to patients health and safety. over time we saw isolated cases of problems in terms of infection, we would investigators. they are all associated with some lapse in the disinfection protocol. in 2013, late 2013, we learned of outbreaks involving an antibiotic resistant strain of bacteria where on investigation it seems all of the procedures for this election had been followed. after that, we began to look --

work closely with the cdc and with the companies making these to try to understand what are some intrinsic design challenges in order to enable the scope to do its job. it has to twist around and has an elevator mechanism. we are actively engaged in trying to come up with better strategies for the -- disinfection to increase the margin of safety. we are going to be hosting an advisory committee meeting. >> can you give me full fda review to me, and protect against it happening. i am deeply concerned about it. >> we are very actively engaged. a lot of activities will be happening as we continue to strengthen safety and improve devices progress i appreciate that.

on a broader issue as always been a global leader, but today sequestration really threatens that leadership. i think it is critical that we build a bitar -- bipartisan budget deal. we are just about to enter into the budget process. then you explain how sequester impacted research -- impact of research at nih. >> it was a serious blow to momentum $1.55 billion or taken a way our budget in the middle of the fiscal year resulted in our inability to fund 750 grants that otherwise would of been funded that year. those good ideas got left on the table. as you know, we were able to make up some of background in the subsequent years, but even

in 2015, we did not recover the entire $1.5 billion loss in 2013. the results of that come in terms of what they have done to investigators, really has been quite significant. the overhaul likelihood, if you send your best ideas to nih, has dropped over the last 10 years. the budgets became flat. inflation is eroding our research. this is something which puts america at a limited competitive's -- competitiveness status. here's a graph from 2011 to 2013 in terms of the change in percentage of gdp invested in research. you can see countries like china, brazil, south korea, are increasing their investment. they're reading from our

playbook from the 1980's and 1990's. the standalone graphic is losing ground. the consequence is we are also losing jobs, opportunities and science, potentially young investigators. some of them are starting to give up. >> sequestration, going in again, what is that doing. >> that hangs over us like a dark cloud. we stand to lose another $19 billion. the consequences of that are really painful to consider. >> thank you. >> thank you senator murray. >> dr. collins, dr. hamburg, welcome. dr. collins, in your testimony he talked about specific patient needs. what role does biomarker qualifications play in advancing

these patient focused therapies. >> again, i appreciate the question. we had a three-hour meeting yesterday and one of the topics was biomarkers. as dr. hamburg said in her opening statement, there are a lot of markers that have been used for a long time. measuring your blood pressure is a biomarker. of course we would love to see biomarkers developed for something like alzheimer's disease, which she also mentioned. i pointed out this accelerated medicines partnership, that is one of the goals for alzheimer's. we are making sure that all clinical trials are trying out new ideas and they use the same set of biomarkers. if something starts to work, maybe as a blood test, david is a protein in spinal fluid, maybe it is a scan. we wouldn't -- we would know that, and we would begin to utilize that. >> you are nih and fda

participants in the biomarker group. how many biomarkers has a qualified since 2006? >> i/o markers consortium -- consortium is charged with identifying possible biomarkers that need research. the fbi -- fda has the role of qualifying those biomarkers if they reach that. >> so they have full consortium. >> they need to evaluate. i will depend on dr. hamburg to specifically investigative process. rigorous studies have shown it is actually a predictor.

>> fda drug development tool qualifications program is developing animal models for use under the animal rule. a few weeks ago, your colleague was before the committee as part of an oversight hearing. as you know human efficacy studies are not feasible in the medical countermeasures for it the fda's animal is particularly important for such products, which is why i emphasize the importance of finalizing animal rule guidance before this committee. as far as i can tell, there has been no further movement since that hearing. when is the animal rule guidance going to be finalized as required by law? >> let me begin by thanking you for the extraordinary work you've done to advance public health preparedness and the development and availability of importance countermeasures.

the animal rule is an aspect of this that is key. we do need to the medical countermeasures against certain threats where the disease may not exist in nature. we would certainly never want to expose people to the disease to actually see if the new drug or vaccine actually works. we have taken the rule very seriously, it is one of those regulatory science areas that is challenging because we want to be able to know that using animal data, which is often imperfect, we can make a good assessment of safety and effectiveness and appropriate use of a product against what is generally going to be a terrible life-threatening disease. we have been working on the animal rule for quite a while. we did put for it a draft guide

and comments and it on that back in august when he 14. we got a lot of print -- response, and we have had meetings. >> is a site -- is this a priority? >> it is. >> when will we have a final rule? >> it will be soon. it has been a priority of mine from early in the tenure. i have been working on these issues before he joined the fda. it is a scientific challenge and in fact, the guidances, the draft guidance has shaped work that has been done, and moving forward. it has not stopped progress. we will get it done. i will go back from this hearing and remind the team that there is a's -- a very important senator waiting for that. >> i would be remiss if i didn't mention at the same time bio

similar pathways, and the fact that we have yet to have that final guidance. i go to what dr. collins said in response to senator murray's statement on what happens on sequestration. there's no consistency. it you cannot fund the things you think might generate. >> i would say this, there are a lot of companies and a lot of efforts that are waiting for an animal rule to be finalized. they are waiting for the pathway to bio similars. we just approved the first bio similars at fda and we don't have a pathway. we don't have a final guidance for the other manufacturers out there. you have a company that had won approval but no one else knows how to do it. my suggestion is, this is as important as how we fund

research. having enough i/o similar markers qualified, having final guidance for bio similars. having a final rule on the animal rule is all part of how we have a robust response to disease. i think both of you. >> thank you. senator mccluskey. >> thank you senator. a bipartisan effort to really promote life science innovation in this country, which leads to neil ideas -- new ideas, new research, new products, but not only save lives but create jobs in the community. i've going to welcome dr. collins, and dr. hamburg here. i have a great joy of having both nih and fda located in my state. we have to outstanding leaders here.

in every day and every way we think about how we can advance position in these agencies. i would like to thank them for hanging in there. many of the impediments that are created, not only to try to find new ideas, maybe we need to get back to old-fashioned ideas of working together. dr. hamburg, i know that you are leaving the fda, the you will continue to serve in any -- many capacities. you are the longest-serving, are the longest-serving, here we are. i would also like to take this opportunity to thank the man -- men and women who work in these agencies. you have to know that for my 28 years of service is to wake up every year and think about how i can make the world a better place. i have these two fabulous agencies where my job is to help

you be you. i cannot tell you the pride and enthusiasm and joy way that has brought me. let me get to what i think are the three criteria. number one let's respect the mission of the agency. it lets respect the men and women who work at agency. i think recep goes a long way to improving morale. around goes a long way and increasing productivity. i would hope the congress of the nine states would embrace the men and women to work in our federal agencies, and not treat them as throwaway lines on top shows. the second is adequate resources so you can do the job and have the tools you need. third, let's approach reform and a targeted way as the chairman has indicated. focus with specific problems

and specific solutions. i posit that to my members to think about the three r's. which then goes to my question senator murray raised the question of sequester. that then goes to predictability. did you share with the committee the impact. many reports say there has been a big turnover and fda. many accusations are not justified. could you share with us what that means in terms the predictability, sustainability as well as the adequacy. we know that you need more. what would predictability mean

>> we know that predict ability is key. it is essential to us to be about to do our job. we need to layout programs that may not be occurring in time frames. we need to be a will to recruit the best and the brightest. so they need to know that they are going to be working in an environment with a are going to get the resources that they need and support that they need in a continuing way. we need every dollar that we get. as is noted, we have a broad span of roles and responsibilities overseeing products that matter. we are stretched very thin. uncertainty and instability in our programs make it harder for us. >> and therefore -- the other

with the predict ability, what about you dr. collins? >> i appreciate your question. senator, your strong support has been valuable. we are all grieving that you're planning on moving away in two years. we hope that there will be opportunity for more conversation in the meanwhile. i think the idea of stability is crucial for biomedical researchers, especially those early in their career, have visionary ideas that they are fearless on taking on. the technology now makes new problems able to be tackled. they are uncertain if there is going to be long-term support for that. here is another graph, what has happened to your likelihood of getting supported by nih over the last 50 years. traditionally, it has run about 30%.

it is now 16%. that means five chances out of six, your idea will get a no. that means your science is left on the table, unattended. that is discouraging. if we could turn that corner and that uptick there is aimed to try to do that. we could turn this circumstance around. we could regain the momentum and leadership that we have had. it is at risk if we cannot do that. >> what is the adequacy? during the a sequester fda could use the user fees that the right of sector was paying and. here is the private sector giving the money after arduous work to create a contemporary, that was one. and the day before sequester they announced they lowered

cancer rates in the country 12%. we were getting ready to print pink slips. i don't think that's the right way to govern. >> thank you senator mccluskey. >> thank you mr. chairman. this is my first time publicly to be living knowledge of the contribution to senator mccall ski and her service. i want to publicly thank her for all she has done. it has been a pleasure serving you. dr. hamburg, i don't want to be piling on, but senator burr is right on target. this is a long lead up to a question, i apologize for that. it is an important question that needs to be answered. you are blamed biotechnology and you refuted that. it is true that certainty follows revelatory processes.

i find it troubling the fda has so much difficulty working through the regulatory process. last year's user fee bill congress updated manufacturers suppliers of gas. we are still waiting on the report. some say that it's resistance in the agency -- instead the fda seems to rely heavily, and less formally on graph guidance. these approaches do not offer legal, regulatory, certainty. they failed to ensure any policies that are enforceable evenhandedly among stakeholders. last may chairman alexander, myself, and many members sent you a letter opposing specific questions about draft guidance. we received the answer 10 months later, last night, 12 hours before the hearing. in that hearing you attached 172

draft guidance issues, one of which goes back to 1988. how is this affective regulation and how is this effective process? >> we are taking a very active look at the various guidances and what states they are in. a guidance is just that. it is a guidance to inform industry about our current thinking and the process of developing a final guidance is useful in that process. the draft guidance ghosts -- goes forward and enables us to go forward. how we are thinking about the problem, and you asked questions, and get information back to further engage with critical stakeholders. it is an ongoing process. guidances are not regulations of the force of law. it helped provide especially,

when there is a more dynamic issue at hand. it provides a mechanism to begin an important conversation with a broader set of stakeholders, and continue it to the final guidance. i agree with you, we should not have that many guidances and draft. i think that while the process of moving from a draft to a final guidance has value as well . having the final guidance is important and provides more certainty. i hope it will not be me coming back before you, but i hope soon we will be able to demonstrate what has been done with the respect to some of those guidances that are in draft that may no longer need to be updated , and those where we can translate. this is an area where frankly we are not the only ones involved in shaping the guidance process. it does have to go through

series of other reviews before it can be published. i figure point. >> one other question relating to that point. i am a victim of melanoma twice. the surgeon general issued a report that melanoma is costing america 8.1 dollars and help. i heal it -- here very little from the fda regarding that. we worked hard on the sunscreen innovation act lester. we tried to enact ingredients to be at approved. we are still waiting for that. can you tell me why the fda is so reluctant to follow through in terms of the sunscreen innovation act. >> we are committed. preventing melanoma is a high priority, as well as developing new treatments for it. prevention comes first. we are committed to it was laid out in the sunscreen innovation act, in terms of responding to

the identified timelines. we do need to work with industry to get the data we need to assess safety and effectiveness. that is of course because these products are used widely applied often, and hopefully with the right amount used chronically. we need to understand about the extortion of these chemicals and what that means for safety. including of course, many young children who may be at greater risk interns -- terms of chronic use. we want more options in terms of sunscreen products, but we want to work with industry to make sure the ingredients actually work, and that they are safe. >> my time is up, but i would like to urge you to everything you can to expedite those

approvals. thank you. >> thank you. >> i'm calling on senators in order of seniority of their here the time of the gavel. senator bennett. >> thank you, mr. chairman. thank you very much for holding this hearing and thank you both for your leadership and dr. hamburg, i'm sorry to see you go, which i know is chairman feels as well and i'd like to ask -- a number of years ago colorado bioscience community came to me and said we can't raise venture capital anymore in the united states. it's all going to europe. it is all going to asia. a lot of that had to do with the regulatory uncertainty at the fda. as you know to team up with thunderbird, senator hatch to write the breakthrough therapy legislation, a new leadership that is responsible for the -- and a lot of people about their there would only be one or two drugs in that pipeline.

there have been 22 drugs approved as a result of that legislation and there are 55 more drugs in the pipeline as i understand it. it has succeeded beyond our wildest dreams. it is fair to say and i want to thank you for that. as you begin to leave, i ask you to talk a little bit about the shift in the culture at the fda and as a result of that designation how we are going to keep that going after you leave. >> well, first, let me thank you for the work that you did on breakthrough and so many other things and for inviting me to talk to your bio tech community in colorado and i've done it in many other places as well. including recently massachusetts. and those kinds of listening sessions with the medical device and pharmaceutical and bio tech industries is incredibly important because we hear the concerns and we heard loud and and clear in my tenure and we looked at programs and how we could strengthen them. the breakthrough designation has

been enormously successful as you know. it was more successful than we thought and it's not come with additional resources, so it is an example is something you want to be able to extend, but it comes at a cost. but an incredibly important lesson that comes with breakthrough and confirmed is the value of early engagement by the fda with the product sponsor to really helped shape the product development and research agenda, and then continuing contact. and that has really made a difference. we see it in breakthrough in in other areas as well as we look at some of our recent approvals. we can see in informal analysis that when we engage early especially pre- ind, we can , really help the product development process take critical time and cost off of

their product development because we can really say you don't need to do that study, but do this study. use this approach because it will get to the answers that will really make a difference in our approval process, so i think that's been enormously exciting but it does signal changes for the future in how fda organizes itself and how we work with the broader research and industry community. >> i hope that's right. i've heard the same thing from developers of these drugs, they're saying they feel the fda is engaging with them and a much more productive way than it used to. my hope is that we will hear about medical devices and other things going forward. i would ask you one other question. over the last few weeks, we have heard about infections, and even death in california and north carolina hospitals from cre -- i apologize for my voice today. i'm glad there are two doctors here. >> we don't always have the treatments you need.

>> the cdc director has called a nightmare bacteria. another bacteria has been directly offending -- affecting our wounded troops returning another bacteria has been directly affecting our wounded troops returning home from iraq and senator hatch , you and i know we've been working on relation to establish and to treat serious and life-threatening infections. legislation is is support of antibiotic developers, public health groups and provider groups. your team has been enormously helpful in working with us on legislation. could you describe how this new pathway will protect patients' safety while ensuring the parpts -- the patients who have unmet needs for antibiotics can gain use to these important drugs? dr. hamburg: it's important as we face a world where resistance is is growing that we ensure we have new antibiotics in the pipeline, especially antibiotics for infections that are resistant to the available

antibiotics. and we see increasingly operates in many different settings where antimicrobial resistance is causing a preventable burden of disease and death because we can't treat those infections. the path what you're describing is an important one, because if you look at in the infectious organism in the disease, it can be quite heterogeneous from more minor infections to the antibiotic resistant ones that we were just talking about. as you look across that whole spectrum of patients who are infected, you have a very different risk-benefit calculation that if you focus on the more extreme, serious, life-threatening cases where there's serious antibiotic resistance, so we can develop a product that is targeted to that part of the spectrum, the risk-benefit calculations can

come into a clear focus. we know we need drugs and the risks can be higher because the benefits are higher in that context. we need to make sure that physicians using these drugs understand that they are really being approved for a limited use, especially population -- a special population and should be labeled as such. but it will enable more products to be developed rapidly and then gets of patients who need them. as they are in use, we can learn more and perhaps extend the indications for use, but it enables us to move much more quickly off the dime to create more products and creates new incentives for companies to get involved because they can see a pathway that perhaps is shorter and more streamlined.

>> thank you, senator bennett. now, i have senator cassidy, whitehouse, and warren. next for senator cassidy. senator cassidy: one, great job. in my six years, you have done a remarkable progress, so thank you for that. dr. hamburg: thank you. senator cassidy: you've recently put out your fda's transparency initiative. i've tried to understand your agency, but don't understand it as you, but it seems like there's different divisions that do different quality of work in terms of approving new applications and intuitively there are some which have higher turnovers than others. i spent -- suspect those with lower turnover are those with

better output. now, i see that as a diagnostic. frankly, i think that indicates in those divisions with high turnover and lower output, there's probably some issue there in management, leadership, you name it, that is a problematic. will there be more information regarding that so that we and oversight can look at that on a granular level, trying to get a sense how your successor could perhaps improve those processes? dr. hamburg: certainly, the transparency initiative was a multifaceted undertaking intended to both expand understanding of what the fda is, what we do, how we do it and why. but also to hold us accountable in critical areas of activity and really post for everyone to see the progress we are making on critical issues. you are right. the different parts of the fda are functioning with somewhat different performance with respect to aspects of their work. you know, as it relates to both management and assuring that we have consistent, high-quality management and oversight has to do with having adequate resources. senator cassidy: but the

resources flow between the two so one division would it have far more resources than the other? dr. hamburg: >> not always because -- senator cassidy: >> so, if not -- dr. hamburg: >> we were talking about the user fees before. senator cassidy: i just have limited time. let me go back to my point because i have a question for dr. collins. if you can make that information more available, i think that would help us as we looked on a granular level because that is our responsibility to provide the oversight. senator cassidy: just one point there. the user fees are often targeted to specific programs through a negotiation programs, so they -- the programs with user fees have a bit more flexibility, and hopefully more predictability, in terms of resources. i'm a doc and apparently dr. that doesn't want a gastroenterologist taking care of his cough. that said -- clearly, our goal is transitional research correct?

dr. collins: yes. senator cassidy: now, some of your mds and some go to phd's. do you track what percent of the grants go on to ph.d.s and those which go to mds result in transitional research? is there a difference? dr. collins: >> we do track that. as you know, our workforce is made up of a variety of individuals with different backgrounds. phd's are the majority actually. mds and md phd's are also significant contributors. in general, the mds tend to be more focused on translation or clinical efforts, but some of them are doing basic science. senator cassidy: i get that. and what percent of the -- put it this way. that's taxpayer wants translational research, right? i come from academics and some are content with writing a paper, but not necessarily looking forward to the translation. so, when you track, how much weight is given to someone success in translation, and if someone is really successful in translation, perhaps not as good a place else, but really give a translation, how much would that

weigh toward their future of being awarded a grant if you have first prize -- precise statistics, i would like to know what percentage to have grants go to md phd's are mds. how many of translator result in translational research, and if there is a difference, it seems perhaps more like we should wait to the md phd if there bias is translation. dr. collins: i can provide that data for the record. we have encouraged translation at nih by the mounding of this new center, the center for advancing translational sciences, which is providing resources to enavailable the kind of science they might have trouble doing by themselves. so we're very focused on this. just a small caveat though. i would say we need to be careful not to discount the value of that fundamental basic science, which has been the mainstay of nih's success. senator cassidy: i accept that

but i know there are some that don't have the entrepreneurial kind of next step and we can help with that. and that's, lastly, i'm just going to say this because i've said it before. in your testimony, you mentioned about the great success that we have had with hiv in terms of eradicating. i'll point out it still seems to be 10% of your budget and the alzheimer's dementia is a $800 million now and hiv is $3 billion, which is 10% of the budget. and cbo just released, and this won't show up well, our national debt, which they say by 2025 will be 77%, which they say is dangerous to our future. knowing that we're going to go into a period of strained resources because of our last six years escalating national debt, i would again push that if hiv-aids, as you mentioned, is substantially addressed, still problems, but substantially, and alzheimer's dementia is a balloon, medicare and medicaid are just going to go banqueting -- bankrupt dealing with this. we should start shifting more

aggressively resources from that which has been addressed to that which we are confronting. just making that point once more. i yield back. >> thank you, senator. senator whitehouse. senator whitehouse: thank you both for being here today. rhode island is a small state and we tend to have a lot of small and entrepreneurial companies. and i'm concerned that when there is fda or other regulatory disadvantaged that a company must bear to bring a product online, that has a lot harder on the small company than it does on the big one. i noticed that in the accelerating medicines

partnership, all the participants seem to be the big manufacturers, and obviously, if you are big manufacturer in a world in which only big manufacturers can succeed is a good world because you are not going to get a lot of objection from the big manufacturers. how do you push back against the incentive of big manufacturers to squeeze out little ones and make sure that little manufacturers get the attention that they need and are included in these types of processes and are health or your process? -- helped through your process? i mentioned the accelerating medicines partnership, start with you, dr. collins and i asked dr. hamburg the same thing. dr. collins i appreciate the

question because we are very much in support of the idea that all the partners in this ecosystem need to flourish in the public and private and aims to try to do that by making all the data immediately accessible to everybody, including the small biotech companies. this is a rather unprecedented kind of partnership. and recognize that the pharma is taking part are paying for half of the cost of the research. it is during $30 million over five years -- half of it from nih grants and half from companies. it is all sitting around the same table to design the process, so it should empower everybody. what we learned in this process and making data accessible. that would be the only way nih could see this as something we can support, and the companies have gone along with it, which is really quite impressive on their part. in terms of other things, we have a very big or small business program that supports a lot of biotech companies. and i could cite you a number of stories that are highly profitable companies that started out on the basis of an nih grant and we are increasing our support of sbir proposals and shortening our timetables for review of those because weeks matter when you are a

small company just trying to get started and you need that in -- initial infusion of grant cash to do the experiments, so we're very invested in this space. i think probably one of my closest relationships in terms of working with the industry is through the biotechnology industry organization, going to their meetings every year, listening to their concerns, and trying to be synergistic but the whole effort that they are trying to mount in terms of finding new cures, devices, and diagnostics. dr. collins --senator whitehouse: my time is running down, so i can ask you to comment on that. can you comment on where there is a controlled pharmaceutical the dea has a process that begins at the end of the fda process. that delays the ultimate approval. to my knowledge, ga has never come to a conclusion that is different than the fda's conclusion. which makes me wonder why we put that additional demand on the process if the outcome is

inevitable, so if you could talk about those two things, that the a process that follows yours -- dea process that follows years and making sure that small providers have a shot up against the big guns. dr. hamburg: try to be quick. on the small business question it is a very serious area of focus and concern for us because many of the medical product companies we regulate our small on the medical device side and in the biotech world, and as dr. collins noted, often, they are one product approval and or if you -- if you weeks away from going under. but yet that is where a lot of innovation occurs. we have tried both to streamline our regulatory processes and provide more outreach and assistance through the process for small businesses, to help with that process, to be more responsive and provide that additional clarity.

we also -- this is one of the reasons why this investment and regulatory science is important because there are common tools and approaches that can be used by smaller companies that can make the same investments, whether it's in the biomarkers area or the trials design. so we are working on small business as a high priority. dea -- it is a complicated system and certainly not one that we have put in place and would it be the way that we structure the process of it were starting from scratch. we make our decisions based on public health and medical care. and our perspective doesn't always align with dea. we do try to work closely with them. in critical aspects of making important drugs available for people. and in appropriate oversight of the use of scheduled drugs, but i would be disingenuous if i didn't say that i've seen some of the disconnects that you have

seen and i think it might be an appropriate time to look at how best to align these different players an important area of work. senator whitehouse: thank you. >> thank you, senator whitehouse. senator collins and warren. senator collins: dr. hamburg, first let me thank you for your service. you and i have discussed many times the technological breakthroughs that are making a real difference for people who are living with diabetes. an example of that is the continuous glucose monitor which is helping patients control their blood glucose levels, which is key to preventing costly, and sometimes deadly, diabetes confrontations. the nih and fda have been extremely supportive of these innovations in diabetes care.

and that is why i was so surprised and troubled when cms decided that it would not reimburse or pay for insulin-dependent medicare beneficiaries to continue to have a continuous glucose monitors. so we have a situation now where an individual with type one, who is covered with private insurance, gets to be the age where they age in to medicare and they lose their coverage for the cgm. this has led me to question whether cms consults with the fda and the nih in making its coverage decisions. do they consult with you and were your to agencies consulted

in the case of this denial of coverage? dr. hamburg: i have to tell you, i was not aware of this situation and i can see why it's concerning to you and i think we're going to have a lot more important breakthroughs in terms of medical devices and new treatments for diabetes that will make a difference. we work with cms. we can work more with cms. we've done some pilot projects with cms to look at how can we do some of our decision making in parallel rather than in an series, so that as data is being collected in the product development space, data that will meet the needs of both agencies can be gathered and examined. you know, there are obviously discussions with cms on various specific products. and as i said, i think you know, in our modern world, we need to do more of that. i would also say your point speaks to an issue that's been a

high priority for me and that i leave fda feeling like we still haven't adequately addressed. which is part and parcel of what we you are trying to do here which is that we have to look at the whole ecosystem for biomedical product development and use them recognize that each of different components that often operate in silos are very interdependent, and one of the things i'm hearing now more and more from investors and biomedical research is that it is not the fda regulatory process that worries them. it is reimbursement issues and getting that right, so i think we really need to take that ecosystem approach. thank you. senator collins: dr. collins i'm going to switch to a different issue because of the interest in time, but i hope you'll respond for the record to my question. dr. collins happy to. senator collins: thank you. you put up a fascinating chart in which you show the tremendous

progress that we've made with cardiovascular disease, with cancer deaths, and with hiv-aids. and what they all have in common is congress has made a sustained investment over the years in nih research and it's paid dividends in better treatments and in falling death rates. i am, as you know, very concerned about the trajectory of alzheimer's disease which is fast becoming our most costly disease in this country. as a society, we spend $226 billion a year caring for people with alzheimer's. out of that amount, $153 billion comes from the medicare and medicaid programs as dr.

cassidy says, the trajectory is frightening. it is going to bankrupt our health care system and it is also causing such suffering for the victims and their families. i know you mentioned the amp and the brain initiatives and i'm excited about those. but shouldn't we be doing even more to do a concerted effort targeted at alzheimer's given what the trajectory of this disease is? dr. collins i appreciate the question and share the concern. when you look at the cost of alzheimer's disease and the care of individuals affected, not to mention the suffering their families go through, we are on a trajectory that anybody looks at it has to be deeply concerned about it. we are certainly ramping up research at a pretty unprecedented rate. between 2011 and the president's proposal for 2016, there will be a 42% increase for alzheimer's research, greater than any other area that nih supports.

is it enough? no. frankly, we don't have enough that i could argue to support all the ideas and lots of other areas. the good news is that alzheimer's disease research is in a very exciting place. we do have new ideas about therapeutics. we have the ability to do drug screens on cells growing in tissue culture that represent alzheimer's compared to normal in a way that we would not have dreamed to have that ability as a model. these are human cells. we can really start to figure out how to address therapeutic in a systematic and rational way and there's a lot of excitement in the field about seeing that go forward. we are doing everything we can to find those partnerships. amp is one of them to make sure we're building and the patient advocates are a wonderful group of supporters as well. but frankly, it is example of the fact that we've lost about 20% of our purchasing power for research since 2003. we really need to be able to get

back on a stable trajectory. that would benefit alzheimer's and that would deal with a lot of other things living out there as our population ages. senator collins: thank you very much. >> thank you, senator collins. senator warren. senator warren: thank you, mr. chairman and thank you, dr. collins, dr. hamburg for being here. i want to say as others have thank you, doctor, for your many years of service. the nation owes you a great debt. over the past 50 years, the american system of medical innovation has transformed the health of literally billions of people around the world. new treatments have given hope to people diagnosed with leukemia, hiv, breast cancer and other diseases that were once a death sentence. the basic mechanism for those remarkable achievements has two parts. taxpayer investment in basic research and investments that turn that research into viable products. of the 21 drugs with the highest therapeutic impact approved

between 1965 and 1992, 2/3 stem directly from discoveries made through government supported research. a recent study in health affairs found most of our truly transformtive modern drugs have their roots in public funding. this is no accident as we've talked about here for decades. congress grew the budget of the national institutes of health year by year. in the late 1990's, both parties worked together to double the budget for nih. the support has dried up since 2003 and the budget hasn't cap -- even kept up with the pace with inflation. as you know, dr. collins, its purchasing power is down nearly 25%. dr. collins, can you tell us how the collapse and congressional nih funding has heard the american -- hurt the american

pipeline of bio medical innovation? dr. collins thank you for the question. because this is the thing that worries me most and keeps me up at night is that we are not taking advantage of the remarkable abilities of american science to innovate to come up with new ideas that prevent and treat disease. one can simply look at the way in which nih has to deal with the ideas that come to us and basically leave about half of the ideas on the table that traditionally we would have funded, and that tells you what we are doing here in terms of slowing down the process of innovation. all the way from basic science through to clinical trials. and you might ask, well, maybe the part that we are leaving on the table is not quite as good as the stuff that we are funding. we have actually looked at that. and because when you look at the top third of applications, this is the really great science that we can't make respectively go back and say that those that scored in the 25th percentile weren't as good. they are indistinguishable. what does that say? that says we're leaving great stuff that would've been supported. and we are of course the foundation in many ways for this

wonderful success story of american science, which is public and private working together and what we discover has led to those breakthroughs that now people take for granted, but we can't keep taking for granted. senator warren: i think our first priority here would be to figure out how the nih, the resources it needs to replenish the pipeline a great research that is the foundation for better treatments and reliable cures, but instead, congress is focused on whether we lower the fda standards for approving drugs. i hear the arguments, but this is a dangerous game. the painkiller vioxx made it through the fda's process, but was later found to cause heart attacks. by one estimate, it killed 38,000 americans before being pulled from the market. dr. hamburg, what impact would lowering the fda's safety and effectiveness standards have on public health? dr. hamburg: as i said in my

remarks, i think lowering the standards would be very, very dangerous, detriment of the the health and safety of patients, bad for the health-care care system, but also bad for our wonderful preeminence in terms of our pharmaceutical biotech and medical device industries, in terms of their ability to actually deliver products for people who need them. we know that fda standards and our requirements around safety and efficacy over the years have actually helped to shape how by -- biomedical research and clinical research gets done. this notion of really structuring our investments in research so that we ask the right questions and we don't just published papers as dr. cassidy was saying, we actually make sure that we are leveraging the opportunities in science and technology to get important

treatments, preventive strategies, and cures. senator warren: so, you're saying if i understand it, the high standards are important not only for public safety, but also for help shaping the research that's going to give us the treatments that we need. dr. hamburg: absolutely. senator warren: i just want to say i am certain there are changes we could make at the fda to help speed up the approval process and get rid of unnecessary bureaucracy. when science supports change i'm eager to make change. but lowering fda's approval standards will not increase innovation. we could abolish the fda tomorrow and we'd see tons of new products on the market, but the goal isn't new products. to boost profits for the industry. we don't want another vioxx. the goal is innovative transformtive products that are safe and effective that will cure diseases, save money, save lives, and to achieve that goal, we need to start with the nih.

nearly everyone in congress says they support funding that agency, but talk is cheap and congress has decimated the nih's budget. single-handedly choking off support for projects that could lead to the next major breakthrough in alzheimer's and many other diseases. we could dismantle the fda, but that won't produce need cures for the disease is that maim or kill us. if we are serious about better health for children and seniors, they congress has to step up and make it real commitment of real dollars for scientific research. thank you, mr. chairman. >> thank you, senator warren. senator baldwin. senator baldwin: thank you, mr. chairman and ranking member. i am encouraged by this bipartisan effort to examine the entire discovery and development process for medical treatments. as someone who was raised by her grandparents, and my grandfather was an nih funded scientist at the university of wisconsin-madison, you can

understand that i have a long-term passion for a strong strong federal investment in basic research. but i remain concerned that budget cuts mandated by the budget control act passed put medical research at risk. in fact, we've been talking about that this morning. in fact, dr. collins, you have cautioned that we are putting an entire generation of scientists at risk. the average age of a researcher receiving her or his first grant is increasing. and budget cuts are discouraging young scientists from entering the field or forcing them to in some cases, leave the country in order to continue their research. to help address this last congress, i introduced the next generation research act that would coordinate efforts within nih and streamline current programs to improve

opportunities for new investigators. it would also promote new policies to increase diversity and improve the success of oin vest gators applying for their second grants. we've discussed this issue a number of times before and i'm encouraged that you share that i want rest and passion here. can you please discuss with the committee any plog that has been made through nih's existing programs such as the early stage investigator program and the director's new innovator award to bolster this emerging research workforce? >> i really appreciate the question because this is such a fundamentally important issue if we are going to have a future where medical biomedical research continues to flourish. we have instituted a number of programs that are aimed to try to encourage that next generation to see a path for themselves as successful and

visionary researchers. one thing that we have done which is now been i think quite helpful in that regard is to make sure if you're an early stage investigators who hasn't come to nih before with a proposal that you compete against other others who have been at this for a while. and that has done quite a bit to equal lies the success rate amongst the new bies. that is one thing. another thing is increase the number of awards a bridge to independence from a post doctoral fellowship. which we are finding to be a very successful way to make that leap from a training position to an independent faculty position in a research intensive university. we're also making sure that we have our graduate students and post docs exposed to multiple