the fact that they have an underlying administrative scheme doesn't mean they can investigate crimes through using this evidence. the court has said time and time again in its administrative decisions that it's really important that we involve the courts because those -- in this case has presented more starkly than any other, that you misuse the administrative process -- >> i think there may be an exception to that principal where the whole purpose of that scheme is to enable the detection of criminal activity. and then the objection would be the whole scheme is bad. you cannot require them to keep books. because it's whole purpose is to detect criminal activity. that's not what you're arguing. they can deep the books in order to detect criminal activity, but if they request the book in order to detect criminal activity, it's bad. it doesn't make sense at all. >> because it's not the argument. and that is -- >> what is the argument? >> their defense of the statute is not that the records are used to detect crime. they are used to deter crime. they don't look at the records to find criminals. all they do is look at the records to make sure we are keeping records. my point is that one day a police officer under this -- it

can happen regularly. if an officer will come in and say i'm not concerned about whether you filled tout the form. i think there might be a prostitute in room 3 and use it for criminal law. >> mr. goldstein, i thought an equally important purpose behind this law is, as you said earlier, prevent harassment. i don't like this hotel owner. i want to drive this hotel out of business. i'm going to be showing number his lobby every day. that's part of what's going on here, right? >> in fact the principal thing this court's precedence has pointed to -- look what's missing in this ordinance. every time they say we identify specifically the records. the question isn't what the records are. it's the loss of sense of tranquility provided by the

fourth amendment. we don't know how frequently and harassing purpose and what reasons at all if police officer will come in over and over again. >> have we used that phrase before? >> which one? >> tranquility? >> i don't think that word is. >> talk about privacy and all that. i'm not sure that the fourth amendment should be expanded to protect the sense of tranquility. >> the problem with tranquil hotel owners. i associate with owning a hotel. >> it is the sense of certainty that the fourth amendment provides that what you do know is that there are going to be limits on when the police come in and say show us your papers. that's what we are talking about. >> i think there's some -- they do it. in hotels they have these notices posted all over about where the first emergency exit is and all that. could police come in and check to make sure the hotel has those posted? >> yes. >> without any warrant? >> because they are in public spaces. >> is the back of a hotel room door, is that a private place? >> take for example in the back

of the restaurant, in the back of the kitchen -- >> i'm talking about every hotel room. >> inside the room? >> they say, look, this is a very important thing to make sure people don't die in a big fire. we want to make sure you have them. let me look at room 12. >> great example for us. that's a fire inspection regime. what has to happen is there has to be a subpoena ahead of time. at the very least this court -- the lowest level -- standard the court has ever applied is in a case called dewy. what dewy said is at the very least if you're not going to involve a court, you have to have a set of rules when these searches are going to be conducted and how often. >> i didn't understand your answer about harassment. maybe it is in the record. or maybe it's because this wasn't as applied. the police, even if this ordinance were invalidated, the police could show up whenever they wanted, couldn't they, and ask for the owner or person at the desk voluntarily to disclose the register? they could be in the lobby as much as they want. exactly how does this aid in harassment of hotels?

>> because of the fact that they are requiring us to produce private records. it was always the case in cases like bar lows, where the police couldn't show up and inspection the premises, they could harass. the court said if you're going -- everyone agrees this is a fourth amendment search. >> it's a public space. i don't know whether it's dispositive, but it's of some relevance. they walk in. two scenarios, one with the ordinance, one without. without, they walk in and said would you in the kindness of your heart look at the register? and the owner says no. i don't want to.

and they come back the next day and do the same thing. that's the first scenario. second is, they come in and say let us see the register. you show them the register. and what? it's a harassment because they sit there for a while and the guests coming in see the police in the lobby? i don't understand -- >> it's the fact that day after day after day we have to give them our private information. and it really will involve a problem, it can harass and put us out of business. imagine the following scenario. we are put in this position because they come up with this hypothetical about when it could be valid. the officers see someone come into the motel. each time they see someone come into the motel they come in and say we are the police. let us see the records. it can interfere -- >> if you had case specific example, that might be one thing. it would help if you could tell me what goes on in this precompliance judicial review. the hotel owner says, sorry. you can't look at the registry. i want judicial review. what is the nature of that

review? >> this court has considered that question in the fair labor standards act. banking context and tacks context. california bankers, donovan and loan stare what it has said is the administrative agent with the police officer, whoever enforces the law, don't have to go to a judge, is a one-page subpoena. then there is an objection by the business owner in any of these context. in banking, these are records that the government requires you to produce. and then what happens is that the -- what generally will be the rule, it's up to the city. the city will put the onus on us to go to a judge. the fact the onus is on us to go to a judge and the objections are limited. which is to say we only get to object this harassment. rule is they almost over give the records. it is the prospect we can go to a judge that tells the beat cop he needs to behave. >> those are the only objections that -- >> yes. >> harassment and using this for law enforcement. >> yes. that's in court's precedence. that's the rule -- >> how many of these courts precedents involve a business that has been treated like a

public utility? there are requirements for hotels how big the room has to be. how many people you can put in a room. even in many locations how much you can charge for the room. the hotel owner is not like the private business. he is a regulated provider of public services that has traditionally been regulated closely over the years. >> the first question you asked is how many times you have been asked that question, the answer is none. the second answer to your question is, in the relevant sense, which is to say how much of this property is protected and private, is that overwhelmingly hotels have constitutional protections. remember, 95% of this hotel is

going to be the guest rooms. and unlike in cases like -- remember they search the open junkyard. unlike cases like bizwell where you inspect the open storage or go behind the scenes, here the police can't do it. the fourth amendment, everybody agrees, protects privacy at the hotel. and so there is a much greater expectation of privacy on our part. >> the question that justice scalia is asking, is there a reason to think that hotels are a more heavily regulated industry than all the other industries that we can think of? >> no. just think about it. california bankers and miller are cases involving banking. banking is incredibly heavily regulated. you have to have a charter. the government requires all types of records. remember, justice scalia, those are the bank customers' records. they are about the bank customers' transactions. what the court said in both those cases, in rare exceptions like the $10,000 requirement. title 1 is constitutional because it requires a subpoena. there is a prospect of getting a judge involved if the bank secrecy requirement is too onerous. >> inn keepers have been regulated for centuries.

they have duties. to the public. i'm just puzzled by this. you concede the record has to be kept. but there are very few reasons for keeping those records other than law enforcement. >> that we disagree with justice kennedy. we have kept these records and innkeepers have kept these records fortime immemorial. we use these records for different purposes. every record of our business transaction. we use them to keep in touch with our customers. it's quite proprietary information. >> motel 6 does this? i never received anything from them. my goodness. [laughter] >> you may not be in their frequent guests. nobody doubts. remember, this is an ordinance that applies to the four seasons, and ritz carlton and everything else. they carve out a subsefment while we are attentive to the

point we are not asserting -- the guests are not asserting fourth amendment rights here let's not lose sight of the fact that these records can show very, very personal information. not just the driver's license information, but whether you stayed at a hotel during a religious or political convention. >> complaining about the privacy interest of the guests. >> justice scalia, here's the point. they agree this is a fourth amendment search, point one. then, what you are doing you have to make an honest assessment whether this information really does further the fourth amendment value of privacy.

it does. because this has private stuff in it. there's just no real dispute about that. i'm sympathetic to the fact that inn keepers have been regulated for a long time. in 99.4% of the jurisdictions in this country, this is not the rule. there are hundreds, but there are 18,000 other jurisdictions in which this is not the rule and apparently has never been the rule. and the nature of that regulation isn't one that impinges on our sense of privacy. we have to take guests, what does that tell us about whether our records are private? certainly we can identify a huge array of other businesses that are regulated. the one data point i want to make. mr. goldstein: that's the point. we they agree this is a fourth amendment search, point one. then what you are doing is if you have to make an honest assessment of whether this information really does further the fourth amendment value of privacy. and it does because this has private stuff in it. there's just no real dispute about that. and i am sympathetic, justice kennedy, to the fact that innkeepers have been regulated for a long time. i will simply say that in 99.4 percent of the jurisdictions in this country, this is not the rule. there are 100, but there are 18,000 other jurisdictions in which this is not the rule and apparently has never been the rule. and the nature of that regulation isn't one that, in the burger sense, impinges on our sense of privacy. we have to take guests, but what does that tell us about whether our records are private? and certainly, we can identify a

huge array of other businesses that are regulated. the one data point that i wanted to make is that in 2002, the department of justice did a study, and it found that 335 different provisions of federal law use the system that i just described for you; and that is the subpoena first in order to get the records. and there's a bare handful of them, none of them involving just bare records with the possible exception of the occ that use this exception that says, you never have to get a judge involved. it is the subpoenas -- chief justice roberts: 99.4% jurisdictions, does that include are you comparing the little hamlet in indiana with los angeles or new york? does new york city have something like this? mr. goldstein: i don't know the answer to the question of that particular city, but, your honor, they're including big and small and so am i. so there are a lot of big cities that don't have this rule. my point is this, justice kennedy -- justice kennedy: but you're you're saying, oh, the hotel has a private interest because it wants to know who its customers. but they can do that by keeping their own record consensually. you have conceded that they can require the information as a matter of law. mr. goldstein: well, that's because your precedents say they can, your honor. and my point is this, because your precedents say -- justice scalia: well, that means it's true. [laughter] mr. goldstein: well and hence, my answer yes. but my point is this: because they can do it here, justice kennedy, they can do it everywhere. the government can require any business to keep track of all of its transactions and all of its customers. and if the government can then just say, all right, now, give

us all that information, then they've reduced the fourth amendment to a nullity. the final point i'll make is that don't be confused with the idea that there's something special about hotels. the amount of government regulation here is massive. the reason that the deputy solicitor general is here on behalf of the united states is that there are hundreds and hundreds and hundreds of regulatory schemes the federal government administers where it is now required to use a subpoena. but what self-respecting regulator wouldn't love -- justice alito: a subpoena, a subpoena is worthless when what is sought is something that can be easily destroyed, hidden or falsified. it's, it's very useful if you're trying to get complicated records that can't be easily altered between the time when the subpoena is issued and the time when the subpoena is enforced. but nobody, nobody issues a subpoena for the murder weapon that one is you know, that you suspect is in somebody's house. so these records are more like the murder weapon where there's something that can be easily falsified. you, you seem to concede when you say that the police can seize them, then, then the subpoena is worthless. mr. goldstein: lone steer says the opposite with all respect, and that is, the records there are how many hours did someone work at what amount of pay. and if you can't falsify that just as quickly as you can falsify who's in room two, then i just don't understand the nature of recordkeeping. the court has insisted on this as a bare constitutional minimum, both to keep the enforcement officer in line and to let us know the enforcement officer is kept in line. it has not it has been attentive to the fact that we don't want to put undue burdens on the government and that is, it's just a subpoena and that we have less than fourth amendment rights. justice alito: you think you

think payroll records in general are no more complicated than the ledger at a motel that runs by the hour? mr. goldstein: in the relevant respect, justice alito, if the question is, did the person work 50 hours or 35 and the record says 50 the actual record would be 30, 50 and i just want to fill in 35, yes. the, the court didn't even think that that was a remotely plausible argument in that the line of cases that i'm describing. chief justice roberts: thank you, counsel. four minutes, mr. rosenkranz. mr. rosenkranz: thank you, your honor. let me start with the facial point and then circle back to the, to the merits. so as i hear mr. goldstein describing the rule, the only objections that are going to be raised are harassment and whether this is for a legitimate purpose, but if that's the concern, that's a classic as-applied challenge.

if a hotel has a cop coming up to them five times a day, they come in and say, this is really harassment. these searches are inappropriate. and if the if it's the purpose of the officer, he's doing criminal investigation rather than actually caring about whether my records are complete, that is an as-applied challenge. now, the plaintiffs have not even tried to demonstrate that this ordinance is unconstitutional in every circumstance. on pages 19 to 20 of our brief we develop numerous scenarios, and mr. goldstein mentioned only one of them. so, for example, where the hotel is required to upload the records to the police department every day, it may not even be a search, but it's certainly less intrusive. justice kennedy: but that's, that's not the statute. i didn't understand those examples because some of those examples, the police could act without this, without this. mr. rosenkranz: well -- justice kennedy: without this -- mr. rosenkranz: so not that one, your honor.

justice kennedy, not that one. so some of them in some of them, the ordinance has the purpose of requiring someone to do something that they would not otherwise have to submit to. but the one that i just gave as an example, the scenario of uploading the documents rather than the police conducting a search on the spot, is less intrusive. and the problem here is that the plaintiffs have tried to invalidate every possible application of this ordinance but they haven't done the intrusiveness, privacy government interest balance that one needs to do for each of them. but let me even circle to the merits because -- justice sotomayor: i'm still very confused about this. there is always a potential exception to a warrant, even a fourth amendment warrant of going into the home, exigent circumstances, there's someone sick on the other side, if there's a fleeing felon into the place, but that doesn't eliminate the need for a warrant. it's not a tell-us-later issue. police can't just keep going in and then fish around for an excuse. that's a process issue.

mr. rosenkranz: understood, your honor. justice sotomayor: you're entitled to a warrant, you're entitled to a subpoena, you're entitled that's what they're challenging, which is they're not challenging all of the other reasons why the police could go in legitimately -- mr. rosenkranz: well, your honor -- justice sotomayor: as an exception to the fourth amendment. they're asking whether this kind of search, generally, without all of those other exigent circumstances or other fourth amendment exceptions is constitutional. mr. rosenkranz: right, your honor. justice sotomayor: is the process here right. mr. rosenkranz: understood. and so let's not talk about the

exceptions. let's talk about another example where the motel continues to keep the register in the open, like they did for 100 years, and then snatches it away when the police come. that -- justice sotomayor: you know something, but that's a different issue. it's in the public. mr. rosenkranz: well, right. and they would -- justice sotomayor: and how often do you think that's going to happen? mr. rosenkranz: and for that reason, they would have no expectation of privacy and the fourth amendment calculus would be totally different. but let me let me -- justice kagan: well, but then it's not a search at all. and, once again, it's not this statute that's doing the work. mr. rosenkranz: well, no, your honor. if they snatch it away, it certainly is this ordinance that is doing the work. justice kagan: you're saying that they have no expectation of privacy. we wouldn't we wouldn't say it's a search at all, and the police can take it away. it doesn't depend on this statute. mr. rosenkranz: well, no exactly. we would we would win the fourth amendment case, but they would but that has been invalidated by deciding this on a facial basis. chief justice roberts: counsel our questions intruded on your rebuttal time. why don't you take an extra minute or so? mr. rosenkranz: thank you, your honor. so let me just emphasize that this is a very narrow rule that we're talking about. we're talking about a rule that is unlikely to be repeated in so many of the other circumstances that have been discussed today. it's about an inspection of only a single book of information that the government requires hotels to maintain and that the that mr. goldstein has admitted the government should can require hotels to maintain.

it's in a context that is especially prone to criminality. people are using these hotels precisely to commit crimes where the gaps are quite detectable in real-time but not detectable otherwise. in an industry where there has been hundreds of years of regulation including a history of warrantless searches that are even broader at the time of the founding, hotels were being searched with without warrants at the time of the founding and a history of a hundred years of police inspections in los angeles itself and even a hundred years of these things being open to the public. if the court has no further questions, we respectfully request that the court reverse. chief justice roberts: thank you, counsel. the case is submitted.

crank's here are some of our featured programs for this weekend. saturday, book tv is live from the university of arizona. sessions on race and politics, civil war, and by magazine writers. sunday at 1:00, we continue live coverage with panels on the obama administration, the future of politics, and football. saturday morning on american history tv on c-span3, we're live from a university in for junior for the civil war seminar. authors talk about the week's in 1855. sunday, live coverage continues with remarks on the surrender of the confederacy. find a complete television schedule at c-span.org and let

us know what you think about the programs do you are watching. call us or e-mail. or send a tweet at c-span #comments. like us on facebook, follow us on twitter. crocs hillary clinton spoke with reporters for the first time tuesday about her use of a private e-mail account while serving as secretary of state. here is a look. there are 4 -- secretary clinton: i opted for convenience to use my personal account which was allowed by the state department because i thought it would be easier to carry one device for my e-mails instead of two. looking back, it would have been

that her if i simply used a second account and carried a second phone that at the time this did not seem like an issue. second the vast majority of my e-mails went to government employees at their government addresses which means they were captured and preserved immediately on the system at the state department. third, after i left office the state department and ask former secretary of state for our assistance in providing copies of work-related e-mails from personal accounts. i responded right away and provided all of my e-mails that could possibly be work-related, which totaled roughly 55 thousand printed pages, even though i knew that the state department already had the vast majority of them. we went through a thorough

process to identify all of my work related he-mails and deliver them to the state department. at the end, i chose not to keep my private, personal e-mails e-mails about planning chelsea's wedding or my mother's funeral arrangements, condolence notes to friends as well as yoga routines, family vacations, the other things you typically find in inboxes. no one wants their personal e-mails made public and i think most people understand that and respect that privacy. fourth, i took the unprecedented step of asking that the state department make all my work-related e-mails public for everyone to see. i am very proud of the work that i and my colleagues and our public servants at the department did during my four years as secretary of state.

crank's at about an hour before secretary clinton spoke here is a look at what state department spokesperson had to say. crocs that is what we have been discussing internally. let me give you an update on where we are. the entire 55,000 release was done in one batch at the end of the review to ensure that standards were kept. the review will take several months. that has not changed. the release will be posted on a website. i will have more information about that soon. the only document we will review are the approximately 300 e-mails already produced to the

committee. they will be reviewed and release priority the whole set. they will be made publicly available. kreg's you are going to put them up publicly anyway. kreg's yes. they will be publicly available. they will be publicly available. >> you realize that might be hard to have in estimate on how hard it will be to go through or how long it will take. >> it is shorter than 55,000. i do not have an estimate on that particular piece. i can check and see if there is more specific to. let me add one more thing. read asked that this week. specifically the criteria would

include national security, personal privacy privilege and trade secrets among others. as for a regular process, we will identify the reason for any reduction. >> one last, did anyone ask did you all ask more in the version as well as paper? >> i do not believe so. i think this has been handled in a specific way for some time. >> see this on our video library anytime at c-span.org. >> the political landscape has changed with the 114th congress. not only are there 40 new republicans and 15 new republicans and 12 new republicans and what new democrat in the senate, there's also more women in congress including the first

african-american woman in congress. keep track using the congressional chronicle on c-span.org. lots of information there including voting results. new congress, best access. on c-span, c-span2, c-span radio and c-span.org. >> this sunday on q1 day, dr. dirt of the georgetown university watchdog project. on how pharmaceutical companies influence doctors on what medications to subscribe. >> the permissions for drugs start 7-10 years before the drug comes on the market. it is illegal to market before it has been approved by the fda but it is not illegal to market for a disease.

so sometimes certain conditions have been exaggerated or exaggerated by importance of mechanism of a drug for example. then blanketed medical journals and meetings and other venues with these messages that are meant to prepare clinicians to accept a particular drug. they also prepare the minds of consumers to accept a particular condition. >> sunday night on c-span's q1 day. -- q7a. coming up, hillary clinton speaks for the first time on using a private e-mail account while serving as secretary of state. after that, washington journal is up. later, ashton carter, secretary of state john kerry and general

martin dempsey testify on the dissidents's request for military force against isis. >> coming up today on c-span3, the senate commerce committee looks at the national wireless flick safety network. on monday, board members approved a public notice for comments on allowing states and territories to opt out of the national network. states can adopt a plan or create their own network that meets standards. that gets underway at 10:00 a.m. eastern. now, the senate health committee looks at the impact of medical innovation on patients. this includes dock or francis collins and commissioner

margaret hamburg. this runs about two hours. >> please come to order. we will have an opening statement and introduce witnesses. 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 plan. but, we do not have two people who know more about what we're talking about the in 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 byrd senator bennett and i have 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 tended 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 to the medicine cabinet. we're not just talking about moving it through the fda. sometimes it takes two, four six, ten, twelve 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 dr. hamburg, who is here today has said that we are left relying on the 20th century approaches for the review of frugal and oversight of the treatment and cures of the 21st century. 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 and some patients with cystic fibrosis, this approach has reversed the disease once thought unstopal. -- 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 mutated gene for which there's now a drug. and i think the legislation senator bennet, senator byrd 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 byrd 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 twelve 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 change 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 have relate to money. some don't. some relate just to the pileup of 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 on on the -- to every student's tuition at the university. so, there are a whole range of things. i'm looking forward to this. 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. >> 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 owe 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 course 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 cabinets, they deserve every assurance that the medicines they take are safe and effective. and that is just as true today. so, 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. >> 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 to especially on their precision medicine initiative.

each witness we've asked -- i'd ask each of you to summarize, if you can, in about ten 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. 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 jen i'm project which led to the first completely sequenced human genome in 2003. next we'll hear from dr. hamburg, commissioners 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

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 -- 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. all right. 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 and 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 a.m.p. this is an unprecedented precompetitive, public/private partnership using cutting-edge scientific approaches to choose the most promising targets for therapeutic intervention. decides nih, a.m.p. partners include importantly the fda, ten biopharmaceutical firms and a number of nonprofits including patient advocacy groups. initially, a.m.p. is focusing on three disease areas that are ripe for discovery at the next generation of drug therapyiestherapies, 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, impasse. 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. now these organoid chips, and you can see the heart chip is beating in realtime 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 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 resonses, the so-called liquid biopsies. and exploring new treatments including combination therapies targeted to the jen etic 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 med send 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 inad nachlt was dying nosed 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 reserpt 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 humor shrunk dramatically, as you can see. this was followed by surgery to remove cancerous tissue plus retreatment with tarcibap today, seven years after her diagnosis, her doctors can detect no signs of cancer. what's more, she 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. >> thank you, dr. collins. dr. hamburg? >> thank you, mr. chairman, and members of the committee. i'm very --. 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. and fda looks 2350rd 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 principle 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 solution that will actually deliver those cures. so let me give you three examples of misconceptions. first, the incorrect but commonly repeated assertion that fda's approval of new drugs lags behind other countries. reality is starkly different. over 75% of the new drugs approved by japan, eu, 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 has set the 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 input. one-third 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 placed 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 to the 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 methodology 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 product. 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. >> 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. in 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 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? and are there things that we can do to change the law to make that easier for you to do? >> well, thank you for the question, senator. we, too, are very concerned about the idea that investigators are spending 42% of their time dealing with administrative matters, instead of directly engaged in research, and we're part of the support of that survey. which showed that number has not really changed from 2005 to 2012. we are undertaking a number of things that we have the ability to do to try to limit the amount of administrative oversight but not all of that falls within our purview.

some of it comes from other directions. some of it is from the universities themselves. things that we have done are to standardize the biographical sketch, the cv that individuals have to provide when they apply for a grant. that actually turns out to be a substantial asiance. something we're in the middle of, where perhaps some help could be offered, is a revision of how to interpret the common rule that oversees the research involving human subjects, which has not gone through a revision in 20 years and which does not currently take account of the risk involved in study and applies a great deal of oversight to some studies that are truly low risk, as if they were, in fact, invasive drs >> dr. cons may i interrupt in this way. could you be willing to work with us to identify what those things are specifically so that during this next several months we can -- we need to make changes in the law that we can help with that? because i want to ask you and dr. hamburg this question. >> yes. >> and give you. we don't want to waste our time in the next year. and we can't do everything.

so, could you say now, and then if you want to submit it later in addition to your statement, what would you -- what are the one or two or three things that we should focus on, and in order to make the greatest contribution to the goal of moving medicines, devices, and treatments from discovery to the medicine cabinet as you put it, or to the doctor's office? and each of you. >> senator, i appreciate that question. and i have a long list, and i very much look forward to talking with you at greater opportunity -- >> we'll do that. >> but if you want me to name two, one which sounds pedestrian but is an incredibly vexing situation, and terribly wasteful for sciences' time is the rigorous oversight of attendance of scientists at scientific meetings. this applies to both nih and fda. we're currently spending about $16 million and using run dreads of employees to go through a process which as far

as i can say has relatively little, if any, added value. all of this triggered by some misas ventures by other agencies who convene conferences in places like las vegas, for which we are all now paying the price. but scientists going to conferences is a critical part of how we move things forward. how new ideas emerge. and it is very much being inhibited by this very heavy handed oversight and we could much benefit from your help there. the second one i could say, nsf and the department of energy and their scientific budgeting that happens every year, they're allowed to carry funds over into a second year. we are not. so we have come up to the end of september, oftentimes with money that we need to spend, or it goes away. if we had the opportunity to carry that over, wouldn't cost another dime, we could be more flexible in how we spend the taxpayers' money. >> thank you dr. collins. dr. hamburg? >> i certainly agree with what dr. collins said. are you looking specifically for administrative issues or broader?

>> anything. i just want to make sure we don't waste our time. that we focus on getting a result. one or two things, whatever you think. >> let me step to a slightly higher level in terms of what i think are two critical and related needs in terms of being able to advance fda's activities, and, in fact, support biomedical research and product development. one is that i do believe we need to invest more money in regulatory science that develops the knowledge and the tools and approaches and strategies that really enable to assess in an effective and efficient way the safety efficacy, quality and performance of a product. it's been an underappreciated, underdeveloped, and underinvested in area of our overall biomedical product enterprise and it's proving to be really essential as we are trying to take that last set of steps from research and development, into a product that will really make a difference in people's lives. and that we've laid out, i think, an important exciting research agenda. and we've done work with nih in this domain. i think the other areas to recognize is that fda and our

scientists have a huge amount to contribute to the overall process of product development as well as our important responsibility for review. and you know, certainly for us to be able to engage in a consistent way earlier, as research plans are being shaped so that the right studies are done, so that the return on investment of moneys in research all along the way are really driving towards a product that works. >> thank you very much. senator murray? >> thank you very much. dr. hamburg, before i go to broader topics, i wanted to ask you about the recent outbreaks of drug resistant bacterial infections that are associated with the use of the special medical scopes known as duodenoscopes. one in my home state of washington there were 32 patients infected and although it's not clear what caused their deaths, 11 have died.

how -- fda was supposed to have been regulating these scopes. can you explain how this could have happened and what actions fda has taken? >> the doodenoscopes are important medical devices that serve a critical role in patient care and diagnosing and treating a series of important problems and they are, in fact used in more than 500,000 procedures a year in this country. usually with great benefit to patients, and it allows an approach that is less invasive than open surgery, and overall has less attendant risks to the patient's health and safety. over time, we saw isolated cases of problems in terms of infection, and duodenoscopes and we would investigate those and they were always associated with some lapse in the disinfection protocols. in 2013, late 2013, we learned

for the first time of some outbreaks, unfortunately involving an antibiotic resistant strain of bacteria where on investigation it seemed as though all of the procedures for disinfection had been followed. and after that we began to work closely with our colleagues at the cdc, with the health care provider community, 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, or have to kind of twist around and has what's called an elevator mechanism. so we are actively engaged in trying to come up with better strategies for disinfection and recommendations to increase the

margin of safety. we're going to be hosting an advisory committee meeting. we're working with -- >> can you submit the full fda review to me so we can understand how this happened and protect against it happening? because i'm deeply concerned about it. >> as are we. we are very actively engaged, a lot of activities are going to be happening moving forward as we continue to try to strengthen the safety of patients and improve what are very important medical devices for care. >> i appreciate that. on a broader issue, dr. collins, the united states has always been a global leader in biomedical research and innovation. but today as you and i both know sequestration really threatens that leadership and i think it's critical that we build on the bipartisan budget deal that i reached with congressman ryan last year. the house rolled back those

cuts from sequestration. we're just about to enter another budget process. can you explain to all of us today now sequester impacted research at nih? >> well, thank you for the question. it certainly was a serious blow to momentum. the 1.55 billion dollars that were taken away from our budget in the middle of the fiscal year. resulted in our inability to fund about 750 grants that otherwise would have been funded that year and those very good ideas basically got left on the table. as you know we were able to make up some of that ground in the subsequent years, but in 2015, we did not recover the entire $1.5 billion that was lost in 2013. the results of that in terms of what they've done to investigators who are already struggling with difficulty in getting their grants funded really has been quite significant. the overall likelihood, if you send your best ideas to nih of having that supported, has dropped over the course of the last ten years, since the budgets became flat and inflation has been eroding away. and our ability to support research. and it is important to point out, and you've made this

point, that this is something which puts america at a limited competitiveness status, as well. if you look to see what other countries are growing to show your graph here from 2011 to 2013 in the change in percentage of gdp invested in research you can see that countries like china and brazil, south korea and so on, are substantially increasing their investment. they're reading from our playbook from the 1980s and '90s, whereas we stand alone in this graph as actually losing ground. the consequences of that is we are also losing opportunities for science. we're losing jobs. and we're potentially at risk of losing young investigators who are beginning to wonder whether there's a future for them, and some of them are starting to think about it. >> and the threat of that sequestration going in again in a few short months, what's that doing to you? >> that hangs over us like a dark cloud. because if sequestration is not dealt with we stand to lose another $19 billion. we've gone to medical research over the coming years, and the consequences of that are really

painful to consider. >> thank you. >> thank you, senator murray. senator burr and then senator mikulski. >> dr. collins, dr. hamburg, welcome. dr. collins in your testimony you highlighted the potential to better target medicines to specific patient needs. what role does biomarker qualification employ in advancing these patient focused therapies? >> again i appreciate the question. i mentioned that we had a three-hour meeting yesterday between nih and fda and one of our topics was biomarkers because of our shared interest in trying to move this agenda forward. as dr. hamburg said in her opening statement there are lots of biomarkers that have been used for a long time. measuring your blood pressure is basically a biomarker that we use to assess risk of

cardiovascular disease and stroke. we would love to see biomarkers develop for something like alzheimer's disease which she also mentioned. i pointed out this accelerated medicines partnership that we're doing jointly with industry, as that is one of its goals for alzheimer's so we're making sure that all clinical trials that are trying out new ideas about prevention of alzheimer's disease use the same set of biomarkers. so that if something starts to work, maybe it's a blood test. maybe it's a major protein in the spinal fluid. maybe it's a scan of something like an amyloid in the brain we would know that and we'd be able then to begin to utilize for therapeutics. >> you're both nih and fda participant in the biomarker consortium. >> yes. >> so let me ask, since the consortium was established in 2006, how many biomarkers has it qualified? >> the biomarkers consortium has partnership from nih, from industry and from patient organizations it is not itself charged with doing biomarker qualification. it's charged with identify possible biomarkers that need more research and making sure the research happens. the fda has the role of qualifying the biomarkers if they have reached that standard. >> so, they've got full

determination based upon what the consortium comes up with as to whether they recognize the biomarker? >> they need to evaluate, and i'll certainly depend on dr. hamburg to specifically state the process. whether the science is strong enough for a particular biomarker to be considered validated, qualified, so that it can be used for rigorous studies have shown that it actually is a predictor of what you want it to predict. >> dr. hamburg, let me turn to you, if i could. fda's drug development tool qualifications programs notes the importance of 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 and some medical countermeasures. therefore fda's animal rule is particularly important for such products, which is why i emphasize the importance of finalizing animal rule guidance with dr. boryo before this

committee. as far as i can tell there's been no further movement on this issue since that hearing so i'd like to ask you, when is the animal rule guidance going to be finalized as required by law? >> well, let me first begin by thanking you for all the extraordinary work you've done to advance public health preparedness, and the development, and availability of important medical countermeasures and the animal rule, as you note, is an aspect of this that is key, because we do need to develop medical countermeasures against certain threats where the disease may not exist in nature, and 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 animal rule very seriously.

it's one of those areas of regulatory science that is challengeing because we want to be able to know that using animal data, which is often imperfect, we can make a good enough assessment of safety and effectiveness and appropriate use of a product against what is generally going to be a terrible life threatening disease, so we have been working on the animal rule for quite awhile in the best scientific strategies, engaging with the research community and obviously companies, as well. we did put forward a draft guidance and comment i think ended on that back in august 2014. we got a lot of response, and we've had a lot of meetings -- >> is this a priority? >> it is a priority, absolutely.

>> when are we going to have a final rule? >> well i think it will be soon. i can't say that you'll have it before i step down at the end of the month. but it has been a priority of mine from very early in my tenure, as you may know. i've been working on many of these kinds of issues before i joined the fda. but it is a scientific challenge, and, in fact, the guidances, and the work and the draft guidance has shaped work that's being done and moving that's being done in moving forward. it hasn't stopped prorks edped progress, but we will get it done and i will go back and remind the team there's a very important senator waiting for that as are the american people. >> if i didn't mention the same time, about a similar pathways. and the fact that we have yet to have that final guidance and -- response senator murray's statement on what happens in sequestration. there's no consistency, you can't fund the things you think might generate. i would only say this. there are a lot of companies and efforts out there waiting for a pathway. we just approved the first bio similars in fda and we don't have a pathway.

we don't have a final guidance for the other manufacturers out there, so you've got a company that had one approved, but nobody else knows how to get theirs approved because there's no guidance on how to approach it. my only suggestion is this is as important as how we fund research. that having enough markers qualified, having financial guidance for bio similar ises, having a funl rule on the animal rule is all part of how we have a robust response to disease and we change the outcomes of patients in the future. i thank both of you. >> thank you, senator burr. >> thank you, mr. chairman and thank you for both convening this hearing in the

spirit in which you did. a bipartisan effort that you would promote science innovation in this country. which leads to you new ideas new research, new products that not only save lives, but create jobs in our own community. i would also welcome dr. collins and hamburg here. i have great joy of having -- in my state. we have really every day and every way, think about how they can advance the mission of these agencies. i'd like to thank them for hanging in there because many of the impediments that are created are impediments we create ourself ourselves. not only do we try to find new ideas, but maybe we need to get back to some old fashioned ideas of working together like the chairman has said. dr. hamburg, i know you're leading the fda, but you're going to continue to serve in many capacities and they say you're the longest serving, i'm the longest serving and here we

are, each turning a new page. i'd also like to take this opportunity to thank the men and women who work at these agencies, nih, n fda. you have to know for my 20 years of service is to wake up every day and think about how i can make the world a better place and i have these two fabulous agencies where my job is to help you be you. and i cannot tell you the pride and enthusiasm and joy that that has brought me. so, let me get to what i think are the three criteria for reform and get to my questions. number one, let's respect the mission or the agency and let's respect the men and women who work at the agency. i think respect goes a long way to improving moral. moral goes a long way in increasing productivity and i would hope the congress of the united states would embrace the

idea of respecting the men and women who work in our federal agencies and not treat them as cheap thrill reminds on talk shows. the second is adequate resources so you can do the job and have the tools you need and then third, let's approach reform in a targeted way the chairman has indicated. let's focus on specific problems and specific solutions. so so, i -- to my members here to think about the three rs. respect, resources and reform that's targeted. which then goes to my question dr. collins, and you, dr. hamburg. senator murray raised the question of sequester. that then goes to

predictability. which you share with the committee the impact because each one by dr. hamburg, many of the reports they say there's been a big turnover at fda. whether that's numerically justified, i'm not sure. so many accusations aren't just justified, but could you share with us what that means in terms of the predictableility, sustainability as well as the addequacy adequacy. what will predictability and certainty mean at fda? >> certainly the it is key. we hear it from the industries that we regulate in terms of how we oversee them and it's essential to us to be able to do our job. we need to be able to lay out programs that are not occurring in one year time frames, but over time, we need to be able to recruit the best and the brightest scientists and other professionals that we can that are highly competitive, outside of fda so they need to know that they're going to be working in an environment where they're going to get the resources that they need and the support they need in a continuing way. we certainly need every dollar

that we get as was noted, we have a very broad span of roles and rommeties overseeing products that matter greatly to every american, every single day and we are stretched very thin, so, uncertainty and instability in our funding programs make it harder for us. >> recruit and retain. and therefore, get the experience. >> and to make wise choices. the other then with the predictability, what about you, dr. collins? >> i appreciate the question and senator, your strong support has been incredibly valuable and we are all grievinging the fact you're planning to move away in two years and we hope this can be an opportunity for lots more conversation mountain conversation in the meanwhile. i think the idea of stability is is just crucial. especially for those who are early in their careers. they have visionary ideas. they're fearless about taking on the problems that couldn't

be approached before, but the technology now makes it possible. but when they're uncertain about long-term support for that, that's discouraging. another grab i'll show you mostly troubles i think today invest gitigateors is what's happened to your likelihood of getting supported by nih, which has run around 30%. it's below 20% now. running about 16 or 17%. that means five chances out of six, your idea is going to get a no. and that a means your science is left on the table unattended. that is enormously discouraging. if we could turn that corner and the president's budget as you can see that little uptick there, aimed to try to do that we could turn this whole circumstance around in the united states. we could refwan gain the kind of momentum and leadership we've had unquestioned over the past many decades, but it is at risk.

>> so, one is adequacy. i know my time is up, but i just bring to my committee, two things. during the sequester, fda couldn't use the user fees the private sector was paying in. but here's the private sector giving the money after an arduous work to create a contemporary bah due pha. there was one. and the very day before sequester, they announced they lower ed lowered cancer rates in this country 12%, so instead of pinning medals on people, we were getting ready to print pink slips. i don't think that's the right way to govern. >> senator isaacson and -- >> thank you, mr. chairman. this is my first time publicly to be able to acknowledge the great contribution of senator mccull ski to public health in american and i just want to publicly thank her for all these done. it's been a pleasure to serve her on this committee. dr. hamburg, senator burr is right on target and this is a long

lead up to a question and i apologize for that, but it's a very important question that needs to be answered. you made a reference in your statement some blame the lack of investment and bio technology on the fda and you refuted that, but investment follows certainty and certainty follows regulatory processes that work, so i find it troubles the fda has so much difficulty working through the regulatory process and last year's user fee bill, congress directed you to fix the problems that have affected manufacturers and suppliers of medical gas. that was a year ago, yet we're still waiting on a report and some say we're heard there's resistance in the agency to doing so in issuing new regulations. instead, the fda seems to rely heavily on approaches such as guidances and untitle working letters. these don't over certainty and in the case of untitled edd letters, they fail to inensure any letters and stakeholders who are similarly situated. last may, the chairman and many members of this community sent

you a letter posing questions about the agency's use of draft guidance. we received the response last night. 12 hours before this hearing. in the letter, you attached 172 outstanding draft guidance issues. one of which goes back to 1988. show this effective regulation and effective process? >> well, we are taking a very active look at the various guidances and what stage they're in. it's important to understand that a guidance is just that. it's a guidance to inform industry about our current thinking and the process of developing a draft guidance to a final guidance is all extremely useful in that process, when the draft

guidance goes forward, it enables us to put forward how we are thinking about the problem and to ask some questions and get information back to further engage with all of the critical stakeholders. and it's an ongoing process. guidances are not regulations with the force of law, but it helps 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 that we should not have that many guidances in 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 as we were discussing, so i hope it won't be me coming back before you

but i hope that soon, you know we will be able to demonstrate what has been done with respect to some of those guidances that are in draft that may no longer really need to be and those where we can translate it into final and this is an area where frankly, you know, we are not the only ones involved in shapeing the guidance process and it does have to go through a series of other reviews before it can be published as final, but i take your point. >> one other question that relate to that point in a different way. i'm a victim of melanoma twice and the surgeon general issued a report saying it costs america 8 $.1 billion a year in health. it's a major portion of his recent statements. i hear little from the fda regarding that and we worked hard on the sunscreen expedition act to try to expedite the ingredients to be approved for overthe counter sunscreen products. can you tell me why they are so

reluctant to follow through? >> we are committed to following through and preventing melanoma is a -- prevention comes first. we're committed to what was laid out in the sunscreen innovation act in terms of responding to the identified timelines and process. we do need to work with industry to get the data that we need to assess safety and effectiveness and that is of course because these products are used widely, applied often and hopefully, with the right amount, they're used chronically and they, we need to understand about their absorption of these chemicals and what that means for safety and efficacy in the individuals using them, including many young children who may be at greater risk in terms of

chronic use, so, we want to move forward. we want to have the american people to have more options in terms of sunscreen products and the protection it can afford but we want to work with industry to make sure the ingred yents in those work and that they're safe, especially for chronic use. >> my time is up, but i'd like to urge you to do everything you can to expea diet those approvals. >> thank you, senator. i'm calling on senators in order of seniority if they were here at 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 -- 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 only wanted to drugs and that pipeline, but 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 warmly 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 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? >> 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 strip -- 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 70 -- how senator cassidy, white house, and warns. next for senator cassidy. >> one, great job. in my six years, you have done a remarkable progress, so thank you for that. >> thank you. >> 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? >> 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. >> but the resources flow between the two, so one division would it have far more resources than the other? >> not always because -- >> so, if not -- >> we were talking about the user fees before. >> 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. >> 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? >> yes. 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? >> 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. >> 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 day with a future of being awarded a grant question? 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. >> i can provide that data for the record.

we have encouraged translation at nah -- 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. >> 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 hundred million dollars 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. >> 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 come all the participants seem to be the big manufacturers, and obviously, if you are big manufacturer in a world in which only big manufacturers consists the -- 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? i mentioned the accelerating medicines partnership, start with you, dr. collins and i asked dr. hamburg the same thing. >> 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 farm is that are 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. >> 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 they wonder why we put that additional demand on the process if the outcome is inevitable, so he 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. >> 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 diet -- 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 signs 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 conical 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 not 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. >> thank you. >> thank you, senator whitehouse. senator collins and warren. >> 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 -dedicated -- 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, it's to be the age

where they agent to medicare and they lose their coverage for the cgm. this has led me to question whether cms consoles with the fda and the nih in making its coverage decisions. do they consult with you and where you to agencies -- were your to agencies consulted in the case of this denial of coverage? >> 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 -- series, so that as

data is being collected in the product development states -- space, data that will meet the needs of both agencies can be gathered and examined. you know, there are obviously decisions 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. >> 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. >> happy to. >> thank you. you put up a fascinating chart in which you show the tremendous progress that we've made with disease -- 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. im, as you know, very concerned about the trajectory of alzheimer's disease which is

passed -- fast becoming our most costly disease in this country. as a society, we spend $226 billion a year caring for people with alzheimer's. at of that amount, 150 $3 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? >> 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 that 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 in this 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. >> thank you very much. >> thank you, senator collins. 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, two-thirds 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 1990s, both parties worked together to double the budget for nih.

the support has dried up since 2003 and the budget hasn't cap 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? >> 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 signs 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 support -- 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. >> 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 curious, 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? >> 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 the local receipts -- 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. 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. >> absolutely. >> 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 size 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 help 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. >> 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 help increase diversity and improve the success of investigators who are applying for their second grants. dr. collins, we've discussed this issue a number of times before and i'm encouraged that you share that interest and passion here. can you please discuss with the committee any progress 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're going to have a future american biomedical research continues to flourish. we have, in fact instituted a number of programs that are aimed to try to encourage that to see a path for themselves as successful and visionary researchers. one thing that has been helpful in that regard is to make sure that if you are an early stage investigator who hasn't come to nih before with a proposal, that you compete against others of that sort, as opposed to being thrown into the main pool with very experienced investigators have been at this for a wild and that has done quite a bit to equalize the success rates for those not been in this business. that is one thing. another thing that we have done is to increase the number of awards which are a bridge to

independence which are awards which we are finding to be a very successful way to make that leap from a trained physician to an independent faculty position in a research intensive university. we are also making sure that we have our graduate students and postdoctoral's exposed to multiple different kinds of career pass because not all the need to end up in a research track faculty in an intensive university. there are jobs and industry jobs and policy, journalism, and many other places where phd level individuals are needed and we want to make sure people find the right match for themselves. we have started new programs and early independence award, one i'm quite excited about, which basically allows a very talented phd to skip the postdoc and go to an independent position. i go to presentations every year and it is the most exciting day

of the year for me because of their vision and their ideas. similarly, we have this new innovator award where you can apply if you previously had an nih grant and your idea has to be out of the box, groundbreaking, a little wacky for you to be allowed to be applied for that proposal. and would look at the output of that, it has been truly impressive the outcome that we get. all that is great, but it doesn't solve the main problem that we have, which is this loss and purchasing power for research. we can try to balance things as best we can, prevent -- protect those young investigators. we can only go so far and we really need to turn the corner. >> i appreciate that and you know resources are obviously key to this, as well as the coronation of programs that we have discussed in the bill that i introduced and will be shortly reintroducing. the flipside of that, dr. collins, is what would be the impact of nih's current programs for new researchers, as well as

impressive new initiatives and congress should not reverse sequestration? >> i think we continue to see this downward curve, which is very troubling indeed. surveys have indicated close to 20% of researchers supported by nih are now contemplating moving to another country or another kind of career path because of concerns of a half. i just spent -- last week, i was in san diego. i met with the md training students in so-called medical scientist training program. there was a room full of the most incredibly gifted, talented future physician, scientists you could imagine. in the past when i've met with groups like that 10 years ago it was all about the signs and how excited they were, but this was a group whose brows were for a -- were furloughed. -- were furrowed. that's what i meant to say, who were really deeply anxious about whether there's a path for them.

their questions weren't so much about science as to whether i could give them a sense of optimism about their future. i tried, but it wasn't as easy as it should have been given the talent in this room. >> senator casey. >> thank you, mr. chairman. >> i want to thank you and the ranking member for having this hearing. these are deadly serious issues the ones that dr. collins just spoke to, about the impact of funding. it is probably the worst example of how foolish and we can imagine. and sometimes, it comes down to one name, one person, one case. there's a young girl in pennsylvania, 9-year-old, who thankfully is healthy right now. emily whitehead, who had a particular kind of leukemia and the only way her life was saved was because of an experimental t cell therapy pioneered by folks researcher, i should say, nih

funded researchers at children's hospital in philadelphia. i have to ask what it comes to these debates about funding levels, which frankly, are rather bizarre when you consider the outcomes, positive outcomes that we have to nih, i have to ask what it down the road because we didn't make the investment because congress failed, would the next emily whitehead be saved? so, i think it's worth not just contemplating, but using those examples as a spring board to action. dr. collins, i just want to go back to something you mentioned before. and i know it's my way of reiteration, but it's important to repeat ourselves around here. people get the message a little better. did you say that nih has lost 23% of its purchasing power since 2003? is that accurate?

>> that is, in fact, accurate and i can actually show you a graph that would maybe make that more clear. if you look there at the l lines, -- the yellow line, that is the nih budget adjusted for fx of inflation. you can see that doubling up to 2003 in the steady deterioration since then, and that adds up to about 22% or 22% loss and purchasing power of the last 12 years. >> and the other part of this which you highlighted, and this is one i had not heard, the percent of those contemplating moving out of the u.s. because the lack of funding or, i guess it would be uncertainty regarding funding, what percent of that are researchers? >> in this particular survey, it was 18% who said they were significantly contemplating that kind of drastic step. i really appreciate your raising emily whitehead as an example of what we need to have more of. i met emily whitehead in the white house. senator alexander was there that

moment -- morning as well. emily was there for the announcement by the medicine initiative as was her doctor carl june. this is the kind of amazing success story that we believe is out there in greater numbers but we have to be sure that we're investing in all of the steps it takes to get there. what happened with emily, you can trace back 50 years of hard work understanding immune system and understanding cancer. ultimately getting to that point. it didn't just arise out of nowhere. >> dr., i wanted to ask you about the president's initiative, the precision medicine initiative. in that, in the context of emily and other children, tell me about how that can and any other undertaking or initiative that nih will be involved in, will focus more on the pediatric research, the pediatric research at least of those breakthroughs. >> well, the precision medicine

initiative aims to have an early focus on cancer and a longer term effort to try to build this million strong cohort across the nation, to try to take advantage of a coalescence of really exciting technological opportunities. one is of course the genomic revolution, to get information about dna at a low cost. another is the advent of electronic health records, which are now the norm in many health care delivery systems. another is the ability to use wearable sensors. people are excited about having access to detect various aspects of human physiology. whether it is some been at the text blood glucose or something that is monitoring your environmental exposures or your diet or your blood pressure. all those things are coming into their world. to have a very large school -- to have a very large scale distribution across gender crossed young -- across geography, we can really begin

to figure out what are the risk factors for disease and what can we do about them and how can we monitor and treat chronic disease more effectively. having that very large scale effort, this is a joint effort between nih, our partners at fda , and the folks at onc who are involved with electronic health record. we are enormously excited about the way this could transform our understanding of biomedicine. >> can i just add one brief comment? i just want to underscore that as you think about what can be done to really harness the extraordinary advances in science that are occurring today, and the resources that nih so rightfully needs and desperately needs to ensure that important work basic clinical and translational gets done, that you not forget that in order to actually see those products, those ideas become real work products -- real word -- real world products, it has to be accompanied by appropriate

investments in fda that give us the opportunities to develop our area of science to afford that final bridge to a real world product and to help make sure that the investments and the research at nih are being done in the most efficient and streamlined way as they are trying to actually move that product through the development pipeline into the product. and when disconnects that worries me a lot, and i'm sorry, but i have to say it because it is the last time in front of this community -- committee that everyone thinks that if you want to deliver on the promise of science, more investment in nih, that is critical in foundational, but you do not want in fda that isn't fully equipped to oversee the products that are coming before them, that isn't well staffed to do efficient, modern, regulatory reviews, and you want to be able to bring the knowledge and expertise of the fda and product

development into these early stages. >> i heartily agree with my colleague and would like to endorse and would endorse everything she just said. >> thank you for your indulgence. >> thank you. >> thank you, mr. chairman for calling this hearing and thank you to you both for your service and dr. hamburg, we are working closer with you on a couple of things and thank you for your service and we are sorry to see goes. i also want to apologize for just getting here. i had a hearing in judiciary that was also very important. i'm proud to represent minnesota, as you know, dr. hamberg. and our medical device industry. and we've spent some time working together. and when i first got in this job and had some -- dr. sherman came

to minnesota and had some discussions with the industry, roundtables with him, and i noticed a kind of a different culture between the regulators and device manufacturers, and i wondered why that would be. and a life science alley, along with the fda did something that i think for the first time ever was a private-public consortium on regulatory science. and i just want to know -- ask you how you believe that is going. the name of it escapes me. it is the medical device innovation consortium. ntsc. >> yes. how is that working?

>> it is an example of the kind of thing we can and should be doing. as you know, bringing together private industry academic researchers, not-for-profit organizations, and government together under one organization that is committed to advancing the regulatory science needed to advance medical doll eyes -- device development. it has grown enormously since it was started. there was initially some skepticism, perhaps. but it has grown. and it is identified critical areas of research, whereby advancing research that is partnership -- this partnership, it will benefit medical device development much more broadly because of his doing things like helping to design innovative clinical tropical -- trial approaches that will make the clinical trials less cumbersome and make it easier for products

to go into clinical trials to demonstrate safety and efficacy in developing computer bottles -- computer models and other simulations that without the cost, the potential risk to patients, you can really examine whether a device will work and how the design should be tweaked , etc., how we can better integrate patient reported outcomes and their experience of using a device into the development and review process. so focusing on some of the most port and issues before us -- important issues before us doing , it in a way that advances the science and doing it in a way that creates knowledge that becomes a common good for other product development in the future. >> thank you. and glad that it -- we're proud of that private-public partnership is working. i want to talk a little bit about precision medicine and what it has done.

and sometimes when i think about precision medicine, i think it was born a little too early. i think of what things will be like 20, 30, 40, 50 years from now. let's talk about ldt's. university of minnesota has developed a panel of more than 1200 genetic variations that can be tested for -- trenton fire risks for specific -- to identify risks for specific genetic diseases. the mayo clinic in rochester, minnesota, has made significant progress in identifying ldt's , but these folks are concerned that not thoughtful are careful enough could hamper the

potential of ldcs -- ldt's undermine the target of root causes of disease. i applaud the chairman and the ranking member for working with the fda and industry efforts to hold a series of briefings on this relatively new topic. but dr. collins, i would like to know what role nih will have in advising the the fda and to what extent the two agencies are engaged with one another, which i think senator collins talked about -- no relation. as a researcher yourself, what is your view on how the two agencies should work together to promote safe and effective technologies that is ethical and safer patient without interfering with the innovative work that you are doing? >> thank you for the question. and this is an area that the nih and others are working closely right now to a cop is what you have said.

to make sure that the kind of laboratory developed test in the field of genetics, where things are growing, are offered to patients in a way that benefits them and doesn't slow down innovation, but has appropriate oversight, particularly in high risk situations where a false result can lead to decisions that can be quite harmful. the fda released back in the fall guidance on risk-based oversight of laboratory development test. we think that is a thoughtful document that has now become the foundation for multiple workshops, including one held february 20 on the nih campus to try to get additional input about this. what we can do that is turning out to be a nice partnership in a specific way is we have already a data base called clin var that is across what has been reported as far as this dna variation being contacted -- connected with this particular

disease or disease risk. so that data base is being curated in ways people can find the information. but you can't look at that and know which you can rely upon and might be a result that one person found in one other person didn't. if you need an expert panel on top of that. and a group that we called clingen, clinical genomics, and looks at whether a particular variation has been shown with a medical risk, like a mutation with evil with breast cancer and with a certainty and what they think about the whole set of variations and information that is there. the fda is very interested in that particular nih funded effort for them to be able to have expert advice about what you can trust and what you can't. that we are not the regulators. the fda has that role. this is a great opportunity for our relatively roles to be nicely interdigital hated -- in

terdigitated and it will be critical for medicine, as we see more of this play out with this cohort of people as we play information back, that it is right and they can trust it and reviewed by experts and the regulatory >> and dr. agency. hamburg and since this is your last hearing in your current capacity, would you like to have the last word on that question or any other question before we wind the hearing up? >> on that question i would just say that the world of diagnostics is complicated but it is very important because at the end of the day, it is what guides the ability of a health care provider or a patient consumer to make sure they are getting the best possible treatment for the condition that they have. it also -- having accurate reliable diagnostic tests is crucial to actually be able to do the fundamental research that

will reveal the opportunities and treatment, prevention, and care. because if the test is inaccurate, all of that research isn't going to mean much. so we think that at the core of all of this is the core of our responsibility to make sure that diagnostic tests work. whether they are laboratory-developed tests or are much more advanced generation sequencing which dr. collins was talking about, using diagnostics to give us vastly expanded information so one diagnostic tells you about thousands, millions of variants, and not just one diagnostic disease, but at the end of the day, our goal is not to create unnecessary regulation, but to be able to assure the american people that their health care providers and these companies that make these products, that when a product goes into the marketplace, it will do what it says it will do, and, in fact

that kind of regulatory foundation is common sense. it also is what enables innovation to be driven forward. because when you have time -- some tests that aren't held to the same standard as other tests, then the incentive for those were coming from the device -- the traditional device industry developing fda-related diagnostics, incentive for them to stay in the business when someone else can create it and send it to market without any review is problematic. so it is kind of an interesting example of why things get very , located, but at the end of the v.a. -- at the end of the day the fda's role is to help speed innovation to patients who need that innovation, but we want innovation networks and innovation that will make a difference of promoting and protecting their health and that will benefit our health care system and the industries that are so much a part of the united states economy.

>> thank you for doing that. and i apologize, mr. chairman, for going so far over my time. >> no, that's fine. senator murray, do you have any concluding remarks? >> dr. murray, well stated. thank you for both of your testimony. this was a good hearing. senator alexander, i look forward to working with you on that. >> thank you. and dr. collins, do you know offhand -- you mentioned the success rate has declined over the years. what about the absolute number of grants? has that gone up? >> the absolute number of grants has been bouncing around. it was around 10,000. >> 30 years ago it was -- >> i'd have to get you the number. >> i was trying to compare that to the success rate. >> but the biomedical community has grown in that timetable. i can get you the specifics. >> it would be interesting to see that. >> thank you to both of you. thank you for being here.

very important that you were here and we thank you for your six years of service at fda. and i hope you'll accept our invitation to stay in touch with us especially over the next year , as we work on these issues. dr. collins, you're going to still be here. >> i am. [laughter] >> and we're going to stay in close touch with you. this has been a good conversation and the fact that the two of you were here helps signal the importance of it. the attendance of the senators. of course, by 2017, we will be in the midst of the user fee discussion. but the issues we tend to get into are different from those. and what i would say to those in your agency and to the administration, this is a train on a track to get to the station. it is going to get somewhere. some of us are on the appropriations committee and we'll be working on the sequestration, the funding levels. that is one thing that we with do.

but there is also the question, as i mentioned, of the 42% administrative cost. if there are some things we need to do, some laws to change and some other agencies, if you could get that from 42% to 32% that is $3 billion at one time. so there is the question of reallocation and other obstacles that you could run into that if you could change that, that would make our life better. this is, in no way, trying to diminish the accomplishments of the fda or the nih, as to say we are in this exciting era, the house, the president, the senate, are all headed in the same direction, we would like to get there within a year or so and we would like to have your help in doing that and doing that well. this is an unusual opportunity to get a result in a town that doesn't that often see the president and the republican congress on the same train headed in the same direction toward an important station.

so, i think by your being here you help to emphasize that. we look forward to continuing our discussion. the hearing record will remain open for ten days. members may submit additional testimony for the record. today. the committee will stand adjourned. quite the senate foreign relations committee hears from defense secretary ashton carter on the president's request for military force against isis. the secretary has already expressed concerns with the presidents three-year timeline for force. he will be joined by secretary of state john kerry and joint chiefs of staff chairman martin dempsey. cli coverage beginning at 9:30 a.m. eastern here on c-span. then live at 230, secretary carter holds a joint news conference with michael fallon at the pentagon, they are expected to discuss u.s.-u.k. military relations. >> on the next washington

journal, a conversation about the war powers act and the president's request use military force against isis. are guesses benjamin we looks of the print -- brookings institution. a look at the legal debate on the authorization debate for the use of force. we will talk with brian petula for the center of american progress. washington journal is live on c-span everyday at 70 of eastern , taking your phone calls, tweets, and facebook comments. >> here are some of our featured programs this weekend. saturday starring at 1 p.m. eastern, c-span2's book tv is live from the university of arizona, with a tucson festival of books, featuring discussions on race and politics, the civil war, and by the nation magazine writers and callers throughout the day with authors. sunday at 1 p.m., we continue our live coverage with panels on

the obama administration the future of politics and the issue of concussions in football. saturday morning at 9 a.m. eastern, on american history tv on c-span3, we are live from longwood university and farmville, virginia waste 60 annual civil war seminar with authors talking about the closing weeks of the civil war in 1865. sunday morning at 9 a.m., we continue our live can -- live coverage with the immigration of confederates to brazil. find our complete television schedule that c-span.org and let us know what you think about the programs you are watching. e-mail us at comments at c-span.org. send us a tweet. join the conversation, like us on facebook, like us on twitter -- follow us on twitter. >> keep track of the republican led congress and follow its new members through its first session. new congress, best access on c-span c-span2, c-span radio

and c-span.org. hillary clinton spoke with reporters about her use of a private e-mail account while serving a secretary of state. she said her decision to use the account on one mobile device was out of "convenience" and that her 30,000 work-related e-mails will be made public she made the remarks after giving a speak on women's issues at the united nations. the news conference is 20 minutes. secretary clinton: good afternoon. i want to thank the united nations for hosting today's

events and putting the challenge of gender equality front and center on the international agenda. i am especially pleased to have so many leaders hear from the private sector standing shoulder to shoulder with advocates who have worked tirelessly for equality for decades. 20 years ago, this was a lonelier struggle. today, we mark the progress that has been made in the two decades since the international community gathered in beijing and declared with one voice that human rights are women's rights and women's rights are human rights. because of advances in health, education, and legal protection we can say that there has never been a better time in history to be born female. yet, as the comprehensive new report published by the clinton foundation and the gates foundation this week makes clear, despite all this progress, when it comes to the full participation of women and girls, we are just not there yet.

as i said today, this remains the great unfinished business of the 21st century. and my passion for this fight burns as brightly today as it did 20 years ago. i want to comment on a matter in the news today regarding iran. the president and his team are in the midst of intense negotiations. their goal is a diplomatic solution that would close off iran's pathway to a nuclear bomb and give us unprecedented access and insight into iran's nuclear program. reasonable people can disagree about what exactly it will take to accomplish this objective. and we all must judge any final agreement on its merits. but the recent letter from republican senators was out of step with the best traditions of

american leadership. and one has to ask, what was the purpose of this letter. there are peer -- there appear to be two logical answers. either these senators were trying to be helpful to the iranians or harmful to the commander-in-chief in the midst of high-stakes international diplomacy. either answer does discredit to the letter's signatories. i would be pleased to talk more about this important matter but i know there have been questions about my e-mails so i want to address that directly and then i will take a few questions from you. there are four things i want the public to know. first, when i got to work as secretary of state, i opted for convenience to use my personal e-mail account, which was allowed by the state department, because i thought it would be

easier to carry just one device for my work and for my personal e-mails, instead of two. looking back, it would have been better had i simply used a second e-mail account and carried a second phone. but at the time, this did not seem like an issue. second, the vast majority of my work e-mails went to government employees at their government addresses, which meant they were captured and preserved immediately on the system at the state department. third, after i left office, the state department asked former secretaries of state for our assistance in providing copies of work-related e-mails from our personal accounts. i responded right away and provided all my e-mails that could possibly be work-related which totaled roughly 55,000

printed pages, even though i knew that the state department already had the vast majority of them. we went through a thorough process to identify all of my work-related e-mails and deliver them to the state department. at the end, i chose not to keep my private, personal e-mails e-mails about planning chelsea's wedding or my mother's funeral arrangements, condolence notes to friends as well as yoga routines, family vacations, the other things you typically find in inboxes. no one wants their personal e-mails made public and i think most people understand that and respect that privacy. fourth, i took the unprecedented step of asking that the state department make all my work-related e-mails public for everyone to see.

i am very proud of the work that i and my colleagues and our public servants at the department did during my four years as secretary of state. and i look forward to people being able to see that for themselves. again, looking back, it would have been better for me to use two separate phones and two e-mail accounts. i thought using one device would be simpler and obviously it hasn't worked out that way. now i am happy to take a few questions. nick is calling on people. >> madam secretary, on behalf of the un correspondents association, thank you very much for your remarks and it's wonderful to see you here again. madam secretary, why did you opt out using two devices at the time? if this hadn't come out, it

probably would not have been an issue. if you are a man today, would all this fuss be made? secretary clinton: i will leave that to others to answer. but as i said, i saw it as a matter of convenience, and it was allowed. others had done it. according to the state department, which recently said secretary kerry was the first secretary of state to rely primarily on a state.gov e-mail account. and when i got there, i just wanted to use one device for both personal and work e-mails instead of two. it was allowed. as i said, it was for convenience. and it was my practice to communicate with state department and other government officials on their .gov accounts so those e-mails would be

automatically saved in the state department system to meet recordkeeping requirements. that indeed is what happened. i heard just a little while ago the state department will begin to post some of my e-mails which i am very glad to hear because i want it all out there. andrea, thank you. >> can you explain how you decided which of the personal e-mails to get rid of, how you got rid of them and when? and how you will respond to questions about you being the arbiter of what you release? and can you answer the questions raised about foreign contributions from middle eastern countries, like saudi arabia, that abuse women or permit violence against women to the family foundation? whether that disturbs you as you are rightly celebrating 20 years

of leadership on this issue. secretary clinton: those are two very different questions. let me see if i can take them in order. i will give you some background. in going through the e-mails there were over 60,000 in total sent and received. about half were work-related and went to the state department and half for personal that were not in any way related to my work. i had no reason to save them but that was my decision because the federal guidelines are clear and the state department request was clear. for any government employee, it is that employee's responsibility to determine what personal and what is work-related. i am confident of the business we conducted and the e-mails that were produced. and i feel once the american public begins to see the

e-mails, they will have an unprecedented insight into a high government official's daily communications, which i think will be quite interesting. with respect to the foundation i am very proud of the work the foundation does. i am very proud of the hundreds of thousands of people who support the work of the foundation and the results that have been achieved for people here at home and around the world. i think that we are very clear about where we stand, certainly where i stand, on all of these issues. there can't be any mistake about my passion concerning women's rights here at home and around the world. so i think that people who want to support the foundation know full well what it is we stand for and what we are working on.

right here. >> i was wondering if you think you made a mistake in exclusively using your private e-mail or the response to the controversy. if so, what have you learned from that? secretary clinton: i have to tell you, as i said in my remarks, looking back, it would have been probably smarter to have used two devices. but i have absolute confidence that everything that could be in any way connected to work is now in the possession of the state department. and i have to add, even if i had two devices, which is obviously permitted -- many people do that -- you would still have to put the responsibility where it belongs, which is on the official. i did it for convenience and now, looking back, think that it might have been better to have two devices from the very beginning.

>> did you or any of your aides delete any government-related e-mails from your personal account? what lengths are you willing to go to to prove that you didn't? some, including supporters of you, have suggested an independent arbiter. to have them look at your server , for instance. secretary clinton: we did not my direction to conduct the thorough investigation was to err on the side of providing anything that could be possibly viewed as work-related. that doesn't mean they will be by the state department, once they go through them. out of an abundance of caution and care, we wanted to send that message unequivocally. that is the responsibility of the individual and i have fulfilled that responsibility

and i have no doubt that we have done exactly what we should have done. when the search was conducted, we were asking that any e-mail be identified and preserved that could potentially be federal record. and that is exactly what we did. and we went beyond that and the process produced over 30,000 work e-mails. and i think that we have more than met the request from the state department. the server contains personal communications from my husband and me. i believe i have met all of my responsibilities. and the server will remain private. i think the state department will be able over time to release all of the records that were provided.

>> madam secretary, two quick follow-ups. you mentioned the server. that is one of the distinctions here. this was not gmail or yahoo!. this was a server that you owned. is that appropriate? was there any precedent for it? did you clear it with any officials? did they have full access to it when you were secretary? will any of this have any bearing or the affect on your timing or decision about whether or not you run for president? thank you. secretary clinton: the system we used was set up for president clinton's office. it had numerous safeguards. it was on property, guarded by the secret service and there were no security breaches. so i think that the use of that server, which started with my husband, certainly proved to be

effective and secure. now with respect to any sort of future issues, look, i trust the american people to make their decisions about political and public matters. i feel that i have taken unprecedented steps to provide these work-related e-mails. they will be in the public domain. and i think that americans will find that interesting and i look forward to having a discussion about that. >> madam secretary, how can the public be assured that, when you deleted e-mails that were personal in nature, you did not also delete e-mails that were professional and possibly unflattering? what do you think about this republican idea of having an independent third-party come in and examine your e-mails?

secretary clinton: first of all, you would have to ask that question to every single federal employee. the way the system works, the federal employee, the individual, whether they have one device, two devices, three devices, how many addresses, they make the decision. so even if you have a work-related device, with a work-related .gov account, you choose what goes on that. that is the way our system works. we trust and count on the judgment of thousands, maybe millions of people to make those decisions. i feel that i did that and even more, that i went above and beyond what i was requested to do. and again, those will be out in the public domain and people will be able to judge for themselves. >> madam secretary, madam

secretary -- excuse me -- madam secretary, state department rules when you are secretary at the time were perfectly clear that if the employee needed to turn over those e-mails to be preserved on government computers. why did you not do that? why did you not go along with state department rules until nearly two years after you left office? also, the president of the united states said he was unaware that you had this unusual e-mail arrangement. the white house counsel office said you never approved this through them. why did you not do that? why have you apparently caught the white house by surprise? [laughter] does all of this affect your decision in any way on whether or not to run for president? secretary clinton: let me try to unpack your multiple questions. first, the laws and regulations in effect when i was secretary

of state allowed me to use my e-mail for work. that is undisputed. secondly, under the federal records act, records are defined as reported information regardless of its form or characteristic. and in meeting the record-keeping obligation, it was my practice to e-mail government officials on their state or other .gov accounts so the e-mails were immediately captured and preserved. now there are different rules governing the white house than there are governing the rest of the executive branch. in order to address the requirements i was under, i did exactly what i have said. i e-mailed to people and i not only knew but expected them to be captured in the state department or any other government agency that i was e-mailing to at a .gov account.

what happened in, i guess, late summer, early fall, was that the state department sent a letter to former secretaries of state not just to me, asking for some assistance in providing any work-related e-mails that might be on the personal e-mail. and what i did was to direct my counsel to conduct a thorough investigation and to err on the side of providing anything that could be connected to work. they did that. that was my obligation. i fully fulfilled it and then i took the unprecedented step of saying, go ahead and release them and let people see them. >> why did you wait two months? why did you wait two months to turn those e-mails over?

secretary clinton: i would be happy to have somebody talk to you about the rules. i fully complied with every rule that i was governed by. >> were you ever fully briefed on using your personal address e-mail with the president? secretary clinton: i did not e-mail any classified materials to anyone on my e-mail. there is no classified material. i am certainly well aware of the classification requirements and did not send classified material. >> [indiscernible] secretary clinton: because they were personal and private about matters that i believed were within the scope of my personal privacy. and that particularly of other people. they had nothing to do with work.

i didn't see any reason to keep them. at the end of the process. >> who was forced to resign two years ago the cause of his use of personal e-mail. secretary clinton: i think you should go online and read the entire ig report. that is not an accurate representation of what happened. thank you. >> thank you. thank you all. >> an hour before a former secretary clinton spoke, state department jen psaki took questions on the review and release of hillary clinton's 55,000 pages of e-mails sent during her tenure. here is a look. jen psaki: that is consistent with what we have been discussing internally, let me give you a brief update on where we are.

we will review the entire 55,000 page set and release, at the end of that review, to ensure that standards are consistently applied throughout the entire 55,000 pages. we expect the review to take several months, that has not changed. the released will be posted on a public website, i will have more information about that hopefully soon. the only documents from that 55,000 pages we will review him a separate, earlier release of the approximately 300 e-mails already produced to the select committee, those will be reviewed and released fire to completion of the entire set. those will be posted and made publicly available. >> even if you haven't filed a request, you will be -- we will be -- you will put them up publicly so anyone can see them? jen psaki: yes, they will be publicly available. they will be publicly available.

>> i realize it might be hard for 55,000 pages to have an estimate of how much time it will take to go through them by hand, but 300 seems a little bit easier. jen psaki: it's 900 pages, which is the 300 e-mails. i don't have an estimate on that particular piece, i can check and see if there are more specifics. let me add one more thing specific redaction criteria has included, and would include since we are following the same standard, national security, personal privacy, privilege, and trade secrets. as for regular process, we will identify the process for regular redaction's and that is something that brad asked about last week. >> did anyone ask him at giving the volume of this, did you all ask for an electronic version of it as well as the paper? jen psaki: i do not believe so.

>> see the full state department briefing as well as hillary clinton's news conference on a video library anytime at c-span.org. here are some of our feature programs for this weekend on the c-span networks. saturday starting at 1 p.m. eastern, c-span2's book tv is live from the university of arizona for the tucson festival of books. featuring discussion on race and politics, the civil war and by the nation magazine writers with collins throughout the day with authors. sunday at 1:00, we continue our live coverage with the festival with panels on the obama administration come the future of politics, and the issue of concussions in football. saturday morning at nine eastern, on american history tv on c-span3, we are live from longwood university in farmville, virginia for the 16th annual civil war seminar, where historians and authors are talking that the closing weeks of the civil war in 1865.

sunday morning at 9:00, we continue our live coverage of the seminar with remarks on the surrender of the confederacy and the immigration of confederates to brazil. find our complete television schedule on c-span.org and let us know what you think about the programs you're watching. call us, e-mail us, or send us a tweet. join the c-span conversation like us on facebook, follow us on twitter. the political landscape has changed with the 114th congress, not only are there 43 new republicans and 15 new democrats in the house, and 12 new republicans and one new democrat in the senate, there is 108 women in cars, including the first african-american republican in the house and the first woman veteran in the senate. keep track of the members of congress using congressional chronicle on c-span.org. it has lots of useful

information, including voting results and statistics about each session of congress. , best access, c-span, c-span2, c-span radio and c-span.org. live today on c-span, defense secretary ashton carter, secretary of state john kerry and joint chiefs of staff chair general martin dempsey testify on the president's request for military force against isis. later, secretary carter and british defense minister michael fallon discuss u.s., u.k. military relations at the pentagon. up next, "washington journal" is live with your comments and calls and today's >> a conversation on the war powers act in the request of military force against isis. our guest is benjamin wittes.

then lid on the debate for the use of force. we will speak with danielle plet ka and brian katulis. ♪ ♪ (202) 737-0001host: good morning. john kerry and martin dempsey will be on capitol hill this morning testifying before the senate foreign relations panel on the request for the use of force against isis. live coverage at 9:30 a.m. eastern. more to come on the fight against isis and before we get to that, we will begin with hillary clinton in new york yesterday answering questions about her private