those things. until the president does that, this is going to be a train wreck. >> host: next call for representative andy harris, a republican of maryland, comes from gary in forest, virginia, on our republican line. >> caller: good morning. >> guest: good morning. >> caller: have, i've been a insurance salesperson for high and health. i'm a software engineer and also a small business owner. i have a real good perspective of what's going on with this thing. but what's interesting, and i'm just going to make one comment then move on, almost all of my life i've voted republican. but the republicans in the last ten years have become kind of insincere in what they've saying -- in what they're saying, and i've moved away from the republican party because of that. ..

i used to work for a company come and large companies of about 20,000 employees. our insurance ran for all of us was around $400 a month. that's the full cost to the company. for the health insurance. now, and what we've got here is a situation that we're trying to fix this and if we want to fix this what we would really do is say, take the health insurance, turn it all into individual policies. in its companies wanted to pay

for each employee's insurance, they could pay it is an individual policy. in other words, each individual policy, and there's a model for this. aflac does this all the time. >> host: can you wrap this up very quickly? >> caller: if they wanted to do this -- >> host: we got the point. >> guest: thanks. personal with regard to sincerity i hope you realize that we are very sincere that the affordable care act isn't going to work, it's not good for america to help america gets the message that's what we've been saying since we got elected as majority of house and 2010. with regards to the idf, you're right. if we move toward more individualized purchase, that will work as long as you can structure large groups based on individual purchase which is at what h.r. 31 windows.

we incentivize it by providing the same income tax break to an individual that employers now get. by doing that we will encourage young people to buy insurance. we will encourage families to get individual insurance to fit their needs. we think that's the way to go. they want more choice, not less choice which is what the affordable care act gives them. >> host: ron daniels, what is the actual cost of care at a hospital? does he don't even know? >> guest: part of the problem with this system that we have built up where again hospitals have to transfer costs for payment of a medicaid patient, for privatization, from a cash paying patients are we have created a huge bureaucratic system that costs money and is nontransparent. so the answer to this question is, it's very difficult to figure. all you can do is you can divide up al all the money a hospitals been divided by the number of days in hospital, you get a cost. budget act record individual

basis, a lot of the numbers honestly our accounting gimmicks. >> host: did you have a set price for the work you did as an anesthesiologist? >> guest: i'll tell you what's interesting with our health care system. i was providing anesthesia for childbirth and i was provided this at hopkins for over 25 years. in the 25 years i've only had one patient ask me what the cost was. because it has totally insulate people from the cost of health care. only one person in 25 asked me how much is this going to cost me. >> host: what was your answer? >> guest: to be honest i couldn't tell her because i would have to do, tell me who your insurer is an and if you're a cash paying patient, special in of the price was the highest. it's the only industry in which he becoming to pay cash come you're going to pay the highest price. then it depends on what insurance companies negotiated with my group because i was a member of the hopkins group

practice, it depends on what they negotiated with. a medicaid patient the government said it. it was not a simple question. when you going to purchase any other product, the price is on the shelf or the person selling you the product knows the price. totally hundred and health care. >> host: fort meade florida independent line. >> caller: good morning and thanks for c-span. great program. i have a direct question. first unlike in a small statement and then i would like to ask the represented a direct question. and my statement is this. i'm in this country now 35 years. i always, a republican. i'm not independent at the reason why because, i think i'm pretty political savvy enough on what's happening all the time.

i've been following this obama here and i look at every bill that was presented to either defund or do something with obamacare that republicans have presented to congress. and i read most of them, and i have not seen one of these bills that really and truly will actually serve me as a citizen of this country at my grade level. and when i look at this, and i'm seeing if you're so sincere and republicans to stand here and say they are really and truly a representative of me. now, here's my question to the congressman. can you please tell me, read us one item on any one of your bills that will say to me as a citizen that is now, my average salary not is under $30,000,

tell me with a family of five, tell me which part of any one of your bill that you have presented that would serve me now that i don't have insurance. >> host: thank you. >> guest: thanks for the question. h.r. 3121. go, look at the. the provision that allows a tax creditcredit to be given to evey american american family that will cover the entire cost of a policy. this is what -- for the lower price policy. so you can get a policy and basically have a tax incentive by that policy. this is for every american. you don't have to be employed by someone. you can just be self-employed. you can just be unemployed. you can have an individual policy. that's a benefit to every american. h.r. 3121 to with regards to the readability of bills, i'm a doctor, not a lawyer but i will tell you bills are written in

legislative language. that's what they have to be written in, and i congratulate you for reading through those bills but i will tell you it's very difficult to understand without -- >> [inaudible conversations] [inaudible conversations]

[inaudible conversations] >> time for reasons having

expired, the subcommittee will reconvene in the chair recognizes the gentlemen from texas, mr. green, for five minutes of questions. >> thank you mr. chairman. when mic'd up versus austin restore environment that would promote the development of the new antibody drugs to address the growing public health threat, drug-resistant bacteria. i'm proud to have worked with leaders on this committee, dr. gingrey at a coalition of other members to advance last to be we've always said that this was a good first step but more must be done and i know from your testimony today that's too. thank you for your leadership, dr. woodcock and also going the new antibody telomere in april cdc released a report on drug-resistant bacteria. in the report cdc states that antimicrobial resistance is one of the most serious health threats to our country. dr. woodcock, does the fda agree with the cdc on the nature of this threat?

>> absolutely. spent in this report cdc, a handful strategies that address the threat. one of the main message data was develop new antibiotics. as i understand that part of the challenge of the new developing other products is drug-resistant oftentimes begins in limiting the population in approving a drug the fda for use in a limited population can be difficult. dr. woodcock, on june 4 of this year you were quoted by the national public radio as saying he hoped congress would pass legislation soon to make it easier for fda to approve new antibiotics. what type of legislation were you referring to when he made those statements on npr? [inaudible] >> i'm sorry. there have been discussions in the task force referred to earlier that talked about a program for limited use, that is

specifically directed where there's some population of broader population. one of the problems we have with the antibiotics as you well know is overuse. what we're concerned about if we approve an antibiotic for a limited use, drug-resistant organism, that they be temptation to use a more broadly and that would lose its effectiveness. so we feel that it should be explored, that congress could make some kind of program that would really send a signal about limited use and then could in a byproduct stewardship. >> well, i'm working on legislation with my colleague dr. gingrey, the next step focus primary on promoting antibiotics to be used in limited populations. is there anything that you believe we should keep in mind as we trapped this legislation? >> i feel that a strong signal

from congress to the health care community about stewardship would be extremely important. fda frequently approves drugs for limited population, but usually there isn't that sort of an orphan population. there isn't that sort of temptation they will use a broadly in a much broader population. so one of the main things is a signal from congress that it's fine to do limited population out of their broader disease with a very small development program, but then it should be that stewardship by the health care community to not use it more broadly. >> i know if you do with any infectious disease specialties they talk about that, and can we statutorily, because i know in medical practice a doctor make a decision on their own and that may be part of the problem. but you can't limit it to just, for example, people who deal

with infectious diseases. >> we feel there shouldn't be an upper limitation like that because it's not feasible. patients coming. they have infections. they have a resistant strain in the 20. doctor should have the discretion to approach can use appropriate antibiotics. however, i think a signal, a prudent and stewardship would be, would be a mechanism. i think it would be very effective. >> i'm almost out of time but the other issue is we need to make sure we keep this, because what may be successful a year from now or 10 years from now we will still have people who develop those resistance so we need to keep that pipeline going for these new levels of antibiotics. and other ways to treat these terrible illnesses. as health care gets more advanced, it's important that both congress and the fda be responsive to the changing world. many of the processes that fda

are decades old, drug-resistant, medical software and personalized medicine are going to strengthen limits of the outdated statute. i hope we can work together and have fda as an active partner when drafting this, protecting not only public health but also long-term. mr. chairman, thank you for your time. >> chernow but it is the vice chair of the committee, doctor burkas. >> i apologize i wasn't here earlier but have some obligations on the house floor. i do want to take this opportunity just to recognize the fact that this subcommittee in fact the energy and commerce committee as a full committee did its work in what was sometimes a very difficult collection -- election year 2012. all of the people who write in the important papers around town said we couldn't do it, and you and mr. upton did it. the bill went through regular order, asked the subcommittee, passed the full committee.

went over to the senate, conference with the senate. then the president signed into law on july 9, 2012. no one knows that because there was no signing ceremony and there was no press present, but congress can actually function in a very reasonable way. if you'll recall during the reauthorization discussion actually i work with ranking member pallone on the concept of the advisory committee to make certain that they were staffed with the very best expert to serve patients well, serve you and your agency well, and reduce backlogs and save resources. and so it looked to me like the initial thing, reports i'm getting argued. do you have any updates for the committee speak with yes. we have been able to remove several steps that were very time consuming within that advisory committee process, members for specific committee. that has helped us streamline the program.

of course all advisory committee members are still subject to this broad federal conflict of interest declared that and that's fairly stringent as well. but the additional steps have been removed and that's been helpful. >> sometimes hope that someone on an advisory committee who has some knowledge of the pathophysiology them a be involved in the disease under which we are concentrating treatment. >> i would say it's essential. >> there's going to be a rare disease meeting in january of this year, correct? >> i believe so. >> looking forward to improving the regulatory process for approving drugs for rare diseases. you held a similar meeting in 2010 and issued a report with recommendations. can you can update us as to the implications of those recommendations made three years ago before advance of its next meeting in january? >> i think we're doing extremely well on rare diseases. with established a rare disease

staff. we are tracking all the rare diseases. in 2013 we approved a large number of products for rare diseases. every one of them was approved based on a circuit in fiscal year 2013. there's 12 products for rare diseases and one was approved on an animal role without human efficacy testing. so we do have a robust program and we're going to try to take it to the next level as we have more meetings. >> dr. shuren, agenda for some time i've been -- only applications, and this guidance put out by your department that only products that could significant restrict patient access and restricting sales of these products. is there any evidence out there

of patients being harmed by research only use products? >> we do have evidence of companies are putting those products out for research use only but actually promoting them for clinical diagnosis. in cases where -- having been shown the start to be accurate. and in times where we've taken action is predominantly where there's already a simple proof of clear test that would be there as an alternative. we've recognize some of the concerns. i will tell you, one of things in there was about putting on the makers of researchers only that they should reasonably know about the people they're selling it to, their intentions. that's what something weird loud and clear. i want to tell you we have heard those comments. that will come out of the final guidance. that final guidance will come out probably by the end of this month and we will get you a copy of that. >> i appreciate that but specifically do you have evidence of patients have been harmed by using the research use only? >> i am not aware of the

specific patience of windows. we can look a little further. >> thank you and i would appreciate your further investigation. finally, dr. woodcock, january 1 of 2012 i lost access to low-cost over-the-counter asthma inhaler. when am i going to get that back? >> well, i can't talk publicly about applications that might be pending and so forth, but certainly that status remains. we certainly heard your concern. >> thank you. >> the chair thanks to joan and that recognizes the gentleman the, ms. castor, for five minutes. >> thank you, mr. chairman and welcome. dr. woodcock, in september in tampa we had the ohio florida conference -- bio florida conference with researches and

manufactures and folks develop in charge of all across the state. fda was kind of to send dr. richard -- thank you, for the center for drug evaluation and i want to thank you very much because i know the budget are very tight, but to have folks that are leaders that fda be able to interact directly with folks in my stay was greatly appreciated, so thank you. and the conference focused a lot on the future of drug approval. so we are pleased that the federal laws are working well. i think the number one fear of everyone, the topic of this conference turns to sequestration. because people are rather surprised that even the fda relies a lot on user fees, the user fees are subject to sequestration. this is not smart. some of the announcements i've

seen come and tell me if these numbers are right, that to your budget, i don't know if this is the entire fda budget or just your section, that in fiscal year 2013 you were subject to sequestration of $209 million, and on top of that 85 million in private funding. the user fees were sequestered at the same time. and then in fiscal year '14, if it's a question is not replaced you're looking at a cut of 319 million. and 112 million of that, you can explain that, on top of that or as part of that is the private funding user fees. i mean, this has got to have a harsh impact on development of new therapies, on wiki of devices, on review of innovative drugs. tell us what you're facing now

at come in your shop. >> well, the sequestration has been very difficult. of course, you have appropriated support for these programs as well as the user fees. some of the programs have been subject to understand is that total for user fees has been 79 million in the last fiscal year, but, frankly, how these are calculated is above my pay grade. but it certain has happened to you are user fees that we are not able to access for device and the fdasia program and that would continue. and what happened with fdasia we negotiated and bill was passed. it recognized the new agreements on rare diseases, patient focused drug development and these other programs. and then the sequestered removed practically the whole amount that was negotiated for these new programs, these patient

focused programs and other programs. we have put on the patient focused drug development meetings regardless but our rare disease application of our rare disease staff has been delayed because of the sequestered, and similarly with the number of the other programs that we agree to. >> so that's not good news for families across the country, families with rare diseases that rely on your agency but it seems like we've taken a step forward with the federal laws that have given you certain authorities and expanded user fees, but then it seems like on the other hand, sequestration brought by the congress is going to handicap you. can you characterize over all the what -- i mean, this is a bad time to shortchange fda. can you characterize what it means where you're very concerned? and i would assume you would recommend that sequestration be replaced going forward.

>> as i said, the whole financial issues are above my pay grade. that's really up to congress. however we are in the threshold, and i think with devices, too, of a revolution in biomedicine and we're starting to see the benefits of that. we need to be able to have the programs that can respond to that, and also programs that can get for those older drugs, get to low-cost, affordable generics out on the market probably. and at the same time shepard those innovations, both devices and drugs, that are going to make a difference where people are still suffering from untreatable diseases. we really, i passionately feel we have to deliver this to the public. we have to make sure i registered programs are up to the task of dealing with drug-resistant organisms competition with the new science that is coming forward. and we are always close to the bone, as you know, in fda.

we have to shepherd our resources very carefully. and this threatens -- more data than just having our staff. are we going to translate these innovations into benefit for the public. >> thank you spent the chair thanks the gentleman and that recognizes the gentleman from illinois. >> thank you, mr. chairman. i'm glad to follow my colleague from -- would you stop doing that, morgan. follow my colleague from florida because obviously history is interesting in that this was the president's proposal to go into sequestration. it was passed by the house. i voted for it and the real way to solve sequestration is understand debt and deficits and our internal programs and get those reforms. my fear for any agency that without that, in the expanse of our and other programs will squeeze out the discretion budget whether that's the military, whether that's your agency.

and the sooner we as a nation own up to that, then we wouldn't be having this debate. one of the great things i love about the job of being a member of congress is working with our constituents. so right during votes, i had one of my constituents go and we measured the ohio clock because i have a constituent is building a replicate so we were paid measuring and stuff. so that's an example of, kind of things we do. i also, and it's just lucky that you are testifying when i was approached by a constituent, a member of my church. some going to get a privacy released a statement and we're going to follow up with the fda, but he was supposed to be in clinical trials in september. they have not been called. he's asked me to ask why. so if you all would just be prepared for when we get involved with that, i would appreciate that on behalf of my constituents. having said that, my questions

are to dr. shuren. on the five 10-k, some issues revolving around that which i've been trying to follow closely. many companies are providing us feedback that they're expensive significant shift in requirements for various five 10-k's, particularly concerns are risen about new requirements being communicated by the fda during the five 10-k review that go beyond previously sufficient data requirements. if true this concerns me because in many instances fda has not issued any new guidance on public communication regarding policy changes. so the question is has the fda change its data requirements for submission types without issuing updated guidance, documents, and if so can you tell me why the change in the consistency? >> first of all i want to say that oftentimes if we're asking

a company for additional data, sometimes it's in response to the data they provided to us, that there had been issues in what was submitted. one thing i will ask is if you companies he believes that something has been changed and changed in a properly, you are very welcome to send them directly. i promise you i will look into it. >> thank you. adherence in this committee prime to enactment of fdasia you acknowledge that in some cases the cdrh reviewers are asking for data to support product applications that they should not be asking for. the also indicated in an october 2011 document that you plan to work on training reviewers to avoid these sorts of data requests. can you give us an update on this and what steps have you taken to address this? >> so we've taken a variety of steps to assure that the questions that we asked our need to know rather than nice to know. i will tell you given from a rogue analysis it is not common

but it happens in a consensus. one of the things we've done is we've been reorganizing in our premarket review offices, and thanks to you we been bring in additional managers were oversight oversight of the process. we change policies and procedures to put more checks into the system. we have also put in a fact check. with a high risk devices we had to dedicated staff who will review any and all major deficiency letters that go out for accuracy and appropriateness. we have had biweekly premarket review rounds were issues get raised, we're getting with the reviewers and the managers at that point. and, of course, we've been training for everyone. >> i'll end on this. what, iwhat, if any, consequence there for reviewers who ask questions beyond what is appropriate? and are those on like their performance review evaluation so if it happened numerous times, many of us have been managers of

personnel and the reality is you've got to document, document, document especially on a federal employee who may not be responding to the proper directions. directions. >> i will first say and i'll put this in because my folks can sometimes get a hard read. they are a great group of people, the a very smart, dedicated and they've been working exceptionally hard to implement fdasia and to make changes think it's reflected by frankly a free market review numbers. the bottom line is our performance is getting better and it's getting better for the first time in a decade of worsening. and that's a lot of credit to them. making changes is hard when it's a large organization, and they're going to be clips along ththe way and this are responsie to keep good oversight. in the center and when things do arise we do engage with the individual. we try to educate and work with them and keep on top of them. >> if the chairman would just -- to follow up, of course, indicating if there is numerous examples and writing it down is

part of a good personnel status. i hope you would consider into the. >> yes, sir. and i was having one who is not performing properly, that goes for anything, and appropriate documentation in the file and also discussions with the employed. because you always want to come if an employee isn't doing well, to try to help them to get back on poor -- on par with performance. >> thank you, mr. chairman. and thank you to our witnesses for being here today. i'm so pleased that we are able to reschedule. what i consider a very important hearing. i'm very pleased that fdasia included parts of my sentinel assurance for effective devices act, also known as the safe act in its final form. one section of the bill was to ensure swift release of the udi, the unique device identifier rule for public comment to improve device tracking and aid

in any potential recalls. so, dr. shuren, i want to commend you for getting the final rule out on udi. i know it's been a long time coming, and i'm glad that you finalize its offense can finally move forward. one concern we have heard from consumer groups has been that the final udi and unique device identifier or want to make sure people know what i'm talking about, rule does not require the identifier to i shall be on the individual product itself. can you explain the decision to not require the udi to be on each one of these products? >> one of the principal drivers was cost, cost to the companies. we want to picture that implementing and putting for this important regulation that we keep in mind what the burdens may be for companies to try to comply. so that was the major reason. we do still keep in marking devices in with one exception, and that you make a device that would use more than once and it

will be reprocessed. in that case the lately that came along with a product that had the udi got thrown away. now it's moving over to someone else and you would know what the device was unless you mark those devices and that is a requirement. >> okay. that's good to know. my safe act also build upon existing sentinel program at fda a program that enables fda to actively query automated health care data to evaluate possible drug safety issues swiftly and secure the safe act and section 615 of fdasia both broadband usage to the medical device space which will benefit consumers and producers alike by catching problems early and ensuring that data, not conjecture, but did he determine our safety policy. unfortunately, the rollout of sentinel on the drug side has taken many years. more than many in the field think is necessary. so i think that expansion to the device act will not be plagued with the same delays. kenya each evening a brief

update on where the agency is with sentinel? i would appreciate a longer update for the record, but just quickly can you explain for us how udi fits into fda's post-market surveillance of medical devices? how will it be good for patients and for providers and for manufacturers? >> so, the udi is absolutely essential. it's a condition for having sentinel or medical devices. and the reason is, right now it is very hard to link a device with a patient's experience with a device in electronic health information, electronic health records. unlike drugs which had a new drug code that they could use right away, we didn't have anything for devices. so the udi we need to have in place and that's going to take a few years. biting into what we are also doing is the following. we are identify, helping develop new and validating tools to be able to go through information to find out what our better understanding with device and we're working with our

colleagues at cedar with epic were also, center would be a broader post-market surveillance system. so electronic health information and registries will be the backbone. we to assess much as an fta system that truly a national system to meet the needs of industry, health care providers, insurers, fda. so moving forward, the brookings institution is very soon going to call for the creation of a multi-stakeholder planning board to start telling the governance structure, policies and procedures for such surveillance system which we think is important not only for identifying problems but being able to use push market information to lower burden and better informed decisions on premarket approval, health products get to market, help doctors and patients make better informed decisions. >> finally and briefly, another piece of fdasia was a key component of my heart for women act, a bipartisan legislative focusefocus on doing all we cano address women's heart health and address health disparity.

section 907 of fdasia require an examination of the extent to which david on how approved medical products affect women minorities and ethnic groups be collected can analyze and publicly reported. this is an important step but concerns persist, i know and i will be submitting many questions for the record and appreciate your team's attention to this matter. i don't think as much time for you to respond. i just want to put that out, we will follow-up with you. >> the chair thanks the gentleman and that recognizes the gentleman from pennsylvania, dr. murphy. >> thank you. appreciate you being here today. would like to take a moment to ask about an important medical issue divides, although is not part of fdasia. bft has regulations about proper means of complex medical devices such as radiation therapy and imaging equipment. manufactures are required to recommend maintenance standards to hospitals and physicians who collected data and how that equipment is kept and serviced.

my understanding is a center for medicaid and medicare servicemen issue guidance telling hospitals that are free to vary from the manufactures maintenance recommendation on these types of devices. we cannot do with an automobile or refrigerator. these are highly specialized piece of equipment and when he devices improperly service, the consequences can be deadly. when a "new york times" series of 2010 raise concerns about patient deaths from improperly calibrated diagnostic and therapeutic equipment this committee held hearings in the matter. i'm concerned the weakening of equipment maintenance standards could have some severe consequences or patient safety and the party responsible for that device is the manufacture. if something goes wrong it's that companies in on the label even though they're not the ones who made the maintenance changes. i believe the fda has waited on this action by cms, is that true, dr. shuren? >> yes. >> can you discuss your positions on this? >> our concern is that the

maintenance schedule is one part of assuring that that device main safe and effective, and would work with the companies on what is the appropriate maintenance schedule to ensure just that. as you mentioned these are technologies that may be committing radiation but wonder make sure not only are you getting accurate images of patients come your to make sure they're also getting the right amount of radiation, not too much. so i could maintenance schedule is essential. >> and that's why we erase certain concerns and shared those with our colleagues at cms. >> let me ask another issue, and a preview but i want to make sure we have on the record. we are all concerned about hospital borne infections, e. coli, mrsa and other infections which spread in hospitals, and take your -- people are compromised, transmit patients come in center. and people used substances that are put into plastics and

clothing to try to reduce infections. there's also the element of copper which and research understand has shown that basically e. coli, mrsa and other diseases are killed in minutes, where as those same diseases can last for weeks on plastics and stimulus steel. the epa has said any regulation on this is in the fda's hands and they're not going to do anything about it even though they have other jurisdiction over copper. i wonder how this will work at the ft in terms of expediting this -- it's not a new element. it's been around for billions of years and it seems to me it ought to be something we can use. which we know can get handles, entrées, equipment and supplies where these diseases can be killed right away. and you comment on the procedure to take on this and can anything be sped up in the process of? >> we are happy to look into it,

and we have, if it's a medical device and it has copper on it, and and the effectiveness something that my center would generally take care. it is not only medical device, such as the at the ineffective, they tend to work by chemical action, that's what if there's a company or companies dealing with it, it's important that we connects we figure out exactly what we're trying to do and help them as best we can. >> help me understand because i want to make sure i in in the right way. if it's a door handle or a touch like entering an i see you, if it's a switchblade in the hospital room, with those be medical devices or would they be -- >> a lot of those basics oftentimes are not spend what category speak with you are not getting into -- >> so what category would they be in? the epa is an fta has to approve them. dr. woodcock, do you have -- >> they would only be considered a drug if he had the disease claimed in humans. you know, we don't usually

regulate doorknobs as drugs spent i would think not. >> i think we talk about some jurisdictional like murkiness here that we would need to sort out. >> i would just hope. let's put that on the record. we will get you information and hope that she and epa can discuss fairly quickly. the 50,000 people who die every year from hospital borne infections and the $109 we spent come if this can be reduced by silicon the we ought -- and out of work together. thank you so much. >> recognize the gentleman from new york for five minutes. >> well, thank you very much, and welcome to both of you. follow both of your work, and thank you for your service. i believe that the good work done by this committee, the food and drug administration safety and innovation act was likely the best health care related legislation done by congress last year. a little more than year after its passage i'm pleased that this hearing is taking place we

can continue to him monitor this important law. i've always fought for those with where disease but on the author of the als registry act. which i have done with congressman burgess, particularly interest in the government and approval of drugs for rare diseases. therefore the aspects of fdasia i'm most interested in is the movements made to the exaggerated approval pathway in this part of the law. to meet diseases like moscow dystrophy are why the exhibit approval pathway somewhere. fdasia -- mushy just the is the most common legally genetic disorder children worldwide infecting one in every 3500. there's a cure. is always fatal and the best hope for those used to treat the symptoms. i have a group of people in my

district that called this disease to my attention. in recent years the research pipeline has held much promise as potential lifesaving therapies appear on the horizon making elements of fdasia particular event to this research community for this week the fda informed therapeutics that its extremist the drug was not a candidate for the accelerated approval pathway at this time. i recognize that since they have enough of a new drug application most of the discussion between them are confidential but i hope they will continue to pursue the treatment for deschenes and help the fda will continue to provide a clear feedback to the company as they move through the first clinical trial to so dr. woodcock, can you elaborate on how you envision the enhanced accelerated approval pathway working? >> certain but as i said in fiscal year 2013 we approve a large number of rare diseases

and all of them were based on in points which is the foundation for accelerated approval. granted -- we granted a number of them political because we felt enough information had been provided that a confirmatory trial would not be necessary. so we certainly are using the accelerated approval in rare diseases, and what the fdasia instructed us to be was to really consider additional in points, including intermediate clinical endpoints. in other words, clinical endpoints that are reasonably likely to predict clinical benefit. we intend to do that. >> thank you. that me ask another question. recognizing the challenges in developing therapies within the rare disease space, how is the fda working with companies to ensure proper parameters for success and failure being established at the clinical trial process and are for excrement of medications could possibly be considered under the accelerated approval pathway?

>> we try to work one by one because of course each one of these diseases is different. one of the most important things that can be done by the patient communities is to establish a natural history of the disease through data so that we understand and can predict what will happen if there's an intervention you contacted tammy patient you need in your trial. this hasn't been done before, and so we've really been pressing on that. i think we've seen a lot of progress but we work with the companies one by one to help them design their trial, and as i said, we set up a rare disease staff. all that has been inhibited because some of that money has been influenced either sequester spent well, thank you. let me talk about the sequester, and building on what ms. castor asked. i didn't vote for the budget control act things which reduce

huge sequestration mess. i'm very frustrated that the user fees date as part of agreements reached in fdasia being sequester. so why don't i ask dr. shuren, can you talk about how sequestration impacts the ability of the fda to meet goals agreed upon as part of fdasia? >> it is making it challenging. we are meeting the goals now but in 2013 we saw about an 8% in cut to critical funding for training of our staff, our reduce debt. want to be on top of cutting-edge technology. so are 15% cut in our ability to recognize national, international standards which provides particularly for industry. we had a 50% cut in regular science to have better tools for assessing medical devices, faster and at lower cost which is a big deal for industry. i had to shoot 50% of my operating dollars into payroll in order to are the people i committed to hire them. so most of my extra money beyond

paying for employers is to pay for the rent, keep on the lights, that money and the photocopy. i have very little to put into really improved program that still needs a lot of help. as we going to 2014 in this continues i'm not going to have the money to be able to hire and maintain the people we committed to hire and maintain. it's a big deal for us and sequestration and it's important user fees. mostar program is defined by appropriate dollars and those cuts come they're killing us. we are -- years before trying to actually turn the program around and this is making it very challenging. >> the gentleman's time has expired. the chair recognizes the gentleman from virginia, mr. griffith, for five minutes. >> thank you very much, mr. chairman. dr. woodcock, greatly appreciate the passion you showed earlier in your testimony. i would agree with you on that passion, particularly about bringing innovative treatments for rare and terminal diseases.

i had a little bill that would allow folks to get early access to early approval to those drugs in order to help them. and what we believe will actually lower the cost of some of the extreme edition. i do want to talk about a bill and know what we're hearing today we avoiding over in the senate and hous house passed thg quality and security act, it was a bipartisan bicameral compromise to prevent another fungal meningitis i would like to associate with a sterile products where we had 64 americans unfortunately die as result of that situation. i am proud of allegedly and that i worked on with congressman gene green and diana degette. ultimately, although we had a different package originally, we came to a compromise with our senate colleagues and with your agency and other for to the senate getting around -- i've afford to the senate passing the bill and it being signed into

law. i'm committed to engage in oversight to make sure that patient safety is being properly protected but i also at fort hood agency developing the notification system that congressman green, congresswoman degette and i've offered to ensure that the fda works more closely with the state boards of pharmacy to prevent another public health crisis. that's being said was in areas that we thought we might able to get fixed that we didn't in that bill that have raised some concerns and i would like to ask you about those in regard to the drug quality and secure the act. in its previous draft guidance, the fda recognizes the importance of maintaining an office stock of compounded drugs that doctors can readily access and administered to patients in their offices. can we rely on the agency to continue to allow doctors and hospitals to order and keep compounded drugs on hand for office use? >> well, we're going to have to see what is in the final bill, if it's enacted, and then as i

understand it it really removed the court disparity, which i didn't fully understand but was a problem. and so, and leaves the previous statute more or less intact and we can implement it aggressively. and, obviously, that's one of the considerations in there, is what our the four walls of what is federal, what is state and what is permitted. >> we didn't change anything in regard to office use, and so there's some concern that maybe we should have put in. i hope that we can count on the fda. i know maybe you can answer that today but i would hope that we can count on the fda to leave that part of it that was working very well which the fda had previously done, leave it intact because i don't think there was any intention, sermon not on our side but that be changed in any way. likewise, repackaging of products has typically been regulated by the agency in the

same fashion as compounded drugs. repackaged still drugs are vital for many patients, especially those in ophthalmology, ophthalmologic health issues. likewise, can we rely on the fda not to go in and create chaos and to restrict access for these repackaged still drugs and limit the impact of burdensome regulations on the practice? >> our intent certainly is not to create chaos, but we do i think one of the goals, mutual goals is to prevent contaminated drugs. and that's really our role and your goal as well. >> it is, and we just, there was some clarifications that everybody decided to let go and hope that it works out and so i'm just worried about those very. the last three that i have is the nuclear pharmacist. they compounded drug products that have a short radioactive half-life an and must be quick o deliver to help indicate. sometimes this must be done in advance of a patient's specific

prescription. can we rely on the fda to continue trying to monitor that in the same fashion they did before this bill was passed? i know the senate will pass it either today or next week, but anticipating that sense was a compromise worked out between the two bodies in the fda, what are your thoughts? >> the nuclear pharmacies have not represented a problem here. we haven't steamed with them. been very successful in implementing a regulation of positron emission facilities and that's gone very well. and so i think we should continue along that path. >> i appreciate it greatly, and that would be remiss, you know, it is good to see a witness with passion and your dedication. women always agree on how to get there but i always appreciate the fact that you come in with honest answers and a willingness to try to work things out. but i appreciate that. with that, thank you i yield back. >> recognize the gentleman from maryland, mr. sarbanes.

>> thank you, mr. chairman. i want to pick up on the end of those comments, and thank you, dr. woodcock, are being here. you are one of the most professional and knowledgeable witnesses we have the pleasure to bring before this committee from time to time. i thank you for your testimony, and yours as well, dr. shuren. i do want to thank the chairman for convening this panel today, and the committee hearing so we can get a sense of how things are progressing. these days sort of bipartisan legislation that we all get behind is hard to comply. come by. so it's nice to have the opportunity to do good things that are already resulting from the passage of this reform. and we appreciate your testimony in that respect. i was going to ask as well about how these, the kind of user fee resources god, switches of sequester which i think you've

answered that. it's particularly jarring i think to the industry, the notion that they are putting forward to the user fees resources from industry, and even that gets implicated by the sequestration that's been put in place, and hopefully we can address that for all the reasons that you have raised. i don't have a lot of questions necessary on the topics you are covering because i think you've done a good job addressing them. i did want to ask something slightly off topic, which is as a result of redistricting in maryland i now have the privilege of representing some portion of the white belt facility, and had the opportunity to get a tuerk recently -- white oak. and see the tremendous facilities that are provided there. i wonder if you could just speak to the benefits of not being able to co-locate so many of the fda personnel and have the labs

there near each other and what that represents in terms of the ability of the agency to function? >> we really appreciate this, because when i took over cedar, first it was in 14 different locations scattered around the metropolitan area here. we expect to a move this summer that will move the generic drug program to the white oak campus but and also with the biologic therapeutics regulation which has been located on the other campus with the associated laboratories. the white house. also our colleagues in the biologic center with whom we work on policy very closely. so for the drugs into this is a tremendous advance, will allow us both to our new generic office on campus as well as build a quality regulation which i spoke about earlier where we're going to have the same unit regulate pharmaceutical

quality across all different types of drugs. and also it will enable us to work with our colleagues at cedar very closely, and the benefits of having the device center right near us, archimedes because there are many combination products with this new technology that's coming about. the combined elements. so this is been a tremendous advance for us. >> it's been a big deal for us as well. i would also put a plug in on personalized medicine. so much of it depends upon having the right diagnostics tied up with the therapeutics and we were very closely with our colleagues at theater, having done hallway is essential. and having the lab is hosted absolutely critical work, and has worked also helps countries getting product to market is so important and when the challenges we face in the current budget climate is we're getting to the point, getting arclose to the foot of storage turn off lights in some of those labs. >> thank you very much. i yield back.

>> the chair now recognizes mr. guthrie for five minutes. >> thank you. they get for coming. this is the beginning. it's one of those things that when you run for congress you don't think about these kind of issues. there are other things you more readily read about going to get to utilize the are five important to constituents and we have people come continuously and they're looking for devices, looking for approvals. i think mr. shimkus talk about what specifically that's looking, and desperate situation but it's important that we work together. i have a couple of questions. one is on the custom devices, and dr. shuren, this is for you, those made for -- request by the physician are critical important for patient care but are not viewed by many as lucrative. in section 16 of the fdasia, we associate manufacturers modify an existing device for which that already existed instead of making an entirely new device. the fdasia language limits the manufacture the fight against per year of a particular device

type and some have expressed concerns that fda may entropy this to say can offer five patients per year versus just by devices. only five patients need a custom device and i think that might render that kind of ineffective. so i just wonder how that -- how you interpret that. >> no. we're not putting such a strict limitation on. we will put out draft guidance to try to better clarify clarification of the provision which we think are very important provisions. we support custom devices, and we think it's so helpful that congress actually put in a much more your standard for what is a custom device and will provide that cleared event in terms of interpreting it. i would also add that companies do not need to come to us in order to go out with a custom device. there's no pre-marker review on a. it -- the simple report to his annual. hopefully in the next few weeks we'll have that guidance to we can have a fuller discussion with interest about it.

i will also say in this case is where they don't meet the statutory definition of a custom device, there are other mechanism we have in place to assure that patients who need a device that isn't otherwise approved on the market can get it. .. has gone from over 1,407th 2,004, they've doubled its budget to 385 and during this

time submissions, pma has decreased. however studies have shown the report we are all aware of that recent times have gotten 43% slower in the past few years and so sequestration does have an effect. but there's been some substantial increase in the budget at the fda as well. one of the central tenants of the prescription drug fee program is to provide more certainty and predicted to be on the timeline for fda to make the decisions to approve a drug. in terms of continued innovation and patient access to new medicine for companies to have predictability of the fda and make decisions on applications? >> because these companies invest up to a million dollars in development programs and then they need to launch and they have to do a lot of activities to get ready for the launch. they have to get their facility ready, all sorts of distribution and different things. and so, just knowing what the

sequence of events is going to be and when that time on the market will be is extremely important to keep this enterprise afloat. >> i agree. do companies receive patents frustration for the time it takes to go through the fda process? >> i don't understand this very well. they get restoration at the time of approval. so they get to that, but there can be things eating away at the patent in the interim. >> and it is important because our investment resource is second to none in the world some of the device companies for better opportunities to get approval of the process and appreciate the work that you've done in the industry and leadership and research and certainly not go slow and unpredictable process so thanks for working to make that better.

>> we are starting to see some changes. i got cold this week by a company that said we are actually going to conduct our first study overseas and given the changes they are going to start it in the u.s. and we are hearing that from other companies as well. the numbers you gave in terms of the report from 2010 that's actually what i would say he is the high point of the watershed mark for the program it provided a decade of worsening and since that time those numbers are actually down. they are improving in the review. i hope i didn't -- >> it will doubled since 2004 so there has been increased funding event though you are under sequestration now. >> that concludes the first round of questioning. you are recognized for five minutes for a follow-up. >> can i just ask you briefly about the decision by the fda to

reschedule the load, is there any updates you can provide? >> let me explain the process. what we do is ask along with the national institute for drug abuse to provide a recommendation to the hhs who then provides a recommendation to the dea and goes through a comment process and the dea does the scheduling. so what we announced is simply the fact that we intended to recommend that product would be up to schedule. >> is there a report pending that we have not yet seen or that hasn't been made correct? >> what we need to do, any scheduling action we send something called a factor analysis which is stipulated under the controlled substance act and findings based on that and we write that up and send

that to the hhs who then will evaluate it and send recommendations to the dea. that process you should see a factor. we should be moving the process along fairly soon. >> so we will have access to that report? >> i don't know at what point it becomes public that we can get back to you on that. >> it is a concern all over the country an there are some things that require prescriptions and they can't be called in over the telephone in the middle of the night, but someone who has run out of a postoperative medication and still needs help has the ability to get that help to that patient without an emergency room visit. so it is important. we had a hearing i guess it was

on the ban over-the-counter come of the epinephrine treatment for bee stings. i don't remember quite honestly who was here from th the food ad drug administration but i asked if there was a cap over the counter so people would have the availability of the got into trouble of using drugs and either they got legitimately or illegitimately and then that was the feature of the story on cnn not long ago. where are we in th that process? we have gone to great lengths not just over-the-counter but down there with the front of the pharmacy if there's ever going to be any effort over the counter. >> we are certainly encouraging forms as you know now it is compounded nasal spray and so forth and has been used by paramedics and so we are

certainly encouraging the development of sort of dosage forms that can be used in emergency situations and then we would certainly consider whether the over-the-counter access was needed that criteria for over-the-counter and then we would approve emergency treatment overdoses by friends and relatives for example. >> again it was a pretty startling film clip that the doctor showed on that series and again it made me think about the possibility that again, no one wants to come down the use of the list of drugs but on the other hand you hear about it and usually it is a teenager in our communities and it is a terrible tragedy when it happens. if there were another option maybe that would be a good thing. >> we agree. and if lives could be saved that way that is something that we should dro draw to words and wee

very aggressively pursuing this. >> it would be better if it never abused the compounds in the first place but for the matter of first aid perhaps that is something that should be considered. thank you for the recognition. i yield back. >> now for a follow-up. >> i know that when we were debating the various proposals around this reform one of the issues as where to draw the line into the proper balance should be in regulating medical devices we wanted to make sure that on the one hand we have sufficient regulation in place and you have sufficient authority at the fda to ensure that these devices are safe and effective and so forth. at the same time not have so much regulation that it becomes burdensome on the industry to

the point of clashing innovation and investment. and i would be curious for your thoughts on how the industry is responding to where we kind of put that line where we struck the balance and in particular i would be curious to hear you talk about the new more streamlined process that you have with respect to classification of devices from class one all the way up to class three where i gather that now you can use a kind of administrative process that doesn't necessarily involve full-blown rule-making commented so forth in every instance and maybe you can give some examples of how that how you use that authority. after much discussion that

occurred, there was general support for the u.s. standard of reasonable assurance of safety and effectiveness and the question then becomes what does that actually look like for the particular kind of devices? what we have done is put in this new benefit book that is much more flexible and patient centric to set the needle with you well in the right place. one of the things we are going to be following up in the coming months is to start talking about the circumstances that can be shipped to the post-market setting and not come from ice patients that an appropriate reduction of burden on the companies and address some of those cases in the post-market setting and that will include new pathways for high-risk devices as well. i think that's important. regarding classification committee provided some changes or the process one is the fact that we can now issue in order rather than a regulation. succumb in some respects, it's

gotten a little easier. but let me tell you one and it's been helpful, let me tell you one wrinkle we have and that's if we do want to impact reduce the burdens on companies appropriately so because with more experience, we realize that wrealizedthat we should lower te classification. from class to class one. we now have more steps to go through and we must put an advisory committee meeting where before we didn't have to do that. and that is actually making it more challenging for us under appropriate circumstances to reduce regulatory burden on companies. >> the chair thanks the gentleman. we have a couple of members detained on the floor. i would ask unanimous consent to recognize them as they come in for five minutes. you are recognized for five minutes. >> the office accommodation was created to deal with products and all biologic products.

for instance, some companies are toying with the idea of combining drugs and devices into solutions for antibiotic something that they care about personally as you know. however, the current approval method forcing companies wit wht they mainly a device product to go through a drug pathway because it induces a chemical reaction may discourage companies from investing in the breakthrough technologies because the pathways and best suited to what their product is. with the reality of combination products when the reality of the combination products were not realized, what steps has the fda taken in light of its current 1970s framework to work directly with these companies who present the agency with 21st century technology like these combination products? >> the agency setting up the office of companies and products

which sits in the office of the commissioner is there to help determine what is the appropriate pathway for those combination products to go through and they have been more recently trying to provide clarification when the primary pathway would be device or drug. but when it is a combination product, there are needs that would be meant for let's say if it is a device or the drug and for the drug side. so even if it is a product that we have primary responsibility for, if it has a biological component we go to the center for biologic standards it is a drug company and we go to the center for drugs. this is a very challenging area. i have to tell you this because given the way that the law is, we have been able to minimize the duplicate of burden if you well in the challenges on the post market site for reporting more on the good manufacturing processes. but when it comes to the standard for approving products, the law right now is very challenging for the combination

product makers. >> the bipartisan act took important steps to encourage the development of antibiotics by focusing on the census to the new companies to keep companies in the marketplace. and at this time can you provide me the number of cola fight infectious disease products that have been designated since the law was passed last year? >> we have designated a 27 products with 16 distinctive acts coming and that number will continue to probably increase. >> well, i really have to commend the fda on that and realize the desire to meet with antibiotics and acting quickly to implement the program. i have received plenty of positive feedback from companies not just in my district, but who have been able to achieve benefits through the game act. i think that he would appear agree that more needs to be done to combat resistance. one is susceptibility tests,

interpretive criteria or breakpoints. and as you know, the breakpoint criteria used particular infections, susceptibility or resistance to a specific antibiotic in the clinical decision-making. with the growing public health threat of antibiotic resistance, it's increasingly important to ensure that physicians have these tools they need to prescribe the right dose of the right antibiotic for the right patient in the right situation. given what we know about the science breakpoints and i told you, to keep pace with regulatory science in europe. our u.s. patients receiving the best medical care using the most up-to-date science of the breakpoints for antibiotics are not accurate? >> well, they would not be. we have updated these criteria for about 121 of the 200 named antibiotic labels that exist.

however, we feel that it would be more -- remain more up-to-date if we didn't have this information remaining in the drug label but it would be about to point to a webpage and possibly the standard development organizations who are actually out there on the ground in the communities and are getting the information on an ongoing basis. even when we have approved and antibiotic, we only look at a few organisms and as you know that physicians have to use the diagnostic criteria in the devices on the test for susceptibility for a wide range of organisms many of which may not be in any drug label. so, we think that we need a more dynamic and effective process that reflects the ongoing experience. >> i have about two seconds. i want to ask you to connect with me today to work with my office to fix the breakpoint

issue as well as look towards other ideas to address the epidemic of anti-biotech resistance, one of the chief threats to public health today. >> we would be delighted. >> mr. chairman, thank you. >> that concludes the questions for the members. i'm sure members will have follow-up questions and we would ask you to respond promptly. i would remind members that they have ten business days to submit questions for the record, and that means they should submit their questions by the close of business on tuesday, december 3. very informative hearing. thank you very much and for your patience. without objection, the subcommittee is adjourned.

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of the house energy and commerce subcommittee on health is wrapping up. we are looking now live at the floor of the house in the final moments of the debate on a bill that has been presented by the chairman of the house energy ant converse committee fred upton of missouri to allow people to keep previous healthcare plans for a year and allow new sign-ups for the plans that would drop by insurance companies as part of healthcare law. this coming a day after president obama's announced tha he would allow insurance companies to offer old plans bur wouldn't allow new sign-ups that shortly, and after that vote ordering if we will take your calls, you can watch that on oul companion network c-span.

it comes directly out of detroit and recalls those winter sundays. sunday is my father got up early and put his clothes on

>> robert hayden is one of the major poets of our time. i find whatever i feel like reading poetry, i take down his books and i go over them again and again. his poetry principally, but also his prose. i think one of the attractive features is that all of his poems are written in different styles, different voices come in different forms and techniques. he was very deliberate about this from the very beginning.

many poets write well but did do they write essentially the same over and over again. but he was determined to try to make every problem unique as it could be so he writes historical poems, personal poems, comic poems, dramatic poems. so he's a fascinating figure because he represents the world of early detroit, detroit and the teens and 20s in 20th century and all the way through the depressions, the aftermath of the war, the life that people lived in the 50s and 60s and of course he was a chronicler of the civil rights movement. and there are so many areas in which he has written beautifully written, telling my. so i'm delighted that there is

attention being paid to him at his centennial. waiting for the daily white house briefing to take place. that's coming up scheduled for 12:45. on wednesday president obama hosted the white house tribal nations conference at the interior department. conference includes leaders from the 566 federally recognized tribes to meet with the president and members of the white house council on native american affairs. each federally recognized tribe has been invited to send one representative to the conference. cabinet secretaries speak about their department goals in advancing the well-being of those living in tribal communities.

>> good morning, everyone. secretary-general, thank you for your leadership of the white house affairs council but more importantly, sally thank you for inviting me to the city today. i am honored to be here. i don't think that the senator is here yet, but he would like to express appreciation for the leadership of the senate committee on indian affairs when he had that post. i know there are probably other distinguished members of the congress president and greetings to you as well. brian, the president of the national congress of american indians, other distinguished guests and among them i include our doctors. it's great to see all of you. ladies and gentlemen, as is my custom, let me begin by greeting tribal elders and tribal leaders with deep respect.

that's part of michael sure as well. and i extend that deference to all the veterans who are here this morning. and so with your indulgence let me invite those who are veterans to stand if you are able to come to raise your right hand if you can't stand and let us have this opportunity to acknowledge your service. [applause] >> thank you very much. american indians and alaskan natives have a long and proud history of service to country and courage in battle. that goes back to even before there was recognition of citizenship. 14,005 in world war i. 44,000 served in world war ii and among them the doctors for more than 30 tribes.

some 10,000 served in korea. among them former u.s. senator r in the northern cheyenne indian navy admiral clark a veteran of both world wars so a three war veteran. over 80,000 native americans serve in vietnam. operation iraqi freedom and the specialist was the first native american woman to die in combat. the first american to die in operation iraqi freedom, but the third generation in her family to serve in the war. today some 30,000 native americans serve around the world preserving the warrior ethic that is so much a part of your culture. let me greet you in the tradition of where i grew up in the middle of the pacific. we say hello how -- aloha and

welcome. i grow up in the 1940s following the attack on pearl harbor. men from my community like medal of honor recipient senator daniel inouye went off to fight world war ii with indomitable courage, determination and sacrifice. and in doing so, they were among the most highly decorated army units not just in world war ii but in the history of this country earning 21 medals of honor for the units that only existed about three and a half years. they fought and bled so that young japanese americans like me would have the full citizenships of -- privileges of citizenship. they are in the community today and that is true of your communities as well. of the war in korea quickly followed and then vietnam became my turn to go in 1966 that i

never planned on being a soldier but 38 years went by pretty quickly. a lot of that have to do with falling in love with the american soldier. it focused on two things. accomplish the missions that you are given with the best care to your people, your soldiers and their families. today the secretary of the va, i have the privilege of continuing that care, caring to those i went to the war within vietnam and for those i sent to the war as a serving chief of staff of the army and then caring for those giants as i call them in the history of our country who saved the world during world war ii, saved the nation during the 1950s. among them are heroes who during world war ii destroyed enemy machine gun nests, forced the third one to surrender, detroit tiger tank single-handedly, and

then drove to other tanks off. access did -- exhausted he managed to wound to soldiers barely a mile to get them for safety. for his actions as you would expect, he was presented the highest award for the medal of honor. he went on to serve in both korea and vietnam. another three war veteran. they were known to you very well and got a great honor to the tribe in world war ii and he helped his marine comrades raise the national colors. after the war, he suffered terrible mental issues and died from exposure. he was buried with full honors and then arlington cemetery. that is the reason, at least one of the reasons i'm here today.

not here in this conference room, but here in this job. i cannot change the records of injustice in our history and they are there and there are many were the lack of trust that some may have about this department. but i do intend to make things better and i need your help. most know that it's a large integrated healthcare system with over 1300 points of care. 152 medical centers, 829 829 829 community-based outcome clinics and 300 readjustment counseling centers and about seven or eight outreach to travel the most remote areas and rural areas of the country to find the veterans where they live. the va also provides about $10 billion in educational benefits annually along with ari duncan.

second only to the department of education and most of you know about this as a post 9/11 g.i. bill. but $10 billion of opportunity. they are outhere are only zero y in the nation. the va is the invasion's ninth largest insurance enterprise with $1.3 trillion of coverage and a 6.7 million clients and we operate the country's largest national cemetery system, 131 cemeteries. 337,000 good people come to work every day at the va. about one third of us are veterans. we bring the same determination and initiative and leadership and we learned a uniform to the duties. as we were taught, people don't care what you know until they know that you care. and so we are pursuing and still

pursuing better ways to serve. the health service signed an updated memorandum of understanding to enhance collaboration and resource sharing between the two agencies. then in december of 2012 working with secretary sebelius we signed the national reimbursement agreement, so far under that agreement over 2,000 eligible native american veterans have received va reimbursed care from the health service and the tribal health programs. as of today, 106 facilities are reimbursed on the sites. we've also entered into the reimbursement agreements with 35 tried tangible entities and we are working closely with 62 more. for fy 2014 this coming year president obama has budgeted $52 million specifically for the va reimbursement to the tribal health programs.

we can do much more this year. [applause] we are expanding the home-based primary care program to reach by colo kidding resources at the health service hospitals, clinics, tribal clinics and va community-based outpatient clinics that are adjacent. over the past five years, the office of rural health has dedicated $45 million to fund 101 initiatives located across indian country. mobile clinics as i mentioned, ptsd, homeless veterans and then the tele- health projects that increase native american veterans access to healthcare specialists while minimizing the long commutes especially for the chronically ill. they funded over $18 million to the veterans living.

to honor your culture by ensuring that native american veterans related to rest and the tradition of the tribes, we have committed more than $19.5 million to the rosebud and the seminal nation of oklahoma. over the last three years to construct new tribal veteran cemeteries on tribal land. and fy 2014 -- [applause] in this next year in 2014, five more grant proposals will total nearly five and a quarter million dollars. in january, 2011, t the va established the tribal government relations to improve communications so we could be more responsive to your needs. deputy assistant secretary john garcia and many of you know him and the director stephanie birdwell also known well to you

my personal trusted agents working with the tribes are charged at increasing tribal veteran access to the va benefits and services that they turned and so we are looking to increase our outreach. february, 2012 i signed our first tribal consultation policy so we can communicate directly with tribal governments on the veteran related issues affecting indian country. over 156,000 american indian and native slip in the united states and are committed to providing equal access to all veterans anf you understand the threat and the difference in the landscape, you will appreciate that commitment means that whether you are living in an urban area or you are a rural veteran or the most remote locations like the outer banks of alaska or maybe even guam, 700 miles

beyond honolulu, our commitment is to provide as best we can equal access to every veteran that matter the condition, and that it includes veterans living on tribal land. and with the support of the congress, the president has increased its budget request for the va by over 50% since 2,009. is it, rural, urban, native american all earned the same benefits and services in our commitment. i took this to help make things better for veterans quickly and interchange the department for the long term so that all veterans including the native american veterans will be well served and treated with the dignity and respect that they've demonstrated in serving in our country's uniforms. it's been an honor to be with you again this morning. again, thank you for the invite.

may the almighty continue to bless our nations. thank you all very much. [applause] >> ladies and gentlemen, kathleen sebelius the secretary of the united states of health and human services. [applause] good morning everybody. it's my great pleasure to have another opportunity to be at this historic meeting of native americans and mask and only natives. here i want to recognize my colleagues, secretary sally jewll who has been a terrific addition to the cabinet and a wonderful colleague and partner on a lot of issues. thank you for hosting today and

for your leadership. you just heard from secretary shen seki. we have worked together on a variety of initiatives and benefits to indian country and i'm going to talk about a few of those. there will be the great leader of the indian health services doctor young said who is a better help to the indian country and thank you. and stacy who works with our intergovernmental relations department. i'm also pleased we have some of our staff members here. one of the things i did is create a secretary tribal advisory committee that has been enormously helpful not only to meet all of our senior leaders and not only budget issues and priorities and gary who is the

former chair and i want to thank him for his service in the past so thank you all for being with us today. i attended a special session of the novel donation council. it was an interesting opportunity for me because i had an opportunity to hear directly from the delegates about the challenges they face from day-to-day for the aids prevention and treatment. they shared some of their concerns as well as hopes for how to improve health and wellness throughout the novel donation. and i wanted to take this opportunity to offer some thoughts on a few of the priorities that we share. building our government to

government relationship, obligations to closing health disparities and reinvigorating health and wellness in the tribal communities throughout the country. so, the research shows that nearly one in three american indians and alaskan natives don't have health insurance. one in three. that compares with 62% of all non- eligible americans who are covered with insurance, but within the alaska native and american indian communities are only 36% are covered so the challenges they face are real and so are the opportunities to expand services and access to coverage. for example, if every state in the country were to expand medicaid, and i can tell you that something the president and i are dedicated to continuing to pursue, 94% of uninsured american indians and alaskan natives who qualify for

financial assistance to get health insurance whether through the new health insurance marketplace, through medicaid or check. so we have a pathway of getting people into the health system in an economic fashion. closing disparities in the tribal communities have been a priority as long as there has been an obama administration. our president inherited the worst economic crisis in a generation but he insisted on forging opening the lines of communication and investing in indian countries. you will hear from him later today. as a result, we have been able in the obama administration to make more progress for indian countries and we have made in a generation. what may give you a few snapshots from hhs. before obama, president obama took the oath of office, there was a steady decline in the

number of children and head start who spoke a tribal language at home into the classrooms in the curriculum if it is a big step forward for the next generation. for any of the facilities that were a legible for the national health service corps. this is one of the best-kept secrets in the industry. the national health service corps is the peace corps for healthcare providers. if you are going to be in an underserved community the government hopes to pay off some of your student loan debt or gives you a scholarship. they can even accept these healthcare providers including doctors and nurses and mental health practitioners.

every facility can be eligible more than 600 in all and we have national health service corps going in as facilities across this country and that's a very good news. what's more as many of us remember all too well it isn't long ago that the reauthorization of the indian health care improvement act was just stuck in congress. indian health services is here to stay. after permanent reauthorization many of you in this room worked tirelessly to make this happen and if it wasn't for your work we would be having a very different conversation today. but as encouraging as the progress we have made together has been, all of us recognize that washington politics has put much of that progress at work due to the so-called sequester cuts.

and unconscionably 804,000 fewer outpatient business for ihs patients. 804,000 trips that should be to the doctor or to see a nurse or keep people healthy due to the budget action. it's not only told the cuts they can take but they also been kids can be kicked off of head start. the facilities are understaffed and the tribes without the ability to staff the facilities we have used their own resources to build. now can the president has a commitment come and it is doing everything that he possibly can to minimize the effect of the cuts on the indian countries. but we need your help to talk to congress. it's congress has to take action on a realistic budget getting rid of sequestration and

preventing the next round of arbitrary cuts from having a potentially devastating impact. last year at this conference i was able to announce the finding and you just heard from general shen seki of the reimbursement agreement. again, something that you all worked on for some time. and so far in th the tribal site received nearly a million dollars of reimbursement because of this agreement. we have been working to make sure that your sources are heard in the state level and federal decision-making. and as i say in the hhs we have created a departmentwide secretary tribal advisory committee, and in fact we are meeting tomorrow. and i continue to urge other colleagues throughout the cabinet to look at that model because the staff meets three times a year not just with me but with all of our senior

leaders. we need on policy and budget issues and to begin from our priorities and they help to direct our initiatives. one of the areas is reducing barriers to eligibility, access to the hhs grants. we are a big department and we have a lot of grants that go into communities for a whole variety of health services. but what we have learned very quickly is that the entities, communities, travel communities and others that need the grant money the most don't have the grant writers, don't have a sophisticated staff to track the money and can't even really follow the puzzling maze of undergrad are doing and when they come out and what they are for and how they could best benefit. if the roadmap for where the money is and how to access it and what kind of service that would provide and even technical

assistance and grant writing. to better understand the obstacles to remove them and the grants can be especially significant for behavioral abuse and behavioral health and substance abuse services issues that are really important to deal with and in the tribal communities that used to be that the tribal nations were largely on their own in their fight against alcohol and substance abuse. and today our department has a dedicated office working with tribes as they develop detailed action plans and coordinate resources from across the federal government. the grant applications are now in a simple and easy to use booklet thanks to the work and we are doing the training sessions with tribal communities across the country efforts are

also getting a very big boost from the recently announced. evil which was released last week. what the rules as which was passed by congress a's behaviorl health and substance abuse services are now on equal footing for insurance companies with physical health. so come you can't have a limited number of days or inpatient or outpatient debate whether you are seeking help for behavioral health or substance abuse or a cancer diagnosis, you must be treated the same. it is a huge step forward and new insurance policies will now include behavioral health and substance abuse services. so about 62 million more americans will have access to services and treatment. i know a lot of you in the indian country are working on efforts are bound health and wellness and particularly health and wellness with children. the effort on childhood obesity

led by a great leader and a championing is an initiative called let's move. to try to ensure that all kids have an opportunity to grow up healthy and pursue their dreams. let's move in indian country to focus specifically on the first american children. i have some notes to share with you. we are entering a new partnership. is he in the room this morning? what you stand up, please and let us recognize you? thank you so much. i'm being extra nice because i hope it will help me with my golf game. we will see about that. but i really want to recognize that he has done amazing work with his foundation.

identifying best practices in areas for collaboration. i want to recognize that this effort couldn't be more important we are talking about the next generation and we are talking about living longer, healthier, more prosperous lives. the reducing obesity is one of the most important initiatives that we could work on together and again, i want to thank you for your efforts in focus and leadership in this area. one of the most important things we can do is to decrease disparity in access to an affordable health coverage. to reduce the disparities by lowering the cost of making quality care more accessible to people across the country. it's made the polic policies str

and with the new health insurance marketplace, there is an opportunity for those without insurance to purchase insurance on their own and get covered. if you are a member of a federally recognized tribe and you buy a private insurance plan through the marketplace, you may not have to pay any out-of-pocket costs like copayments or deductibles and if you are eligible for services through the indian health service, and urban .-full-stop graham or tribal program come you cannot only n. roll through coverage to the marketplace, but you may be eligible for special exemptions to make it easier to qualify for medicaid or s. chip coverage. we know that there are a variety of ways to enroll, and in spite of the issues that have plagued the website it is getting significantly better so you can go online to the call center, you can go in person or meet

with someone to get a paper application and fill out a paper application. we help patients in rural to get covered. we remain committed to building on this work to ensure that all american indians and alaskan natives have access to quality affordable health insurance and life quality affordable lives whether they are living on a reservation, on the tribal land or in an urban area. they were inspired by the iroquois great wall of peace and the principle of righteousness, justice and health. of thosthose principles have a w meaning today. there is no righteousness without justice. there is no social justice as long as there are unacceptable disparities in health. therefore, we continue to be

committed to working with you to move this effort forward and to move towards those great principles of righteousness and better health for all. [applause] >> security of the united states department of transportation. [applause] good morning. it is a pleasure to be here with you and i also want to extend my thanks to secretary jewell for the invitation to be here today and for all of our tribal nations and our tribal leaders who are here, thank you for being here today and i know that many of you have traveled a

great distance. i am proud to be a part of the president's initiative to build a more respectful collaborative relationships with groups or nations closer to the shared goals. the department of position is very clear. residents of the tribal nations need and deserve safe roads and bridges and access to reliable public transportation. you know as well as i do that transfer tatian is a lifeblood to communities, families, people. and when we deliver on the promise of connecting every person on the shores to 21st century opportunities, that includes tribal communities all across america that is the key

part of the mission of the department of transportation. we are committed to ensuring a agaiagame that everyone, regards of where you live, has access to safe transportation. today i am happy to announce the latest evidence of that commitment. as we or $8.6 million to 183 tribes to help improve transportation safety on their land. they will protect the roads for everyone who depends upon them, helping to improve the quality of life for tribal communities at the same time. the projects cover a wide range of safety planning, engineering improvements, enforcement and emergency services in safety education. just as an example, the invasion and oklahoma will receive $525,000 to modify the key

intersection with new signal lights, better signage and improved acceleration and deceleration like this. it will receive $100,000 to create safe havens for people stranded by vehicle breakdowns or impassable rivers. most significantly, these new tribal transportation safety grants will go directly to the tribes for the projects and planning in indian country. [applause] they work directly with the highway administration on these important projects without having to go through governors or county officials.

it's going directly to the tribes many of the grants will provide tribal governments with the funds to develop brand-new safety plans for the program will see an improvement that will extend into the future. the national highway traffic safety administration is also working hard to boost safety among the tribal communities. nationwide is about 86%. yet among the native americans, that number drops to 68.5%. this is significant because it has an impact on our ability to save lives 65% of passengers killed and a car crash were unrestrained. but among tribal nations, a full two thirds of those killed were not restrained at the time of

the crash. .. >> in our partnership on transportation in indian country, it doesn't just improve safety, it also connects people to opportunity. we know and you know that a rebuilt road or a new transit system can be the difference between a child getting to school