going to be proposed part of the regulation due to the widespread stakeholder concern about the cost and complexity of the regulations after the law emphasized the need for science and risk-based flexible approach. and i urge the fda to improve the responsiveness to the congressional inquiries. there is one letter i sent last july, to which i have not yet received a response. and in that line i will send in writing a question that senator fisher of nebraska has that she would like answered. i won't deal with that orally that i will provide that separately. ..

from her previous post that new york's department of public health and mental hygiene and the u.s. department of health and human services. and dr. hamburg, we thank you for sharing your expertise with the committee and being here today. your statement which is an extensive statement, which i got through yesterday, last night, it will be a part of the record in its entirety. i'd like to ask maybe, giddy up to 10 minutes to go through that, if you'd like rather than just five, but maybe, however close you can keep it but below 10 minutes. i'm going to request the record remain open for 10 days for

senator smith's statement or questions for the record. a couple things, at 10:30 i have to leave. you probably do, too. both of us have to leave. [inaudible conversations] >> good. and then i think, well, we have i think senator franken said he will take over at that time if we continue on beyond that, beyond that time but we are managing a bill on the floor that we have to leave four at 10:30. so again, dr. hamburg, welcome and please proceed. >> thank you very much, and i know that you're pressed for time so to give my oral statement relatively short. you know really, thank you, mr. chairman, and members of the committee, for the opportunity to be here to discuss important initiatives that fda has been working on with regard to the implementation of several new laws recently passed with this committee's leadership.

the food safety modernization act, the food and drug administration safety and innovation act, and the drug quality and security act. i also want to express my gratitude to you and the members of the committee for championing the passage of these landmark laws. they all represent remarkable accomplishments done as you noted in a bipartisan way, and they are important to public health that cannot be overstated. we also welcome the opportunity to return to the committee to provide a more detailed review of our implementation of the t cells nine family smoking prevention tobacco control act, as you requested which really lays a strong foundation for protecting the public health from the harms of tobacco products. first, food safety. reducing foodborne illness in the united states is one of the fda's most important responsibilities. the toll it takes on public health is profound, an estimated 40 million illnesses, 120,000 10 hospitalizations, and 3000 deaths every year from foodborne

illness. moreover, the overall negative economic impact of foodborne illness in the united states including cost to farmers and food prices as and consumers may be as high as 77 billion per year. thanks to you and your colleagues who enacted the food safety modernization act, fda has tools to significantly lessen these impacts. business central framework is aimed at building preventive measures across the food system from farm to table. including parties safety, modern preventive control, guarding against intentional contamination, modernizing oversight of imported foods and ensuring safe transport. over the past year fda has put forth several proposed rules on these topics for public comment, but new rules alone won't get us to our goal. fda must have resources to implement them to provide the technical assistance to small food processors, for example, to

build the capacity of our state's as partners in this important effort. and also very importantly to begin the long delay process of better oversight of imported foods which are increasingly important in our food supply. simply put, without a significant increase in resources we will not achieve fsma vision of the modern food safety system and safer food supply. with respect, building on the successful model, the food and drug administration safety and innovation act reauthorized user fee programs for innovator drugs and medical devices and also established two new important programs for bio similars and for generic drugs. coming at a time of continuing budget constraints, this is a the source of funding is essential for new products to patients in providing the capability and consistency for industry. the law also gave 50 new authority to better protect the

drug supply chain in an increasingly global marketplace. in addition we provide the agency with new authorities to combat drug shortages and also to stimulate and the bacterial drug development, enhance truck for pediatrics and encouraged drug and device product innovation. i want to highlight just a few of the successes we've already seen. as part of negotiated agreement with him into fda committed to makbe much enhanced performance goals for medical device reviews. since fiscal year 2010 we've achieved a 27% decrease in the backlog of lower device applications and to 10% decrease in average total review time. for high-risk devices we've seen a 43% decrease in the backlog and the 32% decrease in average total review time. and recognizes the need to stimulate investments in antibacterial drugs, fdasia

created incentives for the development and since the passage of trenton fda has granted 41 qualified infectious disease product designations under this new program which i think is a promising start. i'm pleased that after a series of interventions, including use of new authority provided under fdasia, the number of new drug shortages decline vary significantly from 251 to 117 between 2011-2012, then felt even further to 44 in 2013. however, there do continue to be shortages that persists for longer periods and we're working aggressively with all the tools at our disposal to prevent and mitigate them. with respect to the drug quality and security act, the last time as was noted that i appear before the committee we were in the midst of a nationwide public health crisis related to the fungal meningitis outbreak caused by compounded medications. and thanks truly to this

committee's leadership we now have the drug quality and security act which contains important provisions relating to company oversight and also outlines steps to an interoperable system to identify and trace certain prescription drugs. as was noted within one week of passage at dick u.s.a., fda took actions to begin implementation including issuance of three draft -- drafty guidances, nominations for drugs again it cannot be compounded and significant stakeholder outreach has been undertaken. as of this week 35 firms have, in fact, registered with fda as outsourcing facilities and winking to keep content inspections of compounding pharmacies and to take enforcement actions as appropriate to protect patients. without a doubt empty is what those have undergone huge transformations through these important new laws. our commitment to implementing the responsibility entrusted to this agency by congress to improve the lives of the

american public to protect their health, safety and welfare, is unwavering. we are committed to working closely with you on these important new laws as well as so many other issues, and we really believe that our work is vital and the partnership with you is vital, and we're making a difference in the lives of americans. thank you. >> thank you very much, dr. hamburg. and will start a round of five minute questions here. i have two tracks i want to go on. i don't know if i can get them in in five minutes but i'll try. and that is, have you addressed, if you catch her, perhaps i'll submit the question in writing addressing sodium consumption and reduction of sodium in our foods. but i really want to focus my question on opioids.

in 2002, doctors in america wrote 144 million prescriptions for opioids. 144 million. 10 years later they wrote 241 million prescriptions for opioids. 4030 people died from overdose in 1999. 16,651 died in 2010. more than heroin, opium, everything else combined. that's oxycontin, percocet, vicodin, all those. on october 25, 2013, the fda approved a new hydrocodone, zohydro. 40 experts urge the fda to reconsider its approval enters a statement they made, quote, in the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new dangerous high

dose opioids, end quote. president of the physicians for responsible opioids prescribing said quote, it's a whopping dose of hydrocodone packed in an easy to crush council but it will kill people as soon as it's released, end quote. and then i found that was in the newspaper this moment, the "washington post," where i'm getting some of this information, i don't know if it's right but i'm just reporting what they said, the advisory panel, your advisory panel voted 11-2 against approving zohydro and yet the fda would have improved it. now, again what i find startling is in the united states we have 5% of the worlds population, but we have 99% of the world's consumption of hydrocodone. hydrocodone, the most prescribed pharmacy drugs in the u.s.

as i said 131 million -- 241 million for opioids for hydrocodone, it was 131 million prescriptions in 2011. i didn't realize we were so painful in this country. what's happened? we had a hearing on pain last year. i may have to have another one. pain clinics. you go to a doctor in their prescribing painkillers, opioids. people go back and get them refilled. you've got a pain? go to the doctor. what's happening to our doctors in this country? when we had a panel here last year, they said a lot of it is not this a logically cause. they may have a physiological manifestation but it's not this a logically cause. the fda comes along and proves what i understand to be something that is 10-20 times more powerful than oxycontin. when your advisory panel voted

111-2. could you address your so? >> it's a very complex problem, erasers public health threat and we're working very hard to address what fda continue to make sure that patients with legitimate pain needs get what they need but also to recognize the serious addiction potential of these drugs and that we need to do what we can internally and, of course, work more broadly with all the components. as you know, prescribed or practice is an important component of this overall problem. with respect to your question of zohydro, let me address the best i can. hydrocodone is a very important opiate for the treatment of legitimate pain and, you know, we do have many medical needs for both acute and chronic pain management. hydrocodone up until the

approval of zohydro is only available in a product that also included acetaminophen which has significant liver toxicity. and for some patients as you know, some patients respond to different drugs differently and some can tolerate hydrocodone much better than they can tolerate other opiate drugs. but at the lower doses were it available in the combination product, series of risks if you opt the dose of the hydrocodone of liver toxicity and syria's i threatening complications am the acetaminophen. so this product is unique in terms of its availability as a single hydrocodone product without the associated liver toxicity risk. it was approved. the advisory committee met actually before we put in place more stringent labeling requirements around the use of this class of drugs, that we

think are important for assuring appropriate usurpations with legitimate pain. it is approved as a scheduled to drug, which means that there are additional restrictions on prescribing. physicians have have a special license. there are limits on prescriptions. no refills. there's special security precautions and requirements that have to be undertaken with respect to the storage of the drug, and reporting requirements. it's a scheduled two drug that has these additional requirements to limit its use and totally to make sure that it is prescribed and used appropriately for pain where it is required. in addition, there is rams for this drug product that places further restrictions on the use,

and also requires the company to make available physicians training for its appropriate use. so we recognize that this is a powerful drug, but we also believe that a properly used, it serves an important and unique niche with respect to pain medication. and it meets the standards for safety and ethics, recognizing its addiction potential and understanding, of course, the broader context of the serious problem of opiate medication abuse and misuse in this country. we weigh carefully risks and benefits, and we hope that as a nation we can make progress in addressing all of these issues that contribute to this ongoing and very serious misuse and

abuse epidemic. and we will continue to push hard. we are trying to ensure that work is going forward with respect to the science and technology so that hopefully we can move in that direction going forward. >> thanks. i have a follow-up question. my time is out. i will submit those inviting. thank you. senator alexander. >> thank you, mr. chairman. doctor hamper, i've problem energy and implemented a compounding pharmacy though i would like to just discuss that with you a little bit. i think we understand each other on this. one of the reasons in my opinion for the tragedy was some confusion about who is on the flagpole, whose job wasn't to regulate the massachusetts facility. and my understanding is now the law clears that up, that a compounding pharmacy that uses,

that compounds still drugs may choose to be regulated by you, or if not their regulated by the state. is that right? >> well, first let me thank you for your leadership on this issue and the important issue of trying to clarify through legislation the important aspects of the compounding pharmacy law and requirements for oversight. i would say that this is a very, very important step forward in terms of that effort and also really defining a new role for the fda. i do have some concerns, and i think that you are aware that fda as a legislation was being shaped was concerned about come in fact even with clarifying 503 a so we now know it does apply nationwide, it is still possible that a compounding pharmacy

could be in compliance with some aspects of pfizer three a compounding a specific product for specific patient with a prescription, et cetera but might be out of compliance with other components such as compounding an fda approved drug or other aspect. and so there still is an opportunity for some confusion there and with respect to 503 b., we are concerned that it is voluntary companies choose to register with us and be under our oversight. some may not but if this sort of hideout in 503 a traditional compound we may not even as it is i don't have five minutes i want to get to a three-part. i understand that but, and the cynical of course wanted to go further but a lot didn't go there. didn't go that far. but fundamentally you've got 35 facilities that already agreed

to be regulated i you and at the same time, you are able, you're issuing warning letters to others. and so a couple of questions on that. on your follow up to the warning letters, i also understand that some states are indicating, i've heard, that they may require an outsourcing facility that's chosen to be regulate by the fda also to be regulated by the state as a pharmacy. that wasn't the intent of the legislation. it was to permit a facility to choose one or the other. >> you know, i have not heard that specific concern. states very as you know considerably in terms of their laws and their resources to the oversight of compounding pharmacies. what i have heard from states is

that when there are these large facilities that are manufactured high risk, still an injectable projects that they often don't feel equipped to provide that regular oversight and so they hope that those facilities will register with fda. >> but at least under the law manufacturers you've got. deregulate manufactures. outsourcing facilities are all yours. the rest are the states. but when will you be issuing more, i guess you call them draft quality standards, so that the other compounding pharmacies will know what would be expected of them if they choose to be an outsourcing facility. >> well, we are working to develop the good manufacturing practices guidelines for those outsourcing facilities, and we will get that out as quickly as we can. i think that the kinds of

facilities understand this sort of broad framework that they can expect in terms of good sterility practices, et cetera. but this is very, very important, a high priority for us and we will be moving forward. >> do you have any estimate of how many of these facilities that compound still drugs exist that are eligible to be outsourcing facilities? >> we really don't know what that number is a, and we are hoping that now applicable to this important new law and begin this process that we will begin to get a much better sense. and, of course, we are also increasing our partnership with the states and actually we're having a second-50 state meeting next week to help strengthen the communication both the understanding of what this new law means for all of us and also to make sure we have the right systems 14 occasion, and we've also been doing a lot of

outreach with health care providers, hospital systems, et cetera. because we hope that they will see this, the outsourcing facility mechanism, as what is best for their patients in terms of assuring quality and regulatory oversight and that it will become the standard of care. some more and more companies will declare themselves to us and we will be able to work with them in this way. >> that is my hope, too, and i would be anxious to watch this as it moves along. thank you, mr. chairman. >> i have in order warren, senator warner, -- center in see, senator murphy and senator casey. and senator franken. senator warren. >> thank you very much mr. chairman, ranking member alexander. welcome, dr. hamburg. so the cdc estimates that more than 2 million people develop antibiotic resistance infections in the united states every year. and there's increasing scientific evidence that the overuse of antibiotics in animal

agriculture is contributing to the rise of antibiotic resistance. the more we use an antibiotic, the less effective it becomes at fighting resistant infections. if we continue to use 30 million pounds as antibiotics in food animals every year, which is about four times as much as we using people, we are likely to have a lot more resistant infections and fewer antibiotics that work when we need them. so the fda's most recent guidance documents on the subject concluded that the use of antibiotics in animal agriculture for production purposes to promote growth in animals, i'll quote you, may contribute to animal testing antibiotic resistance. but the fda says that antibiotic use for disease prevention is all right, and you've asked pharmaceutical companies who

sell antibiotics to animal grows to voluntarily withdraw their fda approvals for those uses. we've heard preliminary reports that all 27 companies that manufacture in animal atlantics agreed to comply with this directive and will submit supplemental new drug applications to revise their labels. surely the removal of production use from the market is a good first step, and i'm hopeful that this will lead to decreasing use of atlantics. but the fda's guidance doesn't guarantee the prudent use of antibiotics in the context of disease prevention. even with every animal drug company agreeing to comply with the fda most recent guidance, there could still be a lot of antibiotic use in animals that is ostensibly for disease prevention but it still far more than necessary and will continue increasing resistance.

so how will these guidance and the fda's review of labeling changes ensure that we're reducing the antibiotic use in agriculture and decreasing the risk of perpetuating resistance? >> thank you for the question mark sets and the port of topic and it's one that on a personal level i been working on for most of my career. and i really am encouraged by some the steps we're taking out. i think they will make a real and enduring difference. as you noted, we put forward the guidance asking for companies, both innovator manufactures and generics, to show us how, over a period of time, they will remove the products for growth promotion purposes, what we call

non-judicious use of antibiotics. we've been very encouraged her to companies, there was a 90 day period for them to report to us their plans for how they would voluntarily comply, and that just closed and we have gotten preliminary indications of various participation. we will review what they put in writing to make sure that we're comfortable and will work with them if we don't take it adequate addresses. with respect to your question about how do we ensure though these antibiotics don't continue to be used inappropriately, although not targeted for the growth promotion, for prevention purposes, we are also going to be moving the oversight of the use of these products to the supervision of a veterinarian, which isn't the case now. so it would be much more like what your family with as a prescription from a doctor and

the release of a drug, the same will be true with veterinary oversight of the use of these products for the preventive and treatment purposes. and, of course, there will always be a need for antibiotics to treat animals for important illnesses they may have and also there is a role for prevention. but we want to make sure it's appropriate and adequately supervised, and especially that is important when there and the byproduct of important for human medical needs as well. >> i appreciate that and emerge out of time here, so i would just make a note about the use, but it is over so veterinarians have to prescribe. i think it's a very good first step, but veterinarians are permitted to prescribe for anything that's on label use. and so long as they are permitted to use it effectively for preventive disease, that means there's a possibility of

just continue to keep these drugs out in circulation, keeping them out of all the time even with the approval of a veterinarian. and i'm just concerned. i'll submit the rest of my questions for the record so we can go back to this in some detail, could you going to speak and i'm happy to discuss it further, and we will be able to work in oversight of the prescribing practices of the internet in ways that may be speeded i appreciate that. just want to encourage you along these lines. thank you very much, dr. hambu dr. hamburg. >> thank you, mr. chairman. dr. hamburg, thank you for being here and thanks for your service. i'm sure you're probably aware, skin cancers reaching epidemic proportions in the united states. in fact, one person and our dies now for melanoma, not to mention disfigurement of squamous cell and basal scale and other skin cancer but it's been since 1990 was the last time the fda approved an application for an enhanced ingredient for

sunscreen capability at are some applications that of impending longer than a decade for action. senator reid, democratic cosponsor and this off, and you're familiar with the think some of the initials -- initiatives were taken, will introduce legislation to make more transparent and more rapid determination in terms of skin care ingredients and products. we don't want in any way legislate what fda should approve, but we want to get a more transparent and a more effective system of evaluating these important ingredients for this terrible cancer. would you commit to work with our offices august ensure that we get a more rapid response to these determination? >> absolutely. i would agree with you it has been taking too long. and we are eager to work with you on -- were moving toward on the sunscreen additives and getting back to sponsors on our assessment. we also are looking at whether

we can modernize the overall framework for how some of these over-the-counter products submit applications and are overseeing to really try to streamline it and make it more responsive to our modern world. >> we will certainly work with you and your office to be a positive influence because we don't want to make the decision. we want the decision to give me. we know that's your responsibility. second question has arisen in my district or my state, from a couple of copies that asked the question. i'm not going to get into a specific question of the product i want to ask about the length of time it takes for fda to respond to an appeal of an fda decision. we have a particular case that was brought to my attention where a decision was made by fda, the company governed by that decision appealed the decision based on scientific facts and determinations that were submitted. it's been two years since, and they still haven't gotten an answer. last july when the call for an update they were told the decision was been and would be

there any day. that's been eight or nine months ago. what can people expect on an appeal of determination by the fda in terms of a reasonable time within which to get an answer to that appeal to? >> it would depend on the product, the nature of the appeal, the regular pathway that the appeal was being undertaken such can't give you a one size fits all answer, but i would say that i recognized how important it is to make sure that these processes work, work well, that they are clearly understood by the companies in terms of what timelines will be. and i think it's no doubt an area where we can often be more efficient and responsive than we have been. we really are committed to trying to do the best job possible, but not knowing the specifics here, i can't tell you

when. i do believe i saw a letter from you, and that we are moving forward on that in a relatively time away. but i will get back to you on your specific query more broadly. i was in over the last couple of years we've been working very hard to streamline and modernize our regulatory system to really address some of the business process issues that slows things down and to recognize the importance of good clear communication with companies around these kinds of activities. >> i understand with the breakthroughs in medical science and pharmaceuticals and devices sometimes devices use pharmaceuticals and you can't determine which one they are. >> that isn't true. >> very complicated. >> now. in this arena as in many other arenas, the world, our authorities were first

established looks very different today and that's why we had to modernize through fdasia and fsma updating the compounding pharmacy laws common center. and so we are always needing to really look at whether our systems match the real-world needs spent i appreciate your attention very much in my time is almost ups i would just say i'm going to get another question. it is very important with regard to fda is considering the regulation of medical kiev to their some considerations but it's a great deal of interest in that topic. >> we need to look at congress is responsible as well so i look forward to talking to you about that. thank you for your services. >> thank you, senator. senator bennet. >> thank you, mr. chairman. i'd like to thank you and the ranking member for holding this important hearing. commissioner, welcome back. i want to take a minute before ask my question to thank you for the fda's work over the last few

years. it hasn't been easy to intimate a conference of fda reform bill while beginning to also -- compounding bill. you came out to my home state of colorado in 2011 and listened to many people in our bioscience committee all across the state or having difficulty communicating back and forth with the fda, and you made a commitment than that things are going to get better. and i can tell you that honestly, i've heard this to many people back home. facing a very positive change at the fda and i think a lot of that is due to your leadership. nothing is perfect, but i hear consistently how much things have improved at the fda and other have of my constituents i want to thank you. >> thank you. >> i also was pleased to see the imitation of a bill that i worked on with senators byrd and hatch agreed a breakthrough therapy designation for drugs that have shown dramatic results early in the approval process.

debate over 40 treatments have received this designation. we passed that bill. if you asked me would be sitting here today with 40 drugs i would've said you are delusional but but that is, in fact, what's happened. drugs that are trying to cure various kinds of cancer and assisted by brooks us, and many other life-threatening conditions. i visited a number of colorado patients that are receiving breakthrough therapies and i can tell you firsthand that italy has made a life-saving difference for many who tell me that their dreams only to live a normal life. that's all they want to do. like everyone else. something the rest of us take for granted. so as a result of this effort to get drugs to patients more efficiently we've seen a number of people writing to her office asking for more direct dialogue with the fda regarding, should be considered to be breakthrough therapy. no one wants to unduly influence the signed and dated that fda looks at the conflict there should be an avenue for patients to inform the fda of their opinions about what might be

considered for breakthrough. commissioner, in light of all the work of the has already done, i wonder whether you could talk about the effect this new designation has had at the agency and for the industry and for patients? and whether you might be willing to have a more open dialogue with patients to consider information they would supply with respect to breakthrough therapy designation. i apologize for the long windup, but i'm excited to see something in our government working well and want to give you the opportunity to talk about it. >> i could even answer that would be very long. i will try to be succinct. it's been such an important and exciting new opportunity for us, and we appreciate that it was included in the legislation. frankly, it's been much more popular and successful than we had anticipated. the sad at the sight of that is that we actually don't, didn't get new resources to intimate this program, but we have been able to identify a very large

number of exciting drugs that really holds promise to treat serious, often life-threatening illnesses. we've been able to approve three different products for four different indications under this breakthrough therapy pathway. and i think that we will continue to see it as a very important program. it underscores i think another set of important points that have broader ramifications for our work at the fda. one of the aspects of it has been so successful is the early engagement with the fda review teams and senior level scientists at the fda to really help shape what is the best development and strategy so that we can ask and answer all the critical questions, to address the safety and efficacy question, but actually move it

through the system as quickly as possible so these promising drug candidates can get to the people who need them. and in that regard the opportunity is critical. and another aspect of fdasia underworked we actually have been also establishing a series of meetings with patients around some critical disease area to get their input in terms of how the disease manifests itself or condition in their lives, how we should be thinking about patient reported outcomes in many instances as the magical part of our study design, and how to really make sure that we are helping to address critical unmet medical need while trying to help feed innovation and product development. >> my time is up because my long winded, but i want to thank you. mr. chairman, i want to thank you because your leadership, including this, really has made a material difference, and they

think as we see the fda exercising its muscles around this one part of the pipeline, my hope is that we are, as you are sort of imply, we can sit across the fda as we think about how to make sure the united states maintains its leadership in bioscience going into the 21st century. so thank you. >> thank you, senator bennet. again, my thanks to you because you are the one person on this mean that spearheaded the effort for a couple of years and so i'm very grateful for you sort of taking that over and running with it. appreciate it very, very much. senator enzi. >> thank you, mr. chairman. senator roberts, i forgot from both of you were on that issue. now that i think about it. thank you, that's right. senator enzi. >> thank you, mr. chairman. that used up to 10 seconds of my time las.

[laughter] i would follow up on what's in the war was asking about, the animal and the bugs that's important in wyoming and a proposed that you defeated director. director. she comes from a very heavily populous state. i come from a very sparsely populous state and wonders underserved by large animal veterinarian's. so with some different problems. and in light of her one question taking up all five minutes, i'm going to cement that one in writing. >> okay. >> i worked with senator tester on the tester amendment which was food modernization act that provides specific accommodations for preventive controls in the law for small farmers and producers. what's the status of the implementation of that? >> the tester amendment in particular or more broadly? one of the things as we've been doing outreach in response to developing our proposed rules, and now as we take comments, one

of the things more broadly than just the tester amendment is the impact on small farmers and the fact that we have a system where they are very different types of producers, and we need to find a way to ensure greater food safety, but not impose undue burden. >> i would submit that one also. i have heard a number of concerned from a food producers about the overly prescriptive framework when considering the preventive controls for human food. what concerns me even more is that it doesn't appear as though the fda has appeared -- adhered to the requirements of the administer procedures act that went about publicizing those rules. can you provide this committee with a commitment that you will adhere to the requirements of the administrative procedures act on for the rule-making? >> i can and i have not heard that concern but i would say the thing we have done a remarkable job in terms of outreach and

engagement and taking comments and responding to comments. so i will go back and asked some questions about that and will certainly follow up with you. >> we will provide more detail on that, to them. so for my next question, we are concerned about the abuse deterrent formulation, make it harder to crush, inject. if the agency established a clear pathway and standards for abuse deterrent claims, companies i think will continue to invest in this kind of research. i've been troubled to hear from the drug manufacturers who are working towards that he would like to adopt these deterrent formulations. they are kind of stymied and confused by the fda's lack of clear and consistent standards. when do you plan to finalize the guidance, and can we expect the guidance to also include generic versions? its integral in the fight for prescription drug abuse to use

all the available tools and the regulatory uncertainty is slowing down the particular toll and i think that's unacceptable. so could you commit to me to finalize the guidance within maybe the next six months? >> i think the guidance is for important and lays out how we think about it. in all honesty, the science and technology also need to be developed here though. we really need to incentivize companies to work of art on this. we want to be able to provide them with as much clarity as possible because it's such an important area and we need to develop these deterrent approaches are these powerful drugs. >> there's no timetable laid out for its? >> i'm not sure what the timeframe is. i know we issued the guidance, maybe a few months ago, a year ago. and so we -- >> i would like a fairly extensive answer on it.

i appreciate the efforts on it. there's also a new pathway to approve bio similars and others are involved in crafting a bipartisan proposal to create a pathway, and doubly discussions to ratify the user fee to support that program. you mention resources earlier and i'm very interested in how both are unlimited and particularly committed to ensuring that the of the mentation is consensus driven with the original law. again, i'm looking for a commitment that the fda will be transparent, that you issue guidance that's needed to ensure we all understand, and also give the stakeholders which, of course, would include us the opportunity to engage with you on the key policy questions before the final decisions are made. >> absolutely committed to that. we are standing at the program as you well know, and have had many discussions with companies that either developing or interest in developing bio summers as a part of that new program and pathway.

>> thank you. i've got some additional questions but my time is up. thank you. >> let's see, where are we now? senator casey. >> mr. chairman, thank you to much. doctor, grateful for your presence your and your good work. i wanted to try to get to at least two areas. one is on this issue which allows law enforcement and others to be able to administer a drug in case of an overdose to reverse a. i want, in particular wanted to highlight an element of legislation. totom udall, senator udall have senate bill 1657 which is increasing safety of prescription drug use act of 2013. one of the provisions would ask or does ask the fda to

reconsider the status. that's what have you speak to that. i know you can make a determination you today but i just wanted to have you speak to that issue. in terms of its value ask, in the context of law enforcement but more particularly as well to deal with a crisis situation as an overdose. >> as you know it's a very, very important medicine in terms of being able to reverse opiate overdose, and certainly used on a very frequent basis and very effectively in the health care setting. we have been concerned that many opportunities when it could save a life have been limited because they occur in the committee, not in health care setting. we've actually encouraged and reached out to manufacturers of this product to consider coming into us with a formulation that

could be provided as an autoinjector or nasal inhaler that could be more available in committee settings, law enforcement, or others potentially could take advantage of this kind of formulation, and it i think could save lives. so we are encouraged by the response we've had from the manufacturer. and we will continue to work on this important issue spent appreciate that. i know that the chairman raises this issue, a lot of people were working on this, it is stunning as chairman harkin said, the numbers we've seen. the whenever that i keep coming back to is people who abuse prescription drugs are 19 times more likely to abuse hair when. just stunning. our state of pennsylvania is now third, unfortunately, third place finish that we did not want to have in terms of heroin abuse.

so if substantial and we are seeing at night in the stereotypical fashion, not urban communities or places where you might, you know, the popular image of this kind of abuse is in big cities. wwe're seeing it in rural areas and small towns, very substantial but let me just move to one more issue that the chairman also raised. zohydro, am i pronouncing that right? one issue under the chairman raises question of the advisory committee recommended against the approval of the product, but also apparently the product was approved without any abuse deterrent properties, is that correct? >> that is correct. >> and i guess a related question to what the chairman asked is, the conservative think a number of us have, and i'm

sure you share this concern about the implications of allowing this new product on the market without these abuse deterrent properties. could you speak to that? >> i would love if we had abuse deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. we are moving in that direction. we put out as you noted guidance for how we would be thinking about reviewing and approving abuse deterrent formulations. what they would need to be able to demonstrate. because it doesn't do any good to label something as abuse deterrent if it isn't abuse deterrent. and right now unfortunately the technology is poor, and there's one abuse deterrent for malaysian that is in the marketplace, recently approved. it's abuse deterrent in terms of immediate crushing for uses

injection or for sniffing. it doesn't prevent abuse or misuse when taken orally. and, frankly, it's not where we need to be. it's an important step forward. it demonstrates utility and opportunity, but when you to continue to work with companies and the broader scientific and engineering community to come up with better abuse deterrent formulations. we also are committed to working on developing non-opioid pain medicines because that would make a huge difference as well. because acute and chronic pain needs to be treated. opiates are very effective for acute pain, less effective or chronic pain, but we don't have a lot of good alternatives at the present time so that's another commitment that fda has made to work with companies to try to develop non-opioid pain

medicines that really like a difference for patients. >> i think i'm out of time. i will submit some more for the record. thank you. >> thank you. >> we will go next to senator roberts. >> thank you, mr. chairman. dr. hamburg, thank you so much for coming. i know your time is very valuable. this is a senator in c. question 2, the same question he asked. i think you pretty well summed it up that it gets pretty specific, so i'd like to go through it. i think your answer to senator enzi was yes, that's the answer i'm looking for. so we will get -- event attracted there is concern as you know from our food industry leaders about the implementation of the food safety and modernization act. specifically concerns related to the preventive controls for human food proposed rule that i believe is still open for comment.

and their specifically interested in the proposed rule mentioning testing and supplier verification requirements and the preamble but does not provide a specific requirements in rule. this can get pretty expensive to say the least and there is a whole host of organizations which i will not go into who are very worried about this. can you assure me that you are not finalized a rule with these more are scripted testing and supplier verification requirements, the ones that are so expensive, unless they go through a full notice and comment period regulatory process including the revised economic analysis? in kenya also assure me that this will not be issued as an interim final rule? >> what i can assure you is that we have really from the very beginning tried to reach out to all of the different

stakeholders, hear their concerns, and we've done lots of public meetings, visits, meetings with specific groups and individuals, all trying to get input. it's been a complex set of rules to put forward. many different sometimes competing interests and concerns. we have gotten a lot of response back. we are going to be carefully going through all of the comments when the different comment periods, and on the rules. we may well read issue -- read issue codified language on certain key provisions because of some of the kinds of concerns that you have raised and i have heard the concerns that some of the economic impacts and the nazis as well. so yes, we will work in a very deliberate, transparent way and continue to try to drill down on these critical questions so that we end up with something that

will really work. >> i appreciate that. i think that's a long yes, but at any rate, and i thank you for going into that. in the food and drug administration safety and innovation act, we asked the gao to look at how regulations and guidance policies or practices could be modified. streamlined, expanded or discontinued in order to reduce or prevent such drug shortages. this was also discussed at length with the fda staff during the drafting of the legislation. can you tell me where the fda is with regards to the internal review of the regulations and what's been done to address instances in which the fda policies are or were leading to drug shortages of? >> i think a huge amount of progress has been made and the drug shortage area. certainly our team which has been expanded as well has been working i think it, you know, long hours and very diligently

to address both existing shortages and imminent potential shortages in this country. obviously, industry plays a critical role, and the shortages that occur generally occur because of issues with either their supply chain our products, or importantly quality concerns in the manufacturing. shortages in recent years. the passage of fdasia has helped to strenn progress that was being made and really enable us to institutionalize important ways of interacting with industry and important activities within fda. so we are moving forward, and i think it made real progress, and they think we have systems that are working and need to ccontine

to be strengthened, of course, but i -- >> pardon me for the interruption. i only have about 11 seconds, but where is your internal review of revelation. what would you say that stance now. are you halfway through? where are we? >> you know, we are -- with respect -- i'm not quite sure when you say the internal review with respect to regulations. we are -- we have some delays in getting the reports up to you. >> it's an ongoing process but you are getting there. >> we are getting there. i really to think that it is a system that is working. >> okay. i appreciate that. thank you, mr. chairman. >> before we go to senator baldwin, i just want to thank senator roberts for your work on the compounding bill.

now we will go to -- >> well, thank you, mr. chairman. i appreciate that. >> happy to compound with you anytime. [laughter] senator baldwin. [laughter] >> thank you. and i want to thank you, for convening this hearing and giving us the opportunity to ask questions of you. welcome, dr. hamburg. >> thank you. >> wisconsin is home to a vibrant community of innovative medical device companies, and there's, always interesting things going on. wisconsin innovators are making significant contributions to medical treatment with a breakthrough technologies. such as a state-of-the-art colon cancer screening test, and a pioneering sepsis detection device but in the last several years the fda has taken on some

encouraging steps to enhance patient access to safe devices and to spur product innovation. and we are very excited about some of those. in particular, the fda's pilot program of parallel review that allows both the fda and cms to simultaneously review innovative devices for market approval and coverage determination. this will help streamline the process for companies and the patients who are served by those innovations. so, commission, the fda center for devices recently indicated that the agency plans on establishing a new pathway to accelerate the approval of certain devices for patients with serious unmet medical needs. ..

hoping you could elaborate on the development of this new pathway, and specifically if you could tell me how the fda will assure predictability throughout the process for the device companies and importantly, how well the agency make sure that the needed evidence is collected post-market, and a post-market setting to guarantee patient safety. >> so much exciting innovation in the medical device arena, and

the center has been working hard in a number of arenas to harness those opportunities in science and technology for the innovation pathway, the entrepreneurs and residence program, and looking now at how we can learn in some ways and address the center and pathway is to try to build in some new mechanisms recognizing that really understanding safety and effectiveness and benefits to patients of a product has to be sort of a lifecycle product approach and that's as we look at the preapproval we also have opportunities to deepen our understanding in the real world views with post marketing surveillance in the collection of data and additional studies that are continued that has been a theme on the drug side for quite a number of years and

continuing now. and i think that is part of the center for the device and strategic plans going forward, and as you noted, this approach of integrating in the post-market studies into the overall assessment and ongoing device is key and is being shaped and we are going to be eager to work with the patients and consumers and others as it moves forward. >> thank you all and look for more details with great interest. mr. chairman and i'm going to submit additional questions but think you begin for the opportunity. >> welcome. appreciate all that you do.

there have been good questions asked about approval of certain drug shortages that i have a concern with. but in all fairness to your time i want to shift to a couple subjects that probably haven't been brought up and one is the shellfish ban the chinese have imposed on the coming-out of parts of alaska and the west coast. this is an issue that might be narrow in its scope but has a great impact in a portion of my state impacting some basically family-owned businesses that we are taking a real hit right now. we sent a letter on march 6 to encourage that there would be a delegation to go to china to discuss this issue to see if we can't get faster resolution.

i understand from no noaa it is scheduled and is going to include ustr and the foreign service but not the fda. the question to you this morning is can you give me any assurances that we are fast tracking the resolution of this issue and what the role is and if he will be sending somebody as part of that delegation and if not, why not? >> this is an issue that has a great importance in this something where noaa and the department of commerce has a lead in the interaction. we have been providing information and support for them as well as information about public health assessment to the chinese and the chinese counterparts as well.

we are not going to be a formal part of the delegation that we will be working with them and supporting them and we have an office in china to provide additional support. so, we will have input but we are not in the lead on this. our focus is on the public health assessment. >> i understand and appreciate that. my only concern is if there are issues that arise in this meeting that speak to the specific jurisdiction i would hate for things to be held -- >> we will be available to them to provide that technical support. >> then i would like to turn to a subject that i have brought up before this committee. and no offense to the chairman here. we often refer to this as a frienfrankenfish no offense to e

senator in any shape or form. >> offense taken. [laughter] spinnaker there is inflatable fish that i've seen. >> that is worse. [laughter] >> that is worse. i don't want to consume a time talking about how bad the name is. we will refer to it as genetically engineered fish and salmon. i have strong reserves. i don't need to show you pictures of the beautiful alaska salmon. i hav have them here been here w you a picture of the eel palace where the dna is taken from this slimy ugly bottom feeding fish that is injected into a beautiful examined in an effort to cause these fish to grow quicker so that they can get to the market more readily. i continue to strongly oppose the fda approval in genetically

examined. i don't be leave the fda has that quickly studiehada quicklye environmental effects and economic impact not only on the wild salmon ourselves but on the seafood market and let alone the potential health impact on humans. so given the concerns that i have and many others have, can you assure me that the fda is prepared to deny approval of the sale of the salmon to consumers if your agency determines it cannot guarantee that it's safe to? >> if we could guarantee that it wasn't safe to eat then it wouldn't pass our approval. we wanted this assurance and we don't know that it's safe to eat. we don't be leave that it's been determined that this genetically engineered salmon would be safe to eat. we also haven't been able to

determine whether it would impact and jeopardize the wild alaska salmon. so i would ask again you look very critically at this. of the threat i believe not only to humans for consumptions of this bizarre fish but the threats to the wild stock and then if in fact they should advance to a level of approval i have been demanding that the agency provide very clear labeling to consumers that is in fact what they would be purchasing for consumption. so what i am thinkin thinking ht of all a level of assurance that if it's not safe to eat it's not going to be out there for sale. but if it is determined that it should be allowed, that there

would be clear labeling of loud. >> i know time is limited. complicated issue. i can assure you we have been taking a very systematic science-based approach. it does represent the first in its class so to speak. as a product and also a pathway for reviewing approval. we also undertook an environmental assessment as i think you know. and to address your concerns in the wild salmon populations and we published in december of 2012 hour preliminary findings and we sought a comment and i think we got what was it 33 or 35,000 comments so this is a topic people care a lot about and we are taking them very seriously. and, you know, we will be moving

forward in a delivered and a science driven way reflecting all of the important inputs including obviously the perspectives that you brought forth today and earlier as we consider this product application. >> my time is expired but perhaps you and i would have an opportunity to discuss further not only the ge salmon but progress we are making in other areas. i have some other questions i was at it for the record and i would ask you pay particular attention to the level of inquiry about how we are doing with the research and the giant meetings we have been having and how we can advance a cure. >> do you have any other questions for the record including the records of frankenfish? [laughter] >> we will include an. >> thank you mr. chairman.

>> senator hatch may be coming that i will take a round of questioning. first of all, welcome. i want to start by thanking chairman harkin and ranking member alexander for calling this important hearing and for the leadership they've both showed regarding policy issues in the purview. it's been a pleasure working with both of them, and in the form of a number of policies and the pharmacy compounding legislation in the past in november, which i helped to develop with them and said roberts anhis hairroberts and i, doctor hamburg, for working with us so closely on that. in your testimony, you noted that it allows the companies to

register as outsourcing facilities or what we call outsourcing facilities. this was a critical component of the bill. can you tell the committee why this is so important and how does this new option improve public health and preventive the new outbreaks? >> this is targeted on a high risk products and in just the -- indigestible when we have consequences for health this will enable for the companies that choose to register a higher level of assurance in terms of good manufacturing practice and adherence with the kind of manufacturing procedures that need to be undertaken to make these products safe. so, we think that this is hugely important as i mentioned earlier, we certainly hope that

companies will choose to go with this pathway and that importantly, the marketplace will view this as an appropriate standard of care for the safety and protection of their patients in the health care systems will seek out those that have not just registered. that's the first step. but actually have submitted applications and have become outsourcing facilities with us and are part of our program of ongoing oversight, which would include regular inspections to ensure compliance with these important manufacturing procedures and safety protections. >> as you know i am proud to represent minnesota, where we have a true culture of innovation particularly in the medical device industry.

i've spent a lot of time with the startup device companies which is a major source of innovation in the industry, and innovation for the next life site ebay's co- savin. they were doing our rnd before the therapy that improves lives. and i have been doing my part to fight for our device industry in minnesota and around our country, the american device industry and that's why i've been fighting the device tax before it was proposed and i'm working now to find a bipartisan solution for the tax once and for all and i want to do everything i can to help pick

sure our companies which base international competition are able to succeed. so in this vein, another area that i've done a lot of work on is making sure the process and review is streamlined as much as possible. and the fda -- they have different cultures and i've often seen the fda and the licensure sort of talk past each other. in minnesota we did something that i think is remarkable. the fda and minnesota's life science which happens to be the largest state-based life science trade association in the company. they formed a partnership i worked hard to support that is the medical consortium as you know.

and this public-private partnership is the first of its kind and its goal is to create efficiency and quality of regulation, and it's i guess its studieitstudies or talks about regulatory science. can you tell me what progress has been made in advancing innovation and benefiting patients because of the creation of this organization? >> i felt badly that i forgot to mention it when i was responding to the senator as an element of what exciting things are happening in the area of medical device innovation. it is a public-private partnership that as you mentioned and i think that it's gotten off to a very good start. it was announced i think together we launched its not long ago and it's doubled in size i think 238 or so different members and expands the device

companies consumer groups, patient groups, research organizations and the fda is part of it. it created a research agenda to focus on how can we advance the underlying science so that we can get the promise of science to people more quickly and focus on the number of critical areas lick the clinical trial so we can ask and answer the critical questions more efficient week and hopefully also encourage more device manufacturers to do their studies in the united states rather than overseas where it might be cheaper and less cumbersome focused on patient reported outcomes i and how to actually integrate that into device development which is very important across all medical conditions and products but devices and one of the things that excites me is developing computer simulations and models so that you can study

some of these devices in that context instead of animal models or people in the early stages so that's number one you can manipulate things and play with it more but also reduce the cost and potential risks to patients but still get important information to again move things that have promised into the marketplace and making a difference in peoples lives. i think it's a wonderful public-private partnership. thank you for your leadership in helping to make it possible and we are committed to working with it and we are seeing benefits already and we see more importantly the foundation for lots more progress. >> thank you for your role in that and your excitement about it.

>> i would like to revisit the goals that you identified in modernizing how the agency considers new therapies and closing the regulatory science gap. those are ones we obviously all share and there is a continuous level of frustratiocontinuedleve patients and manufacturers behind other countries in both timeliness and up to date understanding of critical responsibilities including clinical trial design and assessing the value of new therapies and how the risk evaluation and mitigation strategies are tools to protect patients and allow access to the high-risk products where the patients are desperate for treatment. and the senator's opening statement and questions he mentioned the case where the committee voted against a product and then was overridden by the fda. i talk about a little different situation and that is dealing

with multiple sclerosis. the fda made a decision to break with an overwhelming advisory committee voted to support the safety and effectiveness of the therapy for multiple sclerosis and then the agency chose not to approve the drug despite its having been approved in other jurisdictions based on the same dataset. can you explain the logic behind the decisions and what did the fda see that the advisory committee could not? >> first let me address the question about us in terms of we are i think at the cutting edge in terms of the review and approval of new products if you look at the drug is approved in recent years about three quarters of them approved in the united states first and on the devices apart from the highest risk devices we are i think at par with comparable other countries in terms of review times etc.. we do ask for more clinical data on the high risk devices.

so i think there is some urban mythology about where we stand in comparison to the review times in the leadership and i would have to say that a user fee programs were both devices and drugs have made a difference in our ability to be as competitive as possible. with respect to the advisory committee and the decision making the advisory committees are a very important component of the review process. but they are not determinative as you well know. and we seek expert advice in many ways including the advisory committee that is infused with a free product that's been viewed of course. but it's sometimes frustrating for me i have to say when people ask questions about a specific product and why we cannot prove that information is confidential information that we are not allowed to share.

but i can assure you that the fda teams take their job very seriously going through and a systematic way the data that is available to them and assessing safety, efficacy and the overall risk-benefit and the benefits to patients and their often are things that are not obvious that does make a difference in terms of a decision that is made. >> and the advisory committee isn't -- >> the advisory committee is a very important part of our input on a decision. i would say the majority of times are but not always. they are not getting the full story? >> i would say there are many components to the review, and

the advisory committee is an important piece of that. but the advisory committee is not spending time with the patient level data that review teams are and there are, you know, i think aspects of the review that the committee is not always engaged in. but we value their input and take their input very seriously and we try to engage the subject matter experts to the greatest degree that we can. >> the only reason i noticed this one is it had been approven approved in 30 other jurisdictions in the same data set for the other jurisdictions are considered wrong. that is a decision i guess the fda can make. my time has run out. >> would you care to ask another question?

whether it is your turn. >> i know, but go ahead. >> i know that the fda is under way inside generic drug user fee act and it's my understanding not all first generic applications have been approved on the same day as the patent expiration. is there a reason for that? >> this is a program that as i think you know we have had backlogs. that is a big part of why the user fee program began the passage. we are moving forward in implementing that hiring and addressing the backlog in critical ways and also importantly addressing the issues of expanding our capacity so that we can do those critical inspections. which increasingly are often overseas. but so we are not where we need

to be yet. but we are committed to moving forward. and we have made progress, but there is a lot more work to be done. >> i will submit some additional information that i would like on that like how many applications the agency has received for these first generic products and how many have missed the approval of the earliest possible date and what you're doing to ensure that the future generic applications are reviewed. so interested in more detail on that. again, thank you for being here today to answer questions. we don't get this opportunity very often and you've done an outstanding job. >> when we did the reauthorization of the user fe fees, we worked closely with you and your ranking member on the committee and with chairman

harkin to make sure that the devices that go through the process are approved. it didn't have to go back to the agency and insignificant change is made to the device such as the color of the label or the packaging that has changed and i know just recently they sent the modifications report to congress and i want to first congratulate you on that and i understand that they held a public meeting as the answer in preparing the report and engaged in a healthy dialogue with interested parties and appreciate all that you do to work with the industry again. this is about working with the industry and in this case develop the report. and again this is another great example of the collaboration and

communication. what have you learned from the industry as a result of this collaboration? and as you prepare the draft guidance on this topic which i understand to be the next step do you anticipate the sort of fda industry collaboration will continue? >> this collaboration is key because i think at the end of the day the goal is to provide the best medical devices for their needs. but i think it has been very valuable in helping us to better understand the way in which this industry works. as you well know, it is not a one-size-fits-all industry in terms of their very small device companies and much larger device companies with very different needs and experience. the range of the device product is expanding rapidly and getting

more complex. so we need to work together to be able to keep progress moving forward. and ultimately to deliver what patients need. but, you know, we have -- i wouldn't say that always the interactions are easy. but it's been very valuable to listen and to learn and we have tried to be as responsive as possible and i think it is making a difference. >> shouldn't necessarily always be. as a part of [inaudible] i work with senator alexander that created new incentives for medical device companies to develop products and treat rare conditions. in your written testimony, you noted that you had and approved

five new products under the provision. so, thank you again for your work. can you explain why it is so important to reward innovators for developing products to treat rare conditions? in this case it was a condition that adults had if those conditions were already a treatment for pediatric use that had already been approved. can you talk about why it's important to have these incentives? >> it's very important that we have the right incentives to get the companies to invest in developing the technologies where there may not be a huge marketplace with a return on investment that wouldn't necessarily be clear. but where there is a central medical need and where these products, you know, really will

matter in addressing an individual either pediatric or adult patients medical needs and requirements, so i think we see this on the device side and on the drug side of that you cannot always assume that these important healthcare and public health needs will be addressed without looking at what are the opportunities and what are the barriers anbarriers and/or theis to help ensure that the work goes on in the use often under addressed areas. >> i'm glad we have had success on these products. senator, any more questions? >> okay. great. then thank you doctor hamburg for your testimony and for your service. this hearing is adjourned. >> thank you so much.

>> secretary of state john kerry is in the london meeting with the russian foreign minister. lavrov spoke to reporters and said there is no common vision between the u.s. and russia on the ukraine. here are his comments. >> translator: the secretary didn't voice any threats against russia and the sanctions will live in an information space where we are hearing what is being discussed in washington or europe. we understand the sanctions is a

counterproductive instrument and if the decision is made as to its certainly wants to indicate its missions developing now. will it take any measures there is no point in guessing now. >> the russian foreign minister and secretary of state john kerry met for several hours in london. secretary kerry said washington and the international community will not recognize the outcome of the referendum in crimea from ceding ukraine. he said he put forward several ideas on how to respect the sovereignty and address the russians concerned. but the russian foreign minister made it clear that president putin wouldn't take any decisions until after sunday's vote. eight u.s. senators are in ukraine right now while the

congress is in a weeklong break and included republicans john mccain, john barrasso, john clay, john hogan and johnson, democrat dick durbin, christopher mercy and sheldon whitehouse. senators mccain and durbin have been tweaking other meetings with officials. senator durbin says that in ukraine to stand with ukrainian people work with more hopeful democratic future. and that's from john mccain committed to sit down with officials from ukraine interim government. >> what our unique challenges in defining the, you know, the war in cyberspace. but the hostilities are and what military actions. >> from the policy perspective we are still trying to work our way through those issues. i think what is applicable here is the fact that whatever we do within the tiger arena in the international law will pertain that if we find ourselves getting to the point where we be pleased that cyber is taking us

down the armed conflicts on rrw that the rules and the law will pertain every bit as much in this domain as it does in any other. i don't think that cyber is inherently different in that regard. i think those sets of procedures and policies and of the law as a nation have been in good stead and represent a good point of departure. >> the senate armed services takes up intelligence and military nominations. saturday at ten eastern. and on booktv >> the suggestion is when we see freedom of choice, most people

go their own way, what i think we often mean is they know best. the government doesn't know best and so the notion of autonomy is a pretty elaborate word and is basically a way of saying people know better than outsiders to about what will make their lives go well this sounds abstract but the mistakes are real and concrete which is the question when we think about our policies at least a lot of the question is are people going to be sick or are they going to be miserable, are they going to be dead. we have a policy whether it involves savings for retirement or if it involves privacy on the internet or if it involves air quality. if we can think of some way that

makes them less likely to be sick or miserable or dead, while also letting them alternately go their own way if that is what they want that's probably a good bargain. >> former obama administration official on his latest by. the nominee to head the national security agency testified before congress on tuesday pledging greater transparency of the surveillance agency. he confirmed mike rogers also lead to the u.s. cyber command. admiral rogers is joined at the confirmation hearing by general paul ha selva who has been. and audible conversations [inaudible conversations]

[inaudible conversations] [inaudible conversations]

>> good morning everybody. the committee meets to consider the nomination of general paul selva of the commander of u.s. transportation command trans- con and the nomination of admiral michael rogers to be commander of the u.s. cyber command, director of the national security agency and director of the central security service. we welcome the nominees and thank you for your years of service and for your willingness to continue to serve in the positions of great responsibility and we thank your families who gave up so much to enable you to serve trans- con which encompasses the air force mobility command and the navy's militarmilitary c. (-left-parent the surface deployment and

distribution command as the linchpin of the strategic mobility. trans- con has played a crucial role in supplying the operations in iraq and afghanistan. it's also taken the lead in bringing troops and equipment home from afghanistan. we would be interested in the views on how long we can wait for a bilateral security agreement to be signed by president karzai or his successor and still meet the december 31 deadline for removing all of our people and equipment from afghanistan and the events him and i emphasize in the events that we end up without an agreement. like other elements of the department of defense, trans- tm faces threats because of the commercial sector to supplement its transportation capacity. it must be sensitive not only to the vulnerability, of its own computer systems but also to the older ability oold inability ofe

companies that it relies on to mobilize, transport and supply the troops. our committee will soon release a report on cyber intrusions affecting transcom contractors and the extent to which information about such intrusion reaches transcom and other key entities within the department of defense. that's an issue which touches both of the nominee's perspective commands area we welcome your thoughts on dealing with this ongoing problem. last month we heard testimony from general alexander regarding a number of pressing issues currently facing the command. we look forward to hearing the admirals views on many of the same issues including the qualifications of the personnel at the military services are making available for their cyber

units. the tools and the data sources that these tools would have to work with the ability of the military services to managed the careers of their growing country of cyber specialists and the steps that should be taken to ensure the reserve components are effectively integrated into the cyber mission. the committee will also be interested in the views on the collection of telephone call records, the collection of the content of internet communications and other programs that have raised public concerns about threats to privacy and civil liberties. for example, we would like to know your reaction to the recent statement of the privacy and civil liberties oversight board with respect to section 215 telephone calls record programs and this is the board saying

this, that they have not identified a single instance involving a threat to the united states in which the program made a concrete difference in the outcome of a counterterrorism investigation. and we would be interested in knowing what steps he would take if confirmed to assess the continued value of this program and to way that value out against the potential impact on privacy and civil liberties. do you support the president's recent directive to modify the program so that the records are no longer held by the government while ensuring that these records can be accessed when necessary? and what is your view on the threshold or standard is that the government should be required to meet to search through such data? admiral rogers will play 18 hole in providing advice on these and other issues. so, thanks again to both of our

nominees for being here today for your service to the nation over many years and your willingness to continue that service. senator inhofe? >> two weeks ago i expressed to general alexander might support for the progress underway at cyber command to normalize the cyber planning capabilities and despite these critical strides, the lack of the cyber deterrence policy and the failure to establish meaningful norms that punish bad behavior and that have left us more vulnerable to continue the cyber aggression. in particular i'm deeply concerned about the well-publicized events by iran that involved the campaign of the cyber attacks on the u.s. banks and the financial sector and another involving the exploitation of a critical navy network. the administration's failure to acknowledge or establish penalties for these actions in the country in north korea,

russia, china and places where american infrastructure such as the power grid or the wall street had greater risk to read the president has to be serious to develop a meaningful cyberpolicy and transcom provides the lifeline for every other combatant command by enabling them to execute a wide array of missions from combat operations to the humanitarian relief from training exercises to supporting the coalition partners. i'm interested in your assessment of these, the readiness of transcom and its components including the viability of the commercial sector to support transcom missions and i'm also interested in your assessment of transcom's ability to meet the requirements. general fraser testified last year that the number of cyber attacks had doubled from 45,000 in 2011 to nearly 100,000 in 2012.

the committee has been investigating these incidents and it appears that there are a number of factors to address to ensure they have the information necessary from its many contractors and to the mission criteria data. i look forward to hearing from the nominees and how they intend to work together to show these issues are correct and trans- transcom's unclassified networks and not many people know about it and i won't draw a distinction between the cyber attack and military attacks in places where we have a chance to talk about the questions. >> we are delighted to have the senator with us this morning to introduce one of our nominees and it's always great to have you with this committee and to call on you now for your introduction. >> i'm here to introduce mike

rogers to the committee. i've known mike rogers for almost 40 years. we were in the same poem room in high school. i had the honor to work with him as a reservist when he was the head of the joint chiefs of staff. i would say that you cannot pick a better guy who has a stronger work ethic were detailed orientation van mike. i wanted to say being a republican i haven't supported in nominees the president. i would say this is the best american that you could pick for this job to thank you for that introduction int and the first question we were going to ask is what did he know about you in homeroom. he's going to tell some secrets

you have unleashed on yourself. we will call on the general. of course senator you are free to leave or stay. general. >> chairman, senator distinguished members of the armed services committee it is an honor to appear before you today as the president's nominee to be the commander of the transportation command. first i want to thank the members of the committee for their steadfast support of the airmen mobility command who throughout the last decade have literally moved mountains to support the soldiers, sailors, airmen and marines in iraq and afghanistan. it's because of your support they've been able to find the support and reache reached it's important to finish them. i look forward to working with you and other relevant committees to navigate the

challenges of leading the men and women of the united states transportation command. i'm proud today to introduce you to my wife seated right behind me that has served with meat and by my side for our 34 years of marriage. since our graduation as classmates from the united states air force academy she served in uniform for nine years and gives generously of her time noher timenow to support the amr men and their families that are a part of their mobility command. she is the love of my life and apart from my mother is one of the very few people that can give me the -- what i need when i step away from the win line. i can think of no better person to serve from the capacity that he's been nominated. i look forward to working with the soldiers, sailors, airmen and marines of the transportation command of an active guard reserve and civilian counterparts as well as the network of commercial

partners that provide a distributiothedistribution and s networks that make the nation successful. i appreciate the trust and confidence of the president and secretary defense and general dempsey has put me considering me for the position. i'm grateful for the opportunity to be the before you today and i look forward to your questions. >> general, thank you so much and glad to introduce your family. i should have indicated you are both welcome to introduce family and anyone else that is here to support you. we are glad you did that. admiral. admiral. >> chairman, ranking membe membr inhofe and distinguished members of the committee, thank you for the opportunity to appear before you today. i'm honored and humbled the president has nominated me for duty as commander of the united states cyber command and designated as the next director of the security agency. i also think secretary defense hagel and the joint chief of staff general dempsey or their confidence in my ability to assume these duties. i'm joined today by my wife, 30

years ago one evening back here in washington, d.c. she took a chance on even young lieutenant rogers which goes to show great things can happen. i want to thank her for her love and support for the past nearly 29 years of marriage and for her service to the nation and most importantly her willingness to take on an even greater set of challenges if i'm confirmed. i've always believed the life in uniform is even more difficult for our spouses and families than it is for us and i'm blessed to have a great partner. not with us today are our two sons, eight naval officer out on duty which on a day like today it sounds like a great place to be and patrick, a hard-working college student. hard working college student. i'm also honored to be here alongside general paul silver who indicated we've had the pleasure of working together before and i can attest to his

ability first hand. if confirmed by look forward to working closely with members of this committee and addressing the significant cyber challenges facing the niche in today and into the future. we face a growing array of cyber threats from foreign services, terrorists, criminal groups and who are increasing their capability to steal, manipulate or the story information and networks in the manner that risks compromising our personal and national security. they do so through a man-made environment that is constantly involving the use of techniques and capabilities that are continually changing. something easier for individuals or organizations. by priya reddy will be to generate the capabilities and capacities needed to operate in this dynamic environment and provide senior decision-makers and fellow operational commanders with a full range of options within the favorite arena.

i will partner aggressively with others in doing so particularly with allies and partners those in the private and academic sectors and in the department of defense and agencies and organizations across the u.s. government as far as the congress. i am mindful that the nsa are two different organizations each having its own identity and oversight mechanisms both executing often linked missions that. each has a potential take the other stronger in executing the missions and i will work to ensure that each is focused. when there is differing opinion between them i will make the call as the commander mindful of the mission of each is to deliver better outcomes. i will also be ever mindful that we must do all of this in a manner that protects civil liberties and privacy is of citizens. i will ensure adherence to the policy law and oversight mechanisms in place and i will be a partner in implementing the

changes corrected by the president with respect to aspects of the national security agency mission and my intent is to be as transparent as possible in doing so and in the execution of my duties as confirmed. to the men and women of the agency in the cyber command, i thank you for your commitment to the security of the nation and for your professionalism. iaiab leaving you and the missis you execute. i'm honored to even be considered for duty as your leader and if confirmed by look forward to joining the team. i want to thank general keith alexander for his almost 40 years of service to the nation. he has a solid foundation in the cyber command for those that come behind him. he's made a huge contribution and i thank them for all that they have given the nation. finally let me conclude by thanking those men and women too numerous to name individually have given me the love and

support of my life to live the dream i have had since i was literally a young boy of being a serving naval officer. from those who shaped me in my youth to those that have guided or in some instances flat-out kicked me in my time if u-uniform when i needed it the most i thank them and replies that i am in no small part here today because of the efforts of so many others in my life. thank you for the opportunity to appear before you and i look forward to answering questions. >> we have questions we standard we ask of our nominees and here they are. have you both adhere to applicable laws and regulations governing the conflict of interest? do you agree when asked to give your personal views even if those views differ from the administration and power? >> yes, sir. >> have you assumed any duties or undertake an action that would appear to present the outcome of the confirmation

process? >> no sir. >> will you ensure your staff complies with the deadlines established for the requested communications including questions for the record and hearings? will you cooperate in providing responses to congressional requests? well those witnesses be protected from regretful for their testimony or briefings? >> yes, sir. >> do you agree to appear and testify before the committee? >> yes, sir. >> do you agree to provide the documents including copies of electronic funds of communication in a timely manner when requested by the duly constituted committee or to consult with the committee regarding the basis for any good-faith delay or dial providing such documents? >> yes, sir terry >> thank you both. let's try seven minutes. general, let me start with you. >> i ask this in my opening statement for you to consider

the question how long can the negotiations in a bilateral security agreement continue before transcom is at risk of getting cargo out of afghanistan if there is no bilateral security agreement and we have to leave afghanistan completely by the end of the year? >> my understanding from consulting with the staff on that question is that through the early fall we still have sufficient capacity in a variety of networks we are using to deploy from afghanistan to be able to make the decision at that point to be able to give you a specific date i would have to consult with the general and i would be happy to come back to you with a more definitive answer. >> the next question for you, general, has to do with the cyber intrusions and whether or not they affect the information.

is it not important that transcom know of cyber intrusions that was a risk even if they do not immediately affect the data? >> yes, sir. as you are aware the networks we use i and the transportation command consists of the country with thcompletewith the relatioe logistics providers so roughly 90% of the information in my current position as the mobility command and i suspect inside this petition command as well troubles a close tobacco across the networks and being able to maintain the security through appropriate mechanisms insid ine of the commercial companies is critical to the success. we have an obligation to be able to assure the validity and the veracity of the information that we pass on those networks, so as a result one of the initiatives that has been taken is to include in all of our commercial contracts a stipulation that

commercial providers provide us with information into their networks. i am not aware of the details of the report but i look forward to working with your staff on being able to work those details if confirmed. >> the president ordered a transition to end the section 215 ~ from data collection programs as it currently exists to quote preserve the capabilities that we need but without the government collecting and holding the data on the call detail records. do you agree -- what in your view is the capability that need to be preserved in transitioning the program has the president directed? what are those essential capabilities? >> there is a process on going to work through that. one of my thoughts in particular

would be the ability to work on the new mechanisms that we would in place and to do so in a timely manner to generate information and insight in a way that enables us to act in a timely way. >> do you agree that the government itself doesn't need to hold all of the records in order to determine whether terrorist suspects overseas are communicating with persons located in the united states? in other words is it possible that a third party could be designated to hold the data on the one hand and then have to service providers keep the data on the other hand? ..

useful but not critical. and the oversight board said that quote we have not identified a single instance involving a threat to the united states in which the program a concrete difference in the outcome of the counterterrorism investigation. you have an assessment of how -- first of all, the utility of the program and how that utility compares to the level of concern that the american people have about its perceived impact on privacy? >> first as a nominee i'm not in position to rea