nation. and we're examining similar issues regarding debt collecti collection. stopping deceptive and unfair and harassing debt collectors has long been a priority of the ftc. we receive more consumer complaints about this industry than any other. as part of this work were focusing on reports of egregious an unlawful debt practices aimed at spanish-speaking consumers can something we've also seen in our law enforcement. one scam we recently stopped first defied a spanish consumers and then followed up trying to collect money for faulty substandard or even never delivered goods by threatening to report the consumers to immigration authorities. aske..

collecting your personal information, amassing detailed profiles on each of us, and, largely without our knowledge or content, selling that data to businesses and other brokers. earlier this year the ftc released a report titled data brokers, a call for transparency and accountability which lays

out to the extent to which you don't know them, data brokers know you. they know where you live, how old your kid are, what you buy, your income, your ethnicity, your health conditions, your hobbies. our report makes several policy recommendations to bring operations of data brokers into the light and to give consumers more control over their personal information. one of my concerns and an issue that -- >> good morning. >> goo morning, joe. how did you sleep? better than the night before i bet. >> what a great day it was yesterday. colleagues, i think, director clapper set the tone yesterday talking about the national intelligence strategy and issues that the intelligence community is confronting and the job they're doing confronting those issues. the session with directors -- >> that was amazing.

>> that was great. >> in all my time in government i don't recall ever seeing four directors on a stage certainly at that time. but i think it is rare for them to have the opportunity to have the discussion with each other. >> absolutely. >> they have meetings but i think that was -- >> not only discussions but the questions were excellent from the audience and certainly from kim. those were good responses i thought. >> and probably like you, i was also touched with the other side of this, one of the most memorable things to hear that on constitution day the dni and his key leadership and entire lx population retook their oath. that reminded me, i think all of us as intelligence professionals why we started this. >> absolutely. it was appropriate day, wasn't it? birthday of the cia and u.s. air force. >> absolutely. birthdays. [applause] >> that last plenary session

bill and their team on was powerful, very powerful. i think we all responded to that. yesterday was full and i sure what everyone heard and you did, and breakout sessions were outstanding and so sus stan tiff. we wanted to be in four different places. >> you and i got to gadfly that way unlike attendees. i hid them all. >> that was out standing. >> one of the big complaints there was too much choice. that is not a bad problem to have. >> i think we'll have that same problem today. >> i think we will. >> we'll start with chairman rogers and dutch ruppersberger, the ranking member. that will start this morning. then we will have an outstanding pan on oversight. we have a great moderator working on that, jj green. we have a few outstanding other sessions throughout the day. certainly closing the day, the

last plenary with fbi director comey. >> that will be great. today our focus was accountability. if yesterday was effectiveness, today is accountability and transparency. we've asked director comey to talk about the way ahead and possible strategies for increasing trust and transparency and competence. so it will be interesting. >> it will be a great day. i encourage all of you to ask questions. there is so much going on in the world. we talked quite a bit about isis yesterday. what is happening in ukraine. regional issues, functional issues, the counterterrorism, counter proliferation, ask those questions. that is what we're all b what a great opportunity today. mo, i look to you to introduce our next speakers. >> thank you, joe. i've got a real privilege and pleasure and that is to introduce a very strong partnership. so i'm going to talk about their partnership first and then them as individuals.

they will come out and we will get our morning started but as partners i think, as you know, you know what the hp si, those of us in government paid a lot of attention to the hpsi, right? main body for authorizing funding and overseeing execution of that funding for all intelligence activities. i think what is so interesting about chairman rogers and ranking member ruppersberger, they share an enormously common bond, which is, national security is not a bipartisan issue. it is a non-partisan issue in their view. and i think all of us have heard and more importantly seen concrete demonstrations of a partnership that is truly bipartisan at a time when that may not be fashionable. if that was the politically correct way to say that. all right. that is their partnership and that is why we are so fortunate

to have both of them here today. and, i'm going to just start with a little detail on mike rogers. she is a person who i think we have all seen is a strong advocate for both a strong intelligence community, and also strong rule of law. he actually was a commissioned army officer which is something i don't think people talk about as much as they talk about his service to the nation as an fbi agent. this is a gentleman with a long history of service and his desire for safeguards for the country and they include safeguards of civil liberties. so we are very fortunate to have chairman rogers representingmichigan'sth congressional district. dutch ruppersberger many of us know. i grew up at nsa, we love him.

maryland second district nsa is in dutch ruppersberger district. an amazing history of bipartisanship, commitment to a strong national security, community, but also commitment to rule of law. long time baltimore county executive and he represents maryland's second congressional district which i said is home to maryland's largest employer, do i sound like claim before commerce, nsa, where i spent a good deal of my time. i think what is important together this partnership is responsible for what's a rare show of bipartisan ship. four intelligence authorization bills. signed into law under their joint leadership. that is probably enough said. with no further adieu we will ask chairman rogers and ranking member ruppersberger to join us along with moderator jj green.

[applause] >> anywhere? yeah. >> well, i guess everybody is looking at me. >> somebody has to start. morning everybody. >> good morning, everyone the thank you sop for being here. this is an awesome opportunity to do a little bit more than what we usually do in the media and that is run around, chase people, and ask obnoxious questions, most of which they don't want to answer especially

when they work in your space. but we've got two of the preeminent mind in intelligence and national security with us today and we're going to hear from them what their thoughts are on some very significant issues that are taking place in the world, not the least of which is what is going on in washington. we all know that the white house is the capitol of the world but congress is the crossroads of the world and anything that takes place in your space in the national security space has to go through there. so first we're going to hear from the chairman of the house intelligence committee mike rogers, and then we'll hear from his partner, vice chairman, the ranking member of the house intelligence committee, dutch ruppersberger. then we're going to take some questions. i will be the moderator for that and i ask for your patience. chairman rogers. >> thank you very much, jj i do appreciate your work in radio venue being able to flesh out

those stories the way you do i think is pretty -- if you haven't had a chance to hear him i suggest you look him up. i just want to take a minute. we had longer remarks prepared and we decided we weren't going to do that. we would rather get to questions. but i do want to say this, the oversight piece and accountability piece and for those of you who are in the space professionally, thank you very much for what you do for your country. yesterday really brought it home to me how important oversight was in the processes of it that we could spend an hour talking about but just from the general notion that we have a civilian, publicly elected body with all the classification that is responsible for all of the oversight, policy development and budgeting for the 16 intelligence agencies. it sound like a lot. if you throw the word congress in there that is enough to scare the bejesus out of the anyone, right? yesterday we met, dutch and i met with about 100 parliamentarians all across

europe, to come here, really, fairly aggressively about how bad our u.s. intelligence services are and, you know, why are we doing what we were doing and isn't that a terrible day for america? and one thing struck me in the course of that dialogue is that dutch and i have a very good idea of what all 16 those agencies are doing. they had very little understanding of what their own intelligence agencies are doing, not even close. and that oversight, yes, as keith alexander used to describe it as the wire brush treatment with congress, is a very important part of allowing the credibility of our intelligence services to do what they do because it has that stamp of approval if you will on behalf of the american people but its elected representatives who serve in congress and again i could go in for an hour about

all the processes that wee done and when dutch and i got to the committee, we decided it is so important, the national security is so important, the world is falling apart right in front of us, we better do this in not just a bipartisan way but non-partisan way if we're going to do that. we decided to do it and we reformed the way the committee operates. we believe it's a functioning oversight body that actually provide a service to the intelligence community and to the american people. doesn't mean we always agree. doesn't mean that we don't disagree with the intelligence community sometimes and, we advocate and push and legislate for changes in that particular community. but at the end of the day, when they're doing really hard work around the world, in that space, that is really hard to operate in and somebody bumps into somebody, we can honestly and in good conscience come to the american people and say, yep, that may not have been great, but we knew about it. we were overseeing it, we

budgeted it and we approved of it. and i think, in the last few years, as you can see, all the things that we may have bumped into along the way in that very difficult space of intelligence, i think you would find that dutch and i and almost 100% agreement stood behind our decisions and the intelligence community decisions as they went out and did their work. and so again, yesterday just brought it home to me completely. they will go back and all the politics surrounding what the nsa did or what the contractor that stole americans secrets and ran to, ran to russia did to them, for them or with them. >> talking about snowden? >> i refuse to say his name. but i will tell you that. at 9 end of day we lacked back and walked out of that meeting we thought what a great system we have, it is not perfect. what a great system, we as members of congress can advocate

for the good things we do. we have the leverage an ability to change things we disagree with in the intelligence community. this is the right way to do it. those changes we made together. we have been partners in this process, i think have been an important step for providing some cover for, again, you all doing the great work that you do across, really across the globe and here in the united states. so for that i want to say thank you and i'm going to turn it over to dutch. we can answer some questions. >> thank you, mike. i first thing i do want to say, mike as chairman has done a tremendous job. mike and i in the beginning were both on the at the against committee and came to leadership. we were very concerned about our past history on our intelligence committee. we couldn't get budgets passed of the we had a lost partisan politics and we weren't doing our job to oversee the 16 committees we oversee. it was about oversight. we decided we would get together

and get our staffs to work together and our staffs do a lot working with all the committees we deal with. as far as what our challenges are and oversight generally, oversight a important and we do a lot of oversight, because all the intelligence committees and agencies budgets. we have hearings, we come in and we talk and what mike and i also tried to do, in the past it seemed congress was always trying to knock somebody down. you're doing this wrong, you're doing that wrong. what our philosophy is we'll build you up, we'll hold you accountable but we'll build you up so you can do the job. believe me we have so many issues out there right now. whether it is terrorism issue. the isis issue. whether it is cybersecurity which is very dangerous. people say to me and mike and i are the "gang of eight." what keeps you up at night? i say three things. spicy mexican food. weapons of mass destructions and

cyber attacks. we're losing in this country, mostly china, i say china, but other countries too, we're losing billions of dollars of american dollars because the cyber attacks, most all of our companies, even fertilizer companies because china has fertilizer companies. we have a lot to do as far as our priorities. another issue a lot of people don't talk about anymore but so important to us as a country is space, and our space programs and what we do in that regard. now one question, i will stop because i think it is important we answer the questions but the issue that of oversight and what we do, i think, 9/11 commission talked about maybe having another group together, another committee. i don't think mike and i see that as a way to go. it creates another level of getting to the bottom line as quickly as you can. i think important thing we need to do is when you're dealing with, say as an example, you're dealing with issues involving

terrorism, it is important, i think that the leadership of the armed services committee, of the foreign affairs committee, of the homeland security committee and intelligence committee come together. we talk about the issues to make sure we're not missing anything. by the way we do that now. we go but might want to formalize that a little bit more but i'm not in favor of creating, if you know congresspeople are running around, they're running around trying to go to committee hearings and a lot of them have much to do they don't do a lot. so it is important that we, i think create that system that is necessary for us to do the oversight that is necessary. let's get to the questions. >> just one comment on that committee they're trying to create. part of the problem is people believe if i don't see the oversight on front page of the newspaper, no offense to my media friend -- >> none taken. >> that is not oversight. that there isn't any oversight happening. i think we take exception to.

that. we'll give you two interesting numbers. last year 130 specific meetings to the national security agency, either staff members or hearings related to the proper and consistent oversight. this year we've done 100. now, hopefully you don't see any of those and you haven't seen any of those. that the way the committee's designed to do it. we have to protect the classification of those programs. it doesn't mean there isn't oversight and doesn't mean we haven't made changes. we suggested changes. made changes. we demanded changes. effected through budgets and policy decisions we make on the committee and i think it is very, very important to understand just because you don't read it on the front page doesn't mean there is good oversight happening. >> i know we asked for questions but after snowden, we'll do this all day, jj. about the lack of oversight. we have tremendous amount of oversight with nsa. we do the same with cia and

other agencies. there was oversight and good news, chairman feinstein, senate intelligence committee and saxby chambliss and mike and i are very close. we work together. we've gone to afghanistan together. we came together, all of this national media out there it is ridiculous because it is not true. perception was there. mike and i realize we have to deal with perception. we change ad major law on bulk collection. we took all the bulk collection away from the government and now it is a different process. so you have to adjust especially for the american people. they, they are worried about privacy as they should be and we have to make sure that all of our laws balance out the privacy versus what we need to do in tell against. questions? >> so, questions. i have two favorite duos. one are mr. and mrs. jj green, sr., who have been married for 57 years and this is the other duo. seems like they have been

married for a long time. the real point here the reason why i like this duo so much because they actually get their work done. they're from different political parties but they actually work together. what they're saying here is not something they're just saying. as national security correspondent at wtop for the last 10 years i've had opportunity to observe them for a good part of that time and watch them work together. so in view of what i watched and learned, i have got some yes, sir for you. a couple written down on note cards but a couple coming here based on time and space i have had to observe you and your work. i know you know significantly more about what is going on internationally you often discuss and i know you can't for obvious reasons but there is a pressing question this morning in my mind. we know that the world is spinning faster and faster and faster. responding to all those threats

is getting more and more difficult every day. and now, a new threat, i understand, in the middle east has emerged. and it is kind of hard to get people to talk about that, at least within the that day or so. what can you tell us about this new threat that is emerging from the middle east? >> it's old with a new twist, let me put it that way. we knew, i think that what you're talking about. >> al qaeda. >> al qaeda. >> had forward-deployed a group of al cade associated individuals whose sole purpose is to put together an operation, excuse me, i'm not trying to be cute here. i just really look bad with orange jumpsuits with numbers on the back, so i'm trying to make sure i get this part right. >> understood. >> make me look very boxy.

very unflattering. [laughter] the -- >> sorry about that. >> that's okay. so this particular group, but we take it as a very serious threat , threat stream, one we're concerned about. sometimes it gets lost on the public discussion based on threat of isil because that is a threat. i think other threat is probably more immediate. what concerns us most bet it, working with aqap. other al qaeda affiliates to put together a operation that is successful, mainly targeted at aviation targets and all of that has been public but it is serious and rising up and it is interesting where you see these operatives isn't necessarily where you might have seen them before. you might see some in iraq and syria and north africa, putting the plan together in conjunction with another affiliate. that's a new twist the way we see it. so you have the immediate threat we continue to push back on,

this al qaeda threat. and, encourage our intelligence services to do what they can. in addition, to what isa growing national security threat which is isil and their ability to get people back into the united states. >> with this new threat what do you see as their goal or is there a one specific goal. or is it a bunch of them. >> best defense against terrorism is intelligence. we need to get as much tell against as we can. we have unique resources that no other country has but we also need at the against from the ground too. so we know who we're going at, where they are, how we'll deal with them. we, as far as isis is concerned, we knew they were there for years but, remember in syria, which is the most dangerous place in the world, you had assad, chemical weapons issue. then you had the moderate group. they all of sudden got

reinforcements. unfortunately reinforcements were al qaeda and isis. you had that problem, everyone was focusing on assad. you had problems with al qaeda and moderates. we were standing behind. and, what happened, isis, as we know is so severe, al qaeda kind of kicked them out. ieses is very strong. they have probably close to a billiondollars. they were, most of who they were, because and their scrape militarily were the old saddam hussein military fighting iran. remember when we came into iraq, when the worst things we did was get rid of their military. this military was the military at that point al qaeda hired and it was close to over 100,000 of them and that was the insurgency. now we resolved that and we were able to get out of iraq. by the way the reason we came out of iraq, maliki wanted us

out, number one, and number two, they wouldn't give us an immunity agreement to protect our soldiers. we'll not put our soldiers at risk there. we have this issue with isis. and they had momentum and they're smart and they're good and, the sunni population in iraq were not fighting with them but allowing it to happen because of maliki. hopefully we'll be able to turn that around but getting back to whole intel generally, we have to show to the world we're strong. we're not going to take it but we'll protect our homeland. rare that our country, 60% of our country wants us to take on isis. our strategy is coalition. we have to get arab countries involved and start having arab countries put boots on the ground. our citizens don't want us with another two or three years in iraq and afghanistan. but we have to do what we have to do to coalesce our governments and make sure we need to do what we need to do.

>> both of you voted yes for the authorization, for the money and permission and everything that the president and the administration asked for to train and vet the syrian opposition but, it is pretty clear, it is going to take more than just the authorization and money to do this. it is going to take, in some people's mind a herculean effort to train up this force and get it on the ground and get it operational and actually in a place where it can make a difference, against, isil and against, you know, all of the things that they're fighting against in syria, assad aside. but when you look at this situation and you could kind of slice this up into something that is going on for a few years, you talk about 5,000 soldiers trained up, is it

enough, is it soon enough, can it happen soon enough and what need to happen in order to make it effective? >> i would look at it several ways. so dutch and i are at a little disadvantage because we have watched the vetting process develop over a year-and-a-half probably. and how you would vet those individual. how you would get them to training camp, logistics involved in all of that. and it is complicated. this is not easy. this not an easy solution. if i believed this was only part of this plan, i wouldn't have supported it either. it won't work in and of itself but we do have to have, i argue, individuals, that are trained under, to our standard, under the law of war, that have the interests and capability and again, you don't have to, you don't, you just have to be a little better than the enemy in these cases. if we can give them those skills, and they have that intention and will take some

direction from the coalition, which is incredibly important and the united states, we think that you can probably have the first individuals back into syria within four to five months. now that is not 5000. but it can be a unit that cohesive, has good command-and-control, has the ability to move on intelligence selected targets. can take a little direction but that will also take, by the way, this whole boots on the ground thing makes me nervous, if that is going to be, if that unit will be effective you have to have u.s. personnel with special capabilities downrange. so this debate, that doesn't mean the 101st airborne division but certainly means for many people in this room understand that you have to have the ability to move intelligence collectors downrange with these units as well as people can help them with command, control, logistics and development and other sustainment issues. if we don't have that as part of

it guaranty it won't work. the second part of that has to be other kinetic action happening in syria shouldn't wait four months or two months candidly. if we don't finally send a message to isil and thousands and thousands of people sitting in canada and united states and great britain and germany today, who are thinking boy, looks good to me, they're winning. i believe in the caliphate, maybe that is where i need to be which is why they have 15,000 people already there, if you think of that number, it is astonishing, 15,000, you have to cut the pipeline off. in order to do that you have to show they're not winning, they're not 10 feet tall. they're just a bunch of criminal thugs, who slit people's throats and rape women. they're the most brutal things that you can think walk face of the earth and need to treat them that way. i do believe it can work. it is not going to be perfect.

this whole notion we should stop saying moderate rebels, when you look at folks fighting there, we'll prefer anyone that doesn't just hate us outright when they wake up in the morning. i will take that. that would be a good day for us. and there are individuals there, and this is important too, i think it gets lost in the debate, you know they're fighting isis today. they're taking casualties fighting isil elements today. they're taking casualties fighting al-nusra front, they're taking casualties and sometimes feeling overwhelmed and sometimes a friend can be helpful in those particular circumstance. this is the other part i thought was critical important and at least media and others, the saudi arabian government is publicly acknowledging they will be in a part of this fight. that is huge. we've had strong relationships

with the saudis for a very long time. a public act nonement, i think you will see other, some other of these partners step up very soon. also very engaged and publicly acknowledging it. if we want to defeat them, that is the path to me to do it. had we not voted on that and not voted yes, i guaranty you we would have lost all of that because they're already a little gun-shy. i think if you take those elements. this not a great plan. probably not the plan i would have put forward, given circumstance we're in i thought this was important step to get to defeating and dismantling. >> military is not only way. it is a component what we have to do. if you look iraq we were in there military. we left and didn't get the hearts and minds of the people. what mike is saying about sunni, especially saudi arabia, that is what is has to happen.

that is what isis doing makes a big difference? >> mike and i are really concerned we have americans who have passports going to syria, to get, becoming radicalized. we had a situation where an individual went to syria. trained as suicide bomber. parents went back and blew himself up and killed other people. he could have done something in the united states. our concern is not only isis but there are other groups out there, but al qaeda in arabian peninsula, there is a lot of people out there planning and plotting to attack us because we're the ultimate goal right now. we have expert bomb-makers who are putting, like plastic bombs in laptops and trying to get them through airplanes and that type of thing. we have to keep eye on isil that is getting a lot of national media and ha is serious and we

have a plan. what you want to be leader of the world and coordinator you have to show strong leadership, when the vice president said we'll follow you to the ga gates of hell. that turned around a lot of momentum. made a lot of american people together and allies felt good and they will behind us and give us resources to do the job. >> it is our job to make sure they don't make a wrong turn. >> the best way to demonstrate exceptional i am is to demonstrate it and talking about it. thank you for bearing with me on myselfish questions and appreciate the prerogative to do that. now to your questions. you mentioned a minute ago, boots on the ground, if we want to avoid resuming ground combat role in iraq, don't we and others have to restrain and -- retrain and reequip iraqi armed forces? >> this is also the one that send me into orbit. that it was a leadership problem

in iraq military. so you had a political problem that was disintegrateing. he was, maliki was clearly deciding to go and put his emphasis on his shia friend. and when he did that, he corrupted the leadership channels in all of these military units. and so, think of this. before this was happening, when isil was on the move and coming across the berm, rather than issuing order through the, from the civilian government to the military chain of command which is the way we would do it here, he decided to pull all of his senior leadership away from those units while they're under siege, back to baghdad, to have a discussion about the way forward. you take your leadership away from those units, at the point where you're getting into contact and there is some uncertainty about who my friend are or not, if it is my government or someone else's government, it is going to collapse which is why i think

you see the administration putting so much effort, hey, we have to get this government piece fixed, right, that is correct. but we can walk and chew gum at the same time. i can't even say it so apparently we can't do it. >> a piece of this -- >> walk and chew gum. >> that's what it was. thanks. that's why dutch and i are here together. we'll be here all week by the way. try the lamb chops. you're going to love them. [laughter]. the peshmerga, so everybody said, my gosh the peshmerga we were counting on melted away, the kurdish fighters in the north, melted away. the problem they were running out of ammunition. they were outgunned. these are military units that were in strategic retreat. they were not in free fall. we were saying if we want to protect the soldiers we have to move back and rearm. if you look at these problems it frustrates me a little bit and we spent all the money and they

melted away. that is very simple high level argument about what the problem isn't. i do believe we can re-engage some of these units. it is all about leadership. when the united states military is standing next to your side, amazing how much courage and conviction and effectiveness you get out of those units and we've seen it time and time and time again. we have to re-engage that. you can't just walk away from these units. they will need a little help and nuturing along the way. i do think that is component we can fix. we have to fix leadership portion of it. the officers and, their senior nco corps is not much to speak of but their officers need to be at the fight constantly showing leadership. that piece goes away we'll never get that back. who can put that back in nobody can do that like the united states military. so i do think that equation can get back. you saw what happened to the peshmerga today once they were armed and freshened them up a little bit. is boots standing behind them.

they immediately re-engaged in the fight and have been doing very, very well. so that piece can come back. we shouldn't just, again, i'm not a believer in telling enemy what you won't do. can you imagine fdr naming five things that we wouldn't do to beat the japanese? all right, not a good plan. and so i argue we ought to stop doing that now as well. we ought to stop saying what we won't do. if we believe this is a threat to the united states, we ought to say what we will do, which is dismantle them and beat them completely. i don't think anyone is calling for beg military manuever units. i'm certainly not. i think there is a way forward on the training piece and troops on the ground issue in iraq and syria. this coalition i think we're doing well if we don't loose you our nerve and keep moving forward. >> the reason you're dealing with what you're dealing with

there are some voices out there, i hear from both side and talking to administration and talking to the other side as well. there are those who say you should do this and those that say you should do that but at the end of the day it is your job in congress, your oversight function, that guide most of what the government does in all of these situations especially, these, situations like this, hot spots, et cetera. because, there is a need for the congress and american people to be involved in all of this. do you get the sense that there is enough oversight, or, not enough oversight? into on our committee, yes. we, as a committee are accountable but we try to build up our agencies. we sit there. we talk to them. what are your priorities? what do we mead to do? unfortunately, sequestration which makes us weaker as a country, you don't cut everything across the board. that is causing as you problem especially in intelligence and

national security. but, yeah, the oversight. now unfortunately it depend on committee and relationships of the leadership too. starts with leadership. mike and i made a decision to work together. if you look at record we're passing budgets and doing those types of things right now. let me get back to the other issue that you talked about as far as what we need to do, as far as to win the war. one of the things we can't do, mike said it, we can't tell our enemies when we will come and attack them and what we'll do. we can't respond to the national media because that is what the people are hearing. we have to do the right thing and make sure when we are going to focus and take is be out and bring them to justice, do it our way and based on solid intelligence. that is where our strategies are right now. >> so time is slipping away. we have about five minutes left and i have 48 questions. so i'm assuming as we go through this i will shut up in a second. if we don't get to some of

these, perhaps you guys can respond to some of these. >> mike do 20 seconds. i will do 30 seconds. >> first question, you mentioned a balance between privacy and national security and intel space. what is the position about this balance? you kind of mentioned a little bit about it earlier and what guidance is provided to the agency? >> we spend a lot of time on this eshoo. i think we've found the right balance and there is more protection than people realize when it comes to what the nsa is doing. i think in a lot of cases if they found out what the intelligence community can't do, people would take their breath away, including u.s. citizens traveling to syria and fighting. if we don't reach that certain level of legal probable cause, good luck, i hope nothing bad happens when they come home. and so, i do think that we found that the right balance. go ahead and talk about it. >> we want the privacy, we need

to debate privacy, there is no question about it but in the end we have to have a bill and we need balance there. americans don't want to have their fourth amendment violated of the so all the laws we put together have balanced that. mike and i bought into the aclu to listen to them. we tailored our legislation to deal with that. i can tell you based on other countries we have more protections on privacy and constitutional rights than any other country. look at britain, look at france. they don't have checks and balances including a special group we have on our fisa bill a privacy group that oversees things we do. so the oversight's there. two intelligence committees. justice department. you have the administration there. you have the courts. you have the all of that there together. >> so now we're into it lightning round. we talk ad lot about war. we talked a lot about other elements, privacy. so what about cybersecurity? when is there going to be some comprehensive meeting of the mind that is going to actually

manifest itself in legislation? >> go ahead. >> we have a short window to get this done in lame duck. i've had good sessions. dutch and i both had good discussions. i happened to bump into the durbin in the hallway. >> talking about senate. >> senate is a hurdle. we pass ad bipartisan bill twice on pretty difficult subject and bringing all stakeholders in the room working it out. the problem was it is 13 page bill and hard to take anything serious in congress if it is anything short of -- >> in this congress we got 300 votes, that is miracle in this congress we're in now. people don't realize 80% of the networking controlled by private sector. our intelligence committee good as see anybody seeing attacks come in. we can't really share information. like being weather forecaster and see sandy coming up the east coast and you can't warn anybody.

this, the target. ladies, target, whatever, the other attacks occurring are coming more and more and more. we need to pass this information sharing. voluntary bill. we've addressed issues of privacy. and if we don't, we're going to keep this happening. believe me i said in the beginning china is very aggressive. they have stolen billions of dollars, not millions, billions of dollars from our businesses. sometimes some companies are getting 2,000 attack as day. >> congressman rogers just leaned over and told me what we all love to hear from editors at work and that is you can run long. thank you, sir. considering the fact that this guy is leaving venue of congress and going to become the competition, a little afraid of that. >> not true. >> he is divorcing me. still fighting over child support and alimony. >> but to get back to the questions, ambassador, thank you so much. we have a few extra minutes. they're willing to stay with us.

so, the question i'd like to ask you is, at this point is, in your view does president obama require a new congressional authorization for the operation against isil? >> look at the time. [laughter]. >> got to stay on time. >> understood. >> i believe that congress should do it. i believe that we should step out and provide the authority to the president, to go after isil and any of its nom de guers wherever they are. i think congress should play affirmative role in that decision. we're going to put people at risk and i believe put people at

risk in places not covered by the amuf. i think we need to do this from congress's per speck i at administration says if you like to do it, that would be fine. he need to say, i need to have this, and you should give it to me and at the same time, congress ought to have the courage to stand up and say we need to do this and we should do it. we all agree isil a threat to the united states and european allies. i don't think anyone disagrees with that. let's give authority probably, so the average american citizen says everybody will be engaged. it may be hard. we may lose people. we'll be serious about this. if we do that we need to give affirmative authority to do that. i think. thanks mom. [applause] >> that is your dad. the president is now using article ii of constitution saying protect american lives and that is what he is doing on the short term receipt now.

when we get to the position as mike said, when we're going to be there from duration and long term we need. now it was a test vote we had couple days ago. mike and i had to really get votes to get that passed because there are a the of people on his side, we both, on our caucuses democrat and republican, got more votes in our caucuses than nay votes but it was close. so either you have to understand in congress, this is the problem we have, this congress because somebody else has different point of view, that doesn't mean they're the enemy. what mike and i had to do give them facts and why and what we need to do to in order to protect ourselves, congress has to be involved. we're in great government because of checks and balances and between president, congress and judiciary? >> let's stay here and you're a big space fan and very knowledgeable for those of you who don't know. do you think intensity of the

intelligence community on counterterrorism since 9/11 has led to insufficient attention to issues such as space technology, wmd and other elements? >> i'm worried about space. when we responded to russia when they came out and, we thought they were going to control the world, sputnik, jfk put a lot of money. we became the most powerful country in the world. we had rocket science. we went to the moon. that was great. everyone in the country knew who astronauts were. now that has changed. we have nasa. we have intel space and we have defense. there is not a lot of money for everything. if we don't continue our space and don't let the american people, we need to let the american people know how important space is. now, we just have, so far we've been able to keep the resources where we need to be from an intelligence perspective. mike and i worked very hard to do that. but, sooner or later, china and russia are very aggressive when

it comes to space. i believe, if there is ever going to be, we don't want another world war, it will be space and cyber. we also need younger generations to go into space. the younger generations don't know a lot about space. so we're not getting rocket scientists into the space program. of the russia and china are communists countries take their 4.0 student and say you go into space. we need a plan. one of most important things for our country. average things in every day life, gps systems, everything the public can understand. when it comes to defense and intel, we're probably the best in the world. that is why we have resources and we can get intelligence no one else can get. >> quickly, we protected space investment parts of our budget. we do hard to do that in every budget cycle we've done. i would like to put more in there. this year we went $500 million over the president's budget you. >> did that as republican? >> yeah. last i checked the constitution

says defend the united states. >> i agree. >> i got that part now. i'm not very part but i read that piece. [applause] >> so we protected both on cyber. we actually plussed up cyber spending. and in space we've gone through, we worked through some issues but i think we put us on a path to protect some of that money. i do think you can do both at the same time. the problem it doesn't get attention probably that it deserves. space is rapidly becoming contested space. that's a problem for the united states. we need to make sure that we, our resources are meeting that next generation challenge. >> so speaking of the next generation and space, there are some significant concerns and a couple of questions have been asked about cybersecurity, perhaps in the relationship to space. how do you belief the u.s. can best get the message to china, to russia, to any other country that wants to infringe upon

intellectual property as they have been accused of on many occasions and there has been some seth proof, from the ncix, at least a couple years ago, how do you get message to them. >> you leverage then. china needs the united states to grow. one of things, i've had this conversation with china. basically have said, you know, if our citizens are, see what you're doing to us stealing billions of dollars and you're hurting our jobs and economy everything else, we'll put the word out don't buy china. you will be hurt by that but you don't want that. >> does that create sort after pseudo info war? >> when you have billions of dollars stolen from your businesses and that, you have to do something about it. and i think the president needs to, understands that. he has got to stand up, to leadership to leadership. you can't, what we need is a global type of program where

people, where countries will have, can not steal and if they do, there will be accountability. >> so in other words, you just can't ask them nicely? you have to go after? >> you have to ask chinasly because it is diplomacy. china you don't bang them over the head. there are ways to communicate with different countries. i don't trust russia. i will tell china don't go to bed with russia and you will pay. >> somebody will not get a good night's sleep in that arrangement. >> now i understand why he is not going to to begin some intelligence or substantive news operation. it will be comedy. >> he wants to be a comedian. >> you will probably be his first guest, right? >> let me just, cyber is the greatest national security threat that america has not ready it handle. i never seen anything quite like it. and it is ramping up. so now you have international criminal organizations

performing at the level of nation-state cyber hackers. the longer we let this thing go, the worst we are. if we want impact on china and russia, we have a whole host of things we should do. i argue we ought to go after companies that have used stolen information from the united states, all of that, good. but the number one thing that we should do is protect ourselves. normally if it's a missile deployment, anti-missile system, that is easy. the government can do it. we can self-deploy it. we can protect the united states. 85% of the networks out there are private networks. so when we talk about offense, flicking our enemy or adversary, guess what? when that attack comes back, it doesn't come back at the united states necessarily. goes into private networks. we need to come up with a system to embolden our private sector to protect itself. that is why we've done the bill not once but twice. we're in this last window. if we don't get this bell done in lame duck this year, the

whole process starts over. and i guaranty you, that it will take another two years to get it done. that is the first step in protecting ourselves is allowing cyber sharing, allowing the intel community to provide in lastfied way malicious -- classified way in way that private sector can protect itself. we got trapped up into this debate somehow that is privacy issue. it is not. it is about protecting your privacy as you operate on a u.s. network. today don't have that privacy. your zeros and ones are swimming next to russians and chinese and international criminal organizations and iran and north korea is trying to get in the business. by the way al qaeda is out recruiting individuals that have the capability to get into the business. we better fix this year. call your senator. >> you know, the white house has been working a lot closer to us. they have been communicating

with us on a regular basis now with isis. so i think they understand that threat especially because of target and some of the other and it will keep coming. >> okay, we've got time for one more question for brief answers. >> yes. >> yesterday dni clapper used term immaculate collection. >> what? >> immaculate -- >> that is pedantic. using big word when you can use little words. >> got you. used that word, that term to describe the expectations of intelligence commune behavior. what kind of informed congress do you explain that the intelligence business is not a perfect science? >> you take that one. >> thanks. [laughter] >> you're the chairman. [laughter] >> two things keep me up. spicy mexican food, questions like that. >> wmd and cyber.

>> and these questions. >> you know, part of our problem and our challenge is, we have working finks of doing the oversight in a classified way, to protect those programs, to make sure they're getting resources. to make sure they're comporting with the law. that is a big part of what we do every day. on the public side of, of this has been, probably as frustrating as anything i ever gone through in the last year with a missed amount of nsa and other things. including what we're dealing with our european colleagues. just trying to get facts married up with the opinions where they got those. it has been, immensely challenging. and it has been very difficult to even catch the imagination of the public, hey, this is, this stuff's not easy. and, every day, we are a whisper away of getting one piece wrong that lets one person through to do something god awful here in the united states or our european allies. we're always that little bit away from making that mistake. and so, we have tried to, at

least, try to apply the facts so people can have informed opinion. now it is not going very well. i'm not sure i know the answer to that. the reason we're saying that, i'm not sure i know the answer. >> what did you just say? >> i have no idea. at least it wasn't going to get us in trouble today or this morning. and so what we've tried, again what we're trying to do is at least let americans know what we are doing. the problem is, after they watch a little bit of tv and watch a great movie somewhere and read a newspaper article that didn't get, base their whole article on one slide out of 1000 slide deck and clearly not going to get it right it is hard to unwind them. they believe we're listening to every phone call. they believe that happens. we can type in master computer and teach in a word and figure out whatever that code word and pick up a terrorist operating in cleveland and it is really frustrating to try to wind that back to understand, no, we

follow the law. we have, if it is u.s. citizen, we have very high standards. overseas it is nearly impossible. you're dealing with billions and billions and billions of communications and our intelligence services job to narrow down to one person of interest. i really don't care about aunt may's bunions. i have bad news for you. not that interesting. >> you better believe that. and that's our frustration. how do you do that? how do you get america focused on the what the real work is doing, what the real challenge is. we're working at it. i'm not sure we figured it out yet. >> technology is growing and we have to maintain and stay ahead of russia and china on technology. when we grow with technology, internet was great but look at all the attacks and things occurring renow. we need to be leaders and stand up and put together a system. the other thing too, my staff always give me a hard time when i say something negative about the media, what is driving mike and i crazy after the snowden

eshoo and things are coming out, not all the media, you would hear national media, nsa is listen to you. nsa could care less about aunt molly's bunions or pizza, they are really focused people and dedicated people very up about the criticism they had after snowed debt. we were able to answer issues. i believe snowden can make it into a positive. it's a negative. we lost a lot of information. we lost terrorists we were on because he gave outsources and methods. if we address this now, there is a lot that is out there we could talk about what needs to be cleared, what doesn't. we have too many clearances in my opinion. we don't need to have everybody have classified, information. the key is not giving outsources and methods. that is what we have to protect at all times. i don't know if we answered question. >> this was our challenge. this is a professional, successful business person in

the united states. the other day he is telling me, he thinks all of this is just a bun of hooey all the threats are a bunch of hooey. we won the cold war. we don't have any nuclear missiles to worry about. this is an educated professional person. >> cuckoo. [laughter]. >> it was dutch's uncle. >> my aunts don't have bunions. >> but if you think about that statement and how far we have to go, right? so the intelligence community has worked itself into a corner. right? you're all sweating about it. you're laying awake at night trying to worry about the next proliferation issue or next cyberattack or terrorist attack or next rising army we have to worry about dangerous somewhere in the world but america doesn't see any of it. the example that he used i found this interesting, he said, hey, my kid don't have to get under the desks anymore to worry about a nuclear attack.

if you think about it, how dumb was that? . . pretty interesting. look at what the russians are doing with their tactical nuclear arsenal. very concerning stuff but the public doesn't see any of it. because of the work our intelligence communit communityd keeps that they they think everything is on. all we have to worry about is

what kardashian has tweeted today. [laughter] that's a problem for us. we have got how to get around it. when you have folks like that, take that position, i got we have got a lot of work to do. just not to scare people but scare them out of their daily life, but to clue them in as to what are the real threats and what is our intelligence community doing to keep us safe at night? that's a challenge that will be a long-term challenge i think. >> this is the precise reason why i personally believe news is not what people are talking about. news is what people don't know. it's our job as journalists to bring it to them. and i congratulate you for having the stupid because they are the epitome of pulling the curtain back and letting to see what's going on with a kidding way sources and methods and secrets. and i thank you so much, chairman mike rogers and ranking member ruppersberger. give them a hand. [applause]

>> and you can watch the remarks of the house intelligence committee leaders, mike rogers and dutch ruppersberger come anytime on the website at c-span.org. also more on this summer on national security and intelligence later today. fbi director james comey will be speaking starting live at 245 eastern on c-span2. not house energy and commerce subcommittee on health has gaveled in. they are hearing on the challenges of antibiotic resistancresistanc e. congressman joe pitts is the subcommittee chair. >> thank you, mr. chairman. and certainly appreciate the fact were having this hearing today. it is necessary as we proceed with the initiative to talk about some of the things that are most important, some of the things that are relied upon and familiar in our front line of our ability to fight infections, and those are animatics.

antibiotic resistance, specifically resistant strains is a growing problem. equally troubling despite high spread support is the lack of a pipeline of new drugs again improve on previous generations or fight drug-resistant strains. a lot of facets to this issue and there is no single silver bullet solution. but here's the deal. our drug arsenal is our drug arsenal. today the committee continues to probe the various market reasons why we're not producing new antibiotics and that the properr market incidents every illiterate pathways exist to encourage the development of new drugs. very important strides have been made in fda safety and innovation act most notably through the game act but they were just the first steps. art of the deal is once nature of doubts it's hard to force nature to on a doubt. these resistant strains are out there and they are not going away. once this has taken place we are not going back and that's why we need to continue his pipeline of

new drugs. i would also just point out, i'll make a historical note, since the election in scotland was yesterday in scotland is going to be part of the british empire and, of course, it was a famous scotsman, sir alexander fleming, developed come is credited with the discovery of penicillin, but sir alexander fleming, the is only come he couldn't produce a lot of penicillin. and it was andrew moyer, from indiana, who actually develop the deep fermentation process that allowed penicillin to be mass-produced and really made a significant difference in the lives of our soldiers, or the saving of lives of our soldiers returning from world war ii, and parenthetically drop the cost of penicillin from $20 at that time, a significant amount of money, to less than 50 cents. we know we can do this, and we know we should do this. we have done it before.

the forefront of innovation and that's what the commission is all about and i think that's an important part of our discussion but i will submit this article on andrew moyer for the record. >> without objection. you'll be entered into the record. >> the chair now recognizes the member and now recognizes the ranking member. >> thank you, chairman pitts. in 2006 in my state of new jersey a 17 year old honor student named rebecca went to the hospital and within days died from a resistant strain of mrsa. mrsa. although doctor for a identified affection and treated with available antibiotics, it failed to respond to treatment advancing rapidly and cutting her life short. the stores are all to comment on all the more frustrating given the remarkable advances of american medicine. the threat posed by antibiotic resistance bacterial or superbugs is growing as the supply of new antibody drugs is dwindling due to drug manufacturers decline interest and ability to produce new drugs

to meet this threat. in the cdc report released last year they find too many americans are infected with antibiotic resistant bacteria each year, and, unfortunately, 23,000 will eventually die of the consequence of their infection. additionally, five to 7% of patients in american hospitals will acquire infection during the course of the treatment and though the majority of these infections can be treated, this complicates the recovery process and ultimately imposes greater costs on patients and health care system. due to the current state of the market, manufacturers are incentivized to focus efforts also were at the expense of r&d with new antibiotics to combat these rapidly involving -- evolving strains of bacteria. this reason why congress include many of the provisions of the gain act in today's legislation which was signed into law in 2012, the gain act was an important step for solving this problem. we are supporting manufacturers in the development and introduction of new drugs

largely through the use of marketing exclusivity. so far we've seen meaningful progress because of being committee has approved a number of new drugs, and with priority review these drugs are able to come to an imminent infectious disease threat and reach patients at an accelerated pace. our we should also number by other laws such as the hatch-waxman act is so successful. of congress intervened, we should be sure that it achieves the necessary impact on the pipeline of new drugs to safeguard the public health. in pursuit of the greater good, government struck a balance between the interests of private industry and the public in society rates benefits. so that's why i have concerns about ideas such as transferable exclusivity, the practice of giving a specified period of exclusivity to accompany the use of any product it wishes as a report for developing a new antibiotiantibioti c.

this is the recipe for higher cost of drugs with no direct connection to the cost of developing new antibiotics. but there are some ideas worth further examination such as the adapt act introduced by congressman green and gingrey. that would establish a limited population approval pathway that would permit fda to approve drugs based on smaller clinical trials. try to there a number of angles the government and private industry can take to make this problem head-on and i think we agree this is an issue which warrants further action and i welcome the opportunity to hear from our witnesses. and a special welcome to adrian thomas from johnson & johnson which is headquartered in my district and i'm always pleased to see you, representative camp in front of our committee. i would like to yield the remained of my time to mr. green. >> thank you, ranking member, for yielding. i'm pleased to learn yesterday the white house announced a presence executive order, the

national combating antibiotic resistant bacteria, carbon strategy. we need to control bacteria and carbs i district recently both the world health organization and the united kingdom joined the united states and recognizing antibody resistance as a global threat. fighting antibiotics consistent with both the public health at a national security priority. it's a threat i take seriously. the fda has played a central role in this important effort and i think the agency for the work. we must all work together to ensure we have effective antibiotics for the future. in 1929, alexander fleming invented the process for the first antibody wonder drug, penicillin. such discoveries for the 21st century can happen as well if would encourage greater investment to develop new novel antibiotic drugs. animatics have said billions of lives, major therapies like surgery, chemotherapy and care for neonatal infants if possible.

by nature bacteria become resistant over time. in addition may choose an inadequate diagnosis contribute to the antibiotic resistance. most antibiotics are less affected or infected against infections. the consequences must not be underestimated. with each day more patients will have few or no therapeutic options because of the resistance available. i thank the chair and ranking member for this hearing today to antibiotic resistant must be a high priority for this committee and central of our way of how we treat and cure disease and the 21st century. i want to thank my colleague congressman gingrey for partnering both on the gain act was congress and also on the adapt act this congress. i yield back my time. thank you. >> the chair thanks the ranking -- the gentleman and recognizes dr. gingrey for five minutes. >> mr. chairman, on what you thank you, thank you for calling today's hearing within the 21st century cures initiative entitled wasted on the

antibiotics resistance a new drug development. let me first command chairman upton and a colleague from colorado for spearheading this bipartisan endeavor that looks at ways we can address emerging challenges in health care industry. i have participate in a number of hearings and roundtable discussions and different each to be very beneficial to all the members of the subcommittee. mr. chairman, we all understand that antibiotic resistant pathogens are a growing concern not only across the country but across the globe. according to the cdc in atlanta, each year more than 2 million americans get infections that are resistant to antibiotics resulting in the death of some 23,000 people, and costing our health care system nearly $20 billion in direct costs, probably $35 billion more in indirect costs, lost time from

work, et cetera. this year alone both the world health organization and the uk have acknowledged this looming threat. just yesterday the obama administration took action on antibiotic resistance as well. through the signed executive order, the national strategy on combating antibiotic resistant bacteria an in the president's council of advisors on science and technology, referred to as pcast, and they will be issuing a report. this is an issue that is now receiving global attention. unfortunately, according to the fda new antibiotic approval has decreased by 7% since the mid '80s. combination including of course the high cost of drug development and the small profit margins have helped drive companies out of the anti-infectious space to markets where return on investment is much higher. you think your favorite drug whether it's for arthritis or

whatever, they said they can make a lot more money and there's a lot bigger market. these few incentives for companies to pursue new antibiotics had yielded a stagnant research and development pipeline for antibiotics, and it is ill-equipped to keep up with the evolving bacteria. mr. chairman, i am glad congress has been a true leader in this arena. with a partnership of my colleague from texas as the other league author, sponsor of the gain act, we could find a path for this legislation to be signed into law and it was in july of 2012. as many of the witnesses testimony today, the gain act has been an important step to encourage new development of antibiotics by focusing on economic incentives to keep companies in the game, in the market. however, despite these advances, there's still more work that needs to be done. that's precisely why mr. green and i authored h.r. 3742, the adapt act during this congress.

this legislation is a logical next step to the gain act to develop a new pathway at the fda for antibiotics aimed at treating merging threats and limited and high need populations when they have no available option at their disposal. the a top act will also streamline the process by which the fda updates breakpoints information so doctors and medical researchers have the most up-to-date information which to expedite decisions in the drug approval process. mr. chairman, the model of the 21st century cures initiative works on the gain act and the adapt act has been a true bipartisan product, and i commend mr. green for his continued effort with me on both pieces of legislation. earlier this morning both of us spent an hour on "washington journal" discussing our efforts

addressing drug-resistant bacteria with a sense of comity, befitting our committee. and i think mr. green as a moderate and hopefully all the viewers and listeners would agree with that. and with that in mind i look forward to hearing from all of our witnesses today, the first and second panel. i had the pleasure yesterday of meeting with dr. barbara murray who will be on the second panel, the president of infectious diseases society of america, and here's some of her accounts of life-threatening infections with her own patients. i'm even more motivated to continue the fight against drug-resistant bacteria. i will give a quick anecdote, mr. chairman, i know i'm running out of time but my brother is one year older than me and in 1941, he was sick as a board home with pneumonia and the family doctor came to the house and told my parents, said he was going to die unless they gave

him a shot of this do i antibiotic called penicillin. my brother james got that shot of penicillin, and fortunately he lives. there have been some days since then i wish he hadn't. he beat me up every day since then, and still does. but that's m my own little and t don't, dr. murray. mr. chairman, as we continue with 21st century cures initiatives we must work in a bipartisan manner to address this growing problem across the country. ultimately i believe the adapt act as an extent in the fight and it's my hope we will market this legislation during the lame-duck session later next month. until then i welcome the testimony that we'll be hearing today to further educate members of the subcommittee on ms. kreegel important issue. make no mistake, the cost of inaction in the fight against life-threatening infections is great and the cdc has already provided us with statistics to prove it. today's hearing will serve as a

great way to raise awareness on this important issue. mr. chairman, think you're finding the time. numbers are for chairman upton. i look forward to continue to work with all of my colleagues as this process moves forward. thank you for the extra time and being a little soft on the gavel, mr. chairman, and has i yield back. >> the chair thanks the children and thanks enforce leadership on this issue. now recognizes the ranking member of the full committee, mr. waxman, for five minutes. >> thank you very much, mr. chairman. we of hearings in this committee in 2010 on the problem of antibiotic resistance and the fact it is growing and dangerous threat to public health. but certainly an issue that deserves a full and complete attention of this committee so i'm pleased you're holding this hearing. our overarching goal should be to ensure that people continue to benefit from these life-saving treatments, oath here in the united states and around the globe.

it has been an inherently difficult goal to achieve. after all, when we use these antibiotics it leads to the development of pathogens that can no longer be treated by those antibiotics. rather than use it or lose it with antibiotics, it is use it and lose it. so we are at great risk of losing much of the progress that has been made in fighting infection and subsequent disease. many americans die or are infected each year from antibiotic resistant microbes. we pay a high price in other ways as well, additional hospital stays, hospital readmissions, increased doctor visits, all at unnecessarily to the nation's angel health care bill. it will take a multipronged approach to overcome this very serious problem. there's no question that our arsenal of effective antibiotics is dangerously low today as a

result of antibiotic resistance. so we need to replace ineffective antibiotics with me once. in the 2012 fda user the legislation we enacted a law designed to trade incentives to companies to replace those analytics and develop new ones. that legislation included provisions from what was called the generating antibiotic incentives now act, called the gain act. and that granted a five year period of exclusive marketing for new antibiotics for serious and life-threatening diseases. i look forward to hearing today from our witnesses about what impact that legislation is having on investments in these drugs, exclusivity, rewards drug companies by allowing them to charge higher prices. as a result it also imposes a

significant burden on patients and on the health care system overall. so we need to approach this particular form of incentive with great caution. one bad idea, my opinion, is the concept of transferable market exclusivity, which is sometimes called the wild-card exclusivi exclusivity. this form of exclusivity would give a company that developed a new antibiotic the ability to transfer a term of exclusivity to another drug. any other drug that they have. this is a hugely costly ideas that leads to unfair cross subsidies to if astrazeneca were to develop a specified antibiotic, they could earn a term of exclusivity that it could transfer to nexium, a treatment for heartburn which is the second highest grossing drug last year, and earns over

$6 billion. even if the term of exclusivity were just six months, that would result in a report of almost $3 billion. that means nexium patients pay higher prices for longer even though they may never actually take the antibiotic itself. as we tackle the problem of antibiotic resistance, we need to ensure that whatever form of the incentive takes, bears some reasonable relationship to the amount of the investment the company is making. i hope we'll discuss today another approach to getting you and vioxx on the market. that's what's been referred to as the adapt act, or the antibiotic development to advance patient treatment. that bill would establish a limited population approval pathway that would prevent fda to approve drugs based on smaller clinical trial.

this is an idea worth examining. if we did create such a pathway, any drugs approved as a result would need to be clearly marked with a prominent symbol to alert providers and patients that the safety and effectiveness of these drugs has only been assessed on a limited population, requiring a designation is integral to the idea of a limited population of approval pathway because providers have to know that these drugs are to be used only with -- when absolutely necessary, otherwise they would not only put patients at risk but will continue to the more rapid the element of the at the microbial resistance to the drug. in addition to incentives for developing new antibiotics, we got to find ways to cut back on the overuse and misuse of these drugs. patients cannot expect to get them every time they come down with a cold, and physicians should only prescribe them when they are truly necessary.

perhaps most importantly, the indiscriminate administration of these drugs in animal agricultural operations needs to stop. we should mandate an end to this practice, but if we cannot take that step we should at least have a better data can have a better data to how and where antibiotics that are on humans are used in food animals. we know practically nothing about this situation. as a recent reuters article points out, the data exists in the hands of major corporations producing these animals, mr. chairman, another 30 seconds -- >> go ahead. >> i have a bill that would finally give the public access to this information, h.r. 820, the data act. i hope this comment is bill could be included in the 21st century legislation. i thank the witnesses for being here today and for the testimony. and try to like to ask unanimous

consent that a statement prepared by congresswoman louise slaughter be included in the record. she's talking in a statement about ways to combat antibiotic resistance and foster new drugs. >> without objection, so ordered. i have unanimous consent requests. i'd like to cement the following for today's hearing record. -- to submit. the flag and general's office of network, an official veterans organization representing three quarters of all living u.s. armed forces flag and general officers. secondly, a statement from pharmaceuticals, a global pharmaceutical company headquartered in lexington, massachusetts, and thirdly a statement from the california health care institute, chi, statewide public policy organization representing california's leading biomedical innovators over 275 research

universities and private nonprofit institute, venture capital firms and medical device, diagnostic, biotechnology and pharmaceutical companies. without objection, so ordered. all members written opening say this will be made a part of the record. at this point we have two panels to present testimony. on the first panel today we have again dr. janet woodcock, director for the center for drug evaluation and research, u.s. food and drug administration. thank you very much, dr. woodcock, for coming to your written test and will be made a part of the record, and you will be given five minutes to summarize your testimony before questions. so at this point you're recognized for five minutes for your opening statement. >> thank you, mr. chairman, and members of the committee for holding the string on this important issue. there is broad agreement that antimicrobial resistance is worldwide crisis that is going to require major efforts to

combat. in 2012 of the congress took a significant step in passing gain act. which we been implemented to in europe, the innovative medicines initiative which is a public-private partnership has launched a major research effort on antimicrobial resistance. yesterday the administration released a national strategy for combating antimicrobial resistance, a high level task force was established by executive order to carry out and develop an action plan to carry out the goals, the strategies and multisector efforts to attack this problem in all its diverse forms by bolstering his research, enhancing product development, improving or surveillance which has already been alluded to, resistance and use of antimicrobials, modifying the use of antibiotics in food

animals come and strengthening international collaboration. pcast, which is the president's council of advisors on science and technology, also released the scientific report and scientific recommendations yesterday. over the past year the center for drugs the fda has been very busy on this issue. we have issued many new or revised guidance is on at the microbial drug development. we approved three drugs designate under the gain act. we've recently cosponsored a workshop on the topic with the national institutes of health, and, of course, our fellow centers, the essential biologics has been working on a vaccine, another way of addressing this problem and the device center working on testing methods. despite all this progress we must recognize a robust pipeline of new interest additional antimicrobials does not currently exist.

nor are there large number of drug discovery laboratory out there working to bring forth the next generation of candidate drugs. so we don't have a robust pipeline. the reason for this apparently is primarily absence of commercial incentives to antimicrobial development. this problem must be solved one way or another if we're going to prevail in our fight against the ever-changing microbes. we don't just need right now, which we do need urgently, new treatments for resistant organisms. although we need it urgently, we need to keep introducing additional treatment against common conditions as well. sensor existing armamentarium is an heavily going to weaken over time. so we don't just need to respond to the credit crisis. we need a robust pipeline going forward. because this is such a multidimensional problem, we all

must work together to prevent the loss of these critical weapons against disease. so i'm very happy to answer any questions. >> the chair thanks the gentleman. i'll begin the question and recognize myself five minutes for that purpose. dr. woodcock, yesterday fda commissioner hamburg posted a blog post titled ftas take on the executive order and national strategy to combat animatic resistant bacteria were she wrote, quote pew -- few issues in a healthy ours critical and time urgent as combating the growing threat of antibiotic resistance. it is a hybrid for fda to work with our partners to find solutions for this series public health problem, in the code. would you explain the urgency of this situation for public health and national security? [inaudible] >> press your -- >> as members have already stated, for public health we are already seeing people who, in

fact, cannot be treated with any existing therapy that we have. and i think the threat here to public health is that we can have emerging epidemics of these organisms that they will spread. right now they're fairly limited and sporadic but they will spread and we will be in a situation where we literally can't treat an infection that is unfolding in a wider sense. in addition each year we are seeing greater and greater resistance problems for ordinary micro organisms. at the doctors are having to turn to what we would call second or third line antimicrobial agents. we used to preserve for very selected situations. as that occurs more resistance to those will be fall. so eventually we will be empty-handed. >> in the case of antibiotics even slight variations in the

bacteria's genetic makeup, can be the difference between a drug working or not working. understanding that bacterial resistance compound this problem many times over, why is it important for our antibiotic drug pipeline that we have multiple drug options for the same class or family of drugs? >> yes. well, what we know when we develop an antimicrobial evolves over time after that antimicrobial is used. and after time it may be that it can be effective against certain forms of an organism and not against other more resistant forms. if the mechanism of resistance is a different. there are many different mechanisms of resistance. that's why having large number of drugs in a class or even improvements in the class can be extremely helpful in this situation because you can match the antimicrobial to the organisms were trying to treat. >> do we have the type of drug

redundancy highlighted above that we need to effectively combat this problem right now? >> we do not because it's sort of the cutoff line, the antimicrobial that are no longer useful against many infections is getting higher and higher every year. especially for certain types of bugs. >> do you believe that we need to further incentivize new drug and diagnostic development if we were to appropriate address the issues of antibiotic resistance? and if so what would you recommend? >> i do believe we must incentivize it because the current situation shows that the incentives have not been enough to stimulate development in this area. so for drug development, apparently developing antimicrobials is still not attractive enough. it still doesn't appear, you know, that might be a loss to business, that there is an attractive enough business model to build those robust programs

that are needed to both discover and then develop new classes of antimicrobials. for diagnostics i will tell you that, that louis pasteur and alexander fleming would recognize the methods we use today. because they invented them. there's a lot of room at the top for improvement in we are using genetic sequencing of human genome which is huge compared to the microbial genome, but using clinical practice of advanced methods is not the norm. and that improving diagnostics, tremendously supplies clinical trials and also treatment. >> talk about incentives. do you believe such incentives could be used in other unmet areas other than just

antibiotic? >> well, of course i believe that that is possible. however, i think mr. waxman said that there are trade-offs. you have to balance -- there are always trade-offs in putting these incentives in place, and i being a physician and a scientist, i am not the most qualified person to make those trade-offs. i think congress really have two-way those. i can tell you that the urgency to, public health urgency for this problem, is severe and will continue editing to hear that from other experts as well. we are not over the hump. we have not succeeded in developing a system that will continue to generate effective new antimicrobials. we don't have that. we have sort of heroic efforts here and there. >> thank you, dr. woodcock. my time has expired. that chair recognizes ranking member for five minutes. >> thank you, mr. chairman. both the executive order issued yesterday and report of the

president's council of advisors on science and technology emphasized the danger of antibiotic use in the agricultural industry. while it's clear we should do more to encourage greater research and development of new drugs, it also makes sense we should be investing in efforts to limit the present spread of drug-resistant bacteria strains to make the best use of existing drugs so they can remain effective for longer periods. so dr. woodcock, in your tests t when he pointed ftas cooperative effort with cdc to promote greater stewardship including the get smart campaign. i'd like for you to elaborate on this partnership on fda's role in the initiatives laid out in yesterday's executive order. >> obviously there needs to be better stewardship both in human use of antimicrobials as has already been said about half cdc estimates of antimicrobial outpatient prescriptions are not necessary given the condition of

-- the condition a patient has. especially people only take the drugs for a little bit, it can lead to big problems. and also in the animal world, now, in the human area, collaborating with cdc on these efforts but cdc primary is the lead on improving better use in health care and that's a multifaceted effort. in the animal health in space, fda has put out a guidance, calling on manufacturers to cu's of come discontinued use of important human antimicrobials for growth promotion in food animals. and they have secured the cooperation of all the manufactures are engaged in that space, my understanding, and then there would be a process whereby those indications are withdrawn and then use in food animals would be required under

the supervision of a veterinarian for a health condition in the animal. so that would be a great improvement. also as was discussed in the report yesterday though, we need better surveillance and data to understand the length -- the link between at the micro the use in animals or humans in the develop of resistance. that's still rather poorly understood. >> all right, thanks. i wanted to get fda's views on certain aspects of the adapt act. as understand the purpose of the bill its goal is to facilitate fda's ability to improve and about its have been tested only a limited population and for which the need for the drug is critical. i know you offered to approve drugs test and of the population. for example, of drugs for rare diseases. i'd like you to point even white existing accelerated approval mechanism are not getting current needs and also like you to address what he believed the adapt act is currently drafted provides fta with sufficient authority was sure that i tapped

antimicrobials will be labeled in the way that clearly establishes them as different from other antimicrobials. it seem seems as if we can sittn drugs on the market tested only in limited trials we need to be confident that providers and patients understand the care with which these drugs must be used. >> yes. well, we think the adapt act has element that we have been discussing for a long time. let me explain. some of the situation. we approve drugs for limited population all the time. orphan drugs, where subsets. but generally speaking the clinical kennedy is not tempted to the clinical community, use for a cold, somewhere inside deficient or some cancer, rare cancer of whatever. with antimicrobials the big problem is really the use outside of where it would really clinically be indicated.

and one of the barriers who are highly resistant organisms is the occurrence is sporadic. we are very lucky that they're not widespread outbreaks. but because they're not widespread outbreaks it means that testing of them and brought population is difficult. and actually the good news because otherwise we really be in trouble if there were large numbers of people suffering like this. so that means by definition everybody get these drugs in the market for these small populations of resistant organisms, you left out small trials. you will have more uncertainty about the effect. samore uncertainty about the effects, worry that they will be used in conditions where it's not warranted. those are the two issues we are trying to address. in orphan conditions, yes, there's uncertainty about the effects but the orphan community

that uses these drugs, usually those are some specialist who are treating a very rare disease and they have a very good understanding of what the study was done on the drug and so forth but it also may be the only drug ever studied for the condition. so our thoughts, and we have the administration has not taken a position on this, but we have thought about this, that to offer very small development programs is a big incentive but the quid pro quo really is to send a signal to the clinical community, you know, some kind of signal, some kind of message that this is special. there's more uncertainty and also really good use, good stewardship about this particular product. because using it in a lot of conditions where it's not awarded would also more rapidly increase development of resistance. >> thank you. >> the chair now recognizes the gentleman from georgia,

dr. gingrey, five minutes for questions. >> well, mr. chairman, thank you for recognizing me. i know that vice chairman of the subcommittee, mike lee, dr. burgess, was scheduled to go next, and i thank you for letting me ask my questions now. dr. woodcock, thank you, also, as a witness. we've had you before our committee many times as i've been on the committee. and you're just always so straightforward and to explain things in a very clear way. and i mean that sincerely. you do a great job and we appreciate that very much. i want to continue in the line of questioning that mr. pallone started, and again, and i have limited time so let me get right into that. congressman green and i have been working on this adapt act as you know, and it's

legislation that supports the fda's flexibility to consider all forms of evidence in addition to data from clinical trials when considering novel antibiotics. how important do you believe adaptive and unique trials design can play in encouraging you as a byproduct of drug development? and before you answer that part, just, and i'm sure everybody at the hearing knows this, but in your typical phase three trial before a drug can get to market, you are going to have to have a population of 1000 or more people that you are treating. and there are also other requirements that they can't have had an antibiotic within 24 hours of the start of the trial, or at one point it was three days i think and then we got down to 24 hours.

but, you know, you're going to have a limited population of people that have these diseases, and when they get to the hospital, sick as heck, the first thing the dodgers going to do, emergency room physician, is there going to hang some antibiotic, even if it's wrong. they're going to start treatment and then all of a sudden they are not eligible and you have a limited number of people come if you wait until you get 1000, it's too late. so if you will kind of take that step further, discussed that for us. >> thank you. and thank you, and mr. green, for your leadership on this. i think it's very important. yes, there is a range, and i think that's what people have to recognize, there's a range of the government programs that are needed for common conditions, outpatient pneumonia. we have a lot of drugs out there that still work, right, that as we introduce new drugs we want them to be just as good as the

other drugs. they wanted larger development programs, and that's true for many. but for these very rare, fortunately, resistant organisms that are multi-drug-resistant common there's almost nothing to treated them, these cases are occurring sporadically here and there, or in outbreaks in icus or something like that. we have to think of different ways of evaluating new treatments. we can't just set up a trial and wait for all this to happen and expect we can and will thousands of people. and it is true, in fact if we enrolled thousands of people, it would have been too late because this would be a terrible thing. so it is true that all antimicrobial drug develop it is very difficult. in addition to the economic problem there's a huge difficulty in doing trials, especially people who are really sick. you can't use a placebo obviously. you don't know because the

problem with diagnostics. you may not know for a few days what organism they are infected with. and so there are all these technical problems that make it very difficult to antimicrobial drug development. so because we have a tremendous unmet medical need for people where there is no treatment available, typically what we do in that case is we except more uncertainty. and that means novel trials that we might do. >> dr. woodcock, speaking of that uncertainty, i think that is probably why, and i commend the president for this in his executive order of just yesterday, the $20 million award for the development of these point of care diagnostics, both someone could take a pill or a piece of tape or something and put it inside of their mouth and

if it turns a certain color, you know what you're getting with right there and you don't have to take a shotgun approach. you can immediately go right to what you need. i think it's a great thing. >> i agree. if we could bring diagnosis of infectious disease into the 21st century. we just made a huge advance and accelerate the development of therapy, so that is a good thing. >> thank you very much, mr. chairman. i yield back. >> now recognize ranking member of the full committee, mr. waxman. >> thank you, mr. chairman. i also want to say to dr. woodcock, this may be the last hearing what you and i will have the opportunity to publicly talk like this, but you've done a wonderful job at the fda, and your responses to questions from both sides of the aisle have been very, very thoughtful. i want to commend you for the work you've been doing, and thank you for it. i want to echo the comments by mr. pallone about the imports of strong labeling statement, or logo, in the context of the

adapt act. i think it's essential the drugs they're a prominent statement describing the of review pathway by which they came to market. without this requirement, i'm not sure the whole thing would work to do pretty much less likely to achieve its purpose of fostering and facilitating the development of critical new antibiotics for life-threatening resistant pathogens. and additionally inappropriate or in judicious use of the drug to develop this pathway could result both in patients harm and a more rapid loss of the drug antibiotic resistance. site just want to underscore that point. i want to ask you about a concept that you mentioned in your testimony designed to spur development of new antibiotics, delinkage. as i understand it, under this model the sale of antibiotics would be linked to the return on investment. we don't want -- we want to make

sure the antibiotic are sold and user antibiotics that can stay effective for as long as possible. so some of the funding mechanism would be created besides their traditional way of selling more drugs to a sure that a company was able to make a profit to developing an antibiotic. as others have noted the usual pharmaceutical business model doesn't fit very well in the case of antibiotics. we need, however, to recognize something they need to recoup their investment make erasable property others have raised the notion of a wildcard exclusivity. i mentioned in my opening statement. i think a very dangerous idea. we don't want to force patients taking one type of drug that has been developed for another. so assuring that an antibiotic developer still can make a profit without linking that

profit damage antibiotic is actually sold seems like a brilliant way to approach this problem. could you elaborate on this, tell us more about what ideas you have along these lines? >> well, yes, because right now we have incentives that actually weigh against our objectives. our objectives are that we have the most judicious use of new antimicrobial possible, yet the incentive, if you spend $500 million developing this drug, you need to recoup that amount of money and a fair profit to stay in business and develop the next generation. and so these incentives are sideways to each other, or countervailing. and so that one idea has been raised that we mentioned to delink the need to have a large volume of antibiotic used which would then lead to faster development of resistance. so if that were delink from -- >> do you have ideas on how to

do that? >> as i said i am really not a good at financial matters. sorry. >> we can depend on you for everything, economic advice as well as pharmaceutical and other things fda does. let me talk to you about another issue, and that's stewardship using antibiotics judiciously seems to me this is a critical component of any effort to address the antibiotic resistance problem. just released report on combating antibiotic resistance from the president's council of advisors in science and technology, pcast, stresses the importance of increasing the longevity, current antibiotics by uprooting the appropriate use of existing antibiotics, and it discusses the need to look at both human used in animal use of existing antibiotics. we know there's a lot of inappropriate use of antibiotics, both on the human side and i believe on the animal

side. but pcast report describes the important role the diagnostic simply introducing this type of inappropriate use. do you agree that diagnostics are an important stewardship efforts -- you allude to this order, but can you describe how the widespread adoption of diagnostic tests could help preserve existing at a biotic spikes is fda taking action to foster the use of these? >> i believe diagnosis should be the foundation of therapy. and, unfortunately, in the infectious disease space, often you are treating well before you know or before you ever know, like what the person has. this is a fundamental problem. like i believe the advent of rapid stress testing has really reduced the use of drugs for presumptive strep that often is a cold or something, upper respiratory infection in one sort or another. if we could get more certainty

into the diagnosis early, be able to reassure the doctor and the patient or family that no, this is not a dreaded bacterial infection that needs antimicrobials. we could go a long way i think to lowering this in the appropriate use. so diagnostics are the key. it's just we are far away from that right now. we need to stimulate that. >> dittemore incentives for that? >> i believe so. >> thank you. thank you, mr. chairman. >> the chair now recognizes the vice chair dr. burgess. >> thank you, mr. chairman. dr. woodcock, again welcome to our little subcommittee. your last statement, diagnostic is the key. it's not, this was not part of this discussion today but we have had discussions on diagnostics and i realize it's not your part of fda that is talking about increasing the regulation of testing, particularly laboratory

diagnostic tests or laboratory development tests rather, but that is, i mean that factors into the equation. you're talking about the length of time it takes drugs to get through the pipeline but if it also takes the testing longer to get to the pipeline, we are actually making things harder on ourselves, are we not? >> yes. well, we have recently, for example, we've had a workshop with brookings on this issue with the codeveloping of the technical issues that the final guidance that we put out recently on codevelopment and continuing diagnostics that for life-threatening disease we're going to go ahead and approve the drugs even if the test isn't fully done you. there are technical problems in getting these tests developed a right now. i think all of us believe for many of the genomic tests that next-generation sequencing is really going to be a key, and really rapidly improve this situation. so i have great hope that that will be coming soon.

because we are facing it now. every disease -- so cystic fibrosis for example, actually there one and 50 communications in the chain to each of which may translate to a slightly different phenotype and the prognosis. and so we need to rapidly -- that goes with cancer and many other diseases. and so we really need to rapidly get to a point where we have a to stand that we can all agree upon so that we know what we're dealing with. yes, it will rapidly improve development of the drugs for these serious conditions. conditions. >> i share your enthusiasm for genomic testing. i am somewhat more pessimistic because it seems like i can remember doctor allies, and my first term on this committee which was many, many years ago, talking about some of the same things and it's sort of like the jetsons flying car. we are still waiting for that to happen. on the issue, and you at hhs,

did your study on antibiotic commission, the incentives for development of new drugs, rapid diagnostics for bacterial diseases, talked about moving the needle monetary terms for companies and reduction of the time for clinical trials, correct? >> yes. >> is it possible to move the needle on that? >> well, i believe for a limited population, that is possible. that's only one factor, but if you have a very high bar getting on the market, then you're going to need much stronger incentives. i believe for those very rare, right now, resistant organisms, we could have a very small development programs and their be societal agreement that having a treatment available for those is better than having nothing. and so he could have a very small develop a program. we simply would like to have a signal then to say to the

clinical community, no, that this is different. okay, no, that this didn't have a huge development program. we are offering you a tool but you ought to be a where that, and provide good stewardship of this tool. so we do believe in most cases it is possible, and even for common diseases, we have worked with new guidance is to try to lower the cost of a development program so that the pipeline can be more robust. >> on the issue of judicious use and the stewardship, i hear the blurbs that are set on that, but when you try but using things outside, it indication can we tend to think of a world in which we live, but i'm from texas and just a little bit south of texas there is a different world where there's not a prescription required and you can so we go to the pharmacy and say i need this and the

pharmacist may direct them to a particular drug, on images simply come in with a recommendation from a family member and make that purchase. so it's obviously harder to control that within the jurisdiction of the united states when it's happening right outside, is that not correct? >> totally agree. everywhere is right outside with the modern air travel. and so we're getting soldiers back from combat who have acquired a very tired resistant infection. we have travelers are coming back in the united states who have been -- there are many country for antimicrobials are used very freely and may be available to consumers without intermediaries. >> it concerns me that we want to put the onus on doctor treating a patient in an emergency room, with a concerned family. we are putting all the onus on our physician year when the greater wide world, none of

those constraints exist. i agree with labeling. i agree with making the indications well known, but i don't think we should ever try to put the federal government in the position of second-guessing the judgment of a physician. >> well, we agree with that. because the treatment is empirical we can indicate, you know, it has to be suspected. you can't say come you can't treat a patient because this was instead in clinical trials if there's nothing else available. or the clinicians must use best judgment when a treatment is that when a patient cash that we want to get the best directions and information to the clinician so they are aware of not only what clinical situations they're dealing with but how much information pertains to drug and what kind of drug it is. ..

>> not only is actually kind of hard to discover new antibiotics, it's expensive to develop them. and the reason is it's really you have a patient before you with pneumonia who could have all sorts of different organisms