>> well, i'm always reluctant to draw too big or too quick of a conclusion from the outcome in the particular case. what goes on in the courtroom with respect to what evidence is admissible, how the witnesses perform, what influences a jury, it's hard to draw greater conclusions from that, although many people and many commentators do exactly that. in our case, we have a different standard approach. and i think that it just underscores the point that the care and concern that we give our cases is always the right approach. but you can't always predict the outcome. >> even to the hedge fund case. because of course evidence, and

what you present in court matters here. with regard to insider trading, even the hedge fund case, conversation that people have on wall street. one man's insider trade is another man's gut feeling. a simple conversation. it's a very fine line. these are hard cases to prove. >> well, i don't know if they have hard cases to prove. first of all, i think enforcement authorities across the country typically don't bring the cases that are right on the line or there's a great deal or lack of evidence of the intense or knowledge on the part of the parties. generally, the authorities bring cases that they believe are clearly over the line. and candidly, if you are speaking in code, if you've gotten information that you know was pursuant to the promise of confidentiality, if you pass is on with a warning not to divulge

it from anybody else, one person said i could go for jail for doing this. there is characteristics, >> those are the wiretaps you like when they say it like that. >> it generally gives a pretty good and clear indication as to whether or not this information was key in the violation of duty and confidentiality. >> do you have any sense that this activity was in any way fueled by the economic crisis we've just financial questions. is there more people willing to take the kind of risks because they've been through a very difficult time. it's hard to get people's motive. when you comes to the law, you don't have to prove the motive in the case. i would say, about hedge fund activity, it's just the vast number of them. and the competitiveness of that market.

not everyone can do that. and i think there's a great deal of competition amongst funds. that can drive people to cross lines they wouldn't otherwise. >> right now we have the congress and financial regulatory reforms to require large hedge funds for the first time with the sec mandatory registration. some do voluntarily. what difference is that going to make in the course of your work? >> i think it would make a difference. registration would allow us to have inspections, and allow us to have greater transparency into their trading activity, a largely greater flow of information that we would be able to obtain. a greater level of knowledge, and the requirement of the firms

rigorous. >> all right. since you encouraged the bernie madoff situation. what is the first thing that comes to mind when i say bernie madoff, what's your first reaction? >> throughout the division and agency, we recognize that madoff was a terrible tragedy. we something that we deeply regret. it's clear from the inspector generals report that we did not do the job that we should. we've acknowledgeed that for some time. mostly, the terrible tragedy. we understand the consequences for the individuals for retirees, for charitable institutions, and we've taken that lesson across the agency in every division. and we have an attempt to give some meaning to this. rewatched is procedure,

structures, and programs in a way that we can avoid this from happening again. >> let me ask you again. in august, some the enforcement division that you started to push through. can you site something specifically that you think would have made a difference in this case that could have caught before what ultimately happened? >> well, i guess a couple of things. we are creating specialized groups that focus on particular areas of transactions, markets, practices, products, just to we have a greater expertise. so that when you embark on investigation, you have a deep knowledge of that product or that market or that so that you can know exactly where to focus the resources and target your questions and your inquiries in a way that stands a greater chance of detecting the wrong doing. better communications across the division, better training, and a creation of a office of market intelligence which would be -- gather in one place within the

division of enforcement. all of the tips, complaints, and referrals that receive to analyze them, to triage them, to kind of better harvest intelligence, and see connections between them that we might not have been able to see in the past. >> there's wisdom out there. give you the chance to shoot it down. everyone on wall street, step ahead. these people are smarter. there's no way the sec is going to be one step ahead, says some. how do you respond? >> i think the track record proves otherwise. just to take two or three days a couple of weeks ago, you charge charged the second of the case. we charged jpmorgan with bribery, we charge valueline with a provision of the brotherrage services, we -- brokage services. we do every bit of inquiries on

a regular basis. it may take us a little while to get there. these investigations can be challenging to difficult. look at our track record. i don't think those are inclined can take much comfort from it. >> there's been a change since you took off in terms of some of the powers of your investigators. the ability to initiate an investigation before the commission votes to give you that authority. how much of a difference has that made? >> it's made a significant difference. we now have the ability thanks thank to the endorsement commission to issue subpoenas without having to go through some the procedures step that is we had to. it means that if we are not getting cooperation or proper response from those that are targeted from our inquiries, they can find a subpoena on their desk immediately, rather than having to wait some time for it to be approved. at the same time, we recognize

that the commission form a valuable function of oversight. so we'll continue to communicate to them as to which investigations we're opening. and go to them for approval in those situations that are unique, or novel. but it gives us the ability to move quickly in the appropriate cases. >> you listed some high-profile investigations that have been launched on your watch. how do you respond to those people. the sec has battered because the madoff situation. right now is a good time for the sec to make a big speech, list a bunch of high-profile investigations, but there may not be much there. this is a publicity effort. >> that's odd. i guess i would say read the complaint. companies are paying real fines of significant amounts. so this is not an effort to

respond to critics. we respect what the commission has done. >> so this doesn't represent the new enforce. what does it respect? >> well, the cases are. i mean certainly under chairman sha peer row and the commission, there's been an effort to revitalize to take a hard look at it and decide where there restrictions or procedures or practices that hampered the enforcement effort, and thanks thanks to her efforts, and those of the commission, we've been able to accomplish some of that. i think it's given, the message is clear. it's given a sponge message. they are there to do the enforcement job. they'll be safe when they do. i think her efforts within the propro -- proposals have all

combined to bring a real sense of mission back to the enforcement division. >> i want to open it up to some questions. let me ask you one more. as the debate plays out between the house and senate, there's some competing ideas. what's the one thing congress could change to help you do your job better? >> just cash. >> unfortunately, i was going to say a lot of cash. >> look, resources are very significant. i don't mean to bore you with statistics. and compare the numbers of persons about 3500. and versus the number of regulated institution that is we're responsible for. which is probably 35, 36,000 in terms of transfer agents, nourishers. you compare that ratio 10-1 to the banking regulators which

have more like a 1-1 ratio to regulated institution. combine that with regulating, and we're obligated to fair it out with fraud and wrong doing committed by anybody regardless if they are associated with a regulate institution. you add to that possible requirements that we are there to regulate hedge funds. it means we have a very significant challenge. including one nor funding. >> you always connect -- the fees you connect right now about 1.4 billion, i think it was last year. >> correct. i think that's the how the banking regulators are funded. i think it would be a great step forward. not only because the amount, but

because you can have a consistent force to plan and budget going forward. >> we've got a question over here. sir, if you could say your name and your questions. >> start off with mr. khuzami, i'm a venture capitalist. but you just mentioned the potential for regulating hedge funds. and that legislation is working its way through both houses. can you talk about how you might approach that? and agree to that you would look broadly and what really is the violation of regulations to be looking for? >> well, the regulations would require -- the registration requirements would wire hedge funds to adopt the various requirements in terms of compliance and ethic programs, disclosure, and requirements.

and we would typically see having our examination staff would conducting inquiries and exceptions with respect to those funds. apply those requirements to the funds, and see what's short comings of their work. in addition to as i mentioned having kind of transparent information of actual trade data that we could see was going on. it would also be a great benefit for us to use the information detect patterns. so really, it's just to comply with the requirements of the law which are pretty clear under the investment advisers act. >> of course, there's someone some concern about sharing

proprietary information. >> i think that's not a concern. we deal with lots of information. and we have strike rules of making sure that information doesn't end up in places that it shouldn't. >> all right. another question over here. sir, your question? >> yesterday, i was listening to bloomburg on the radio. the former commission was on the air being interviewed. talking about senator dodd's proposed legislation. and specifically mentioning the whistle blower fees or payments made to whistle blower. he was opposed to that. what's your thinking? >> there's -- we've endorseed legislation which would give us the power to throw out the whistle blowers. we don't have in generally across the division. i think it's a great idea. look, with the amount of tips

and complaints that we receive, it could be a great benefit of us to get high-quality, high-value information that comes from whistle blowers or another one of our initiatives is being able to start to turn to former cooperation, where we can get their information and evidence in exchange for potential leniency. those kind of have a common pump, high-quality, high-value evidence into the commission early on by insiders, by those in the know, rather than necessarily months or years after the fact, having to wait through large lines of information to recreate the case. we want good strong, credible information up front and early. we have to offer an reward, as long as it's transparent and what we are doing, and there are

restrictions and guidelines on making sure that the rewards that are given are appropriate, and that the evidence being offered meets the criteria. and is in fact actual, original evidence of wrong doing. >> i think we have a question over here, sir. >> i'm from texas. given the downturn on the market, and given the situation that we have with short seminars, it's certainly in that given market, we think that the short seminars are given up information that is almost useless. have you or the sec looked into that any way? or have you considered it? or is it prevalent or more prevalent today than it is five years ago? >> we are looking in those areas. we brought, i think, a couple of cases, violations of it with

requirements having to close out and cover short positions and individual or firms that have encaged as the way of avoiding that requirement. and i think, you know, we have investigations into those areas that you mention, but i'm afraid i'm not going to be able to say much more than that. >> sir, right here. >> i'm with the hawthorne group. due to the ethical restrictions that you have on comments on ongoing investigations, this is late in the afternoon, can you tell us the biggest gang of fools that you've run into. somebody that came up with a bizarre scheme to probably fraud themselves. there must be something that you can add in here. >> we love hearing about gangs fools. >> i can tell you about one case. it's an older dale case that i

had as a criminal prosecutor as the u.s. attorney office in new york. it was an individual who had age 13 began on the portfolio that was patterned after the investments as the assignment in business class in junior high school. he was able to convince a number of highly well-known banks to loan him a significant amount of money based on what was a fictitious portfolio, and he used that money to buy himself a very fancy house in california, and a golf stream jet, and traded profitability, i might add, that was in the 1990s when markets were on the upswing. and then eventually convinced a couple of investment banks to underwrite his ipo, which going

to be a insurance company that was going to be located right down the street from warren buffett in omaha, nebraska. only the day the deal priced did the sec learn that there were some activities about the activity. and the ipo was withdrawn, and the whole scheme unfolded. and he and his coconspirators were set on bail. despite all of the due diligence by banks and investment banking firms, this individual was able to pull this off for a number of years. that's one that always stuck in my mind. >> well, we can take one more here in the audience. >> just following up on the short selling question. so a year ago, we had the ban on short selling of financial. obviously in emergency situation, extraordinary circumstances, there were benefits and disadvantages. that seemed to be a function of responding to the price as

opposed to fraud. how do you feel about that now looking a year back, and what about the converse if we have a bubble and prices were moving very quickly to the upside, would you support some kind of ban on the purchasing of financial stocks? >> you know, i think i'd be reluctant to predict what position i might take in that area. you know, as enforcement lawyers, our focus is more on conducting investigations, and fairing out wrong doing rather than the rule making process, which been impacted, and there's been lots of inquiries in research in that area. i think i probably beg to decline to answer. but thank you for the question. >> let me sneak one more in on bernie madoff if i could. he's in jail right now in north carolina. prison, i should say.

there are active investigation going on. how long is this going to take for y'all to wrap up? are we going to see more people charged in the madoff situation? >> sorry, i'm going to have to decline to answer that. just can't comment on ongoing investigations. >> all right. you've been kind enough with your time. i appreciate it. [applause]

>> thanksgiving day on c-span. at 10 eastern, bill clinton is presenting steven spielberg with the award. also part of a panel of the obama presidency. and from the jfk library, nick berns on terrorism and nuclear weapons. at five, hip hop artist and actor ludicrous on the youth. and later howard dean on the economy and capitalism. the national football league announced recently that it would require teams to seek independent neurologist when evaluateing concussion injuries. the announcement came after roger goodell appeared earlier.

when it came to conflict of interest issues. join us tonight for this part of that hearing. that starts at 9:15 on our companion network. >> the main topic is health care. the senate debate on their bill is set to begin next monday tolling an hour of general speaking. amendments will be considered throughout the debait. -- debate. of course many interest groups either opposing health care legislation. here's a look at a couple of them. >> a year from now, i'll break my leg, and my parents will have to sell our house, because we couldn't afford health care. >> three months from now, i'll never need. and the parents will go bankrupt, because they couldn't afford health care. >> two years from now, i'll be diagnosed with leukemia, and i'll die, because we couldn't

afford health care. >> 8 million. >> we all deserve health care. >> the democrat national committee is responsible for the content of this advertising. >> saturday night as americans laid down for sleep, democracies laid down their beliefs. sold out their constituents, rolled by pressure from president obama and harry reed. they voted to move forward the government run health care bill, our nation does not want and can't afford. one member sold her vote to the highest bidder. one member sold out his principals. two more lost what little creditability they had on fiscal responsibility. another put the interest of the left of his party before his own state. and another voted one way after saying he was for another. it's no wonder why democrats voted in the dead of night.

>> now an interview with republican strategist, alex castellanos. he recently spoke at the museum in washington, d.c. he's interviewed by rick klein for a half an hour. >> well, some of this is easy stuff. really where he left off a few minutes. are republicans going to win the house back next year?

>> you'd have to, if you were just playing the odds, you'd have to say, no, i guess. you'd have to say the traditionally the party on the power in a cycle like this only gains high teens low 20s. but i think there's a pretty good chance we might. i think it depends if right now we're -- republicans i think are somewhat content just letting president obama's failures be our success. if that's as far as we get, then we'll probably win close to 30 seats. but president obama's failures aren't our successes. they are our opportunities. if we step up to the plate and kind of evolve a little bit to the next generation of republicans, yeah, i think we can actually get in the low 40s, and maybe even better. when president clinton lost what 54 seats, something like that? his popularity ratings were

under 50. with president obama, that won't be the geometry. his personal popularity is separate from what people are voting on as policies. and we want him to succeed. he represents an america, an improved america. we don't want to go back to a more rationally deviced country. we don't want him to fail. but i think the dynamic for the next election is going to break pedal. you have the white house, the car has no brake. anking.

you can take the price control mechanisms and instead of top-down putting them in washington, with three smart guys deciding how to save health care money, more market-oriented approach where you put price control mechanisms, patients and doctors, safeway's holding down the cost for quite a while. there are things you can do toward reform, shopping across state lines, there are lots of things you can do to empower some real market-based reforms. republicans have come forward with that and interestingly enough david axelrod said 80% of this we agree on. they could have taken that 80% and box something up and had it done by christmas. >> you referenced leadership. there is no -- no one speaks for the party, no leaders in the party, you heard that about democrats, you hear that now the republicans. what kind of party of power, what should republicans be doing

to build up leaders to put people forward that can speak to the american people ask choices for the republican party? >> i was telling someone the other day this is going great other than the fact we don't have a script or a leading man. other than that it is just terrific. this is a natural part of the cycle. there is frankly not a lot -- maybe it is wrong to say we can do but probably will do. nothing new groove in the shade of the big. 3. we have a dominating force -- now that is gone. the sunlight is hitting again and we are seeing the beginnings of new leadership sprouting up. this happens. democrats have the doors. we are finding new voices. perhaps we found some this election tuesday in virginia. i am sure we will find more. it may take a cycle or two to

get the new generation of republicans out there. all of a sudden we're seeing a lot of republicans encouraged to run, a lot of new candidates as a result of tuesday's election. >> what lesson do you thought of bob macdonald's victory? beside a big shift among independents. do you need to run to the center to be successful republican? >> guest: yes that are two ways of doing that. the lessons of the past election, the democrats are in this wonderful place where when you ask why they're going to win in 2010, because the republicans are a mess, they are divided and eating their own, i have told that story. usually when you tell that story, that is a bad place. the republicans are very unified at this point. we are unified, fiscal issues, a

big umbrella. you saw it in congress when voted against the stimulus and in places like florida where the fellow out of the mainstream is one guy who happens to be the governor. every other republican in the state doesn't understand why we voted -- why the governor was part of the huge stimulus. the republican party is incredibly unified in places where there is weird geometry and the conservative party and all that. those are not the issues that are dominating the electorate and probably won't be going into the next election. why don't we talk about jobs and growth. that is what we are unified about. what are the lessons from tuesday? bob mcdonnell is a conservative republican. you could call him and a thousand others, how did he win? not by abandoning his principles but having faith that they're the best way to organize society

going forward. there are a couple ways to do it, try to stimulate top down, and a closed system or stimulate the economy bottom up. that is what bob mcdonnell was talking about. he was not less conservative but explaining how to create jobs, parents would be free to school their kids as president obama did. the lesson is you don't have to become a democrat to get elected as a republican. you can get elected as a republican by explaining how your ideas and principles are the principles that created 4% of the world's population and created the world's wealth and prosperity. >> your point about florida, if

you run to charlie crist, leaving aside florida -- >> guest: no one is -- if barack obama stood up tomorrow in the democratic party and said i have a great idea. george bush's tax cuts are terrific, the best thing ever. what do you think would happen to him in the democratic party? he would have stepped out of the mainstream at that point. charlie crist has to be the guy who steps out of the mainstream of the republican party and independents. >> host: does olympia snowe need to win back the party to win back the majority? >> guest: republicans who believe in the principles that republicans and independentss believe, probably shouldn't spend more than you taken or of the degeneration is that that gounod's how high they will pay, you should have more faith in people to grow the economy

bottom up than a few smart guys in washington. those are things republicans generally believe and as long as republicans do, and inclusive message that brings more people in and by the way we are really democrat light and you can embarrass a republican, half of one. that is a much better message and more encompassing message, that is what independents heard. state level races all up and down virginia. >> host: you said the republicans don't have a leading man. there is a leading woman in the republican party. we are about to answer an intense panel with a book

relief, she was on oprah, this phenomenon, is it a good thing for the republican party to have someone that consumes this much every time she speaks? >> host: >> guest: fascinating character and that is what the news loves to play. the president is stopping by alaska as he begins his trip to asia. i don't believe he is going to announce that he is resigning from office and going back to writing books any time soon. it is going to be tough for sarah palin who has stepped back from the governorship with the explanation her state would be better off without her to now explain why the other 49 states would somehow be better off with her. she has stepped away from public

service side of life. a hugely powerful force. remember the two week she first came into the john mccain campaign read the two best weeks of the john mccain campaign. why? because she gave john mccain something he could give his own campaign, being a real maverick, it allowed cider, a real populist. a lot of the obama administration's problems now are that he has become the elite. america looks at wall street benefiting, the smart guys all getting together and cutting the cards themselves but what has he done for me? the message obama is putting out there is very different from the message of the campaign. he had a very empowering message in the change we have been waiting for. changed start from the bottom up. since the election, if you are the american people you are screwed. you are helpless. there's nothing you can do. only we in government can save

you. you are not the hero of this great story, you are the victim. that populist resentment and this empowerment is what feeds the sarah palin surge. what is going to happen is she will get up there in 2012 and not run and have a big speech and then 20,000 people will show up and the media will laugh at her and ridiculed her and how could that -- and her populism and she will give another speech and have 30,000 people. she will be a large force in the republican party. it would be nice to see it much or and it would be nice to see it channel not only in to what we are against but what we can do if we empower people bottom up to grow the economy and things like that but other than that i wish her success in the book business. >> host: you think of her in the category of power like glen beck verses someone that we are considering as presidential in

2012. >> guest: the people who are the base and i am the base, they have a different job. their job is to animate the base and carve a small slice of the market and make a radio audience or a group of folks who buy books. both sides have that. democrats have their crazy base and we have our crazy base and i mean that. the job of a political party is to take those principles and build upon them, not abandon them. lead that base across the middle. obama did it, reagan did it, republicans can do it again. the job of parties is very different from the job of a radio talk-show host but when you see republican's leaders are only the leaders of their base that means we haven't begun our journey. we haven't begun -- the problem is not the base we have, it is the transformation leaders that we don't but that is coming.

>> host: times requested or two. >> i am in the center of the state, ground and zero for the economic crisis in this country. many of us were wondering, met romney might run for governor in michigan, kind of cool to help us out. obviously that won't happen. he has been traveling. he has been speaking. he has been raising money and so forth here and there. what would you like to see next time if there is a met ronnie candidacy that did you did not see this time in terms of what he has to say, his message, anything. what would you like to see from a met ronnie candidacy that you did not see last time? >> that is a good question because it is not just say and what didn't happen last time. we will be in a different world. last time was the transformation election and the curtain drops and it is this the world we live

in much like roosevelt, kennedy, reagan, new world out there and we look at the transformational figure to make sense of it. who are we as americans and where are we going? the democrats had that in a candidate. they have evolve that way in a person but not in ideas. they have regressed to one pilfer every meal. we haven't done -- made that generational leap forward in either candidate's or policy. what would i like to see nick ronny or whoever renominated is next time around? stand up and tell us how we are going to get to the next place, how would you believe in and republicans believe in will take us to a better place. it may be a transformational election for republicans again. we have also seen that

transformation scaring the hell out of us. the candidate republicans and americans and independents may look for next time may also be less of a transformational guy and more of a consolidator. who is going to make us safe? you can make the argument that there is a plenty out there. maybe we don't want the exciting guy. maybe we want the dollar guy. just lock the doors and quit pouring kerosene on the fire. >> who is the dull guy? >> i am not saying anyone is the dull guy but a less -- we had charisma. there is an argument that may be a little less charisma would do. >> one more question. i will just do one closing one. 2010, how important is it for republicans to start the rebuilding next year? is this the do or die an election? if you don't see a big chunk come back in congress will the republican party throw out the

play book and start over? >> if we believe for me to accept that i believe freedom doesn't work and liberty is not the greatest idea in the history of man and am powering the american people is not really a good idea. can we find leaders, can we find our voice to say that? the important thing for republicans to remember is there is a different a electorate out there. we have four million millennials going to the electorate every year. the melting pot has a lot more ingredients in it than it ever had. if we invented what republicans and conservatives believe today would we talk about it the way we talk about it now? no. i was up at harvard a year ago. kennedy school. those kids are so empowered. nobody ever told them what to do. they think like conservatives, they just don't know it.

they call it organic growth, growing things naturally. we say it is individualism and underpin orship. at an end of the day if we are not only comfortable with thinking our principles are good traditional things that have done a lot of good for this country, the communications age in a mobile -- these are the principles that are the best way to organize society looking ahead. we will do really well. >> guest: >> host: thanks. >> guest: pleasure.

>> the national football league announced it would require teams to seek out independent neurologist's when evaluating concussion injuries. a shift from recent policy which allowed team doctors to make the diagnosis. the announcement came after commissioner roger goodell appeared before the house judiciary committee. join us for the second part of that hearing which begins at 9:00 p.m. eastern on c-span. thanksgiving day on c-span. at 10:00 eastern, bill clinton will present steven spielberg with the liberty medal from the national constitution center. stanley greeneburg and alex castellanos assessing the presidency and the jfk library in museum, nick burns and lesley on terrorism and nuclear weapons.

hip-hop artist and actor ludicrous on youth mentoring and howard dean and dick armey on the economy and capitalism. thanksgiving day on c-span. >> this thanksgiving holiday we have four days of booktv on c-span2. beginning thursday morning we will feature books on history, public policy and politics. you can see taylor branch on the clinton takes and hear from two of the little rock nine. what the authors of super fre o freakonomics and government contractors with allison staying her. from thanksgiving morning through monday morning, watch c-span2 on booktv. to get the full schedule go to booktv.org and follow booktv on twitter at twitter.com/booktv. happy thanksgiving. >> c-span's student contests is here. $50,000 in prizes for middle

school and high-school students, top prize $5,000. create a eight minute video on one of our country's greatest strengths and challenges. it must show varying points of view. deadline january 20th. winning entries will be shown on c-span. grab a camera and get started. now a house hearing on h1n1 swine flu vaccine. you will hear about setbacks in the production and distribution of the vaccine. this is a joint hearing of commerce subcommittee on health and oversight. it is nearly four hours. >> the meeting will come to order. today we are having a joint hearing of the health subcommittee and the oversight and investigations subcommittee and the hearing is titled h1n1

preparedness, an update of distribution and production. we will begin with opening statements from members of the subcommittee. the chairman and ranking members of the two subcommittees will be recognized first for a five minute opening statement followed by five minute statements from the chairman and ranking member of the full committee and chairman america. other members of the subcommittees will be recognized for two minute opening statements and i will begin by recognizing myself. let me explain the purpose of this hearing is to get an update from the main stakeholders' involved in the manufacturing and distribution of the h1n1 vaccine and to shed some light on where we currently are in the process and what we can expect moving forward. the most recent estimates from the centers for disease control are truly alarming. over the past six months it is likely that twenty-two million people in our country have been infected with the disease and 98,000 have been hospitalized.

today it is estimated that 3900 individuals have lost their lives to h1n1. unlike regular flu that affects predominately the elderly population, the vast majority of h1n1s have occurred in people between the ages of 18 to 64. even more tragically, the cdc estimates that 540 of these deaths have occurred in children and these numbers are significantly higher than earlier estimates and as we move further into flu season we can only expect to see them increase even more. we now know that this virus and vaccine is unlike flu vaccines that we produced before in that it is extremely difficult to grow. early estimates on vaccine about are based on how vaccines usually behave in the production phase. to anyone involved in this process, h1n1 could be very different and those of manufacturers have been able to speed the growth of the vaccine by selecting the fastest growing strains we are lagging behind where we originally thought we

would be with our production numbers. fortunately this particular vaccine appears to be highly effective in creating an immune response in individuals and for adults one small dose of the vaccine will produce enough of a response to protect from h1n1. but these early delays in production are rearing their ugly head as our country watches the disease spread and take lives while vaccine is still hard to come by. forty-two million doses are available for distribution which is about half what we originally expected to have by this time. it is no wonder that story after story in the papers and on the news highlight the frustration that the american people are facing in trying to get the vaccine that will protect them from the disease. we gear accounts of individuals waiting in lines for hours at clinics, some cannot find clinics in their neighborhood at all and areas are still waiting to receive even their first doses of the vaccine. there's a school district in my home town that has yet to receive the vaccine and

understandably the parents are irritated. this frustration is exacerbated by accounts that seem to have more than enough vaccine in some areas or getting the final production from h1n1 poses more difficulty all. we are getting a lot of disparity. people are confused and angry. that is why myself and the chairman are holding this hearing today. i would like to better understand how the production of vaccine is going and when we will be able to expect enough vaccine so that all individuals who want it can't get it and will this happen before floozies in is over. at like to understand more about the distribution process. the states make their own distribution plants and do the ordering of their states through the cdc but how are these plants created and how do states make the determination? and which distributors to prioritize? we have a number of very important individuals with us today who have been working around the clock on these issues

and i would like to welcome you all. we appreciate your taking time to provide us with this update today. we understand how difficult this process has been. we are not here to beat you up but to get some answers particularly on where we go from here. i would like to -- let me just thank chairman stgupac for helping me put this together. we will go to mr. walden at this point for an opening statement. >> thank you for convening this important hearing. h1n1 has been dominating the news. parent and the general public's concern for the last couple months. i am hopeful this subcommittee hearing can answer questions and discuss solutions and challenges are rising from the first flu pandemic in 40 years. has many of you know i have firsthand experience with h1n1. i think i was the first member of congress to go on record as likely having -- being diagnosed

as likely having h1n1. i have not been vaccinated because like the majority of my fellow members of congress i don't fall into the cdc's priority groups and like millions of other people across the country who had h1n1, i felt rotten for a few days. is not something you want and not something you want to pass on to others but i followed my doctor's advice and the cdc's directions and stayed at home to rest for at least two days after my fever broke which is what i was told to do and luckily i was fortunate and recovered quickly. others have not been so fortunate. last week we learned approximately 4,000 people, 4 -- 440 of them cheese and -- children from h1n1. the fact that it had young children so hard and the rising news reports of rising pediatric deaths have scared the daylights out of parents. you see this played out in a number of parents lining up with small children at public vaccination clinics for hours at a time and flooding their

pediatricians's offices with phone calls trying to hunt down the vaccine. from the folks i hear from in my district they can't find the vaccine. based on statements made by cdc parent encountered being able to vaccinate their children by october or november. originally cdc projected forty million doses would be ready by the end of october. only twenty-three million doses were available. instead parents here report every day on the news about rising pediatric deaths and vaccine shortages and delayed. some wait in line for hours only to be told when they get their there is no vaccine left. today i hope we can get some concrete answers about when the vaccine will be available. i want to hear from the vaccine manufacturers about reasons for the delay and what can be done now and in the future. each age as secretary kathleen sibelius was before the energy and commerce committee on september 15th and testified that by mid october a, quote,

large scale campaign for vaccinations would be underway. she stated repeatedly that there would be, quote, enough vaccine for everyone. secretary kathleen to bilious says the vaccine manufacturers painted an overly rosy picture of their production. is that the case or did the virus not perform as expected? i don't think fingerpointing exercises are particularly helpful at a time we're facing one of the biggest public health issues in recent years and a somewhat panicked public but there have been repercussions no doubt about it. i want to learn about how h h as has assisted state and local health department in preparing for this pandemic. in my district hospitals are implementing their incident command plans because of emergency rooms being hit with waves of patients with flu like symptoms. these patients are coming at a time when doctors pleaded no nurses and hospital staff are homesick with the flu or taking care of their children that are home from school because of the

flu. we are looking at a situation of increased patient volume and decrease staff capacity. hospital administrators are monitoring staff levels and patient volumes on an hourly basis so if they reach a tipping point of hospitals can cancel elective surgery is to ensure adequate staffing to care for patients in the emergency room and those admitted to the hospital. when i called the hospitals in my district, each one of them ask where is the vaccine that we were told was coming? let's get the facts on the table about the reasons for the delay and one h h s knew about it. if there were production issues how can they be corrected and if there are communication issues between the manufacturers and the public, how they can be fixed so parents are not unnecessarily confused. when the administration promised enough vaccine for everyone, people want to know it is coming. i am interested to hear from dr. lurie and dr. shcuchuchat about

what direction it has been given to hospitals to prevent this confusion in the future. this is the first pandemic in 40 years and the first since congress began providing funding starting in 2006 for pandemic prepared as. we were deeply concerned about the possibility of a pay -- pandemic spreading a bird flu that could be 40% in mortality. unfortunately, this one is not as deadly. congress has appropriated $13 billion for this effort. we need so we can figure out what works, what didn't, and what we should do going forward. so i particularly interested in the technologies for vaccine production, whether we can do better in the future. i understand that one of the manufacturers, met him yet has been able to meet its delivery schedule in part due to the different kind of technology that company uses to make the lives and tenuate of vaccine.

even though it grows the virus in chicken eggs, which is uncertain and unpredictable and yielding a sufficient supply they have achieved that result. i know that as part of its pandemic preparedness planning hhs has awarded contracts to companies to look into the cell-based production as well as other ways to deal production times. i'd like to know about the status of these efforts and whether we are doing enough to ensure that we are repaired for a pandemic influenza. welcome to witnesses and the for discussing important public health issues with them. thank you for her testimony. thank you for the hearing, mr. chairman. >> german stupak. >> thank you for working with me and our staff to do this joint hearing today and i think we have good hearing wind up. we're not here to point fingers but i matter we can do things that are in the. today we continue our city's oversight of 2009 pandemic h1n1 flu by examining more closely the production and distribution

of h1n1 vaccine. this'll be the third hearing of the energy congress committee held this year on the h1n1 influenza. according to the center for these disease control and center as of november 13, 2009, influenza activity was widespread in 46 states, all so which is likely h1n1 influenza. there've been 22 million infections, 9000 under hospitalization, 3900 doubts from the h1n1 by risk, 540 of which have been pediatric deaths. as a conservative figure because not every child to die from flu related causes has been diagnosed with the flu. to date, there've been more pediatric deaths from the h1n1 then usually occurs in the entire annual flu season. and september, secretary sibelius went before the committee indicating that by mid-october the u.s. department of health and human services would be up and running with vaccines. in fact, the cdp said the doses

of h1n1. they had not arrived back cover 22nd. news reports have indicated that because of shortages of vaccines, doctors were dealing with worry and panic parents who wish to have their children vaccinated well stated local health care departments are experienced in long lines after producing for parents, children, and pregnant women. jpmorgan and goldman sachs have been receiving the vaccine's report individuals in high-risk categories. and let's not forget about the report cited military officials with terror suspects being held at guantánamo bay would receive the vaccine before most americans. like many districts around the world, my own district in northern michigan has been affected by the h1n1 and a variety of ways. since the outbreak began, michigan has had over 500 schools have done because 25% or

more of their student bodies are absent with flu-like symptoms you since september 1, 1226 people have been hospitalized in michigan with flu-like symptoms. 35% increase over last week when 801 cases were reported. the oversight investigation subcommittee along with the health subcommittee have a responsibility not to merely lie on media accounts, they get to the bottom of the situation. while we are not here to point fingers at who is to blame for the delay in production and distribution of vaccine, we do need to shed some light on the process between the government and the manufacturers. given the urgency of the circumstances and the need for expeditious action, cooperation between manufacturers and federal agencies is imperative to ensure that our country is prepared to respond to h1n1 and future pandemics. when the h1n1 virus initially broke out, we knew very little including how americans would react to the vaccine and if we

would need more than one dose per individual. a vaccine didn't even exist. we did not know how different h1n1 vaccines were from the vaccinations for the seasonal flu. in addition to discussing the specifics of h1n1 vaccine production and distribution, i hope we can shed some light today on our vaccine process. it is my understanding the manufacturing process for the h1n1 vaccine relies on obsolete influenza vaccine technology that are subject to use inherent uncertainties and delays such as incubation periods. as a result, we'll continue to face similar challenges responding to future influenza outbreaks, both outbreaks of strings such as the 2009 h1n1 strain and a pandemic or seasonal influenza we face every year. many experts including the cdc director tom friedman have said that support to the two den college is such a cell-based vaccine production. we would hear from for the five

manufacturers that the u.s. government has contracted with to produce and distribute h1n1 vaccines. these manufacturers will give us an in-depth knowledge of production challenges that they've raised and share their thoughts on how we can improve this process as we move forward. smithkline was not invited to testify as their vaccination was just recently approved by the fda. joining the manufacturers is that there david lakey, commissioner of the state health services who would be the voice of the state health departments across the country. and dr. jeffrey levi executive director of trust for america's health, nonpartisan organization dedicated to make disease prevention and national priority. i look forward to hearing from all of our witnesses today and delving deeper into the challenges that both the government and. thank you mr. chairman. i yield back. >> think you german stupak. gentleman from kentucky,

mr. whitfield. >> thank you mr. chairman. i expect that they will has received many phone calls from the district, as i have come in complaining the shortage and wanting some answers and expressing their fear for their children and their families. as you said, we've had about three hearings on the subject matter, but today i really want to focus on my perspective on really the relationship in the interaction between the federal government, the state government, and the manufacturers in the distribution process. number two, why have there been production delays, specifically why wax and why has it been difficult and growing the virus? is it because of technology, visit process, is it something else? and then third of all, i would like to touch on how does the u.s. compared in getting this

vaccine now with other countries? and how do our problems compared to those problems? and without i yield yield back the rest of my time. >> thank you. full committee chairman, mr. waxman. >> thank you very much i want to thank you and chairman stupak for holding this joint subcommittee hearing on the h1n1 virus and how we are responding to it. the reports on h1n1 are sobering. as of last week, 46 states are now battling the disease, cdc estimates that perhaps 22 million people have been infected with h1n1 and as many as 98,000 have been hospitalized and about 4000 have died, including 540 children. this is a harsh reminder that we don't need a bioterror attack or other man-made disaster to threaten our health and make us worry for our children.

in several ways, we have been well prepared. the federal and state governments have been very ready for a pandemic for several years. our surveillance work and were able to catch the h1n1 relatively early in its spread. federal and state governments have developed an exercise pandemic plans, public education has been commendable. there are five safe and effective fda approved h1n1 flu vaccines now available and fda has the authority for emergency use authorization to allow for unapproved pharmacy drugs and other products to be used to prevent and treat h1n1 flu. fda has used this authority to make antiviral diagnostics and personal protective gear available in the fight against this flu. but there are clear gaps in our preparedness. we had widespread disease before. we had vaccine. and vaccine supplies have been

more limited than we had hoped. at the same time, hospitals and other health care providers have been stretched to capacity. we know that the best way to protect ourselves in the flu h1n1 or seasonal flu is to get vaccinated. because of this, the obama administration contracted to purchase 195 million doses of h1n1 vaccines. they also picked up the full cost of the states for purchasing the vaccine. the hope was that a robust vaccine supply would arrive before inspections began to soar and everyone is working as quickly as possible to meet that goal. these hopes were not match. the past several weeks have reminded us that the process of making flu vaccines is unpredictable and challenging. williams of chicken eggs have to be injected with virus in the virus has to grow. unfortunately, this virus grew much more slowly than anticipated and the slide has

caused most of the delay in producing delivery needed vaccine supplies. as understandable frustrations in the face of a growing number of infections and long lines of vaccination clinics, parents understandably are concerned about hitting their children immunized as quickly as possible. i want to make sure that everyone meets the vaccine has access to it. at the same time, there've been unprecedented levels of collaboration among federal agencies. the vaccine manufacturers, and the states. according to experts, the manufacturers ability to produce the vaccine within six months after identifying the virus is impressive. these efforts, while significant, are not enough. for those people who are still seeking immunization. i look for it to today's testimony so we can understand where we are in the epidemic and the vaccination effort. we also need to learn how the

process can be improved. both of the short term so that people can be protected from this disease as quickly as possible. and in the long term, so that when we face the next flu pandemic we can be even better prepared than we have been this year. i think the witnesses for appearing today. i look forward to their testimony. i yield back my time. >> thank you chairman waxman. next we have the gentleman from illinois, mr. shimkus. >> i do want to mention our sincere prayers for those weblogs family and loved ones during this illness. they are throughout the country and i think a lot of districts have been a fact day. information has been good. and as far as there's more people washing their hands, covering their mouths, greg walden mentioned staying at home. i think that is a thing that information has been very, very

helpful. information is also than harmful. in this rushed atmosphere of people lining up for, you know, the injections or the mist sprays. so my concern is we've got to be real about the projection of information to the public. because the public will respond appropriately. i think the road of expectations has really caused this dilemma that we are in. the other thing that i think we should focus on it, this is something that we've had a year, in essence, to prepare for her. what if in our first pandemic after september 11th, there is something that we cannot prepare for, we do know not what his head, and how do we ramp up, get information out, and then respond. i think that is as critical of a question in the homeland security terrorist debate as

responding to something we can prepare for. so there's a lot of things we can learn from in the hearing today. and i appreciate the first panel and the follow-up panel. i think will be very attentive to your testimony and i think there'll be a lot of good questions for members. i yield back my time, mr. chairman. >> thank you mr. simcoeshimkus. >> mr. chairman, i thank you and i want to commend you and chairman stupak for holding this hearing which is very important. this initial outbreak of march of the h1n1 influenza in mexico. the federal government state and local health department health providers, vaccine manufacturers, and many others have been working overtime to produce and distribute the h1n1 vaccines and educate the public on precautions that can be taken

to prevent the spread of influenza. since april 42, people in michigan have died since contracting any strain of influenza. more than 1200 have been hospitalized and over 584,000 have reported flu-like symptoms. across 48 states, there've been 3900 deaths from h1n1 virus. 9800 hospitalizations and 22 million infections. the high number of deaths from h1n1, in particular, the high number of pediatric deaths has increased the demand for the vaccine. a demand that is unlikely to see that anytime soon. this vaccine first became available in the beginning of october, and as of november 5, approximately 35 million doses have become available. this is well below the cdc

production of 40 million doses by the end of october. there is no doubt that manufacturing the vaccine in short order is a difficult task. and this country has had difficulty with flu vaccines before. this task requires scientists to identify the virus directly, determine the appropriate most effective method for a vaccine, and then manufacture millions of vaccines to be distributed, all with the pressure of completing the task quickly and most importantly safely. i know that there are many and for seeing roadblocks for manufacturers, whether it even the difficulty in producing vaccines in an egg-based system, the shortage of appropriate egg supply, equipment and equipment failures amongst other things else. and while this shortfall is a disappointment, i think we better serve the american people when we focus on reducing a safe and effective vaccines and

having it made available in a safe and efficient manner. history has taught us, speed over safety is shortsighted when it comes to flu out rakes. in february 1996, 1976, 2 recruits at fort dix fell sick from the h1n1 flu strain. congress responded quickly. that national influenza program was produced and one week later signed into law by president ford. we were forced to deal with the cost of the consequences of our actions, which ultimately led to great public mistrust of immunization, as a program was misspelled and lives were lost. it is appropriate to respond to the national threats, but we need to remember to be deliberate and thoughtful and wise in our response. the h1n1 outbreak distribution of the vaccine provides the federal government with an opportunity and responsibility

to closely examine our pandemic response system. for hhs and cdc in particular, this means examining the way in which our governments communicate with the public. for fta this means examining the methods in which the vaccines are approved. for many of my colleagues and for many of those testifying today, my goal is to ensure that safety and health of the public while at the same time looking forward to how we can best prepare for future pandemics and how we can learn from the ongoing events of the day. this will include examining the national strategic stock pile and whether it is adequately supplied, preparing our scientists and manufacturers with the most effective and efficient technology, to create and produce vaccines as well as looking to whether or not the congress has provided adequate funding for hhs, cbc, and fda.

it gives them the resources needed to carry out their missions. today i believe this hearing will be held for answering these questions and others. i look forward very much, mr. chairman, pallone, and chairman stupak for working with you for hearing what our witnesses have to say today as we seek to mitigate the outbreaks of h1n1. thank you mr. chairman. i yield back the balance of my time. >> thank you, chairman. next is the gentleman from texas. >> thank you, mr. chairman. like many others on a sunday afternoon, the football game was interrupted with the notice of a public health emergency about a new kind of flu. we had a conference call later that day for members of congress. i don't know how many were actually on the call, but i remember thinking at that time our greatest danger to your is

not anticipating how aggressive this virus could be if we were faced with a influenza for which most of us do not have approved existing immunity. that is sort of where we are today. fortunately the story is not as bad as it could've been in many last year that it might be. but nonetheless, if it points up with some of the difficulty that has been, mr. chairman, i will say i'm grateful to have three hearings. it seems to me when we were preparing for a possible avian flu pandemic in 2004, 2005, and 2006 we have many more hearings were just the preparation for that possible pandemic than we had after we find ourselves in the throes of this illness. now, we do have to ask ourselves how could we have ms. anticipated the ability to produce vaccines? we saw this coming, we knew it was coming, we had reports over the southern hemisphere that it

wasn't as bad as we could have been, but yet there were some vulnerable populations which would need perhaps aggressive use of vaccination protocol. and we find ourselves in our district without being able to provide even the vaccinations for those high risk individuals. in fairness, i do want to say that i've had good cooperation from the cdc, department of homeland security, department of health and human services came to my district in office and had a roundtable with school districts in my area so that they could be better prepared. they took a lot of the last april and may for closing a school district early, but they were frightened of what might happened if not anticipating the severity of the illness. and then just finally, i personal note, i want to thank dr. lakey for being here from the department of health. he has been good enough to do conference calls with members of the texas delegation as we work

our way through the difficulties of the distributional issues of getting the vaccine where it's needed and will also think dr. hamburg who was kind enough to take my call after the news reports said that texas was getting expired panama flu to protect its citizens. and this is one of the problems that we had in 2005. read a lot of antiviral as the illness doesn't materialize and how long is the shelf life. and indeed, there were tests done to ensure that shelflife was longer than what was stamped on the box. it was a public relations aspect that we didn't correct that. i thank them for helping me through that public-relations crisis. thank you mr. chairman. i yield back the remainder of my time. >> thank you mr. burgess. gentleman from california. >> thank you mr. chairman for holding this joint hearing on h1n1 preparedness production and

distribution. i appreciate the witnesses being here today and i look forward to their testimony. as we've heard from our constituents, or experience in our own families, h1n1 pandemic has proven to be widespread and really highly contagious. since the vaccine was slated for distribution in october and mid-october i along with i'm sure probably all of my colleagues have received countless calls from constituents asking when they can get the vaccine. lines of patients have been out the door and around the block and the news has been filled with stories of empty clinics and angry parents. while i don't think there is one source to point to relative to production in the distribution problems, i'm interested in looking at the systemic reason for the somewhat antiquated vaccine products we have today.

for more than half a century, the united states has been using a base technology to create vaccine. while it is safe and effective, it's a slow-moving process. across europe, vaccine developers are using the faster process of incorporating the million sales to grow the vaccine. as we begin to explore cell-based technology, i would pose the question will there be an adequate fda approval for this new vaccine? i'm also interested in hearing in the vaccine manufacturers from how they ramped up reduction in some cases to ten times their normal production schedule. we know that production of a delayed for h1n1, a harmful but relatively moderate virus compared to something more lethal like the spanish flu. but in the case of a stronger virus, the higher fatality rate, what our country be able to produce enough vaccine for everyone in a short time.

here it so i look forward to questioning the witnesses, welcome them again, learning more about how we can improve vaccine reduction in our country and again thank the chairman for this joint an important hearing. i yield back. >> thank you ms. eshoo. gentleman from pennsylvania, mr. murky. >> thank you mr. chairman. as we look at how we are handing this crisis in our government, i reflect back on a few years ago when we are faced with a sudden unanticipated problem of hurricane katrina, which led to an unfortunate between 131800 lives lost in the flood itself. it also resulted in a flood of members of congress repeatedly in bitterly attacking the administration and anyone else in town because the government mismanagement of the whole

issue. now, of course, it begs the question, would we blame this time for where we are, or should we stop the game and simply get down to the business of understanding we want to painfully candid and brutally honest assessment. do we have any weaknesses and what do we want to do about it? i hope it is this case instead that we use this hearing as a non-fraternity to be honest with each other. we are all deeply concerned with the thousands who have lost lives, the thousands been hospitalized, and quite frankly the millions who were buried they might be affected by this latest by resetting our nation. we recognize the incredible scientific achievement and quite frankly like to compliment the manufacturers for working so hard and try to develop the vaccinations and this is done for sending out these things to help us deal with this virus. we still have a long way to go

and we are having this hearing today because we are concerned. something is not going right, whether the goals were set too high, too unrealistic, were done somehow to say the worry of the public that we were not ready to do. or can we really meet those goals? i'm looking forward to hearing from all the witnesses today. have a very talented panel. i'm excited to hear what you have to say, but more than anything else that seizes opportunity to be honest, not political, and really work for some foolish is. i yield back my time. >> thank you gentleman from texas. >> thank you, mr. chairman. thank you for holding this hearing today for h1n1 production and distribution. texas allocated its order, but has not been filled because of supply the vaccines. i worry that states like texas, which is the second-largest state, whether receiving their fair share of vaccinations. we are a border state and that

comes great deal or borders along with strict transmission. i welcome dr. lakey who is testifying on our second panel today. he assured me that texas is receiving its fair share of vaccine to the state is continuing to order the maximum amount. the issue is whether the issues that production. our colleague represented gender murphy left on immunized against influenza act. the bill would allow hhs to perform a voluntary multistate demonstration. influenza vaccination centers inclination was school nurses. local health departments, community health care providers. @@@ úrbrbá

and how we can fix it and i hope you will learn from the mistakes and hopefully make it much better. i yield back my time. >> thank you, gentleman from missouri mr. blunt. >> thank you mr. chairman and day care, chairman stupak, for holy this hearing. this is an important topic obviously and one we ought to be concerned about. i have been concerned about both

the vaccine distribution process and frankly the misleading overestimates of vexing availability. i believe mr. waxman is the chairman of the full committee said in his statement that the administration's hopes were not met. well, it's apparently hope does not get the job done here. in addition to their hopes not being met i think it's outrageous that suspected terrorists at guantanamo bay and wall street people who work on wall street were apparently slated for access to the vaccine and head of the people that held congressional silver in danger. since october 43 million vaccines have been made available but that falls far short of the 159 million people considered to be at high risk because of these complications. it also falls short of the government's original projection that 120 million vaccines would be available by mid october. in fact, just last week the

government was still estimating that 8 million vaccines were going to be shipped when only 5 million were released. i don't know how we can be this far in the process and still be 40% off in our when we guesstimates so i'll be interested to hear the answers to those questions in missouri alone. there have been 60 school closings this year since the beginning of you're last year during the same time there were none. since october the fourth approximately 21,700 people in missouri have possible cases of h1n1 flu. during the first six months of last year's flu season there were 28 cases of all kinds of flu. and sadly last week in misery the eighth person died from complications with h1n1. i want to know in a peaceable i want to work for -- and the people i work for where this problem met its failure to

understand the problem, to recognize the problem, to move forward with the problem, and with vaccine delivery how long ago did we know that the vaccines are not going to be available and what we could have done about it and mr. chairman i expect some of the questions to be answered and am grateful to you for holding this hearing. >> thank you, mr. blount. the gentleman from pennsylvania, mr. doyle. >> thank you mr. chairman and i want to thank you for pulling this hearing on the issue of h1n1 prepared this at such a relevant time. as the centers for disease control as recently reported that h1n1 the strain has now claimed over 4,000 lives since april of this year, of those over 500 were children. i'm very sad to report that just this past week in newborn baby died at children's hospital of

pittsburgh located in my district of suspected h1n1 flu. it confirmed as being h1n1 death, this will be the first reported infant death. in the state of pennsylvania alone 9600 cases have been reported, nearly 200 of them in my congressional district. this is, indeed, a very serious problem. this pandemic is different than what we're used to dealing with, the targets unlikely an unusual population, the strain also affecting younger people with more than 70 percent of the reported cases in pennsylvania and calling people and of the age of 25. antiviral are playing an increasingly poor role infighting this epidemic and unhappy that the fda has recognized this by emergency use authorization for intravenous administration of these potentially life-saving drugs. i do have serious concerns about the reports of the difficulty doctors have had in obtaining enough vaccines for their

patience and am anxious to hear our witnesses testified to this. this year's distribution plan for the vaccine was unprecedented and am extremely interested in the opinions of our panel of its effectiveness. i think that this hearing will serve as an important venue to hear from all sides of this issue and help us all work together so that in the future we know what works and we know what must be improved upon. i look forward to hearing from witnesses and i want to thank you all for your testimony today and again i want to thank the committee for holding this important briefing and i yield back. >> thank you. the gentlewoman from tennessee, mr. blackburn. >> thank you mr. chairman and i want to say thank-you to each of you for taking your time to prepare in, be in front of us. we do appreciate it and i join other members on this panel in extending our sympathies to those who have lost life, who haven't found a serious

complication to their health through this process. i bring a perspective as being a grandmother and also a good friend in to lots of schoolteachers that have kept me informed of what is happening on this. i have as a greenbaum, a daughter who has an 18 month old in a five month old. and i know them on a blogs have been filled with the frustration of young mothers trying to get to this vaccine. in has been like playing where is moldova. trying to find who has it. we have done a disservice to induce young mothers because you all knew this was coming, appropriate preparations were not made in, and these are some of the questions we're going to get to today. i want to talk with you about the delay is and what you think has caused those. the communications processes,

were the breakdowns have been between utah and hhs, because we have different messages coming out. that's confusing to the public. i think also the process is place for approval or distribution and then certainly looking at the diagnosis confirmation portion of that and then let's talk about lessons learned and how we move forward. doctor, i had pulled a writer's article, a comment she made in hear you say i think the key barrier to immunization effort is really the fragility of the public health infrastructure. add love to explore that, with you. thank you all, thank you mr. chairman, i yield back. >> thank you. gentlewoman from california, ms. hartmann. >> think he mr. chairman. so far there have been 3900 deaths in the u.s. from the h1n1 flu with 266 deaths in

california. in this compares favorably, it is less than annual deaths that are expected from the seasonal flu. i suppose that's good news but i agree with chairman waxman that this is our rehearsal for a major terror attack from some sort of trial -- biological weapon and i think our grades are very mixed in terms of preparing the public. i think we have done very well and i commend the panel and i commend others in our federal government for making the case calmly and providing lots of details for what the public is supposed to do. i give that in a. in terms of preparing the taxing we've had a lot of mixed results and i suppose that could be a b -- but in terms of distributing the vaccine i would give us a d --. and a lot of that is a lack of preparation to states and localities for exactly what they

should do with scarce resources. i was personally scared because i have a pregnant daughter-in-law who had to spend weeks in york city finding a doctor who had in the vaccine. she did get vaccinated but in my district the beach city health district, one of the first providers able to offer the vaccine, had a drive in events recently. people drove more than 100 miles from as far as santa barbara and san diego turning what was supposed to be a local event into a regional scramble, the line of cars leading back for miles, police deployed to manage the crowds and all this mayhem was just for 3,000 doses of vaccine. it was a disaster and out other areas are not doing the same thing as my time -- as my time expires the distribution piece was a familiar and i hope our witnesses have learned from this and we will move forward much more effectively. thank you mr. chairman. >> thank you, ms. harman.

the gentleman from georgia, mr. gingrey. >> thank you mr. chairman, today the subcommittee on health investigation will have an important opportunity shed light on our government at work and what is a matter of life and death and hopefully we will be able to gain a few answers to the many questions our constituents have asked us about h1n1 prepared is in the obama administration's response. mr. chairman, from fiscal year 04209 this congress appropriated $07 billion for pandemic the preparation and congress provided additional 6.4 billion in the fy09 supplemental bring in the toll since fiscal year 04 for pandemic food preparation to almost $13.4 billion. without question the promotion of a public health and a starting lives of americans is an important national priority. but we also have a solemn duty to surly scrutinize every time we break because every single

dime is one more ious with on the backs of our children and grandchildren like we for decades to come. both the american people the schoolhouse and fiscal health have to be pryor is for this congress. mr. chairman, i made this point because i have been since about this government's response to h1n1 and i believe that it may be a microcosm of what's in store for health care legislation in the house passes becomes law. with this government prior rising ksm to receive this one have enough for guantanamo bay but not enough for grandma k, we have a problem. is this what the american people expected, with the american people deserve? and the same time this congress continues to put to them and their children further and further into debt. mr. chairman, i think not -- i hope today will be able to pull back the curtain that the american people so they can see how the government attempts to manage their health and their

collective pocket books. and i yield back. >> thank-you, gentleman from arkansas, mr. ross. >> thank you mr. chairman, i'd like to thank the chairman and ranking member for having the energy and commerce committee called today's hearing on h1n1 purvis. over the course of this year we have seen the strain of influenza spread to a global proportions. later declaration of national emergency. according to the cdc as of november 13th, 2009 influenza activity was widespread and 48 states, almost all of which is likely h1n1 flu. for the law if there have been a 9800 hospitalizations, 22 million infections and 3900 deaths from the h1n1 virus. 540 of which have been confirmed pediatric deaths. both public and private sectors have attempted to work together in expend effort to ensure adequate vaccine production and

delivery to patients. unfortunately such efforts have fallen short and we've seen major delays in access to this much new vaccine. as a result we have thousands of individuals including those in high-risk categories. still, waiting for the vaccine as we find this pandemic. i'm also deeply concerned about the impact of a h1n1 on our children and our schools. during seasonal flu outbreaks 95 percent of deaths are usually among those older than 65 before the swine flu 94% of the deaths are occurring in those young insisted five untypically among those for younger than that. my concern is ever appear to want to get the job vaccinated should have the opportunity to do so. the delays in getting the vaccine to the american people must be addressed and fix now. clearly there are problems in the current process in place that could have been prevented. the public deserves answers as to why there such a shortage in

supply of the vaccine when h1n1 has opposed such a serious health risk for months. i look for to hearing answers to this and other related questions and with add mr. chairman i yield back. >> thank you. gentleman from pennsylvania, mr. pitts. >> thank you mr. chairman, and thank you chairman -- chairman stupak for chondroitin this hearing. i'm sure all of us have received phone calls in e-mail's from ages parents wondering if they will be able to obtain the h1n1 vaccine for their children. i am sure that we have all been stopped by a constituent back, wondering when the vaccine will be available in their area worried that there's a shortage. today we will hear from the government departments and agencies tasked with responding to the h1n1 pandemic and from the manufacturers of the vaccine itself. to determine how much vaccine has been produced and how much more is on the way and how is being distributed in allocated.

i anticipate we will hear suggestions for how production and distribution could occur more smoothly in the future. on our second panel i would like to specifically welcome friel hoss back, associate as president of immunization policy and government relations, head of the santa fe global influenza pandemic crisis team. the u.s. headquarters for santa fe in my home state of pennsylvania. the side is also the only domestic manufacturing site of injectable bluegrass scene and the employees there have been working around the clock to provide seasonal and h1n1 influenza vaccines. i will also like to welcome paul, president of csi of syracuse, which has its headquarters in king of prussia pennsylvania house of my district. mr. chairman, again i think to an accord to hearing the testimony of our witnesses and i yield back my time. >> thank you.

the gentlewoman from wisconsin, miss baldwin. >> thank you mr. chairman for holding this very important hearing. i want to highlight three issues that i hope our witnesses will address according to their expertise to during our hearing this morning. clearly a thorough response to any public health emergencies such as a flu epidemic requires the permission between local, state and federal public health agencies and labs and unconcerned about resource shortages at the state and local level particularly with regard to personnel in modern information technology and communications. i have a bill on that matter and would like to hear your insights on how those resource shortages have affected our response to this h1n1 flu. secondly i would like an update on the state of renovations and improvements that many of my colleagues have referenced that help us do a better job next

time. manufacturing, technology is, the use of adjutants, and alternatives methods of vaccine delivery beyond the injection or nasal sprays. lastly and i think most importantly to me, i would like the witnesses comments on our lack of domestic manufacturing of h1n1 and seasonal flu vaccine. this is of great concern to me and i asked of our secretary of health and human services when she last was before the committee, it appears we have five contracts with five manufacturers for h1n1 vaccine, only one does men fighting in the u.s. and the state of pennsylvania. i think that every to ever face a much greater who flew that prevents -- presents a greater virulence it would be a question mark whether we would be able to get supplies of vaccine

production sites and other countries. any country that hosts vaccine manufacturers would want to assure that their own population was protected first before permitting the export and so i'm very concerned about the lack of it domestic manufacturing and presence in and buy your comments on that. i yield back. >> thank you. the gentleman from oklahoma, mr. sullivan. >> thank you mr. chairman. thank you for holding this joint hearing on the national h1n1 at swine flu preparations especially on the current status of the vaccine production and distribution. i'm interested today in examining the lessons learned from both the administration and vaccine manufacturers in terms of responding to the national public health emergency. to date manufacturers have delivered 48,000,000-point -- 40.5 million doses of age one and one maxine and the department of health and human services has hoped to have as

many as 120 million doses by now. obviously there is a large gap between the administration promises and what they're able to coordinate and deliver. i'm concerned that the administration's plan was overly optimistic and that this has led to confusion with the american public. since september 1, 890 oklahomans have been hospitalized due to complications from influenza and 27 persons have died. 90 percent of the h1n1 related deaths have been persons less than 65 years old. health officials in my state announced yesterday that all oklahomans who want to reduce their risk of h1n1 infection eligible to receive a h1n1 influenza vaccine. while vaccine supplies are limited, demand from party groups has dipped to a point for all oklahomans can begin to receive vaccines. h1n1 influenza activity has been widespread in oklahoma since early september and even

throughout the statewide monitoring as recently shown a decline in influence-peddling two hospitalizations, this virus is expected to circulate throughout the winter months. the possibility exists that another surge of it h1n1 flew the of the current line and we need to be prepared for this contingency. i look forward to hearing the testimony of our witnesses today and examine how we can continue to respond to this public health emergency. i yield back the balance of my time. >> thank you, the gentleman from florida, ms. castor. >> thank you, chairman, and good morning to our witnesses. the cdc and secretary sibelius and all of you have done exceptionally well in your public health outreach. you have kept americans informed about the risk in basic prevention methods to combat the spread of the virus such as hand washing and the use of alcohol base sanitizers and i appreciate secretary sibelius' visit to

florida last week. she visited the east manatee family health care central and printing, florida and we met personally with representatives from the health department community health centers and other providers to add the area to review local distribution of the vaccine particularly to people in high-risk categories like pregnant women and young children and others with asthma and diabetes. my greatest concern right now it is the spread of misinformation. especially on the internet. just over the past weekend i was talking with a doctor who i know who is also -- you were said tampa general hospital, is married to an ob/gyn, and they were explain to me that they're running into the problem of pregnant women and other high-risk categories that have read something on the internet two that has discouraged them from receiving the vaccine. after talking with them i went on-line to see what is out

there. they're right, there's a lot of misinformation on the internet two. one website called it a complete load of nonsense that mainstream media and american public health officials state that the benefits of a h1n1 vaccine for of with the risks, they're frightening bring the women who are at high risk to think that they might miss kerry of fear vaccinated. in this website reports it is responsible for death, paralysis, seizures and other ailments so we have got our work cut out for us. but it doesn't stop there except a major cable network did a segment with a so-called infectious disease expert advising parents not to vaccinate their children and a clear that he would not tax and his own children climbing the vaccine and others are not safe. and the cause more serious devastating conditions. in your testimony will you please address how we can effectively combat the spread of

misinformation and continues to empower communities with accurate information and continue to encourage those especially in high-risk categories to receive a the vaccination. thank you, i yield back. >> thank you. the gentlewoman from illinois. >> thank you, chairman colonna and the chairman stupak, i wanted to put on the record and effective manner in which i stated illinois is handling the h1n1 flu vaccine and administration. the illinois department of public health has a h1n1 specific website that contains a wealth of information about vaccine availability, prevention information. the city of chicago said the six clinics to administer h1n1 vaccines and city colleges. chicago vaccinated to 1,000 people in that seven days

following the opening of the free clinics. there are a number of issues surrounding the infection death rates in illinois that exhibition explanation. maybe you have these answers. why is the highest number of h1n1 deaths among adults age 25 to 29? these numbers to file all the things that we previously knew about who viruses. do we have the correct distribution system as giving the vaccine to banks and companies like goldman sachs and nbc, the best way to distribute the vaccine? our current lack of research data, it limits our ability to draw a concrete conclusions and if we're unable to draw conclusions and there's no way we could construct an adequate or a ragged response plan which only increases are rest so i hope to hear about the public health plans and research effort is underway to help us better understand the disease and innovation prevention and treatment methods that are

emerging. i think of illnesses for being here today to help shed more light on the situation particularly as we're learning new information every day and i look forward to your testimony. i yield back. >> thank you. gentleman from utah, mr. matheson and. >> want to thank both chairman stupak and chairman,. we have had our outbreaks of h1n1 in schools and communities and seen over 623 hospitalizations due to the influence of this year as well as 14 deaths. our state has worked with the federal chairman and and overtures to make as many vaccines available to residents and am looking for to hearing how we can better improve our strategy for responding to the public health crisis. to date by state of utah receive 296,000 doses and providers reported having administered or 106,000 doses of vaccine as of november 7. baller states magazine continues

to arrive in the vaccine is in limited supply. i represent the state with the youngest population in the country. so i am continuing to borrow about to make sure our children get access to the vaccine in a timely fashion. i'm also concerned by several reports in the uptick of counterfeit medications. u.s. food and drug administration has issued warnings to consumers to use extreme care in purchasing a product over the internet that plan to divest, prevent, treat or cure the h1n1 flu. the agency issued this warning after the fda recently purchase and analyzed several products represented on-line as tamiflu. the fda notes on its web site that one of the orders which arrived in an unmarked envelope with a postcard from india consisted of unlabeled white tablets take between two pieces of paper. when analyzed by the fda the tablets were found to contain acetaminophen the benefit of the active ingredients. i am worried about -- i'm working on legislation to address the rising tide of the medications that my colleague

mr. boyer counterfeiting lucrative business and i hope my colleagues will try to work with me to address this to come before this committee. thank you mr. chairman, i yield back the balance of my time. >> thank you. the gentleman from ohio, mr. >> thank you mr. chairman. for conducting this important hearing. we have heard today already a couple of allusions to guantanamo bay and i think want to even katrina. i am as concerned as anybody about the specter of a case of getting this vaccine does the work my son and i guess out like your assessment whether that is, in fact, happening. but more and personally i think it is important that we understand what we can do as legislative body at this point

to enhance our ability to manufacture and distribute the vaccine in a better way. obviously we've seen far too many deaths across the country, certainly a high of in my congressional district has been no exception to that and also interested in hearing your opinions concerning other ways that we can come back to this h1n1 medvedev. apart from administrating vaccine. my colleague from florida of reverence to the misinformation campaign that seems to be occurring out there. i'm curious as to the educational component that we can promote and siblings why can't washington -- hand washing and things of our constituents can do to put themselves in a better position and finally your assessment as to those who are most likely to get sick and die

if they contract the virus, what they can do in particular diabetes. i am understand that the abuse have a particular risk tractor. and how we can from their legislative perspective it at this point in time do everything we can to maximize our ability to combat this troubling epidemic. thank you and i yield back my time. >> thank you. the gentlewoman from ohio, ms. sutton. >> thank you mr. chairman and i appreciate you holding this hearing so much has changed since this committee held its first hearing on a h1n1 back in april. at that time the h1n1 flu was just breaking in there were only 91 confirmed cases in the u.s. including a young boy in my district. ..

>> we want them to get it. we've heard the reports of wall street employees having access to the vaccine. and it certainly undercuts the public's confidence in the distribution process. which is important. and it's important that we

correct the record so that people understand what is and isn't happening. but it's also just critically important that we do everything we can do effectively deal with h1n1 from this point forward. and frankly, this won't be the last flu challenge that we have. so that we can formulate the proper way to respond to these kinds of challenges in the future. i yield back. >> thank you. the gentleman from indiana. pass. geewoman from colorado. >> thank you very much, mr. chairman. i want to thank both of our chairman for having this hearing today. i'll submit by statement for the record, because i'm sure every single thing i had in there has been said by other members of the committee. let me just say this, the

oversight investigation committee has had hearing over the years on flu pandemics. the good news about what has happened with this pandemic is our public campaign, our awareness has been terrific. and congresswoman said. we still do not have an alternative to the egg-based vaccine. we were assured at the september 15th hearing that we were ramping up production, we knew h1n1 was coming, and those vaccines would be readily available very, very soon. that obviously has the big problem with our response to this pandemic. it's not so bad because as it turned out, this particular straight, while fay till, and we feel badly about the fatalities that we had is not as virulent as thive yen flu. if this had been avirulent flu

strain, we have millions of casualties already. now my own daughter who is a type one diabetic spent weeks going around to get a vaccine, only to finally get it last week. i have to say, the 13 years that i've been on this committee, we have got to fix this problem. we can't wait until we have the next pandemic that we have an alternative to egg-based vaccine. so again, to both of the chairman, i want to thank you for having this hearing. i want to say at least this member of congress intends to keep pushing even when this is out of the headlines to make sure we find the alternatives. because if we don't, it'll be on our shoulders the next time we have a pandemic. and it's avirulent pandemic that causes millions of deaths. so i intend to do everything that i can to make sure that

will not happen the next time. >> we thank the gentlewoman. next is the gentleman from kentucky, mr. murphy. >> thank you very much, mr. chairman. i appreciate this hearing today. i appreciate it especially as a parent of a current 15-month-old h1n1 patient at home. he's doing fine. but i'm looking forward to the testimony today. for a number of reasons. one i think that this conversation about how our federal government is interacting with the state government is in important. i know you are going to spend some time talking about how you turn your recommendation for distribution systems into best practices. but i'd also like to hear about your interactions with statements regarding preventive measures. we've had a number of long-term school closures in kentucky due

to outbreaks. i think one of the difficult things for local school districts have been an inability to really get the best information regarding how they should approach small or larger-sized outwreaks in school systems, in day care settings, and so i think a lot of us will be interested in hearing about how you are seminating those recommendation down to school districts and other settings in which you have a lot of kids. and second, just to partner and build on the remarks of representative baldwin and degette, i think a lot of us are very interested in the progress for this season, and next season. i know that hhs has already given out some fairly large research grants to companies, one actually located in my district, protein sciences to start building some nonegg-based

processes that have, i think, some real potential. and i'm interested in whether you think any of those processes might come online this season, or whether we're looking into the next outbreak for next season for come of these processes. i think there is a lot of questions. but i think that you've answered many of them so far. i think you've done a great job in getting information out to the public. i think this hearing could help you build on that. and i yield back. >> gentleman from the virgin islands, christiansen. >> i didn't hear you. >> the gentlewoman passes.

oh, her mics not working. i'm sorry. >> thank you. thanks to all of the chairs and ranking members for having this hearing as a physician and former public health administrator, you can imagine the issue is of great concern. as someone who has managed emergencies in the past, i know how important communication, and controlling panic, and the spread of the disease in this case. since the spring when we were first made aware of the h1n1 widespread in 48 states and two territories. as of the last report that 80 cases in the virgin islands. i'm sure there are more now. and 444 cases of 34 deaths in the puerto rico. i'm very concerned that half of the children that died from h1n1 between april and august for

african-american and hispanics children which is considerably more than the representative of the population. i'd like to hear something of what is being done to outreach to those communities, as i have asked before. i want to say that several years ago, i introduced a rapid cures act. which would increase research to shorten the time for both of the drug and vaccines. i didn't introduce it in this congress. i was assured the research was being done. i thought we'd be further along. the shortage shows that we are probably not. i'm hoping that the limitations that we face in providing adequate vaccines will field valuable lessons going forward. and i look forward to the testimony of our witnesses. >> thank you. >> thank you, mr. chairman. mr. chairman, i want to thank the members of the panel both for their work, and for being here today. i represent the community around st. francis, which represents

the closest thing to the american ground zero for this virus. frankly we have -- this is the problem that we're trying to deal with the complicated health thing. a lot of people who look at the own experience. we have swung wildly from pole to pole for the enormous problem that's going to smite us all, to this is not a big deal. we have the very same people who with have been get government out of our health care are now saying how much how come government isn't doing a better job with our health care? i hope you had a strong and stern talking to the viruses that refused to grow fast enough. i hope that the ones that haven't been performed have been dismissed. they are growing in chicken eggs. when we ask this. but the bottom line to all of this is to some degree, we've

all participated in a small way to dealing with the notion. even the vice president of the united states, i think probably regrets saying he would recommend his family members not to get on the subway in new york city. where you can't catch things. but i'm not sure swine flu is going to be at the top of your list. the point is that we to some degree in government, we exaggerate our ability sometimes to be able to be a against mother nature and the laws of medicine, and some degree chemistry, and physics and the like. i think that you should be commended for trying to keep a level conversation tone, even in the face of many different cross currents. we should try to learn each time we have one of these instances what we can do better. i think to some degree, a lot of what you've done now is based on lessons that have been learned. but i think that it's also important that we as the legislative branch empower y'all to do the job that you can.

and then do our best to give you the elbow room to make smart medical decisions in environment that the hyper tense, hyper sensitive, and often polluted with a lot of misinformation. i appreciate you being here to help us do that. >> thank you. the gentleman from georgia. >> i thank the chairman. and thanks to the witnesses to the participation that worked. for the testimony, i'll wave in opening. >> gentleman from iowa. >> thank you, mr. chairman. it has been a long time since the word smite has been uttered in this hearing room. and unlike my youthful college from connecticut, my three children are in another high-risk category, college students. but i'm concerned about the delay in productions of vaccine and the shortage of both the h1n1 and the season flu vaccine and the process of vaccine

distribution. there has been severe shortages in my state of iowa, which is the number one egg production of area. i'd like to speak out for all eggs. in my state, thousands of iowans were out access, and left them vulnerable to the virus. as of last friday, they had confirmed 19 h1n1 victims. they include my district, and more than 500 iowans have been hospitalized. that's why you can imagine how outraged i was to learn a couple of weeks ago that some of the biggest company in new york, my apologies, including goldman sachs, jpmorgan chase were receiving large doses for the

employee. i don't think that big wall street firms be given priority, while thousands of iowans are going without it. i sent a letter on november 5th expressing my experience concerns about distribution process and urging her to ensure that the vaccine is distributed based on risk and need, not based on wealth, or profession, or zip code. i haven't received a response. so i hope that you folks today can shed some light on this process, what additional corrective measures, if any, having taken. and explain to me and my constituents why the companies were receiving the vaccine when so many of my constituents were forced to go out, i'm talking about seniors, compromised individuals, and children. i look forward to the testimony, and learning why the iowans that i represent who'd like to receive the vaccines, and would like to receive them soon, will receive access and what is being

done to promote expansion of the availability of the virus. thank you. >> gentleman from maryland. >> thank you, mr. chairman. i'll be very brief. we're looking forward to your testimony. i'll be curious to hear you describe where things have done compared to where you thought they would be. the last time we had a hearing, at the beginning of the process, you made or talked about certain contingencies and i'm interested to know how the advance of the disease has panned out against the original projections. it helps us make judgments of -- as you project further. and that would be both with

respect to the advance of the disease and with respect to the way we are responding to it. and i just want to echo what congressman bradley just said. if there are going to be delays in the distribution and if what's been manufactured is less than what we hope to have at our disposal at this point in time, it comes even more critical -- i mean it's always critical to the distribution be done in a fair way. but it becomes even more critical that it be done fairly. because the larger context is that there are shortages. and it makes people, i think, much more resentful, and rightly so, when they see an unequal distribution, and one that's not occurring according to the criteria that you've laid out. so i think that's probably a lot of interest in having you address that in your testimony. and i yield back my time.

>> thank you, mr. al much. gentleman from new england. >> thank you very much, mr. chairman. i too will be brief. i'm delighted that we are holding this hearing this morning. i look forward to the witnesses. obviously what's going on with the swine flu is something that americans are asking lots and lots of questions. we're hearing that this is something that is easily spread, and yet we were told several months ago that there would be adequate sac vaccines. and there aren't. i know people have been contacting my office to find out where they can get vaccines. i think what happened here is people's expectations were rising when the government announced that there would be no problem and people would have enough vaccines for use. i think if that had not been

stated or said, perhaps people's expectations wouldn't be so high. but the double whammy of not having enough vaccines plus the announcement that there would be enough for people has made -- have made people think that something is terribly wrong. i've had some discussions with with some of the people testifying today. they have helped to me to understand what's happening. i think we really need to ensure that something like this really never happens again. i know that people in my district have been wondering. my staff director had his two little boys last week both come down with swine flu. people have been calling my office and wanting to know where they can get vaccinated. we've been trying to help them the best we can. people are confused and angry at the same time. i look forward to the testimony to hear what the witnesses have to say. and i thank you, mr. chairman,

for holding this very important hearing. and i yield back. >> thank you. i believe we've concluded the opening statement. so we will now proceed to the witnesses. let me call or introduce the first panel. starting with my left is dr. ann, who is director of the national center for immunization and respiratory diseases at the center for disease control and prevention. and then we have dr. nicole who is a assistant secretary for preparedness and response for the department of human services. and finally, dr. jesse goodeman who is chief scientist and a public health for the food and drug administration. now in accordance with the policy and the oversight investigation. i have not done this before. because of the policy of the

oversight investigation, all testimony at today's hearing will be taken under oath. and i am to advice you that you have the right under the rules of the house to be adviced by council during your testimony. and i have ask tow initially if you wish to be represented by council. and if so, you would have to state the counsel's name, doctor? >> no, thank you. >> dr. lorie? >> in. >> you said no? and dr. goodeman, no. okay. so then we're going to stand. each of you should stand. we're going to take an oath. you're going to take an oath, i should say. you raise your right hand to take the oath. you swear or affair that the testimony you are about to give is the truth, the whole truth, and nothing but the truth. let the record reflect that the witnesses applied in the affirmative. you are now underoath. thank you.

and we'll start with the opening, five-minute opening statement. i think y'all know that you can submit a longer statement in the record. but we'd like you to try to stick in the five. thank you. >> thank you, chairman, and ranking members and members of the subcommittee. i'm really pleased to be back to talk about the comprehensive response to the h1n1 pandemic and to answer your questions. a brief update, we released new estimates for the toll the virus has taken in the first six months of the pandemic. 22 million infected or ill, 98,000 hospitalized, and sadly almost 4,000 deaths. the virus is spreading in considered widespread in 46 states. and in many areas, it is beginning to decrease, the burden of illness. but in some it is still on the upswing. there's been no change in the illness pattern. still just a younger person's

disease. many people with underlying conditions or pregnancy effected with severe complications. so far no change in the virus. it hasn't become more virulent or changed genetically. we still the vaccine is an excellent match with the virus that's circulating. but unfortunately, the trajectory is unpredictable. we do not know how long it will last. we know that flu season can last until may, usually we don't know how much the flu strains will have. many unknowns. that makes it even more important that we strengthen our response. without the investments of congress in preparedness and strengthening our ability to cope with the pandemic, we would be in much worse shape than we are today. we -- i'll go through cdcs response, and others will talk more broadly. we identified and characterized the virus. we developed candid vaccine

strains. we carried out surveillance in the u.s. and abroad and direct our interventions. our aggressive response has been science-based. we have rapidly deployed life-saving medicines and other material from our stockpile, laboratory kits were prepared in record time, and distributed to all of the public health labs in the u.s. and 150 other countries. we deployed field teams for the state and local, and continue to support the state and locals in what is imply mennation effort at the front lines. we've issued prevention and mitigation. we expected disease to increase this fall before vaccine was available. so we worked very actively with other sectors to make the best use of anti-viral medicine to work with education on ways to better intervene in schools without as disruptive effects as we saw last spring. we focused on businesses and

health care workers and so far. communication has been a priority for all of us. we've done outreach with new need ya and old media and our partners. the vaccine has been unprecedented. but of course like everyone, i'm disappointed in the initial production. and we've been held cap ty really to the slow-growing virus. however, today, i can announce that there are 49.9 million doses of h1n1 that are available for the states to order. it's not as much as we wanted to have, or frankly what we needed to have. but every dose that's coming out is being moved to places where it can go into people, and help protect them. at cdc we worked to develop recommendation to prioritize the use of scarce vaccine for those at highest risk of disease, or most likely to spread. we have a distribution system that gives each state a prorod

population-based share of the vaccine. trying to have as fair of process as possible. the states and local health authors are the implementers. they are working very closely with the providers, hospitals, can community health centers, with others, schools, for instance, where vaccination efforts can go forward rapidly. 34 states so far have initiated school-located vaccination to reach large numbers of children promptly. not as many have been able to be completed. but more are happening every day. we know that the state of maine expects to finish their school campaigns by the end of this year. we have done all of this mindful that the environment makes communication and emphasis on the safety of vaccines for the forefront for many. so we've done this without

cutting my corners and strengthened our safety monitoring to address any unanticipated problems. we're working hard with the partners across government, and in problem with the state, local , and tribal authorities who are directing the program where they are. they have been working tirelessly to make this succeed. i'm happy to detail some the efforts they've been making in the comment period. when we have the opportunity to look back on this public health challenge, we'll have time to reflect on the accomplishments that made it possible trailedly detect and track a previously unseen virus, and get a vaccine developed in record time. we'll have time to more systemically search for lessons in production and delivery that we can apply. and to rebuild the public health system that we all rely on. but today we need to adapt from the recent experience and maintain our focus on the days, weeks, and months ahead. we will have more vaccine to put

in the past, and it is our commitment to continue to work closely with our state and local public health partners to ensure it is as effectively delivered to those who need it most. i look forward to answering your questions. >> thank you. dr. lorie. >> thank you. i too am -- >> maybe put that mic a little closer. >> is this better? >> and talk into it directly if you can. >> thank you for the foresight in helping to rebuild the infrastructure. as a result, we we decided to pursue, we had preexisting contracts with manufacturers already licensed in the u.s. to get us out of the blocks quickly for manufacturing vaccines and preparedness efforts on hospitals and health care systems to be ready. my office has a response related to this pandemic. first, and work with the interagency.

secondly, to stimulate the develop of and contract for vaccines and anti-virals. third, to monitor and ensure that we can back states and communities if they get overwhelmed. and finally, the state prepared for any other emergency. not to take our eye off of the ball. this hole response has been a public private partnership from the get go. starting with vaccines, as, you know, we developed a new vaccine with unpres dented speed. and this was made possible by investments in basic and clinical science, manufacturing, regulatory processes. and would not have been possible at all without our partnerships of industry. and while modest amounts came ahead of schedule, a combination of production yields, late completion of seasonal vaccines, problem with new filling lines, decision in the home country of one manufacturer caused the availability of vaccine. not just for the u.s., but around the world. and while the number of doses that's been produced and

distributed and continues to grow, we remain vigilant to ensure steady supply. we talk with manufacturers almost every single day. we constantly monitor the progress of every lot produced working to make you are ground. and right now we have full-time staff in the tails of two of the manufacturers. in addition, secretary sebeilus and i have worked together to make sure there's not obstacles in the way. while these delays are are frustrating to everyone, we need to remember that the virus is real enemy here. and the way forward to improve the manufacturing capacity, using newer, faster, and more predictable technology, so the virus of the future does not defeat us. anti-viruses have been another response of we've supported the development, issuing the first

authorization for intravenous anti-viral. we have created three types of anti-viral drugs. we are also focused to remain able to care for those who need it. we can now grant to decompress hospitals and other payments. letting them use those emergency plans. and we stand ready to deploy when necessary, including vaccination teams, clinical, and laboratory staff, and temporary medical facilities. and our first ever vaccination team is headed to delaware to do just that. we've also partnered closely with the private sector health care, including health insurer and the public health community to find ways to pay for vaccine administration so cost is no a barrier to people who want to be vaccinated. let me shift to a minute for lessoned learned. clearly, it's the support of

congress and the past few years have been critical to enable us to respond so quickly. and yet it is clear the chronic underinvestment whether at the federal, state, or local levels, or in the manufacturing infrastructure, has real world consequences. and we cannot afford to let this happen again ever. while we've made vaccine in retro time, our trajections were based on the experience with seasonal flu, and h5n1 vaccine. we're optimistic in the face of what has proved to be a daunting challenge provided by mother nature. and despite the best efforts of federal government and our partners in the private sector. congress and the public has rightfully asked the projections about numbers of doses. and we want to be transparent, but at the same time provide all of the caveats about the

uncertain name of the projections. this has been a real challenge. especially as measures are captured that omit about such caveats. and this is led to frustration for everyone involved, especially the public. as an a important part of this transparency, and part of our public private partnership, we will start releasing this week, together with all vaccine manufacturers, the number of projected doses by manufacturer for a success of two-year periods. in this past week, storm-related delays nearly derailed to many states. from maine to alabama. and i want to credit the hard work of cdc staff who worked all weekend to ensure the vaccine would be ordered and shipped so that clinics would go on as planned. but we are far from done with the science related to vaccines. and with building manufacturing capacity in the united states. we're excited that the first cell-base facility will open next week in north carolina. but my fear, frankly is we'll

decide we don't need to worry. confronting future public health emergencies as well as for day-to-day public health for years to come. i too, too look forward to your questions. >> thank you. dr. goodman? >> chairman stew pack and members of the subcommittee. i appreciate the opportunity to be here today to describe f.d.a.'s activities in this response. first when this influenza virus emerged in the spring, we said this can't be business and usual, and we immediately stood up an incident command system spobs with several teams in anti-virals and vaccines. this allowed us to mount a flexible response with our partners inside and out of

government. our vaccine team acted immediately along with c.d.c. to begin the steps to produce a voinls even before there was a decision or knowledge that we were going to need one. as you that we were going to need one. as you heard in record time vaccine was produced and became available and i can assure you everyone of this effort government and industry has done everything possible to get as much vaccine to as many as possible without cutting corners and note this committee is concerned that a vaccine is safe. it's very important perspective here is that the entire world is struggling with biology of this virus, the challenge of reduced manufacturing yield and frankly the entire world's struggling with inadequate vaccine manufacturing infrastructure. yet despite these challenges we face in the u.s. and the frustration we've been talking about, this country is one of the first to mount an effective large-scale immunization campaign. many people have asked us that

the fda how can we be confident in a vaccine produced so quickly. we have this paradoxical situation where many one faxing and many don't trust it. and i'd like to say that to the answer is recorded and to reassure the american people. the vaccines we have approved are made with methods that are tried and true, every year fda and mandate many pressures follow specific careful steps to produce new influenza vaccines every single year. and these steps have produced safe vaccines year after year ending at 200 of millions of doses manufactured and use in the u.s. and we follow this exact same scientific and regulatory approach for this 2009 h1n1 vaccine. in response to some of the disinformation that was mentioned, i think by congresswoman castor, one of the things we have done for example

is my commissioner, dr. hamburg, with our working together sent a letter to every physician in the united states to explain about the vaccine, how it was produced and to provide a balanced review of the benefits and risks of the vaccine but clearly we have a lot more work to do their. you've heard from the others that your investment in pandemic baroness have been critically important with respect to domestic capacity and want to say that in many fda in accelerated manner licensed and medicinal facility at santa fe pasteur and swift water that the company has said has dramatically increased ability to produce a vaccine and that is helping us now so that's important but clearly we have much much more to do. i would also say during this response we have worked with hhs to bring on-line multiple additional filling lines to help make sure we can get the vaccine produced out there as quickly as

possible. now on september 15th we licensed for vaccines against the influenza virus, a fifth last week and i also wanted to point out again in a collaborative efforts with this esl manufacturer who submitted data to us we were able to extend the approval of the vaccine to include children down to six months of a to were very concerned with. now, while we expect these vaccines to have the same excellent safety record as seasonal vaccine every year we're taking nothing for granted. the same intensive oversight of these facilities, the enhanced safety monitoring, dr. schchat mentioned, and i want to point out that every single vaccine must be evaluated, tested and then released by both fda and the manufacturer before its use in people. now, because of the limited time i won't go into the work we've done on anti-viral san diagnostics but i do want to say that we have prevented old for emergency use authorizations

discarding of antiviral segui scientifically no sats and that's helped avoid shortages. diagnostics have been fielded in record time within weeks of a new disease thanks to cdc's efforts of our work with them collaborating to evaluate those. you have heard about protecting the public from fraudulent in counterfeit products and we almost immediately put a team in place to serve the internet, to deal with consumer complaints. my favorite is the magic wands that can protect against everything including anthrax and h1n1 but you also heard there are issues of counterfeit in an approved medications and we're continuing to be vigilant in this respect and we've actually put a widget out there so others can spread the word with the lists of counterfeit products. now, looking ahead, i really do feel much has been accomplished in a very short time in is because of the strong collaborative efforts. the people you were sitting here

and many more are talking every single day, talking with the states and the manufacturers and this has been going on from day one. but we need to ask ourselves and we are asking ourselves what do we need to do more of right now for this epidemic in moving toward. clearly fair that we need more capacity, self based manufacturing, and viet fda are committed to make that happen. we recently last year or the year before provided died in so we can get a self based vaccines but we also want those to be safe. we are supporting with hhs to develop ever confident in your technologies to help us respond even faster and i think as i heard from one member this is important not just about flu, this is important about another emerging infectious disease if we have sars, bioterrorism attack. we need a strong technologically advanced vaccine infrastructure. now, due to time, i think i will

stop there but just to say that we at fda are very committed to working with our partners in you to protect the health of the american people. we move forward with a very flexible rapid response while taking our responsibility about the safety of these products very seriously. we really want to encourage strengthening our infrastructure here. i also want to mention this is a global issue and we in the u.s. can work with global partners to strengthen the global response. none of us are safe and well protected from infectious disease until we all are. so i thank you for your support for public health, your support for the fda, in your interest in this issue. thank you very much speak up -- >> thank you to all of you. the way we perceive it is we have five minutes questions from members going back and forth, for members to pass on their

opening they get seven minutes and get to add their opening to the five. i'm going to start with myself and i want to start with dr. schchat. the big concern, the biggest concern i hear from my constituents is about the distribution and then know that the cdc as guidelines for distribution basically leaving the distribution of to the states as long as they meet the guidelines. my concern is whether that is a good way to go about a. i suppose you assume that to the states and localities since they are closer to people would have a better -- to be the best way to distribute but that's been seriously questioned in the last few months or so and, of course, being from new jersey the biggest issue has been the wall street companies, goldman sachs, citigroup -- i literally being from new jersey hear about this constantly. why is it that new york i guess, you know, gave goldman sachs and

wall street firms the opportunity to do this? i am told that employer based distribution is one of that research guidelines and perhaps it was assumed that they would do well since they have health clinics and have a good distribution amongst their employees. but i guess the concern would be, you know, if you leave the distribution to those who do it best and the ones to do best happen to be high-powered wall street firms then they're too concerned -- that makes sense given they would be hostile and not do as well a job distributing but is a greater need and then the second thing is whether or not some of these firms would only give it a high-risk people as opposed two maybe they're ceos or somebody else. so that is a concern. my question really would be, why does the cdc leave it up to the

states to create the plan for distribution and within it perhaps be better to have some other federal mechanism rather than doing it this way? and want prevents -- what prevents some day led goldman sachs getting it when it may be should be going to a clinic? and monitoring how they go about it? >> thank you. the cdc issues national standards about the populations at greatest risk for disease that are recommended to receive vaccine when there is a scare situation, so we issue that as a national level setting. we leave it to the states with large cities like new york city to find the best ways to put maxine in the path of the private population to identify the many. new york city actually put hospitals and doctors' offices first. they put employer clinics and a

lower tier in small numbers of those is went to some employers. >> but the problem i am hearing -- i don't have a lot of time -- in some of those cases, i don't remember which wall street firm that was, they actually had access and didn't need it. so you could argue that maybe they are getting fewer dosages, but in a very well be that maybe all or most of what they got should have gone to the hospitals because there is a greater high-risk pool their. how do we prevent that? >> i think that issue was of concern to all of us. dr. freedman and sent a letter to all the health officers reminding people about our priority groups and how critical it is for all of us to adhere to them. every provider or venue that gets vaccines signs an agreement that they are going to follow the recommended target population. >> and i understand -- i'm not suggesting although some have that goldman or others are given to people other than the high risk although some are concerned about that. but have you thought about the

fact that if you do it that way or the states do it that way it may be giving it to people that have a better distribution network within their employers but they may not have as great a need? it sort of like when there is a grant program, the guy that does the best grant application and gets the grant for as maybe there is a greater need for the person who doesn't have an expert to do it, you know? >> we have a major commitment to vulnerable populations and the underserved and to make sure we're not leaving behind those without could access. most of the states have carried out these larger clinics to get people who don't have doctors offices to go too. >> if you could just -- i don't know if you have but i would like to see maybe get back to me at some point to talk about why this kind of distribution is better as opposed two maybe looking at some kind of a federal alternative. i don't know that too have looked at that but if you could get back to us at some point.

>> thank you. >> the other thing i want to ask dr. lurie, when secretary sibelius' testified on september 15th basically she left us with a feeling that we're on track in terms of adequate supplies and vaccines. i know that turn out not to be the case. some of you explain why and i am sure we will get more questions from other panels but you did mention underfunding. i don't remember her saying anything about lack of funding. use said that there is underfunding or chronic underfunding was one of the contrary reading factors. that's the first time for that and also little sister because i don't remember her mentioning it. >> let me try to clarify here. i think the chronic underfunding has been in the faxing infrastructure overall as opposed to the response so it would have been wonderful if we have had more manufacturing capacity in the u.s. by this point. if we have had self-paced or

recombinant technologies that could surge and really produce large amounts of vaccines. but you know, we have invested in that over the past few years, we need to continue to make a much more robust investment and so that's the chronic underfunding for the vaccine manufacturing capacity of this. i think we all know that the chronic underfunding in state and local public health has been a different kind of problem. congress has been extraordinarily responsive to the very acute needs that we had to deal with as pandemic and when i'd love to see in this situation is that we can sort of apply prevention in that sense and really get ahead of this for the next pandemic. >> again, i don't want to say i don't want to be two guys up today but when it is something like that that progress can make a difference it really is important that if the department or anybody feels that there is a need for more funding to d tell

that to us and again i would ask you may be to get back and give us more information about this chronic underfunding in writing because a lot of things that come up here we can't do anything about but that is certainly something that we could. >> we look for to working with you on that. >> thank you. thank you. we have eight minutes left, we have three votes, mr. shimkus says he would like to go next before we break and then after him we will break and come back. >> thank you mr. chairman and i'm going to be pretty sure it's, but i appreciate to bar its focus. in my opening statement i hope that we do and after action review on this process to help us be prepared because the questions he is raising is really the question that i've been having under a terrorist attack, biological elements and weapons of mass destruction and ickes into what was said.

we have to have a way to streamline the process and get approvals quickly and that would be the debate on diggs vs. cells and how quickly -- i understand the fda responsibility but if you have a mass of possible pandemic we had better have a way to subvert the regular order for the needs of the whole. and move rapidly. to us like his comment on the adjutant. i hope there is a process in place and if there is not one -- time former military and after every training exercise you do after action review. will that be done, dr. schchat? >> we have had several in process reviews already and we're committed to after eshoo reviews as part of our routine procedures. >> dr. lurie. >> i would add to that and add that there are processes in place for emergency use

authorization so that if this pandemic were to become much more severe etc. we would be able to shift to other products under emergency use authorization and aspen part of our planning since 2005. >> if something kids that we don't know about and look at this time than i guess we identified it and then isolate people until we can roll out -- >> absolutely -- there are several mitigation steps and one of the things we did this summer was up a guidance for mitigation. when what to do with the current level of severity and what we might do it a virus mutated and was much more severe so no automatic school closures and the setting but as things change substantially we would go too much more disruptive intervention and so we do have things we are available having knowing the vaccine supply might not come soon enough. >> dr. goodman and.

>> i really appreciate your comments and we want to have a very agile public-health response especially in emergency. i do want to mention in that respect it took us about adair two when there was a need for anti-viral, not approved for children under one year old, but to treat children under one year old and work with our colleagues at nih and cdc an issue emergency use authorization, full transparency to the public. not the kind of data required for approval but i appropriate riss benefit weighing and public-health response. this is a tool you and congress have given us and we're ready to use when there's the right emergency and as recently in the last couple weeks with respect to the questions, the senior scientists of every agency have sat together and revisited that decision and decided to we want at this point to switch to these complex discussions but that is being revisited in action and are committed to continue after action. the biggest improvements we can

make for a strengthening this infrastructure and getting new technologies ready ahead of time. we are better prepared than we were a few years ago things to your investment but we have a long way to go. >> and i will end by saying i think education is a key. the positive aspect is the public is really better stewards of everybody else public health by better health practices and that will be the key thing before we can roll on to this. thank you mr. chairman. >> thank you. we have three votes and will come right back after that. the subcommittee is in recess. [inaudible conversations] >> the subcommittee will reconvene and our next member is the gentleman from wisconsin, miss baldwin. >> thank you mr. chairman.

i mentioned in my opening statements three topics that i hope to hear more on, i know i will get a chance to exhaust those three topics in q&a but let me start with dr. lurie on the issue generally of domestic production of vaccines. you have been asked a question that by mr. walden that i think time didn't permit you to finish answering regarding the policies in other countries where vaccine is manufactured. and i wondered if you could basically generalize those policies but also tell us specifically what happen in the case in australia. >> sure, i think many countries including the united states, in the united states we have the defense production act. basically what that tells us is that if we need material for the safety and security of this country that we can prior to rise that and i think many

countries have that kind of situation and that they need to prior to arise for their country. that's why its own form for us to get to domestic manufacturing capacity in the u.s.. essentially something that we learned and realized during our pandemic planning early on and, in fact, to an earlier when we realized several years ago we down just 21 licensed in the u.s. and i think people worked very hard to get to the point that we are today and now we need to get to the point where we have much more domestic manufacturing capacity. i think in the case of a csl, there are based in australia and have a similar kind of arrangement or requirement within us joined government. remember the southern hemisphere has an opera get a different time and so australia was experiencing a pretty severe outbreak. they decided it needed vaccines a first for its home country.

now when that happened in csl let us know that right away and we immediately for able to downgrade are projected numbers of doses of vaccines and at the same time we have worked for a closely with the manufacturer so that as soon as they met the requirement for their home country never able to start making and shipping to assist us. >> in addition as you ever heard they have also committed additional data recently said that the vaccine can be used then to lower agent children and that was recently a lesson. >> also in my opening statement talk a little bit about using this pandemic, seasonal flu as well as the h1n1, to learn and to innovate and i am wondering what your thoughts are in three particular areas. one is faster manufacturing processes whether cell based or

things that -- other opportunities their. use of adjutants, and other open as a methods of vaccine delivery, something other than injection and nasal spray. if we were two have a very maryellen's influenza next year -- material and influenza, where would we be today? what is your sort of time horizon for when these innovations are going to be more generally available? >> i think it's a great question, i think again you have a strategic plan to really try to move as toward monitored manufacturing technologies in manufacturing capacity in the united states. as i said, the first cell this facility has its ribbon cutting next week in north carolina but actually i don't think will be having a flu vaccine in for another year. but when all is said and done

and that ought to get as to the point where we can be able to make 150 million doses of that is still far short of the capacity that we would need a public health emergency. in addition, sell based vaccines still require the virus to grow in cells so we need to move toward retirement technologies and other kinds of technologies. we have invested in in some of those. i think there's a lot of promise and a number of the new methodologies. i can yet predict where they're going to come on-line but i also want to say that it's great to be able to do those things but once you do that we can't forget we have to manufacture to scale with whatever those are and so we have to be thinking now about how those new technologies in manufacturing capacity need one another so not everything is done one after another. and so that is i think another real challenge that we have. with regard to adjutants, i

think we all know and believe that adjutants have a lot of promise. dysuria debate as it is our release for two reasons -- you need less vaccine and the other is you don't get in. immune response to the vaccine. they help you get a better in the response, a substance that you mix with the vaccine. there's a lot of work going on right as we speak to understand the experience with adjutants, trial's been done by the manufacturers, as well as nih mixing one company's adjutant with another's vaccine to make sure they're safe and effective. and depending on the outcome of those trials, i would expect that if there are promising the manufacturers will submit applications to the fda, but that we are not there yet. and then in terms of the alternative methods, people are working on things like patches,

transdermal method and some are working on vaccines that you can eat. no, there are a lot of very exciting breakthroughs in the science that i think you're going to move us for ford. some are more ready than others, but it would be great if you could use a patch instead of a shock, for example. >> is my understanding that some of that technology may have an impact on increasing the effectiveness of the vaccine. for example scan of micro nato application verses injection. and i think. >> we are continuing to learn more about those but a lot of these new technologies are very promising in terms of getting a good immune response -- the immune response gets into the body to make that response that is a difference in some of the different technologies. dr. dittman might want to amplify on that. >> i would add one thing which is there is a lot of amazing innovation incredibly promising

technologies. we have vaccines in this country, just not for influenza. we have licensed recombinant vaccines, just not yet for influenza. i think those things are making some real technological progress and those of things we're going to see progress very soon. but one thing i wanted to say is we see even in the most sophisticated manufacturing technology is there are still challenges producing large amounts of things consistently and of high quality. so even with some of the most advanced biotechnology products out there today, this is complex challenging manufacturing. it is not like -- for all of the problems of relatively reliable clearly is not all technology and has many disadvantages but i'm just pointing out that some of the newer technologies are going to need the same kind of care and that what works in a mouse or in a very small

production it is not always the same the sometimes takes time to get to industrial scale and be sure it's going to be safe and high-quality for people. .. emerging infectious disease spread, to have vaccines much, much faster, and there is promising technology that can help us do that. >> thank you. i want to thank all of you for your comments today. i know that we did have some questions that i and others asked if you could get back to us in write. the process is that members can submit additional questions in writing to you, and usually they are just supposed to be submitted within the next 10 days. so you may get some additional written questions to respond to as well. but thank you so much for an

important issue that you are involved in. you had some comments? >> i wondered if it would be ok if i responded to something i heard in a couple of comments earlier? >> of course. >> i was concerned, and we haven't really had a chance to correct some misunderstandings here, and that has to do with vaccines going to guantanamo or terrorists. there is no vaccine on its way to guantanamo. there is no plan to vaccinate terrorists, or mum mum ahead of there's a program that's handled by dod, but i think it's one of those things that get out there in a travel spirally and there's a lot of misinformation. there is no vaccine honestly there. >> all rights. thank you very much. i'm sorry, he hasn't had a

chance to ask a question, so go ahead. >> mr. chairman, i'm pleased that the first panel is still here. i have some concerns and i'm interested in full disclosure. i've been a bit of a downing comments as a position member about our response to this crisis, this pandemic as it is now, and of course my great concern was us creating a pandemic of fear. i think we have certainly done that and we also have, since 2006, when we were dealing with avian flu, probably in the aggregate of appropriated something like 12, $13 billion. feel free to correct me if i'm wrong on my numbers. but a lot of money. and of course, as we track this

and the concert was whether or not to develop and spend billions of dollars in the process of developing a vaccine specific to h1n1. different of course from the regular vaccine that we will be producing for seasonal flu. i think the decision was going to be made, i guess was made on the basis of how virulent this strain became and what kind of changes might occur. was it getting worse, and i think that you said in your testimony, maybe all three of you, that the strain really hasn't gotten worse. and the virulence has not increased. but one thing i did notice here lately was that all of a sudden we went from 1000 deaths in the united states, literally overnight to 4000. and that a little, i find a

little disingenuous, but then this explanation that we originally were be seen cases of h1n1 on laboratory evidence. but then we are using a mathematical formula that we kind of extrapolated or estimated. you know, some people may be in the coc babies to go work for the census bureau with that kind of calculations. i have real concern about that. in fact, i brought along with me a blank death certificates where it says cause of death and contributing earth. and i would be really curious to know how many of those 4000 cases does the death certificate said the cause of death is h1n1 viral influenza. >> thank you for those comments. communication is really important to all of us and being

clear and not confusing. we did not overnight go from 1000 deaths to 4000 deaths. all along we've been talking about using a variety of surveillance system appropriate to the period of the pandemic and the efficiency of data collection. and we said that reported cases underestimate the true burden of disease. for seasonal influenza, when we talk about how many deaths or hospitalizations they are, that's not based on individual reporting by doc yours and health departments. it's based on a lot of different data sources and modeling those data. what we did last week was release estimates that took information from a couple of very good surveillance system you hospitalizations data from our emerging sect games in ten different states. information from 30 or 35 states, depending on the week about laboratory confirmed hospitalization and laboratory confirmed deaths. we used those two as a ratio to

understand from hospitalizations how many deaths might there be. we looked at the influenza-like illness surveillance system to divide up things into high, medium, and low at any one time in terms of how common the transmission was. and then we used correction factors that were based on community surveys that were done to really understand for how many illnesses are in the community, based on telephone surveys for everyone who actually goes to the doctor. how many people i see a doctor get a lab tests done. >> with all due respect, i want to make one other point. and i appreciate your explanation. i hope all the panelists, all three doctors understand my concern. the state university of west georgia is in my district and they weren't having a problem given access to the vaccine. i know that's been the main theme of this hearing, why we didn't develop, i don't know, millions, literally 50 million

vaccines by a date in october when it was only 15 million or whatever. but state university of west georgia had no problem, they had plenty of vaccine, they had 11,500 students in only 141 were willing to be vaccinated. and a lot of them were very concerned, and let me just give you a quick quote. most students are saying that they haven't gotten the swine flu yet, so they believe that they are not going to get it at all, said sandra jones. there are also people telling students not to get the shot. there is some who are afraid of the side effects of the shot and they read about 1973. they believe the government did not contest the shot at all, and quote. mr. chairman, i know i've extended beyond my time. if the panel would allow the courtesy to respond to this. because i think this is a huge issue. i don't care, you know, we've

got 100 million vaccines and 10% of the population is willing to take the vaccine, even though they are high risk, whatever really accomplish your? >> if i'm going to let you answer this question. but i've got to be careful here, dr. lurie as you open up to the wonton memo thing, chairman stupak wants to say something, too. so we'll do those two women will be done. we're not done. mr. green is here. i give up. respond to mr. gingrey. >> sure, you raised one of the most challenging aspects of this pandemic. at the very signed him people are waiting in line, driving hours to find vaccines. we have supplied way in excess of demand in some communities. we have huge information needs to feel and i think we are really committed to break the myths about the safety of this vaccine. what we do know and what we don't know.

there's a website flu.gov.as a lot of information about myths and facts that might help the college students understand what is the case. we've actually planned for some or outreach for used such as college students to reach them and have them understand what is a threat to them, what is the risks are not about the vaccine. but we have is very exquisitely challenging time where, do we risk raising demand in some communities like that, at the same time with so much extra demand versus our supply elsewhere. and that is one of the reasons why we've really focused on state and local support because in your community, or public health efforts understand on the ground, you know, we've got a supply demand mismatch the other way at west georgia college whereas in the national level we may not understand the community supply and demand. so really one of our things to focus on state and local distribution or direction of where the vaccine goes is because of that trust of the community about awareness of what's going on with the local community. so i think, if you want to get

back to -- >> are you done with mr. gingrey's response. let me please explain what was happened. so dr. lurie asked to take some time to talk about guantánamo. and mr. stupak just wanted to clarify and ask a question about that and then we'll go to you. >> dr. lurie, you don't have anything to do with the military and getting the control drug to the military do you? >> know, the whole department is run by the department of defense. >> so you don't know of people at guantánamo have received it, you don't know if the 218 international terrorist wielded u.s. jails have received it? you don't know that because it's handled by a different part? >> what i can tell you is on military installations. >> what is your source? >> run by the department of defense and they have pretty

strict criteria. >> arrived, they do. >> diploid health care workers, civilians and contractors. >> but the point is they did not receive it. you don't know that. when major diana r. heaney says they'll be receiving it on november 2, they could arty have the vaccines done in guantánamo. it is now the 18th, 16 days and they could have it. you don't have any personal knowledge of it. >> know, what i was trying to do is correct in misconception about how the vaccine was distributed. i do not have knowledge of that. >> i required to do it. and even these detainees will have a right to accept it or refuse it. but the point being this was released november 2 at the time of the height of the shortages and american people were upset about it. i have no problem, but i just say under oath, with dolby testifying you don't have personal knowledge of.

>> all right. mr. green. >> thank you mr. chairman and i appreciate the patience of our witnesses. but that's just the way it works here sometimes. i appreciate you being here and i guess the frustration we've had about the health subcommittee and a benefit on the health subcommittee of the oversight hearing with a number of hearings this spring. the most recent one in september. and it seemed like the best plans that we had just didn't pan out. and it's not necessarily with the delivery system. we'll ever not at the next panel. where the commissioner and we also have on the manufacturing side the next panel. but there's been talk for many years about what we need to do for pandemics. and yet, here we have web relatively is candid nature. a month ago we had a security hearing in texas and we have a thousand people died. now it's up to 4000.

if it had been something much worse than h1n1, we would be sitting here and say why don't we have tens of thousands of people dying for avian flu. what do we need to do for the agencies, all your agencies and in congress need to do to live up to the plans and expectations that we had from the earlier hearings, where we were going to have enough vaccine, distribution center was there. now we don't know if the distribution center is there simply because we don't have enough vaccine, although we know something is working because people are lining up all over the country to receive it. and the other question i have is my concern that the lack of regular flu vaccine, or at least the participation. and the one thing we know is hopefully the next year or the next flu season we will have h1n1 and went the seasonal flu, but that we need to make a national effort to increase the

seasonal flu vaccinations. and that comes from all of us. we have seen an uptick, but i want to see what we can do. cheapest thing we can do for the business community is the flu shot for the employees. with that in the time, two and a half minutes, for all three of you. >> i think there are several things we can do to strengthen our response for seasonal flu as well as for future pandemic, which i do believe we will have. we have a public health infrastructure that is weak right now. it has been suffered many job losses, many furloughs, and that leads us a little bit of a weekend court to refine to this kind of thing. we do not sufficiently use information technology that could help connect the electronic health records and the private health care system for public health needs. we could do much better targeting a priority groups if we had better information systems.

some states have immunization registries that were to be well, but they don't often reach to adults. we don't have a strong adult immunization program in the u.s. adult providers have and have really stepped up the way pediatricians have two use prevention at the forefront. >> i think that, but we're going to run out of time. we are talking about pre-nutrition. we have a vast program for children. we no h1n1 targets children and young adults. i had my 62nd birthday three weeks ago and is the first time i said it's the first time i'm glad i'm 62. the problem is we don't have the vaccination. >> i think there's two things we certainly need a more robust vaccine production with the new technology with broader manufacturing capacity. but with children, if you look at this pandemic it's really disproportionately affecting school-age children they don't go to the pediatrician very often and they don't get vaccinated very often compared to younger children, one -year-olds and two euros. so there's a terminus opportunity to strengthen

school-age children. many states are having vaccinations for the h1n1. those could be modeled for seasonal flu, for instance in the future. but there's a lot of work to do before we would realize the efficient delivery system that would like to have. >> certainly. and i would really second dr. schucat's comments about strengthening the infrastructure at all levels are at condition, as we talked about some already this morning, we do need to get to much more robust manufacturing technologies. we talked about the fact that there's some promising new development and we need to continue to invest in pulling those claims of technologies along so they can make vaccines faster and more reliably. and those in a development to somehow meet the large-scale phase manufacturing capacity so were we to have another emerging

infectious disease, and other pandemic, that we would be able to get vaccine out in very large quantities, much faster. and not be reliant on what we have now. >> mr. chairman, i know i have run out of to time. i know we use the polio example many times. i think our agencies need to look at that and say, how do we deal with this because next time it won't just make a sick for a few days. it may be killing a lot more people than 4000 people. i'm worried about the pandemic on something much more serious. thank you, mr. chairman. >> thank you. i get them going to stay thank you again. i won't repeat what i said again. i thank you so much and again get back to us with any written comments. we would appreciate it. and now we'll call the second panel. >> thank you.

[inaudible conversations] [inaudible conversations] >> we will call her second panel witness that. this includes the president as he is so inc. dr. vas narasimham. hopefully i said that right. president of vaccine u.s.a. dr. van machielse. and dr. phillip hosback is vice president of immunization policy and government relations. dr. lakey is dr. of the health services and dr. jeffrey lev three is dr. for america

stressed out. i welcome all of our witnesses to testify in here today. in accordance with the oversight and investigations subcommittee, witness testimony will be taken under road. we've be advised that under the rules of the house or the right to be advised by counsel during your testimony. whenever you wish to be represented by counsel? everyone is shaking their head know so i will take that as a know. therefore, i will ask you to please rise and raise your right hand to take the oath. do you swear or affirm testimony to give the whole truth, nothing but the truth, in the matter pending before this committee. let the record reflect the witnesses have applied in the affirmative. you are now under us. we'll are a five-minute opening statement from each of our witnesses. you see that the blogger for the record. mr. perreault we will start with you. for five minutes, your opening

statement. [inaudible] >> you might want to pull the mic up and make sure the green light design. will start the clock and be all set. >> so good afternoon chairman stupak and members of the committee. i am paul perreault. the u.s. distributor of influenza vaccine manufactured by her parent company, csl ltd. located in melbourne australia. these to be here today to discuss her experience in manufacturing the h1n1 vaccine come a specifically for the united states. csl biotherapy think it's important to understand how the government and industry can best work together to help assure vaccine availability for influenza pandemics. i want to enjoy this committee that csl biotherapy is committed to providing the entire amounts of both the h1n1 bulk antigen and the finnish vaccine doses so that we have agreed to in our

contract and the department of health and human services. we take the h1n1 pandemic very seriously and have been a leader in developing and delivering to combat this virus. csl has manufactured vaccines since 1916, are world-class influenza vaccine facilities have the capacity to produce up to 80 million doses of trivalent,. our seasonal flu vaccine was launched in the united states in october 2007 and indicated for ages 18 and above and as you heard dr. goodman stated last week, our h1n1 vaccine received fda approval for administration to individuals six-month or 17 years of age as well. our h1n1 vaccine come in multidose virus primera sol free syringes. csl initiated the western world's first human trial with the 2009 h1n1 vaccine. and published our research findings in the new england journal of medicine, demonstrating the efficacy of a single 15-microgram gross.

this data along with the results of clinical trials in infants and children were communicated rapidly, regulatory and public health authorities in the united states and globally. recognizing their value to the public health decision-making. in may 2009, hhs and partner percy beard to see whether we might be able to provide it h1n1 vaccine for the united states. csl biotherapy is entered into a one-year special contract, initiated on may 28, 2009, to provide 36 million dose equivalents of h1n1 bulk antigen to the united states government. csl biotherapy does not have a previous pandemic congress of the united states government. as part of the agreement signed in may, csl has made it clear that it had a preexisting contractual obligation with the estonian government to provide vaccine to that nation first, should who declare a pandemic era i want to discuss that this had no impact on for filling our schedule submitted to barnett. csl received a first h1n1 by

received from the new york medical college. the yields from this lot were approximately one third to one half of the average h1n1 influenzae here. as a result of these low yield, csl communicated to barta the overall timing of the h1n1 bulk antigen delivery. on the 18th of august, csl received a new vaccine that was introduced in the manufacturing process. yield improvements in excess of 80% compared to the previous seed were observed, or revised or sent to hhs on december 14, incorporating on the c. block. csl remains committing to the yield of h1n1 vaccine. csl has invested in fill and finish capabilities in europe and illinois to improve the ability of influenza vaccine. the facility has achieved licensing of its new state-of-the-art syringe fill and finish line this september.

i'd like to recommend measures to help assure availability of the pandemic vaccine, first i would recommend there be a focus on producing a greater assortment of influenza feedlots earlier that can be utilized in the creation of future pandemic influenza vaccines. the poor yields resulting from the first available see that at a significant effect on the juice the juice in the amounts of the vaccine. it's a ten recap in prior gilding feedlot could've been avoided, higher output could have occurred sooner. second, new adjuvants could help reduce required dosing, which would make more antigen available for additional vaccinations. a supportive environment for new adjuvants with influenza vaccine could facilitate in this advancement. finally, more education about the benefits of influenza vaccination in the achievement of higher vaccination rates, closer to cdc recommendations would help to prevent influenza and support readiness. our passion at biotherapy is is to improve lives and we wish to do our part in protecting the

united states population from h1n1 and seasonal influenza. we will continue to work with the government collaboratively. thank you for the opportunity to speak and i welcome the opportunity to answer any questions. >> thank you. dr., you would like to testify. pull that up and turn the mic on please. >> i want to thank chairman stupak, chairman pallone. and the members of the committee for the opportunity to speak with you today. novartis is the leading manufacturer. along with her predecessor companies we have been a leader in the development and supply of vaccines to the united states for over 25 years. today i would like to highlight to the committee novartis vaccine commitment to u.s. influence the vaccine and our dedication to prevent every possible incident and death from influenza. we suggest for its lowball hitter said.

we have had a pot and successful partnership with hhs, including active collaborations on cell culture vaccines, adjuvants, stockpile, and new production facilities. novartis vaccines is committed approximately $1 billion in influenza vaccine development and production since 2006. importantly, with hhs support were constructing the first cell culture manufacturing facility in the united states, located in north carolina and with its ribbon-cutting later this month. this facility will help ensure the rapid availability of pandemic vaccine for the american people and the future. for this pandemic, we continued our commitment to u.s. pandemic response and public health. first and may we voluntarily dedicated the entire vaccine output from our manufacturing facility in liverpool, england, to the united states. this facility recommends half of our capacity. we did this because of our long partnership with hhs for going to potential opportunity to

quadruple the output of this facility using art adjuvants. second, our entire organization is worked round the clock is for u.s. vaccine production. we've made large investments come out of 300 additional staff, accelerated new production lines and have been operating a production facility with a high level of quality and efficiency. third, we rapidly started and enrolled broad range of radical trials in more than 9000 children and adults in less than three months. our data showed in early september a single dose as opposed to two is adequate for adolescents and adults and we recently showed that a half dose may be sufficient. worse, we have prepared for hhs to start adjuvants that is currently licensed in being used exclusively outside the u.s. for h1n1. we have demonstrated in recent u.s. little tile setter adjutant can significantly increase u.s. h1n1 vaccine supply. fifth, we successfully supplied 27 million doses of flu vaccine by early october. now most importantly, in

partnership with u.s. government, we have overcome tremendous challenges to produce a safe and effective pandemic vaccine in less than three months. the challenges have included bluegills, multiple production in certainties, compressed timelines. despite these challenges, novartis has shipped over 18 million and adjutant and doses to the u.s. government and we are fully on track with our production, a tremendous of publishing it. we also believe based on experience busier the importance of opportunities to improve endemic preparedness in the future. these opportunities include the need to move manufacturing into the 21st century for influenza vaccines using new technologies such as art cell culture technology, now being used license for seasonal pandemic use in europe. there's a need to accelerate regulatory pathways for novel influenza adjuvants in pandemic vaccines. we need to develop new testing methodologies to speed up the vaccine formulation and quality release which can often slow down vaccine availability. we need to maintain the

strategic national stockpile for rapid deployment in the case of a severe pandemic and finally as noted by other members, we must support seasonal influenza vaccination demand to ensure that suppliers are not forced out of the market as has happened in the past. novartis vaccines continues to do everything possible to maximize the rapid supply of a safe and effective vaccine and close collaboration with hhs. we believe well when taken into full contact the project did partnership to produce, test, and deliver a safe and effective h1n1 vaccine to the u.s. has been a remarkable success. @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @

the son of our loom as technology since september in 2000 -- we plan to deliver those doses. the $42 million of h1n1 vaccine along with the billing our commitment of 10 million doses of seasonal maxine represent an increase of 700% in medimmune vaccines compared to last season. importantly medimmune manufacturing for h1n1 had no impact on our commitments to deliver 10 million doses of seasonal vaccine and, in fact, we're able to accelerate --

deliver the pursed h1n1 vaccine to barter. due to manufacturing efficiencies unitard technology the intranasal vaccine was the first available and remain significant proportion to the vaccine available. we finished the manufacturing of all 42 million doses of vaccine, all of which is now on u.s. soil. we're now on the process of filling the vaccine is specialize single dose nasal spray mist. as of friday november 13th we have shipped approximately 13.2 million doses and over 96 percent on track with delivering the orders placed. medimmune unique technology provided a significant surge capacity for both vaccines, the success uses their technology as a strategic preparedness. as a result of medimmune vaccine

we submitted a proposal regarding alternative delivery device in order to further contribute to public health efforts. the development and manufacturing process for our intranasal vaccine to riss from the shot in several important ways. we develop our own unique way to grow the vaccine while most manufacturers rely on cbc or other reference labs to generate the vaccine. a critical element to of pandemic preparedness efforts is that we use it pattern of technology known as reverse genetics, directly craig multiple strains and then we can select one i gross and has not othernesses their properties. like the shot, our vaccine is also produced but unlike the shot we generate between 60 and 100 doses of vaccine. longer-term replacing database technology with cell manufacturing would be a key, if

i do believe that this technology used to manufacture will have similar yield advantages as the one i mentioned. medimmune has a program focused on the development of the itself venture based vaccine, however fta requirements have increased the cost in the development program by several years and the program is now on hold while medimmune and hhs it all with their appropriate password. now is the time to collectively about with what we have accomplished and what we can do better. it is critical that a u.s. government continue to encourage high level of seasonal vaccination as well as in public education campaigns that increase awareness of the benefits and options in the influence of vaccination. additionally it is key that a government agencies and industry to a late develop a blueprint process and requirements along key areas including, for example clinical development,

requirements and distribution to avoid any roadblocks that could delay the delivery of vaccines in the future. in a few years that we have been in existence we believe they've done a remarkable job. medimmune is pleased to be delivering intranasal vaccine with expectations and we look for to building up our successful relationship in collaboration with the u.s. government. i will be pleased to answer any questions. >> thank you, dr. perry dr. hosbach, your testimony please. >> good afternoon mr. chairman, they given the opportunity to testify regarding h1n1 and the ones that pandemic production development and delivery. my name is dr. hosbach and i'm the vice president of immunization of policy and government relations and responsible for coordinating the pandemic response teams. and we're the largest manufacturer of influenza

vaccine in the u.s. producing about 45 percent of the u.s. and europe influenza vaccine supply and i the only manufacturer of active vaccine on u.s. soil and oliver seasonal and h1 -- h1n1 at maxines are produced in swift water, pennsylvania. this site which includes two state of the art influence the manufacturing facilities and one that that was licensed as you heard from dr. goodman, operating 24 hours a day seven days a week with more than 2,000 dedicated people involving in getting that maxine out the door. many have made great personal sacrifices to ensure we produce the largest number of h1n1 doses in the shortest amount of time all insuring vaccine safety and regulatory compliance. out like to start my remarks by focusing on one a remarkable achievement the u.s. response to this pandemic early as. and to the close collaboration of industry with hhs, at the ncbc we're prepared for this pandemic then we would have been at any other time in history. the virus was identified in late

april and manufacturers received the strains in late may. less than four weeks later large-scale manufacturing was initiative and by early october there was an fda approved vaccine being administered, is truly a success story. nevertheless we understand the committee's interest in this process as there are always opportunities to improve sanofi pasteur began shipping vaccines on september 29th which was earlier than anticipated. we have received orders from hhs for 75.3 million doses of both antigen delivered by the end of the. we will meet this commitment. while sanofi pasteur represents 75 million doses of the two and 50 million purchased by hhs i'm proud to say that we represent almost 50 percent of what has been delivered to cdc to date. sanofi pasteur succeeded in providing the vaccine as projected however there were some factors that impacted our considerable abilities and extensive preparation. the most significant factor was the lower-than-expected production yield for the see the

strain. it's unfortunate fact that mother nature but we sometimes see lower yields for seasonal flu. however, the initial use for h1n1 were exceptionally low. utilizing our expertise we been able to optimize the productivity of the virus and our current h1n1 yield should not be as significant factor going for. since april 30th we participated in weekly phone calls with hhs agencies including farda, cdc, fda and nih during which you provided on going updates and we voice and transparent about our progress. we now project will not only catch up completely but may be ahead of schedule in the coming weeks. the media coverage regarding h1n1 maxine schroeder this have spurted egg-based might be outdated and the production method we produce has seen many technological advances as a service to get a process proven adaptable to emergency situations like the current pandemic. in fact, this year provides us with an opportunity to compare the availability of with

vaccines compared with the egg-based technology and those using cell culture. in the end of these of the necessary uses a similar time frames and large-scale production initiated at nearly the same time. contrary to popular perception a cell culture is not a new production process and been around for about 25 years and does not save substantial time and it comes to producing influenza vaccine. it does not produce a saver are more effective vaccine and doesn't necessarily increase yields which was the critical variable this year. the production of a vaccine in all small steps many of which are the same regardless of the technology or medium used. for example growing antigen canada began after they virus is isolated and sent by cdc. following in the production method all vaccines must undergo quality control and safety testing. this testing accounts for approximately 85%, 85 percent of the production time.

this year's sanofi pasteur faced the complex challenge of producing to maxine simultaneously. i'm proud of the work of our people in ensuring that sanofi pasteur will not only is commitment to deliver 75 million h1n1 doses to hhs but also its promise to deliver all doses to its customers before the peak of the annual flu season. it's important to note that we still have a long blue season ahead of a spear, again it's a credit to all involved we been able to respond as well as we have to dissent and wallace important to discuss where improvements can be made i believe is equally important to recognize the accomplishments. mr. chairman, thank you for allowing me the opportunity to testify and i look for to any questions. >> thank you, dr. lakey. >> mr. chairman, members, ranking member, my name is dr. lakey, to permit a state health services as an honor to be here today. i've been in this position for three years and have the

opportunity to service in multiple public health events including hurricane dolly, ike and to stop, my background is an infectious disease physician in training in pediatric and told infectious disease and like members that have testified earlier i been affected by this. i was a first health officer to death of active and my family was also infected. history taught us that in the massacre and the challenges are timing and severity of the next pandemic but the last one was 40 years ago. state governments have planned and exercised their plans over many years. the challenge in 2009 was that this was significantly different than a high severity pandemic that many plan for. and therefore we are having to respond as we are also hearing how this disease. defining its severity. because of these differences are state and nation as a whole had to rapidly selector plans to match the situation in this ability to adjust the plans according to what you see is

critical component to any successful response. and this perplexing our plan included modifying our planet related to the distribution of the novel of h1n1 vaccine. previous pandemic plans had anticipated a high level high severity pandemic and many have focused on mass vaccination clinics, however mass vaccination clinics have many challenges as i've listed in the information i've given you. we also looked ask will based clinics and have their own challenges like i've listed in the information i provided some both strategies have significant challenges. in light of our real world experience texas and many others decided needed to adjust the plans related to the severity of this pandemic. we decided to use the private sector and the public health providers to local of the province in our state as much as possible to direct to providing the vaccine to the patient that they usually care for. this method allows us to target the vaccine to those prior

populations. we've worked with pharmacies it to figure out how we could provide vaccines so they could provided in the private-sector. devastates are using alternative strategies based on their. is, public health infrastructure. structured in many different ways across the united states and the resources and capabilities each have. in order to facilitate this texas had to develop new resources and tools in order as to register providers then pre identify individuals within each priory population. we have made that web based application and linked it to our primary information source at www.texas blue.org. we have 12 us in 600 and health care providers in texas that are part of this distribution system, registered to receive vaccines and of those we been able to apportion vaccines to 7,000 providers and our state. in order to complement the system we have worked with 211 in order to address concerns with health care providers or

general public in order to secure them to or confine vaccine. due to the limited supply discuss today, states have had to further adjust these plans to help insure that the most vulnerable individuals are protected. for example texas so far has been allocated 3.7 million doses of that. we've been able to order 3.3 million doses. however, that's the amount of vaccine we were told we would have available back a month ago in mid october. because of a limited supplies we had to turn in our population is based on risk and the type of vaccine is available. gradually expanded those groups as additional vaccines became available to us. i've outlined in the system for the distribution of vaccines to providers in this in a texas and information i provided you and note that once the fda approves and releases a lot, the cdc of worms this is about the type of vaccine available and that a lot of additional work has to take place. we have to match the providers

that want vaccine with that available ensure they still want that vaccine and make sure that they are ready to accept that. it's a challenge to match the current priority groups and to the providers that these populations serve and also ensure that we have a geographic distribution across a large state like texas. this can get complicated and tedious process. we been adjusting our awareness as we've got to the seven and recently adjusted our plans to ensure that 20 percent of the allocation that kantor is a went to the local health departments of the good will and the gaps that the private provider business of supply. alibi to finish my time by mentioning several challenges that we have faced as this pandemic. note this pandemic only occurred seven months ago and has been noted here a lot of work has taken place across the u.s. and relatively short amount of time. furthermore all this work was accomplished and a background and significant reductions in public health across the west. we estimate approximately 15,000 public health positions

eliminated over the last year across the united states. now despite this success there's a national perception that we are falling short. partly because i believe we set expectations too high at the amount of vaccine available initially. in the national supply has been adequate to meet the public demands created. additionally we create the perception that vaccines would be available to all party groups immediately. these priority groups account for almost half of the u.s. population and because of a supply limitations we as a state had to narrow down as priority groups in order to get the best use of that limited resources. there's also confusion about that process of how vaccines are allocated among ordered and shipped and the steps i go into ensuring and gets to the individuals that need it and our differences between how the state's manage that because of the difference structures. these misperceptions have led to false impressions as states are either not pulling down a lot

meant or that they are not being allotted the amount that should be accorded to the population. both of those impressions are false. there's also a challenge in developing tools to link individuals that are seeking vaccines with the providers that have the vaccine and various tools have been developed including web based tools, there are challenges with those tools and the providers we are shipping doses to me only receive this, the vaccine and if we put their name on the web page we may steer a lot of the individuals to those sites and give another false impression that vaccines would be available. i think that would compound the current challenges we're having. instead of doing that we in the state of texas have worked with 211 and provided them a list of the providers and have steered individuals to 211 and give individual guidance on when they concede vaccines in their communities. we also as i noted earlier sent additional vaccines to the local health providers.

>> please summarize. >> i think we also have a challenge related to the public health funding in that has been alluded to earlier today. the intermittent nature in which some of the funds have come down, one time bunning and has been difficult but and i to say thank-you to the funds that have been made available to the public health emergency response funded this last year. those have been very important. and finally i like to say that we appreciate the commitment of the cdc and the office of assistant secretary for purvis response for how they engaged in local and state public health. we have continuous dialogue with them in order to work out issues to best serve a population of united states. thank you. >> thank you. dr. lee bayh, your testimony. >> thank you, mr. chairman. thank you for this opportunity to speak to you today about our preparation in response to the 2009 h1n1 pandemic. i'm here on behalf of just for america's health, and

nonpartisan advocacy dedicated to saving lives by making prevention in national party. why understand that today's hearing is a result of considerable frustration with current h1n1 vaccination program i want to emphasize four critical points. first, public health system at all levels of government has moved with remarkable speed in approving h1n1 vaccine and getting them to as many americans as supply permitted. we've moved as fast as or faster than any of the country in the world. second, the vaccine is well matched to the circulating virus and has been proven to be safe and effective in clinical trials and offers the best possible protection against the disease. third, whenever our concerns with production capacity are today and the federal government not made a multibillion-dollar investment in enhanced faxing production capacities since 2005 we would be in far worse shape the limits on supply we are experience of the limits imposed by the science and technology. the decision to use central purchasing and distribution of roche as assured as supply

became available and it's been equitably distributed across the nation. and finally the federal government has been remarkably transparent with the american people about this pandemic since it began last spring. public health officials have leveled with the american people making a proper adjustments and recommendations as our understanding of the nature of the pandemic evolves and supply issues arisen. the response to this pandemic has mobilized all levels of government. while the government has assumed responsibility for distributing vaccines to departments, each locality is then responsible for developing its own policies and systems. this is post a number of challenges, particularly in the context of vaccine shortages. first, local health officials received constantly shifting information about how much vaccine would be available and when. this is an issue that is not only critical condition among american people but also in the job of local health officials are more difficult. second-largest vaccination campaign in the u.s. history is taking place with state and local health departments are experiencing devastating losses

because of the recession. of the government has rapidly pump almost $1.5 billion to in the province for pandemic response to this doesn't address the underlying decline in the core capacity of health department's. third, public confusion may well have been exacerbated by the fact that each state and locality as determine how to distribute its apply once received from the federal government. although each department base their plans on larger supply, hhs may want to revisit the issue and consider standardization in future emergencies. it's our hope that this year will contribute to the public's understanding of the complexities of the gramm pandemic influenza vaccine campaign and among the kia wishes midteens critical to the success of the response to this and future epidemics are: first education campaign is needed to assure the american people about the safety and effectiveness of influenza vaccines and all vaccines in general. it's important to remind americans that even with the delays in vaccine availability

they should get vaccinated as soon as they can. we have not seen the end of this pandemic. fda should move toward in assessing the technologies that are in use and other countries including the use of adjuvants and sell based vaccines, however to move forward on an expedited basis without the standardize review would probably have a undermine an already fragile confidence in the vaccine system. congress and the administration should come to consensus on what is inappropriate level of investment in new technologies. this pandemic demonstrated nations has a long way to go not just a vaccine technology but with regard to diagnostics into antiviral treatments as well as personal protection equipment. the biological and man's research the agency has been underfunded since its inception. its support is critical to moving chronic technologies into mass production paraprofessional assessments suggest that they need in the preparation of $1.7 billion rather than the

current $275 million to achieve its mission. we need to provide ongoing support to help the province of building capacity to respond to the public on emergencies just as we don't one of our departments we must move away from the emergency funding mechanisms to respond to public health emergencies. this is one reason we support the funding for corps public funds that is part of the health reform bill. finally congress and the administration should assure replenishment of the strategic stockpile for supplies distributed to states such as 95 respirators, surgical masks and antiviral. we don't know what demand in future wave of this train will require nor can we forget the potential for other strains emerging such as the bird flew of primary concern until last spring. this has shown both our government at its best and highlighted many of the ongoing witnesses and a public health system. as we continue to ramp up our response to this pandemic we must also take steps necessary to assure that when the next

crisis occurs a stronger system is in place incapable of responding quickly, effectively and emily. thank you and look for to your questions. >> thank you all for your testimony. of dr. narasimhan -- how du cera last name? >> dr. narasimhan. >> let me ask you about november 3rd, you signed a letter back to the committee, we asked a number of questions of all the company's here. and the one that caught my eye was on page three, point number five peace said in while the government ordered both khosa and are proprietary adjuvants mf59 which enhances the policy of the louvre vaccine based on available data, quadruple the number of those doses supplied the government also determine the use of adjuvants was not wanted to combat the pandemic and elected not to use the emergency use authorization. these are a number of the questions i ask the previous

panel. it's my understanding and correct me if i'm wrong, and to other countries use your ms of 59 doses? with the adjuvants unit? >> per right, we have two h1n1 license in europe and other parts of the world with an f59 and are exclusively supplying adjuvants vaccines outside the u.s. >> okay. is there a safety issue? i would think the fda said they have not approved it and. my memory serves me to try to get it approved in the u.s. since 2007? >> is not approved in the u.s. but we licensed in europe in 1997. we have a pretty broad range of clinical studies now up to two and a thousand subjects in non controlled trials and 40,000 in controlled clinical studies. to date we have not seen any significant safety signal so but

continued to provide that data to ongoing basis. >> month 15 years here have always been on companies making sure these are safe, you say you been licensed since 1997 and the rest of the well? >> in the elderly and for this h1n1 we have a licensed under six months for the h1n1 and the adjuvants vaccines are less in six months through the elderly. >> i thought i heard dr. goodman of the last panel indicated they have ordered a stockpile of this and at that point to nine for your company. >> that's correct, we are maintaining a stockpile in kentucky. >> i asked when we get to the point where it's adjuvants or not are going to use it because the pandemic is so great in the united states. have they discussed that with you? >> we had a discussion with them an early man as to how to proceed and the decision at that point was only use license platforms moving toward. through the summer and into

september we have maintained that the capability to use adjuvants in case the clinical davis said that was needed and we continue to stand ready to do that but to date we have prepared a the e.u. a collaboration with hhs, we have not been asked to move forward with that. >> i think your testimony you started discussing this 2007, whether you adjuvants or not with the fda in 2000, applied for a license in 2008. is that correct. >> we applied for a new drug application investigational new drug in 2008 and we've been going back and forth with the fda since then. >> the use the this adjuvants issue, that just won't be with h1n1 but really any kind of a vaccine, is in it, because you

can quadruple at least in this case your doses? >> correct, the number of benefits adjuvants, you have children or elderly that don't respond you can make the response to the vaccine in increase the number of doses. another valuable thing adjuvants which was not relevant is that the virus changes so in the spring of the changes there might be the need to relax and everyone in the u.s. whereas with the adjuvants you can cover a certain variation in the virus we have seen in our clinical studies. we have a look at that in this case but it would at least provide that flexibility. >> dr. levi, is a fair to ask you, is it fair to say that this is something we ought to look at as a country? the fda hasn't licensed it. you wanted to make drugs save and that's my concern, i'm sure everyone's concern on this panel. are we missing something here? is it something we should look at closer? >> it's something we should look at closely and i believe that the fda is doing this in good

faith manner. i think when you think about who we are targeting for this vaccine, the bulk of the data for using this adjuvants vaccine and occurs with the elderly, that's not his targeted in this vaccine so we're just beginning to get the kind of data would be associated with kids. but i think the larger question is we have so much maxine hesitancy in this country. so much inaccurate knowledge about whether vaccines are safe and particularly whether this blue vaccine is safe. to add onto emergency use application, a new element that may, indeed, be saved could well have undermined the efficacy of this campaign. >> so this one has been around for since 97 or so and been approved. would it be prudent to maybe leave the decision to the parents? whether or not they want their child to be vaccinated with then h1n1 it maxine and that is to the unaided as opposed two not?

>> it is sometimes hard to understand why there is so much hesitancy round of vaccines in general in particular vaccines. we have had a real public health question as to whether people would accept vaccines that have a new product in it. now, and things have been worse in this had been a much more severe pandemic we may have needed to go that way anyway because whenever risks around hesitancy might have been overcome by fear of the virus itself but i don't think that's where we are. i do believe that we need to move expeditiously in preparation for any pitcher pandemic to be able to better address these questions about adjuvants and other technologies. >> my time is up. mr. walden for questions. >> thank you mr. chairman. for those of us who don't spend our lives in the world you are in, consummate give me a 22nd explanation of adjuvants?

>> adjuvants have been used in vaccines in the united states since 1920's, there is one used extensively. adjuvants he might pull my clothes are. >> adjuvants are actually additives we put into vaccines that boost the immune response so in this case what we would do is make the vaccine as we normally would make it come ad in the adjuvants and see how the vaccine performs and typically a lot less vaccine is needed in the immune responses higher. >> in your clinical trials overseas did i hear you say directly that you haven't seen any adverse response, maybe not any because you boys have some but nothing out of the ban and he would look at? @ @ @ @ @ @ @ @ @ @ @ @ @ @ @ @@

>> i can get back to the exact date. >> and what else do you hear from fda that you need to supply that you haven't. the question is as a company how much can we expect to repeat. with flu vaccines being not as

profitable as they are -- >> are as profitable as they are. which is to say that they are not. which is going back -- let me run this on air. if there were the feared avian flu that we had hearings on the potential of four out of every ten dying because of it, i guess we would declare some sort of emergency, and take whatever risk that there is. if you are using this mf59 in europe, and you're not seeing any real problems, i just wonder what it would take here to get going on that? we should ask fda more? >> i can't speech for the agency. if the severity was such, or the if unadd jew vented vaccines to

work. because they had a unadjuvanted vaccine that did work, the u.s. government has supported a lot of the work that we've done. >> but looking at from where you are today, what kind of timeline do you think? i realize you are regulator, and i don't mean to put you on the spot. what kind of timeline? >> the way we look at this is we have an h1n1, with and we have seasonal, and h5n1. our goal is to get one or all of these licensed as soon as possible. and, you know, we would be willing, of course, to file as soon as we can find a path with fda that makes sense.

>> are we the only country that doesn't allow the adjuvant? >> at least for novartis, that is the only one we don't supply is the united states. >> so if i could just come. >> yes. >> csl has a unique adjuvant swell that we developed in australia. we also have multiple research programs going on with partner companies who developing vaccines utilizing our adjuvant. and this is being manufactured in illinois. it's being used by other companies. >> and as you've used it in other countries, and if i

understand you connect. >> we've done the studies in h5n1 in australia. >> it has to be safe. >> okay. we're also able to produce in the holly springs facility. we expect the mf59 in holly springs to be operational in december. >> all right. my time is expired. i know we have other members here. >> thank you. i was going to use my time with dr. lakey here. you are the state guy. i don't know if you are here when i asked the first panel. all of my questions were able distribution, and also about funding. because dr. lorie brought it up.

how many doses and do you agree that these decisions should be left to the states? or should they be dictated maybe a little more strictly. i know they have guidelines. i know if you were here before, but i've been getting all these criticism about the wall street firms getting the -- brown, the vaccine because they can distribute it better. or some other places. you know, and we're hearing in my own state of new jersey and new york about major despairties. i just want your response. i know you are a state official. you probably think states are great. i just like your response. >> let me provide some background related to how we do this. we have the high-risk groups. those were further prioritized into a group from taking it 159

million to about 49 million. and so the challenge for us has been the changing landscape. how much vaccine is going to be available? you can't provide the school-based clinic if you are imimmunizing healthy young kids. states look at those groups. most states look at healthy workers, pregnant women, as the top individuals we needed to start the program with. the challenge was that the first vaccine was available was the nasal spray. so we couldn't immunize pregnant women. >> just to interrupt you, one of my school districts has the nasal spray. and it doesn't have the vaccine. and they want the vaccine instead of the nasal spray.

>> yes, it's a matching of the vaccine that you have available with your priority groups. and your distribution system. what systems do you have available? and so a lot of us state health officials try to move from large vaccination clinics to using the private sector. >> so you use the state -- you use employers as well, the way new york does? >> we're not using. we're providing it to the physicians that the health care systems, -- >> so you don't actually, i know i'm interrupting where they would go to large employees and have them do the distribution.

>> do you think that -- i mean -- i'm going to criticize another state. would you -- new york obviously uses some of these large employers. does that make sense? >> i don't know the details. >> i know. >> new york, from what i have gathering is that they have been trying to meet the priority groups. and trying to reach pregnant women in different ways that they could do it, and i cannot speak to the state health officers. >> you did mention the challenges of intermitt than health funding. dr. lurie brought up the funding challenges. i don't remember the secretary mentioning that when she was here. if you need money, this is the place to come for the most part these days. talk to me a little bit about that. >> i think there's a couple of

issues. federal fund that were made available. after 9/11, a lot of funds were made available. it peaks, and then it declined. we receive half of what we were receiving earlier on. we also had in 2006 one time funding related to pandemic flu. and so that money was utilized to put together plans. but you can't hire people for long term on one-time funding. so that funding went away. those plans were made. but you can't continue that process after those funds have went away. you were the states could have the leeway to do what they want pursuant to the existing guidelines. >> i guess clarification, that's for the folks that are being

vaccinated. >> in terms of the distribution. >> distribution system. i think where we are, folks are trading up those groups. they used those systems. you have public health that's structured many different ways across the united states. and they use that uniqueness of their system, who they can reach the quickest in order to determine their priority groups. using the same basic philosophy, trying to get pregnant women, young kids, health care workers from the beginning. then how they massage that and adjusted that was dependent on what that state system was. >> thank you, mr. chairman. >> thank you, mr. chairman. and thank you for the panelist for being here. we spent a lot of time on adjuvant and how it boosts us.

i want to focus on the nasal spray. so doctor, i know in your written and opening statements you mentioned this -- the, i guess it's intranasal technology. and the ability to get 80 to 100 versus one through seven doses. can you explain that to us and why that's -- i mean if we are talking about meeting a lot of doses from the layman's point of view, it sounds like a good thing to be focusing on. >> i think two reasons for the one is i think we develop our own seat strain. and using the genetics, we can quickly screen multiple off of the vaccine and select for gross properties, for instance, for the h1n1, we basically screen 23

variants and did not lose any time. we were at production at scale on july 3. i think the other important factor is we were able to actually immediately create an h1n1 strain which produces as much as we have seen in the past. and then the other advantage of the life of the technologies is actually you spray it in the nose. you have the replicates there, and it creates a immunal response. if you compare to the vaccine. you need a very, very small dose. maybe if you compare it from let's call it quantitative versus factor of 50 or lower. so i think that is very important attribute. i can tell you that we have over

100 million doses. we could have gone up by 200 million by the end of this year. >> what peaked my interest is also some of the comments chairman pallone got into the discussion. the nasal spray issue is not for .women. but there's a lot of other. i mean the other two groups there would be no prolix for them. is that true? >> that's correct. >> so i think he mechanicked a school that didn't want to do nasal spray. >> we do not have pregnant women in our label. we cannot administrate the nasal spray to that population. but a majority of the risk population is covered. so i think very important that

there is enough dedication to actually objectively make people aware of the choices available in the flu vaccination technology. because maybe people not only react to the nay stall vaccine, but it may be the same fear factor. and i think those are assumptions in the public that could be avoided by a targeted education campaign where it is emphasissed that the safety and efficacy of the general vaccines available in the u.s. is good. >> thank you, dr. lakey, it title of the hearing is an update on the production and distribution. when i read that, i always think distribution is can the drug get from point a to point b. i think what a better title for this would have been in the decision making matrix of who gets it, not -- for me, there's

no distribution problem as far as you see if when this is produced to a delivery to an end point user is there? >> for the most part no. there is weather events and et cetera that have slowed that down. the distribution system has worked. what else do you think we need to do? you probably listen to the opening statement. if we can't get this right, what do we need to do to prepare ourself beddy for something that would turn out to be a bigger problem? >> i guess i've learned through other events such as hurricanes, you have to take time of what went well? you could have done better just

learning from your experiences. i think making sure that we communicate effectively to individuals real expectations and not set artificially high expectations. because i think the general public will response when we give the right expectations. >> and i agree. my time has expired. thank you, mr. chairman. >> thank you, panel. >> mr. green, questions please? >> thank you, mr. chairman. and dr. lakey, i appreciate you being here. glad we jolt to meet earlier. -- got to meet earlier. i appreciate what you've done three years as the commissioner for health in texas. i guess one of my interest is the delivery system. our big issue is why we don't have enough vaccines. i know you experience it every day. one of the channels that you mention is associated with

school-based clinics and vaccinations. and i noticed in today's use in the chronical, some of my school districts are actually doing it. hubbleable, and i was wondering, are you having any resistance for schools, particularly schools that from school-based clinics for providing the h1n1 for your students? >> i think what we are seeing in texas is a mosaic of strategies working together to get individualed immeaniesed. i think some schools have systems with a lot of experience. and those seem to work. there are other school systems that haven't done that well. haven't done it in the past. they can provide consent. and other challenges. they are folks that you have to have there to provide immunizations. we are using the funds that are

provided for individuals. but all of those things have to come together. that's one part of the system. we are able to do that now. because in texas, as we tied up the number of groups, we've been reaching the high-risk individuals. the children with asthma, et cetera, so we are now able to expand out to some of the healthy kids in our state. >> okay. can you tell us how public health emergency funds help you and other state public health departments set up and operate the h1n1 program. >> excuse me me again, sir. >> how the public health emergency funds that you receive help that. >> yeah, the public health emergency funds came in three components. and they've been critical to the ability to respond. having feet on the ground in order to investigate cases, figure out whether it's h1 or

not, that's been critical. we've been able to improve our laboratory capacity. having the individuals in the laboratory to process samples. that has been a critical component. we've been able to develop the vaccine ordering system in order to make sure that we have that technology in order to accomplish this. 81% of the funds that came in public health emergency response three, we sent out to the local health departments so they could hire the individuals to be able to respond. a lot of them are shrinking and can't provide the investigation, the delivery of vaccine, all of the different man power components without the funds that were allocated in order to hire those individuals. >> dr. lakey, i know you released the report on the pediatrics on the school-aged children.

they are the population most responsible, and the highest rate of attack. there's that report also sites in five a school based pilot program in the state of maryland where flu was administered to children in several secretary and elementary schools. the results were that the program shows significant reduction in respiratory illnesses within households of children that receive the vaccines versus schools that do not participate. it seems like that report, and i'm sure there are others that prove that show school-based facility of course with the parents permission. but they make it available to parentses is the successful way to deliver that. >> absolutely. and certainly using school-based facility for both immunizations and other types of health care are important. this is a tremendous opportunity to reach kids. and, you know, a lot of our pandemic planning assumed that kids would be -- would not.

it would be more like seasonal flu and the elderly would be most vulnerable. as it turned out, young kids were the most vulnerable. and so having, fe with have a strength in school-base clinic and immunization program, we'd be in better shape today. >> mr. chairman, the reason we are hear today, to ask our producers of the vaccination, i know there's been a loot of discussion regarding benefits of new technologies and to produce flu vaccines in the cell culture is at newest one. i understand there's no difference. we wouldn't be producing faster vaccines using cell as compared to the eggs. if each of you as brief as you could, is there something we could do to make it quicker, whether it's eggs or the cell. >> i think culture is not a game changer. i think i'll steel that phrase. the game changer probably is something along the lines of a

universal flu vaccine which you would stockpile. over the course of seasons. and that's a long ways away. in terms of saving time, whether it's cells or eggs, again, dealing with mother nature, you have to doubt the virus to the system that you are utilizing. and perhaps with cells, maybe you save two or three weeks. but in terms of cat, and overall production capacity, i don't think it's a game changing. to get vaccine out there at about the same time. in fact, the two facilities that we have based in the united states. they have the potential to produce 150 million seasonal doses. if you convert to that monovalent, that's 55 doses. there's present of capacity with the two new -- one few facility and our existing payment. we really need to look at is why are we immunizing as many people on a seasonal basis. when people die every year, and

200,000 people are hospitalized. we have recommendation that 275 million people should be immunized on an annual basis. we're lucky to immunize 100 million people. if you want to sustain the production, development of new technologies, we really need to make sure we get more people immunized for the benefit of public health and capabilities. >> i think there's an important dynamic. >> we have two licensed vaccines

now in europe. we are producing for europe. unadjuvanted and seasonal. our belief is you get some speed game and our expectations in a different view. it was on the order of six to eight weeks. in the worst-case scenario for the american public. that doesn't work on different influenza strain. suddenly you have a real crisis. i think there's a wise strategy to invest. simply because we don't know how any other virus will behavior. >> okay. quickly. because again, we're going to have votes here soon. >> for us, you know, the acts are working well.

i think if you can have the cell culture technology also available, you risk you risk the supply of x and those kinds of things. i think the scalability is very critical. and i think especially if you think about the life of the flu technology, we have facility in maryland. these 22500 reactors. the cell culture technology, we could manufacture half a million doses. i think the guarantee supply for the flu vaccine.

>> thank you. and along with other members. we appreciate it. we'll start with the questions. >> you're kind to point out that i did rewind. you finished up on an excellent point. mike levitt came and testified here in 2005. it was very, very difficult to develop the number of eggs that would be needed to produce the vaccines if we'd called all of our chickens the month before. let me just ask a couple of questions of all four of our manufacturers. and i'd appreciate brief answers. but when in this sort of timeline that's been going on. when did you find out with the delay? when did it -- did you really appreciate we're a month behind? >> i'll respond first. i think that we did not, because we did not participate in the pandemic rpf that was put out by the government a couple of years ago. our was different. we started the negotiation in

may and finished in may. which is the fastest i've ever done a contract contract. which was quite nice to see. and we had to submit at that time our schedule that we assumed based on advantage yields. when we sign the contract. within three weeks, we could see the virus was not growing well. we could see the developing strains. in fact, they were 1/2 to 1/3 of when we expected. our expectations were set on 10 years of seasonal assets. as all of the manufacturers here will tell you, each new flu season a flu season. you have a medical background as well.

>> i want to point out for clarity sake, we can't confirm until we receive fda reagents. with initial testing, we saw the reduced yields in july. we communicated our situation weekly with hhs. as the manufacturers. >> it is different. but what about? >> so just the same for us in terms of realizing that we first started out on a very conservative estimate in terms of the yield of the virus. it was actually about 60% of what we thought it was going to be even on a conservative number. we had weekly phone calls with barta, hhs, all throughout the way periodically as we gained new information. >> i'm a little concerned. because i had conversation in august with cdc and nih, and was given assurances that when school started we would be well on our way of having, depending

on the approval process, well on our way by mid october. that was the timeline that i was laboring under. let me ask you a question. in the end of october secretary sebeilus at the senate hearing said she was going to put out a call to the manufacturers to accelerate production. i'm going to assume at that point. is there any you did differently as a result of that call? >> at csl what we did is when we did receive the call, we took another look at our ability to fill and finish vaccine. producing the and antigen is one piece. then you have to get it into syringing. our plans for fill and finish, our inside plans that produce other therapies. so our csl business includes

protein and plasmatherapies for rare diseases. we have to adjust our lines and man power in order to see if we can free up some manufacturing. >> you did that as a result of the call? >> we were evaluate along the way. that was called reinforcement. >> let me just ask if any of the manufacturers. was it problematic for you that you were at the point that you were gearing up for the seasonal flu? and you suddenly had the h1n1 task added to the equation. >> i think it was just a compression of the timelines. we had to complete our seasonal flu at least for the case to complete our planned flu doses which is what we were requested to do. and then we started h1n1 in july. which brings us to the short time frame. go for the runway to get the plan off the ground. >> still, there's been difficulty getting seasonal flu vaccine out. i know our community has been lacking for several weeks.

are we back on schedule with the seasonal flu? in our case they were completed in october. >> completed them. but for example, my walmart back home is out. i know i could, and i should. but for the other vaccine, in our area, it's been harder to come back. dr. lakey may know more about what difficulty we're entonightering there. let me ask pedestrian immune on the issue. -- medimmune. are there adjuvants that you use. >> we don't use any adjuvants in ours. >> because your yield is such that the yield is so high? >> yeah, it's live virus. and it basically replicates in the nasal cavity. you don't need one. i want to highlight that we completed our seasonal manufacturing also in time, and

we were even able to accelerate it to free up more manufacturing capacity for h1n1. >> dr. lakey, thank you. let me just ask you. because texas has had some problems. and some of them made their way into the front page of the newspapers. but when did you learn that texas was going to be having some difficulty delivers on the vaccine shipments? >> i think we learned as vaccine was coming out that it doesn't what we had anticipated. so in early october, as i recollect that when we figured out when we were being told was not that we had been told in the past. >> do you feel that cdc and hhs shared information with you in a timely fashion. >> we've had multiple calls with the cdc and the office of the secretary of preparedness and response. they showed predictions that a lot of them change pretty quickly. >> no, has -- have they been

helpful in helping you adapt to the changes in the vaccine availability? the >> the cdc has been helpful to us in the state of texas. when there has been issues that have arosen, we have called them individually. we have conference calls two times a week. with all of the state health officers to discuss issues and to have a question and answer time period. so they have been available and have answered questions. >> and how about the manufacturers themselves? have nay similarly responded with information when you needed it? or do you communications go directly through cdc. >> my communication would go through the cdc. the manufacturers would discuss that information with the cdc. there hasn't been a direct conversation between the state health departments and the manufacturers. >> and you and mr. pallone talked a little bit about funding. do you get the feeling that the

level of funding, the $1.5 billion was not satisfactory. do you have an idea? >> this is the funding right now. the associate of health officials talked to state health officers to figure out what they think they would need. that survey thought that about 800 million would need to be available in order to continue this response through march. some state health departments are in better shape than others. some, i believe about half of them are predicted to run out of their fur funding by the end of this year. and so you have, again, state health departments are in different situations that the -- when we've tried to look at this systemically, throughout the united states, the number was about $800 million to get all state health departments through the end of the pandemic. >> now you've indicated to me

that you see the number of cases is actually diminished over what it was even just a few weeks ago. yet we are coming up to the holiday season between thanksgiving and christmas. i member my days in the clinics, you typically see a great increase in virus syndrome around christmas time and the weeks shortly after. do we anticipate a resurgence of the number of cases towards the end of the year because of the amount of travel? >> this is correct. as a state, we monitor the percentage of visits to physicians that are for influencelike illness. in texas it's 13, we've gone down to 7%. the nature of pandemics occur in waves. we predict there'll be a third wave. the challenge will be how that third wave corresponds to the seasonal flu. do we hit one and then the other, or seasonal flu on top of h1n1, which would be a challenge

for state health departments. >> and i have to wrap it up. >> a final thought. we're right next door to mexico. this is where it began. is there any thought of what might be happening to the evolution of the pandemic. are they on their 2, 3, or 4th wave around the time that it was introduced last year? >> i don't know if i can excellently answer that. i they -- intelligently answer that. i think they are going to have a way. one the challenges for us is that -- is there a correspondence between the severity and social economic factors? and poor areas of our state, or in poor countries do we have more significant disease? and so we are wrestling with that currently. >> but it exacted us last year when they became ill. we developed symptoms very quickly. >> infectious disease does not respect borders. it came across the border

rapidly. and, you know, throughout the southern part. the hardest part of texas, the part of texas that was hit the hardest was our southern border. if you look at our fatality rates, there's a significant pitch of our border versus the rest of our state. >> thank you, doctor p. >> i yield back. >> well, just in summarize, we're going to have votes here in a few minutes. we'll finish up with this panel and hearing. it's fair to say we're going to get another wave of the h1n1. right now it seems like we're at the calm before the storm. is that because there's more vaccines out there? or what is it? we're going to get ahead again are we not? >> i'm not sure if it's -- there's probably several factors. one the natural history of pandemics coming in waves. i think that's what we are seeing. you'll see differences across the united states. activity is decreasing, and texas is rapidly increasing in other parts of the state, and the new england part of the

nation. and more natural history is they occur in waves. our goal as we vaccinate individuals is that we can blunt that third wave. that's why it's not too late to immunize individuals, between though the wave is drug couriering. >> we have not seen the intensity as in other parts of the country? >> as we get into the colder season, as the humidity changes, as the environment is more conducive to the spread of infectious disease, it is likely to spread. >> let me ask y'all this question. just to summarize. it's my understanding from listening throughout the hearing that there's really was a pretty good cooperation or with the government in working this one out between communications, coordinations, and even moving some contracts quickly. is that fair to say. that usually, there's usually on

the government. sounds like this time all of the preparedness they have done has worked out fairly well. is that fair to say? you are all nodding your head, yes? okay. any other question before we close it down? >> i am distinguished. secretary sebeilus did indicate that we would have what we needed. although they were off the record. i got the information that they would study. was it as mad as what they thought. and in the hands of the providers. at that point the fear was what if it's worse when the school year initialuates. we have to push the stuff out the door before the clinical trialed are finished before the end of september. i'm still uneasy.

my very first statement was i was worried that we were going to underestimate the severity of the virus. >> that has not held true, i think between the know production, and the great demand, it has led to the frustrations that we feel. that's the purpose of the hearing to get to it. i think we learned a lot from this on the previous panel. overall, i think the government cooperation has been pretty good. right above par. so with that, let me conclude this series. that concludes all questioning. i want to thank all of our witnesses for coming today. and for your testimony. the committee rules provide the members have ten days to submit questions for the record. that concludes our hearing. this joint hearing is adjourned.

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>> host: this thanksgiving holiday we have four days of booktv. beginning thursday morning, we'll feature books on public policy and politics. you can hear from two of the little rock nine. watch super freakonomics. you will also see norman from the miami book festival. from thanksgiving morning, right through monday morning, watch booktv on c-span 2. you can also follow booktv on twitter at twitter.com/booktv. happy thanksgiving. >> on this vote, the yays are

60, the nays are 39. 3/5 of the senators having noted in the affirmative, the motion is agreed to. >> with that vote, the senate moves it's health care bill to the floor, starting monday and through december, follow the entire debate, and how the bill would affect access to medical care, the public option, taxes, abortion, and medicare. live here. the only network that brings you the senate, gavel to gavel. >> now an event with john limb -- limbert. he was one of 53 americans held hostage from 1979 to 1982. this is just over an hour. i guess it's not unexpected. but i'll tell you the background to the invitation which is rather ironic.

it'll be on sale downstairs after the event. the book was published by usip in 2009. clearly anticipating the obama administration's desire to break with policy and engage iran. those efforts of course have been complicated by the current political situation which few anticipated. as the secretary said at the recent annual conference on november 10th. he said we have before us a historic opportunity relating to iran. but it will not last forever. it's time to iran to decide whether it wants to focus on the past or move beyond it. whether it wants to dwell and imaginary enemies or make a positive choice about the role that it seeks to play in the world. you can find his speech about iran on our web site by the way. now this is a very important

occasion. we had invited him to speak in october. there was a scheduling conflict, and we scheduled for today. of course in the mean time, the administration had the foresight to appoint him deputy of the state for iran. which seems to be a position that was created for him. there were a few others that know as much as iran as ambassador. he lived there as a child. his parents served with the usiad. he worked there in the peer corp. and studied and learned there. and he had the honorable in being in tehran during the hostage take over. and spent 14 months as a hostage. he received the state department highest award, the distinguished service award, as well as the

award for valor. he went on to have the distinguished career in the state department, serving in many fine and easy posts like djibouti, and finally ambassador in 2000 to 2003. your poor wife. my family got all of the hardship posts as well. i know how it is. in 2003 he was one of the first to enter baghdad with the organization of reconstruction and humanitarian assistance. since his retirement, it's he's a distinguished professor of the international affairs. he's authored two other books, iran, war with history, and sha rod in the age. i should note that he is here today, speaking not in his capacity as the das, but in the capacity as the author of "negotiating with iran" that needs to be made clear for all of the question who wants to ask him questions in the role as the

das. please join me in welcoming jim limbert. >> well, thank you all for coming out today. [applause] >> let me say first of all at my publishers request, i am not going to read from the book. the publisher said if you do that, who will buy it? so i'm not quite sure how to take that last comment. but i spare you reading from the book. but i will rake references to it. the story of this book and of this whole subject for me personally begins with a personal failure. that happened almost exactly 30 years ago. on the 4th of november, 1979. when a group of very unhappy young iranians stormed our

embassy compound. they were unhappy because about two weeks before someone in this folks in this town decided it would be a good idea to admit the deposed and ailing shah of iran to the united states for medical treatment. well, two weeks later, we found ourself in the embassy, behind a steel door on the second floor of the old chancery, the dearly beloved henderson high as some of you may remember. and on the other side, there was the group of unhappy iranians. well, it befell to me to having

made one of probably the worst decisions of my foreign service career to go out from that door, to go out from behind the door, and attempt and, i use this word with some trepidation, to negotiate with this crowd. to see if there was something we could do. and they could get them out, or at least delay them. because what was very clear to us already was that there was -- we were on our own. if anything was going to be done, we had to do it. we had made calls to the iranian government at the time, or at least what passed for the iranian government. something called the provisional government of iran. and it was very clear from that

contact that there was no help coming from that direction. when i called, i think it was foreign ministry, i got a secretary on the line who said, oh, thank you, it's so nice to hear from you. those passports we sent over, are those visas ready yet? and that's what they seemed to be worried about. they were hedging their debts do as to which direction the politics we're going to go. washington was clearly far away. it was 3:00 in the in the -- it was 3:00 in the morning on a sunday morning. in washington. that ended the normal resources available for washington to help us. for example, a high-level call from the secretary of state, or

from a assistant secretary sauders, or wasn't available. anyone who would have taken his call, which is call, done anything. and anybody that could have done anything wasn't taking any calls. certainly not from americans officials. we were on our own. i did it on my own. it was a terrible idea. but no one had a better one. there i was confronting the group of excited young iranians. and my success at this particular negotiation let's say was less than perfect. as a result, i and 50 some of my

colleagues of the guess of the aye talalay. and there we were. well, i'd looked back at that encounter. i often ask myself, is there something i could have done better? what were the weaknesses in my technique? is there some way i should have negotiated that would have had a better outcome? maybe just stay behind the door. if that was the case. although i don't think that would have had a very good outcome. i don't have an answer. perhaps the only answer i come up with is this if you are at a

high-stakes poker game, and your hand is a pair of 2s, you had better either be a very good bluffer, or you should not have been at that game at all. you shouldn't even be there. it came from what i was writing about this in book. and if i could use a burden of proof here for a minute. -- prop here for a minute. you'll notice that i did not call the negotiating with iran. that's deliberate. i did not call it negotiating with islamic republican of iran, i did not call it negotiating with president ahmadinejad. because afterall, those of here

and there are many -- much more to negotiating with iran than the absurdities of presidential statements, coming out of tehran, and the nastyiness of the current system. the question in the book is not should we or shouldn't we. i mean i have my own views. that to me is not important question. the important question is when we finally end -- move to end over -- what has now been a 30-year astrangement, how do we do it?

how do we deal with our iranian counterpart? whatever the counterpart is and whatever government he or she, but more likely he, happens to represent. now in the interest of full disclosure, let me say that by training and background, i'm a historian. and my real love is iran in the 14th century. and 14th century she rods. and that was a time that iran produced some of its greatest masterpieces in architecture, painting, coalition a if i, and particularly in poetry. it was the time of the poet hafez who produced, who's lyrics

are not some of the greatest masterpieces, but the great masterpieces of world literature. so you had a creative, vibrant, artistic people living under rulers who to put it bluntly, were thugs, fanatics, and bigots. now that's 14th century sherods. now it maybe coincidental, but some people have noticed a certain similarity between conditions then and conditions now. but i won't -- you can draw that conclusion for yourself. now my historical dice also comes through the subtitle of the book. which is wrestling the ghost of

history. because my view is that when we in the iranian are in the same room, or when we talk to each other, or when we attempt to talk to each other, that there are ghosts in the room. and that we need to be aware of these ghosts. and these ghosts are numerous, they are strong, they are very powerful, and they are important. there is the ghost of our cia activities, there is the ghost of the old oil concessions, of mr. darcy, for example. there are the ghost going all the way back to the treaty. maybe there are good benevolent ghosts out there. and howard and the embassy

takeover. these ghosts are all there. and they are going to like it or not, they are going to effect how that encounter happens. they will be in the room. now i looked at four case studies here. and two of them actually have nothing to do with the islamic republican. two of them come from before the islamic revolution. those are the crisis of 1945,