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tv   Key Capitol Hill Hearings  CSPAN  February 16, 2016 12:30pm-2:31pm EST

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unified budget that clearly outlines priorities for r&d and procurement or medical countermeasures and pandemic influenza products. such a strategic a doctorate would provide much-needed transparency on governmental priorities and project requirements the something companies to determine what products to pursue in this partnership. the ncm enterprise must be fully fund. project bioshield special reserve fund was created to provide companies with a guaranteed market for mcms establishing any tenure advance appropriation of 5.6 billion. it as rfs indeed prove successful in attracting companies to invest in m.c.m. r&d. 12 incidents were procured during the ten-year period and there are over 200 mcms in the pipeline. progress major congress' initial $5.6 billion investment is now in jeopardy. the sof was reauthorized a 2.8
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billion for fy 2014-2018 rather than a set aside some of many, the program has been funded through annual appropriations and much lower than the authorized amount. iand less than the increase is we're risking a $600 billion, to a $1 billion shortfall. such a sustained deficit endangered the progress we've made and put the 200 product candidates in the pipeline at risk. similarly pandemic influenza has been woefully underfunded the last few years. pandemic influenza is a known threat that is challenging, universal in its persistent nature. it is imperative, pandemic preparedness includes advanced developer of vaccines and antiviral's and diagnostics, rapid response capability building and the replenishment of vaccine and antiviral stockpiles. our plan calls for congress to provide the legislative authorization to define and guide pandemic influenza programs in order to ensure that
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they receive the funding needed. novel incentives to demonstrate the government's commitment to m.c.m. development. one of the most important instances in the report is a priority review voucher for pathogens decide as material threats. the prb is a proven and other incentives help to spur investment in a complex neglected areas of r&d such as neglected tropical diseases. extension of the program to include eternal threats is the by me as a way to offset the dramatic decline in procurement funding for mcms. adding m.c.m. targets to the p.r.v. program may help convince investors that the government is committed to this endeavor and provide certainty to mcms bounty. -- valley. improvement must be made in the contracting process as well as the in addition to robust sustained funding the public-private partnership must be strengthened through
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improvements to make it more efficient and predictable. streamlining is key to ensuring that are not excessive delays in the accommodation of research. i call on congress to simply pass h.r. 3299 strengthening public health emergency response act of 2015. this focus is on many of the issues i have raised and represents a strong initial step to him for many the recommendations of the panel. this subcommittee plays an integral role 30 oversight of federal oversight programs. i hope the energy and commerce committee and the subcommittee in june to examine the issues of bio preparedness for the. the threats facing our nation our real enemy. having products to support our national preparedness relies on the work of a few dozen biopharmaceutical companies. the only way these companies can
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continue vital r&d and capacity building is that the u.s. government demonstrates a strong commitment to them i providing clear priorities, sustained funding and real incentives. if we invest well now in the broader set of known threats we will be better prepared to pivot and respond when faced with an unknown threat. thank you again for the opportunity to testify and the work of the blue ribbon study commission. i look forward to your question. >> now dr. o'toole you are recognized for five minutes. >> thank you, mr. chairman. is that better? thank you, mr. chairman and ranking member degette -- technology, yes. thank you, mr. chairman. i am very happy to hear today to discuss this topic which has
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been a preoccupation of mine for most of my professional career. i want to thank you for your kind introduction and emphasizes the views i express my own and not those of in-q-tel. i want to start by congratulating the blue ribbon study panel on your excellent report. which i hope will be highly influential. i endorse censure the panels sense of urgency about preparing the country's vulnerability. fidelity briefly address three issues. first i want to emphasize the nature and the significant a biological weapon threats and explain why is a first tier national security problem. secondly, i want to describe why naturally occurring epidemics almost certainly will increase in frequency and impact in the coming years. natural epidemics, it's important to understand, are different from deliberate iowa tax. the latter would be faster --
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bio attacks. if we cannot handle natural outbreaks more effectively, and efficiently, we have no defense against a logical weapons. thirdly, there is a major revolution in our understanding of how the biological world works, and our ability to manipulate it. the advances in bioscience and biotechnology should be part of the foundation of u.s. bio defense against both natural and elaborate epidemics. these advances are going to be extremely beneficial to humankind across many different fields that go beyond biomedicine. but it also means that we now have created a world in which there is wide access to advance biological knowledge and the materials needed to build and disseminate biological weapons. as the defense science board said in 2001, a and a.j. go in
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terms of scientific advances, there are no technical barriers to nonstate actors including terrorist groups and lone wolves carrying out devastating bio attacks that could kill millions and cost billions. but these advances in science and in biotechnology also for the first time give us powerful tools that could allow us to prevent and to rapidly detect and quench epidemics, whatever the cause. i'm going to give you some examples of critical technologies which might have realized the panels assertion that innovation is a key ingredient and that dramatic improvements in biodefense are within reach. first of all the potential destructive power of biological weapons is begin to that of nuclear weapons. in 1993 the congressional office of technology estimated a
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kilogram of anthrax drop on washington, d.c., in ideal weather conditions would result in one to 3 million deaths. that's about the same tall as a one megaton hydrogen bomb. these statements are not based on speculation that on decades of development and field testing by the u.s. military during the offensive biological weapons program of the united states which was ended by president nixon in 1969. we also know that the ussr had a massive secret offensive program created after they signed the biological weapons convention in 1972. these were both ambitious and at least in the case of the u.s. highly successful programs. during the cold war the u.s. field-tested many different bioweapons in realistic conditions including releases for error, boats, ships and subways. to classify doctors from the '60s clearly recognize the strategic power of bioweapons.
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we do not know the fate of the soviet effort. in the half-century since the u.s. ended its program there has been a revolution in bioscience. advances in many fields including pharmacology and aerosol biology and our ability to read, write and edit dna, the code of life, have resulted in tremendous beneficial achievements by these advances have also meant the global spread of bio knowledge that access to sophisticated biotechnologies. the materials and know-how needed to build a bio weapon have many legitimate uses. these are dual use technologies and as the chairman said this makes the task of collecting intelligence about covert bioweapons programs exceedingly difficult. we are going to see an increase in the tempo of naturally occurring epidemics which we can talk about in the discussion. i want to end by saying that there are two critical
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technologies have not gotten sufficient attention in our biodefense program. the first is rapid diagnostics upon which we spend very little money and for which there is a very big market problem that makes it difficult for private companies to pursue diagnostics. and the second is vaccines. i see i'm out of time, mr. chairman, so i will await your questions. thank you. >> now recognize dr. parker for five minutes. >> morning chairman murphy and ranking member degette. thank you for the invitation to appear before you today. it is an honor to do with secretary shalala and congressman greenwood or representing the blue ribbon panel and undersecretary o'toole was one of our nation's highest regard by defense lives. i will put an explanation point on the bioterror threat. for my part i have been involved in biodefense since 1982 to the present. from the cold war to the rise of violent extremism and rapidly
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growing risk of naturally occurring transboundary emerging infectious diseases. i have been at the eye of the storm. witnessing the evolving biological threat over my career. today i am more concerned than ever about the risk of biological threats, including biological warfare, bioterrorism and emerging infectious diseases. biological threats are serious whether naturally occurring, from an attack or accidental release. the american public is starting to realize the threat of emerging infectious diseases following ebola and now presumably zika. off of the threat of biological warfare and particularly biological terrorism is very real, it is less well understood. if there's any good news, the number of countries ought to be conducting some type of a list of biological weapons activity, it has gone down from the end of the cold war from about 12 to
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five. but those countries include china, iran, russia, syria and north korea. and their operational scenarios for use are no longer limited to limited targets. today the risk from nonstate actors, extremist groups, or individuals on civilian populations is our reality. biological weapons are sometimes called the poor man's atom bomb come a term first used during the cold war because biological weapons as we've heard have the potential to cause mass casualties on this guilt of a nuclear weapon. even a simple bioterror attack as her earlier today can have a devastating consequence such as occurred on anthrax letter attacks in 2001 that took five lives, second something more, and over 32000 people took antibiotics because of potential exposure. and it could've been much worse
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from that simple attack. some question the seriousness of the risk today because for the violent attacks have not followed, and fortunately additional attacks have not occurred which i partially attribute to successful counterterrorism strategies. why further attacks and not occurred given the relevant these of such an attack was coupled with our boulder building is up for debate. i do not want to overstate and underestimate the threat and risk of biological attack and i cannot predict the future. but we cannot ignore that extremists intend to do is harm by any means, and they are not poorly constrained and the methods they use. the intent to acquire and use weapons of mass destruction of the likes of al-qaeda, isil and others is known. intelligence gathering is actually difficult to detect. we should not take the lack of intelligence as lack of threat.
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the discovery of an isil computer containing plans to develop plague as a bio weapon should give us pause. just this week the director of national intelligence confirmed reports that the islamic state used a chemical warfare agent in iraq and syria. the islamic state is growing rapidly, as resources, controls message infrastructure and safe havens and is recruiting scientists that could be capable of developing chemical and biological weapons. it may be a matter of time before a biologist becomes a self inspired by the extremist. we must assume the threat is real answers. in addition to bioterror attacks them naturally occurring and infectious diseases continue happen with greater frequency. pandemic potential and viruses, sars, west nile, chikungunya, dengue and now seek a real expenses that tells wounded on the verge of a global pandemic any time. are biological for prepared his
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response must also be ready. anytime. biological threats are not new. we seem to pay attention only when an outbreak occurs or an attack occurs. and ignore between outbreaks. a tie between outbreaks are they interested in the period though it's precisely when urgent actions are needed to optimize resources to hold our preparedness and response systems. before closing i would also like to add that initiatives global health security and one health are critical and to enable work on the convention site. i would like to thank the members of the subcommittee taken for this opportunity and i'm happy to add to any questions you may have. thank you. >> thank you, doctor parker and all the panels. that's pretty sobering testimony. let me start off and recognize myself for five minutes. first, dr. o'toole. you refer to do this a first tier national security problem, and a bio attacks are faster and
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fiercer. it seems like these natural outbreaks are really test funds for prevention and how we handled ebola, sars, how we will handle the zika virus gives us an opportunity to work to respond. i don't think we are at all we need to be. given that is the reason they more concerned what is concerned about the threats of our terrorism? >> -- threats of bioterrorism? >> i think you are right. i think our response national occurring epidemics should be seen as test runs. everyone here has lived through a lot of natural epidemics at this point and we have gotten better. again i think for the first time we can actually contemplate the strategy of creating a foundation such that we could rapidly design and build, for example, a vaccine suitable for a particular threat in a much
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shorter time than now is the case. i think we do have to prepare for a whole array of threats which we are not going to be able to predict. the other issue that doctor celena mention is that about of our response depends on the state and local public health department. they have lost almost 50,000 people since 2008. and so one could argue that our capacity to respond to an epidemic today has diminished compared to didn't and that's a problem. >> thank you. would it be fair to say the bipartisan panel's general concern is that biological threats are increasing while important aspects o of the use f biodefense prepared his are actually declining or inadequa inadequate? >> i think that's fair and ago
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dr. o'toole. our infrastructure for dealing with these has gotten weaker, starting with the state and local response. what the debates we forgot in the ebola discussion is the states are our first line of defense. we've been putting resources and building the public health infrastructure for years with block grants from the cdc. those have been weakened. if you don't have a state of local response, think about the outbreak of diseases caused by food poisoning, for example. it's that infrastructure that is the first line of defense for these biological issues that we're talking about. if we don't have a strong state role with their laboratories and tracking systems and it's difficult for us to pick up something that's going to
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recover the window will recur over long period of time. that's what we talk about the vice president. because it's very difficult for anyone else to pull in all of the actors, the private sector as well as the public sector agencies. >> so as we have increasing number of these naturally occurring an accident occurring bio attacks, is our diminished capacity just because restraint or because we've actually lost ground in dealing with these issues over all? >> i think your original question is the threat going with the capacity is decreasing, the answer is absolutely yes. if you think about the bioterror threat and to think about isis and to look at what they have been able to do with rifles and assault weapons and so forth. it's clear and obvious that their intention is to kill as
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many infidels as they possibly can. you can do a heck of a lot better job of using chemical and biological weapons than you can with conventional armaments. they want to do that and there's evidence that they are trying to figure out how to use the bubonic plague. they're trying, they have a plan to poison the turkish water system. so the intention is clear. while that's happening the same technology, synthetic biology, that's enabling our companies to do amazing things in terms of developing new drugs and new products is also making it easier to formulate these new weapons. so the threat is growing. to see that in the face of all that, the federal government's commitment to funding barda, funding our ability to develop these countermeasures is diminishing is frightening. i'm glad you're having this hearing because a hearing you don't want to have is one that
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happens after tens of thousands of people have lost their lives and you're sitting here asking yourselves and government officials why we were not ready. >> i see my time is up her i will now recognize ms. degette for five minutes. >> thank you very much your mr. greenwood, you are exactly right, this is what keeps me up at night is, is the responsibility that the subcommittee has to actually move the ball forward, not just to have these hearings every so often. the chairman will tell you, every year, like in about july, i start nagging to have a hearing on pandemic flu before we're out of in the middle of the flu season. but i think with a blue ribbon panel is saying is we need to go further than that. we need to have a system in place that's not based on
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response after the fact. with your assessment? >> absolutely. if i may let me describe to you what that system is. the only thing that stands between these pandemic viruses and intentional bioterror attacks, the only thing that stands between those things and the safety of our people is frankly a handful of private companies in this country who are willing to take the risk of developing countermeasures. this is unique. you don't sell those countermeasures at wal-mart. the only potential procurer of those is the federal government. those companies like every little biotech company relies on investors and those investors that put their money into conventional, an i.t. company company would want to they're looking for return on investment. if they see a system that's not certainty to lack of certainty
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that these products would be procured, they will put their money elsewhere. >> we have only seen this in the pandemic influenza program and trying to prepare for that. and with these cuts, some wondering maybe secretary shalala you can talk about how to funding cuts have hampered a response to the potential pandemic flu outbreaks? >> i wouldn't underestimate in addition to the private sector those very fragile biotech companies. the importance of the national institutes of health and the fundamental signs that we are doing. because if you don't have that you wouldn't have the companies. so it's a combination of things. >> the problem is you need to get the basic research. and then you also need to have a robust pandemic flu program so that you can support development in the vaccine by the private companies. it really is a partnership.
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>> and vaccines have not been a major priority of the multinational pharmaceutical companies. they don't make enough money from them. particularly when the government is the only purchaser. as was pointed out, they don't have a lot of confidence that we are going to give them a margins they can give them the kind of investment. this is a real challenge. let me make one other point. health as a national defense issue is relatively new. 20 years ago no one was thinking about a national security issue related to some aspect of health. think of this as the cutting edge of a dramatic new, new conceptualization of our defense. we are talking about the birth of a nation. at about the health aspects of that. >> let me ask you, what is it that the panel recommends central applies to the centralized leadership in the
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vice president's office of? >> since i sat in the major agency responsible for many of these issues and since we now have a homeland security agency, the fact is the responsibility for different aspects of this are spread across the government. and even delete agency concept will not solve that. or in my judgment aids are sitting in the white house. bazaars work best when there's an emergency. if you really want to build up infrastructure you have had a powerful person at you can't have that in a cabinet agency which is a. of all the other cabinet agencies. so the vice president is the only person who can cut through that, talk to the private sector and simultaneously pakistan localocal governments, and put l those pieces together. he's also the only person that can demand a unified budget out of omb and across the
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government. >> this was a bipartisan recommendation? >> and have to tell you i hesitated. so it is set in a government agency, a powerful government agency, hesitate to transfer power to vice president gore to the white house in general. cabinet agencies have a certain amount of tension with the white house's. at the end of the day this is one of the areas where you need a unified budget. the only other place where the unified budget is actually in intelligence. so this is a parallel to that, to pull all the pieces together. it's important enough to identify the vice president. vice presidents always have time to take the of the responsibilities. [laughter] >> thank you very much. thanks. >> with all due respect to our very nice vice president spent i'm sure he will be pleased you said yes lots of time on his hands spirit we have discussed this with the current vice president that it's not he
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particularly that we identified by the office itself. >> we'll bring him in here and ask them about that. recognize mr. florez for five minutes. >> hard to follow the. dr. parker, you said we should actually preparing for biological threats sometime between outbreaks. in 2006 congress created barda to do exactly this. as you've explained we continue to go in crisis mode only when havwe have an outbreak. what else should the government do in these enter epidemic periods? >> thank you, congressman. actually in answering your question i'm going to come right back to the centralized leadership line, important that is. i will answer it with an example in the experience and my own career, and that very same time in 2006, as the pandemic at all hazard preparedness act was passed, barda was created. we got very concerned about
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endemic influenza to the point that an emergency supplemental was appropriated in that time, six, $7 billion. it was accompanied by a very strong white house led pandemic influenza strategy, coupled to a pandemic influenza implementation plan. this is so close example i think that is happening today a kind of reflects the centralized leadership strategy that we did for pandemic influenza that accompanied an appropriation that really covered almost all the department agencies, state, local, private sector that were involved in pandemic preparedness back at that time. is the limitation plan contained over 300 action items to it
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identified lead department agencies and supporting department agencies that it was very detailed are, in fact, chemical department of the time, hhs, there was a lot of complaints that it was micromanaging and maybe superseding department authorities. maybe it was. but we got stuff done. it allowed us took office things that otherwise we would not have been able to do. i just offer that as an example of something that we have already done. let me also add that we had, we were very responsible for meeting our milestone matrix our part of the supplementation plan, both in the executive branch and to congress because all congressional committees that have the appropriate oversight for the department agencies were regularly being
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updated. earrings were happening on progress of that plan. .-- hearings were happening on progress of that plan. .. >> the brsp relied or focused heavy on the threats that we face today. can you tell me what's possible given the rapid advances in synthetic biology and how have these advances in synthetic
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biology escalated the threat? >> virtually anything is possible today e theoretically. smallpox is an ancient, huge virus. it would be very difficult to create synthetically a functional smallpox virus. there are many other choices available. we know, for example, that the soviets created a vaccine-resistant plague strain. new gene editing techniques make that kind of creation of resistant viruses quite straightforward, although nonresistant pathogens can do a great deal of damage too. i'm not sure it makes sense to go to the trouble of making a synthetic bug. but what we are missing is the opportunities on the upside that synthetic biology and other advances allow. >> right. >> okay? i mean, we are in a
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revolutionary phase of biological science, and virtually none of this is being leveraged against our biodefense needs. we need a lot more than improved contracting procedures in barta. we need a commitment to revolutionize the way we make vaccines. same thing with diagnostics. we can do this. we can shift the advantage to biodefense, but we can't do this with incremental, you know, tweaks on the programs we have now, in my opinion. we need a much deeper investment in bioscience and biotech. >> okay, thank you, that's helpful. i yield back. >> thank you. i now recognize mr. tonko for five minutes. >> thank you, mr. chairman. welcome to our witnesses. the -- dr. o'toole, in your testimony you speak of the need to talk advantage of recent developments in bioscience to rapidly develop tests and manufacture vaccines against
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emergent infectious diseases. can you speak to the role that the centers for innovation and advanced development and technology play in this process, and is this program indicative of the types of public/private partnerships we should be pursuing in this space? >> i'm sorry. >> centers for innovation and advanced development in technology. >> yes. they can play a very critical role. for example, new diagnostics have a very difficult time getting approval to be paid for. so that discourages innovative biotech companies from making them. imagine the difference it would make if we had a rapid diagnostic test right now for zika, and we could very clearly say you're infected, what is the outcome of your pregnancy, or you not infected -- you're not infected. same thing for ebola. imagine if we were able to tell within minuteses if somebody was
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infected with ebola, preferably before they're symptomatic. the technologies for a whole host of new diagnostics are out there. the path to the making money on them is very, very troubled both from a regulatory point of view, it's almost as hard as it is to get a new drug through, and the return on investment is not nearly as great. and also from the payment mechanism. so, yes, the centers have a tremendous role to play. >> thank you. and, secretary shalala, how does the first recommendation that you've shared with us today get off the ground? should there be a congressional mandate to have the executive branch explore and implement if experts agree it's needed? what are the next steps to take us forward? >> you know, i'm not sure what the answer to that question is, whether congress can designate
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the vice president of the united states as a different branch. you certainly could make a recommendation in this area, and i think the fact that this committee would make a recommendation as part of a more integrated piece of authorizing legislation would have an effect. it is a new recommendation. if you look through all the other commission reports, this is the first time this has been elevated to this level. so i think both a combination of the visibility and some enthusiasm from congress, from this committee in particular, would convince the next president of the united states to look at it very seriously. and, of course, there are budge implications in that -- budget implications in that, particularly tying it to an integrated budget approach which i think we all think is extremely important and in which there have been very few examples at a very high level.
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probably intelligence is the major one, the defense kinds of ones, you know, the defense agency itself usually leads. so it would take some identification by this committee, i think, that would make a difference. >> congressman, can i get 15 seconds on that. >> sure. >> i'm not a lawyer, let alone a constitutional lawyer, but i think that the congress can provide the authorization to the vice president, and then perhaps it is up to the president and the vice president to decide to utilize that authorization, but i think that's probably the way it would work. >> thank you. thank you to both of you. and, secretary shalala, given the complications created by transferring technology from an innovator company to the centers for innovation and advanced development and technology, double it would be men -- do you believe it would be beneficial to establish a single location wherein the complete process from innovation to manufacture can take place quickly and nimbly in order to rapidly
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respond to the various emerging threats? >> you know, periodically the leaders of government on both parties have looked at that process and seen whether we can fast track it so that we can get products faster to market. there are so many jurisdictional issues if a product has to go through the fda process, for example, if it's exempted from the fda process. so i think that that's an example where a vice president looking at the process and making recommendations about the integration because it's a piece of the larger strategy where that would make a difference. we certainly did that when we looked at, during my time when we looked at fast tracking aids drugs, for example. and we were able to take different elements and put them together in a way that protected
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safety but also moved the needle very quickly in that area. but that's why because there are so many agencies of jurisdiction you need someone to think it through. >> thank you to even of you -- to each of you. mr. chair, i yield back. >> thank you. now recognize ms. brooks for five minutes. >> thank you, mr. chairman, and thank you to our panel for being here today. i was a u.s. attorney in 2001 and was part of the response in the anthrax attacks and actually had an office where that powder was sent to, you know, multiple government offices were receiving powder which, you know, terrified that employee who opened the mail not knowing if it was actually anthrax or just powder. and i have to tell you, i thought -- i was in federal service until '07, and, you know, felt like we were moving forward, but i have to until you until this report came out and
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until we've seen kind of the lack of adequate response to ebola, quite frankly, i really do believe we have stepped back and that we have just moved from crisis to crisis. but i just encourage my colleagues, this is an outstanding report with 33 recommendations. it is a road map. it is a blueprint. and it is, in part, the basis upon which congresswoman eshoo and i introduced 3299, the strengthening public health emergency response act of 2015. and i want to talk about that because i really appreciate all of these recommendations. i encourage my colleagues throughout congress to read this book. because you as experts talk to experts around the country as well. it's not just the people on the panel. a lot of work went into this, so i commend your work. mr. greenwood, can you please share with us the merit that you see in returning the contracting authority to barta, back to
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barta which is in my bill, and you talk about the importance of that and what has happened and why we're not able to get, you know, vaccines and our medical countermeasures through the pipeline as fast as we need them? >> well, thank you. the -- originally the contracting authority was with barta, and it was changed. it was moved, i'm going to refer to my notes here, it was moved to the office -- an office called the acquisitions management contracts and grants office. and the problem is that the it can call experts -- technical experts are not there. and they are, in fact, at barta. and, in fact, because of certain regulations, there's a firewall between the two, and sometimes they actually cannot speak to one another. so this is -- imagine how frustrating it is for a company trying to get a contract. and it's talking to folks who know a lot about contracts, but they don't know a lot about this issue, about medical countermeasures. and so i think it makes all the sense in the world to eliminate
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that level of bureaucracy, put the contracting back at barta where it belongs so that the experts in the field can talk to the experts in the company with whom they are attempting to create contracts. >> thank you. and with respect to the companies trying to get vaccines into our stockpiles, can you and dr. shalala please talk about the fact that we don't have a sufficient coordinating mechanism in our national strategic stockpile also identified, so we don't even have -- if i'm not mistaken -- the right coordination between cdc and barta to have the right vaccines in our stockpile. can you talk about that? >> yeah. yes. and we made recommendations in that regard, because system is weak now and needs to be strengthened. thank you, congresswoman, for your leadership on this issue as well. >> thank you. mr. greenwood, any comments with respect to the stockpile? >> it goes to the central point
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which is that we are, that we are not organized as a government to effectively and quickly respond to either pandemics or bioterror because the authorities are diffuse, they don't always talk to one another, and that's, that is exactly why a central, unified plan, a strategic plan, a central budget and giving the authority to the vice president makes all the sense. >> and i think citizens believe and know we have these stockpiles and believe that they are adequately, that they are adequately filled with the proper rights -- types of vaccines. would anyone else like to comment on our national strategic stockpile? dr. o'toole? >> i'm the chair of the national academy committee on the strategic national stockpile right now. and they have made tremendous progress in the last 20 years. the problem with the stockpile is that the new drugs that are going into it are largely
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biologicals, and they're very expensive, and they expire this if two and three years -- in two and three years. so there's a pipeline of new countermeasures coming in that increases the cost of the stockpile, and everybody's budget is staying flat. so the limitations on the countermeasures we have in the stockpile, first of all, are budgetary limitations. i mean, this is an expensive proposition. the stockpile already holds about $7 billion worth of stuff. but we're talking about having to cover multiple cities with these sometimes very expensive drugs and vaccinings. we need a cheaper way to do it which is why i say you're never going to be able to create a stockpile that has everything you want in it against every contingency. we have to move to a strategy of being able to quickly design and manufacture at scale what we need. >> thank you all for sounding the alarm. appreciate your leadership. i yield back. >> thank you.
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now recognize mr. mullin for five minutes. >> [inaudible] [laughter] >> thank you, chairman, and thank you for the witnesses, for being here. i first want to thank ms. shalala and mr. greenwood for this report. i'll tell you the more i learn about it, the more i wish i wouldn't read it. i'm serious. it's very troubling when you understand the false security that we have even from something as simple yet dangerous as the flu to the most serious threats that we're facing today. and in a previous hearing, i was talking about our cdc's national stockpile, strategic stockpile that we have, and in particular the weaknesses that we have there. following ms. brooks here, i want to get a little more in
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depth about what you see is maybe our biggest weakness, maybe the biggest two weaknesses, some of the most, some of the biggest threats we have with the stockpile, some recommendations. don't get into it too deep, just maybe one or two that we can start working on in the committee here. >> well, i actually think dr. to tool is the expert -- dr. o'toole is the expert on the stockpile issue and that she has outlined what the challenges are in the stockpile. it doesn't cover everything, it's expensive to maintain because they have a short shelf life. it was a good idea at the time, but constantly having to renew it is our biggest challenge. there -- i think that most of us think that there are other issues we can address. we certainly -- and, certainly, scientific issues that would give us a longer life in some of these areas. and i think on the production
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side that, tara, our ability to produce something faster and not being totally dependent on the stockpile is probably where your iom commission -- >> you know, and yesterday i had a meeting with some biodefense individuals, and they were telling me there is technology they're looking at that would extend the life, the shelf life through maybe a dry freeze, is that correct? and then also they're retesting it, too, and some of it that was designed will go two or three years will last as long as 15 years. so they're constantly retesting it. but how do we dispense it? how do we get it out? having a stockpile is okay, but it doesn't do us any good if we can't get it to where it's needed. >> the original idea was to use the v.a.s because they're spread across the country, and they do keep a certain amount of -- >> we're having enough problems with the v.a. right now. >> they're well located, the
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v.a. hospital system and warehouse system. the government has also contracted, i think, with fedex to move palettes around the country. -- pallets around the country. the military is not well situated to do that kind of thing, so there's been discussions in the government and a strategy for moving pallets of drugs very quickly using, i think the contract was with the fedex system originally to move pallets around the country when there are outbreaks. >> ms. o'toole? >> the big problem with the stockpile is traversing what's called the last mile. it's not about delivering to the state public health departments, it's about getting it into the hands of people. and as you can imagine, that dispensing function is very complex. washington state is going through pharmacies. not -- that won't work in every state, particularly rural states, although most americans live within reach of a pharmacy.
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advanced deployment is also being used in those very few states that can move very, very quickly to dispense such as new york city. one thing that would definitely help is more money for state health departments and local health departments to do drills on dispensing. these are invaluable, but they're very time consuming and expensive. and they simply don't have the money to do them. new york city does them, some of the big municipalities do them. but making those a more viable way to practice would, i think, make an appreciable difference. >> that's a great recommendation. mr. parker? director parker? >> i just wanted to come back to centralized leadership. we've been talking about vaccines for 15 years or more. the last mile of dispensing medical countermeasures, that is the hardest challenge. in fact, there was an executive order in about 2009, 2010, and i was just discussing this with
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one of my colleagues from public health from chicago yesterday. it seems that that work has just disappeared. but with centralized leadership, focused work on how to solve that last mile of actually dispensing the medical countermeasures would go on. and we need that, because it's one thing to have a stockpile, and it's one thing to be able to get it, fedex to get it to an urban center, but actually getting it into people's hands is a huge, unsolved problem. >> thank you. i'm out of time. appreciate it. >> thank you. now recognize ms. castor for five minutes. >> i'm going to scoot over a little bit, how about that? well, good morning, and thank you to the panel for your terrific work on this important subject. ms. shalala, the folks at the university of miami are, we're so appreciative and ever across the country for your service. i know they miss you there. but it's great to see that you
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continue on in your service. i wanted to focus on hospital preparedness. during the ebola outbreak in africa in 2014, we took a critical look at hospital preparedness and its important role in our nation's response to biological events. at that time in response to that the president requested emergency supplemental funding for ebola. the congress responded. now with zika we're having to do that again. this doesn't seem to be the most efficient way to prepare for emergencies. i'd like to ask a few questions about this, about what we can do to assist hospitals throughout the country in their response. you know, we had some that were very well prepared, like emory university, what a terrific job they did because of their association with the cdc. and and nih, of course, was at
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the forefront in that ebola response. but some did not do quite as well x there's no mystery -- and there's no mystery that if that had been more serious, that a lot of hospitals across the country would have struggled. so what lessons do you think we learned from this, from the ebola outbreak in africa and the few cases that were, that came to the u.s.? i'd like to ask maybe ms. o'toole first. >> hospital preparedness is very important. i think between 2002 and 2008 it did improve for two reasons. first of all, disaster response drills are required for accreditation by the hospital accrediting facility. again, for hospitals doing those kinds of drills is expensive and difficult. there also was a cdc/hhs flow of
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money to hospitals to help them with bioterrorrism and pandemic flu preparedness. and what happened with that money is the hospitals started forming coalitions. in my city in 2001, baltimore, the mayor for the first time got all the ceos of the hospitals together in one room. this is a private sector, competitive industry. they don't necessarily cooperate, let alone collaborate. and those cdc funds made a real difference. these regional coalitions of hospitals were used to figuring out how they were going to share resources, share information, etc., etc. that funding has been cut in half -- >> okay. >> -- since 2010. that makes a big difference. >> secretary shalala, the panel's report mentions that disease-specific preparedness funding is the most inefficient and costly manner in which to fund preparedness. what are the alternatives to
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disease-specific programs especially since many states have frayed their public health infrastructure? how can we respond better and give the hospitals in our local communities the tools they need? >> we have specific recommendations in this area including a study stream of funding, we recommend that it be done through the accreditation system and through cms. in addition to that, we've represented a tiered system. every hospital in this country cannot be prepared for every complex disease. so both the regional coordination, but more importantly, identifying those hospitals that can have special rooms set aside. in florida, for example, all of us looked at, particularly at the great public hospital in miami whether we could build separate rooms with separate access to handle ebola patients.
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and, in fact, went through and exercised to make that possible. a great public hospital that sees all sorts of diseases probably is the best place to do that as well as academic hospitals around the country. so creating a tiered system in which we know where we would send patients once they're stabilized, obviously, that would have the capacity and the separation to be able to handle these diseases is certainly the way to go. we have some specific recommendations both on funding, on the accreditation process, but in particular on creating a tiered system in this country that would give us coverage across the country as there are outbreaks. >> i think that's a very important recommendation, and i would encourage the committee to act on it as soon as possible. thank you very much. >> recognize mr. cramer for five
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minutes. >> thank you, mr. chairman. and thanks to the panelists. i want to focus on this incentive issue, congressman, that you've raised. i will admit that what i'm about to do is very dangerous, i want to think out loud for a little bit and also admit you're not going to adequately inform and educate me in five minutes, so you're going to have to come to my office and help me work through this idea. because you've all done a great job as has the panel, the blue ribbon panel, in scaring me to death. so i'm adequately prepared to understand the threat. and i think that's very important. but in our political world, of course, when it comes to the appropriations process, part of why i think you don't see congress acting or the government acting proactively is because we respond to the people we represent. and they will blame us when we're not prepared, and they'll blame us end when we spend money
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foolishly. of course, we're talking about finding a way to invest in something that we hope is never needed. and so that's our political dilemma. i would -- starting with you, congressman greenwood, and others if you want to weigh in, maybe just elaborate a little bit more on the srf, the prv, how we could help pharmaceuticals, the private sector feel comfortable with investment and the innovation. and we've talked a fair bit about it, but if there's a way we could elaborate just a little bit more to help me better understand how we're going to do this. and i might also emphasize is there a way to put a cost benefit analysis on this? be for example, ms. castor was talking about emergency responding. that's a cost. that's a cost that could be avoided, perhaps, if we were better prepared, right? so has there been some work done in that arena that helps me assure my constituents that
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we're not just appropriating, but that we're efficiently and effectively governing? >> well, thank you for admitting that we frightened you. [laughter] and, obviously,ing our constituents, your constituents are not clamoring for this because it's a sleeper. >> yes. >> no one is thinking that this is going to happen. and as i said earlier, the hearing you don't want to have is the one about why we were unprepared for the event that was so tragic. so i think to some extent, you know, leadership involves informing your constituents. and this hearing is an important part of that, that that threat is real. i calculate when it comes to bioterror that, you know, they have the -- the terrorists have the motive, they're trying to acquire the means, and despite our best efforts to deflect that, over time the likelihood of that happening is one over one, okay? it's going to happen. and we have to be, we have to
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believe that. it's not -- we have to believe that that threat is real. so in terms of what works to be prepared, we talked about the contracting reform which is a minor thing but an important thing, and congresswoman brooks is a leader on that. we've talked about the need for there to be sufficient funding to actually procure these mcms when they're developed. and it's -- the secretary was completely correct when she said not to underestimate basic research at the nih. that's critical. but when it comes to just like in every other medical -- medicine that we adopt can, when it comes to actually adopting the product and manufacturing the -- developing the product and manufacturing the product, to invest money in that. and the companies are willing to take the risk that maybe they will fail at the science, but the investors are not willing to take the risk that if they succeed, the federal government's not going to be prepared to reward them by procuring the product.
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so that's critical, and you need enough money over time to be certain so there's a certainty that when you get to the end of the road and you get your product approved, that congress habit moved the money around -- hasn't moved the money around, and it's no longer there. >> secretary shalala, i can see you may want to weigh in on this. one of the things -- i appreciate that your national defense analogy, because i was thinking a lot about we spend billions of dollars on weapons we hope we never use, right? now, they do have the benefit of being a deterrent understandably, but it isn't dissimilar. we have to constantly make this case. so thank you for that and the centralized leadership as well. i'm still struggling with the whole vice president thing myself. but the more you talk about it, the more sense it makes, so appreciate that. anything else anybody would add to what the congressman said about -- >> yeah, i would like to add a little bit and perhaps maybe just pull on the contracting itself as well.
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.. just basics contracting that could make it more readily accessible that the innovative biotechnology companies would actually do business with us in the government is something to look at as well. >> thank you very much. if which could solve dod contracting in context of this that would be bonus. that would be a cost benefit
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analysis. >> recognize mr. green for five minutes. >> if we could solve dod contracting we probably could have them audited. welcome to the panel. combat emerging and reemerging infectious diseases particularly drug resistant infections which can cause catastrophic loss of life and which started to make minor innexts fatal. without greater antibiotics we have future resemble one before these drugs were developed. many medical, chemotherapy, organ transplantation. the challenges presented by the rise of drug resistant bacteria which we have no effective treatments are representative of the challenge facing medical counter measure product development. the market forces simply do not work and fail to foster the kind of pipeline we need. in 2012 this committee passed and congress passed the gain
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act. again this in this current session in the 21st century cures act we removed financial and regulatory barriers for antibiotic drug development. secretary shalala, can you comment on the counter measures for emerging infectious disease's with pandemic potential, specifically please explain why there is such a need for a government to play a leadership in this space. >> well, i think it's pretty straightforward that the only purchaser will be the government. there is not a private sector market for these particular biologicals. and therefore the government both has to incentivize the companies financially so that, and, i think the other thing to understand, jim can explain this better than i can, these are
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relatively small companies, often with a small number of products. we've known a lot about the biotech industry. they're fragile. i don't like to use the word fragile when you talk about them, so unless they know that they're going to be compensated and reimbursed for the cost of development, not just the cost of production but the cost of development, unless there are financial incentives i don't know how we're going to move very quickly in this area. we've had some experience. congressman waxman in the orphan drug act, we had a lot, we had a lot of diseases which there were very small markets at least initially and the congress in its wisdom passed legislation that encouraged companies to invest in creating drugs and
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treatments for a very small part of the population. our problem here is we start small but we may need a production line that's huge at the end of the day. i don't know any other way to do it except with financial incentives. we just, i just don't know, i think everything that we've learned, not just that i'm a capitalist. it is just that, from our view in a public policy issue, when the market is going to be the government, there is no other way to get a very small pflum per, or -- number of industry people to invest unless they know there is going to be a market the at end of the day. >> jim, welcome back to your committee. >> thank you, congressman. so nice to see you. one of the proposals we have is priority review voucher, prv. and the beauty of the i, if you look at, congress in its wisdom looked at neglected tropical
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diseases. we knew there was no financial pull. these diseases occur in places like africa, the countries are so poor they really can't afford to buy the product. so investors just aren't putting their money there. when congress created priority review voucher it works beautifully. what it does, it says to a company if i can get a drug approved, even if i don't make enough return on my investment from the procurement of that, of that product, another, maybe a large biopharmaceutical company will pay me, and these things have gone, only two or three have sold, gone for 200 million, 300 million, $400 million. doesn't cost the taxpayer a penny. pfizer or merck or glaxo buys that, gives them for shortened review period for some other product. that doesn't cost taxpayers any other money either. they pay the fee and get their product approved, sometimes they don't get the product approved.
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if they do gets on market faster and goss off patent anyway. still doesn't have any cost to society. >> mr. chairman, i know i'm out of time but we had legislation that's in the senate that would fast track because we recognized government can be the one who has to do it because free enterprise can't invest that money for something but there is legislation, hopefully the senate will deal with cures and complete package that our committee approved overwhelmingly. thank you, mr. chairman. >> that would be nice. recognize, vice-chair of the full committee. i'm sorry, miss blackburn. >> yeah, that woman from tennessee. i tell you what, dr. parker, i am so happy to see an aggie on the panel. i've got aggies in my family and, they always bring good, common sense seasoned wisdom to the table so happy to see you there. of course mr. greenwood.
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how much we appreciate your insights on this and your dedication to the biotechnologies and the work that you've done there. just a couple of things that i, i want to touch base on. in talking with some of my research centers, and in tennessee we have such an aggressive biotechnology group. and when i was in the state senate i helped to formulate that group. so they have got a good underpinning and it doesn't matter if it is vanderbilt or st. jude's or whatever, they talk to me a good about it about the right balance between government and regulatory oversight and then the ability to incent. mr. greenwood, i'm so pleased that you just mentioned the priority review voucher for the mcms. i just think this is, when you look at these medical counter
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measures that is just so important that we have that. and it doesn't matter if it's a material threat, if it is something like zika. we have to have a way to go about this but i want to come to something that dr. o'toole mentioned and then, congressman greenwood, if you will kind of answer to that. basically her point was you move products to a point of scalability and then if you need something, you're ready to move with it. and can push that scalability quickly. so let's go back to that voucher, mr. greenwood. if you will continue that conversation and build that up, the importance of that, how you would address these something that is material threat or like
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the zika virus, which right now there is not a vaccine and people are saying what are you going to do, why didn't you know this was a problem? the olympics are coming to brazil. people have been vacationing for months in the zone that is affected, et cetera. so let's go back to the importance of having that priority review process for such, for this type of occurrence. >> so there's great uncertainty for a company to, we've seen our companies, proudly, jumping into this zika issue and trying to do some research on it very quickly to develop products but i remember a company that, member company of bio, that was involved in trying -- look like it was close to having something on ebola. they almost didn't want to talk about it because their stock was fluctuating on this all of sudden everybody would invest in the company and saw another company doing something and people would pull out.
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it created unpredictability and volatility. and so it is an example of how the normal, the norms of economics don't work in this field always. so the priority review voucher takes away, one of the uncertainties. that uncertainty is, it doesn't take away uncertainty of, can we make this product and will it be safe and will it be effective? that is always a risk. i will tell you, that doing that is harder than putting a man on the moon. most companies fail and most projects fail. so it's hugely risky to even bother trying. but if you do try, and do you succeed, you, the only reason your investors are giving you the leeway to go and do that is because they think that somehow they'll get a fair return on that investment. one way to do that is have enough money in the reserve fund so that the, and have it there, not just year by year but have it there multiple years so
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companies can know and investors can know, if we succeed here we'll buy the product and get our investment back. but the priority voucher review is different way to could that. because they have become so valuable, it is a huge driver, a huge incentive because if you can succeed, you have priority review voucher for zika, companies know if they could succeed and not only would they have the great satisfaction of being able to spare people from this disease and god forbid more children born with micro ensevenly but they would -- micro ensofaly and they would have the voucher take it to the nice return and use it in the next countermeasure. it's a no brianer to me. i know there is some political questions about it, i don't
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think there should be, cost taxpayers nothing. costs society nothing. provides nothing but benefit. >> thank you. >> yield back. >> gentlelady yields back. i recognize dr. burgess from texas for five minutes. >> thank you, mr. chairman. thank you for the panelists for being here today. i apologize missing part of the hearing. we're having our budget season, mr. greenwood, you will remember what that is like. never a dull moment around here today. dr. o'toole, i just want to ask you because we've had several hearings over the past several years, just, just for context, my congressional career goes from sars now to zika. long enough for people back home to say term limits but on the other hand there may be some value in seeing some of this stuff over a continuum. but, you referenced in your testimony what are called laboratory-developed tests.
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zika comes into focus because, okay, you have a polarized chain reaction, only a few places can do it. pretty valuable, pretty accurate but hard to get. you have to go through a health department to get it. there is igm anti-body but it will crossreact with some other viruses. you're not sure your result is accurate. would you just speak to the regulatory hurdles you describe in your laboratory developed tests? because we in this committee have been studying that. there is a movement as you may be aware to move the regulation of laboratory-developed tests from cclia, clinical lab improvement amendment, which is basically from the center for medicaid and medicare services to the food and drug administration and require basically the licensing of laboratory-developed test just as if they were a new drug or
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device and we know the problems with the timeline of those things. so could you just speak to that briefly? >> yes, thank you for the question. congressman. the reason fda is so concerned about diagnostics because they can have life or death consequences and we might want to think about different standards for diagnostics during public health emergencies. >> i'm going to interrupt you for a minute. >> that is called clinical judgment and i you and i understand that because we trained as physicians and that has to be part of the equation. it took me three years to get from dr. suring at the fda a list of the problems he was worried about with the problem of laboratory-developed tests. where are the outlyers, where are the problems? to his credit, last time he was in here a few months ago he did produce a list of 20 tests they
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may be problematic. there are 11,000 laboratory-developed tests and they are useful every day of the week in a clinician's office. i'm sorry but continue. >> so let me narrow the problem down to tests we need particularly for infectious disease and particularly during epidemics. we need a variety of different kinds of test. as you know you want a very sensitive test when you have a low prevalence but you don't want that same test when you're in the middle of an epidemic. so it gets tricky. however, here's the problem. it is very difficult to evaluate a new diagnostic against ebola or even a zika if you don't have curated samples. if my view the government, you could put it in dhs or fda, the government should develop a curated bank of diseases by which we're worried, so companies, especially these
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small agile, fragile companies could come to test their diagnostics against them so they could much more rapidly give fda useful data on how well their tests work. that's one. secondly, i think fda has emergency use rules for medical countermeasures during public health emergencies, we ought to think about the emergency use tools for diagnostics which i think we can actually create rather rapidly and manufacture quickly. >> i will tell you last year or 18 months ago during the peak of the ebola outbreak in september i went to a hearing in foreign affairs committee where we heard the fda actually put a clinical hold on a drug called tk ebola that time in use treating patients with ebola. i didn't want to hear about clinical holds. i want to hear about clinical trials. really seemed like they were a obstacle faced with this
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worldwide scourge. dr. shalala, i have to ask you a quick question on your, i appreciate your listing out the recommendations of the blue ribbon task force. in my political training which granted was a street level course, i was taught you only do three things. if you produce a list of 33 things, no one listens to after the third one but i did read through your list. it is a good list. it is exhaustive. i hope it is not static because one of the things we worked on the twenty-first century curse bill, whole inoperability of electronic health records and if we do not address that fact in this, in the recommendations that you have, i think that's actually going to stymie the ability for researchers and clinicians to communicate rapidly, identify data to be sure, respect patient private rights but at the same time we need to have ability for rapid learning within the system
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whatever develops. >> well as you know there has been a lot of progress on electronic medical records in this country and continues to be and you're absolutely right, it's the touchstone piece. i should say that even though we have 33 recommendations, we have actually staggered them. to, identify those that we think congress should do immediately have more midterm value and longer term strategy. so we very carefully laid out a strategy that, would be workable for congress. >> all right. thank you, chairman. >> and the federal agencies at the same time. these are not just recommendations for congress. >> very good. i yield back. >> thank you, gentleman yields back. i recognize mr. bill rack kiss for five minutes -- bilirakis for five minutes. >> thank thank you for allowingo sit on this very important hearing. as former chairman of the
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emergency response committee for homeland security, i recognize the need for the country to be proactive, not just reactive to host of biological threats both natural and man-made. i am glad i continue to be involved in the energy and commerce committee. i appreciate given the opportunity to sit in on this subcommittee. secretary shalala, you earlier mentioned the state and local agencies are the first in line against defense and outbreaks of attacks. you also said much of the funding through the block grant programs have been weakened. what should we do to enable state and local entities to be prepared to respond to outbreaks and attacks? is there enough focus on medical surge capacity and mass prophylaxis capabilities? do we need flexibility in our grant programs? >> [inaudible]
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our point i think in the report is that the funding from lab work on down over a number of years, you see the grants and states is pretty flexible. in fact there is -- the states are really underfunded in terms of their infrastructure. as was pointed out -- public health experts across the country. >> could you turn your microphone on please? >> yeah the microphone. >> turn your microphone on please. >> we've lost 50,000 public health employees in our states and local governments as well. and that has to be properly funded. the tradition has been to have almost a block grant that goes from cdc to the states. i believe in that tradition.
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i believe in the relationship between the cdc and states and local governments to build an infrastructure, because the cdc is not a line agency. when we're in an emergency we think they are but it's really the states and local governments, and their public health departments that are responsible for both the tracking, identification, for all of us in this country. and, we have to make sure that infrastructure, states are under great fiscal pressure in this country. we have to make sure that infrastructure is beefed up and stays in place. >> thank you. next question for the panel. you all mentioned the lax of comprehensive biodefense strategy and the need for centralized leadership. what if any protocol is in place now to enable coordination between the agencies such as dhs, cdc, hhs, and various state agencies when there is a disease outbreak?
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and what capability gaps exist in coordinating efforts between agencies? what makes coordination a challenge? we could start with the secretary. >> i think earlier i talked about the fact that there were multiple agencies that are involved when we have an outbreak like this and while hhs has very strong responsibilities and has the scientific and public health expertise, homeland security, the defense department, there are all sorts of agencies across the board. we have made a very strong recommendation that the vice president be the ongoing coordinator in, in this country because the lead agency concept no longer works when you have various jurisdictions involved. in particular, when you need to work with the private sector, with state and local governments. unlike fema, which basically can order people around, it's very difficult for one agency.
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i say this reluctantly. because as former hhs secretary i wanted to own the world but, when you don't have proper jurisdiction, when you don't have the leverage, then you have to elevate it, elevate both the responsibility and we're much more sophisticated about the role of the private sector, the development of diagnostics and that this has to all be part of overallustrategy in this country. >> thank you. >> i just want to add to that and the need to be able to elevate it and that centralized leadership not only is needed at the federal level and to try to close these gaps between each individual department and agency because they want to exercise their own authorities but there are gaps between them. this will transcend all way down to state, local, private sector level. if you have centralized leadership coming from the white house, that's done, that
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will help break that and transcend that leadership. as an example you mentioned surge medical at the local level. it is not just public health thing. it will be more logistics. why emergency management and other disciplines will be so necessary to affect, your example, surge medical, dispensing of antibiotics it is more logistics. public health doesn't do logistics. that is really why it is so important to centralize leadership concept is so critical. everything comes back to it and it transcends the federal, state, local, private sector levels to close these gaps we have between multiple disciplines and agencies that have to contribute to biodefense. >> thank you. i'll yield back. thank you, mr. chairman. >> now recognize mr. griffeth of virginia for five minutes. >> thank you all for being here today. dr. o'toole, during the ebola outbreak there were weaknesses identified in our system we're now witnessing again with zika.
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surveillance, detection, diagnostics. overall how would improve surveilance of animal disease outbreaks strengthen our surveillance of human disease outbreaks and make us better prepared for dealing with epidemics? >> well the majority of emerging infectious diseases come from animals. there are diseases that affect both humans and animals. so we definitely need to do a better job looking at those hot spots where we're likely to see spillover from one species to humans. most of the hot spots are in tropical zones. in the jungles of south america of asia and africa. most of the -- are in temperate zones for starters. we're beginning to have tools such as high speed genomics that can give us much better handle of what diseases might be able to spill over. we out to think about funding field surveillance of these hot spot ecosystem force starters. secondly we ought to fund much
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more rigorously the usda exists program for looking at agricultural animals because, you know, modern methods of agriculture put sometimes tens of thousands of animals together, creating our own industrial hot spots for spillover and we've seen that with flu, and the loss of turkeys and chickens in the past years. thirdly for humans we need much more strategic approach to surveillance. we spent billions, literally billions on surveillance the past 15 years. some things worked, some things haven't. we have done a terrible job at lessons learned. we ought to go back to figure out what really has made a difference of the part of that is again, we sound like broken records, funding state health departments because that's where the rubber meets the road but we have to help state health departments do a better job. diagnostics, again, critical,
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critical, critical, critical. clinical disease is very vague. if you don't have diagnostics to say this is zika and this is dengue, you will have hard time figuring out what is going on in the middle and at the beginning of the a epidemic in. would i be careful spending large amounts of money in particular surveillance programs unless you know exactly what they are growing to do, will it work and who will use that information. >> my next question was going to be, are we doing an adequate job of integrating human mall and environmental health. i think you already answered that by saying no, we're not doing just a great job of integrating those. secretary that lala, how do we do better job integrating those three components to have better strategy to prepare for whatever is next? >> i think our major recommendation is that we put this responsibility in the office of the vice president. that we really need national leader with clout to integrate
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all these pieces. help us think through a strategy because the integration itself will have to be done by agencies and by others. but the strategy, having metrics for it, keeping people accountable, that we elevate that to the office of the vice president. >> i appreciate that. dr. o'toole, lots of concerns being raised about zika and our athletes competing this summer in the olympics but also spectators and coaches that go down, family members, et cetera. do you believe we will be ready? obviously brazilians will have to do some things. this is an international effort. do you believe we'll be ready to be able to defend our folks or have the biodefense efforts ready to defend our athletes and spectators and coaches and family members who go to the olympics this year? >> well i understand the deep concern that zika has raised.
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whenever children are affected, grown-ups get deeply, deeply worried and that's happening here. i will say there are dozens of very dangerous mosquito, even tick-borne diseases that have been with us for millenia and you can to some extent protect yourself from mosquito bites by using deet and dressing well and sleeping in places with screens and so forth. that's not a perfect protection. it's not a zero risk. we have to wait and see till we have more information about what is really going on. we have known there has been more or less an epidemic of dengue and chikagaga. and dengue is serious disease in south america for a few years.
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that hasn't stopped people going down there. we have to wait until there is more scientific data on zika. i know nih is working on a vaccine. i wish we had one. i think if i were a young woman who was pregnant or getting pregnant i would think twice about going to south america right now but i think for most people there are ways to at least mitigate the risk. >> all right. >> chairman with your indulgence, 30 seconds on the zika question? thank you. wanted to point out, aside from medical countermeasures on zika there is a whole field of looking at how to bio engineer mosquitoes which we already know how to do so they are actually, they're all males. they don't bite. and they mate with the females and progeny don't survive. i think that is a fascinating new technology that may be part
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of the part of the solution to this problem. >> thank you. i know we have votes in a few minutes, but ms. brooks if you have one quick follow-up question. >> one quick follow-up, question, thank you, mr. chairman, to mr. greenwood with respect to the priority review voucher program. can you share with us existing prv programs for rare pediatric disease or neglected tropical diseases increasing the biotech invests in this area? can you give us some examples where you've seen that already happen? >> i'm probably have that in my notes. if i had time i would be whispered to, just say -- >> if you would like to submit it for the record, that would be fine. >> we'll submit that for the record, but suffice it to say that it is working. it has created both in the area of pediatrics and in the area of neglected tropical diseases. it has generated tremendous amount of interest and investment and it is, it is working perfectly well just as
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congress intended. i have no doubts that it would work well in this field as well. >> and do you believe if we added dhs's material threats to the fda's prv program it would spur additional development of the medical countermeasures? >> i think that is precisely what needs to be done and i have no doubt whatsoever that it will be successful and inspiring investment in this very dangerous field. >> thank you all. >> yield back. >> dr. burgess do you need a quick follow-up question? >> yes, secretary that lala, you have -- shalala, you spoke about the vice president as overseer of all this i appreciate the fact that there are too many agencies and too many people involved, and when too many people are involved no one is in charge. i get that. >> too many committees of jurisdiction. >> i don't quite share your enthusiasm for putting this into the executive branch. perhaps it should be a speaker's position but nevertheless, i will just tell you, i was down
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at the border, rio grande border last weaken and you realize you've got cdc map that shows mexico and central america being purple with zika and my state is the other side of a relatively narrow river. just seems to me we don't pay enough attention to border control. i know you can't stop mosquitoes at the border but really the issue is, stopping people who are infected or potentially infected and right now we are undergoing another surge of unaccompanied minors and family units and to the best of my ability to detect we're not looking. and that is a point of great concern to me. so, all of other things we talked about are extremely important. let us not forget border control. that is, that is an issue as well. >> i will leave that to europe comments but i would say that we
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also have to beef up global health. and that is pan american health organization which is part of the world health organization. we can't stop mosquitoes from coming across-border whether in people or they're just flying across but, it's not only beefing up our own infrastructure. we, one of the things we learned with ebola is that the world health organization doesn't have the kind of authorities it needs. it doesn't have the resources they need. so it is not a state and local issue or a federal issue. it is also an international issue and i think your point about border security is also but i would put it in the context of international health security and of looking at the agencies that we have now, the international agencies that we have now and we know they're weak.
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we learned that during ebola and previously. this committee might have a hearing because there have been recent reports on international health organizations to take a look at those relationships as well. >> thank you. votes in any moment. follow up with two quick questions. if you can't answer us, get pack to us. like to answer from each of you, do you know countries that modeled programs of very thing you're describing we would love to know about that. does anybody know any offhand. would you like to get back to us on that? >> my comment i would say if we don't have it i would be surprised -- >> to be fair there are centralized health systems in smaller places that may be more integrated. i think we have different levels of government. we have different levels of responsibility. we can't use their models. we'll have to put our own system together. >> thank you.
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another question to get information to us on the record, based on the recent georeport on failings of bio watch programs including lack of valid performance data should we continue to fund it? do you have an answer for that or want to get back to us? >> would you repeat the question, mr. chairman. >> should the federal government continue to fund bio watch program because of gao report including lack of performance data. >> i think we'll get back to you on the record for that. >> miss o'toole, can you answer that? >> i'm a long time critic of bio watch but, i think you should continue to fund the current program for defined period of time until we have a strategy for what we're going to go do next. think it the notion biowatch or the nextgen bio spec watch, series of environmental sensors can protect country is
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wrong-headed. technology isn't good enough. cost effect in this ratio is not advantageous. we need new generation of technology. it is not there yet. again diagnostics make a difference. you need the sensors to protect high-risk targets and national security events and so forth. the problem with biowatch right now, it is not characterized as gao points out very graphically and accurately, we don't know that it works. it is not clear that it doesn't work. it has a very limited range of bugs that it looks for. and to really cover an area of a city you would need a lot of those machines. so it would be very expensive. >> thank you. with that i want committee first of all, yes, miss degette? >> thank you, first of all, with all due respect to my friend in texas, i don't think any kind of border control, even building a wall, is going to stop the vector borne diseases from coming over.
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i know that is not what you mean but what it does really highlight is how we are an international community. it is not just the mosquitoes coming. we have not had ebola cases come here because of international travel. it is so unbelievably critical we take this report seriously and that we really work hard as a committee, and mr. chairman, i want to commend you again for calling this hearing. i know you're planning to have a classified briefing when we come back from the february recess. i think that's a good other step and then, i would just finally offer my input and the input of the minority staff and members to help come up with a robust hearing schedule for the rest of the year. i think if there is nothing else we do, then spend our time on this report and the recommendations, trying to get our arms around it and get that sense urgency to our respective leaderships so that we'll have
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been successful. >> thank you. >> i want to thank everybody again from the commission for doing this deep dive because it really is important. >> and i, let me also announce on march 2nd we'll have a hearing on the zika virus where many of these issues will come up. we'll take a deep dive in that as well as what my friend said about getting into classified briefing and some of the biodefense issues. critically important and should be a wake-up call for america but as you said a couple times, mr. greenwood, we may not do these things until after the fact and that would be a tragedy. so we'll get moving on that. in conclusion i want to thank all the witnesses and members that participated in today's hearing. i remind members they have 10 days to submit questions to the record and ask witnesses respond promptly to the questions and with that, this committee hear something adjourned. -- is adjourned.
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[inaudible conversations].
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>> here on on c-span2 we take you live to the atlantic council in washington for the launch of task force on future of iraq with panelists include former u.s. ambassador to iraq, ryan crocker, also james jeffrey, former deputy national security advisor and general barba row former national force iraq deputy chief and introduced by jon huntsman, former governor of utah here in the atlantic council. should get underway momentarily live on c-span2.
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[inaudible conversations]. [inaudible conversations]
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>> i would like to take this opportunity to welcome everybody on batch of the fred kemp, our intrepid president, and the entire atlantic council family. it's a great honor to welcome you here to this afternoon's launch event of the hariri task force on the future of iraq. let me say rafik, a member of executive committee is here. we thank you and what you have done to make this center a reality and its work so recognized. i would also like to offer thanks to both conrad adenour and american university of iraq for their generous support of the iraq task force. before we begin, let me just note that our event here is on the record and is being live streamed online. for those of you on twitter, i encourage you to follow using
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#future iraq. delighted to welcome distinguished group of speakers. we have two former ambassadors to iraq, ryan crocker, chair of the iraq task force and gem jeffrey. a former commander of the iraq training mission, general michael barbaro. thank you very much for joining us today. with four civil wars in 2015 and isis's rapid growth over the past 18 months, the middle east continues to be fraught with conflict and instability. that has exacerbated security concerns around the world. we're here today to do a deeper dive on one particular state, iraq. that holds immense geopolitical and strategic importance both in the middle east and more broadly across global communities. as defeating isis dominates the agenda, for many countries in the middle east including iraq,
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it is crucial that we also take into account the deep-seeded dynamics preexisting in each of those countries that will need to be addressed when crafting sustainable solutions for peace. inspired by the ongoing work of the atlantic council's middle east strategy task force, that is chaired by executive vice-chair of the atlantic council steve hadley, and honorary board director, madeleine albright, the iraq task force seeks to go beyond the defeat of isis and conduct substantial research into the iraqi case. the task force will bring together a broader array of international stakeholders and experts to collaborate to identify ways to stablize the iraqi state, reconcile its warring communities and build a basis for long-term stability in the country. the group will think through the demobilization of iraq's militias, the future of iraq's sunni community, the prospects
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for kurdish independence, paths to improving iraq's governance and economic performance, and plans for the reintegration of internally-displaced people. to do so we have gather ad team of 25 of the world's leading experts on iraqi politics chaired by ambassador ryan crocker who we will hear from shortly. the work of the task force will culminate with a book and series of polly-oriented papers complete with recommendations for governments and the international community. both the middle east strategy task force and the iraq task force are part of a broader atlantic council effort to inject strategic thinking on the u.s. foreign policy. with a specific aim to empower the international community and regional players with long-term approaches to respond to the challenges within the middle east. we hope to develop a comprehensive set of policy recommendation for the long-term
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support of iraq's stabilization, in time for the transition to a new administration here in the united states. so without further adieu, i would like to turn over to atlantic council senior fellow an executive director of the iraq task force, who will introduce our distinguished group of panelists and moderate the day's discussions. >> thank you. well thank you all very much for joining us for the launch of the task force on the future of iraq. it's really been a passion project of mine for a long time and a lot of you have given me advice and guidance on how to put this together and which questions to really focus on and, how to move forward with this so it is the most useful that it can be both to the u.s. government in terms of our devising after long-time strategy for the stabilization of iraq beyond the defeat of isis but also to develop useful
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policy tools to share with the kurdish regional government and with the iraqi government in baghdad and we really aim to bring policy measures to the forefront, learning from the mistakes we've made and also from the lessons we've learned from over a decade of u.s. involvement in iraq and i have with me a distinguished panel who have years of experience? iraq and who i am going to ask them difficult, reflexive questions to try and draw out how we can really bring lessons learned to bear on our future engagement with iraq which frankly as much as we've tried to turn away from, it really is a country in which we need to have long-term strategic engagement. and so the more foresight and strategic thinking we can bring to bear on that the better for
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all. so i'm going to start with ambassador crocker. ambassador, you were ambassador to iraq between 2007 and 2009, which we all know was a period of quite dramatic stabilization in the country. when you reflect on that time how do you account for the shift from violence to stabilization and the shift from very, parts of the population being very alienated from the political process towards their willingness to really take part and to give baghdad a chance? >> well, thanks. and it's a pleasure to be here. let me just say a word about our larger purpose, the future of iraq task force. it's axiomatic that iraq will have a future. the question is whether the u.s. is going to be part of that future, seeking to shape,
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channel, guide, processes, to a better place than what we're seeing right now. i approach this, the 20 five experts that have been assembled know more about iraq than i do. may not sound like it as we pontificate up here, but as we go into the task force it is to take a fresh look, make a series of assessments, challenge each other as we do it and then try to provide something useful to a new administration. we arguably over the last dozen years first did too much, as a government and now is arguably are doing far too little. so this will our effort nestled within the fantastic work that
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steve hadley and madeleine albright did on the middle east, to try to provide a way forward for a new administration which is going to need it. of course everything good that happened in '07, 09 was entirely due to me. there is nothing like being in the right place at the right time. i think jim and mike would agree with that. i think there were a number of factors that led to the achievement of relative stability and relative inclusivety on the political level. the surge really counted. i got there in the early days of the surge in the beginning of 2007 and could watch it work in
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districts like gora. that was my first, my first week there, i went to dora, just as surge troops were moving in. completely devastated neighborhoods where the only protection, largely sunni inhabitants thought they would ever have from marauding shia militias was al qaeda. with the surge troops, not just the number of troops, but the changing mission, protection of the population, you could see how life came back to parts of dora because we had a small operating base there. so the surge in the sense of security it brought to populations primarily in baghdad but really around the country
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made a huge difference. with that politics could be workable again. i worked obviously very closely with nouri al-malaki and others. prime minister maliki obviously came from a certain background and had a certain world view called highly sectarian but he knew what he needed to do for the country. i mentioned to jim over lunch, we taught the iraqis a lot of bad things, maybe the worst was the budget supplemental process. but the iraq's first budget supplemental in 2007, $250 million, went to the sunni province of anbar. it took a fair amount of lifting with the prime minister to get them there but he could see that how important that was to pull
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iraq out of the chaos of civil war and provide at least the hope of a unified country. so, again, security, security, security, but security to trigger a political process. we saw that in the course of those two years, how, deals could be done in parliament, bringing kurds, sunnis and shia together. for compromises, compromises they could not quite fashion on their own but if the u.s. was in the middle of it, getting something here, giving something there, we could help put it together. i certainly start with that bias if you will and i would be interested in what jim thinks about it, being there at a later time. really were the essential middlemen when i was there.
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for lots of reasons the horrors of the saddam years, the unspeakable tragedy of the civil conflict in '06 and early 07, compromise just wasn't something iraqis were going to do. but we could get in the middle of it and make those things happen. with the kurds, i would have interesting conversations with the kurdish leaders at that time. and when they got way too interesting i say, hey, guys, remind me, what were the very worst of times for iraqi-kurdistan? and there would be some debate because there were a lot of really bad times in iraqi-kurdistan but almost always they come back to the
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fall, the awful virtual genocide or attempted genocide of saddam against the kurdish people. would i say right. so what was the best of times? that one was easy. right now, today, this is it. never been so good. and i'd say, right. so don't blow it. in other words, don't overreach. recognize that the best future at that time for the kurdish region was within a unitary iraqi state. that would not threaten kurdish security and would provide a solid economic basis through the 17% budget share. so, again, from a pretty bleak beginning in early '07, there was no guarranty the surge wag going to work. i remember watching casualty counts go up. god, mike, you lived that, when
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we had over 120 dead in june 07, that number sticks with me, everyone of them a person, everyone of them an american and i could not say the at end of june in 2007 as we looked at those figures that their sacrifice was going to turned tide but it did. it brought the basic security on which we could then build the various political and economic structures. >> thank you. ambassador jeffrey, you were there as ambassador later under the obama administration. could you reflect a little on what ambassador crock hears said. under the obama administration was the u.s. still prepared to act as a middleman in kind of doing the diplomatic heavy lifting and bringing the various components of iraqi society
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together, or had the u.s. mission in iraq really changed by the time you were ambassador? >> yeah. i think i will start with a with explanatory story, it involves ryan. he may not remember this. before he went out there in 2007 he came to visit us in nea. he came into my office, i looked up at him, i said, ryan, only you can save iraq. i wouldn't repeat and embarass his pithy answer. many of you who know him how he responded. he had a good laugh, went on to other things. in many ways, ryan, dave petraeus, george w. bush, and most importantly iraqi people saved iraq in that period. and every day when you look around the rest of the middle east, iraq is looking a bit better compared to -- it has constitutional system. it has a democracy. it actually votes. people who don't do well are driven out as prime minister. that has happened repeatedly. and it's managed to stem the
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tide of isis but, asking has changed totally apart from the united states. we have that for another discussion. something has changed in the world since that period of time. for three decades, this is walter russell mead more than jim jeffrey, but worthying about, but almost three decades after 1987, '89, we didn't face real existential global or major regional challenges. we dealt with each problem, be it north korean nukes or taiwan incurrings, afghanistan, colombia, iraqs as a problem we would work at in generally positive world. things have been shifting, not in our direction, particularly but not only in the middle east for the past three or four years. and iraq was getting caught up in that when i was there. in terms of the obama
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administration, president obama came in, i mean he ran famously because we're revisiting the whole thing now, on a opposition to hillary clinton's vote in 2002 on going into iraq. he is the guy who voted against it. and who, was going to withdraw all the troops. well, actually, he didn't have to withdraw all the troops because in fact the u.s. government had agreed in 2008 in security agreement that we would withdraw all of our troops by the end of 2011. so, president obama came in with a double success story. iraq was relatively stable. and our fighting and particularly casualties both iraqi and american were way, way down, and, we were on a glide path to withdraw all of our troops by

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