then we move into early march, super tuesday, the start of winner take all primaries which means the delegate count is critical. as we watch that continue for the candidates, we will get a better sense of whose message is resonating and who is on the path to the nomination. next, a senate hearing on u.s. preparedness for biological threats. then gina mccarthy talks about the clean water act and the clean power plan. after that, new mexico governor sus susanna martinez gives her state of the state address. now a house hearing on the nation's preparedness for biological threats. it comes following the release of recommendations from a special panel on biodefense. this is just over two hours. >> good morning. we will begin this hearing.

we will have votes in a couple hours. we want to make sure we move quickly through this. before i start, i want to acknowledge that our good friend and ranking member of the committee, frank palone is not with us because his father died. we keep his family in our prayers. i did not personally know his father, i know he raised a good son. so we thank him for that. we will continue on from there. next, joined today also with my colleague who is wearing denver broncos orange. congratulations for a super -- they must be a good team, because they beat the steelers. now on with our hearing. good more than, we'r good morning. we're reminded those that seek to do us harm through a variety of harms, including biological attacks. the threats are growing and

every changing. we are ill prepared to detect and respond to the threats as rapidly as needed. we have been caught flat footed too many times in the past. we face a deadly enemy we cannot see. our methods to find it are inadequate. we may know know it's there until it's too late. this is frightening. the federal government's ambivalence towards biological threats must end. today the biological threats confronting the u.s. fall into three categories. one, naturally occurring. two accidental and three intentional acts which are ofas terrorism. it's easier formation statements and terrorists to obtain b biological weapons than ever before. given the ease, it's difficult for the intelligence community to collect, analyze and produce intelligence about biological threats. the threat of a biological attack is not as remote as one would hope.

the at the same time, pandemic and other pathogenic diseases are occurring with greater frequency and spreading more quickly throughout the world. as populations put pressure on remote areas and with ease of global travel, we will see more and more infectious diseases emerge. since 2002, the world has seen outbreaks of sars, cholera, influenza, measles, ebola, mers and zika. everyone has a plan until they are pufnched in the face. we were not prepared for ebola. this is what shakes the public's confidence. instead of ensuring the u.s. had strong central leadership, the administrati administration's answer was to serve an ebola czar. a zika outbreak threatens the continental u.s. it could have greater consequences if it brings increases in microcep hmicrocep.

the latest budget request continues to leave gaps of more than $1.8 billion in project bio-shields, special reserve fund and pandemic flu counter measures. over the last three years, this subcommittee has examined the impacts of and our preparedness for biological incidents. we have held hearings on our flawed response to the ebola crisis, ethe need for better preparedness, the unsafe practices by the department of defense, the handling of live anthrax. in the coming examine the response. each topic has a common denominator. the federal government was not prepared. for years we have lunged from crisis to crisis reacting to what just occurred instead of planning for the next outbreak or attack. the subcommittee's oversight

work has made a difference. but i am concerned that the federal government locks an overall plan. instead of being reactionary, we must be proactive with a new approach. last fall, the blue ribbon study panel published its national blueprint. the panel examined the current state of the united states related to prevention, deterrence, preparedness and response to name a few. this is not a book that should sit dusty on a shelf but one the people should read. i am pleased that two distinguished commission members are here today to speak about the important work of this panel. we thank you. the panel's findings that we are dangerously vulnerable to a biological event because we lack leadership and overall strategy are frightening. the panel made 33 recommendations, many which fall within the jurisdiction of the energy and commerce committee and impact work that this subcommittee has done and will continue to do. the need for improved leadership

echos throughout the report and is a theme we have heard far too often about the federal government. without leadership, there's no coordination of biodefense research, preparedness and other issues. without leadership, there's no strategy. the panel also makes a number of specific recommendations. we must improve our biosurveillance and biodetection capabilities. we need to detect pathogens in the air in hours and minutes, not days. agencies already collecting surveillance data should share it, not squirrel it away. we need a platform that allowed for vaccine development that can be applied not only to what we know about but also to the ones we have not yet discovered. the energy and commerce committee and this subcommittee in particular must take the lead in understanding and improving our biodefense capabilities. i thank our witnesses for being with us today. we look forward to hearing your testimony. now i recognize i ranking member of the subcommittee. >> thank you.

i want to welcome our witnesses. in particular, former congressman greenwood who sat right there for many years and who sat next to me while we had a lot of the hearings on these issues that you mentioned in your opening statement. i know he is just as frustrated as you and i are about the fact that we still continue to lurch from crisis to crisis in this country without any kind of unified or comprehensive response to some of these issues. when i was listening to your opening statement, mr. chairman, i thought to myself, who says bipartisanship is dead, because my opening statement mirrors yours to the point of talking about some of the very same examples that you discussed. so i won't read the whole opening statement, because i do not subscribe to the adage that everything has been said but it hasn't been said by everybody. so i will put it into the record. i just want to highlight a couple of the issues.

we have the zika virus going on as you mentioned right now. we're scrambling once again after the fact to deploy the appropriate resources to protect our citizens as this spreads. last year, it was the ebola outbreak. we did finally organize to respond to that. we're still trying to put the systems in place to make sure that ebola doesn't spring up again. this national blueprint for biodefense made a number of important findings on how to respond to these natural occurring threats. but also how to respond to deliberate attacks. as you mentioned, mr. chairman, the panel made three dozen recommendations to better posture our government to respond to these emerging biothreats. now for those of us who were here during the fall of 2001, we remember vividly those little

few envelopes of anthrax that arrived on capitol hill. the chaos that it caused within congress. offices were closed. buildings were fumigated. some congressional business was suspended. thousands of staffers and members of congress lined up to get tested for exposure. even worse, of course, some of the workers in the postal centers died. this was a relatively small attack. imagine what would happen if we had a large attack in a major metropolitan area or some place else. that's why we have to be organized to deal with these things. that's what brings us back to the findings of this panel. you know, there are a number of really important recommendations. and i recommend to every member of this panel and every member of the audience that you read -- you read the actual blueprint. because it is sobering. but i think that the top observation that's made in this

blueprint is that the nation is under prepared for a bioattack because we still lack centralized biodefense leadership. the panel recommends appointment of a single national leader under which preparedness for and response to biological threats could be consolidated. the panel recommends this authority be institutionalized in the office of the vice president of the united states. and what the panel says is that this will, quote, ensure that biodefense will be addressed by every administration at the highest levels with adequate access to the president. i think this is a very unique recommendation and one that we should explore. and i just want to say one more thing, mr. chairman. one of the grand traditions of the oversight and investigation subcommittee is to shine light on issues like this and to actually move the dialogue forward. so i was really gratified to hear you saying in your opening statement that you don't just

intend to have this hearing today and let this go. i think if we really have a series of hearings diving deeply into the recommendations of the committee and take their recommendations that we have some of these hearings, we actually can make a long-term difference in how this nation is prepared. and that may be the very best legacy that not only this blue ribbon panel but this subcommittee can leave. i will put my full statement in the record. i would like to ask unanimous consent to put ranking member palone's statement in the record. i yield back. >> i will ask unanimous consent that any other openi ining statements be in the record. without objection, they will be. i believe you don't have an opening statement. we want to make sure we hear everything and every member gets a chance to ask questions. we will move forward. will introduce the witnesses on the panel for today's hearing.

the first witness on today's panel is the honorable donna shalala. former secretary of health and human services. she has demonstrated strong commitment to public service from the peace corps to the department of housing and urban development. she's a recipient of the medal of freedom and is president and ceo of the clinton foundation. we appreciate your time. next my friend and colleague from pennsylvania, the honorable jim greenwood, former congressman from pennsylvania. chairman of the subcommittee from 2001 to 2004. he served since 2005 of president and ceo of biodevelopment committee. he has aided in the development of biotech solutions to major challenges in agriculture and health care. dr. tara o'toole who is a senior

president at a non-profit strategic firm that works to facilitate cooperation between technology startups with the u.s. intelligence community. dr. o'toole, formerly served ace under secretary of science and technology at the department of homeland security and assistant secretary for environmental health and safety at the department of health. thank you for being here. now i will yield to mr. flores who will introduce our next witness. >> thank you. i thank you for holding this hearing today and for the courtesy of allowing me to introduce one of of my classmates and a fellow texas a a aggie and expect on public health. at texas a&m, he oversees the largest private partnership with the biomedical advance research and development authority, commonly referred to at barta for vaccine development and manufacture. prior to his current role, dr.

parker had the career in public and military service including serving as a deputy assistant secretary of defense for chemical and biological defense. in that position,itarymilitary' readiness. dr. parker served as a principal deputy assistant secretary in the office of the assistant secretary for preparedness and response at hhs and in a similar role at the department of homeland security. mr. chairman, thank you for allowing me the time to introduce dr. parker. his leadership positions are critical to the topic before this committee. thank you, dr. parker, for being with us today. i yield back. >> and if there's no more statements, we will proceed. this committee is holding an investigative hearing. when doing so, has had the practice of taking testimony under oath. do any of our witnesses have any ok

objection to giving testimony under oath? the chair advises you that under the rules of the house and committee, you are entitled to be advised by counsel. do you desire to be advised by counsel? all the witnesses say no. if you would rise and raise your right hand. i will swear you in. do you swear the testimony you are about to give is the truth, the whole truth and nothing but the truth? thank you. all the witnesses said i do. you are now under oath subject to t to the penalties of the code. we will entertain you with a five-minute opening statement. you are recognized for five minutes. turn the microphone and turn it close. >> good afternoon mr. chairman, members of the subcommittee. i submitted testimony for the record. thank you for inviting us here

to present our views and recommendations of the bipartisan blue ribbon study panel. i'm pleased to be joining jim greenwood. we are here on behalf of our co-chairs, joe lieberman and tom ridge and other members of our panel, tom daschle and former homeland security adviser ken weinstein. it's also good to see dr. jerry parker who was one of our exofficials as well as dr. tara o'toole who advises all of us on this important subject. we are deeply concerned about the biological threat, whether intentionally induced, naturally occurring or accidentally released. i want to emphasize those three issues. because this is not a report just on intentionally induced biological threat.

it also covers the naturally occurring ones or the accidentally released. i want to take a moment to address the threat now, but let me recommend that you get a classified briefing at your earliest opportunity. make no mistake, we have been told that our enemies are seriously considering the use of biological weapons. during the invasion of afghanistan, the united states uncovered evidence that al qaeda was trying to develop biological weapons. more recently, isil has gained control of enough land physical infrastructure, scientific expertise and professional military personnel to potentially create and deploy biological weapons. and they have expressed their intent to use them. additionally, the verification protocols associated with the biological weapons and toxics are weak and do not do what the world needs them to do, differentiate between legitimate

and malicious activities. we are concerned about the threat of naturally occurring diseases with pandemic potential. it's often very difficult for our scientists to guess the correct combination of viruses that will even make up the strain of influenza that will circulate the following year. nevertheless, diseases do not have to kill millions to produce impact. there are a number of diseases that have is a fektaffected new florida and puerto rico and the u.s. virgin islands over the last two years. zika virus is on the move as well. in some cases, resulting in microcephali who contact it from the mother. the first case has occurred in the united states. in dallas. which was the first city with an ebola case.

this transmission did not occur from mosquitos. it was sexually transmitted. imagine the devastating societal consequences if we cannot stop the spread of this disease. accidental releases contribute to biological risk. i'm sure that you are aware of the recent laboratory biosecurity and biosafety mishaps at a number of our high level laboratories. the organisms in which these laboratories work are too serious, too infectious and too deadly for us tos react indign t indignantly. our attention span tends to increase and decrease as different events occur and their impacts fa s fade over time. since i was secretary of health and human services, i have seen three administrations increase

and decrease their emphasis on biological threats, usually in response to and after recovering from incidents such as the anthrax events, sars, mers and ebola. now we're all gearing up again for the zika virus. we need a leader at the highest level to take responsibility and develop a strategy and a unified budget and lead the whole of the government along with non-governmental partners to improve our national biodefense and to do so attentively and consistently. we recommend that that person be the vice president of the united states. one of the few who can get the government agencies and the non-governmental partners to work together. we are not necessarily talking about new programs or funding. instead, we believe we can build

on existing programs and infrastructure. let me give you a few examples. we ought to be able to take an environmental biodetection system that was originally designed for the battlefield, for example, evaluated and if it seems useful then modify it to fulfill our needs domestically. we should see how we could build on our pre-existing pervasive and familiar system of community pharmacies to get pharmaceuticals to localities in the midst of a biological incident and maybe create smaller caches in advance. we cannot defend on a federally driven public point of dispensing model or take our hospitals, which meet accreditation criteria, we can use that to address specialties like trauma, for example. doing the same for biodefense

would cultivate better hospital preparedness for major infectious disease events. in doing so, we could create a str hospital system in advance knowing exactly which facilities are best positioned to handle cases. the funding we could get is far greater than what is currently available through the hospital preparedness program. while we support this grant program, it's simply never going to be resourced enough to meet the need. >> i want to make sure we have time for everybody. >> i'm closing. in closing, i want to note congress plays a critical role in providing necessary oversight and legislation. we need all of you to consider these recommendations and hopefully to move forward. now after you have heard from jim greenwood, we would be happy to answer any questions you

have. >> thank you very much. mr. greenwood, you are recognized for five minutes. >> thank you. i'm tempted to ask unanimous consent to insert your opening statement and the opening statement of the opening statement as a preface to our report because it's gratifying to see how aligned you are with our recommendations. thank you for inviting me to discuss preparedness for biological threats on behalf of the panel. as the former chair of this subcommittee, i am honored to testify here today. this is timely, not because of biological events has occurred but because one has not occurred on u.s. soil. whether it's the reintroduction of smallpox by a terrorism, a dirty bomb in an urban center on another pandemic influenza outbreak, as the panel notes in our report, we are under prepared to respond to these threats. we must take immediate steps to be better prepared. it has been a privilege to serve on the study panel with my

colleagues. our report starts from the premise that the threat is real and it is growing. what we are prepare -- we are better prepared than a decade ago due to federal and private sector investments. the fact is we are still dramatically under prepared. our report outlines 33 recommendations. we as a panel all strongly support the first recommendation calling for a centralization of leadership over biodefense in the office of the vice president. i would like to further focus on the recommendations related to strengthening the public private partnership as industry plays a key role in protecting our nation. consider a company with a novel technology applicable to the biothreats of emerging diseases identified by hhs. this company wants to partner with the government. but there's so many unique market challenges. unlike products with a viable commercial market, the market for most medical counter

measures is defined and supported by the federal government making it a major source of research funding and the primary purchaser of vaccines, therapies and diagnostics against these unique threats. many companies begin research at their own risk, conducting r & d before receiving federal government funds. over the last few years, a government funding for mcm r and d has been decreasing as the number of threats have been increasing. the investor community views these products as risky and a distraction from similar products that have a clear commercial value. making it difficult to raise the necessary r and d funds for mcm in the private capital markets. the regulatory panthway is not always clear. industry has seen a drop in the level of funds for the purchase of the final mcm. for many companies, the biggest risk is they will invest

significant funds and time developing a product only to find there is no clear procurement strategy from the u.s. government due to said shifts in priorities or dirth of funds. we support a multi-year strategic plan and budget that clearly outlines the priorities for r and d and procurement of medical counter measures and pandemic influenza products. such a document would provide much needed transparency on governmental priorities helping companies determine what products to pursue in this partnership. the mcm enterprise must be fully funded. the project bio-shields special reserve fund was created to provide companies with a guaranteed market for mcm by establishing a ten-year advanced appropriation of $5.6 billion. the srf has proved successful in tracting companies to invest in mcm r and d.

12 mcm were procured during a ten-year period. there are over 200 in the pipeline. the congress made due to the initial investment is now in jeopardy. the srf was reauthorized at $2.8 billion for 2014 through 2018. but rather than a setaside sum of money, the program has been funded through annual appropriations and much lower than the authorized amount. unless funding increases, we are risk a $600 million to a $1 billion shortfall. it endangers the progress we have made and puts the 200 product candidates in the pipeline at risk. similarly, pandemic influenza has been woefully under funded the last few years. it's a known threat that is very challenging giving its persistent nature. it's imperative that our preparedness include development

of vaccines, anti virals and diagnostics, rapid response capability and the replenishment of vaccine. our plan calls for congress to provide a legislative authorization to define and guide pandemic influenza programs in order to ensure that they receive the funding needed. novel incentives could demonstrate the government's commitment to mcm development. one of the most important incentives in the report is the priority review voucher program. for pathogens designed as material threats. the prv is a proven and valuable incentive that has helped to spur investment in other complex and neglected areas of r and d such as tropical diseases. an extension of the program to include material threats is viewed by many as a way to offset the dramatic decline in procurement funds for mcm. adding mcm targets to the prv program may help convince investors that the government is committed to this indefsher and

provide increased certainty that mcm have value. improvement -- improvement must be made in the contracting process as well. in addition to robust sustained funding, tit must be improved t make it more efficient and predict predictable. steam lining is important. i call on congress to swiftly pass hr-3299, the strengthening public health emergency response act of 2015. this bill focuses on many of the issues i have raised today and represents a strong initial step toward implementing the recommendations of the panel. this sub did tcommittee plays a integral role. i commend your attention to preparedness and the letters sent to the administration about flu vaccine supply and plans. i hope the energy and commerce

committee of the subcommittee examine the issue further. the threats facing our nation are real and many. having products to support our national preparedness relies on the park of a few dozen biopharmaceutical companies. the only way these companies can continue vital r and d and capacity building is if the u.s. government demonstrates a strong commitment to them by providing clear priorities, sustained funding and real incentives. if we invest well now in the broader set of known threats, we will better -- we will be better prepared to respond when faced with an unknown threat. thank you again for the opportunity to testify. and the worth of the commission. i commend the subcommittee for examining this and i look forward to your questions. >> thank you. now dr. o'toole, you are recognized for five minutes. >> thank you, mr. chairman.

thank you, mr. chairman. technology. yes. thank you, mr. chairman. i am very happy to be here today to discuss this topic which has been a preoccupation of mine for most of my professional career. i want to thank you for your kind introduction and emphasize the views i express are my own. i want to start by congratula congratulating the panel on their excellent report. which i hope will be highly influential. i especially endorse the urgency about repairing the vulnerability to highly kwen shall bioevents. i want to address three issues. first, i want to emphasize the nature and the significance of biological weapons threats and explain why it's a first tier national security problem. secondly, wasn't 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 bioattacks. the latter would be faster, fiercer and it may be that many victims are beyonds recoup. but if we cannot handle natural outbreaks more effectively and efficiently, we have no defense against biological weapons. thirdly, there's a major revolution in our understanding of how the biological world works and our ability to manipulate it. the advances in bioscience and biotechnologies should be part of the foundation of u.s. biodefense against both natural and deliberate epidemics. these advances are going to be extremely beneficial to human kind across much different fields that go beyond biomedicine. but it also means that we now

have created a world in which there is wide access to advanced biological knowledge and the materials needed to build and disseminate biological weapons. as the defense science board said in 2001, an age ago in terms of scientific advances there are no technical barriers no non-state actors, including terrorist groups and lone wolves, carrying out devastating bioattacks 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 their cause. i'm going to give you some examples of critical technologies which might help realize the panel's 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 akin to that of nuclear weapons. in 1993, the congressional office of technology assessment estimated a kilogram of anthrax dropped on washington, d.c. in ideal weather conditions would result in 1 to 3 million deaths. that's about the same toll as one mega ton hydrogen bomb. the statements are not base on speculation but 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 secret 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 release from air, boat, ships and subways. declassified documents from the '60s recognize the strategic power of bioweapons. we do not now know the fate of the soviet effort. in the half century since the u.s. ended its offensive 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. these advances have meant the spread of bioknowledge and access to sophisticated biotechnology. the materials and know how needed to build a weapon have many legitimate uses. these are dual used technologies. 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 discuss. i want to end by saying that there are two critical technologies that have not gotten sufficient attention in our biodefense program. the first is rapid diagnostics upon which we have spent very little money and for which there is a very big market problem that makes it difficult for private companies to pursue diagnosti diagnostics. the second is vaccines. i see i'm out of time. i will await your questions. >> thank you. we recognize dr. parker for five minutes. >> thank you. good morning chairman and ranking member. >> pull your mike close. that would help. >> thank you for the invitation to appear before you today. it's an honer or to be here.

and under secretary o'toole is one of our most highly regarded leaders. for my part, i have been involved in biodefense since 1982 to the present. from the cold war to the rise of violent extremism ae isism and of emerging infectious diseases, have i have been at the eye of the storm witnessing the 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 tarting to realize the threat of emerging infectious diseases following ebola and now presumably zika. although the threat of biological warfare and particularly biological

terrorism is very real, too, it is less well understood. if there's any good news here, the number of countries thought to be conducting some type of elicit biological weapons activity, it has gone down from the end of the cold war from about 12 to five. but those countries include china, iran, russia, syria and north korea. their operational scenarios for use are no longer limited to military targets. today, the risk from a bioterror attack from non-state actors, extremist groups or individuals on civilian populations is a reality. biological weapons are sometimes called the poor man's atom bomb. biological weapons have the potential to cause mass casualties on the scale of a nuclear weapon. even a simple bioterror attack as we heard early early today

can have a devastating consequence such as kurd from the anthrax letter attacks in 2001 that took five lives, sickened 17 more and over 32,000 people took antibiotics because of potential exposure. it could have been much worse from that simple attack. some question the seriousness of the risk today because further bioattacks have not followed. fortunately, additional attacks have not occurred, which i partially attribute to successful counterterrorism strategies. why fushlgrther attacks have no occurred? couples with our vulnerability, it's up for debate. i do not want to overstate and under estimate the threat of a an attack. i cannot predict the future. but we cannot ignore that extremists intend to do us harm by any means and they are not morally constrained in the methods they use. the intent to acquire and use

weapons of mass destruction by the likes of al qaeda, isil and others is known. intelligence garagering is extremely difficult to detect a biological capability and imminent threat. but we should not take the lack of intelligence as lack of threat. the discovery of an isil computer containing plans to develop plague as a bioweapon should give us pause. the director of national intelligence confirmed reports that the islamic state use ad a chemical warfare act. the islamic state is growing rapidly, has resources, controls infrastructure and safe havens and is recruiting scientists that could be capable of developing biological weapons. it may also be only a matter of time before biologists becomes a self-inspired violent extremist. we must assume the threat is real and serious. in addition to bioterror attacks, naturally occurring

emerging infectious diseases continue to happen. pandemic potential influenza, sars, ebola and zika are real experiences that tell us we may be on the verge of a global pandemic any time. our biological threat preparedness response enterprise must be ready. any time. biological threats are not new. but we seem to pay attention only when an outbreak occurs or an attack occurs. and ignore it between outbreaks. the time between outbreaks are the period that is precisely when urgent actions are needed to optimize resources to hone our preparedness and response systems. before closing, i would also like to add that initiatives in global health security and one health are critical. and they enable work in the prevention side. i would like to thank the members of the subcommittee again for this opportunity. i'm happy to answer any questions you may have. thank you.

>> i thank you, dr. parker and the panelists. it's sobering testimony. let me start off i recognize myself for five minutes. dr. o'toole, you referred to this as a first tier national security problem. bioattacks are faster and fiercer. it seems like these natural outbreaks, they really are a test run to prevention, how we handle ebola, how we handle sars, deceit can a virus, gives us an opportunity to work on prevention, detention and responding. i don't think we are at all where we need to be. given that, is there reason to be more concerned or less concerned about the threats of bioterrorism? >> mr. chairman, i think you are right. i think our response to naturally 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 shorter time than there is now the case. and i think we do have to prepare for a whole array of threats which we're not going to be able to predict. the other issue that dr. shalala mentioned is that a lot of our response depends on the state and local public health departments. they have lost almost 50,000 people since 2008. and so one could argue that our capacity to respond to an epidemic today has did i minute ois ished compared to them. that's a problem. >> secretary shalala and congressman greenwood, would it

be fair to say your panel's general concern is that biological threats are increasing while important aspects of the u.s. biodefense preparedness are declining or inadequate? is that a proper conclusion? >> yeah. i think that's fair. i echo dr. o'toole. our infrastructure for dealing with these has gotten weaker. starting with the state and local response. one of the things that we forgot in the ebola discussion is the states are our first line of defense. we have been putting resources and building the public health infrastructure for years with essentially block grants from the cdc. those have been weakened. and if you don't have a state and 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, with their tracking systems, then it's very difficult for us to pick up something that's going to recur that we know that's going to recur over a long period of time. that's why we talk about the vice president. because it's very difficult for anyone else to pull in all the actors, the private sector actors as well as the public sector agencies. >> chairman greenwood, as we have increasing number of these naturally and accidentally occurring bioattacks, is our diminished capacity because we're strained or because we have actually lost ground in dealing with these issues overall? >> i think your original question is the threat growing while the capacity is decreasing is -- the answer to that question is yes.

if you think about the bioterror threat and isis and you look at what they have been able to do with rifles and assault weapons and so forth, it's clear and it's obvious that their intention is to clear as many as they can. you can do a heck of a lot better job at that using chemical and biological weapons than you can with conventional armame armaments. there is evidence that they are trying to figure out how to use bubonic plague. they are trying -- they tried to -- they have a plan to poison the turkish water system. the intention is clear. while that's happening, the same technology, sin thet ynthetic b that's allowing companies to do macie i amazing things, is making it easier to formulate these new weapons. the threat is growing.

to see that in the face of all of that the federal government's commitment to funding barta, to funding our ability to develop these counter me eercountermeas diminishing is frightening. hearing you done want to have is the one that happens after tens of thousands of people have lost their lives and you are sitting here asking yourselves and government officials why we weren't ready. >> thank you. that could happen at any time. my time is up. >> thank you very much. mr. greenwood, you are exactly right. this is what keeps me up at night is the responsibility that this subcommittee has to actually move this -- 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 actually in the middle of the flu season. but i think what the blue ribbon panel is saying is we need to go even further than that. we need to have a system in place that's not based on response after the fact. would that be your assessment, too? >> 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 a handful of private companies in this country who are willing to take the risk of developing countermeasures. as has been said, this is unique. you don't sell those countermeasures at walmart. >> right. >> the only potential procurer of those is the federal

government. those companies, like every little biotech company, rely on investors. those investors can put their money into a conventional biotech company, into an i.t. company, anywhere they want. they are looking for return on investment. if they see a system that's uncertain due to lack of certainty that these products will be procured, they will put their money elsewhere. >> we have seen this in the pandemic influenza program and trying to prepare for that. and with these cuts -- i'm wondering, maybe secretary shalala you can talk about the how the 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 science that we're doing. because if you don't have that, you wouldn't have the companies.

it's a combination of things. >> you need the basic research. and then you also need to have the robust pandemic flu program so that you can support development of the vaccine by the private companies. the priv companies. so it really is a partnership. >> vaccines have not been a major priority of the multi national pharmaceutical companies. they don't make enough money from them. particularly when the government is the only purchaser as was pointed out here. they don't have a lot of confidence that we will give them the kind of margins they can get from other kinds 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. so think of this as the cutting edge of a dramatic new conceptualization of our defense.

we are actually talking about the defense of a nation and about the health aspect of that. >> let me ask you, why is it that the panel recommends centralized leadership in the vice president's office to coordinate all of this? >> well, since i sat in the major agency responsible for many of these issues, and since we now have the homeland security agency, the fact is that the responsibilities for different aspects of this are spread across the government. and even the lead agency concept will not solve that, or in my judgment, a czar sitting in the white house. the czars work best when there's an emergency. if you really want to build up the infrastructure, you have to have a powerful person and you can't have that in a cabinet agency which is a peer of all the other cabinet agencies.

so the vice president is the only person that can cut through that, talk to the private sector and simultaneously talk to state and local governments. and put all those pieces together. he's also the only person that can demand a unified budget out of the omb and across the government. >> this was a bipartisan recommendation. >> it was a bipartisan recommendation. i have to tell you, i hesitated as someone who sat in a government agency, a powerful government agency, i hesitate to transfer power to a vice president or to the white house in general. as you know, cabinet agencies have a certain amount of tension with white houses. at the end of the day, this is one of the areas where you need a unified budget. the only other place we have a unified budget is actually in intelligence. so this is a parallel to that, to pull all the pieces together. and it's important enough to identify the vice president and vice presidents always have some time to take on other responsibilities.

>> thank you very much. thanks. >> with all due respect to our very nice vice president. >> i'm sure he will be pleased you said he had lots of time on his hands. we now recognize -- >> we have discussed this with the current vice president. it's not he particularly that we identified, but the office itself. >> we will bring him in here and ask him about that. recognize mr. flores for five minutes. >> hard to follow that. doctor, you emphasized in your testimony we should be urgently preparing for biological threats in the time between outbreaks. in 2006, congress created brta to do exactly this. as you explained, we continue to seem to go in crisis mode only when we have an outbreak. what else should the government do in these inter-epidemic periods? >> thank you, congressman flores. actually, in answering your question, i'm going to come right back to the centralized leadership and how important

that is. i will answer it actually with an example. in my own experience, my own career, and that very same time in 2006, as the pandemic and all hazards preparedness act was passed, we got very concerned about pandemic influenza to the point that an emergency supplemental was appropriated in that time, $6 billion, $7 billion. it was accompanied by a very strong white house-led pandemic influenza strategy coupled to a pandemic influenza implementation plan. this is the closest example i think that has happened to date that kind of reflects the centralized leadership biodefense strategy that we actually did for pandemic influenza that accompanied an

appropriation that really covered almost all the department agencies, state, local, private sector. they were involved in pandemic preparedness back at that time. this implementation plan contained over 300 action items. it identified lead department agencies and supporting department agencies. it was very detailed. in fact, in my own department at 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 to accomplish things that otherwise, we would not have been able to do. so 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 milestones of metrics that were part of this implementation plan, both in the executive branch and to congress, because all congressional committees that had the appropriate oversight for their department agencies were regularly being updated, hearings were happening on progress of that plan. so i just offer that up as an example of something in the past that i think is in the spirit of what the panel has recommended that would drive us a long way forward to doing what we need to do in that inter-epidemic period and before an attack occurs. >> thank you. i think that's helpful. i also want to compliment you on the great work you are doing in the public/private partnership. dr. till, the world health organization recently assessed the impact of synthetic biology on smallpox preparedness and control, and the scientific group found the risk of re-emergence of smallpox is

increased due to the low cost and widespread availability of technology and know-how on how to create the smallpox virus. so the brsp relied or focused heavily 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 biology escalated the threat? >> virtually anything is possible today, 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 non-resistant 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. okay? i mean, we are in a revolutionary fight as a 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 tweaks on the programs we have now, in my opinion. we need a much deeper investment in bioscience and biotech. >> thank you. that's helpful. i will be exhausted by the time

i yield back. thank you. >> thank you, mr. chairman. welcome to our witnesses. dr. o'toole, in your testimony, you speak of the need to take advantage of recent developments in bioscience to rapidly develop tests and manufacture vaccines against 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're not affected. same thing for ebola. imagine if we were able to tell within minutes if somebody was infected with ebola. preferably before they're sympt symptomatic. the technologies are out there. the path to 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, how does the first recommendation that you have 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 the vice president of the united states, you certainly can 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 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 of 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 the congress can provide the authorization to the vice president and then perhaps it's up to the president and 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. secretary, given the complications created by

transferring technology from an innovator company to the centers for innovation and advanced development and technology, 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 respond to the various emerging threats? >> you know, periodically, the leaders of government 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 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 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 each of you. mr. chair, i yield back. >> thank you. i now recognize miss brooks for five minutes. >> thank you, mr. chairman. thank you to our esteemed 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 multiple

government offices were receiving powder which terrified that employee who opened the mail, not knowing if it was actually anthrax or if it was just powder, and i have to tell you, i thought, i was in federal service until '07 and felt like we were moving forward but i have to tell you, until this report came out and until we have 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 on the basis upon which the congresswoman and i introduced 3299, the strengthening public health emergency response act of 2015. 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 talked to experts around the country as well. it's not just the people on the panel. a lot of work went into this. 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 barta, which is in my bill, and can you talk about the importance of that and what has happened and why we're not able to get vaccines and medical countermeasures through the pipeline as fast as we need them? >> thank you. originally, the contracting authority was with barta and it was changed. it was moved, i will refer to my notes here, it was moved to the office, an office called the acquisitions management contracts and grants office. the problem is that the technical experts are not there. and they are in fact at barta. 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 the folks who know a lot about contracts but they don't know a lot about this issue, about medical countermeasures. so i think it makes all the sense in the world to eliminate 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. with respect to the companies trying to get vaccines into our stockpiles, can you 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?

>> yes. we made recommendations in that regard because the 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 which is that we are -- that we are not organized as a government to m quickly respond to either pandemics or bioterror because the authorities are diffuse, they don't always talk to one another and that is exactly why a central unified plan, strategic plan, a central budget and giving the authority to the vice president makes all the sense. >> i think citizens believe and know we have these stockpiles and believe that they are adequately filled with the proper types of vaccines. would anyone else like to

comment on our national strategic stockpile? dr. o'toole? >> i'm the chair of a national academy committee on the strategic national stockpile right now. 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 biologicals and they are very expensive and they expire 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. this is an expensive proposition. the stockpile already hold about $7 billion worth of stuff. but we are talking about having to cover multiple cities with these sometimes very expensive drugs and vaccines. we need a cheaper way to do it

which is why i say you are 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 and scale what we need. >> thank you all for sounding the alarm. appreciate your leadership. i yield back. >> i recognize mr. mullen for five minutes. >> thank you, chairman and thank you for the witnesses for being here. i first want to thank the secretary and mr. greenwood for this report. i will tell you the more that 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, and to follow on miss brooks here, i want to get a little bit more in depth about what you see as 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. o'toole is the expert on the stockpile issue and we have 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. i think that most of us think 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 side, our ability to produce something faster and not being totally dependent on the stockpile is probably where your iom commission -- >> yesterday i had a meeting with some biodefense individuals and they were telling me that there is technologies they are looking at that would extend the life of -- the shelf life through maybe a dry freeze, is that correct, and then also, they are retesting it, and some of it was designed to go two or three years has lasted as only as 15 years. they are constantly retesting it but how do we dispense it? how do we get it out?

having it in a stock pile is okay but it doesn't do any good if it's housed in one place and doesn't get to where it's needed. >> one of our recommendations was to use existing community pharmacies. the original idea was using vas because they're spread across the country and do keep a certain supply. they are well located, the va hospital system, and warehouse system. the government has also contracted with i think fed ex to move pallets around the country. the reason for that is the military is not well situated to do that kind of thing. there has been extensive discussions in the government and a strategy for moving pallets of drugs very quickly using i think the contract was with the fed ex system originally to move pallets around the country when there are outbreaks. >> miss o'toole? >> the big problem with the stockpile is traversing what's called the last mile.

it's not about delivering the stockpile to the state public health departments. it's about getting it into the hands of people. as you can imagine, that dispensing function is very complex. washington state is going through pharmacies, that won't work in every state particularly rural states, although most americans live within reach of a pharmacy. 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 are very time-consuming and expensive. 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 suggestion. mr. parker? >> everything you're asking really comes back to centralized leadership. we have been talking about this for 15 years or more. the last mile of dispensing medical counter measures, that is the hardest challenge. in fact, there was an executive order in about 2009, 2010, and i was just discussing this with 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. we need that, because it's one thing to have a stockpile and it's one thing to be able to get it fed ex'ed 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. >> the chair recognizes miss castor for five minutes.

>> i'm going to scoot over. good morning. thank you to the panel for your terrific work on this important subject, and secretary, the folks at the university of miami were so appreciative and everyone across the country for your service. i know they miss you there. but it's great to see that you 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 are having to do that again. this doesn't seem to be the most efficient way to prepare for

emergencies. i would 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 nih, of course, was at the forefront in that ebola response. but some did not do quite as well. 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 have learned from this, from the ebola outbreak in africa and the few cases that were -- that came to the u.s.? i would like to ask maybe miss o'toole first. >> hospital preparedness is very important. i think between 2002 and 2008,

it did improve. two reasons. first of all, disaster response drills are required 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 money to hospitals to help them with bioterrorism 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, et cetera, et cetera. that funding has been cut in half since 2010. that makes a big difference. >> secretary, 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 disease-specific programs, especially since many states have frayed their public health infrastructure? how can we respond better and give our hospitals in local communities the tools they need? >> we have specific recommendations in this area, including steady stream of funding. we recommend that it be done through the accreditation system and through cms. in addition to that, we have recommended 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, and in fact, went through an exercise 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. i would encourage the committee to act on it as soon as possible. thank you very much. >> recognize mr. cramer for five minutes. >> thank you, mr. chairman. thanks to the panelists. i want to focus on this incentive issue, congressman, that you raised. i will admit up front that what i'm about to do is very dangerous. i'm going to think out loud for a little bit and admit you are not going to adequately inform and educate me in five minutes. so have yyou have to come to mye and help me work through this idea. you have all done a great job, as has the panel, the blue ribbon panel, in scaring me to death. i'm adequately prooepared 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 are not prepared and they will blame us when we spent money foolishly and of course, we are talking about finding a way to invest in something that we hope is never needed. so that's our political dilemma. starting with congressman greenwood and others, maybe elaborate on the srf, the prb, how we could help pharmaceuticals, the private sector, feel comfortable with the investment and the innovation and we have talked a fair bit about it, but if there's a way we can elaborate just a little more to help me better understand how we are going to do this. i might also emphasize, is there

a way to put a cost benefit analysis on this? for example, miss castor was talking about emergency responding. that's a cost. that's a cost that could be avoided perhaps if we are better prepared. so has there been some work done in that arena that helps me assure my constituents that we are not just appropriating but that we are efficiently and effectively governing? >> well, thank you for admitting that we frightened you. obviously, our constituents, your constituents are not clamoring for this because it's a sleeper e. >> yes. >> no one is thinking that this is going to happen. 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, leadership involves informing your constituents and this hearing is an important part of that. that this threat is real.

i calculate when it comes to bioterror, terrorists have the motive, they are trying to acquire the means, and despite our best efforts to deflect that, over time, the likelihood of that happening is one over one. it's going to happen. we have to be -- we have to believe that. we have to believe that the threat is real. in terms of what works, to be prepared, we talked about the contracting reform which is a minor thing but an important thing. congresswoman brooks is the leader on that. we talked about the need for there to be sufficient funding to actually procure these mcms when they are developed. 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 develop, when it comes to actually developing the product and manufacturing

the product, that's private sector is the only place where that is done. to invest money in that, 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. so that's critical. you need enough money and 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 hasn't moved the money around and it's no longer there. >> secretary, i can see you may want to weigh in but one of the things, i appreciate that your national defense analogy. i was thinking we spend billions of dollars on weapons we hope we never use, right? they do have the benefit of being a deterrent understandably, but it isn't dissimilar. we have to constantly make this case. thank you for that. and the centralized leadership

as well, i'm still struggling with the whole vice president thing myself. the more you talk about it, the more sense it makes. so i appreciate that. is there anything else anybody would add to what the congressman just said about the investment? >> i would like to add a little bit and perhaps maybe just pull on the contracting itself as well. as we have heard, many of the companies in this space that are really contributing to biodefense and particularly those that are bringing the more innovative solutions are struggling themselves. and the typical far-based government contracting is really contrary to the biotechnology industry in and of itself. so i would think, i have actually been encouraged recently with some pronouncements by dod to begin to start using some authorities they already have like other transaction authorities. i think also taking a look at what other things in just the basics of contracting that could

make it more readily accessible that the innovative biotechnology companies would actually do business with us and the government is something to look at as well. >> thank you very much. if we could solve dod contracting in the context of this, that would be a bonus. that would be a cost benefit analysis right there. >> recognize mr. green of texas for five minutes. >> if we could solve the dod contracting we could probably have them audited. i want to welcome our panel here. the blue ribbon study panel in biodefense highlighted vulnerabilities in our ability to combat emerging and reemerging infectious diseases, particularly drug resistant infections which could cause catastrophic loss of life and have already started to make even minor infections fatal. without greater investment in antibiotics we face a future that resembles the days before these miracle drugs were developed, one in which people died of common infections, many medical advances we take for granted become impossible including surgery, chemotherapy

and organ transplantation. the challenges are representative of the challenge facing medical countermeasure 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 act and again, in this current session, in the 21st century cures act we worked to remove the financial and regulatory barriers to antibiotic drug development. secretary, can you elaborate on the study's recommendation for incentivizing the development of medical countermeasures for emerging infectious diseases with pandemic potential, specifically please explain why there is such a need for the government to play a leadership role in this space. >> well, i think it's pretty straightforward that the only purchaser will be the government. there's 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 relatively small companies. often with a small number of products. we have known a lot about the biotech industry. they are fragile, i like to use the word fragile when you talk about them so that unless they know that they are 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 are going to move very quickly in this area. we have had some experience. congressman waxman and the orphan drug act, we had a lot of

diseases in 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 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. i just don't know, i think everything that we have learned, it's not just that i'm a capitalist, it's just from our view at a public policy issue, when the market is going to be the government, there is no other way to get a very small number of industry people to invest unless they know there's

going to be a market at the end of the day. >> jim, welcome back to your committee. so nice to see you. one of the proposals we have is the priority review voucher, prv. and the beauty of it, if you look at neglected tropical diseases, we knew that there's no financial pull, that these diseases that 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 the priority review voucher, it works beautifully, because what it does is 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 product, another maybe large biopharmaceutical company will pay me and these things, there are only two or three of them sold but they have gone for $200 million, $300 million, $400

million. doesn't cost the taxpayer a penny. which simply gives them a shortened review period for some other product. that doesn't cost the taxpayers any money, either. they pay their fee, they get their product approved and sometimes they don't, but if they do, it gets approved a little faster, gets on the market and by the way, then it goes off patent sooner so it still doesn't have any cost to society. >> mr. chairman, i'm out of time but we have legislation in the senate and it would fast track because we recognize the government's going to be the one that has to do it because free enterprise can't invest that money for something, but there is legislation and hopefully the senate will deal with cures and the complete package that our full committee approved overwhmgoverwhm overwhelmi overwhelmingly. thank you, mr. chairman. >> recognize the vice chair of the full committee. miss blackburn. >> yeah, that woman from

tennessee, tell you what. dr. parker, i am so happy to see an aggie on the panel. i have 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. how much we appreciate your insights on this and your dedication to the biotechnologies and the work that you have done there. just a couple of things that 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 and so they have got a good underpinning and it doesn't matter if it's vanderbilt or st. jude's or whatever.

they talk to me a good bit 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 measures, that is just so important that we have that. and it doesn't matter if it is 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 scaleability and then if you need something, you are ready to move with it. and it can push that

scaleability quickly. so let's go back to that voucher. mr. greenwood, if you will continue that conversation and kind of build that out, the importance of that, how you would address these for something that is a material threat, or like 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 -- we have seen our companies and proudly jumping into this zika issue and trying to do some research on it very quickly to develop

products. but i remember a company, member company of bio that was involved, looked like it was close to having something on ebola and they almost didn't want to talk about it because their stock was fluctuating like this. all of a sudden everybody would invest in that company and another company was doing something and people would pull out and it created unpredictability and volatility. it's an example of how the norms of economics don't work in this field. the priority review voucher takes away one of the uncertainties. that uncertainty is that it doesn't take away the uncertainty of can we make this product and will it be safe and will it be effective. that's 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 you do

succeed, the only reason your investors are giving you the leeway to go and do that is because they think that somehow, they will get a return, fair return on that investment. one way to do that is to have enough money in the reserve fund so that -- and have it there not just year by year but have it there multiple years so companies can know and investors can know if we succeed here, they will buy the product and we will get our investment back. but the priority voucher review is an entirely different way to do that. and because they have become so valuable, it is a huge driver, a huge incentive because if you can succeed, say right now where you had a priority review voucher for zika, companies would know that if they could succeed, and if they not only would they have the great satisfaction of being able to spare people from this disease and god forbid, more children born with microencephaly but

they would have this product they could sell to the marketplace at a very nice return and use that money to invest in the next counter measure. i think it's a no-brainer to me. i know there's some political questions about it but i don't think there should be because it costs the tax payers nothing. it costs society nothing and provides nothing but benefit. thank you. >> thank you. yield back. >> i now recognize dr. burgess of texas for five minutes. >> thank you, mr. chairman. thanks to our panelists for being here today. i apologize for missing part of the hearing. we are having our budget season. mr. greenwood, you will remember what that is like. so never a dull moment around here today. doctor o'toole, i just want to ask you because we have had several hearings over the past several years, 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 about what are called laboratory developed tests and zika comes into focus because okay, you got a chain reaction but only a few places can do it, it's pretty valuable, pretty accurate but it's hard to get, you got to go through a health department to get it. there's an igm antibody but it will cross-react with some other viruses so you are not really sure if your result is accurate. would you just speak to the regulatory hurdles that you describe in your testimony and 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 the clinical lab improvement amendment which is administered through the center for medicare and medicaid services over into the food and drug administration and requires basically the licensing of laboratory developed tests just as if they were a new drug or 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. first of all, the reason fda is so concerned about diagnostics is that they can have life or death consequences. 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 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 the doctor at the fda a list of the problems that he was worried about with the development of laboratory developed tests. where are the outliers, where are the problems. to his credit, the last time he was in here a few months ago, he did produce a list of 20 tests that he said these may be problematic. but there are 11,000 laboratory developed tests out there 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 that we need for infectious disease and particularly during epidemics. okay? we need a variety of different kinds of tests. 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 are in the middle of an epidemic so it gets tricky. however, here's the problem.l!sñ it's very difficult to validate a new diagnostic against ebola

or even zika if you don't have curated samples of those diseases. in my view, the government can put this in dod or hhs or fda. the government should develop a curated bank of diseases about which we are worried so that companies, especially these small fragile companies could come and test their diagnostics against them so that they could much more rapidly give fda usable data on how well their test works. that's one. secondly, i think just as fda has emergency use rules for medical counter measures, during public health emergencies, we ought to think about emergency use schools for diagnostics which i think we can actually create rather rapidly and manufacture quickly during public health -- >> i would just tell you last year or 18 months ago during the peak of the ebola outbreak in september, i went to a hearing

in the foreign affairs committee where we heard that the fda had actually put a clinical hold on a drug that was at that time in use in treating patients with ebola. clinical holds. i wanted to hear about clinical trials. it really did seem like they were an obstacle faced with this worldwide scourge. i just need to ask a quick question and i appreciate your listing the recommendations of the blue ribbon task force. in my political training which granted, was a street level course, i was sort of taught that you only do three things, if you produce a list of 33 things, no one listens to you after the third one. but i did read through your list and it is a good list. it's exhaustive. i hope it's not static because one of the things that we have worked on on the 21st century cures bill is electronic health records and if we do not address

that fact in this -- in the recommendation that you have, i think that's actually going to stymie the ability for researchers and clinicians to communicate rapidly, to identify data, respect patient privacy rights but at the same time we need to have that ability for rapid learning within the system, whatever develops. >> as you know, there's been a lot of progress on electronic medical records in this country and continues to be and you are 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 that have more of a midterm value and a longer term strategy. so we very carefully laid out a strategy that would be workable for congress. >> thank you.

>> and the federal agencies at the same time. these are not just recommendations for congress. >> i yield back. >> i now recognize mr. bilirakis for five minutes. >> thank you for allowing me to sit in on this very important hearing. as a former chairman of the emergency preparedness response communications subcommittee for homeland security, i recognize the need for the country to be proactive, not just reactive, to a host of biological threats both natural and man-made. i'm glad that i can continue to be involved in the energy and commerce committee. i appreciate being given the opportunity to sit in on this subcommittee. secretary, earlier you mentioned that the state and local agencies are the first in line of defense against outbreaks and attacks. you also said that much of their funding through block grant programs has been weakened. what should we do to enable state and local entities to be

prepared to respond to outbreaks or attacks? is there enough of a focus on medical surge capacity and mass prophylaxis capabilities? do we need flexibility in our grant programs? >> [ inaudible ]. -- the funding has gone down over a number of years. the cdc is pretty flexible but the states are really underfunded in terms of their infrastructure as was pointed out by public health experts across the country in the states -- >> could you turn your microphone on, please?

>> we have 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. 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 are in an emergency, we think they are, but it's really the states and the local governments and their public health departments that are responsible for both the tracking, the identification for all of us in this country, and we have to make sure that infrastructure, the states are under great fiscal pressure in this country and we have to make sure that infrastructure is beefed up, that stays in place. >> thank you.

next question is for the panel. you all mentioned the lack 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, and what capability gaps exist in coordinating efforts between agencies, what makes coordination a challenge? we can start with the secretary. >> well, i think earlier, i talked about the fact that there were multiple agencies that were 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 and we have made a very strong recommendation that the vice president be the ongoing coordinator. in this country.

because the lead agency concept no longer works when you have various jurisdictions involved, and 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 and i say this reluctantly, because as a 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 are much more sophisticated about the role the private sector, the development of diagnosticses and that this has to all be part of our overall strategy in this country. >> i just want to add to that, the need to be able to elevate it. 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. but this will this will transcend down to the state and local level. that will help transcend that leadership. as an example, you mentioned surge medical at the level. it's going to be more logistics. that's why emergency management and other disciplines are going to be so necessary to effect in your example surge medical dispensing of antibiotiantibiot more logistics. public health doesn't do lo gistings. -- logistics. the centralized leadership concept is so critical. it transcends, the federal, state, local and private sector levels to close these gaps between the multiple disciplines

and agencies that have to contribute to bio defense. >> thank you, mr. chairman. >> thank you very much, thank you all for being here today. dr. o'toole, during the ebola jaut break, there were witnesses in our system that we're witnessing again with zika, detection, diagnostics. overall, how would improved surveillance of animal outbreaks help us better prepare for 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 are likely to see spillover from one species to humans. most of our surveillance is in

temperate zones. we have high speed genomics that could give us a handle on what diseases might be able to spillover. secondly, we ought to fund much more rigorously the usd a's existing program. modern methods put 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. we spent literally billions on surveillance in the past 15 years.

we need to figure out what's really made the difference. part of that again, we sound like broken records, funding state health departments. because that's where, you know, the rubber meets the road. but we have to help state health departments do a better job. diagnostics, again, critical, critical, critical, critical. clinical disease is very vague. if you don't have been a diagnostics to say this is zika and thens denghi, you're going to have a hard time figuring out what's gong on at the beginning and middle of an epidemic. particular surveillance programs, they don't work unless you know what they're going to do and who's going to use that information. >> the next question was going to be, are we doing a good job of integrating human and animal environmental health. and i think you answered that.

secretary, how can we improve those three components to develop a more comprehensive strategy to ensure we're prepared for whatever is next? >> our major recommendation is we put this in the office of the vice president, that we really need a national leader with the clout to integrate all these pieces and to help us. to help us think through a strategy. the strategy, having the metrics for it, keeping people accountable, we've all recommended that we elevate that to the office of the vice president. >> i appreciate that. lots of rules about zika. the coaches, the family members that will all go down. bubl that we will be ready.

obviously the brazilians will have to do things. this is an international effort, to be ready to be able to defend our folks, or have the biodefense efforts ready to depend 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. whenever children are affected, grown-ups get deeply, deeply worried. that's what's happening here. i will say that there are dozens of very dangerous mosquito and even tick-born diseases that have been with us for mill len yeah. 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 more information about what is going on. we have known there's been more or less an epidemic of denghi and chicken gungha. and denghi is a serious disease. we have to wait in there's more information about zika. i wush we had a vaccine. i think if i were a young woman who is 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. >> would you indulge me 30 seconds on the zika question? i want to point out, aside from medical countermeasures on zika.

there's a whole field of looking at how to bioengineer mosquitos, which we already know how to do. they're all males, they don't bite, and they mate with the females and the progeny don't survive. it's a fascinating new technology that may be part of the solution to this problem. >> i know we have votes in a few minutes. but if you have 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 investments in this area. can you give us some examples where owe eyou've seen that alr happen? >> i probably have that in my notes. i would just say -- >> and if you would like to submit it for the record, that would be fine.

>> i will submit that for the record. suffice it to say that it is works, it has created both in the area of paediatrics and the area of neglected tropical diseases, it has generated a tremendous amount of interest and investment, and it is wo working perfectly well. this is as congress intended. i have no doubts that it would work well in this field as well. >> do you believe that we added dhs's material threats to the fda's prv program, it would spur additional development of the medical countermeasures? >> i think that's precisely what needs to be done. i have no doubt whatsoever that it will be successful in inspiring investment in this very dangerous field. >> there are too many agencies

and too many people involved. and when too many people are in charge, no one is in charge. and i get that. >> and too many committees of jurisdiction. >> and i'm not -- 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 at the border, the little rio grande border last weekend and realize you've got cdc map that shows mexico and central america being purple with zika. in my states, the other side of a relatively narrow river. it just seems to me we don't pay enough attention to border control. i know you can't stop mosquitos 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 the other things we talked about are extremely important, but let us not forget border control, because that's an issue as well. >> well, i'll leave that to your comments, but i would say that we also have to beef up global health. this is part of the world health organization. whether it's people or they're just flying across. beefing up our own infrastructure, one of the things we learned with ebola is the world health organization doesn't have the kind of authorities it needs. it doesn't have the resources they need. and so it's not just a state and local issue or a federal issue, it's 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 looking at the agencies that we have now, the international agencies that we have now. and we know that they're weak, we learned that during ebola and previously. and this committee also might have a hearing because there have been recent reports on the international health organizations to take a look at those relationships as well. >> thank you. >> i would an answer to each of you. if you know countries who model programs of the very thing you're describing, we would love to know about that. any of us know any offhand or would you like to get back to us on that? >> my only comment is if we don't have it, i would be sr. surprised if anyone else in the world had it. >> to be fair, there are

centralized health systems in smaller places that may be more integrated. but i think that we have dpircht levels of government, different levels of responsibility. we need to put -- we can't use their models. we'll have to put our own system together. >> thank you. >> another question, just hope you can get information to us for the record. based upon -- given the recent geo report on the failings of bio watch programs, including the lack of valid performance data, should we continue to fund it? >> i'm sorry, would you repeat the question. >> should the federal government repeat the biowatch program given the report on its failings and problems including the lack of valid performance data? >> i think we probably will get back to you on the record with that. >> 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 a defined period of time until we have a strategy for what we're going to go do next. i think the notion that bio watch, or even the next gen bio watch, a series of environmental sensors can protect the country is wrong headed. the technology just isn't good enough. the cost effect in this ratio is just not advantageous. we need a new generation of technology. it's not there yet. again, diagnostics would make a big difference. you do nies these sorts of sensors to protect high-risk targets and national security events and so forth. the problem with biowatch right now is that it is not characterized as gao points out very graphically and i think accurately, we don't know that it works. it's not clear that it doesn't work. it has a very limited range of bugs that it looks for.

it would be very expensive. >> i want the committee to -- >> can i just say something? thank you. first of all, with all due respect to my friend from texas, i don't think any kind of border control, even building a wall is going to stop these vector-born diseases from coming over. i know that's not what you mean. but what it does really high ligt is that we are an international community. it's not just the mosquitos coming. we even had ebola cases come here because of international travel. it is critical that we take this report seriously and work hard as a committee. i just 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 i would just offer my input

and 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's nothing else we do, spend time on this report and recommendations, trying to get our arms around it and get that sense of urgency to our respective leaderships and it will have been successful. and i want to thank everybody again from the commission for doing this deep dive. this really is important. on march 2nd, we will have a hearing on the zika virus where many of these issues will come up. we'll take a deep dive as well as what my friend said about getting into classified briefing and some of the bio defense issues critically important and should be a wake-up call for america. but as you said a couple of times, mr. greenwood, we may not do these things until after the fact and that would be a tragedy. in conclusion, again, i want to thank all the witnesses and members who participated in today's hearing.

members have ten business days to respond to the record. with that, this committee meeting is adjourned.

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