people from this disease, and god for bid, more children born with microcephaly, but that they would have this voucher that they could then take to the marketplace and sell it at a very nice return and use that money to invest in the next countermeasures. it's a no-brainer to me. i know that there is some political questioning about it, but i do not think there should be, because the cost the taxpayers nothing, it costs society nothing. it provides nothing but benefit. >> recognizing dr. burgess of texas for five minutes. dr. burgess: thank you for being your today. i apologize for missing part of the hearing. we are having our budget season. mr. greenwood, your member what that is like. never a dull moment around here today. you, because we

have had several hearings over the past several years. just for context, i congressional career goes from sars to zika, long enough for people back on to say, term limits. on the other hand, there could be some value in seeing some of this stuff over a continuum. but, you referenced, and your testimony, about laboratory developed tests. becausemes into focus, you have a primary chain reaction, and only a few places can do it. it is pretty valuable, pretty accurate. but it is hard to get. you have to go three health determined to get it. there's my gm, antibody. it will cross-react with other viruses. you're not really sure if the result is accurate. speak to thet regulatory hurdles 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 basically which is administered through medicare and make services, over into the food and drug administration and requires, basically the licensing of laboratory developed tests, as if they were a new drug or device, and we know the problems with the timeline of those things. could you just be too that briefly? hon. o'toole: yes, thank you for the question congressman. first of all, the recent 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. >> let me 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. years to getree from the fda, a list of the problems that they were worried about with the development of laboratory developed tests. where are the outliers? where are the problems? to its credit, the last time you've been 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 and a clinician's office, so, i'm sorry, but continue. hon. o'toole: let me know the problem down to tests that we need for infectious disease, and particularly, during epidemics. we need a variety of different kinds of tests. as you know, you want a very ansitive test when you have low prevalence, but you do not

want that same test when you're in the middle of an epidemic. so, it gets tricky. however, here's the problem. it is very difficult to validate a new diagnostic against ebola or even zika, if you do not have curated samples of those diseases. my view, the government, you can put this in dod or hhs, you can put in fda, but the government ofuld develop a curated bank diseases about which we are worried. so that, companies, especially the small, agile, fragile companies can come and test their diagnostics against them, so that they can much more useful data.fda on how well their test works. that is wondering secondly, i think that just as fda has emergency use roles, for medical countermeasures, during public health emergencies, we are to think about emergency use tools for diagnostics, which i think we can actually create, rather

rapidly, and manufacture quickly. >> i would just say last your 18 months go-go, during the because ebola outbreak am 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 column -- drug called ok ebola which was in use at the time. i want to hear about critical trials. it really did seem like they were an obstacle, face was worldwide scorch. i need to ask a quick question. i would appreciate your listening to the recommendations of the blue ribbon task force. in my political training, which granted, was a street level course, i was sort of talk that you only do three things, you produce a list of 33 things. i did read through your list, and it is a good list. it is exhausted. i hope it is not static,

because, one of the things that we have worked on on the 24th century cures bill, is the whole issue of interoperability of electronic health records, and if we do not address that fact in this recommendations that you have, i think that was actually stymie the ability for researchers and clinicians to committee rapidly, identifying data to be sure, respecting patient privacy rights, but at the same time, we need the ability for rapid learning within a system, whatever develops. shalala: there continues to be -- you're absolutely right, it is 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. we very carefully laid out a

strategy that would be workable for congress. federal agencies at the stained time. these are not just the conditions for congress. >> iraq as the german for five minutes. >> thank you. for allow me to sit in on this very important hearing. as the former chairman of the emergency preparedness and response to medication subcommittee for homeland security, i recognize a 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 energy and in the commerce committee. i appreciate being given the opportunity sitting on this committee. secretary shall elect, earlier 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 weekends. 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 capacity, and mass prophylaxis capabilities? doing a flexibility in our grant programs? dr. shalala: [indiscernible] [indiscernible] [indiscernible]

>> could you turn your microphone on, please? lost 50,000 we have public health employees in our states and local governments. ,hat 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 is really the states and local governments and their public health departments that are responsible for both the tracking, identification, for all of us. in this country. we have to make sure that

infrastructure, states are under great fiscal pressure in this country and we have to make sure that the infrastructure is beefed up and stays in place. >> thank you. as for the panel. you mentioned that the lack of comprehension by a different strategy and the need for what, ifed leadership, any protocols are 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 capabilities exist in courting efforts between agencies, what makes coronation a challenge? will start with secretary. dr. shalala: i think earlier i talked about the top -- fact that there were multiple agencies involved when we have a topic like this. while hhs has very strong response abilities and has the scientific and public health expertise, homeland security, the defense department, they're all sorts of agencies across the board, and we have made a very

strong recommendation that the vice president be the ongoing coordinator. because, thery, lead agency come -- concepts no longer works when you have various jurisdictions. in particular, when you need to work with a private sector, with state and local governments, unlike fema, which basically could order people around, it is very difficult for one agency. i say this reluctantly because as a former hhs secretary, i wanted to on the world. when you do not have proper jurisdiction, when you do not have the leverage, then you have to elevate it, elevate both responsibility and we are much more sophisticated about the role of the private sector, the development of diagnostics, and that this has to all be part of our overall strategy in this country. >> thank you.

>> i want to add to that. it is not only needed at the federal level, and to try and close these gaps between individual departments and agencies, they want to exercise their own authority. but, there are gaps between them. this will transcend all the way down to the state and local, private sector level. it is only if you centralized leadership coming from the white house, however that is done, will help kind of break that and trends in that leadership. as an example, you mention surge medical. at the local level. it is not just a public health thing. in fact, it will be more logistics. that is why emergency management and other disciplines are going to be so necessary to affect in your example, surge medical dispensing antibiotics. it is more logistics. public health does not logistics. so that is really white is so important, the centralized leadership concept is so critical. everything comes back to it. federal,ends the

state, local, private sector levels. to close these gaps that we have between the multiple disciplines and agencies that have to contribute to bio defense. thank you. >> i will you'll back. thank you mr. chairman. >> i recognize mr. griffiths of virginia. mr. griffiths: thanks for being here. dr. until, during ebola outbreak, their weaknesses identified in our system that we are now witnessing again with the cut. surveillance at section, diagnostics, overall, how would improve surveillance of animal disease outbreak strengthen our surveillance of human disease outbreaks and be better prepared for dealing with epidemics? the majority of emerging infectious diseases come from animals. there are diseases that affect both humans and animals. we definitely need to do a better job looking at those hotspots where we are likely to see spillover from one species to humans.

most of those hotspots are in tropical zones. in the jungles of south america, and asia, and africa. most of our surveillance is intemperate sense. for starters. to haveow beginning tools such as high sequencing genomics, high-speed economic, that actually give us a much better handle of what diseases might be about to spill. we ought to think about funding field surveillance of these hotspot ecosystems. for starters. secondly, we had to fund much more rigorously the usda's existing program for looking at agricultural animals. because, modern methods of agriculture that sometimes tens of thousands of animals together , creating our own industrial hotspots. for spillover, and we have seen that with the flu. and the loss of turkeys and chickens in the past years. thirdly, for humans, we have to have a much more strategic approach to surveillance.

we have spent billions, literally billions, on surveillance in the past 15 years. some things have worked, something cap not. we have done a terrible job at lessons learned. we ought to go back and figure out what really has made a difference. wet of that is, again, summit broken records, funding state health departments. the rubbert is where meets the road, but we have to help state health departments to a better job. diagnostics, again, critical, critical, critical. is very diseases, it vague. if you do not have a diagnostic to say, this is zika virus, you are going to have a hard time going out what is going on at the beginning, and at the middle of an epidemic. i would be very careful about investing large amounts of money , in particular surveillance programs, unless you know exactly what they are supposed to do, whether they were, and was going to use that information. my next question was going to

be, are we doing an adequate job of integrating human-animal and in by mental health and i think you already answered that, and i would say no, we are not in a great job. how can we improve integrating those three components to develop a more coverage of strategy to ensure that we are prepared for whatever is next? lala: i think our major recommendation is that we put this response billion the office of the vice president. that we really need a national leader with the clout to integrate all of these pieces. and to help us think through a strategy, because the integration, itself, will have to be dumb agencies and by others, but the strategy, having the metrics for it, keeping have allcountable, we met recommended that we elevate that to the office of the vice president. >> i appreciate that. dr. o'toole, lots of concerns , and oursed about zika athletes competing the summer

olympics, not only our efforts, but all the spectators will go down, the coaches, family members, etc. do you believe that we will be ready? obviously, the brazilian's last is something, it is an international effort, but you toieve that we will be ready be able to defend our people or have about defense efforts ready to defend our athletes and the spectators and coaches and family members who go to the olympics this year? understand the deep concern that the zika virus has raise. whenever children are affected, grown-ups get deeply worried. that is what is happening here. i will say that there are dozens of very dangerous mosquitoes and -borne diseases that have been with us for millennia. 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, but that is not a perfect protection. it is not a zero risk. until weo wait and see have more information about what is really going on, we have known that there have been more or less an epidemic of gain the --. it is a serious disease. in south america, for a few years, that is not stop people from going down there. i think we have to wait until there is more scientific data about the zika virus. i know nih's working on a vaccine, i wish we had one. were a youngif i woman who is pregnant, or getting pregnant, i would think twice about going to south america right now. people,hink for most there are ways to at least mitigate the risks. >> would you indulge me for 30

seconds on this zika virus question? thank you. i wanted to point out that aside from medical countermeasures, i'm zika virus, there is a whole field of looking at how to bioengineer mosquitoes, which we already know how to do. so that there actually -- they are all mills, they do not bite. and they mate with the females, and the progeny's do not survive. i think that is a fascinating new technology that may be part of the solution to this problem. >> thank you. i know we have votes in a few minutes, but if you have a 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 the area, can you give me examples of where that is already happened yet though -- happened?

hon. greenwood: i probably have in my notes. >> if you'd like to submit it for the record, that would be fine. hon. greenwood: we will cement that for the record. suffice it to say, it is working, it has created both in the zone of pediatrics and in the zone a of neglected tropical diseases, it has generated a tremendous amount of interest and investment. well,working perfectly just as the congressman intended. i had no doubt it works well in this field as well. >> you believe that if we added the dhs material threats to the fda's prv program, it would spur additional development of the medical countermeasures? hon. greenwood: i think that is precisely what needs to be done, and i've no doubt whatsoever that it will be successful and inspiring investment in this very dangerous feels. >> thank you, you'll back. >> a quick follow up question? >> yes, you have spoken about the vice president as sort of

the overseer of all of this. i appreciate the fact that there are too many agencies and that there are too many people involved and went to many people are in charge, nobody is in charge and i get that. la: and to me committees of jurisdiction. >> i don't quite share your enthusiasm for putting this into the executive branch, perhaps, it should be a speakers position, but nevertheless, i will just tell you, i was down at the border of the rio grande, last weekend, and you realize that you have cdc map that shows mexico and central america been purple with zika virus and my state, the other side, a narrative to -- relatively narrow river, it just seems to me that we do not pay enough attention to border control. i know you cannot stomach it is at the border, but really, the issue is stopping people who are infected or potentially infected and right now, we are undergoing

companysurge of and a minors and family units, and to the best of my ability to detect, we are not looking. that is of great concern to me. so, all of the other things that we have talked about our extreme important, but let us not forget border control because that is an issue, as well. halala: i believe that your comments, but i would say that we also have to be -- beef up global health. that is a pothole. the pan-american health organization, which is part of the world health organization, we cannot stop mosquitoes from coming across borders. whether it is in people, or they are just one across, but, it is not only beefing up our own infrastructure, one of the things that we have learned with the world health organization does not have it kind of authority that it needs.

it does not have the resources that they need. just a state and local issue, or a federal issue, it is also an international issue. i think your point about border wouldty is also -- but i put in the context of international health security. -- looking at the agency agencies that we have now, the international agencies that we have now. we know that they are weak. we learned that during ebola and previously. this committee also might have a hearing because there have been recent reports on the international health organization to take a look at those relationships, as well. >> thank you. i want to follow up with two quick questions. if you cannot answer this here, get back to us. thatu know of countries have modeled programs to do the very thing that you are describing, we would love to know about that. does anybody know any offhand or would you like to get back to us on that? >> if we do not have it, i would

be very surprised that anyone else in the world had it. >> to be fair, there are centralized health and stems in smaller places, that may be more weegrated, but i think that have different levels of governments, different levels of response ability, we need to put -- we cannot use their models. we will have to put our own system together. >> another question. i hope you can get the information to us. recent report on the failings of iwatch programs, including the lack of valid performance data, should we continue to fund it? do have an answer for that? >> would european that? >> should the federal government continue to fund the biological and given the recent gao report on its failings and problems including the lack of valid performance data? >> i think we probably will get back to on the record with that.

>> can you answer that? >> i'm a longtime critic of biological. but, i think you should continue to fund the current program for a defined timeframe until we have a strategy for what we are going to go and do next. by ank the notion that watch or even the next gentile watch series of environmental sensors can protect the country is wrongheaded. the technology is just not good enough. the cost effectiveness ratio is not advantageous. we need a new generation of technology. it is not there yet. again, diagnostics, would make a big difference. you do need these sorts of sensors to protect high-risk targets and national security events and so forth. the problem with bio watch right now is it is not characterized out, verynts graphically, and i think accurately, we do not know that it works. it is not clear that it does not

work, it has a very limited range of bugs that it looks for. area of aally cover a city, you need a lot of those machines. >> thank you. first of all, with all due respect to my friend from texas, i do not think that any kind of border control, even building a wall, is going to stop the vectorborne diseases from coming over. and, i know that is not what you mean, but what it does really highlights is how we are an international community, it is not just the mosquitoes coming, we have even had ebola cases come your because of international travel. so, that is why it is so unbelievably critical that we take this report seriously. and that we really work hard as a committee, and mr. chairman, and want to commend you for calling this hearing. i knew you're planning to have a classified briefing when we come back from the february recess,

and i think that is a good step. and then, i would just finally , and the input of the minority staff and members to help come up with a robust hearing schedule for the rest of the year. i think if there's nothing else that we do, then we should spend our time on this report and the recommendations, trying to get our arms around it, and get that sense of urgency to our respective leaderships. now that we will have been successful. and i want to think everybody again from the commission for doing this deep dive, because it really is important. >> let me also announced a march 2 we will have a hearing on the zika virus, where many of these issues will come up. we will a deep dive in that, as well as what my friend said about getting into briefing on some of the by defense issues. really important, and should be a wake-up call for america, but as you said, a couple of times, we may not do these things until

after the fact, and that would be a tragedy. we will get moving on that. in conclusion, i want to thank all the witnesses and participants of this hearing. there are 10 business days to cement questions for the record. i asked that the witnesses respond quickly to the questions. with that, this committee hearing is adjourned.

>> democratic president shall candidates bernie sanders and hillary clinton are making a campaign stop in minnesota tonight, speaking at a fundraiser hosted by the

democratic farmer labor party and st. paul. caucuses in the state are scheduled for march 1. our live coverage of the dinner gets underway here on c-span in about one hour, starting at 8:30 p.m. eastern. road to the white house began in iowa. the caucuses which date back to 1972, and then we move to new hampshire, the quintessential first in the nation primary, which has a long and rich history. now, we really begin to test the candidates and their message. to south carolina, the first set in primary, and then to the party caucuses in nevada for the democrats and for the republicans. more than likely, we will see a number of candidates probably drop out of the race and the fields within narrow. then we move into early march. super tuesday, the start of winner take all primaries, which meant for the delegate count will be critical and as we watch the delegate count continue for the candidates, we will get a better sense of whose message is resonating and who is on the path to the nomination.