Skip to main content

tv   Responding to Biological Attack Pandemics Infectious Diseases  CSPAN  June 15, 2018 9:00am-11:03am EDT

9:00 am
the head of the selective service said publicly that they felt they were under attack. clearly you can draw a line from what they did to the draft ending in 73. >> sunday at 8:00 eastern on c-span's q&a. .. >> the chief scientist at food and drug and a c.d.c. official and the preparedness response and the subcommittee, live coverage on c-span2.
9:01 am
today the subcommittee continues its oversight over the u.s.'s preparedness for biological threats and endangering the public health. today's hearing to hear from top experts and good agencies to protect the public and explore where i am -- improvements need to be made. they're evolving and in some cases intensifying. the seasonal influenza claimed the lives of 172 children during the recent flu season making it the deadly seasonal flu season for children on record. in recent years the u.s. has also seen an increase in the number of antibiotic resistent bacteria. around the world viruses are emerging, adapting and in some cases reemerging. and currently there's an e e
9:02 am
bo will. a outbreak and the rated by the influenza risk assessment tool as posing the greatest risk to cause a public pandemic. and the address to president obama and the senator in my home state of mississippi as well as the anthrax and the foreign terror threat is the reminder of intentionnal biological attacks. today's hearing is timely considering the committee is considering issues for the all prepared ne preparedness act pop-up that's set to expire in september.
9:03 am
that would not only provide critical certainty for public health agencies and industry partners it would also bring about much-needed reforms. one such reform proposed in the legislation is transferring control of the strategic national stockpile from the c.d.c. to hhs's office for assistant secretary for preparedness and response to improved management of the stockpile. a year ago reported system ic look at the stockpile, deploying it during a health emergency. these need to be addressed as does the training of local stake holders on counter measures. administrative reforms are also of interest. for example, are there ways to improve the timeliness of the decision-making process on
9:04 am
threat assessment and appropriate counter measures. effective threat detection has been a subject of committee oversight. in 2016, the committee questioned the c.d.c. about the effectiveness of its laboratory response network or lrn which is responsible for developing essays for public health labs to test for agents. in a may letter c.d.c. reported lrn only developed three essays approved to detect specific federal threat assessed agents. and the lrn had those cleared under the emergency use authorization after yearly 20 years of this program with $135 million in funding over the last decade could the lrn cleared a significantly higher numbers through the rigorous 510-k process? finally, maintaining public confidence in critical federal,
9:05 am
biopreparedness research is essential. in response so safety lapses in 2014 and to an expert panel's recommendations, the c.d.c. and fda each formed new offices in 2015 to centralize and elevate oversight of laboratory safety with the directors of those offices reporting directly to the agency head. these changes send a strong message that lab safety was a top priority backed by the clout of direct backing from the agency head. unfortunately, both agencies seemed to be backtracking from this good direction. in fda's case after the direct report organization or reorganization, the sudden change is curious and would seem to be a step in the wrong direction. so we need to hear more details about the basis for this new direction. i would like to thank the distinguished members of our panel for being here today and
9:06 am
for your service to our country. i now recognize the ranking member of the subcommittee from colorado for five minutes. >> thank you, mr. chairman. i know we agreed that preparing this country for a bioincident is of critical importance. the threat as you said is real and it's growing. in april c.d.c. reported in 2017 colorado saw 25 cases of an antibiotic resistent bacteria known descriptively and patients died. it's possible for them to quote, spread like wildfire. if that happens we need to know we're able to respond. we've looked at this issue manile times over the years as the panel well knows, it's a regular appearance and i want to thank you for coming again. and again and again we've found
9:07 am
that the federal government has to scramble to address biosafety incidents. those of us who were here during the fall of 2001 vividly recall the chaos that a few small envelopes of anthrax caused on capitol hill. offices were closed, buildings were fumigated, some congressional business was suspended and thousands of staffers and other personnel lined up for days to get tested for exposure. far worse, some of the workers at our postal service were affected and died. in 2009, we again had to scramble to produce sufficient doses of the h1n1 swine flu vaccine to protect against the new strain of the disease. 2014, hospitals and health care providers were not adequately prepared to arrive for the ebola patients. and one case in dallas, the hospital failed to diagnosis ebola to a patient that had
9:08 am
traveled to africa and it was later transferred to two health care workers. in the days and weeks that followed, important questions were raised how this was handled and were we prepared for the larger event. in 2015 the sika virus focused on that. and i would like to know what lessons we've learned from these incidents and how the agencies are doing to better prepare for the next crisis, because there will be one. for example, do we have adequate medical countermeasures in place to respond quickly when an outbreak occurs or a toxin is released? do we have the capacity to quickly deliver countermeasures to the doctors and nurses who will actually use them and do the health care workers understand how to deploy the countermeasures? similarly, research into
9:09 am
emerging pathogens and pathogens that mutated is key to helping us quickly respond to new and expanding outbreaks. how is this research forming our methodology. are we prioritizing. and i want to hear more about how our agents can ask to coordinate the response efforts. each one of the agencies has a valuable role to play, nobody can operate effectively alone. in fact, one major finding of the blue ribbon panel's report of the bio-preparedness, these agencies must work together to respond to pandemics. and the blue ribbon report found that the government must dramatically increase the support provided to local
9:10 am
jurisdictions to help them build and sustain their bio-defense capabilities. local employers like hospital health care workers will be under an emergency. and i want to make sure that we're adequately supporting these providers as well as state and local health departments so they are able to detect when the incidents happen and respond appropriately. mr. chairman, i'm hoping that we've made tangible progress in this area, but again, i urge us to revisit the work of blue ribbon panel and findings to determine what more we need to do to better prepare the nation for the threats we will be discussing today. i can't thank our panel today enough for the tireless work they put in to keeping america safe. we always have a great opportunity to hear from you and we know that you're working hard. we think by having you come up here and taking the time, it really helps us represent our constituents, and it helps all of us be better prepared for
9:11 am
the next emergency that faces us. thank you, and i yield back. >> gentle woman yields back. the chair now recognizes the chairman of the full committee, gentleman from oregon. >> thank you mr. chairman. and thank you to our committee for work on this and our panelists not only for guidance for the issue, but what we tapped into you for along the way so we appreciate your professionalism in our policy debates. the topic bio-preparedness hits home for me. i think i was the first member of congress to be diagnosed with h1n1 years ago. know the a distinction i was glad to get, but one apparently i had. and more than that, 30 years ago, religion group moved to oreg oregon, you may have seen a documentary on netflix called "wild country" and if you read
9:12 am
judith miller's book it took the federal government a year to admit that's what it was, they grew their own salmonella and sprinkled it over salad bars in oregon and 671 people many of whom i know, delivered biological attacks are more at risk. there's increase risk of infectious diseases as we've seen with influenza, our medicines must be updated. our ability to recognize new outbreaks are relike on the men and women, the work that you oversee. and john hopkins, with a group of governmental official, including susan brooks was eye opening, the exercise resulted
9:13 am
in a failure to develop a vaccine within 20 months, and that led, in this exercise, to 150 million deaths globally. so, obviously, we've got to do more to be prepared for these types of outbreaks. so, that's where the reauthorization of the pandemical hazards act. it was in 2006 and set to expire the end of september and we intend to move forward with lap legislation prior to that. to reauthorize this hoo law and fine tune it. it's important that congress reauthorizes this law in time and make sure that all levels of government are well-equipped to handle not only emerging biothreats, but chemical attacks, radiological, and mass casualties events. the committee has raised numerous issues regarding biological threats to the u.s. and our nation's ability to respond to infectious disease
9:14 am
outbreaks. for example, the committee examined concerns about the c.d.c.'s management and the security of the strategic national stockpile and the capabilities of c.d.c. laboratory response network. the trump administration is set to transfer from the stockpile to the response known as asper. and how this will work. and our biosurveillance capabilities, innovation could look at our response in the event of an attack or epidemic. i'll be looking forward to that. the federal government needs to act faster to identify material threats. the department of homeland security in march 2018 made a determination for a pharmaceutical based fentanyl, took two years to make this designation. carfentanil was used in a terrorist attack more than 15 years ago.
9:15 am
though it's only after that designation is made that the public health emergency medical counter measures enterprise can approve acquisition. we knew about it 15 years ago and took two years to get that designation. we can do better. and maintaining research relies on federal scientists and researchers working with these diseases and dangerous pathogens in a safe and secure manner. following several safety labs at c.d.c. and fda labs in 2014, both fda and c.d.c. created new offices to oversee and prioritize lab safety. these were positive steps. the recent proposals of these offices raises concerns. i thank you for being here today and i'd like to yield the balance of my time to dr. burgess and hopefully to miss brooks. >> thank you, mr. chairman. and this issue was one that is important and timely for this subcommittee and last week the
9:16 am
health subcommittee had a discussion on the pandemic preparedness act authorized by brooks and eshew. and we heard firsthand about the biological threats to our nation and input on the legislation. the panel is known to us and they're all experts. i look forward to hearing from our witnesses and i thank the chairman and will yield to miss brooks. >> maybe with unanimous consent. >> 30 seconds. thank you, mr. chairman and thank you to our witnesses on the work. we held a hearing how we best combat biological threats, i'm pleased we're once again examining the state of our preparedness. as everyone knows it's not a question of if we face a threat, it's a question once again when we face a threat and we have been reminded by the
9:17 am
stories that we've heard here today that these types of incidents have already happened in our country over the last decade and a half. created in '99, the national stock pile is the repository of vaccines and antibiotics and supplies used in the event of an attack or an outbreak, but h had hs, oig in 2017 issued a report identifying systemic issues with the c.d.c.'s management of the stockpiles. i look forward to hear from our witnesses to make sure that our stockpile is properly managed and we can be prepared for whatever threat we are and will face. i yield back. >> chairman recognizes the ranking member from the full committee, from new jersey for five minutes. >> thank you, mr. chairman. ensuring that our nation is equipped to respond to pandemics, natural disasters and intentional release of toxins. this committee suggested our nation has not always been as prepared as we need to be so
9:18 am
i'm glad that we're having this hearing today and i'm hoping we've made tangible increase in progress to our nation's preparedness. there was a comprehensive review of the federal government's preparedness efforts and the panel found and i quote the nation is dangerously vulnerable to a biological event. it produced an extensive report with 30 action items for our public infrastructure to address. while the blue ribbon panel is the latest high level to examine. but it's not the firstment experts have warned that our ability to respond to biologic and h-remains to be improved. and the emerging health threats that the country faces continues to grow. a child in idaho had an outbreak of bubonic plague.
9:19 am
and we heard that pandemic flu is and oent antibiotibiotics resistance, and making surgery and chemotherapy risky. and there are higher levels of antibiotic resistance and bacteria. and extreme weather events can lead to emergencies. the hurricanes in puerto rico, florida, it extext were a stark reminder of this fact. you must be prepared to address threats from all of these sources. the blue ribbon panels have the bio-preparedness. i hope to hear the agencies established a plan who will take the lead in response to a public health threat and how the efforts will be coordinated. along these same lines, i hope we will learn how c.d.c., nia,
9:20 am
and others are working together to identify the greatest threats and the research, surveillance and response capabilities to target the threats. and how they collaborate with state and local health care providers such as hospital. these entities will likely be the first to see patients impacted by infectious disease outbreak or other incidents and in the most case to dispense countermeasures and those impacted in. 2014 we witnessed negative consequences that ensued when our health care and infrastructure were unprepared to diagnose and treat patients with ebola. the patient in dallas last trance meted ebola to two health care workers. this led to a serious question whether we'd be able to handle a larger scale incident. we have to make sure that everyone on the ground has the resources they need to respond effectively in such a crisis. i want to hear how we're
9:21 am
conducting surveillance so when an outbreak happens or a toxin is released we know as soon as possible. while we cannot anticipate every possible new or mutated pathogen, if we can quickly detect when such a pathogen has emerged, we can respond much more effectively. along the same lines, i understand the c.d.c. is gathering a substantial amount of data from laboratories, health departments and clinicians across every day and we must ensure that the agency has what is effectively used and analyze the data as it comes in and finally, what we're doing to look at medical counter measures to help us respond to a biosafety incident. countermeasures like vaccines as well as therapeutics like antibiotics and anti-virals. and florida you work closely with the sector to develop these products and i hope we'll hear how the partnerships have produced useful, safe and
9:22 am
effective products that address the challenges to be faced. mr. chairman, i'd like to thank our panelists for being here and preparing for these threats is certainly not easy, but i'm confident you're up for the task as long as we do our part and provide you with the resources you need. i yield back, mr. chairman. >> the gentleman yields back. i ask unanimous consent that the members' written opening statement be made part of the record. without objection they will be so entered into the record and in addition, unanimous consent members in congress not on the oversight, will prepared to participate in today's hearing. without objection, so ordered. i'd like to introduce our witnesses for today's hearing. first, we have dr. rick wright director of biomedical advance research and development authority and deputy assistant secretary at the office of the assistant secretary for preparedness and response. next, is dr. ann shugat principal deputy director for
9:23 am
centers at disease control and prevention. then the doctor from the national institute of allergy and infectious diseases at the national institutes of health. finally, we have rear admiral denise hinton, chief scientists at the u.s. food and drug administration. we welcome all of you. and you're each aware that the committee is holding an investigative hearing and when doing so had the practice of taking testimony under oath. do you have any objection to testifying under oath? let the record reflect that all of the witnesses reflected that they do not. the chair then advises you under the rules of the house and rules of the committee, you're entitled to be accompanied by counsel. do you desire to be accompanied by counsel during your tomorrow today? let the record reflect that each of the witnesses reflect they do not. in that case if you would please rise and raise your
9:24 am
right hand, i will swear you in. do you swear that the testimony you're about to give is the truth, the whole truth, and nothing, but the truth? thank you. you may be seated. you're now under oath and subject to the penalties set forth in title 18, section 1001 of the united states code. you may now give a five minute summary of your written statement. and i'll begin with you, doctor, welcome back. >> chairman harper, ranking member and distinguished members of the subcommittee. it's a pleasure to speak today on behalf of our assistant second for preparedness response. to discuss the state of the nation's health preparedness. i'm dr. rick wright, barta, and the deputy assistant secretary for the preparedness response. and mission to save lives and protect americans from 21st century health security
9:25 am
threats. and barta is created to ensure that we have products to protect people from numerous dire threats that we face as a nation. and the staff is dedicated to prepare for and respond to the threats. we are currently coordinating hhs's response to the ebola outbreak in the drc and monitoring influenza in china. the last year's hurricanes, we're there for the long haul, helping to manage recovery and build resilience. there are state and local partners in emergencies. and enhance medical through our national medical system and hospital preparedness program and oversee the procurement of counter measures. we've made great progress in public preparedness response since congress established asper and barta in 2006. barta was to accelerate the
9:26 am
development of life saving medical countermeasures that would not otherwise be available. we use flexible authorities, multi-year advanced funding, public-private partnerships, and deep technical expertise to push, vaccines, drugs and diagnostics toward fda approval. in our 12 years, we have a formed over 200 public-private industry for our mission. i want to acknowledge the hard work of our partners, who, together with the u.s. government, worked very hard to create a more secure nation with not only products, but capeabilities to respond when needed. these partnerships have led to 35 fda approvals of products that form a protective shield for our nation against a range of serious pandemic and emerging infectious disease threats. the bioshield, barta supported
9:27 am
27 vaccines and drugs and addressed national security threats including small pox, bot botchlinum and others, and 14 are in use for stockpile and seven achieved fda approval. these outcomes are the spirit, leadership, partnership, coordination and capabilities working together to protect our nation. while this effort has created life-saving products to be procured by the sns, it's sustained sufficient quantities needed for each threat. critically, each product also represents a company with a response capability that must be sustained to ensure we have these products available when they're needed. project bioshield and the sns together represent a marketplace for these products that would otherwise never
9:28 am
exist. the products would quickly finish without it. they've all played valuable roles in enhancing our preparedness, however, the threats continue to evolve, and technology that modify and create new deadly threats have become simplerment we must modernize our capabilities for an end to end approach, and with new technologies and innovation, the time is here to deploy approaches to these daunting health security problems. last week we announced an initiative called drive, a nationwide business friendly approach to identify, capture ap accelerate life-saving innovation. using authorities you enacted in the 21st skcentury securitie act, inknow he evaluations for safe threats. as you reconsideration
9:29 am
authorization, advance appropriations for project bioshield. without this market the companies are reluctant to work with us. second, an authorization of appropriation for barda's influenza program will sustain our vaccine capabilities, modernize our technologies and bring newer diagnostics in the homes across america. i look forward to working with this committee and colleagues and look forward to your questions. >> thank you, dr. bright. the chair will recognize doctor shugat, thank you. >> thank you, so much for the opportunity to testify before you today. to describe c.d.c.'s role in preparing, detecting and
9:30 am
responding to biological attacks and pandemics and infectious disease outbreaks. the c.d.c.'s role, i'll describe our role in three areas. preparedness, detection and response. the three themes i'd like you to take away are first, the work the c.d.c. does every day in health, layings the foundation for responding to emergencies. second, the c.d.c.'s worldclass and scientific medical expertise assures we're ready to respond to any threat and third, our longstanding connection to state and local health departments, ensures that public health systems function effectively, both day-to-day and through emergency response. let me first address how we prepare for emergencies. c.d.c. works every day with the state and local health department. we have 590 staff assigned to state and local health departments.
9:31 am
we fund the health emergency preparedness cooperative agreement program and the city's readiness initiative. the health preparedness grants go to every state, eight territories and four cities, and these are funds toward staff and enable exercises to test and validate capabilities and pay for laboratory and communications equipment. >> the city's readiness initiative fund the 72 largest cities to develop and test plans to receive and dispense medical countermeasures from the strategic national stock pile. c.d.c. helps assure protection of vulnerable populations against diverse threats. for example, c.d.c. works with the american economy of pediatrics, fda and other stakeholders to look at gaps, and taking a look at the scientific and clinical expertise and longstanding relationships with ap. turning now to detecting
9:32 am
threats. the labs system are able to identify agents causing illness, from chemical and radiation exposure. every year labs all over the world send specimens to c.d.c. because they know we will be able to identify pathogens other labs cannot. and it's before a health threat becomes a crisis. the response network maintains an integrated, scaleable flexible system of 125 federal, state and local laboratories. the development of this laboratory network established in 1999, has provided a larger capacity to test and report more quickly than was previously possible. fogs, during the zika virus outbreak response, c.d.c. and our response laboratories processed over 200,000
9:33 am
specimens to have zika. we're able to rapidly deploy medical and scientific experts anywhere in the world. by the end of the 21-month ebola response, 3,700 c.d.c. staff had shifted from their day-to-day duties to assist with the response. 1500 of our staff deployed to west africa, making over 2000 trips. today we're responding to a much smaller ebola outbreak in the democratic republic of congo. during health emergency c.d.c. communicates. for example, during the 2009 h1n11 response c.d.c. held over 30 television conferences and briefings. 51 morbid and mortality articles to make sure that the public health and health care professionals had the latest and best information. being able to prepare, detect, and respond to public health
9:34 am
threats is a top priority for us at c.d.c. our preparedness and response capabilities are brought on-- are built on broad and deep scientific medical and program expertise. our longstanding partnerships with state and local public health authorities ensures an integrated approach wherever that approach is needed resulting in better responses and better public health outcomes, which translate to better protection of the people we serve. thank you, and i'll be happy to answer questions. >> thank you, dr. schuchat. the chair will recognize the doctor for five minutes for your opening statement. >> thank you very much, mr. chairman. chairman harper, ranking members of the committee. thank you for giving me the opportunity today to present to you the role of the national institute of allergy and ip if he can-- infectious diseases and emerging infectious diseases.
9:35 am
our role in this really dates back many years, but was solidified following the attacks of 9/11 with the anthrax attacks that prompted us together with our colleagues at hhs to develop a strategic plan and research agenda. for our role in that, as you know, the nih with regard to any emerging infectious disease is involved in having a number of approaches, stemming from basic and clinical research, research, resources for both industry and academic communities with the ultimate goal of developing vaccines, therapeutics and diagnostics. we have been in a strong partnership in developing the concepts for interventions and then handed over to them. this slide shows a representative example of key achievements directed specifically at the agents in
9:36 am
our strategic plan. briefly, a better small pox vaccine. next generation vaccines for anthrax. anti-to bessens for botulism, antibiotics for plague and interestingly, the development of an ebola vaccine that ong anti-dated the experience in west africa in 2014. having said that, it's important to point out as we have in the past, and as shown in this interesting article from news day of 2001, the worst bioterrorists may actually be nature itself. it is interesting to point out, mr. chairman, i have been testifying before this committee for the last 33 years. the first time i did, i drew a map and it's shown here and the reason i drew the map, i wanted to point out that there would be emerging and reemerging infectious diseases and the first time i testified before this committee, i put hiv on the map as shown there. today, the map is the same
9:37 am
structurely, but this is what it looks like. and these are the emerging and reemerging infectious diseases. many of them, many of them are curiosities, and are not really of great public health impact, but others are really important and we've experienced them recently, such as ebola, zika and the threat of a pandemic influenza. now, let's take one of these, ebola, you mentioned in your opening statement as others have about the west africa outbreak and the recent outbreak in the democratic republic of the congo. it's important that the c.d.c. and nih and others responded rapidly. you can do good research in the context of an outbreak. we developed, along with others, the vaccine first tried in a phase one trial right in
9:38 am
bethesda at the nih clinical center and went over to africa in a phase two trial. this is the vaccine that was used in the ring vaccination program that was actually involved in the west africa outbreak. if you focus where we are today and the outbreak of the democratic republic of the congo we've learned a lot. let me give you an example. the experimental vaccine used in the ring vaccination program has now been deployed to the democratic republic of congo and even as we spoke today, it is being used in a ring vaccination with 50 rings and 150 vaccinations per ring. interestingly, and as i mentioned before we came, this is here, that in 1995 there was an outbreak in the democratic republic of the congo, to show you the direction between clinical care and research, we brought one of the survivors of
9:39 am
kick wick to bethesda, took their b-cells, cloned it and made an antibody and now the democratic of the congo asked us to ship that to them for their discretion use as a unt could countermeasure and it's a full circle that it came back with something that perhaps could help them. i want to close in the last couple of seconds with influenza. i wrote this article just a few months ago talking about the need for universal flu vaccine. and, in fact, we have developed a strategic plan and a research agenda because of the threat not only of getting a better seasonal flu vaccine, but also, a threat of a pandemic. we can only do that with a vaccine that essential will i is able to protect us against all subtypes of influenza. and i'll close on this last slide. it's not working very well,
9:40 am
story. which is an article that i actually wrote 17 years ago, but it's very relevant today. and what it says is that emerging infections are a perpetual challenge. we've always had them, we have them now and we always will have them. so if they are he a perpetual challenge and risk, we must meet them with perpetual readiness, thank you. >> thank you very much. we have the privilege from hearing from rear admiral denise hinton. you've got five members. >> thank you for the opportunity to appear today to discuss the state of biopreparedness. medical and public health preparedness and response is critically important to the health and security of our nation and i'm pleased to be here today to discuss how fda is a working toward the shared goal of making sure we have the medical products necessary to protect our public from health
9:41 am
threats, naturally occurring, accidental or deliberate. the outbreak of ebola virus disease in the democrat republic of the congo serves as a reminder that biological threats can and often do emerge with little to no warning and can rapidly become global challenges. i can assure you that fda is dedicated to helping end this outbreak as quickly as possible, as we are actively engaged in supporting international response efforts. fda plays a critical role in facilitating preparedness for and response to biological threats. our focus-- our role focuses largely on facilitating the development and availability of medical counter measures for mcm's such as vaccines, therapeutics and diagnostic tests to respond to these threats. toward to end we work closely with our hhs partners testifying with me here today, as well as other u.s.
9:42 am
government partners, product developers and nongovernmental organizations to facilitate the development and availability of mcm's. and fda works closely with the department of defense for the development and ability to support the needs of our nation's military personnel. prior to joining fda and the u.s. public health service dimension corps, i proudly served as an officer in the united states air force. so these are near and dear to me and we're working closely with our colleagues at the dod to support military personnel. at fda we've made it a priority to utilize our authorities to practically work with our private sector and government partners to help facilitate the translation of discoveries in science, and technology, into safe and effective mcn's
9:43 am
available the in the event that they are needed and have made significant progress towards to important goal. for example, since 2012, fda has approved, licensed or clear more than 120 mcm's, including supplemental changes to products and devices for diverse array such as botulism, pandemic and influenza. we have more than 60 use authorizations to enable access to products to respond to threats, including for zika virus, ebola virus, h 79 influenza and the corona virus. while the post collaboration and coordination among the agencies represented today have achieved many successes in the
9:44 am
development, i would suggest that developing mcm's is highly complex and gaps can challenge the development program. such as a lack of models and biomarkers with extrapolation, animals to humans. without such tools, it's difficult to generation the development to regulatory decision making. addressing these gaps remains a high priority for the fda and we've established a broad and robust portfolio of conducting research under 0 your regulatory science program to develop these tools and promote development of mcm's. fda is acutely aware that biothreats can be from an accidental release or exposed agents during the course of conducting research. as such we're working to ensure that our laboratories and work places are operated in a safe and security manner to protect employees, the surrounding
9:45 am
communities and the environment. fda's scientist, i can assure that that the laboratory safety is a high priority for me and the agency. fda remains deeply committed working with its partners and fully using the authorities that congress provides to help accelerate the development and availability of safe and effective countermeasures. though we've made significant progress, we know more work needs to be done. we look forward to partnering with stakeholders as we work to further advance biopreparedness. thank you for inviting me to testify today. i look forward to answering any questions you have. >> thank you very much. i ask unanimous consent that the binder be induced into the record and appropriate redactions, and it will be entered into the record with any redactions staff determines are appropriate of the it's now time for members to have the
9:46 am
opportunity to ask you questions, and i will recognize myself for five minutes. let me begin by saying that in my ten years of service in congress, i don't know if i've ever been at a committee hearing with a better lineup of witnesses, and so, thank you all for being here. we look forward to your responses today. and this is a question that will go rather quickly for all of you and for each witness, which biological threat is of greatest concern to you and why? start with dr. bright and then go down. >> and that's a difficult question. dr. fauci laid out so many and i wish i could take some off the table. but they keep coming at us. and more concerning is technology advancing so much they can change the biological threat today into something we might not be prepared for. i think the greatest threat for any of those is our response capabilities and being able to
9:47 am
respond it anything that comes our way. >> dr. schuchat, was a biological threat at the top of your list? they're all important, is there one that gives you the greatest concern? >> i think influenza, it can affect everyone rapidly and changing with pandemics all of the population of the world can be susceptible. so the threat of a pandemic has to be at the top of the list because it can all happen fast. >> dr. fauci? >> my number one and maybe number two, number three is influenza, also. i agree for the reasons that dr. schuchat has mentioned. when you have a respiratory virus that can be spread by droplets and aerosol, and then you have the situation if there's a degree of morbidity associated with that, you're going to have a catastrophe. we've experienced in real world those types of things, the one that we always talk about 1918
9:48 am
pandemic that killed between 50 and 100 million people and it's likely that it would be an influenza, but if not influenza, an influenza-like virus. we had a scare with sars. fortunately public health measures were able to contain it, but influenza or something like influenza keeps me up at night. >> admiral hinton. >> thank you for the question, i would say the threat that would keep me up at night would be the unknown. if we don't know what that threat may be, we have to be able to anticipate. so, with the emergent spectrum of diseases that would keep me up at night. thank you. for each witness, what area of bio-preparedness is for you and why. >> the bio-preparedness highest priority would be the ability to rapidly detect something in our community or used as a
9:49 am
weapon. the sooner we detect something the sooner we can turn on the machinery and capability to begin making vaccines and drugs. >> dr. schuchat? >> our global security, any threat anywhere is a threat everywhere, our greatest threat is in the weakest country of the world. we saw with ebola, and the ability to strengthen every country to be able to prevent, detect and respond to threats is where i'd place my focus. >> dr. fauci. >> i would agree with those two and add an additional one, may not necessarily be my first, our inability to respond with a vaccine the platform technology where you don't have to wait six to seven months to get a vaccine and you can get it out there within a period of a couple of months, which is doable if we put our mind and our resources to it.
9:50 am
>> thank you. admiral hinton. >> our continued events in the ebola and making sure that we contain it within the specific regions and not let it cross the borders. >> thank you. >> dr. bright, obviously the need to rapidly respond to a biological threat is essential. does the public health system have the capability to deliver, administer medical countermeasures effectively and in a timely manner as we sit here today? >> as we sit here today we're much better and can respond much more quickly than in the past ten years, we've built a national capability with new sciences and technologies. there's a lot of room for improvement. it takes too long to respond adequately to protect everyone in our nation. >> thank you very much. i will now recognize the
9:51 am
ranking member for her questions. >> thank you very much. building on the question just now by the chairman, dr. bright, what system do we need to make to make countermeasures work more effectively and efficiently. asper is a good start. where do we need to go. >> given aastra and the enterprise and working with our public-private partnerships we've learned a lot in the past 12 years, not everything is working as effectively and efficiently. >> what do we need to do? >> improve our communications and transparency and how we work with our bridge our different agencies and bridge government with industry. we need to ensure there's consistency in funding, and availabilities of the partners that we work with can better a line our business models with the government. the efficiency with which we respond, and contractual
9:52 am
measures. >> are efforts underway being made to do those things? >> yes, efforts are underway. >> is there something that congress can do to help you? >> congress has been very generous with the authorities to date. there are things that we can do to improve our language and our other transactional authorities to be able to work more fluidly and flexibly with our industry partners and we'll be happy to submit language. >> we had would be delighted to have that language. that would help. dr. fauci, none of these hearings can go without me asking you about what's going on with pandemic flu and you had said that we're getting closer to being able to develop a universal vaccine and you've said that before because you've been trying to do it for a long time. what does your time frame look like now and what are the barriers. >> congressman degette, the
9:53 am
time frame levels with what you're talking about, there's not going to be one home run flu vaccine. there will be various iterations. i would say about a time frame-- every time i'm asked about a time frame people back off, and i don't want it say something in court that's not able to be delivered. since we spoke last we put into a phase two trial a universal vaccine, a multi-peptide prime with a vaccine boost. being in a phase two trial means you're another step closer to a protect you'll be able to use. >> how long is this trial 0 going on? >> the trial will probably take, it's a phase two trial so probably take at least a year to determine if this induces the kind of response that you would predict would have some broad protection. the first iteration of a universal flu vaccine is not going to be against all flu. >> right. >> absolutely. what we're hoping for is that the first iteration will cover, for example, all of a
9:54 am
particular type. like all of the h 3 n 2's. if we get that successful, then maybe all of the h1n1's. there are two major groups of influenzas, the ultimate perfect one would be one that covers all of them. i think that's years and years and years away, but the first iteration, may be five or so years away. >> i'll ask you the question the same question i asked dr. bright. what can congress do to help you? >> i think that congress has been extraordinary in their positive effect on us in helping us. for example, in the 2018 omnibus we were given additional $40 million this develop a universal flu vaccine and we're getting additional money and the proposal of the house for 2019 budget. so, you've been very supportive and we really appreciate it. >> we think it's a high priority. i think i can speak for everybody in this room. one more question, you're developing lots of different vaccines, small pox, flu,
9:55 am
anthrax, ebola. how do you prioritize your efforts to target the pathogens and toxins that provide the greatest risk? >> that's a very good thing, we do two things, congressman, we target pathogens based on the threat. talking about a buy terror threat, it's the intelligence that we get. if you're talking about the possibility of emerging infection, it's very difficult to guess what's going to come out. >> right. >> so we know and it was mentioned in one of the-- the opening statements that h 7 n 9, for example, if you look at c.d.c. chart, it's way up there as a threat. so we clearly made an investment of a considerable amount of money to develop a vaccine for that. but as i mentioned in answer to one of the other questions, it's to develop platform technologies that's applicable to any disease as opposed to picking out all the diseases and preemptively making a vaccine, in other words, making a vaccine you could easily
9:56 am
apply to whatever is the outbreak. >> thank you, thank you mr. chairman. >> gentle woman yields back. the chair will now recognize dr. burgess for five minutes. >> thank you, mr. chairman, and thanks to our panel for being hered today. and dr. fauci, i wasn't going to do it, but you brought it up. and you said sometimes you give a time frame and if it doesn't work out people will point that out to you. a couple of years ago, i think you gave us a 18-month figure on the zika virus vaccine. how close are we today? >> thank you for that question. so, when you-- when you're proving that a vaccine works or not, in the classical way, you have to get what's call efficacy signal. there has to be infections in the community to have efficacy signal. right now, thankfully for the country involved, the zika infections have been plummeting. however, the phase two trial i
9:57 am
spoke to you month ago is ongoing and accruing volunteers in the study. so there's an interesting possibility. let's say there's not enough zika case toss get an efficacy signal. we have been in a lot of discussions with the help of the fda, if we get a considerable amount and i say thousands of volunteers with safety data, immuno responses and bridge it to the studies, interests there's a possibility that they would at least consider accelerated approval. you can never guarantee anything, but that's at least on the table, so, my short answer to your question, congressman burgess, is that we're on the road to getting a zika vaccine and i feel pretty confident about that. >> and from the fda's perspective, that expedited approval that was talked about is-- is that something we could look
9:58 am
for? >> well, i don't-- i'll let the fda speak for themselves, but you never want to anticipate what they're going to do. you can give them the data and information that they ask for. >> and i may submit that in writing. i want to ask you about the golly gee-whiz thing that can happen to us. a virus d-68 was included on that list. >> yes. >> and c.d.c. has put out a paper on acute myelitis and the incidents of that, that i recognize that it's low, but it does seem to peak every other august. so, as we are coming up on one of those every other augusts, do we know any more about this illness and why it had as had the effect that it has? >> yeah, you know, the outbreak of had the respiratory disease in children from the virus d-68 a few years ago was of concern. it was contemporary with the
9:59 am
outbreak of acute mile lig myelitis, very difficult to prove that one caused the other, there's a good probability they did. they're known to cause neuro pathic problems and when you have a common set of infections, that could be it's a rare end of the spectrum among the common ones so i think we need to be ready for that. unfortunately, there are so many different entero viruses that it's hard to focus on one. there's work on anti-virals that might be promising as having a broader protection, but that's the state of it right now. >> and do you recall it being fairly frightening when we heard concerns from parents? >> exactly, it was happening the same time as ebola in africa and when he president visited he was briefed on ebola
10:00 am
and entero virus d-68. >> let me ask you when ebola was really a much more significant problem, september of 2014, the antibody map had been-- was in trials and then fda put a clinical hold on it. my understanding at the time was there was a type of reaction that was fairly servier. ... several people mentioned zmap. it is now recognized in the tool box. is that correct? >> that's correct. dr. fauci, feel freed to add in. that is correct.
10:01 am
the fda -- roadblock to insure that drugs are safe and efficacious. so the reasons behind that may not be privy to us but we make sure we have a safe and effective available drugs on the market to treat these in emergency situations as well. dr. fauci? >> zmac was part of controlled trial published by the nih in the new england journal of medicine. the diminution of cases were strongly effective of efficacy but not statistically significantly. they can use zmapp on a trial or as compassionate use. but it is available. >> thanks very much. thanks for your testimony this morning. >> the gentleman yields back, who serves as chair of health subcommittee. >> mr. chairman i will ask unanimous content to place into the record the report of the independent panel of united
10:02 am
states department of health and human services to the ebola response in 2015. >> without objection the chair recognizes. miss schakowsky for five minutes. >> i agree with you, mr. chairman this, is extraordinary panel. dr. fauci, 33 years before this committee. that's a long time. we appreciate you every time we zoo you. i also want doctor, i looked this up. dr. schuchat, looks like you're about 28 years. is it more than that? how many? >> 30 in july. >> 30 in july. such experience in all of you. it is really remarkable. i wanted to, i thank all of you for being here today. i'm particularly concerned about the improper and overuse of antibiotics that is driving the growth of antibiotic resistance around the world. i noticed, dr. fauci, in your new map with all the lines, right at the top was antibiotic
10:03 am
resistance on the left there. i feel an obligation to raise this issue for my sister and colleague, the late louise slaughter, who is always raising this issue. in the united states somewhere between 20 and 50% of all antibiotic prescriptions in hospitals are either unnecessary or inappropriate. evidence suggests that antibiotic stewardships programs in hospitals can improve prescribing practices and help reduce the occurrence of antibiotic resistance. so i'm interested in hearing more from our witnesses on this program. whoever wants to, these programs, wants to go first. dr. schuchat. >> the problem with anti-microbial resistance is problem for us. cdc has been investing in efforts to improve stewardship
10:04 am
of antibiotics. by our latest data, two out of three hospitals had antibiotic stewardship program which is a big increase from before. we think there is much more to be done. in addition we have 850 hospitals around the country are reporting on their antibiotic use data to the, the national health care safety network. so we're tracking data. what we find in the health care system is when you tracking antibiotic use and feedback to clinicians how they're doing they can improve. a lot of clinicians are test-takers, we like to do really well on those tests. learning we're not doing so well with our peers in terms of appropriateness of prescribing can improve that we're also tracking resistance. we've invested thanks to the congressional support, we've been able to invest invest in much better, timely, accurate,
10:05 am
quality, antimicrobeal resistance around the nation, where we got the nightmare bacterial reports that we came out recently. behavior change in clinicians is difficult and we're making progress. the hospital is is a good start. it takes more than hospital. we need the outpatient prescribers as well. >> you're saying we do have a tracking system now for clinicians and for hospitals? >> right. what we have -- in our national health care safety network, i'm told that 850 hospitals are already reporting to us on their antibiotic use. it includes 80 va hospitals and 30 military hospitals. they're having that be part of their, it's voluntary but it is part of their ability to monitor what's going on in their own institution. then look across institutions. >> what percentage of hospitals does that represent, do you though? >> i don't actually have that
10:06 am
information but we can get that for you. >> has the cdc identified any obstacles to successfully implementing stewardship programs? if so, how are you addressing those? >> you know i would say that incorporating the outpatient facilities in the stewardship is important. we also found that rural areas, critical areas, were challenged in being able to do all of the things that we recommend in terms of antibiotic stewardship. our program convened, a batch of the rural or critical area hospital stewardship leads who figured out ways to make a difference. we're working with them to share their best practices more broadly. i would say large hospitals are really on the case now and helping the smaller facilities get up to speed is important. >> thank you. in remaining seconds does anybody else -- >> yeah. how we address antibiotic resistance is really a
10:07 am
governmentwide and it is a program called carb, combating antibiotic resistant back tear established a a few years ago, involved what dr. schuchat had mentioned involves the cdc. it involves the fda research component from the nih. to develop new drugs to understand mechanisms to harness the immune system. but also a organization called cache-x. maybe rick, you may want to mention that recently. >> briefly, since 2010, barda spent million dollars to address anti-microbial resistance. we had the first drug license in our program. we have several more in phase two and face three. we realize the early stage pipeline was not sufficient to have a stream of new candidates going into the advanced stage development. we launched a public/private
10:08 am
partnership called carb-x. and bill and melinda gates organization and we have 34 different novel technologies to address new mechanisms of action for new antibiotics and vaccines. >> thank you. my time is up but i hope in addition to development we're looking at prevention here as well. thank you for your courtesy, mr. chairman. thank you. >> thank you. gentlewoman yields back. the chair will recognize the chair of the house ethics committee and valuable member of this subcommittee, gentlewoman from indiana, miss brooks for five minutes. >> thank you, mr. chairman. dr. schuchat, admiral ad hinton if you could pass the kind
10:09 am
binder to dr. schuchat. that is the report for fiscal 2020. a large percentage of the cdc national stockpile budget appears to not go to procuring and updating medical countermeasures for the stockpile but instead goes to a category entitled, knopp -- non-procurement costs. in effort the committee staff asked cdc to provide a breakdown of what is in the non-procurement but we never got it. share with us very briefly and you might need to supplement with written response, what includes in the nonstorage gibbing stockpile. >> thank you for your question. the stockpile has a inventory about $7 billion. so the annual appropriation is just a piece of that. most of the dollars that in the non-procurement go for sustaining and operating. so that would be the rental space, the security for the
10:10 am
warehouses, the staff that work, salaries for the staff, as well as the clinical expertise that's helping with the guidance how to use the products. >> thank you. could we get a written breakdown what that is? because we could not tell what that was. >> that should be on its way to you. >> thank you very much. dr. bright, last year, hhs, oig,ish should a report after conducting five site audits at various national stockpile locations over two year period, they talked about systemic issues, putting that $7 billion that was just mentioned into, great concern. so dr. bright, what actions does aspr plan to take in the transfer that is anticipated october 1st to insure the strategic stockpile assets are available in case of public health emergencies? >> as you probably know we have several working groups working
10:11 am
closely between cdc and aspr to evaluate various components of the stockpile transfer. and -- >> can i interrupt one second. we just heard in her opening testimony dr. schuchat, talk about all the many things cdc does relative to public health and these emergencies and so are you going through all of those things to make sure there is coordination? is that what the working groups are actually doing, figuring out what part cdc is going to maintain and what part aspr will have? is that what the working groups are doing? >> absolutely. there are five different working groups. they're meeting weekly actually and some have daily communications to understand the various components, understand how we maintain the best science and expertise currently in the sns. understand how we're building augmenting relationship between state and locals to insure that is maintained and robust sns enterprise. we're looking at contracting and financing. we're looking at non-procurement
10:12 am
costs as well. we assure you we're doing everything we can to make sure the non-procurement costs are supporting the sns and its mission. >> i have a question with respect, i understand there have been instances about barred today. had to use clinical funds for clinical counter measures for whatever reason cdc declined to secure the measures for the stockpile. how does that uncertainty affect barda's ability how is that addressed in your working groups. >> that is difficult to make the counter measures very risky and lengthy and companies put aside profitable successful endeavor source to work with us. the marketplace is absolutely essential to work with us. we realize as we've been more successful with our partners in additional countermeasures. it created an additional burden on the sns.
10:13 am
we're working with the sns at cdc with internal staff to make sure we address those lapses or gaps in communication and transparency to maersk sure we have a successful. >> thank you. i would like to enter into the record a letter from the blue ribbon study panel on biodefense that was sent to dr. cadlik, with detailed seven recommendations to improve our biodefense posture. >> without objection. >> among those was the need to improve the coordination with state and local partners and to address problems that have existed in the past. can you tell us how aspr plans to engage with state and local partners what it assumes control of the stockpile which is of great concern to state and local partners. >> i agree it is an essential part of an effective enterprise, end to end approach, early detection down to drib unshaft the state and local, tribal, territorial partners are the front line. they are the ones who are distributing and administering
10:14 am
vaccines and treatments. so we are dedicated to working with them, making sure they have a voice in the structure in our system to understand how they need those medical countermeasures and how they need them to be delivered most effectively. doesn't do us to make any new drugs or vaccines if they're not suitable for the front line workers at state and local and tribal territories to delivered a administer. >> they know how to deliver and administer them? >> yes. >> thank you, i will yield back. >> the gentlewoman yields back. the chair will recognize the gentlewoman from florida, miss castor. >> thank you, mr. chairman. last year florida recorded 262 known cases of zika. they were overwhelmingly travel-related cases but of known those known cases 136 were pregnant women. three babies were born in florida with congenital zika syndrome. thankfully those statistics are down substantially from 2015 to 2016 but the threat to young
10:15 am
women of child-bearing years and families remains very serious. a study was published where researches from the cdc and annenberg public policy center determined most people have let their guard down now. that they're not taking the precautions that they should when it comes to zika. so, dr. schuchat, now that you have the results of that study, we end the threat of congenital zika syndrome remains very serious, what do you plan to do to help keep families informed and make sure they're taking all precautions? >> thank you. zika was a devastating new problem to have for a mosquito bite to cause birth defects, something not on any of our radars really. i think you know in may we issued one of our monthly high visibility reports on vital signs on mosquito and tick-borne diseases which have been increasing. trying to get the word out in
10:16 am
advance of the mosquito season so people take the threats seriously. we have a new report coming out on zika in a few months, unfortunately we learned from thousands of pregnancies complicated by zika in folks who reside in the 50 states, to show what follow-ups have been and what has happened to the babies as they develop. we need to make mosquito protection much easier for individuals and we need to have better tools for countering mosquitoes in terms of environmentally safe and acceptable tools for them. we have been appreciative of the investments in strengthening our vector control so that there is better sure sail lance from a vector-borne disease and also better understanding of resistance patterns. so we have the right products that can be used. >> there must be more we can do to communicate to young women and young men especially now, it was very strange that zika became transferable via sex as
10:17 am
well. >> yeah, the signs are still up in the airports but people turn them off. continuing to raise concerns is a challenge when people become complacent. it is sort of our perpetual challenge in prevention. >> thank you. responding to public health emergencies requires us to have a good understanding what is happening on the ground in real time and doctors and nurses and others who work directly with patients are likely to be the first to interact with individuals affected in a public health emergency. how does cdc gather data from these clinicians to detect emerging illnesses and other threats? >> we have a variety of surveillance systems to try to identify both the known threats and the unknown or the new unusual clusters. most important is for there to be a close connection between the clinical community, the doctors and nurses on the front line and their local and state public health authorities. you know the first cases of west nile virus disease in
10:18 am
new york city were detected, there were some animal losses but it was that link between clinicians and the local health department. so part of our day-to-day every-day public health system is vital for the unknown, emergent and -- >> cdc has a laboratory response networks that plays a vital role in preparedness that we can quickly diagnose public health threats using rapid testing methods known as assay. i understand there are no known assay kits available for deadly toxins. what are the barriers developing assay targeting wide variety of pathogens and toxins? >> i think the laboratory response network, lrn, is group of 125 laboratories around the country within two hour drive of 85% of all the population.
10:19 am
they are equipped to use validated, standardized assays to detect a variety of conditions. the cdc has the ability to detect and confirm a longer list of the celebrity agents and dangerous pathogens and we prioritize which of the detection methods or assays need to be deployed close to where people live. which ones can be deployed and maintained centrally because it is quite expensive to have the standards high enough to be able to reproduce the results in all of the 125 hospitals. so while there's 45 select agents we have assays for nearly all of them, many of those are managed at the cdc or at regional centers of excellence while the 125 laboratories can test for the things that we think are the most likely including things like merz where we rolled out emergency use authorization for a new diagnostic test for that. ebola, et cetera.
10:20 am
h1n1 initially. so we try to deploy distally the assays for the threats that are the most important to have local ability to detect rapidly. >> if i could add just a second on that too, that is another area of innovation barda is focusing on with our industry partners to drive diagnostics not only out of centralized labs but put diagnostics in the hand of the physicians in the physicians office in point of care testing and go further to drive doing moss ticks down into the home so people will know earlier when they can be infected with something so they take responsible action to get treated sooner where drugs are more effective and reduce the further transmission and spread of that virus. this area is ripe for innovation to augment our national laboratory support system. >> thank you very much. >> the gentlewoman yields back. the chair recognizes the gentleman from new york, mr. collins, for five minutes. >> thank you, mr. chair. thank our witnesses an follow up
10:21 am
a little more on the laboratory response network dr. schuchat. i think that is in 1999? >> since 1999. >> i lost 10 years. it is 20 years. i deliberately lost those 10 years by the way. so i know you mentioned 125 labs here in the country but this is from what i understand also, there is international labs. i mean we all know the key to a lot of this is early detection, whether it was ebola or some other things, sars, which initially people thought they had the flu, even anthrax. the early detection is the key to jumping on top of this, which means the laboratories that are located outside of the country, i know this is collaborative effort, are you, let as use the word comfortable? how is that collaboration between the united states and other countries around the world, as you mentioned, in many cases these could be in africa and other places for the ability to identify these select agent?
10:22 am
>> the laboratory response network is in other countries as well but i would say there is other means, other laboratories that we collaborate with around the world to help have that rapid detection and response and actually that's really what the global health security agenda is about, making sure there are abilities to find, stop, prevent epidemics wherever they occur, natural or not. and the international collaboration i think is strengthened by the daily links we have in partnership on other threats. you know as you heard we're working on ebola and drc right now. it is the npa virus detection in india based on training the cdc had given to the laboratory in india years before so india could recognize that pathogen themselves without taking time to ship the specimens out of the country. >> following up on that what i would call the proficiency testing that we do for all of
10:23 am
our labs whether on influenza or hiv or any of the stds, i'm assuming there is also proficiency testing program related to our lrns, which is always maybe a little more complicated because the 45 select agents are not nearly as, probably as influenza but can you speak to the efficiency program? how often these laboratories are tested, their workers, how their grades are, so we're in fact comfortable if there is a outbreak they're properly identifying it? >> yeah the proficiency testing and assuring the quality of the laboratory tests is vital. that's one of the reasons we don't have assays for everyone of the select agencies, agents in each of the lrn labs because we want to certify that lab for that test and make sure that they maintain their reagent adequately and that everyone working on that test is doing it the right way. so we really try to prioritize
10:24 am
which assays will be run regularly in every lab because we do have to make sure that every year in, year out, they're getting the accurate results. otherwise it makes no sense to run the test. >> right. is that done yearly, more than yearly? how often is that done? and does the cdc conduct proficiency tests themselves or do you use outside agencies like cap or someone like that? >> let me get the details on that for the committee in follow-up because i don't have all of that myself. >> thank you. i think that is an important piece. so remaining time, admiral hinton, egg-based versus cell-based vaccines, could you comment? is the fda looking at we're moving forward certainly through the influenza season, are you making progress on the cell based? are you seeing positive potential there? >> absolutely. we have both, we have the egg-based and cell-based
10:25 am
vaccines available. and continue to do valuation and work in that area but both are available. both are promising. >> are you, because you know there has always been folks, if nun else would like to comment on potential problems with the egg-based. are we seeing positive steps in the other or? >> we are seeing positive steps in the other direction. and then, as far as the egg-based we run into issues with people having allergens and not being able to have them. having different options to be able to provide and treat people with is promising. and is available. >> dr. fauci? >> there are other problems with egg based which is the reason why we're trying to get away from egg-based and get toward more advanced platform technologies. one of the accidental mismatches that we had in 2016-17, particularly in australia was that the virus was chosen for the vaccine, was put into eggs. as it mutated in the eggs as it was growing it mutated so that
10:26 am
the virus came out of the eggs was not the virus you put into the egg. we had a accidental mismatch. that doesn't happen all the by any means. the idea of growing a virus in a six-mon process is something that we need to, i often say graduate into the 21st century and do it a little bit better with more advanced technology. >> thank you for that, mr. chair, i yield back. >> chair's going to allow dr. bright to finish his response, quickly. >> thank you very much. i with like to add a little bit more to that as well. it is very important to understand the need for diversification, diversified vaccine production systems for influenza. influenza is a tricky virus. eggs are reliable vaccine for a number of years. we're working to find ways to not only diversify and augment our sell-based influenza vaccines but also to improve egg-based vaccines. it is important not to completely disregard a reliable technology without having a
10:27 am
modernize technology to replace that so we're working with each of the manufacturers now to identify ways to make our flu vaccines more effective now while we wait for the universal flu vaccine candidate in the future. >> the chair will now recognize the gentleman from california, mr. ruiz for five minutes. >> thank you, mr. chairman. emerging infectious diseases are a major threat to the health of american citizens and to people around the world. this include both new diseases that emerge in previous populations while known diseases that reemerge. in the past two months for example we seen outbreak of ebola in the congo and nipa in northern india. dr. issue cat what steps are we taking to monitor emerging and diseases in the world and how are we partnering with international players on this? >> cdc works closely with dozens of ministries of health around
10:28 am
the world as well as international partners like the world health organization and world food organization or world animal health organization to be find, stop and prevent epidemic. >> give me example how you do that in very underdeveloped, poor infrastructure nation. >> right. as you know in liberia they suffered from devastating outbreak of ebola in 2014. we have a country office in liberia working closely with them focused on four key areas. strengthening laboratory systems, strengthening surveillance, strengthening emergency operations centers and rapid response and workforce development through the disease detective program we called the field epidemiology training program. that means they can shorten the time to recognition of ebola or something else. >> thank you. >> and respond capably. >> thank you. and in 2014, 2016 the ebola epidemic killed more than 11,000 people in west africa.
10:29 am
we know a physician traveled to ebola from south texas died of ebola. two others contracted survived. what did we learn because of the experience and what changes have you made because of that? >> three key lessons learned. one we need every country to have the ability to find, stop and prevent epidemics. that is what we call the global health security agenda. a second thing was we need the world organizations, the global organizations to be able to surge rapidly when a country's capacity to is overwhelmed and that has actually happened effectively in the democratic republic of congo with this ebola outbreak recently. the third thing we learned infection control is essential. that an issue that is one illness or a couple illnesses can amplify into a very large-scale problem when we don't have adequate infect control. that is important in the united
10:30 am
states for antimicrobe beale resistance and countries developing tb and for sars. >> this patient and two other health care workers contracted ebola were emergency departments, went to emergency departments, were treated in emergency departments. the first line of defense against any emerging infection or outbreak in the united states is going to be the emergency department and also the first-responders. so what are you doing in terms of the cdc to coordinate to make sure that they're well-equipped? i'm going to ask dr. bright that same question. >> we have a family of efforts to educate and keep up to date clinicians that include tens of thousands of clinicians regularly getting updates from us. whether through phone calls. >> very busy clinicians who work in emergency departments, seeing you know, 20 patients at once, to -- >> right. >> how do you integrate that into their daily practice? >> system changeses are really important.
10:31 am
when i saw a doctor at emory last week, before i could even talk to anyone, i was asked have you traveled out of the country for the last three weeks. it is on the phone line before you make an appointment. institutions, instituting systemwide checks can help make sure that you don't have problems with human error. >> okay. dr. bright? >> also i would like to highlight that aspr spent a lot of time with our hospital protection program and our health care coalitions to establish now even a national ebola training center and education center so we can train the hospital and first-responders. we have 178 ebola assessment hospitals. we have 6 the state or jurisdiction designated ebola treatment centers. we have 10 regional ebola and other special pathogen -- >> i'm an emergency physician. i have to take exams like crazy just to keep my board certifications and my licenses. i think integrating it is part of their continuing medical education and training would be
10:32 am
very essential. now the president's budget, or the administration wants to move the strategic national stockpile under the aspr. i'd like to ask dr. schuchat, what are the competitive advantages. why should i even consider keeping it at cdc? >> what i could say there has already been a administrative decision to move the stockpile and so currently cdc is working diligently, very closely with asto make the transfer as seamless as possible and to mitigate any negative consequences that may have been unintended but may occur. i think the critical areas we'll focus are to make sure state and local support is seamless and that we work with state and local health departments every day on a variety of things and know them and know where our gaps are and where we need to make progress. we need to make sure that that close relationship continues in a way that doesn't jeopardize
10:33 am
the american public. second area is the deep scientific expertise that we have across the agency that has been contributed, to maintenance of the sns. so when we need clinical guidance for children, for anthrax countermeasures we can get the best advice, incorporate rate. we need to make sure that continues but we're well on the way of executing those seamless transitions, not transmission. >> gentleman yields back. the chair will recognize the vice-chair of the subcommittee, gentleman from virginia, mr. griffith for five minutes. >> thank you, mr. chairman. after a series of safety lacheses in 2014 mishandling of anthrax and smallpox, in response to recommendations from lab safety panel, both fda and cdc formed new offices to provide oversight of safety an science. rear admiral hinton, i have several questions for you regarding the fda's office of laboratory science and safety.
10:34 am
first, how many labs does the fda have or oversee? >> the fda has 56 lab facilities. >> and do you oversee more than that? >> no, we have -- >> okay. and do you, are those all, you counting everything in a single building or is that all your labs combined? >> within those facilities there may be total of 2800 rooms with those rooms being described as a space, you know, an office, a closet you know. >> yes, ma'am. how many safety inspections of these labs were conducted by the olss over the past year? >> no inspections have been conducted by olss in the past year. however their labs have been inspected by other entities. >> okay. have there been any laboratory acquired infections at fda labs during the past year?
10:35 am
>> there have been two noted infections within the last year. the staff that had acquired those infections have been observed and the case is closed. >> all right. can you give us the reports on those go incidents, please. >> i will work with my staff to get that to you. >> thank you very much. likewise, have there been any potential exposures to threat agents at fda labs during the past year? >> not to my knowledge, no. >> in tab 5 of the document binders, september 2016 letter that the fda sent to the committee intention is hire 13 permanent full-time employees in the laboratory science and safety. olss. the committee was told that the olss is staffed by three, three permanent full-time employees and three detailees. why doesn't the olss have 13
10:36 am
employees promised during a september letter of 2016? >> sir, we have put forth a proposal. as soon as we have the dedicated budget for olss we expect their current staff to possible. they have three permanent staff and three detailed working on this space. >> that is still only puts you at six as opposed to the 13 that was indicated in 2016. >> i agree. we note that and then with the approval of the upcoming budget we will be able to double that, and they will have the 13 staff. >> the fda in the september 2016 letter committed to this committee and in july of 2017 published a notice in the federal register evaluating the olss so the office would directly report would directly report to the fda commissioner instead of the chief scientist. earlier this week the fda told committee staff that the fda has decided to reorganize again and that under the new proposal olss
10:37 am
will no longer be a direct report to the commissioner and will report to the chief scientist again just as they did when we had the lapses in 2014. contrary to expert panel's recommendations. i would like to know first, is the chief scientist reporting to you now? >> well actually -- i am the scientist, yes. >> sorry. >> director of olss. >> is olss reporting to you? >> yes, sir. >> and then you report on up the line? >> yes, i do. >> so why did the fda reverse course in less than a year and decide have the olss revert back reporting to the chief scientist? >> sir, since that was announced we have had the chance over the past year to observe and to see where it might be best fit for the alignment within the office. within the office of the chief scientist which reports into the office of the commissioner and to the commissioner, we work on crosscutting, crosssign tisk issues to include those within
10:38 am
laboratory science space. so we thought that olss would be best aligned there under my direct supervision on their day-to-day activities. the commissioner will be fully apprised of those activities. >> and i certainly mean no disrespect to but that was the same setup we had when there were problems being reported and we had the expert panel come in to give recommendations which fda agreed to. now y'all are backtracking. i understand some different personnel but it seems it me we're just creating the same problem we had before. i see my time is up. i have to yield back. thank you, mr. chairman. >> gentleman yields back. the chair will now recognize the gentlewoman from california, miss walters for five minutes. >> thank you, mr. chairman. dr. bright and dr. schuchat, either through stockpile procurement or through other means how do your agencies insure we have sufficient diagnostic test capacity to identify cases of pandemic influenza or other infectious
10:39 am
diseases? >> terms of development we worked with a number of different manufacturers next few years to develop diagnostics for influenza not only laboratory diagnostics but update point of care diagnostics for influenza so that those are available in the marketplace for pandemic and seasonal influenza detection. >> i would say that cdc both develops assays and helps with validation. a number of years ago there were quite a few point of care tests for influenza detection and some of them didn't perform as well in the field as we had hoped. so we did quite an effort of validation, comparison, shared data with fda and new labeling and improvement in the tests followed from that. so we will develop tests against pandemic or avian flu and other high-threat concerns, develop them through to emergency use authorization when appropriate,
10:40 am
501-k when possible. the 501-k final process is very labor intensive, very expensive and there is a limited number of our tests we're able to put through to that level but we do work closely with fda and darda on number of priority ones? thank you. dr. fauci, you mentioned work by the national institute of allergy and infectious diseases to support research involving diagnostic testing. from a homeland security and public health perspective, multiplex point of care technologies are beneficial because they can be used to simultaneously test for multiple infectious disease pathogens with a single blood or urine sample. can you tell us about the research niaid is doing with respect to multiplex point of care technologies and how these technologies enhance our ability to detect material threats and infectious diseases? >> thank you very much for that question. yes, we are very heavily involved in that both with our
10:41 am
grantees to get concept to develop into something that's translatable as well as contract. as multiplex as you mentioned in your statement is a very important tool of the future. now for detecting outbreaks. for example, we have multiplex assays involving a whole series of particular types of viruses. for example, the flavy viruses which are many of them we have, particularly in the western hemisphere we're involved right now in research for the development of a multiplex that would essentially cover all of the associated flavi viruses. we're doing that with a number of other viruses. there is important, i believe, aggressive on going research program at the nih, mostly through the grantees and contractors. >> okay. >> if i could jump in? >> sure. >> the challenge and beauty of multiplex assays they can do a
10:42 am
lot. the challenge with them, they are argue instruments in centralized laboratory in public hospital or health laboratory. innovation we're driving companies to move pulte plex assays to point of care in physician's offices. to work with the multiplex technologies to push some of those now out into the home. one of our greatest challenges with our diagnostics for any disease is how long it takes for a patient to get to that system and into the system so they can get a sample drawn and can get a result. too much time elapses in that. so we're trying to also use this new technology for multiplex point of care to multiplex point of need, into the home to get people earlier notification, to empower patients to get treated sooner. >> okay, thank you. rear admiral hinton, how many multiplex point of care diagnostic tests has the fda approved for use. >> thank you for your question, ma'am. work in this area is progressing well at fda. we have cleared more than 25
10:43 am
multiplex tests that could be suitable for point of care testing. >> okay. and how many others are currently underassessment by the fda? >> i have to get back to you. i don't have the exact number. >> can you describe the range of capabilities these tests have? how many diseases can multiplex point of care diagnostic tests detect? >> they can detect many. they can detect up to 20 and more at one time. which is incredibly important especially at the point of care. that we can, you know, to help easily detect in order to find the best treatment. >> okay. thank you. i yield back balance of my time. >> gentlewoman yields back. the chair will now recognize the gentleman from georgia, mr. carter, for five minutes. >> thank you, mr. chairman. mr. chairman, i i want to echo your comments earlier what an outstanding panel this is. thank you all for the very important work you do. it is extremely important to our country and we appreciate it very much.
10:44 am
dr. bright, i want to start with you, being of course from georgia i am somewhat concerned even still about the move of the strategic national stockpile and management of that from the cdc to aspr. i just want to be assured again from you, i met dr. redfield i think he is doing a great job. dr. schuchat and i worked together. i can't say enough good things about the cdc and outstanding work they do for our country. i want to make sure they will still have the opportunity to stay involved and to be involved in the medical counter measurement development and everything else that goes along with the sns. >> you have my complete assurance. i echo your comments about the cdc and the work they are doing many many people don't know, i got my first start in science at the cdc as a fellow, coming from emory university in georgia. i understand and appreciate the great scientific leadership of
10:45 am
cdc and relationship with the state and local and value of that we plan to always include that in our assessment and our programs with the new strategic regional stockpile management. >> we talked about it earlier, one of my colleagues mentioned about the concern, particularly for the transfer is not disruptive for the state an local agencies. how can you, how can you assure us, what would you suggest that we do to make that as least disruptive as we can? >> well the most important thing to recognize the value of their voice in the entire process, not just in the transition of management of the sns but the entire end to end process of our efficient response to any emergency or public health emergency threat. so we already have an intentional working group focusing on the state and locals and tribal and territory partners and their specific need and their specific interests it make sure those are encapsulated in our management of the sns. >> great.
10:46 am
dr. schuchat, would you care to comment on that as well? how can we assure this is not disruptive to our local and state communities? >> i think changes by necessity disruptive and you think our job is to mitigate that disruption so people aren't harmed. i think it is on our radar. worry working really closely together. state and territorial health board was at cdc talking to us how we make sure this goes as well as possible. >> let me ask you, i run the risk of being a little self-serving here but wouldn't it make sense to look at perhaps just having as% colocate down to atlanta with the cdc? i recognize you're part of hhs but you know, we have to get out of this mind-set not everybody has to be in washington, d.c. i mean, we got a big country out here. dr. bright, i'm looking at you. >> we have a big and beautiful country, sir and i agree with you and there is no intent to
10:47 am
move the strategic national stockpile from atlanta to washington, d.c. there might be one or two individuals who are located in our aspr office to insure we have smooth and efficient ongoing communication with the expert staff in atlanta, georgia. >> that might be a good compromise. we appreciate that very much. the ebola crisis that we had, obviously it was, we learned a lot of lessons there but i was so proud of the public/private partnership between emory university and the cdc, and all four patients recovered and, just wanted to know, you, will you be using that model in the future for other pandemics and other risks that we might run into? because we are very proud of the work that was down at emory university. i think it's a great example of what we can do in the future. dr. schuchat? >> i would say that cdc benefits
10:48 am
tremendously being located right next to emory and there is a really close working relationship. we were fortunate they did such a terrific job in the ebola and care of the patients there. there is ongoing collaboration and communication and support. i think aspr may have more direct role in the hospitals and the care of such patients and dr. bright might want to comment. >> yes. >> i want to make sure we capitalize and not lose that expert, lessons learned from emory university of the as you may know we stood up a national ebola national training education center based in nebraska as collaboration with emory university, university of nebraska and bellview. >> that's right. >> it is an example when the finest educational centers on ebola and epidemic treatments in world now. >> good. i want to thank you for all the work you do. extremely important. especially shoutout to the cdc and thank you. i yield back, mr. chairman. >> the chair will recognize the gentlewoman from california,
10:49 am
miss eshoo for five minutes. >> thank you, mr. chairman, extending legislative courtesy to me, i'm not a member of subcommittee, but i have a great interest on the subject matter since we're looking to reauthorize popa and all of the listening to what's taken place in this hearing and the superb testimony from each one of you. we have made great progress since the legislation was first written in 2006. so i am pleased but in america we're never satisfied with exactly where we are. we always want to improve. there has been an important pathway of improvement and i thank each one of you. very proud of the two women that are here. rear admiral hinton, it's really is a source of pride to me to
10:50 am
hear you respond to the tough questions that have come your way. to dr. schuchat, it is always a pleasure to hear you. dr. bright, it is, the participate with barta as been an important one. i think you're taking it to new places. to dr. fauci, i don't have any questions to ask you. i wish i could canonize you. you are such a gift to our country. such a gift to our country. you could be in the private sector probably making millions of dollars. you have devoted your entire life to the people of our country and, you make the national institutes of, nih, really stand for the national institutes of hope. you're a leader in that. and i just revere your record, your leadership and what you've done and what you continue to do
10:51 am
to dr. bright, how is restoring barta's contracting authority led to increases in the efficiency and the certainty that surrounds the medical countermeasures research and development? that's my first question. and my second one is, does your agency interpret your existing authority to allow the stockpile to invest in countermeasures other than those explicitly mentioned in the current statute? maybe start with the second question? >> thank you very much. >> do you need any decision authorities? >> we, to be more effective i believe we need to modify some of the authorities that we have that allow to us work more flexibly with our industry. >> you don't need additional authorities? >> we don't need additional authorities. i believe we need to modify the
10:52 am
authorities we have. >> what does that mean, modify the authorities? >> our other transactional authority, for example, does have limitations how we can interface with our industry partners and how they qualify in that partnership. we have drafted language that would allow us greater flexibility to do so. >> have you gotten that to us? >> it if it hasn't been sent to you yet we'll make sure it is sent quickly. >> do darda's existing authorities promote work, but not just at that subcommittee but others, the anti-microbial resistance or antibiotic development? or does your agency need additional authorities to engage in that work? >> we've been working with the authorities we have since 2010 to address antimicrobe beale resistance. one area of authority we think would be beneficial, authority
10:53 am
for pandemic influenza because there is a lot of work that need to happen in -- >> have you gotten that to us? >> we do not have authority yet. >> are you going to make that request of us? >> i believe that request has been submitted. i hope so. >> there was some endings earlier about how important the advanced, i think you might have raised it in your opening statement on advanced appropriations. i believe that, because the senate has different rules on this, that we will meet the standard that needs to be met. that is probably the tidiest way for me to say it but it is critical because if you don't have the advanced appropriations at barda then the, our partners in the private sector are not going to be able to continue the work, the important work that they're doing. >> that is absolutely correct.
10:54 am
our business partners work in long-term cycles and forward-looking cycles and the consistency and assurance that advanced appropriations allows them to have that assurance that we will still be there doing our part so they can plan appropriately as well. >> thank you very much, to each one of you for what you're doing for our country. you're all heroes of mine. thank you, mr. chairman. yield back. >> gentlewoman yields back. the chair will recognize ranking member degette for concluding remark. >> thank you very much, mr. chairman, a moment of personal privilege. i wanted to bring up another issue i think is a real crisis right now in this country. i know we have a lot of hhs agency representatives here and of course aspr under the purview of hhs. yesterday our ranking member, frank pallone, wrote a letter to secretary azar about the hhs office of refugee resettlement and these kids who are being taken by their, from their
10:55 am
parents at the border, and then being put under the auspice of this agency. we have real concerns about what's happening to these children, and we have real concerns about their long-term prospects being taken from their parents. mr. chairman, i just wanted to bring this up because you're going to be getting a request from the minority to have a hearing about this, and we would hope that you would seriously consider this because, we are quite concerned about the human aspects of this situation. thank you. and i yield back. >> gentlewoman yields back. the chair will recognize dr. burgess for concluding remark. >> mr. chairman, thank you. i would point out this committee and this subcommittee in particular has a significant history of oversight over the orr. this, i do feel obligated to point out, this is not the agency that makes the decision about whether or not a family unit is kept together but they
10:56 am
are obligated to take care of whether a child arrives unaccompanied or is, is separated from their family at the dhs facility but that is the responsibility of this, the health subcommittee. we take that responsibility very seriously. in fact it was our work, our work in july of 2014 that allowed them to acquire an actual physician to be in those facilities to assess those children as they were brought in, and it was our committee that raised the question, shouldn't we at least have some way of contacting the children after they have been placed with a family, at least on a voluntary basis. so it was our committee that did that work. and that work will continue. i've been in contact with both secretary azar and with the gentleman that runs orr and i expect to have robust discussions with them going forward. and i yield back. >> if the gentleman will yield.
10:57 am
thank you very much. i look forward to working with you on this. it's a critical issue. i'm on that subcommittee. thank you. >> i want to thank each of you for being here. great insight and expertise. and thank you for participating in today's hearing. i remind members that they have 10 business days to submit questions for the record. i ask that the witnesses agree to respond properly to any such questions. with that the subcommittee is adjourned. >> thank you. >> thanks. [inaudible conversations].
10:58 am
[inaudible conversations]. >> whole thing will be shut down. it will go somewhere else.
10:59 am
[inaudible conversations]. [inaudible conversations].
11:00 am
. . [inaudible conversations] >> and you can see this house energy and commerce subcommittee hearing again tonight at eight
11:01 am
eastern as federal health experts testify on how prepared the u.s. is in responding to a biological attack, pandemics and infectious disease outbreaks. and live coverage continues this afternoon with a look at issues facing president trump's postal service task force. we'll hear about the ways the postal service could modernize its operations and business structure. live coverage from the lexington institute begins at 12 noon eastern on c-span2. >> sunday night on "after words," television and radio host bill press talks about his book, "from the left: a life in the crossfire." he's interviewed by microphone cha -- mona charon. >> who is one of the most persuasive guests? >> john mccain. he was such a maverick, which i liked, sort of consider myself
11:02 am
somewhat a halve vick s and he was rudely honest. he was willing to take on his own party. i wrote a book critical about barack obama called "buyer's remorse" which i got a lot of crap for from my fellow democrats, but there were some things where i believed barack obama let the progressive side down. john mccain was willing to say so. >> watch "after words" sunday night at nine eastern on c-span2's booktv. >> this morning "washington journal" talked with the national republican campaign committee deputy chair about the november elections and possible changes in congress. >> host: we want to welcome congressman tom emmer, bicepty chair -- deputy chair of the republican national committee. thanks for being with us. >> guest: thanks for hav

9 Views

info Stream Only

Uploaded by TV Archive on