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tv   Responding to Biological Attack Pandemics Infectious Diseases  CSPAN  June 22, 2018 3:43pm-5:45pm EDT

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subcommittee heard from doctors anthony fouchy, the director over in national institute of allergy and infectious diseases among others and discuss some of the potential health security threats along with vaccine development and the management of the strategic national stockpile of pharmaceuticals and medical supplies that could be used during a public health emergency. greg harper chairs the hearing. fouch. >> today the subcommittee continues the long-standing oversight of the u.s. public health system's preparedness to respond to biological threats and emerging infectious defenses. the person othe hearing is to hear from the top public health experts on their work to protect the public and explore where
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improvements need be way. the biological threats facing the united states in today's global society are south carolina, ever einvolving some cases intensifying. the cdc reported the seasonal influenza claimed the lives of 172 children during the most recent flu season, making it the deadliest seasonal flew season for children on record inch recent years the u.s. has seen an increase the number of antibiotic resistant bacteria, around the world virus are emerging, adopting and some cases reemerging. there's an ebola outbreak in west africa, and a nipa virus outbreak in india. we have seen humans in china contract the strain of influenza which has been confined to birds them strain it rated by the cdc's influence should risk assessment tool as posing the
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greatest risk to cause a public pandemic. the 2013 address to president obama and senator roger wicker that originatessed in my home state of mississippi and the anthrax mailings is a remind over the risk of intentional piologial attacks. today's hearing especially timely given that the committee is considering bipartisan legislation sponsored by miss brooks and miss eshoo to rethundershower the pandemic and all hazards preparednessing a which is set to spire at the end of september. passage of papah will provide critical certainty for publication health agencies and industry partners and bring about much needed reforms. one such reform proposed in the legislation is transferring control of the strategy county national stockpile from the cdc to hhs's service of the
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assistant secretary for preparedness and response. a year ago hhs's office of inspector general report systemic issues with security and inventory management of the stockpile, riskings cdc venezuela able to deploy the stockpile during a public health emergency ever these issues need be addressed as does improvement of training of deployment of medical countermeasures. administrative reforms are of interest. for example, are there ways to improve the timeliness of the decision making progression on threat assessments and appropriate countermeasures? effective threat detection has been a subject another committee overnight. in 2016 the committee questions the cdc but the efix tvness of the laboratory responsed inworks, lrn, responsible for developing as says for public health labs to test for the presence of
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select agents. in a may 2017 letter to the committee the cdc reported the lrn had only developed three assays. while the lrn has had those cleared by the fda under emergency use authorization, after nearly 20 years of this program, with about $135 million in funding over the last decade, could the lrn have cleared significantly higher numbers of assay through the most fda process? finally, maintaining public confidence in critical federal biopreparedness research is essential. in response to safety lapses in 2014 and to an expert panels recommendations, the cdc and fda each formed new office in 20 a to centralize and elevate oversight of laboratory safety with the directors of those
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offices reporting directly to the agency head. these changes sent a strong message that lab safety was top priority backed by the cloud of direct packing front the agency head. unfortunately, both agencies seem to be backtracking from this good direction. in the fda's case, less than a year after this administration approved the direct report organization or reorganization, the sudden change is curious would seem to be a step in the wrong direction. so we need to hear more details about the basis for in the new direction. i'd like to thank the distinguished members of our panel for being here today and for your service to our country. now recognize the ranking member of the subcommittee from colorado for five minutes. >> thank you, mr. chairman. i know we agree that preparing the country for a bioincident is of critical importance. the threat is growing inch april the cdc reported in 2017
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colorado saw 25 cases of antibiotics resistant bacteria known as the nightmare bacteria because 50% of those infected by i died. thank through those cases were isolatedbe but the same study noted it's possible for these germs to, quote, spread like wildfire. a if that happens we need to know we're able to respond. we have looked at this issue and this subcommittee many times over the years as our panel well knows, a regular panes and i want to thank you for coming again. again and again we found that the federal government has to scramble to address biosafety incidences. those who were here during the fall of 2001 rail the choose that a few small envelopes of anthrax caused on capitol hill. offices cloud closed, buildings fumigated. some congressional business was sounded and thousands of staffers and other personnel
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lined up for days to get tested for exposure and some worker at the postal were ineffectsed and died. in 2009 hes that to scramble to produce sufficient doses of the swine flu vaccine. 2014, hospitals and healthcare providers were not adequately prepared to deal with the arrival of ebola patients in america. in one case, hospital in dallas failed to diagnosis ebola in a patient who had traveled to west africa and differ charged him. the virus was latest transmittedded from they efficient two healthcare workers. in the days and weeks that followed, important questions were raise history this event was handled and were we adequately prepared for the larger event. then of course in 2015, the zika outbreak underscored the need.
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i'd like to know today, though, what lesson wed learned from these incidents and i want to know how the agencies are using what we have learned to better prepare for the next crisis because there will be one. for example, do we have adequate medical countermeasures in flights respond quickly when at outbreak occur's are toxin is release? do we have the capacity to quickly deliver countermeasures to the doctors doctors and nurso will actually use them and do the healthcare worked understand how to deploy the countermeasures? similarly research into emerge pathogens and existing pathogenerals that have mutated is dehelping us quickly respond to new and expanding outbreaks. how is this research informing -- are we dedicating adequate resources. i want to hear how all of our
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agencies, cdc, nye nia coordinate. while each one of those agencies has pick valuable role to play in insuring preparedness, nobody can operate effectively. in fact one major finding over the panel's 2015 record on biodefense preparedness, these agencies must ensheer they're equipment to work together. the blue ribbon report found the federal governments muss dramatically increase the support provided to local jurisdictions to help them build and sustain their biodefense capables. local providers like hospitals and health care human being worker -- hillary rodham clinton workers are on the front line is wand to ensure we're cat lit spokeswoman outing providers a well as state and local health departments so they're equipped to detect incident enwhy that happen and respond appropriately
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movement are chairman i'm hoping we'll hear today we have made tangible measurable progress but i urge to us revisit the work of the the blue ribbon panels to determine what more we need to do to better prepare the nation for this threat insuring that we'll be discussing today. 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 take the time, it really helps us represent our constituents and it helps all of us be better prepared for the next emergency that faces us. thank you and i yield back. >> the chair now recognizes the chairman of the full committee, the gentleman from oregon, mr. walden, for five minutes. >> thank you very much thank you for your work on this and our panelists, thank you, for your guidance on this issue and also what we tap into you for along
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the way and we appreciate your professionalism and your assistance in our policy debates the topike of buyey preparedness hits home for me. i think i was the first member of congress to be diagnosed with h1n1 years ago. not a distinction i was glad to get but more than that, 30 years ago a religious group moved to oregon. may have seen the documentary on netflix called "wild country. " you read judith miller's book "germs" it was the largest bioterror attack in the nation's history and it took the federal government year to admits that's what it was. they grew their own salmonella and then sprinkled it over salad bars and sickened 751 people, deliberate biological attacks are one risk. we are more global travel
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they're increased risk of spread of infebruary shoes diseases as we have seen win influenza. pathow begins, evolve and -- reliant on testing and treatments and capabilities in the men and woman who do the work. lack of preparation is not an option. a mock pandemic exercise last month bit johns hopkins center for health security with a group of current and former government officials includes susan brooks was quite eye-opening. the exercise resulted in a failure to delve a vaccine within 20 minutes and that led in this exercise to 150 million deaths globally. so obviously we have to do more to be prepared for these types of outbreaks. so that's where the reauthorization of the pandemic law preparedness act comes in. it was adopted in 2006 and set
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to expire at the end of september. we intend to move forward with legislation prior to that. our health subcommittee most last tweak consider a bipartisan constitution draft reauthorizes the law and continues to fine tune its. it's critically important congress rethat ares the law and that all members of government are prepared for chemical attacks, cyber security incidents and mass casualty events through let'ses, hearings and investigations the committee as raised numerous issues regarding biological threats to the u.s. and the nation's ability to respond. for example the committee has examined concerned be that's cdc management and the security of the strategic national stockpile and the capabilities of cdc laboratory response network. trump administration set to transfer management of the stockpile from the cdc to the assistant secretaries for preparedness and response, known as aspr and we look forward to hearing more details.
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another area of interest is the improvement of biosurveillance capabilities, innovation could bolster our public health response in the event of attack or pandemic. the federal government needs to act faster to identify and determine material throats. the department of home land security in march 2018 made determine for pharmaceutical based agents such as fentanyl. too years for them to make this designation wrote it was used more than 15 years ago and only after they that's designation is made that the countermeasures enterprise can approve countermeasure development and acquisition. we knew about it 15 years ago and took two years to get that designation. we can do better. maintaining public support for critical biopreparedness research relies on federal scientists and researchers work
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with the diseases and dangerous pathogens in a safe and security manner. fog lapses at the cdc and fda labs, both of them created new offices to oversee and prioritize lab safety. the recent proposals of the agencies to lower the status, their lab safety offices, raises concerns of the committee. thank you for being here today and i'd like to yield the balance of my time doctors burgess and hopefully to miss brooks. >> thank you, mr. chairman remembering and this issue was one that is important and timely for this subcommittee, and last week the health subcommittee had a hearing on the discussion draft of the pan pandemics preparedness act. we heard from witnesses with experience and received input on the draft legislation. certainly with this panel today is well-known espouse they are all expects. i look forward to hearing from the witnesses and i thank you
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mr. chairman and i will yield to miss brooks. >> maybe with unanimous consent. >> 30 seconds. >> thank you, mr. chairman. thank you to our witnesses for your work on this public health national security issue. last february our subcommittee here healed a hearing conditioning how we best combat biological threats and i pleased to examine the state of our preparedness as we prepare to reauthorizes the law. it is not a question of if we face a threat, it's a question of, again, once again, when we face a threat, and i have been roo mind its -- remind that these type of incidents have already happened in the country over the last decade and a half. creteed in. ment -- at hhs, oig in june of. 17 issued a report identifying serious systemic issues within
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the cdcs management of thestockpile. look forward to hearing how we ensure that our stockpile is properly managed and we can be prepared as a country for whatever threat the are and may face. i yield back. >> the gentleman is recognized for five minutes. >> thank you, mr. chairman: ... >> panel found that, and go, the nation is dangerously vulnerable
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to a biological event to produce an extensive report recommending action items for public health info structure to address. while the blue-ribbon panel was most recent trial of a commission to examine our nation's bio preparedness it was not the first and in fact, for many years experts have warned that our ability to respond to biological and other emerging threats must be improved. these regulations remain important today because the emerging health threats this country faces continue to grow. just this week officials announced that a child in idaho contracted bubonic plague and last year and outbreak of the plague killed 200 people in madagascar. in march we hear the threat of pandemic flu among the greatest concerns in the public health world and antibiotic resistance also poses a major threat to public health killing 23000 americans every year and making everyday procedures like surgery and chemotherapy increasingly risky. study shows the warming temperatures associated with higher levels of resistance and
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common strains of bacteria. extreme weather events and also lead to serious public health emergencies, hurricanes in perrigo, virgin islands, texas and florida last year were a stark reminder that this fact that must be prepared to address that one of these sources. blue-ribbon panel participated regulations for being our buy up awareness and i hope our witnesses will show that we have real progress. for example, here the agencies establish a plan 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 cdc and nih are working together to identify the greatest threat and to prioritize the research surveillance and capabilities to target these thoughts. the results focus on how these agents collaborate with state and local how to parents as well as healthcare providers such as hospitals. that these events be the like to see [inaudible] in most cases it
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will be the one to dispense countermeasures to treat those impacted. in 2014, for example, we witness negative consequence is that issued in our healthcare info structure was unprepared to diagnose and treat patients with evil a. this incident led to a serious question about whether he would be able to handle a large-scale event or incident we must make sure that everyone on the round has resources they need to respond effectively in such a crisis. i also want to hear more about how conducting surveillance when an outbreak happens for a toxin is released and we know as soon as possible but we can't anticipate every new or mutated pathogen. if he could contac detected we d respond much more effective. along the same lines i
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understand cdc is gathering data from laboratory in public out apartments and we must ensure to effectively analyze this data as it comes in. finally i want to hear more about what were doing to prioritize development of medical countermeasures to help us respond to biosafety incident and countermeasures include preventative measures like vaccines as well as therapeutics like antibiotic and antivirals. florida, i understand, you work closely with every sector to develop many of these products and i hope that we will hear about how these partnerships have produced useful, safe and products that address our situations. i like to thank our panelists for being here and. for these threats is certainly not easy but i'm confident that you are up for the task as well as we do our part and provide
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the resources you need. i your back, mr. chairman. >> to 20 years back. i ask unanimous consent of the members opening statements be made part of the record and without objection, it must be so entered into the record. additionally, asking's consent that members not on the subcommittee of oversight be permitted to participate in today's hearing. without objection, so ordered. i would now like to introduce our witnesses for today's hearing. first, have doctor rick wright, doctor of biomedical and deputy assistant secretary for preparedness and response. next, doctor and come up with deputy director at the centers for disease control in prevention. then we have doctor anthony felty, director of the national institute of allergy and infectious diseases at the national institute of health. finally, we have where admiral denise, chief scientist at the us food and drug administration.
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we welcome all of you. you are each aware that the committee is holding an investigative hearing and when doing so had the practice of taking testimony under oath. you have any objection to testifying under oath? at the record reflect that they all of the witnesses have reflected that they do not. the chair advises you that under the rules of the house and those of the committee you are entitled to be accompanied by counsel do you desire to be a comedy by counsel during your testimony today? let the record reflect that each of the witnesses have affected that they do not want. in the case, please rise and raise your hand. i will spare you in. do you square that the testimony you are about to give is the truth, the whole truth and nothing but the truth? thank you. you may be seated.
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you are 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 human statement. i'll begin with you, doctor wright. welcome back. >> it is a pleasure to speak today on behalf of our assistant secretary for preparedness response. to discuss the state of the nation's how security preparedness and [inaudible] afteourmission is to protect frm health to security threats. completed. we have products to contact people from numerous threats that we face as a nation. the staff is dedicated to care for and respond to these threats. we are currently coordinating hhs response to the evil outbreak in the drc and monitoring page seven influence
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in china. communities affected by last year's hurricane were there for the long haul we help local health officials manage recovery and build resilience. we coordinate across the federal government to support state and local partners in emergencies. enhanced medical search cassidy for national disaster medical system and hospital preparedness program. we oversee the development and procurement of medical countermeasures. we made great progress in public health preparedness response since congress established in 2006. barnett was created to bridge government industry and to accelerate the development of a life-saving countermeasures that would not otherwise be available and use flexible authorities in multiyear advance funding and public and private partnerships and deep technical expertise to vaccines, drugs toward fda approval. in of years we have formed over
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200 public or private partnerships with the industry but accomplish our mission and i want to pause for one second to acknowledge the hard work of our partners that together with the us government we work very hard to create a more secure nation but not only products but capabilities to respond when needed. these partnerships have led to 35 fda approvals of products the proper protective shield for our nation against a range of the most serious pandemic and emerging infectious disease threats. project by shield barda has ported shields, vaccines to address threats including smallpox, impacts, chemical exposure. fourteen how these are now in the strategic national stockpile for use in an emergency and seven have now achieved fda approval. these outcomes are the spirit of
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leadership, coordination, partnerships and capabilities working together to protect our nation. while this effort has created life-saving products to be procured by the s and s is also created challenges to acquire and sustain sufficient quantities to address the requirements needed for a friend. critically each product also represents a company with a response capability that must be sustained to ensure we have these products available when they are needed. project bio shield and the sns together represent a marketplace that would otherwise never exist and they would vanish about it. all these companies have played valuables and enhancing our preparedness. however, the threat continue to evolve and technology to modify and create new deadly threats have become simpler. we must modernize our
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capabilities and empathize and our approach early detection to the last mile of administering vaccines and treatment to patients. with new technologies and innovations the time is here to apply transformative approaches to these problems. last week we announced a new initiative called drive, a nationwide business family approach to identify, capture and install life-saving innovation. it brings together innovators, government and now the investment community to create solutions for today's threats. as you consider reauthorization, important changes to barda would sustain our abilities. first, advanced appropriations for project bio shield will attract more partners to support our mission and without this consistent and guaranteed market the companies are reluctant to work with us.
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second, an authorization of appropriation for barda influenza program will sustain our domestic flu vaccine production capabilities, modernize our vaccine technologies and bring new treatment investor diagnostics into the home across america. i look forward to working with members of this panel, the subcommittee, congressional colleagues and grateful for the opportunity to present to you today and look forward to your questions. >> thank you, doctor wright. the chair will organize [inaudible] for five minutes. >> thank you. thank you so much for the opportunity to testify before you today to describe cdc's role in preparing, detecting and responding to biological attacks, pandemics and emerging infectious disease outbreaks. today i will highlight the cdc's role in protecting the nation against health threats. i would describe our role in three areas, preparedness, detection and response.
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the three themes i would like you to take away our first the work cdc does everyday in public health lays the foundation for responding to emergencies. second, the cdc's world-class find difficult and medical expertise ensures we are ready to respond to any threat and third, our long-standing connection to state and local health departments ensures that the department function day today and during emergency response. the first address how we prepare for emergencies. cdc works everyday with state and local health departments and in fact we have 590 staff assigned to state and local health departments. we fund of cooperative agreement in the cities ready initiative. the emergency prepared as grants go to every state in and use funds to support staff enable exercises to test and validate
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capabilities and pay for laboratory and communications equipment. the city's readiness initiative funds the nation's 72 largest cities to develop and test plans to receive and dispense medical countermeasures from the strategic national stockpile. cdc expertise helps ensure protection of vulnerable population against diverse threats. for example, cdc worked with the american economy of pediatrics the fda and stakeholders to address gaps in vegas -- taking advantage of the clinical expertise and long-standing relationships with aad. turning now to detecting threats. cdc's lab and surveillance systems are able to detect and identify agents causing illness, ranging from infections agents to chemical or radiation exposures. every year labs from all over the world and specimens to cdc because i know we will be able to identify pathogens that other laboratories cannot.
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rapid notification of disease permits intervention before health threat becomes a crisis. cdc's laboratory response network maintains an integrated scalable and flexible system of 125 federal state and local laboratories. the development of this laboratory network established in 1999, has provided larger capacity to test and report more quickly than was previously possible. for example, during the like a virus outbreak response cdc and our laboratory response laboratories processed over 207,000 specimens. now i turn to response. when there is a crisis cdc response. we are able to rapidly deploy scientific and medical experts anywhere in the world. by the end of the 21 month evil response 3700 cdc staff had shifted from their day-to-day duties to assist with the response.
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this staff deployed to west africa making over 2000 trips. today we respond to much smaller evil outbreak in the democratic republic of congo. cdc communicates. for example, during the 2009 h1 and one response cdc held 39 press conferences in 21 tele briefings. we published 51 morbidity and weekly report articles to make sure the public, health and healthcare professionals have the latest and best information. being able to prepare, detect and respond to public health threats is a top priority for us at cdc. our preparedness and response capabilities are built on broad and deep scientific medical and
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program expertise. our long-standing 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 will be happy to answer questions. >> thank you doctor schuchat. the we now recognize the next doctor for five minutes for the opening same. >> thank you very much mr. chairman. thank you very much for giving me the opportunity today to present to you the role of the national institute of allergy and infectious diseases and addressing file defense and emerging infectious diseases. our role in this dates back many years to what was solidified following the attacks of 911 with the anthrax attack that pounded us together with our colleagues at hhs to develop a strategic plan and a research agenda. for our role in that, as you
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know the nih for years with regard to any emerging infectious disease is involved in having a number of approaches stemming from basic and clinical research for both industry and academic communities with the ultimate goal of developing vaccines, therapeutics and diagnostics. we have been in a strong partnership with barda in developing concepts for intervention which were handed over them for defense element. this slide shows a representative example of some key achievements directed specifically at the category a agents that were in our strategic plan. for example, a better smallpox vaccine with next-generation vaccines for anthrax, introductions for botulism and antibiotics for plague and interestingly the development of an evil vaccine which long antedated the outbreak that we experienced in west africa in 2014. having said that it's important
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to point out as we have in the past and have shown an interesting article that the worst bioterrorist may actually be nature itself. it is interesting to point out, mr. chairman, that i haven't testified before this committee for the last 33 years. the first time i did i drew a map and it shown here and the reason i do the map is 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 structurally but this is what it looks like. these are the emerging and reemerging infectious diseases. many of them are curiosities and are not of great public health impact but others are important and we have experienced them recently such as e bola, and the
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threat of a pandemic influenza. let's take one of these. evil of. you mentioned in your opening statement as other have about the west african outbreak in the recent outbreak in the democratic republic of the congo. it's important that the cdc, the nih and other agencies of the public health service responded rapidly there and one thing that was proven that is important is that you can do good research in the context of an outbreak and we developed with others a vaccine which is called the vs the vaccine was first tried in a phase i trial right in bethesda at the clinical center and this was a vaccine that was used in the program that was involved in the west african outbreak. if you fast-forward a couple of years where we are today with the outbreak we have learned a
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lot and are applying what we learned to that. let me give you an example. the experiment will vaccine that was used in the ring vaccination program has now been deployed to the democratic republic of congo and as we speak today is being used in a ring vaccination with 50 rings and 150 vaccinations for every ring. interestingly, as i mentioned before became, this will get -- in 1995 there was an outbreak in the democratic republic of congo that show the connection between clinical care and research and we brought one of the survivors of this to bethesda to the t cells, made an antibody and now the democratic public of congo has asked us to ship that to them for their discretion use as a countermeasure in the epidemic. it became full circle that our collaboration with that that
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perhaps could help them. i want to close in the last couple of seconds with influenza. i wrote this article a few months ago talking about the need for you 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 the vaccine that essentially is able to protect us against all subtypes of influenza. i will close on this last line. it is not working well, sorry. it's an article i wrote 17 years ago but very relevant today and what it says is that emerging infections are perpetual challenge. we've always had them, we have them now and we always will have them. if they are perpetual challenge and risk must meet them with perpetual readiness. we hope to be able to do that.
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thank you. >> we now have the privilege of hearing from a rear admiral. you are organized for five minutes. >> thank you. thank you for the opportunity to appear today to discuss the state of bio preparedness. medical and public preparedness and response is quickly born to the health and security of our nation. i am pleased to be here today to discuss how fda is working towards the shared goals and making sure that we have the medical products necessary to protect our nation from a range of public health threats. whether it is naturally occurring, accidental or deliberate. the outbreak of ebola virus disease in the democratic 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
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dedicated to help and this outbreak as quickly as possible as we are actively engaged in promoting international response effort. fda plays a critical role in facilitating preparedness for and response to biological threats. our focus, our role and focus is facilitating the development and availability of medical countermeasures for ncm such as vaccines, therapeutics and diagnostic test to protect against and respond to these sets. toward that end, we work closely with our hhs partners testifying here with me today as well as other us government partners product developers and nongovernmental organizations to visit site development and availability. fda also works closely with the department of defense to facilitate the development and availability to support the needs of our nation's military personnel.
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prior to joining in the us public health service commission i proudly served as an officer in the united states air force. these efforts are near and dear to me and we are fully committed to closely working with our colleagues at the duty to support the unique needs of us military personnel. at fda we have made it a priority to utilize our authorities to practically work with a private and government partners to help facilitate the translation of discoveries in science, technology it is safe and effective and seems as part of advancing public health and strengthening our national security. we share congress goal of having faith and effective and seems available in the event that they are needed and we have made significant progress towards this important goal. for example, since 2012 fda has approved licensed or cleared more than 120 mcms including supplemental changes to already
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approved products and modifications to diagnostic devices. for a diverse array of fats including anthrax, botulism, small backs and pandemic influenza. we have issued more than 60 emergency authorizations since 2005 to enable access to products to respond to threats including for the zika virus, influenza virus and the middle east respiratory syndrome virus. while the close collaboration and coordination among the agencies represented here today have achieved many successes in the development of ncm i would emphasize that developing and cm's is highly complex and remain a regulatory science gap that challenges programs. without such tools it is difficult to generate the data
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necessary to support regulatory decision-making. addressing these regulatory science gaps remains a high priority for the fda and we have established a broad and robust cutting-edge research under our initiative regular tory science programs to develop these tools to promote innovation in the development of ncm's. fda is acutely aware that bio threats can emerge from an accidental release or exposure to threat agents during the course of conducting research. as such we are working to ensure that our laboratory and workplaces are operated in a safe and secure manner to protect employees, surrounding communities and environment. as the chief success for the fda accenture you that the laboratory safety is a high priority for me and the agency. fda remains deeply committed to working closely with its partners and fully using the authority of congress to provide facilitate and accelerate the
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development and availability of safe and effective countermeasures. while we have made significant progress we know that more work remains to be done and we look forward to partnering with congress and stakeholders as a work together to further enhance bio preparedness. 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 contents of the document finder the introduced into the record into authorized staff to make any appropriate reductions. without objection, the document will be entered into the record. with any reductions the staff determines are appropriate. is now on time for members to have the opportunity to ask questions and i will recognize myself for five minutes. let me begin by saying that in my ten years in serving in congress i don't know i've been in a committee hearing with a better lineup of witnesses and
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so, thank you all for being here. we look for to your responses today. this is a question that will go rather quickly for all of you and for each witness, which biological threat is the greatest concern to you and why? what start with doctor bright and go down. >> that is a difficult question. there are some a threat the counseling emerge and i wish i could take some of them off the table but they keep coming out at us and even more concerning is technology advancement and that it can change the biological threats we know today into something different that we may not be prepared for. i think our greatest threat for any of those is our response capabilities and been able to respond to anything that comes our way. >> doctor there any other biological threat that is at the top of your list. i know they are all important but is there one because you the greatest concern?
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>> i think influenza needs to be at the top of my list but it affects everyone rapidly and is currently changing and with pandemics all of the preparation of the world can be susceptible. the threat of a pandemic is at the top of the list because it can happen fast. >> doctor. >> my number one and maybe number two and three is influenza also. i agree for the reasons that the doctor mentioned. when you have a respiratory virus that can be spread by droplets in aerosol and then you have a situation if there is a degree or morbidity then you can have a catastrophe and we have experienced in real-world those types of things and the one that we always talk about is the 1918 pandemic which killed between 50 and hundred million people and it is likely that would be an influenza but it is not influenza or influenza -like virus. we had a scare with czars and fortunately public health measures were able to contain it but influenza first or something
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like influenza is the one that keeps me up and i. >> admiral. >> thank you for the question. i would say that the threat that would keep me up at night was the unknown. if we don't know what that threat maybe we may have to anticipate so with the emergency it would be the unknown that would keep you up and i. >> thank you. for each witness what area of bio preparedness is of the highest priority to you and why? doctor bright. >> the highest priority would be the ability to rapidly detect something that is entered our committee are used as weapon. the sooner we detect something the sooner we can begin making vaccines. >> doctor. >> i would say our global health security would be at the top of my list because as you know a threat anywhere is a threat everywhere and i think our greatest vulnerability are in
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the weakest countries of the world. we saw in ebola how rapidly a west african country can be overwhelmed and that was an issue for us, as well. been able to strengthen the ability of every country to be able to prevent, detect and respond to threats is where i place my focus. >> doctor. >> out of agree with those two. in our ability to respond, for example, with the vaccine the modern-day paper century technology of platform technology we don't have to wait six-seven months to get a vaccine but you can get it out there within a period of a couple of months which is doable if we put our mind and resources to it. >> thank you. >> admiral. >> our continued efforts in the evil a and making sure that we contain it within the specific region to not let across the borders. >> thank you. doctor bright if i could ask you honestly the need to rapidly
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respond with biological threat is essential. does the public health system have the capability to deliver and administer medical countermeasures rapidly and effectively in a timely manager as you said here today? >> as we sit here today, we can respond much more quickly than we did in the past ten years. we built a national response capability an international capability incorporating new sciences and technologies and there's a lot of room for improvement and it takes too long to respond adequately to protect everyone in our nation. >> thank you very much i will now recognize the ranking member for five minutes for questions. >> thank you very much. building on the question by the chairman just now, doctor bright, what changes do we need to make to make the system to develop countermeasures work more effectively and efficiently. it's been a good start but where do we need to go?
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>> in my 12 years experience working across government and working with the public, private partnerships we want a lot in the past years. not everything is working effectively or efficiently. >> what we need to do. >> dark medications and transparency in how we work with our different agencies and we need to ensure that there is consistency and funding and availability with the partners that we align with and we need to improve the efficiency in which we communicate and respond to proposals and other contractual mechanisms that we use with our industry partners. >> our efforts underway to do the things? >> yes. >> is there something congress can do to help you? >> congress has been generous and there are things we can do to improve our language and other transactional authorities
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to be able to work more fluidly and effectively with our industry partners and we can submit -- >> we would be delighted to have that language. that would help. doctor, none of these hearings can go without me asking you about what is going on with pandemic flu and you had said that we are getting closer to being able to develop a universal vaccine and you have said that before because you been trying to do that for a long time. what is your timeframe and what are the barriers? >> the timeframe varies when it's about the level and there's not one homerun universal flu vaccine but various iterations. i would say that the timeframe and i know every time when i ask about a timeframe people back off and i don't want to get in court to be able to say something that will not be able
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to deliver but spoke last we have into a phase two trial, a universal flu vaccine the company called ionic backs which is a peptide time followed by a killed vaccine boost. being in a phase two trial means that a step closer to getting the product that you be able to use and i would think -- >> how long is this trial going on? >> it's a phase two trial so that will take a little year to determine if this induces the kind of response that you would predict would have broad protection and the first iteration of the universal flu vaccine is not -- but what we are hoping for is that the first iteration will cover, for example, all of a particular type. all of the each of three and two and we get that successful then maybe all the h1 and one there are two major groups of influenza and the ultimate perfect one would be the covers all of them. i think that is years and years away but the first iteration and maybe five or so years away.
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>> i will see the same questions i asked doctor bright and what can congress do to help you. >> congress has been extraordinary in their positive affect on us in helping us. for example, in the 2018 on the bus we were given an additional $40 million to develop a universal flu vaccine and we are getting additional money in the proposal of the house for a 2019 budget. you've been supportive and we appreciated. >> we think it is a high priority. i speak for everybody in this room, i think. one more question, you're developing lots of different vaccines, smallpox, flu, anthrax, evil a, how you prioritize your effort to target the pathogens and toxins that provide the greatest risk? >> that's a good question. we do two things. we target specific pathogens based on the threat that you are
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talking about a bioterrorist that if the intelligence that we get and if you're talking about the possibility of an emerging infection it is very difficult to guess what will come out. we know and it was mentioned in one of the opening statements that age seven and nine, the cdc chart, its way up there is a threat so we clearly made an investment of a considerable amount of money to develop a vaccine but as i mentioned to an answer to one of the questions is to develop platform technologies that is applicable to any disease as opposed to picking out all the diseases in a preemptively making a vaccine. in other words, making it a kind of vaccine that you could easily apply to whatever the outbreak. >> thank you. thank you, mr. chairman. >> the gentle lady yields back and the next doctor is recognized for five minutes. >> thank you for being here today. i was not going to do it but you
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brought it up and he said sometimes you give a timeframe and even if it doesn't work out people pointed out to you. a couple of years ago you gave up as an 18 month figure on the zika vaccine and how close are we today? >> thank you for that question. when you are approving and vaccine works or not in the classical way you have to get what is called an efficacy signal. there has to be infections in the community to get an efficacy signal. right now, thankfully, for the countries involved the zika have plummeted to very few but the phase two trial that i spoke to you a few months ago is still ongoing and accruing volunteers in the study. there's an interesting possibility here. let's say there are not enough zika cases to be able to get efficacy signal we have been in discussion with a lot of help from the fda about the possibility that if we get a
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considerable amount and i say thousands of volunteers with safety data and inducing the kind of response that you would predict would be protected and you bridget to the studies is a possibility that they would at least consider there would be an accelerated approval. you can never guarantee anything but that is at least on the table. my short answer to your question is that we are on the road together to getting a vaccine. i feel pretty confident about that. >> from the fda's perspective that expedited approval with those -- is that something we can look for? >> i will let the entities a speak for themselves but you never want to anticipate what you can do but you can give them the data and information that the s4 and -- >> i do want to ask you about the [inaudible] that you put up
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was included -- >> yes, it was. >> and cdc has put out a paper on acute myelitis and the incident of that and i realize that it is low but it does seem to peek every kind of august. as we are coming up on one of those every other august do we know any more about this illness and why it is had the effect it has had? >> yeah, you know, the outbreak of the respiratory disease in children from the [inaudible] virus a few years ago was of concern and it was contemporary with the outbreak of myelitis and very difficult to confirm that one caused the other probability and they are known to be able to cause neuropathic problems and when you have a
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very common set of infections it could be that was a rare end of the spectrum among the common ones. i think we do each be ready for that. unfortunately there are so many different viruses that it is difficult to pick one that you could focus on for countermeasure developments. that is a state of it right now. >> as you recall, fairly frightening, the concerns that we heard from parents. >> yes, it was happening at ebola and africa were the president visited cdc -- >> admiral, let me ask you when ebola was a much more significant problem in september of 2014 the antibodies had been in trials and fda put a clinical hold on it in my understanding of the time was there was a
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hertz timer reaction is fairly severe and so we stop looking at it and is there a way when we have a problem in that order of magnitude going on i want some reassurance that the regulatory side is not going to interfere with the delivery of what may be a potent tool. it is now recognized a tool in the toolbox, is that correct? >> that is an feel free to add in but that is correct. the fda is not -- they are a robot to ensure that those drugs are safe and efficacious. the reasons behind that may not be pretty but we make sure we have safe and effective all drugs on the market to treaties in emergency situations, as we
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well. >> it was part of the randomized controlled trial that was run by the neh and published in the new journal of medicine. the result because of the cases of the time were strongly suggestive of efficacy but not enough to be statistically significant so the trial is technically still on and right now in drc they could use it on a trial or they wanted compassionate use but it is available. >> thank you all. thank you for your destiny this morning. >> the gentleman yields back and he serves as the chair of our health subcommittee -- >> mr. chairman, i may also ask the report of the [inaudible] be entered into the record. >> without objection and so interpret the turnout organizes the gentleman from illinois for five minutes. >> thank you, mr. chairman. i want to agree with you that this is an extra ordinary panel and doctor, 33 years before this
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committee and that's a long time and we appreciate you every time we see you. i also want and i looked this up but it looks like you are about 28 years and is it more than that? how many? >> thirty in july. >> okay. thirty in july and such experience and all of you is just remarkable. i wanted to and i think all of you for being here today and i'm particularly concerned about the improper and overuse of antibiotics that is driving the growth of antibiotic resistance around the world. i noticed in your new map with all the lines right at the top where antibiotic resistance is on the left there and i feel and observation to raise this issue my sister and colleague in the late louise slaughter who was always raising this issue. in the united states somewhere between 20% and antibiotic prescriptions in hospitals are
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either unnecessary or inappropriate. evidence suggest that in antibiotic stewardship program in hospitals can improve prescribing practices and help reduce the occurrence of antibiotic resistance. i am interested in hearing more from our witnesses on this program and whoever wants to go first. >> the problem is transformational challenge for us. it threatens modern medicine. cdc has been investing in efforts to improve stewardship of antibiotics and at this point by our latest data two out of three hospitals have a animatic stewardship program which is in big increase from before but we think there is much more to be done and in addition, we have 850 hospitals around the country reporting on their in about
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accused data to the national healthcare safety network so we are tracking data. what we find in healthcare system is when we track animatic use and feedback to clinicians how they are doing they can improve. a lot of clinicians are test takers and we like to do really well on those tests so learning that we are not doing as well as our peers in terms of the appropriateness of our prescribing can help improve that. we also tracking resistance and we have invested tanks to the congressional support and we been able to invest in much better timely accurate, quality antimicrobial deductions around the nation's we got those nightmare bacteria reports that we cannot attend the came out recently. we are making progress in a stewardship program and it's a good start. it takes more than a hospital to
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make that happen. we need the whole plan with outpatient scrubbers as well to be a part of this. >> we were saying we do have a tracking system now for clinicians for hospitals. >> right, international healthcare safety network were told that 850 hospitals are already reporting to us on their in about accused include hospitals and 30 hospitals and their having that be a part of it is voluntary but it's part of their ability to monitor what is going on in their own institution and look across institutions. >> what percentage of hospitals does that represent? >> i don't have that information but we can get it for you. >> has the cdc identified any obstacles to successfully in supplement stewardship programs and if so, how are you addressing those? >> you know, i would say
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incorporating the outpatient facilities in the stewardship is a program and we found that rural areas in critical areas were challenged and be able to do all the things that we recommend in terms of animatic stewardship. our program convened a batch of the rural or critical area spittle stewardship leads who had figured out ways to make a difference and we are working with them to share their best practices more probably. i would say that large hospitals are on the case now and helping the smaller facilities get up to speed is important. >> thank you. the remaining seconds does anyone -- >> yeah, how we address animatic assistance is a government wide and it's a program called carb, combating anti- resistant bacteria and that was established years ago that involves what was mentioned regarding the cdc. involves the fda research
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component from the nih to develop new drugs to understand the resistance and hardest even system but also an organization called carb asked which has a major role in so maybe, rick, and you want to mention that. >> very briefly. since 2010 barda has invested over $130 and addressing a new animatics for in microbial resistance. in the last year we had the first animatic license in our program and we had several more in phase ii and phase three and we also realize that the early-stage pipeline was not sufficient to have a stream of new candidates going in to and stage development. we did launch a public partnership called carb asked in collaboration with naiad and sponsored by trust and the bill inland melinda gates foundation now funded 44 different novel technologies to address new mechanisms of action and new into products in vaccines. >> my time is up but thank you. in addition to development that
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we are looking at prevention here as well and we thank you for your courtesy, mr. chairman. thank you. >> the gentleman with your back in the chair and organize the chair of the house ethics committee and the valuable member of the subcommittee. the gentleman from indiana is recognized for five minutes. >> thank you. if you could pass that binder to me the last page of that binder has a chart that i would like to enter into the record and ask unanimous consent to enter into the record. it's a budget report for fiscal year 2016, 2020 and a large percentage of the cdc's strategic national stockpile but it appears to not go to procuring and updating medical countermeasures but instead goes to it category entitled
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nonprocurement cost. in an effort to inform the discussion today committee staff did ask cdc to provide a breakdown for what is the nonprocurement but we never got it. can you please share with us very briefly and you might need to supplement with written response what makes up the nonprocurement spending for strategic national stockpile? >> thank you for a question. as you know the strategic national stockpile had an inventory of about $7 million. the annual appropriation is a piece of that and most dollars that are in the nonprocurement go for sustaining and operating so that would be the rental space and the security for the warehouses and the staff that work in the salaries for staff and as well as clinical expertise that is helping with the guidance on how to use the product.
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>> could we get a written breakdown about that is because we cannot tell what that was? >> that should be on its way to you. >> thank you very much. last year hhs issued a report and they talked about systemic issues putting that $7 million that was just mentioned into great concern and so, doctor, what does your company decide to take that is anticipated in october 1st to ensure the strategic national will be available in case public health emergencies? >> we have several working groups and asked for to evaluate various components and -- >> can i interrupt? we just heard in her opening testimony talk about all the many things that cdc does relative to public health and these emergencies.
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are you going through all of those things to make sure there is coordination and is that what the working groups are doing figuring out what part cdc is going to maintain and what part asper will have? >> absolutely. this will have daily medication to understand the proponents and maintain the best bias and expertise and how we build and augment relationship with faith and locals to ensure that that is maintained and for a robust s&s enterprise and we look at the contracting and the financing and the nonprocurement cost as well and we assure you that we are doing anything we can do keep those costs that their supporting -- >> respect to there's been instances where barda have used project bio shield funds to approve fda countermeasures because for whatever reason cdc
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the client to procure those countermeasures but how does that uncertainty affect barda ability to partner and is that been addressed in your working groups? >> that uncertainty is critical. it's difficult and the companies have put aside very profitable and successful endeavors to work with us in these areas. that marketplace insurance is essential and working with us so we realize that as we have been more successful with our partners in making additional counter measures it is created an additional burden on the s&s. we are working with the sns and the cdc in our internal staff now to make sure that we are able to address those lapses or gaps in communication or transparency to make sure that we have a successful. >> thank you. i'd also like to enter record that it was sent to the doctor
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with a detailed seven recommendations to improve our bond and posture. >> without objection. >> with among those was to create medication on the state and local partners. can you tell us how after they plan to engage with state and local partners once the control is stockpiled which is of great concern? >> i agree that it is an essential part and effective enterprise and the state and local and tribal territory partners are the line and there administering the vaccines and treatment we are dedicated to working with them making sure
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they have a voice in this rupture and in our systems to understand how they need the medical countermeasures and how they need to be delivered most effectively. it doesn't do us any good to make you drugs and vaccines are not suitable for a front line workers at the state and local and tribal territories to deliver. >> they know how to deliver administer them. thank you. with that to you back. >> they were now organized the gentleman for five minutes. >> thank you, mr. chairman. last year florida recorded 262 known cases of zika and they were only wildly travel related. others known cases hundred 36 women and the three babies were born in florida congenital zika syndrome. thankfully those statistics are down substantially from 2015 and 2016 but the threat to young women of childbearing years and families remains very serious. a study was just published where researchers from the cdc and the annenberg public policy center determined that most people have let their guard down and they are not taking the precautions that they should when it comes to this disease.
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now that we have the response to the zika syndrome is serious what you plan to do to help keep families informed make sure they're taking precautions? >> thank you. zika was such a devastating new problem to have for a mosquito bite to be able to cause birth defects. it's not something that was on any of our readers. i thank you know that a mate we issued one of our monthly high visibility reports of vital signs on mosquito and tickborne diseases which has been increasing. were trying to get that word out in advance of the season so they take the threat seriously. we have another report that is focusing on zika that will come out in two months highlighting what we learn from those thousands of pregnancies that were completed by zika in books reside in the 50 states to show
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what the follow-ups have been and what has happened to the babies as they developed. we need to make mosquito protection much easier for individuals winning to have better tools for countering mosquitoes in terms of environmentally safe and acceptable tools for them. we have been appreciative of the investment in strengthening our control so that there is better surveillance from vectorborne disease and also better understanding of resistance patterns so we have the right product that can be used. >> there must be more we can do to communicate to young women and men. it's strange that zika become transferable via sex as well. >> 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's our perpetual challenge and prevention. >> thank you. responding to public health
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emergencies requires us to have a good understanding of 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 thoughts? >> we have many to detect the known and unknown clusters. most important is a close connection between the clinical communities, doctors and nurses on the front lines in the local and state public health authorities. ...
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>> but i understand that right now there is no rapid test available for those pathogens or toxins so what are the barriers to develop a safe target of a wide friday pathogen the laboratory response network is a group of 125 laboratories around the country within a two-hour drive of all 85% of the population. they are equipped to use validated assay to detect a variety of decision one --dash conditions. the cdc has a longer list of the dangerous pathogens and reprioritize which of those methods or assay these to be
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deployed to where people live or which could be deployed or maintained because it is expensive to have the standards high enough to reproduce the results so while there is 45 select agents we have acted for nearly all of them and many of those are regional centers of excellence with 25 laboratories can for those like where we rolled out the emergency use authorization for diagnostic tests or evil or et cetera. h1 and one initially. and then we look at those assays those that are most important to have those that we can detect rapidly. >> another area of innovation is to drive diagnostics
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without laboratory network to put diagnostics in the hands of the physicians in the physician's office to even go further driving those into the home. people know if they have benefit -- infected to take action to be treated sooner or also stop transmission of the virus. this is right for innovation to augment our national laboratory support system. >> the chair recognizes the gentleman from new york. >> thanks to the witnesses and to follow-up on the laboratory response network since 1999 i deliberately lost those ten years. [laughter] 125 labs here in the country
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but from what i understand there are international labs. the key in his early detection whether ebola or others or stars -- sars when people thought they had the flu but this is a collaborative effort. are you comfortable and how is that collaboration between the united states and other countries around the world? these could be in africa and other places. with the ability to identify these select. >> the laboratory response network is another countries as well that there are other laboratories that we collaborate with to have that rapid detection and response. and to make sure that there is
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that stop to prevent epidemics natural or not and international collaboration strengthened by the link we have with the partnership on other threats. right now in india based on training the cdc gave years before so india could recognize that pathogen themselves without having to take the time to ship the specimen out of the country. >> following up on that proficiency testing that we do for all labs whether influenza or hiv or std, i assume there is a proficiency testing program related to the team 17 that is more complicated because those 45 but can you
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speak to that proficiency how often they test their workers or their grades so we are comfortable if there is an outbreak to be properly identified? >> the proficiency testing and assuring the quality is vital one of the reasons we don't have assay for every agent at each of the t17 lab because we want to certify that for the test to make sure they maintain adequately and make sure they are doing it the right way so we want to prioritize which asset is run regularly in every lab because we have to make sure year in and year out to get the accurate results or doesn't make sense to run the test. is that done yearly? how often and does the cdc
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conduct the proficiency test themselves? or outside agencies? >> let me get the details on that for the committee i don't have all of that myself. >> that is an important piece. in the remaining time egg base versus cell based so can you comment? is the fda looking at this moving forward through influenza season are you making progress toward seeing positive potentia potential? >> absolutely we actually have those vaccines available and we are continuing to do evaluation and work in that area. both are available and promisin promising. >> if anybody else will like to comment on potential problems?
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do we see positive steps with the other? >> we are seeing positive steps in the other direction with egg -based people have allergens so having different options enables them to provide for those people is promising and available. >> error other problems with egg-based why we are trying to get away from the and more toward advanced technologies one of the accident told mismatch is we had in australia in particular was that the virus was chosen for the vaccine was put into eggs and as it mutated in the eggs as it was growing it mutated so the virus that came out was not the virus that you put in. that was an accident told mismatch that doesn't happen but the idea having to grow a virus with a six month process is something we need to
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graduate into the 21st century to do a better with more advanced technology. >> i yield back. >> doctor bright can finish his response quickly. >> i would just like to add a little more to that it is very important to understand the need for diversification and vaccine production it is a tricky virus we have been working to find ways to not only not only diversify the recumbent base but also to improve egg -based vaccines not to just discard reliable technology without having a modernized technology to replace that. we are working with each of the manufacturers now to identify how to make flu vaccines more effective now while we wait for the universal flu vaccine from the future. >> the gentleman from california for five minutes.
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>> mr. chairman infectious diseases are a major threat to people around the world including new diseases from emerging populations as well as those that reemerge we have seen outbreaks in congo in northern india so what steps were taken to monitor emerging and reemerging infectious diseases? and how do we partner with international players on this? >> cdc works closely with dozens of ministries of health around the world as well as international partners like the who and wto or world animal health organization to be able to find and stop and prevent epidemics payment give me an example how you do that in the underdeveloped poor infrastructure nation.
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>> in liberia they suffered from devastating outbreak of ebola in 2014 we have a country office that is working closely with them focused on four key areas to strengthen laboratory systems, surveillance, emergency operations centers and rapid response and workforce development true these programs we call the field epidemiology training program to shorten the time to recognition of ebola or something else and respond capably. >> in 2014 and 2016 ebola epidemic killed more from west africa and the physician traveled from west africa to texas and died in to others contracted the virus survived. what did we learn and what are changes made because of that? >> there were three key lessons learned. we need every country to have the ability to find and stop
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and prevent epidemics that second we need the world global organizations to be able to surge rapid the way a capacity overwhelmed and that has happened effectively in the democratic republic of congo recently with their outbreak and then infection control is essential with an issue a couple illnesses can amplify into a large-scale problem without adequate infection control it is important in the united states for an -- antimicrobial or specially with ebola or sars. >> these workers that contracted ebola were in the emergency department and were treated in the emergency department but the first in line of defense against any emerging defection or outbreak
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will be the first responders so what are you doing to coordinate to make sure that they are well-equipped? >> we have a family of efforts to educate and keep up-to-date clinicians that are tens of thousands of clinicians getting updates. >> for them to work in the emergency department they can see 20 patients at once. so how do you integrate that into the daily practice? >> the system changes when i saw a doctor at emory last week before i could even talk to anyone i was asked have you travel out of the country the last three weeks it's actually on the phone line before they make an appointment the institution is implementing systemwide checks can help to make sure you don't have problems with human error. >> i would also like to
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highlight spending a lot of time with the healthcare coalitions, even the national ebola training center in education center can train the hospital and first responders i now have these assessment hospitals in those jurisdictions with treatment centers and ten regional. >> i am an emergency physician and i had to take exams like crazy just to keep my board certification so integrating and continuing medical education and training would be essential. now the president's budget or the administration wants to move the strategic national stockpil stockpile. so where are your competitive advantages dr. schuchat?
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why do i even consider the cdc? >> there already has been an administrative decision to move the stockpile so currently cdc is working diligently to make that transfer as seamless as possible. or to mitigate any negative consequences that were unintended or could occur. the critical areas are to make sure that state and local support is seamless not wheeler on -- work with state and local health departments every day and to know where the gaps are and where we need to make progress and to make sure that close relationship continues in a way that doesn't jeopardize the american public. second, the scientific scientific expertise across the agency that has been contributed to the maintenance of the sns so to have political guidance for anti- countermeasures we take that best advice to make sure that
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continues but we are well on the way of executing a transition. >> the chair will recognize the vice chair of the subcommittee from virginia for five minutes. >> thank you. after serious safety lapse involving the mishandling of anthrax and smallpox in response to recommendations from a safety expert panel the fda and cdc have new offices to have centralized oversight. rear admiral hinton i have questions regarding the fda office of science and safety. first, how how many labs does the fda have or oversee? >> 56 lab facilities. >> do you oversee more than that? >> no. >> are you counting everything in a single building or
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combined. >> those are facilities maybe a total of 2000 rooms and with those rooms described as an officer or closet or space. >> how many inspections were conducted over the past year? >> no inspections have been conducted in the past year however the labs have been inspected by other entities. >> okay. have there been any laboratory infection during the past year? >> there have been. two noted infections within the last year. the staff that handled infections that has observed and the case is closed. >> can you give us the reports on those please?
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>> likewise, have there been any potential exposures to threatening agents over the past year? >> not to my knowledge. >> september 2016 letter to the fda sent to indicate the intention to hire 13 permanent full time employees and the fda told the committee this week they are staffed by only three permanent full-time employees and three detail ease. why doesn't the 0l ss have those permanent employees that were promised? >> we have a proposal once we have the dedicated budget we expect for the current staff to double. we actually have three permanent staff and three details working on this space be make that only puts you at
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six as opposed to 13 indicated 2016. >> i agree. we know that but with your approval of the upcoming budget we can double that and we will have 13 staff. >> the fda in september 2016 letter committed to this committee also publishing those in the federal register to evaluate the office of it went directly report to the fda commissioner instead of the chief scientist earlier this week they told committee staff the fda has decided to reorganize again and under the new proposal olss is no longer a direct report to the commissioner but as the scientist just as we did in 2014 and contrary to the expert panel recommendations. so first is the chief scientist reporting to you now?
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>> actually i am the scientist. what about olss? >> yes sir. >> and then you report? >> yes i do. >> why did the fda reverse course in less than a year and have olss revert back to the chief scientist? >> since that was announced we have a chance to observe and see where itould ba best fit for the alignment in the office of the chief scientist that reports to the office of the commissioner. we work on cross scientific issues with laboratory science space. we thought olss would be best under the supervision with day to day activities that commissioner will be fully apprised of those activities. >> i mean no disrespect to you but that was the same set up
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when there are problems reported and we had the expert panel to give recommendations which fda agreed to bed now you backtrack. i understand some different personnel but it seems we are creating the same problem we had before. i yield back. >> the chair will now recognize the gentleman from california for five minutes. >> doctor bright and dr. schuchat even through stockpile procurement how do they have sufficient capacity to the pandemic influenza or other infectious diseases? >> in terms of development working with manufacturers over the last ten years to develop diagnostics not only laboratory -based but standardized and updates for point of care to make sure those are available and in the
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marketplace. >> and cdc both developed and helps with validation there were quite a few point-of-care tests and some of them did not perform as well as we hoped so we had an effort of validation and comparison sharing the data with the fda with labeling improvements of the test. so we will develop tests against pandemics or avian flu or other high threat can develop through the emergency use authorization but the 501k process is very labor-intensive and expensive and there is a limited number of tests we can put through to that level that we do work closely with fda on the priority ones - dr. fauci
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working with the national institute of allergy to support research reporting diagnostic changes. from the health and they are beneficial because they can because then they have a single letter urine sample to detect the pathogen. tell us about the research with respect to the multiple point-of-care technology and how they enhance our ability to detect material threat and infectious diseases. >> yes. we are heavily with concept to development as well as a contract that multiplex is a very important tool of the future for detecting outbreaks for example we have multiplex assay involving a
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whole series of types just like the viruses that we have in the western hemisphere and we are involved right now with research of the development of a multiplex to cover all of the associated viruses and we're doing that with a number of other viruses. so there is an important and aggressive ongoing research program at the nih mostly through our grants and contractors. >> the challenge is that they can do a lot but the challenges they are a large instrument through public health laboratory the innovation with a multiplex assay putting into the point-of-care into the physician's office working with those technologies to push those out into the home
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one of the greatest challenges with the diagnostics for any diseases how long it takes for patients to get to that system so they can get a sample drawn and get a result. too much time elapses trying to use new technology from the multiplex point-of-care to the point of need into the home to get those earlier to empower patients to be treated sooner. >> rear admiral how many diagnostic test has the fda approved for use? >> thank you for your question we have cleared more than 254 point-of-care. >> how many others currently? >> i have to get back to you. >> can you describe the range of capabilities? how many diseases can one we
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can do up to 20. at one time which is incredibly important especially at point-of-care in order to find the best treatment. >> i yield back the balance of my time. >> now the gentleman from georgia. >> i want to echo your comments earlier what an outstanding panel this is thank you for the important work that you do it is extremely important to our country we appreciate it very much. doctor bright being from georgia i am concerned even still about the move of the strategic national stockpile in the management of that from the cdc. i just want to be assured again we have worked together
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and i cannot say enough good things about the cdc and the outstanding work they do for our country would i want to make sure there is still the opportunity to stay involved and be involved in the countermeasure development and everything else that goes on with that. >> you have my complete assurance after a year your comments about the cdc are doing many people i don't know i got my first start as a fellow from emory university i understand great leadership at the cdc and the relationship and the value of that. we plan to always include that with our assessment in our program with the national stockpile. >> we talked when my colleagues had mentioned a concern in particular that the transfer is not disruptive for
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state and local agencies. how can you assure us? what do you suggest we do to make that is least disruptive that we can. >> recognize the value of the process not just the transition but the entire and two and process responding to any public health emergency threat we already have the intentional working group with the tribal and territory partners with a specific interest to make sure they are encapsulated in the management of the sns. >> can you comment on that as well? how can we be sure this is not disruptive to local or state communities? >> changes by necessity and our job is to mitigate disruption so it is on our radar working closely together
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the board was just at cdc yesterday to make sure this goes as well as possible. >> i ran the risk to be a little self-serving but doesn't it make sense to have them code locate? >> i recognize you are part of hhs but we have to get out of the mindset not everybody has to be in washington d.c. we have a big country out here. doctor bright? >> we have a big beautiful country and i agree there is no intent to move the strategic national stockpile from atlanta to d.c. maybe one or two individuals are located in the office to ensure that we have ongoing communication with the staff in atlanta georgia. >> that could be a good compromise.
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with the ebola crisis, we learned a lot of lessons but i was so proud of the public-private partnership between emory and the cdc and all four patients recovered. i just want to know we'll be using that model in the future for other pandemics or risk we might run into? we are very proud of the work done at emory university and it is a great example of what we could do in the future dr. schuchat cdc benefit tremendously working with emory and we were fortunate they did such a terrific job in the care of the patients. there is ongoing collaboration and communication and support to play a direct role in the hospitals with the care are
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not lose that but as you may know we have a national ebola training center based in nebraska and it is an example of one of the finest educational centers of ebola in the world now. >> thank you for the work that you do it is extremely important especially a shout out to the cdc. >> the chair recognizes the gentleman from california for five minutes. >> thank you for giving me the legislative courtesy i have a great interest in the subject matter since we are looking to reauthorize and in all of the listening to what has taken place in this hearing and a
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superlative testimony from each one of you, we have made great progress when the legislation was first written in 2006. i am pleased but in america we are never satisfied with where we are. we always want to improve. so there has been an important pathway of improvement. i am very proud of the two women that are here. rear admiral, it is a source of pride to me to hear you respond with the tough questions that have come your way and dr. schuchat it is always a pleasure to hear you and doctor bright, the partnership has been very important and i thank you are
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taking that to new places and t2 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 can 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 the nih stand for the national institutes of health as we are a leader in that. here for your record and your leadership and for what you have done and continue to do. doctor bright, how has that contracting authority leads to increases in the efficiency and certainty that surrounds
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those countermeasures and development? that is my first question. today interpret your existing authority to allow the stockpile for those countermeasures in the current statute? >> start with the second question or any additional authorities? >> to be more effective i believe we need to monetize the authorities to be more flexible with industry. >> we don't need additional authorities that we need to modify the authorities that we have. >> what does that mean? >> the other transactional authority does have limitations on how we can qualify for partnerships so we have drafted suggested language that may allow us greater flexibility to do so.
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>> have you gotten that to us? >> if not we will make sure it is quickly mac so part of that existing additional authority promote work not only on this committee but the antimicrobial resistance and antibiotic development or do you need additional authority to engage in network? >> we have at the antimicrobial existence and then the authority for the appropriations for pandemic influenza because there is a lot of critical work that needs to happen. >> if you gotten that to us? >> not yet. >> will you make that request of us? mech i believe that has been submitted. i hope so.
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>> talking about how important the advancement in your opening statement of advanced appropriations. i believe because of the different rules in the senate that we will meet the standards that needs to be met. but it is critical because if you don't have the advanced appropriations then our partners in the private sector will not be able to continue the work that they are doing. >> absolutely correct they are business partners working in cycles without consistency and assurance of the mass appropriations that allows them to have that assurance to do our part to plan appropriately as well. >> thank you very much for what you are doing for our country you are all here inc.
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you mr. chairman you are back. >> the chair recognizes the ranking member for concluding remarks. >> thank you for the personal privilege i want to bring up another issue i think is a crisis right now. we have a lot of hhs agency representatives here under the perfume of hhs yesterday the ranking member wrote a letter to secretary hhs office of refugee resettlement and those that are taken from their parents at the border and then point under the auspices of this agency you have concerns of what is happening to these children and their prospects want to bring this up because you will be getting a request
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from the minority to have a hearing about this. we hope you would consider this because we are quite concerned of the human aspects of this situation. >> now concluding remarks. >> i would point out this committee and this subcommittee in particular has a significant history of oversight i do feel obligated to point out this is not the agency that makes the decision whether a family unit is cap together but we are obligated to take care when a child arrives unaccompanied or separated from their family at the dhs facility with that is the responsibility of the subcommittee and we take that responsibility very seriously infected is our work in
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july 2014 that allow them to require 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 having a way to contact the children after placed with a family at least on a voluntary basis? that was our committee that did that work and that will continu continue. i have been in contact with secretary azar and i expect to have a robust discussion going forward. >> thank you very much and i look forward to working with you on this because it is a critical issue i am on the subcommittee also. >> thank you for being here for your great insights and expertise thank you for participating today you have
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ten business days to submit questions please respond promptly and with that the subcommittee is adjourned please respond promptly and with that the subcommittee is adjourned. [inaudible conversations] [inaudible conversations]
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the most important issue right now we are in the middle of the budget crisis and as a result of lower oil prices there other revenue streams that need to happen and there are political reason about implementing taxes without additional revenue coming in the alaska's are facing a crisis and one is the opioid and substance abuse crisis the more the funding goes down the more people get upset not living their lives in the way they are happy so they get destitute and self-medicating. >> the most important issue is child hunger and it all links
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to poverty. >> it is a huge chunk of our economy and any economy one of the big social service issues that seems to be the issue that are actively seeking help
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but seems to be moving from place to place but one of the big issues is homelessness and how to combat that. >> and from our perspective the most important thing is to get a long term sustainable fiscal plan in place with ongoing revenue outside of the nonrenewable resources primarily to stabilize education they need to feel their funding in alaska is stable to stabilize schools and most important for all of us is to educate our students in the best way to do that is through the school
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