biomedical advanced research and development authority biomedical advanced research and development authority the biomedical advanced research and development authority (barda) is a u.s. department of health and human services (hhs) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (cbrn) threats, as well as pandemic influenza and emerging diseases.: 140 barda was established in 2006 through the pandemic and all-hazards preparedness act (pahpa) and reports to the office of the assistant secretary for preparedness and response (aspr). the office manages project bioshield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (cbrn) attacks.: 140 biomedical advanced research and development authorityagency overviewformeddecember 2006jurisdictionfederal government of the united statesheadquartershubert h. humphrey building, washington, d.c.employees150annual budget$1.6 billion usd (2020)agency executivegary disbrow, acting directorparent agencyoffice of the assistant secretary for preparedness and responsewebsitewww.medicalcountermeasures.gov/barda in addition to preparing and maintaining bioterrorism responses and countermeasures, hhs, through the aspr and barda, prepares and maintains an integrated system of medical countermeasures for both known or unknown, and re-emerging or novel types of public health emergencies. these include diagnostic tools, therapeutics, such as antibiotics and antivirals, and preventative measures, such as vaccines. barda is an established, official interface between the u.s. federal government and the biomedical industry.: 267 barda also participates in the governmental inter-agency public health emergency medical countermeasures enterprise (phemce), providing coordination across the us federal government in developing and deploying such countermeasures.: 267 barda works with the biomedical industry, using grants and other assistance, to promote advanced research, innovation and the development of medical devices, tests, vaccines and therapeutics. barda also procures and maintains stockpiles of materials, such as drugs, personal protective equipment (ppe) and vaccines, for the strategic national stockpile (sns). history creation and legislative history barda was created and authorized by title iv sec 401 of the pandemic and all-hazards preparedness act (pahpa) of 2006. pahpa amended the public health service act by the addition of section 319l to that law. pahpa provided new authorities for a number of programs to counter cbrn as well as epidemic, pandemic and emerging disease threats, established the position of assistant secretary for preparedness and response (aspr) as well as barda reporting to the aspr, and built on project bioshield, previously created in 2004. pahpa reauthorized the public health security and bioterrorism preparedness and response act of 2002, following the 2001 anthrax attacks ensuing the september 11, 2001 terrorist attacks on the united states. barda was reauthorized by the pandemic and all-hazards preparedness reauthorization act of 2013 (pahpra) and again in the pandemic and all-hazards preparedness and advancing innovation act of 2019 (pahpai). leadership the inaugural director of barda, from its inception in 2006 through april 2008 was carol d. linden, ph.d., who served both as the principal deputy director and acting director. from april 2008 through november 14, 2016, the director was robin a. robinson phd (virology), formerly director of the barda influenza and emerging diseases division. he was succeeded as director by rick bright from november 15, 2016 through april 20, 2020, when he was moved in what later became a whistleblower controversy during the covid-19 pandemic in the united states (sars-cov-2). as of april 23, 2020, gary disbrow phd is the barda director, and was formerly director of the medical countermeasures program and director of the cbrn division at barda. all early barda directors also concurrently served as deputy assistant secretary for preparedness and response. organizational structure barda's 2011–2016 strategic plan described its composition as the office of the director plus seven functional divisions: chemical, biological, radiological and nuclear countermeasures (cbrn) countermeasuresclinical studiesinfluenzamanufacturing facilities and engineeringmodelingregulatory and quality affairsstrategic science and technology in june 2018, barda announced a new initiative, its division of research innovation and ventures (drive). drive is a business accelerator to fund and support the development of a portfolio of healthcare products. roles and purpose barda plays a unique and unusual role within the structure of the us federal government, assisting in getting drugs, deemed essential during public health emergencies including attacks compromising us national security, to market. such assistance ranges from direct funding, procuring and stockpiling medical countermeasures (mcm’s), to helping obtain us fda approvals, including emergency use authorization (eua) if needed. by the rare nature of such public health emergencies, the required therapies or countermeasures, while critical during the emergency, may not constitute a financially viable or profitable investment, for sufficiently large pharmaceutical companies. such gaps in the us government medical countermeasures infrastructure have been described as "bridging the valley of death". in this respect, barda provides services similar to those offered by venture capitalists or business accelerators in private industry, although barda takes no financial stake in the final product once approved by the fda. barda acts in concert with the phemce. these activities (see below) include: setting requirements for medical countermeasures (mcm’s)funding advanced research and development (adr) for cbrn and pandemic mcm’sadministration of national biodefense fund(s)promoting innovation in development and manufacturingacquiring and maintaining mcm stockpiles budget during public health emergencies, barda’s budget may be increased by additional congressional appropriations. in fy 2020, the annual budget of barda was approximately $1.6 billion depending on the precise allocation of costs, including the costs of projects overseen or managed by barda on behalf of the aspr. the proposed budget in fy 2020, not reflecting any additional congressional appropriations due to the covid-19 crisis, was an increase from $1.27 billion in fy 2019, and $1.02 billion in fy 2018. this figure included $512 million in medical countermeasures including $192 million for combating antibiotic-resistant bacteria and $260 million usd for advanced research and development (ard). major initiatives research and development medical countermeasures vaccines antimicrobial drugs therapeutic products diagnostics non-pharmaceutical medical supplies stockpiling programs (see below) project bioshield pandemic influenza emergency supplemental fund strategic national stockpile antibiotics vaccines anthrax vaccine antidotes medical equipment and supplies manufacturing infrastructure setting requirements barda sets the requirements for medical countermeasures in order to reduce the threats of public health emergencies such as pandemic influenza, cbrn threats, and emerging diseases. the requirements formalize the minimum standards private industry needs to use in order to produce medical countermeasures acceptable to barda. formulation stakeholders across the federal government and the public health emergency medical countermeasures enterprise (phemce) specify requirements. once established, these requirements drive barda’s advanced research and development, as well as acquisition. requirements are created consistent with the planning and prioritization expressed in the hhs phemce implementation plan for cbrn threats. pandemic influenza pandemic influenza requirements are defined by strategic objectives established in the "national strategy for pandemic influenza" and the "hhs pandemic influenza plan". advanced research and development overview one of barda's major objectives is the creation of a robust and dynamic pipeline of medical countermeasures through advanced research and development (ard). its goal is to provide multiple product candidates in each program to both account for attrition in medical countermeasure deployment and to establish multi-product/multi-manufacturer portfolios for sustainability and redundancy. barda medical countermeasures include vaccines, antimicrobial drugs, therapeutic products, diagnostics and non-pharmaceutical medical supplies, as well as devices for public health medical emergencies including chemical, biological, radiological, and nuclear threats (cbrn), pandemic influenza (pi) and emerging infectious diseases (eid). influenza and emerging infectious diseases one of barda's key activities includes the influenza and emerging infectious diseases division. this program aims to support the advanced development of vaccines, therapeutic and diagnostic medical countermeasures that address emerging infectious disease threats. nerve agents nerve agents and other chemical weapons are a priority for fighting cbrn threats. vx gas, which was the nerve agent that reportedly killed the half-brother of north korean leader kim jong-un, provides an example. barda also stockpiles an anti-seizure medication, midazolam, developed by meridian medical technologies, to be made available in an autoinjector to treat the effects of nerve agents on the neurological system. antibiotic resistant bacteria in october 2017 barda entered a nine-month $12-million contract with the san francisco-based biopharmaceutical company achaogen, sponsoring late-stage development of c-scape, an antibiotic used against resistant bacteria and a potential treatment against bioterrorism chemical agents. in april 2019, achaogen declared bankrupt. stockpile programs the pandemic and all-hazards preparedness act (pahpa) established barda as the focal point within hhs for the advanced development and acquisition of medical countermeasures to protect the american civilian population against chemical, biological, radiological, and nuclear (cbrn) and naturally occurring threats to public health. barda's stockpiling efforts are focused on building reserves of critical countermeasures as they emerge from advanced development. stockpiling contributes to preparedness in two ways: stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak. establishment of the stockpile helps to ready suppliers to meet the increased demands that an event will bring about, becoming practiced in the production and delivery of products. barda's acquisitions for the stockpile are not one-time events, complete upon the approval/licensure of a product. rather, programs are structured to include incremental milestone acquisitions during late stage development, to make available products still in development that may increase preparedness in an event, pending emergency use authorization. furthermore, we aim to establish stockpiling milestones to address long-term commitments post-licensure. cbrn stockpile programs in fy 2004, the us congress appropriated $5.6 billion usd to the project bioshield special reserve fund (srf) to support the project bioshield goal of acquiring cbrn medical countermeasures over a 10-year period. barda used these funds to support acquisition programs for the procurement of medical countermeasures against high priority cbrn threats. the agency gives funds to pharmaceutical companies to develop countermeasures. as of january 2020, barda had helped obtain fda approval for at least 50 products. pandemic influenza stockpile programs using funds from the pandemic influenza emergency supplemental fund, barda is leading the nation toward the vaccine and antiviral stockpile goals for preparedness for pandemic influenza. in december 2019, barda awarded a $226 million usd six-year contract to sanofi pasteur, a global pharmaceutical company with u.s. headquarters in bridgewater, new jersey, to increase production capacity for an influenza vaccine. in september 2019, a us presidential executive order required the us government to modernize influenza vaccines and technologies in order to improve national health security. strategic national stockpile the public health security and bioterrorism preparedness act of 2002 directed the secretary of health and human services to develop and maintain a strategic national stockpile (sns). the mission of the sns is to provide for the emergency health security of the united states in the event of a terrorist attack or any other public health emergency. the sns is the largest us national supply of pharmaceuticals and medical supplies for use in a small outbreak to a large-scale, multiple-threat emergency. when state, local, tribal, and/or territorial responders request federal assistance to support their response efforts, the stockpile is used to ensure that supplies are available when and where needed. the sns is intended to contains enough vaccines, antimicrobial drugs, therapeutic products, and non-pharmaceutical medical supplies in the wake of any public health emergency including terrorist attacks whether chemical, biological, radiological, and/or nuclear, as well as pandemic influenza and emerging infectious diseases. emergent biosolutions manufactures the only fda licensed vaccine against anthrax disease, called biothrax, which is recommended by the cdc as a post-exposure prophylactic for anthrax infection. as part of a $450 million contract with barda for the sns, emergent also developed the only fda-licensed botulinum antitoxin, heptavalent botulism antitoxin (bat) for treating naturally occurring botulism. canada also approved bat. the us federal government approved a plan against cbrn threats after the 2001 anthrax letters attack, at the time the worst biological attack in united states history. barda also invested in the late stage development of a product called nuthrax developed by emergent biosolutions, which makes the other anthrax vaccine, biothrax. according to homeland preparedness news, nuthrax will be able to provide immunity to anthrax after two doses, versus the three doses under the currently stockpiled vaccine (biothrax). manufacturing and building infrastructure ensuring the availability of medical countermeasures for public health emergencies is central to barda's mission. this includes ensuring that manufacturing infrastructure is sufficient to support the production of required products, in a manner that is timely, reliable and cost effective. barda has taken multiple approaches to bringing