The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response (ASPR) located within the U.S. Department of Health and Human Services (HHS) 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. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA). The ASPR center 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.

In addition to preparing and maintaining bioterrorism responses and countermeasures, HHS, through 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. 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.

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, who served both as the principal deputy director and acting director. From April 2008 through November 14, 2016, the director was Robin A. Robinson, 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 is the BARDA director, 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:

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:

Budget

During public health emergencies, BARDA's budget may be increased by additional congressional appropriations.

In the mid-2020s, BARDA's annual budget remained near $1billion. The FY2024 President's Budget request included approximately $1.015billion for BARDA Advanced Research and Development activities, while the FY2025 President's Budget proposed approximately $970million in funding.

During the COVID-19 pandemic period, BARDA's FY2020 annual budget was reported at approximately $1.6billion depending on the precise allocation of costs, including projects overseen or managed on behalf of the Office of the Assistant Secretary for Preparedness and Response (ASPR). The FY2020 proposed budget, excluding supplemental congressional appropriations related to the pandemic, represented an increase from approximately $1.27billion in FY2019 and $1.02billion in FY2018.. This figure included $512million in medical countermeasures including $192million for combating antibiotic-resistant bacteria and $260million 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.

Research into substitute medical countermeasures (MCM) against nerve agents conducted by BARDA has shown the utility of current atropine solutions used in limited quantities in the treatment of cholinergic pathologies, to promote dilation of the eye, or organophosphate poisoning. Noting the lack of sufficient stocks in the case of mass-casualty situations, citing the 1995 Tokyo subway sarin attack, the study proposed alternate routes of administration (ROI) for atropine. The bioavailability of atropine via alternate ROIs was proven to be effective, though consideration was placed on expansion of atropine stockpiles and the dispersion of MCMs to local entities.

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 weaponized strains of bacteria. 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