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. 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.
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. 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, 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:
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.