Project BioShield was established to help incentivize private industry to develop vitally needed medical countermeasures by providing multi-year funding to support advanced research, clinical development, manufacture and procurement. Without this secure source of funding, companies do not have the incentive needed to develop the medical countermeasures that are critical to national security.
The Project BioShield Act was signed into law on July 21, 2014. Since its inception, the Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response has managed the program and worked to develop the strong partnerships, clear direction, and market incentives needed to make the program a success. Project BioShield funding is used to address national security threats as identified by the Department of Homeland Security’s Material Threat Determination process.
Overview of Key Accomplishments
Over the last seventeen years, BARDA cultivated partnerships with partners in government as well as biotechnology and pharmaceutical companies to build a portfolio of cutting edge medical countermeasures that address some of our most pressing health security threats, including anthrax, botulism, Ebola, smallpox, nerve agents, radiation, thermal or radiation burns, and antimicrobial resistance. Many of the products that have been supported under Project BioShield also received advanced research and development funding from BARDA.
supported under Project Bioshield
added to the Strategic National Stockpile
licensed or approved by the U.S. Food and Drug Administration
Since 2004, Congress has authorized multiyear funding to support Project BioShield. These funds may be used for advanced research, clinical development, manufacture and procurement of medical countermeasures. Products may be purchased under Project BioShield if they are licensed, approved or cleared by the U.S. Food and Drug Administration, or if they may be made available under an Emergency Use Authorization during a public health emergency.
2019 to 2029:
The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) increased the authorization for Project BioShield from $2.8 billion over five years to $7.1 billion over ten years. However, this funding has not yet been appropriated by Congress.
2014 – 2018:
The 2013 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) authorized funding through 2018 for buying medical countermeasures under the Project BioShield Act, and increased the flexibility of the program to allow for the support of advanced research and development programs for potential medical countermeasures. Under PAHPRA, BARDA was appropriated $415 million for advanced research and development and authorized for $2.8 billion over five years for Project BioShield for FY 2014 through FY 2018.
2004 – 2013:
FY2004 Department of Homeland Security Appropriations Act. (PDF - 162 KB) (PL 108-90) and supplement (PL 108-106 Sec. 1201) created an initial discretionary reserve of $5.6 billion to fund the program through fiscal year 2013.