Since passing the Project BioShield Act, subsequent congresses have considered additional measures to further encourage countermeasure development. The 109th Congress passed the Pandemic and All-Hazard Preparedness Act (P.L. 109-417) which created the Biomedical Advanced Research and Development Authority (BARDA) in HHS. This office oversees all of HHS’ Project BioShield activities, amongst other duties. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Questions remain regarding whether these changes have sufficiently improved countermeasure development and procurement.
The 111th Congress faces several challenging policy decisions. Primary among them is assessing whether Project BioShield is successfully encouraging medical countermeasure development. A second issue is whether to allow additional diversions of Project BioShield appropriations, a key element of the government’s market guarantee, to support other activities. A third is whether to broaden what has been a CBRN countermeasure mandate in the face of other threats such as pandemic influenza.