The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (“PAHPAI”) was signed into law in June 2019, and re-authorizes certain federal public health agencies and all-hazards preparedness programs critical to national security. Originally enacted in 2006, PAHPAI equips the U.S. Government with the necessary resources and appropriations to prepare for a wide range of public health emergencies, including new and emerging bioterrorism threats, infectious diseases, natural disasters, and other national emergencies.
Among the governmental entities supported by PAHPAI is the Biomedical Advanced Research and Development Authority (“BARDA”), a component of the Office of the Assistant Secretary for Preparedness and Response under the U.S. Department of Health and Human Services. BARDA is the lead federal authority for developing and procuring medical countermeasures (“MCMs”) to address the public health consequences of chemical, biological, radiological, and nuclear (“CBRN”) threats, as well as pandemic influenza and emerging infectious diseases of risk to the civilian population.
BARDA funds the advanced research and development (“R&D”) of drugs, vaccines, and other high-priority national security products through public-private partnerships with industry. BARDA awards private-sector contracts, grants, cooperative agreements, and other transaction agreements (“OTAs”) to accelerate late-stage R&D efforts, encourage innovative technology, and foster a sustainable marketplace that guarantees continued access to MCMs vital to the country’s national security.
Notably, PAHPAI authorized $7.1 billion in appropriations for the BioShield Special Reserve Fund for the procurement of MCMs through fiscal year (“FY”) 2028. In addition, BARDA’s annual authorized appropriations were increased from $415 million to $611.7 million per year through FY 2023, and the approval threshold requirements for OTAs was raised from $20 million to $100 million. Given BARDA’s mission-centric reliance on the private sector, PAHPAI should pave the way for added opportunity for companies in the growing biodefense industry and emergency preparedness market.
For information on BARDA’s solicitation process, please contact a member of Womble Bond Dickinson (US) LLP’s Government Contracts practice group. Our group has extensive experience guiding companies through BARDA’s unique procurement process, from the strategic pursuit of Broad Agency Announcements (“BAA”), to the submittal of “white papers” and TechWatch meetings. We have assisted clients in the award and execution of over $2 billion in BARDA procurements since the agency’s inception in 2006 in connection with the development of vaccines, therapeutics, and devices to combat ebola, anthrax, botulism, small pox, burn injuries, and seasonal and pandemic flu.