In the next several months, the president and members of Congress will decide whether to continue the funding and authorities associated with Project BioShield, which seeks to expand the U.S. stockpile of medical countermeasures for potential chemical, biological, radiological and nuclear (CBRN) attacks. Congress established Project BioShield in 2004 and provided it with 10 years of guaranteed funding. Two years later, it created the Biomedical Advanced Research and Development Authority (BARDA) to oversee BioShield’s advanced development and procurement efforts. To date, BioShield has developed and procured more than 50 million doses of vaccines and drugs against several CBRN threats, and its investments have provided ancillary benefits as well. Renewing Project BioShield funding and authorities would enable continued research, development and procurement of many promising treatments, which could prove critical if the United States were ever attacked with CBRN weapons.
When President George W. Bush signed the Project BioShield Act on July 2, 2004, he declared that it would “help America purchase, develop and deploy cutting-edge defenses against catastrophic attack.” The act authorized the secretary of Health and Human Services (HHS) to conduct and support research, development and procurement activities for medical countermeasures (MCMs) “to treat, identify, or prevent harm from any biological, chemical, radiological or nuclear (CBRN) agent that may cause a public health emergency affecting national security.” It provided an advance appropriation of $5.593 billion over 10 years, from Fiscal Year (FY) 2004 to FY 2013, in order to create a guaranteed market incentive for pharmaceutical companies to produce CBRN MCMs for which there is no commercial demand.
To date, eight MCMs against anthrax, smallpox, botulinum toxin and radiological threats have been procured. Eighty other candidate MCMs are undergoing advanced development. Unless Congress acts, the authorities and funds contained in the Project BioShield Act will expire at the end of FY 2013. The legislative experiment of BioShield is now subject to evaluation and reconsideration in the House and the Senate, which have both passed versions of reauthorization legislation.
In order to help inform this decision, this policy brief examines the history of Project BioShield. It starts by highlighting the CBRN risks that motivate the U.S. government’s preparedness efforts, providing a historical context for America’s CBRN MCM efforts and highlighting congressional legislation that has complemented or facilitated Project BioShield implementation. The brief also describes the types of MCMs that HHS has invested in and purchased for the Strategic National Stockpile (SNS) and highlights other significant benefits of BioShield funding.