Leadership and Investment
HHS accounts for the greatest spending on civilian biodefense initiatives, with nearly $4.5 billion budgeted for FY 2012, up from $3.85 billion estimated for FY 2011. Next highest is the DoD with $1.03 billion, up from an estimated $733.7 million this year; then homeland security at $511.4 million, up from an estimated $487.1 million. Additional civilian biodefense spending is carried out by the NSF, the EPA, and the departments of agriculture, commerce, and state.
These eight agencies cited by Franco and Sell are among more than 12 federal agencies with biodefense responsibilities, according to the U.S. Government Accountability Office (GAO). Whatever the number, the piecemeal nature of the nation’s biodefense effort was faulted earlier this year by the agency.
“While some high-level biodefense strategies have been developed, there is no broad, integrated national strategy that encompasses all stakeholders with biodefense responsibilities that can be used to guide the systematic identification of risk, assessment of resources needed to address those risks, and the prioritization and allocation of investment across the entire biodefense enterprise,” GAO concluded. “Further, neither the Office of Management and Budget nor the federal agencies account for biodefense spending across the entire federal government. As a result, the federal government does not know how much is being spent on this critical national security priority.”
The closest GAO came to answering how much is being spent was to offer, with attribution only to “a private sector analysis,” the $6.48 billion figure cited by Franco and Sell as the estimated total spent on civilian biodefense efforts by eight federal agencies in FY 2011, according to last year’s edition of their report, also published in Biosecurity and Bioterrorism. Franco and Sell lowered that 2011 estimate to $5.5 billion in this year’s report because of their inability to get full details of biodefense programs affected by the April 2011 continuing resolution.
“Because responsibilities and resources are dispersed across a number of federal agencies, the nation’s biodefense enterprise could benefit from designated leadership—a focal point—that provides leadership for the interagency community,” GAO stated in its report.
HHS says it is working to become that focal point. In testimony July 21 before the House Energy and Commerce Committee’s subcommittee on health, the agency’s ASPR Nicole Lurie, M.D., cited HHS’ 2009 release of the National Health Security Strategy (NHSS). She pointed to one recommendation in the review that HHS will undertake, having committed $50 million in FY ’11 to create a Concept Acceleration Program at NIH’s NIAID.
She said the program will “work with partner agencies, academic researchers, biotechnology companies, and large pharmaceutical companies to identify promising scientific discoveries and expedite their transformation into practical, usable products.” HHS will also create a private not-for-profit corporation that would act as a strategic investor to promising biodefense companies, Dr. Lurie added.
Fostering business investment in bioterror projects is welcome, though the acceleration program and any new initiatives face an uphill climb as Congress hunkers down on new spending. Companies are wise not to plan for it happening soon.
Even existing federal programs such as Project BioShield have not been funded to the extent originally envisioned. Companies looking to fund medical countermeasures are better off pursuing funding through existing programs or better still by raising their own funds.