Departmental priorities for the current and next fiscal years include swapping in replacement drugs for stockpiled anthrax and smallpox treatments that are nearing the end of their shelf lives, and to procure new countermeasures for chemical, radiological, and nuclear materials, according to a June Congressional Research Service report.
Adalja said he believes there is ongoing development of countermeasures and diagnostics on all Category A agents, but some have not reached the point at which they can be procured by Bioshield. Supporting the private sector in getting their products to that point is a key aim of the Biomedical Advanced Research and Development Authority, the 6-year-old HHS branch charged with overseeing Bioshield and other medical countermeasures' development and acquisition activities.
The authority has been a key recipient of the nearly $2 billion in Bioshield funds that have been shifted into this fiscal year to separate HHS programs for work on anti-WMD drugs and other disease projects. A 2012 analysis by two issue experts indicated that about $1 billion had by then gone to BARDA coffers through the prior budget year.
It could not be immediately determined how much money remains in the Bioshield Special Reserve Fund, as not all funds that are allocated have necessarily been spent. The program's mandate ends in the fiscal year that begins on Oct. 1, but two bills submitted this year in Congress would maintain the project.
While the Obama administration asserted the funding shifts would bolster “future successful acquisitions of medical countermeasures under Project Bioshield,” the Congressional Research Service warned last year that “continued transfers would reduce the amount of money available for countermeasure procurement, could affect the willingness of developers to participate in Project Bioshield and might change the respective roles of the federal government and private developers in countermeasure development.”
Continuous withdrawals of money from the program are “concerning,” Adalja said. “I think Bioshield was signed into law with this specific purpose. I think that any diminution in the amount of the Special Reserve Fund hampers its ability to do what it was designed to do.”
Health and Human Services made the case for maintaining the program and ensuring it has needed funding in its new report. “Without an ongoing Special Reserve Fund we risk losing the base of industrial partners we depend on for the development and manufacture of biodefense products,” Lurie wrote.
This month’s HHS document makes clear that the department sees implementation of Project Bioshield and its broader countermeasure program as a developing process.
The department this year issued a strategic plan for its Public Health Emergency Medical Countermeasures Enterprise and has enacted measures suggested in a 2010 countermeasures review, among other work noted by Lurie.
One key HHS aim is to provide funding and business direction to developing biotechnology firms that could deliver medical countermeasures that would have applications against multiple threats.
“Despite our progress since 2004, we continue to face serious threats that could have catastrophic consequences to our public and medical health,” Lurie wrote. “With the continued dedication of our partners and support for investment in novel technologies and productions, our national health security will continue to improve and our communities will become more resilient in the face of public health and medical incidents.”