Center Articles and Publications

Billions for Biodefense: Federal Agency Biodefense Funding,
FY2008–FY2009
Crystal Franco

Biosecurity and Bioterrorism. Volume 6, Number 2, 2008. © Mary Ann Liebert, Inc. Reprinted with permission. DOI: 10.1089/bsp.2008.0025

Abstract: Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series analyzed civilian biodefense funding by the federal government from fiscal years 2001 through 2008. This article updates those figures with budgeted amounts for fiscal year 2009, specifically analyzing the budgets and allocations for biodefense at the Departments of Health and Human Services, Homeland Security, Defense, Agriculture, and State and the Environmental Protection Agency and the National Science Foundation.

Sections:
- U.S. Government Civilian Biodefense Funding, FY2001–FY2009 (Table 1)
- Methods and Sources
- Civilian Biodefense Funding by Federal Agency, FY2001–FY2009
     - Department of Health and Human Services (Table 2)
     - Department of Homeland Security (Table 3)
     - Department of Defense (Table 4)
     - Department of Agriculture (Table 5)
     - Environmental Protection Agency (Table 6)
     - Department of State (Table 7)
     - National Science Foundation (Table 8)
- Conclusion
- References

In the President’s fiscal year (FY) 2009 budget, the eighth and final budget year of the Bush administration and the seventh budget since the terrorist attacks of September and October 2001, the President proposes approximately $8.01 billion in federal funding for civilian biodefense programs, bringing the total funding for civilian biodefense to $49.66 billion from FY2001 to FY2009 (Table 1). The FY2009 Presidential biodefense budget represents approximately 0.26% of the total FY2009 U.S. federal budget of $3.107 trillion.¹ It should be noted that many of the programs included in this 0.26% of the budget are intended not only to improve preparedness for and resilience to bioattacks, but also to improve understanding of and response to infectious diseases and other disasters more broadly.^2,3

In the context of other defense-related funding, 0.26% is a small percentage. For example, the Department of Homeland Security’s (DHS) proposed budget for FY2009 is 1.3% of the total federal budget, and the Department of Defense’s (DoD) budget is approximately 21.0% of the total.⁴ As a subset of defense funding, missile defense programs would receive over $4 billion more than the amount proposed for all biodefense programs included in this analysis for FY2009, with a record high of $12.3 billion, or 0.40% of the federal budget.⁵

Based on analyses from previous “Billions for Biodefense” articles,^6-9 federal funding for civilian biodefense rose incrementally from FY2001 to FY2004. Excluding Project BioShield funds, which were appropriated in FY2004 but have been allocated and used over multiple fiscal years, biodefense funding peaked at $6.05 billion in FY2004 and then generally declined through FY2008. The civilian biodefense budget for FY2009 represents a proposed increase of $417.3 million over FY2008 estimates when BioShield is excluded from the total, and, when BioShield is included, it represents an increase of $2.59 billion (Table 1, Figure 1).

As in previous budgets, the majority of proposed biodefense funding for FY2009 is directed toward the Department of Health and Human Services (HHS). HHS would receive $4.17 billion (52%) of the $8.01 billion total for FY2009—a proposed increase of $169.4 million over FY2008 estimates (Figure 2). DHS would also receive a large portion of the biodefense funding for FY2009 with $2.54 billion, or 32% of the total (Figure 2). This is a large increase for DHS ($2.19 billion over FY2008 estimates), due primarily to the allocation of $2.175 billion in multiyear BioShield funds.

Additionally, the President’s budget requests increases for 4 of the 7 remaining federal agencies involved in biodefense. The largest proposed increase (other than DHS and HHS) is a $115 million allocation to the Department of Defense, primarily for their Medical Biological Defense Program, followed by a proposed $91 million increase for the U.S. Department of Agriculture (USDA) for enhancement of their Food and Agricultural Defense Initiatives. Funding increases have also been requested for the Environmental Protection Agency (EPA) and the Department of State. Under the President’s FY2009 budget, the only agency that would receive a decrease in funding is the National Science Foundation (NSF), which would eliminate or combine a number of its biodefense programs.

Biodefense has been a priority under the Bush administration as illustrated by the Homeland Security Presidential Directives (HSPD), which are both security-related and among the main foci of the President. A number of the HSPDs have direct significance for civilian biodefense, specifically HSPD-8 (National Preparedness, December 2003), HSPD-10 (Biodefense for the 21^st Century, April 2004), and HSPD-18 (Medical Countermeasures against Weapons of Mass Destruction, January 2007).¹⁰ Most recently, on October 18, 2007, the President released HSPD- 21 (National Strategy for Public Health and Medical Preparedness), which emphasizes a “strategic vision that will enable a level of public health and medical preparedness” for threats such as a bioterrorist attack.¹¹

Since the first “Billions for Biodefense” article, federal agencies have become somewhat more transparent in their accounting for, and analysis of, biodefense programs. HHS provides the most readable budget, with a section for preparedness and a subsection for biodefense funding. The USDA also provides a very good summary of food and agriculture defense. Other agencies such as DHS, EPA, and NSF provide fragmented budgets that require multiple personal contacts with the agency representatives to obtain otherwise unavailable data.

       
Figure 1. Civilian Biodefense Funding by Fiscal Year, FY2001-FY2009 (in $millions)

Figure 2. Civilian Biodefense Funding by Agency, FY2009 (in millions)

Methods and Sources
The author used a variety of methods and sources to obtain and track civilian biodefense expenditures for FY2009, including agency “Budgets in Brief,” stipulations included in public laws and accompanying Congressional reports, and personal contact with agency representatives. As in previous analyses, money spent on civilian biodefense in past fiscal years is referred to as “actual funds.” For this article, numbers for actual funds are available from FY2001-FY2007. The author also identified funding appropriated by Congress for civilian biodefense during the current fiscal year (FY2008). While these funds have already been appropriated, it is unclear how much of that money will ultimately be spent on civilian biodefense activities for the year. Hence, FY2008 money is referred to as “estimated funds.” Finally, the author analyzed the President’s budget request for the upcoming 2009 fiscal year to gather data on proposed funding. These numbers are referred to as “budget” funds and are subject to change during the FY2009 Congressional budget and appropriations processes.

In order to obtain accurate and timely budget information for this analysis, a number of methods were used to acquire the data. Departmental “Budgets in Brief” documents were primary resources. However, “Budgets in Brief” often contain only partial information on civilian biodefense programs and may not break funding down to the programmatic level. In cases where federal agencies or departments are made up of distinct operating divisions (eg, HHS and DoD), individual agency or division budgets were also examined. When these documents had been reviewed and still more detailed or complete information was needed, agency public affairs and budget offices were contacted by phone and email.

Inclusion of a line item in the budget for a biodefense program does not necessarily indicate the relative size or location of that program. A number of programs, such as BioShield, may be administered by one agency (HHS Office of the Assistant Secretary for Preparedness and Response [ASPR]) with guidance from another (DHS). Also, biodefense line items may represent programs with many components, such as the DHS Biological Countermeasures program.

As in previous years, every attempt has been made to distinguish items that should be considered for the purposes of this budget analysis as civilian versus military biodefense and/or other homeland security or public health-related programs. For the purposes of this analysis, civilian biodefense funding includes programs, research, or administrative costs that prevent or mitigate bioterrorism’s effect on civilians. Some federal budgets for programs aimed at preventing and mitigating adverse civilian health effects (eg, HHS’s BioShield) do not distinguish how much of the program is specifically targeted at biological agents, in addition to chemical, radiological, or nuclear threats. But as civilian biodefense is clearly a critical part of their mission, these programs have been included in their entirety as a practical measure. Multiple application programs (eg, HHS’s Medical Reserve Corps or the National Disaster Medical System) that may provide a substantial benefit in responding to an incident of civilian bioterrorism have also been included in their entirety. This methodology has undoubtedly led to some overestimation of biodefense funding, because it is likely that some of those funds will be spent on nonbiodefense programs.

Examples of programs that have been excluded from civilian biodefense budget totals in this analysis are programs aimed explicitly at all-hazards preparedness (not bioterrorism preparedness specifically), at nonbioterrorism-related hazards such as pandemic flu, and those programs that have strictly military applications.

Of the DoD Chemical and Biological Defense program budget, only the Medical Biological Defense program, which is primarily focused on medical countermeasures, has been included in this analysis. The remainder of the Chemical and Biological Defense program is focused on military, rather than civilian, applications, including the purchase and maintenance of military-specific vehicles, detectors, and protective gear that are not intended as tools for the U.S. civilian population. Additionally, a large proportion of the program is focused on chemical defense, which is not applicable to this analysis.

DoD’s Medical Biological Defense program has the potential for civilian biodefense applications, has increasing coordination with other federal agencies, and has applicability to civilian biodefense in its biological medical countermeasures research and development activities. For these reasons the Medical Biological Defense Program has been included in DoD and overall biodefense budget totals both for FY2009 and retroactively for years prior.

Any items that could not be tracked in previous “Billions for Biodefense” articles were updated for this version as data became available. Some line items were also shifted when compared to previous articles to reflect the restructuring of various programs, agencies, and departments.

Civilian Biodefense Funding by Federal Agency

Department of Health and Human Services
For FY2009, the President has requested an increase of $169.4 million, or 4.2%, over FY2008 estimated funding levels, for a total of $4.17 billion for HHS civilian biodefense programs (Table 2). The majority of funds requested for FY2009 are allocated to programs within the U.S. Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) (Figure 3).

FY2009 proposed funding increases in the HHS budget include a $46 million increase for CDC biosurveillance initiatives (BioSense, quarantine stations at ports of entry, and real-time laboratory reporting), an $18 million increase in funds for the Strategic National Stockpile (SNS) to help support replacement of expiring stockpiled pharmaceuticals and offset the increased costs of stockpile warehousing, and a $42 million increase to food defense initiatives under the Food and Drug Administration (FDA).¹²

The FY2009 budget proposes $250 million for advanced research and development of medical countermeasures, a $148 million increase over the estimated FY2008 level. Additionally, the FY2009 budget includes a new line item under ASPR for advanced development of next-generation ventilators. This item is budgeted at $25 million.

The Biomedical Research and Development Authority (BARDA), under ASPR, is charged with supporting advanced research and development of new medical countermeasures (eg, medicines and vaccines) against biological threats. These proposed advanced research and development funds would “support research on selected countermeasure candidates with the greatest potential for purchase under Project BioShield and delivery to the Strategic National Stockpile (SNS).”^12(p111) While the FY2009 budget proposes an increase in funding for BARDA initiatives related to advanced countermeasures research and development, Congress initially authorized $1.07 billion in funding for BARDA for FY2006 to FY2008 under the Pandemic and All Hazards Preparedness Act of 2006 (PAHPA; P.L. 109-417).¹³ An estimated $260 million of this authorized amount has been spent through FY2008, with $250 million budgeted for FY2009.

According to estimates from the Center for Biosecurity, $817 million would be required for FY2009 to support 1 full year of advanced countermeasures development, and a sum of $3.39 billion would be required to support a medical countermeasures pipeline that would provide a 90% chance of developing medical countermeasures to fulfill the requirements of HHS’s Public Health Emergency Countermeasures Enterprise (PHEMCE) Implementation Plan.¹⁴

For FY2009, the President has proposed a $62 million cut to the Hospital Preparedness Program grants under ASPR. This program provides grant funding and guidance to states and localities to increase hospital and healthcare preparedness for bioterrorism and other public health emergencies. Similarly, the FY2009 budget proposes a $137 million cut to the CDC State and Local Capacity program, composed primarily of the CDC public health grants, which help increase preparedness of state and local public health departments. In its FY2009 “Budget in Brief,” HHS describes the proposed decreases to these grant programs as an implementation of a “shortened grant period to start the grant period in future fiscal years on June 1.”^12(p111) This shortened FY2009 grant period is intended to align these grants with many state budget cycles and other federal grant programs for future years.

NIH remains the lead recipient of HHS biodefense funds, with an FY2009 budget of $1.64 billion (Table 2). The entirety of NIH biodefense funds is directed to the National Institute of Allergy and Infectious Diseases (NIAID) for its biodefense research initiatives, which include research into pathogens and their interaction with human and animal hosts, as well as clinical evaluation of vaccines and drugs against biological agents.
   

Figure 3. HHS Civilian Biodefense Funding, FY2009 (in millions)

Table 2. Department of Health and Human Services Civilian Biodefense Funding, FY2001–FY2009 (in $millions)
Direct Appropriations to Agency Budgets (Non-PHSSEF)			FY 2001	FY 2002	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007 (actual)	FY 2008 (est.)	FY 2009 (budget)	Totals
CDC	CDC: State and Local Capacity		67	940	939	918	919	823	767	746	599	6,718
	Real Time Disease Detection Pilot Program		–	–	–	–	–	–	–	–	10	10
	Bio-Surveillance Initiative	BioSense	–	–	–	18	59	57	57	34	50	276
		Biosense—DoD Appropriation	–	–	–	0	0	35	0	0	0	35
		Quarantine Stations (at ports of entry)	–	–	–	4	10	11	11	20	53	110
		Quarantine Stations - DoD Appropriation	–	–	–	0	0	20	0	0	0	20
		Real Time Lab Reporting (Enhancing the Laboratory Response Network)	–	–	–	0	10	10	10	10	7	47
		Subtotal, BioSurveillance Initiative a	–	–	–	22	79	133	78	64	110	487
	Supplemental Appropriations (Smallpox)		–	–	100	0	0	0	0	0	0	100
	Upgrading CDC Capacity		22	141	157	0	0	0	123	121	131	695
	Anthrax Vaccine Research		18	18	18	0	0	0	12	8	8	82
	Upgrading CDC Capacity/ Anthrax Vaccine Research b		–	–	–	169	158	150	–	–	–	477
	Botulinum Antitoxin Research		–	–	–	–	–	–	3	–	–	3
	Independent Studies		11	2	2	0	0	0	0	0	0	15
	Other		10	46	20	0	0	0	0	0	0	76
	SNS c		81	1,157	398	398	467	474	496	552	570	4,593
	Federal Mass Casualty Initiative (additional to the SNS)		–	–	–	–	–	50	0	0	0	50
	Subtotal CDC		209	2,304	1,634	1,507	1,623	1,630	1,476	1,491	1,428	13,303
NIH	Biodefense Research (NIAID)		53	199	687	1,629	1,548	1,604	1,624	1,633	1,635	10,612
	rPA Anthrax Vaccine Intermediate Scaleup		–	–	123	117	0	0	0	0	0	240
	MVA Smallpox Vaccine Intermediate Scaleup		–	–	–	75	45	0	0	0	0	120
	Extramural BT Research Facilities		–	92	495	119	149	30	14	0	0	899
	Subtotal NIH		53	291	1,305	1,940	1,742	1,634	1,638	1,633	1,635	11,871
FDA	Food Defense (formerly labeled "Food Safety")		1	98	97	116	150	158	172	171	213	1,176
	Medical Product Countermeasures (formerly labeled "Vaccines/ Drugs/ Diagnostics")		6	46	53	53	57	57	57	56	67	452
	Physical Security		2	13	7	7	7	7	7	7	7	64
	Subtotal FDA		9	157	157	176	214	222	236	234	287	1,692
HRSAd	Hospital Preparedness and Infrastructure (grants)		0	135	515	515	487	–	–	–	–	1,652
	Bioterrorism Training and Curriculum Development		0	0	28	28	28	–	–	–	–	84
	Smallpox Compensation		0	0	42	0	0	–	–	–	–	42
	Subtotal, HRSA		0	135	585	543	515	–	–	–	–	1,778
Office of the Secretary:Revitalization of Commissioned Corps			–	–	–	–	3	4	10	4	30	51
Subtotal, Direct Appropriations			271	2,887	3,681	4,166	4,097	3,490	3,360	3,362	3,380	28,695
Office of the Secretary, PHSSEF			FY 2001	FY 2002	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007 (actual)	FY 2008 (est.)	FY 2009 (budget)	Totals
Office of Public Health and Emergency Preparedness e			0	50	47	41	41	–	–	–	–	179
ASPR	Operations		–	–	–	–	–	9	8	10	14	41
	Preparedness and Emergency Operations		–	–	–	–	–	15	14	17	35	81
	National Disaster Medical System (NDMS) f		–	–	–	–	–	47	47	46	53	193
	Hospital Preparedness Grants  (Moved from HRSA) (includes ESAR-VHP)		–	–	–	–	–	474	474	423	362	1,733
	Biodefense Training and Curriculum Development		–	–	–	–	–	21	21	–	–	42
	Advanced Research and Development (moved from NIAID NIH)		–	–	–	–	–	54	104	102	250	510<