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Authored by Colonel Coleen K. Martinez. | April 2007
The Department of Defense (DoD) has had a unique mission in biological defense research over the past 4 decades. Throughout this history, the military biological disease threats were relatively straightforward, there was little urgency linked to successful product fielding, there was no mechanism by which to gain Food and Drug Administration (FDA) product licensure, and there was little competition for mission or funds. In the post-September 11, 2001 (9/11) environment, however, the scope of potential threats has increased immeasurably, relative funding for the DoD has decreased, urgency to field solutions has skyrocketed, the FDA has provided a way forward to product licensure, and active non-DoD players in this arena have grown exponentially, aligning with newly designated, congressionally mandated funding sources. The old paradigms that governed the DoD research program structure and mission are no longer viable in this changing environment. This monograph examines the current organization of the DoD biodefense research program in light of the changing national biodefense landscape and industry best practices, and argues that all aspects of the DoD biodefense program should be consolidated with all other federal biodefense resources, including those within the National Institutes of Health, to create a single, focused, and productive program. This new agency, subordinate to the Department of Health and Human Services, will be positioned and equipped to provide medical solutions to the warfighter on the battlefield, as well as to U.S. citizens.
He who every morning plans the transaction of the day and follows out that plan, carries a thread that will guide him through the maze of the most busy life. But where no plan is laid, where the disposal of time is surrendered merely to the chance of incidence, chaos will soon reign.
Victor Hugo ~ French dramatist, novelist, and poet (1802-85)
Since President Richard M. Nixon declared the end of the U.S. offensive biological research program in 1969,1 the U.S. Department of Defense (DoD) has pursued a research program strictly for defensive purposes, with the primary objective being development of products to protect the warfighter on the battlefield. DoD, after almost 4 decades of investment in a biological defense program, has contributed significantly to the scientific knowledge base and has produced more than two dozen candidate pharmaceutical products. Three of these candidates are currently in advanced development within the DoD, some have been assumed by the National Institute of Allergy and Infectious Disease (NIAID) for further development, several are no longer being developed and are available for use only as Investigational New Drugs (INDs, also referred to as ?investigational?), several have been dropped completely from development, and several still languish in the technical scientific base awaiting a DoD decision on further investment.2
Gaining Food and Drug Administration (FDA) licensure of products is a difficult task, requiring demonstration of the product?s safety and effectiveness for the stated indication of use. Before 2002, licensing biodefense pharmaceutical products was an impossible task because, for obvious reasons, it was unethical or impracticable to conduct human clinical trials for efficacy. Such testing required challenging a person who had received the developmental medical product with a biological threat agent to demonstrate that the product actually prevented or treated the disease. Recognizing this barrier to licensure, and coincident with a heightened need for biodefense preventive and therapeutic countermeasures, the FDA approved the ?animal rule? in 2002.3 The animal rule allows for licensure in the absence of human efficacy testing, if at least one (more likely two) surrogate animal models faithfully representing human infection and disease caused by the authentic biological agent are available and provide sufficient data to suggest that the product will act similarly in humans.
Approval of the animal rule by the FDA was critical to DoD, since only 4 years earlier, in the midst of Gulf War Syndrome concerns, DoD had been cited in a Government Accounting Office report with numerous deficiencies in its ability to administer investigational products (products approved only for testing in humans and not yet licensed by the FDA for general use) in an operational environment.4 Subsequently, in response to both safety and public perception concerns regarding DoD?s use of investigational products in service members, the Deputy Secretary of Defense directed DoD to use licensed products preferentially over investigational products, and ruled that a presidential waiver was required in the event that an investigational product was to be used in the absence of an obtained informed consent.5 Aligning with these events, the medical biodefense mission appeared to be clear: develop FDA-licensed medical countermeasures to protect the warfighter from biological warfare threats.
The faltering productivity of the DoD biodefense program, despite its world-class infrastructure, talented workforce, and well-defined acquisition framework, appears to be directly related to its convoluted, unnecessarily complex, and circuitous chains of authority with regard to pharmaceutical development coupled with insufficient management, oversight, and accountability. Similarly, U.S. fiscal resources increasingly are poured into non-DoD medical biodefense research without any overarching plans to orchestrate these investments into licensed products. The nation requires a clean excision of all medical biodefense resources from within the federal government and consolidation under a new agency birthed specifically to support efficient product development.
The DoD has tremendous and unique resources and skills that could contribute immensely toward developing critically needed countermeasures against biological weapons. Poor DoD program organization and management, however, have resulted in a dysfunctional program with little success in measurable outcome. While DHHS has a significantly increased budget for a biodefense mission closely duplicative to that of the DoD and, while the NIH (within DHHS) has a stellar reputation with regard to basic academic research, DHHS is inexperienced and unproven in its ability to develop products. Pharmaceutical product development is a long, complex process and requires special organizational structure, highly qualified leadership and management, and long-term and stable resourcing, including funding. The United States would benefit greatly by the consolidation of all federal biodefense resources into a new agency under the DHHS, specifically designed to meet the stringent demands of product development.
1. Henry A. Kissinger, National Security Decision Memorandum (NSDM) 35, United States Policy on Chemical Warfare Program and Bacteriological/Biological Research Program, Washington, DC, November 25, 1969, p. 3.
2. Mark Dertzbaugh, U.S. Army Medical Research Institute of Infectious Diseases, Chief, Business, Plans and Programs Division, telephone interview by author, April 10, 2006.
3. Code of Federal Regulations, Title 21, Parts 50, 56, 312, Subpart I of Part 314, Subpart G of Part 601, New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible, Washington, DC, 2002.
4. Mark E. Gebicke, Testimony before the Committee on Veterans? Affairs, U.S. Senate, Chemical and Biological Defense: Observations on DOD?s Plans to Protect U.S. Forces, Washington, DC: U.S. General Accounting Office, March 17, 1998, p. 9.
5. Department of Defense, Use of Investigational New Drugs for Force Health Protection, DoD Directive Number 6200.2, Washington, DC: August 1, 2000, pp. 3-11.