Medical Aspects of Chemical Warfare (2008) - The Black Vault

Medical Aspects of Chemical WarfareINTRODUCTIONThe Department of Defense (DoD) requires medicalcountermeasures to treat or mitigate illness resultingfrom exposure to chemical, biological, and radiologicalwarfare agents. While medical chemical defensedepends on basic and applied science to gain insightinto the pathophysiology, pharmacokinetics, and pharmacodynamicsof candidate countermeasures, fieldinga medical countermeasure cannot occur until advanceddevelopment efforts complete full-rate production andobtain US Food and Drug Administration (FDA) ap-proval (DoD policy stipulates that military personnelwill only receive medical products approved by theFDA. Quad service doctrine, which appears in ArmyRegulation 40-7, states, “it is the policy of TSG [TheArmy Surgeon General] that drugs used will be thoseapproved by the FDA and procured from suppliers inthe United States.” 1,2 This chapter will briefly describethe US military’s organizations responsible for implementingadvanced development and will summarizethe status of current programs of record.MEDICAL CHEMICAL ACQUISITION ORGANIZATIONSThe acquisition process may be defined as theprocess of developing, acquiring, fielding, maintaining,sustaining, and, when necessary, closing out anyweapons or protective system in the US military. Adrug, vaccine, or medical device used to protect theforce against chemical or biological attack is considereda protective system, and medical countermeasuresare developed and obtained using what is knownas “the acquisition process.” The acquisition processincludes identifying requirements or capability gaps,identifying potential solutions, and developing andacquiring those solutions, whether the acquisitions arefor the development of weapons systems or medicalcountermeasures.Chemical and biological defense programs withinthe DoD are managed by a triad of equal organizations,each of which handles one aspect of the acquisitionprocess. The Joint Requirements Office for Chemical,Biological, Radiological, and Nuclear (CBRN) defensegenerates and validates requirements from the field,such as the need for a skin decontaminant or for aspecific chemical detector. The Defense Threat ReductionAgency, through its joint science and technologyoffice for chemical and biological defense, conductsand supports research and development that seeksto meet these requirements and fill capability gaps. Italso maintains a robust science and technology base.This chapter focuses on the third leg of the triad, theorganization responsible for the acquisition of medicalchemical defense items: the Joint Program ExecutiveOffice for Chemical Biological Defense (JPEO-CBD)(Figure 20-1).In the DoD, all chemical and biological defenseacquisition processes fall under the responsibility ofthe defense acquisition executive (the under secretaryof defense for acquisition, technology, and logistics) atthe DoD level. Within the DoD, the Army is the executiveagent for chemical and biological defense and theassistant secretary of the Army (acquisition, logistics,and technology) is the Army acquisition executiveresponsible for managing these programs.DoD chemical and biological defense acquisitionprograms are managed by the JPEO-CBD, which isheaded by a two-star general, the joint program executiveofficer. The JPEO-CBD manages $1.5 billionin acquisition programs, of which approximately85% are nonmedical programs (boots, masks, gloves,detectors, collective protection, information systems,JointRequirementsOfficeFUTURE OPERATIONAL CAPABILITIESAdvanced Concept Technology DemonstrationsINPUTFORPRIORITIESCOMBATANTSERVICESCOMMANDERSCAPABILITIES DOCUMENTSBUILD POMJoint TestandEvaluationExecutiveJointScience andTechnologyOfficeTRANSITION TECHNOLOGYAdvanced Concept Technology DemonstrationsJointProgram ExecutiveOffice for Chem/Bio DefenseFig. 20-1. Required capabilities, science and technology, andacquisition responsibilities and interactions.Bio: biologicalChem: chemicalPOM: program objective memorandum646