|•||If the interim rule is needed, are there changes that should be made to it based on experiences during and following the Gulf War? If so, what are these changes and why should they be made?|
|•||Can or should the interim rule be narrowed in scope? If so, how?|
|•||Should the rule contain additional procedures to enhance understanding, oversight, and accountability? If so, what are these procedures?|
|•||Are there circumstances under which the use of the interim rule would be justified? If so, what are those circumstances?|
In this chapter, we briefly address issues raised by the Interim Rule that are internal to the DoD, some of which affect the external policy issues; we also discuss questions related to DoD-FDA interactions. Finally, we consider "the Question of Authority."
Internal issues associated with the use of investigational drugs for CW/BW defense include training, education, and record keeping, which have been addressed above; integration of external policy into DoD-wide doctrine, policies, and procedures; CW/BW threat analysis; physical availability of drugs and vaccines (inventories of CW/BW countermeasures, drug/vaccine production capabilities, logistics); and the rules for allocation of drugs and vaccines under conditions of scarce supply. These internal issues, which are summarized in Table 3, are of great importance but are beyond the scope of this study. Here we comment briefly only on two issues: integration and threat analysis.