In August 1990, after Iraq invaded neighboring Kuwait, the United States government mobilized for potential conflict. Operation Desert Shield, in the fall of 1990, involved troop mobilization and force deployment; concurrently, Congress debated the wisdom of going to war with Iraq. Operation Desert Shield, the actual combat in the Gulf, occurred between mid-January and late February 1991, with the coalition forces decisively defeating the Iraqi military.
One threat the United States faced in the Gulf War was that Iraq might use chemical warfare (CW) and/or biological warfare (BW) agents. The Department of Defense's (DoD's) defensive measures against CW/BW weapons, imperfect as they are, included detection, protection, and medical measures (including both prophylactic and therapeutic interventions).
Several medical products were available to DoD for potential defensive and prophylactic use in response to CW and BW attacks. But the FDA had not approved these products for these indications. Thus, the FDA regulatory framework designated these products as investigational new drugs (INDs). Pyridostigmine bromide (PB), a drug for pretreatment against certain nerve agents, had been approved long ago for the treatment of myasthenia gravis in larger doses and for longer times than the anticipated Gulf War use. Thus, there was a prima facie case for safety based on experience in humans; there were also animal studies that supported its effectiveness. Botulinum toxin (BT) was a vaccine used routinely in occupational settings in which workers were at risk of botulism. Both the U. S. Army and the Centers for Disease Control also registered BT as an IND.
DoD wished to be in a position to use PB and BT, if necessary, but also wished to act either in compliance with FDA regulations governing INDs or with formal FDA concurrence that it could act without FDA approval. DoD and FDA recognized that neither DoD statutory or administrative authority nor the federal Food, Drug, and Cosmetic Act (FDCA) or its implementing regulations had been written with the contingency of the Gulf War in mind. The DoD-FDA discus