Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense. Department of Defense Interactions with the Food and Drug Administration

摘要

Chemical and biological threats confront U.S. military personnel today both overseas and in the continental United States, whether in defensive, peacekeeping, or offensive situations. Defenses against such threats are both medical and nonmedical. Drugs and biologics, mainly vaccines, constitute the primary medical defenses. Consequently, efforts of the U.S. Department of Defense (DoD) to protect American troops require the acquisition of drugs and biologics for chemical and biological warfare (CBW) defense. The objective of this acquisition, as is the case for other acquisitions, is to obtain the desired supply of a given product at an acceptable price. This study includes both drugs and biologics, but it emphasizes the latter (mainly focusing on vaccines, a subset of biologics). Vaccines provide advanced protection against biological warfare threats via immunization of at-risk troops and prior protection is a high priority within DoD. In contrast, drugs are useful mainly in treating already-exposed troops. Vaccine development is also more complicated than drug development because it typically involves manipulating live organisms, whereas drugs consist of more-stable chemical entities. DoD has two distinct roles during the acquisition of drugs and biologics for CBW defense: purchaser and developer. As purchaser of a drug approved by the U.S. Food and Drug Administration (FDA) for which a commercial market exists, DoD simply buys what it needs at the market price; DoD acquisition of influenza vaccine is a good example of this.