ABSTRACT
The U.S. anthrax outbreak of 2001 has demonstrated the possibility that biological agents may be used intentionally to cause human disease. This new awareness underscores the urgency of the public health need for safe and effective medical countermeasures. Attention to the challenges in the development of medical countermeasures against biothreat agents can facilitate their availability. A list of the diseases that can result from the intentional use of the highest threat biological agents is presented below. It is followed by a discussion of special issues in drug development presented by these diseases, and of regulatory mechanisms that can enhance the availability of such drugs. The chapter concludes with examples of recent regulatory actions taken by Food and Drug Administration (FDA) to make available safe and effective drugs for this urgent public health need.
