Abstract
“Disease has long been the deadliest enemy of mankind, infectious diseases make no distinctions among people and recognize no borders. We have fought the causes and consequences of disease throughout history and must continue to do so with every available means. All civilized nations reject as intolerable the use of disease and biological weapons as instruments of war and terror.” (President George W. Bush; November 1, 2001)
Successful biodefense will require the coordination of efforts between government, academic, medical, and industrial agencies focusing on improving the nation's infrastructure, response efforts, and scientific capability for dealing with bioterrorist agents. The United States Department of Health and Human Services will play a critical role in strengthening the currently available anti-bioterrorism programs as well as working with all sectors of the nation to improve state, local, and federal capabilities and medical tools needed to combat bioterrorism. The Food and Drug Administration (FDA), in particular, may need to develop new regulatory models that will allow expeditious approval of drugs, biologics, and vaccines with potential to combat the currently identified bioterrorism agents, without compromising standards of safety and efficacy. This review provides an overview of the types of select agents identified as potential candidates for use in a bioterrorist attack, the government agencies and systems already in place to respond in the event of an emergency, and the role of FDA and regulatory affairs professionals in furthering the nation's defense against bioterrorism.
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