Vaccines, pharmaceutical products, and bioterrorism: challenges for the U.S. Food and Drug Administration.

Abstract : In regards to bioterrorism, the goal of the U.S. Food and Drug Administration (FDA) is to foster the development of vaccines, drugs and diagnostic products, safeguards of the food supply, and other measures needed to respond to bioterrorist threats. Many products (vaccines, therapeutic drug and biological products, food, devices, and diagnostics) regulated by FDA could be affected by bioterrorism. Pathogens or pathogen products adapted for biological warfare include smallpox (variola), anthrax (Bacillus anthracis), plague (Yersinia pestis), tularemia (Francisella tularensis), brucellosis (Brucella abortus, B. melitensis, B. suis, B. canis), Q fever (Coxiella burnettii), botulinum toxin (produced by Clostridium botulinum) and staphylococcal enterotoxin B. New products are needed to diagnose, prevent, and treat these public health threats.