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

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. FDA is participating in an interagency group preparing for response in a civilian emergency. This group includes representatives of the Department of Defense; the Veterans Administration; and components of the Department of Health and Human Services (DHHS), such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Office of Emergency Preparedness. In addition, FDA will be proposing standards for the use of animal efficacy data in approving new products to counter chemical and biological agents. The agency is also participating in setting a broadbased federal research agenda to facilitate the government’s preparedness against bioterrorism; is identifying facilities and activities suitable for the production of biological weapons; is involved in product development, review, and testing; and is ensuring that appropriate product surveillance and sponsor compliance are executed in accordance with regulations. FDA’s regulation of medical products is based on science, law, and public health considerations (Figure 1). Research conducted at FDA (in particular at the Center for Biologics Evaluation and Research) contributing to biological warfare defense and other counterbioterrorism efforts is in the following areas: design of new vaccines (e.g., pox viruses); pathogenesis and mechanism of replication of biological warfare agents; new methods and standards to expedite the review of new vaccines and immunoglobulins (e.g., mucosal protection against a pathogen); and stem cell protection and chemokine/cytokine and angiogenic agent defense mechanisms. The development framework of