Countering Bioterrorism

Frequently Asked Questions (FAQs)

Has the Center for Biologics Evaluation and Research had any involvement in countering bioterrorism?

CBER continues to be very active in the President's Countering Bioterrorism Initiative. CBER staff have participated in numerous meetings, briefings, and conferences representing FDA with staff from the Department of Defense, the Department of Health and Human Services (DHHS), and the Office of Management and Budget as well as other DHHS Agencies including the National Institutes of Health and the Centers for Disease Control and Prevention. The Center has also engaged in the development of new regulatory models to accommodate the need for preparedness in the case of an emergency attack. For example, procedures and protocols are being developed to enable the use of investigational new drugs in a highly controlled, safe manner for particular emergency situations, such as responding to a bioterrorist attack that exposed individuals to the agent that causes anthrax.

What types of medical countermeasures are currently available in the event of a terrorist attack?

We have licensed vaccines for both anthrax and smallpox. In addition, we have licensed antitoxin to treat victims of Botulinum poisoning. Since 9/11 and the anthrax attacks of late 2001, CBER has worked with numerous manufacturers to develop and bring to licensure countermeasures against many potential biological agents. There are products in development that include new vaccines against anthrax, smallpox, botulism, plague, tularemia, Ebola, and others, as well as new therapeutics to treat disease caused by these agents and others.

What regulations or guidance documents exist that would help with investigation and development of safe and effective new products that might be used in countering bioterrorism?

In May 2002, the FDA published "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible" [21 CFR 601 Subpart H, as well as 21 CFR 314 Subpart I for New Drugs]. This rule, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions caused by exposure to biological, chemical, radiological, or nuclear substances. This rule amends the new drug and biological product regulations to identify the information needed to provide substantial evidence of the efficacy of new drug and biological products only when human efficacy studies are not ethical and field trials are not feasible. The new rule does not address the need for safety data which still must be established.

Has CBER approved any new biologics under the Animal Rule so far?

CBER hasn't approved any new products under the Animal Rule to date. However, several products in development and on the licensure path are moving towards approval through this mechanism. The Center for Drugs Evaluation and Research (CDER) has approved one product to date using the Animal Rule.

 
Updated: September 9, 2008