sciences, including aerosol toxicology, to encourage the application of the latest biological information, technology and experience to testing of aerosolized biological agents. The committee will use the workshop to inform their report, which will consider whether there are opportunities for improving current approaches to animal testing of interventions against aerosols by applying knowledge from other fields of science.

COMMITTEE PROCESS

On July 6th – 7th, 2005, the Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents convened a workshop at the National Academy of Sciences building in Washington D.C. (see Appendix A for agenda). Researchers experienced in using animal models to test countermeasures against aerosolized bioterrorism agents interacted at this workshop with specialists in other areas of the biological sciences. Some of the speakers helped to place the task in a larger context—analyzing, for example, the Animal Rule of the U.S. Food and Drug Administration (FDA)—while others provided more technical information such as methods for choosing appropriate animal models or characterizing the challenge aerosols. The workshop’s presentations and discussions brought to the fore the latest pertinent scientific experience, information, and technology, which then informed the committee’s report on whether opportunities exist for improving current approaches.

ANIMAL RULE

A serious set of limitations comes from the inherent difficulty of testing countermeasures against infections that are, by definition, naturally rare or nonexistent in the human population and that cannot ethically be tested for efficacy in humans because they might cause serious injury or even death. In response to these concerns, the FDA, which is responsible for licensure of medical products in the United States, developed the Animal Rule, which has been in effect since 2002. This rule states that the agency may grant marketing approval for a new drug product (21 CFR 314 subpart I) or biological product (21 CFR 610 subpart H) based on adequate and well-controlled animal efficacy studies when human efficacy studies cannot be conducted because it is unethical to expose human volunteers to the toxic substance—whether biological, chemical, or radiological—in question. Further details and implications of this important regulatory development will be discussed in Chapter 6.

Importance of Animals in Research on Aerosol-Mediated Disease

Compounding the research difficulties caused by prohibited studies with human volunteers is the fact that data acquired using computer simulations or



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