Whether or not the United States has safe and effective medical countermeasures—such as vaccines, drugs, and diagnostic tools—available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) plays a crucial role in the United States’ preparedness for public health emergencies through its regulation and approval of these medical countermeasures. However, FDA faces unique challenges in evaluating medical countermeasures. For example, conducting standard medical trials may be impractical or unethical when the product being tested is for use in a disaster, and assessing a product’s benefit versus its risk can be complicated if the chance of a disaster is very unlikely but the consequences would be dire if it did occur. FDA and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available.

Two IOM forums—the Forum on Drug Discovery, Development, and Translation and the Forum on Medical and Public Health Preparedness for Catastrophic Events—held a workshop March 29-30, 2011, at the request of FDA, to examine methods to improve how medical countermeasures are developed, tested, and approved. Experts from federal government agencies, the private sector, and academia discussed opportunities to apply cutting-edge science to the product review process. This document summarizes the workshop.