Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model – Workshop Summary

During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system’s ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. For example, if aerosolized anthrax were released over a large, highly-populated area, millions of people could need prophylactic antibiotics within 48 hours to survive. This is only one of many threats, and the United States needs many different medical countermeasures to be prepared for potential chemical, biological, radiological, and nuclear public health threats. However, in an emergency, the best available medical countermeasure may not already be approved by the Food and Drug Administration (FDA), or it may only be approved for other uses.

The IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to discuss current threats, progress made in the public health system regarding the distribution and dispensing of countermeasures, and remaining vulnerabilities. Presentations and discussions focused on two areas in which important advances recently have been made: Emergency Use Authorization (EUA), which permits the FDA Commissioner to authorize the use of unapproved medical products or the unapproved use of approved products during an emergency, and a pilot program of the Postal Model, which uses postal carriers to deliver countermeasures. This document summarizes the workshop.

Author:
The National Academies
Publish Date:
October 2010