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.

The National Academies
Publish Date:
October 2010

Minimizing the Risks of Synthetic DNA: Scientists’ Views on the U.S. Government’s Guidance on Synthetic Genomics

The construction of the poliovirus and phiX genomes from synthetic DNA fragments instigated concerns within the American biosecurity community about the use of chemically synthesized DNA to create harmful biological agents (termed “synthetic genomics”). To minimize the risks of synthetic genomics, the U.S. Government released the draft guidance, “Screening Framework Guidance for Synthetic Double-Stranded DNA Providers” (Federal Register Notice #E9-28328), on November 27, 2009.

The AAAS Center for Science, Technology, and Security Policy has organized a forum for scientists’ from different sector to discuss and react to the draft guidance.

American Association for the Advancement of Science (AAAS)
Publish Date:
January 2010

National Agriculture and Food Defense Act of 2007

Senate Bill S. 1804
Introduced to Senate: July 17, 2007
Sponsor: Senator Richard Burr [NC]
Status: Referred to Senate Committee on Homeland Security and Governmental Affairs, July 17, 2007

Bill states that: (1) the Secretary of Homeland Security (Secretary) shall lead federal, state, local, tribal, and private efforts to enhance the protection of critical U.S. infrastructure and key resources, including the agriculture and food system; (2) the Secretary of Agriculture shall lead federal efforts relating to agriculture, meat, poultry, and egg food products; (3) the Secretary of Health and Human Services (HHS) shall lead federal efforts relating to other food products; and (4) the Administrator of the Environmental Protection Agency (EPA) shall lead federal efforts relating to drinking water and waste water.

National Health Security Strategy 2009

This document presents the Nation’s first National Health Security Strategy (NHSS), which is intended to help galvanize efforts to minimize the health consequences associated with significant health incidents. The NHSS was developed in consultation with a broad range of stakeholders, including representatives from local, state, territorial, tribal, and federal government; community-based organizations; private-sector firms; and academia.
The statutory authority and requirements for the NHSS are provided under section 2802 of the Public Health Service Act.

U.S. Department of Health and Human Services
Publish Date:
Dec 2009

National Policy on the Transfer of Scientific, Technical, and Engineering Information

Presidential Directive
National Security Decision Directive 189 (NSDD-189)
Signed: September 21, 1985

National Policy on the Transfer of Scientific, Technical, and Engineering Information “establishes national policy for controlling the flow of science, technology, and engineering information produced in federally-funded fundamental research at colleges, universities, and laboratories.” That policy indicates that products of research remain unrestricted to the maximum extent as possible. If national security requires control of that research, then it will be controlled through classification.