Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

advancement in knowledge and improvement of those therapies
used in emergency medical situations that currently have poor
clinical outcome.
C. Department of Defense Combat Exigencies
The third exception to our informed consent requirements
concerns the use of an investigational drug or biologic in
certain situations related to military combat. During the
months preceding the Persian Gulf War, DoD had discussions with
FDA regarding the potential use of specific investigational
products in military personnel serving in the Persian Gulf. We
also had extensive internal discussions involving technical and
policy-level staff, as well as experts from other Federal
agencies and academia. It was thought that the products under
discussion represented the best preventive measures for
providing protection against possible attack with chemical or
biological weapons. DoD requested the assistance of FDA in
allowing the use of these products in certain battlefield or
combat-related situations in which they considered obtaining
informed consent "not feasible." FDA gave considerable
deference to DoD's judgment and expertise regarding the
feasibility of obtaining informed consent under battlefield
conditions.
In response to this request, on December 21, 1990, FDA
published an interim regulation amending its informed consent

35