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

Following the cessation of combat activities, the Assistant
Secretary of Defense for Health Affairs notified the
Commissioner in a March 1991 letter that DoD considered the two
waivers granted under the interim rule to be no longer in
effect. He also informed the Commissioner that DoD had
ultimately decided to administer the botulinum toxoid vaccine
on a voluntary basis.
Since that time, the Presidential Advisory Committee on Gulf
War Veterans' Illnesses has recommended that we "solicit timely
public and expert comment on any rule that permits waiver of
informed consent for use of investigational products in
military exigencies." (Final Report, page 52.) FDA has
carefully evaluated the committee's recommendations as well as
other information that has come to its attention. FDA has
engaged in discussions within the Agency, with DoD, and with
others on this important topic. As a result of these
discussions, the Agency will solicit public comment in line
with the committee's report. This public comment will be
directed towards whether the FDA should finalize the interim
rule, modify it, or eliminate it completely.
VI. CONCLUSION
The first layer of the subjects' protection is provided by the
medical research sponsor. It is the responsibility of the

sponsor to design the research study to be ethically and

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