The Food and Drug Administration Confronts Homeland and National Security

Report on a Workshop of the RAND Center for Domestic and International Health Security

by Richard A. Rettig

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In the post-September 11, 2001, environment, the U.S. Food and Drug Administration (FDA) faces many new challenges regarding its policies and procedures for confronting the threat of a chemical or biological attack and determining the role the agency would play. On December 19, 2002, the RAND Center for Domestic and International Health Security hosted FDA leaders, Department of Defense officials, health policy analysts, and various others at a one-day workshop to discuss FDA’s role in homeland and national security. The workshop focused on a RAND-commissioned paper that proposed five recommendations for FDA change. Accordingly, participants analyzed how FDA might modify its policies and procedures to make drugs and biologics, and especially vaccines, more readily available. This paper highlights the core issues of the many debates that surfaced during the day and serves as a foundation for future, similar discussions relating to the issue.

The workshop was supported by the Kaiser Foundation Health Plan. The document was created under the auspices of RAND Health.

This report is part of the RAND Corporation occasional paper series. RAND occasional papers may include an informed perspective on a timely policy issue, a discussion of new research methodologies, essays, a paper presented at a conference, or a summary of work in progress. All RAND occasional papers undergo rigorous peer review to help ensure that they meet high standards for research quality and objectivity.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.