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.