The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense

Department of Defense Interactions with the Food and Drug Administration

by Richard A. Rettig, Jennifer Brower, Orlie Yaniv

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The 1990-1991 Gulf War made clear the U.S. Department of Defense’s (DoD’s) need to effectively acquire drugs and biologics, mainly vaccines, as American troops faced the real threat of chemical and biological warfare (CBW) agents being used in combat. More than a decade after the war, DoD still experiences acute obstacles in obtaining CBW defense supplies — most recently magnified by the department’s attempt to acquire the anthrax vaccine for all its personnel. Key to this acquisition success for the department is its relationship with the U.S. Food and Drug Administration (FDA), which oversees compliance of all licensed drugs and the testing of new medications and vaccines. The DoD-FDA relationship specifically involves matters of licensing, the use of Investigational New Drugs in combat, and the compliance of drug and biologics producers with manufacturing requirements. How can effective communication and procedures improve between the two government entities? The authors recommend such changes as centralizing authority for DoD-FDA relations for CBW drugs and biologics in the Office of the Secretary of Defense and implementing training on FDA regulations for DoD acquisition personnel. Such progress is crucial as the U.S. military faces a variety of new threats in the post-9/11 world.

Table of Contents

  • Chapter One

    Introduction

  • Chapter Two

    The Challenges of Acquisition

  • Chapter Three

    The Industrial Model

  • Chapter Four

    Summary and Recommendations

  • Appendix

    Private Providers of FDA-Related Education and Training

The research described in this report was sponsored by the Office of the Secretary of Defense (OSD). The research was conducted jointly by RAND Health's Center for Military Health Policy Research and the Forces and Resources Policy Center of the RAND National Defense Research Institute, a federally funded research and development center supported by the OSD, the Joint Staff, the unified commands, and the defense agencies.

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