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
The Challenges of Acquisition
The Industrial Model
Summary and Recommendations
Private Providers of FDA-Related Education and Training