Authorization & Regulatory Guidance

USAMMDA Force Health Protection Division Authorization

The mission of USAMMDA’s Force Health Protection Division is to provide urgent investigational treatment, diagnostic or prophylactic options (i.e. countermeasures) to protect U.S. Forces against high-consequence threats. Its authority derives mainly from (i) Department of Defense Instruction (DODI) 6200.02, (ii) Army Regulation (AR) 40-7, and (iii) the U.S. Food and Drug Administration (FDA). DODI 6200.02 states that its policy is to provide the best possible medical chemical, biological, radiological and nuclear countermeasures for personnel carrying out military operations. The DOD is mandated to use FDA-approved products. If such products do not exist or are not mature enough in development, FHP will expand utilization of medical products pursuant to an Investigational New Drug (IND) and/or Emergency Use Authorization (EUA). This action requires the approval of the Assistant Secretary of Defense for Health Affairs (ASD[HA]) with concurrence of the Joint Chiefs of Staff. The FDA Law and Regulation (21 CFR 312) governs Expanded Access to Investigational Drugs, while AR 40-7 regulates the use of FDA investigational products in personnel from all DOD components.

Regulatory Guidance

In order to provide the medical countermeasures to the personnel who need them, USAMMDA’s FHP Division establishes and manages FDA-compliant protocols, product procurement, shipment and inventories, and regulatory reporting. These activities enable execution of protocols worldwide, during emergent events or contingency operations. FHP partners with other government agencies such as the CDC, DOD Joint Program Executive Office (JPEO), sister services, and industry to identify products for portfolio inclusion.

Integrating DOD Instructions and FDA Regulation Processes for these products results in three different types of Expanded Access Protocols (EAP):

• Individual Patient Expanded Access IND: intended for single or small number (< 10) of patients, single incident (< 10)
• Intermediate Population Expanded Access: 10-100 patients, requires formal treatment protocol approved by IRB and FDA
• Large Population Expanded Access: 100-10,000 patients; large, long-term studies; which also requires formal treatment protocol approved by IRB and FDA

In all three cases, FHP assesses the product suitability for EAP implementation by clarifying the public health or military emergency, pulling together the product profile, evaluating how it fits with the Concept of Operations (CONOPS), examining supporting performance and existing clinical data, and conducting a risk-benefit analysis.

In serious or life-threatening diseases or conditions where the affected population is larger than 10,000 and/or if the situation affects more than DOD personnel, a public health emergency has to be declared by the U.S. Department of Health and Human Services Secretary. The EUA would be issued after the following conditions are met: evidence of effectiveness, potential benefits must outweigh known and potential risks of the product, no “adequate, approved, and available alternative to the candidate product.”