Image

Enhanced Engagements for Products Relevant to the Department of Defense (DoD)

Public Law 115-92, enacted December 12, 2017, authorized the Department of Defense (DoD) to request, and the U.S. Food and Drug Administration (FDA) to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. On January 16, 2018, the FDA and DoD announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended for deployed American military personnel.

Utilizing these expanded authorities, the FDA works closely with DoD’s Office of Health Affairs to better understand the military’s medical needs for deployed personnel; give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to products under the breakthrough therapy designation; provide ongoing technical advice to DoD to aid in the rapid development and manufacturing of medical products for use by the military; and, take a closer look at products currently under development to determine opportunities to expedite their availability.

On November 2, 2018, FDA and DoD signed a Memorandum of Understanding (MOU) setting forth the framework for the ongoing partnership and the creation of a robust program that can better serve the health care needs of American military personnel.

Related links

• March 2, 2023: FDA cleared a commercially available laboratory traumatic brain injury (TBI) blood test, which will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions. Abbott's Alinity i TBI lab test offers results in 18 minutes, as compared to the previously approved Banyan BTI test which takes 4 hours, to help health care providers quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury. The DoD, through U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing this test run on Abbott's i-STAT Alinity platform. Previously, in January 2021, the DoD announced FDA clearance of a field-deployable rapid, handheld TBI blood test, the i-STAT TBI Plasma cartridge, which runs on the same platform. 
• August 8, 2022: FDA approved a New Drug Application (NDA) for the use of Midazolam Injection, 10 mg/0.7 mL, autoinjector, for the treatment of status epilepticus in adults. DoD developed the product with Rafa Laboratories, Ltd. According to JPEO-CBRND (the U.S. Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), the autoinjector "improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector."  For more information, see the NDA approval letter (PDF, 302 KB) and product label (PDF, 913 KB).
• February 28, 2022: FDA approved a New Drug Application (NDA) for a naloxone hydrochloride autoinjector for use by military personnel and chemical incident responders for emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected, and for temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. For more information, see the NDA approval letter (PDF, 155 KB) and product label (PDF, 697 KB).
• August 13, 2021: FDA approved a Biologics License Application for TICOVAC (Tick-Borne Encephalitis Vaccine), for active immunization to prevent tick-borne encephalitis in individuals 1 year of age and older. The vaccine is manufactured by Pfizer Ireland Pharmaceuticals; development of this vaccine has been an important need for the U.S. military.
• December 20, 2019: Department of the Army, the Surgeon General-Sponsored Assay Supports First-Ever FDA-Approved Ebola Vaccine in U.S. (DoD news release)
• December 19, 2019: FDA finalized the guidance Considerations for the Development of Dried Plasma Products Intended for Transfusion. This guidance provides recommendations for the development of safe and effective dried plasma products intended for transfusion; it finalizes the guidance of the same title dated October 2018.
• August 29, 2019: FDA Action Makes Blood Product More Accessible to Warfighters in Combat (DoD news release)
• November 2, 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids
• October 29, 2018: FDA issues draft guidance on the development of dried plasma products intended for transfusion
• September 14, 2018: DoD and FDA collaborate to help speed potential countermeasures for Ebola and other viruses
• August 10, 2018: Breakthrough in Malaria Prevention: U.S. Army Medical Materiel Development Activity (USAMMDA) Announces FDA Approval of New Antimalarial Drug (DoD news release)
• July 10, 2018: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product
• February 14, 2018: FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults
• MCM-Related Counterterrorism Legislation
• MCMi Collaborations