Today, the U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.
“We’re extremely grateful to the men and women who defend our nation, often at great personal risk and sacrifice. It’s our honor and duty to support our military personnel by ensuring they have access to safe and effective medical products – especially products that meet the unique needs and settings in which soldiers may require medical treatment,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA has already been working closely with the DoD to identify opportunities to expedite availability of medical products, particularly those products used to treat injuries in battlefield settings. For example, as noted below, the Emergency Use Authorization for French freeze-dried plasma that was issued earlier this year. Our close collaboration with DoD has helped us target and more efficiently address DoD’s immediate product priorities and foster development and review of these products in the most streamlined manner possible. We are looking forward to additional partnership opportunities under the MOU.”
The MOU formally establishes the framework under which the DoD and the FDA will implement the law passed by Congress in 2017 for enhanced engagements between the DoD and the FDA. Under the terms of this MOU, the FDA will work closely with the DoD to evaluate how best to foster access to safe and effective medical products that serve the military’s medical needs; give the highest level of attention to and expedite review of priority DoD medical products; provide ongoing technical advice to aid in the rapid development and manufacturing of medical products for use by the military; and examine products currently under development to determine opportunities to streamline review and expedite their availability. The 2017 law also expanded the FDA’s authority to authorize emergency uses of medical products to reduce deaths and severity of injuries caused by chemical, biological, radiological or nuclear (CBRN) agents or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the U.S. military forces and for other purposes.
“This MOU furthers the existing partnership between the Department of Defense and the FDA to equip our military with the best and most innovative military medical support possible,” said Terry M. Rauch, Ph.D., M.P.H., M.B.A., Acting Deputy Assistant Secretary of Defense, Health Readiness Policy & Oversight, DOD. “Our servicemen and women risk their lives protecting our country. Today’s MOU reflects the commitment of the DoD and the FDA to ensure timely access to life-saving medical products for U.S. troops and to continue fostering the development of new innovative medical products that can help ensure the operational readiness of American troops. We look forward to continuing to work with the FDA as we analyze and implement measures to provide the best possible medical products and care to all military personnel – on the battlefield, stationed around the world and at home.”
The MOU signed today builds upon the approach that the FDA outlined in 2018 to advance the development and availability of medical products to help save the lives of American military personnel in a work plan developed in close collaboration with the DoD. The MOU reflects the agency’s commitment to working to address the medical needs of military personnel, especially by helping to expedite the development and review of medical products that are a priority for the DoD and to aid in the rapid development and manufacturing of safe and effective medical products for use by the U.S. military. Specifically, the MOU sets forth a framework to implement the 2017 law, which included provisions to allow the Secretary of Defense to request, and the FDA to take, specific actions to expedite the development of medical products, and the review of investigational submissions, applications for approval/licensure, and submissions/notifications for clearance for such medical products to diagnose, prevent, treat or mitigate a specific and life-threatening risk to the U.S.
As part of the ongoing and frequent collaborations between the FDA and the DoD, additional steps taken over the past several months include:
- In July 2018, the FDA granted an Emergency Use Authorization (EUA) for the DoD’s emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma manufactured by the Centre de Transfusion Sanguine des Armées (often referred to as French freeze-dried Plasma). That action reflected the importance that both the DoD and the FDA place on efficiently prioritizing and expediting availability of potentially life-saving biological products that are essential to the urgent care of military personnel, especially those in potential battlefield settings. Granting this authorization supported access to this important product and ensures that it will be available if needed.
- In July 2018, the FDA approved the atropine autoinjector device as a medical countermeasure for chemical nerve agent exposure. This drug-device product was developed in partnership with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, and was approved six months ahead of the DoD’s product development schedule.
- In August 2018, following a priority review, the FDA approved the first prophylactic drug for malaria in over 18 years, tafenoquine (Arakoda). This drug was developed in partnership with the U.S. Army Medical Research and Materiel Command.
- On October 29, 2018, the FDA issued draft guidance to help foster the development and eventual approval of dried plasma products. Since these types of plasma products do not need to be stored frozen and can be reconstituted and administered quickly they can be used by military personnel in remote areas without freezers and other support equipment.
“Our enhanced collaboration with our DoD partners has been vital to gaining a better understanding of the health needs of those protecting our country,” said Anna Abram, the FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis. “Today’s MOU is a key milestone in implementing a robust and enduring pathway that fulfills our commitment to expedite access to safe and effective medical products for our military personnel.”