Today, the United States Food and Drug Administration and the Department of Defense (DoD) Office of Health Affairs signed a memorandum of understanding regarding the development and evaluation of medical products. This builds on the work of both agencies to foster and prioritize the effective development of safe and effective medical products to save the lives of U.S. service members.
“We are extremely grateful to the men and women who defend our nation, often at great personal risk and sacrifice. It is our honor and our duty to support our military personnel by ensuring that they have access to safe and effective medical products, especially products that meet the unique needs and contexts in which soldiers may require medical care. ‘a medical treatment,’ said FDA Commissioner Scott Gottlieb, MD. has previously worked closely with the DoD to identify opportunities to accelerate the availability of medical products, particularly products used to treat battlefield injuries. For example, as shown below, theEmergency use authorization for French lyophilized plasma which was issued earlier this year. Our close collaboration with the DoD has helped us more effectively target and respond to immediate DoD product priorities and drive the development and revision of those products in the most streamlined way possible. We look forward to further partnership opportunities under the MOU. »
The MOU formally establishes the framework within which the DoD and FDA will implement thelaw passed by Congress in 2017for enhanced engagements between DoD and FDA. Under this MOU, the FDA will work closely with the DoD to assess how best to support access to safe and effective medical products that meet the medical needs of the military; provide the highest level of attention and expedite review of DoD priority medical products; provide ongoing technical advice to assist in the rapid development and manufacture of medical products for use by the military; and review products currently under development to determine opportunities to streamline review and accelerate their availability. The 2017 law also expanded the FDA’s authority to authorize emergency uses of medical products to reduce death and severity of injury caused by chemical, biological, radiological, or nuclear (CBRN) agents or agents that may cause or are otherwise associated with imminent death. – threatening and specific risk to US military forces and other purposes.
“This MOU reinforces the existing partnership between the Department of Defense and the FDA to equip our military members with the best and most innovative military medical support possible,” said Terry M. Rauch, Ph.D., MPH, MBA, Acting Deputy Assistant Secretary. of Defense, Health Readiness Policy & Oversight, DOD. “Our military men and women risk their lives to protect our country. Today’s Memorandum of Understanding reflects the DoD and FDA’s commitment to ensuring timely access to vital medical supplies for U.S. troops and to continue to foster the development of new, innovative medical products that can help ensure the operational readiness of U.S. troops. We look forward to continuing to work with the FDA as we analyze and implement measures to provide the best medical products and care possible to all military personnel – on the battlefield, stationed around the world and at home.”
“Our enhanced collaboration with our DoD partners has been critical in better understanding the health needs of those protecting our country,” said Anna Abram, FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis. . “Today’s MOU is a key step in implementing a strong and sustainable path that fulfills our commitment to accelerate access to safe and effective medical products for our military personnel.
The MOU signed today builds on the approach the FDA outlined in 2018 to advance the development and availability of medical products to help save the lives of U.S. military personnel in aworkplandeveloped in close collaboration with the DoD. The memorandum of understanding reflects the agency’s commitment to work to meet the medical needs of military personnel, including helping to expedite the development and review of medical products that are a priority for the DoD and assisting in the development and the rapid manufacture of safe and effective medical products for the US military. Specifically, the MOU establishes a framework for implementing the 2017 law, which included provisions for 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/licensing, and submissions/notifications for authorization of such medical products to diagnose, prevent, treat or mitigate a specific and potentially life-threatening risk to United States
As part of ongoing and frequent collaborations between the FDA and DoD, additional actions taken in recent months include:
In July 2018, the FDA granted aEmergency Use Authorization(EUA) for the DoD’s emergency use of freeze-dried pathogen-depleted plasma reduced in leukocytes manufactured by the Army Blood Transfusion Center (often referred to as French freeze-dried plasma). This action reflected the importance the DoD and FDA place on effectively prioritizing and accelerating the availability of potentially life-saving biologicals that are critical to the urgent care of military personnel, especially those on military fields. potential battle. Granting this permission has facilitated access to this important product and ensures that it will be available when needed.
In July 2018, the FDA approved the atropine self-injector device as a medical countermeasure for exposure to chemical nerve agents. This medicinal product was developed in partnership with theJoint 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 malaria prophylactic drug in over 18 years, tafenoquine (Arakoda). This drug was developed in partnership with the US Army Medical Research and Materiel Command.
On October 29, 2018, the FDA releasedorientation projectto help foster the development and eventual approval of dried plasma products. Since these types of plasma products do not need to be frozen and can be reconstituted and administered quickly, they can be used by military personnel in remote areas without freezers or other support equipment.
The FDA and DoD are committed to the ongoing partnership and are confident that today’s Memorandum of Understanding will strengthen these efforts to better meet the health care needs of US military personnel.
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.