In a move to better serve the unique needs of the nation’s warfighters, leaders from the U.S. Food and Drug Administration and the Office of the Assistant Secretary of Defense for Health Affairs signed a memorandum of understanding to foster and prioritize the development of critical medical products.
The signing of the memorandum formalizes the partnership between the FDA and the Department of Defense that was authorized under a law enacted by Congress in 2017. Under this law, DoD is able to request help in speeding up development and review of products used to diagnose, treat, or prevent serious or life-threatening diseases and conditions faced by service members. It also allows for emergency use of medical products for threats that pose a specific risk to service members, including biological, chemical, radiological, or nuclear agents.
The FDA will continue to work with DoD to evaluate how to best access medical products that serve the military’s medical needs and rush review of priority DoD medical products. The FDA will also provide advice for the development and manufacturing of these products, and examine those that are already under development to determine which will streamline review.
The memorandum directs specific actions between the agencies, including semi-annual meetings at the senior-leader levels, quarterly meetings with FDA centers, and collaborations on emergency use of products.
Dr. Terry Rauch, acting deputy assistant secretary of Defense for Health Readiness Policy and Oversight, said the memorandum enables the Military Health System to speak through one voice with the FDA on strategic issues and to move forward on urgent needs with a prioritized DoD list for the FDA to focus on.
“DoD and FDA have always been committed to safe and effective products for our service members, and this [memorandum] really solidifies the needed relationship to provide these most effectively,” said Rauch. “We have already seen increased readiness due to the collaborative efforts with the approval of three medical products since the release of the law.”
The FDA has approved the use of an auto-injector for nerve agent exposure, a prophylactic drug for malaria, and the RECELL system for point-of-care skin regeneration in trauma patients. These products were approved after the release of the law, and the memorandum strengthens these efforts even further, he said.
“These products are critical to warfighter readiness in deployed environments and to the far-forward care settings that we face,” said Rauch. “Battlefield trauma and prolonged field care are at the forefront of challenges in military medicine.”
Earlier this year, the FDA granted emergency use authorization for DoD’s use of freeze-dried plasma. Rauch described it as a life-saving product designed for austere environments, which can now be used in a much more streamlined process under the authorization. In addition, the FDA approved a new malaria prophylactic drug, tafenoquine, in August.
“The FDA has been incredibly helpful and forward-leaning with all aspects of interaction on DoD medical product development,” said Rauch. “We are grateful that there is an increased interest by the leadership to drive collaboration, and we are leveraging that interest to the fullest.”