Back to Top Skip to main content

DoD, FDA working together to benefit warfighters

Dr. Scott Gottlieb, FDA Commissioner (left) and Mr. Thomas McCaffery, Principal Deputy Assistant Secretary of Defense (Health Affairs) (right), congratulate on another following the signing of a memorandum of understanding between the DoD and the FDA.  The ceremony acknowledges the existing partnership and the future collaboration on accessing life-saving medical products for U.S. troops on the battlefield. Dr. Scott Gottlieb, FDA Commissioner (left) and Mr. Thomas McCaffery, Principal Deputy Assistant Secretary of Defense (Health Affairs) (right), congratulate one another following the signing of a memorandum of understanding between the DoD and the FDA. The ceremony acknowledges the existing partnership and the future collaboration on accessing life-saving medical products for U.S. troops on the battlefield.

Recommended Content:

Health Readiness

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.”

You also may be interested in...

A new year marks a new you

Article
1/18/2019
Navy Reserve Sailors assigned to Navy Operational Support Center, Phoenix perform a 1.5-mile run during the physical readiness test at Luke Air Force Base in Glendale, Arizona. (U.S. Navy photo by Mass Communications Specialist 3rd Class Drew Verbis)

Changes in lifestyle don’t have to be drastic to be effective

Recommended Content:

Health Readiness | Physical Activity

CJTH continues to provide superior care for U.S., coalition forces

Article
1/7/2019
A medical team transports a patient by a stretcher to Craig Joint Theater Hospital at Bagram Airfield, Afghanistan, Dec. 10, 2018. Before entering the hospital, patients are thoroughly assessed, administratively in-processed and checked for any explosive ordnance or weapons. (U.S. Air Force photo by Senior Airman Kaylee Dubois)

With a 99.3-percent survival rate, the hospital staff have reason to be proud

Recommended Content:

Health Readiness | Military Hospitals and Clinics

Northstar Dustoff provides aeromedical evacuation in Kuwait

Article
1/4/2019
Army Soldiers assigned to the 2-211th General Support Aviation Battalion, Minnesota Army National Guard, and the 155th Armored Brigade Combat Team, Mississippi Army National Guard, pull a patient from a UH-60L Black Hawk helicopter during an aeromedical evacuation rehearsal at Camp Buehring, Kuwait. (U.S. Army photo by Sgt. Emily Finn)

Northstar Dustoff has completed more than 60 aeromedical evacuations since August 2018

Recommended Content:

Health Readiness

Langley surgical team goes 'purple'

Article
1/3/2019
A joint surgical team comprised of three separate branches assembled to perform an operation at U.S. Air Force Hospital Langley at Joint Base Langley-Eustis, Virginia. Consisting of a Navy surgeon, Air Force nurse and Army technician, the team performed a Functional Endoscopic Sinus Surgery to restore a patient’s sinus ventilation to normal function. (U.S. Air Force photo by 2nd Lt. Samuel Eckholm)

A joint surgical team was organized to perform a functional endoscopic sinus surgery

Recommended Content:

Health Readiness | Military Hospitals and Clinics

Army hospital earns reputation as a top teaching institution

Article
1/2/2019
Army OB/GYN nurse residents train in the CRDAMC simulation lab. The OB/GYN Nurse Resident Program, only offered at CRDAMC, focuses on OB/GYN nursing skills that include childbearing, high-risk and complicated pregnancy, newborn assessment and care and family planning gynecology. (U.S. Army photo by Gloria Montgomery)

CRDAMC has been recognized by healthcare associations and educational institutions for exceptional achievements

Recommended Content:

Health Readiness | Military Hospitals and Clinics

Combat medics improve readiness with individual critical task list training

Article
12/31/2018
A group of combat medics unload a casualty from a MEDEVAC helicopter during a recent emergency medical evacuation training exercise at the hospital’s helipad here as part of the combat medic’s individual critical task list training. (U.S. Army photo by Patricia Deal)

There is no substitution for being pushed around by the rotor wash of a helicopter

Recommended Content:

Health Readiness

If the weather outside is frightful, a little preparation can make it delightful

Article
12/28/2018
Army 2nd Lt. David Stringer, 452nd Combat Support Hospital, leads his group through snowy terrain during winter warfare training at Fort McCoy, Wisconsin. (U.S. Army photo by Staff Sgt. Felix R. Fimbres)

Learn the risks of exposure to cold, and steps to stay safe

Recommended Content:

Health Readiness

Navy corpsman: Carrying the legacy

Article
12/27/2018
Navy Seaman Brandon Taylor, a corpsman, inserts a decompression needle into an essential care simulator manikin during shock trauma section drills. The drills focused on sharpening life-saving skills and capabilities. (U.S. Marine Corps photo by Sgt. Justin Huffty)

Navy hospital corpsmen attend 14-week “A” school at the Medical Education and Training Campus in Joint Base San Antonio — Fort Sam Houston, Texas

Recommended Content:

Health Readiness | Military Hospitals and Clinics

Hospital ship USNS Comfort returns home after completing mission

Article
12/20/2018
Family and friends of crew members aboard Military Sealift Command’s hospital ship USNS Comfort wait as the ship pulls into Naval Station Norfolk, Dec. 18. Comfort returned to Virginia after completing its 11-week medical support mission to South and Central America, part of U.S. Southern Command’s Operation Enduring Promise initiative. (U.S. Navy photograph by Brian Suriani)

This mission marked the sixth time the hospital ship has provided medical assistance in the region

Recommended Content:

Health Readiness | Military Hospitals and Clinics | Global Health Engagement

Super Galaxy: Aeromedical evacuation's biggest ally

Article
12/17/2018
Air Force Aeromedical Teams from the 433rd Aeromedical Evacuation Squadron and the 439th AES complete a training scenario during a C-5M Super Galaxy AE proof of concept flight from Scott AFB, Illinois. (U.S. Air Force photo by Master Sgt. Joseph Swafford)

The C-5M upgrades allowed the proof of concept to work, but Airmen’s innovation is what made it happen

Recommended Content:

Health Readiness

Vaccination is the best defense against the flu

Article
12/10/2018
Vaccination is the primary method for preventing influenza and its complications and getting an annual influenza vaccine is the best way to protect yourself and your family from the flu. (U.S. Army photo by Staff Sgt. Erica Knight)

Vaccination is needed every year because the Influenza viruses change

Recommended Content:

Health Readiness | Immunization Healthcare | Immunizations

Fleet surgical team saves life aboard USS Somerset

Article
12/6/2018
Navy Cmdr. Jeffrey Chao, the Littoral Combat Group One, surgeon, second from left, performs an emergency appendectomy as other medical team members assist aboard the San Antonio-class amphibious transport dock ship USS Somerset. (U.S. Navy Photo by Mass Communication Specialist 1st Class Andrew Brame)

We were able to determine he had acute appendicitis

Recommended Content:

Health Readiness | Military Hospitals and Clinics

New training mannequins help Soldiers save lives

Article
11/28/2018
Soldiers at Fort Benning, Georgia, train one another on using the Tactical Combat Casualty Care Exportable system, a medical trauma training mannequin. Personnel from the office of the Program Executive Officer for Simulation, Training and Instrumentation, brought new, technologically advanced medical training mannequins to Fort Benning to increase the realism of medical trauma training and ultimately to save lives and limbs. (U.S. Army photo by Patrick Albright)

The realism of it creates that white-knuckle sensation and adrenalin for the Soldier

Recommended Content:

Health Readiness

Rabies

Infographic
11/20/2018
Rabies

Although Germany is rabies-free for terrestrial land mammals, rabies exposure remains a concern for U.S. military personnel assigned there because of personal and military travel and deployments to rabies endemic countries. Deployments have become much more variable both in location and duration. Deployments have increasingly focused on enhancing ...

Recommended Content:

Health Readiness | Armed Forces Health Surveillance Branch | Epidemiology and Analysis | Medical Surveillance Monthly Report | Public Health

Malaria

Infographic
11/20/2018
Malaria

This report describes a cluster of 11 soldiers with vivax malaria among U.S. military personnel who trained at Dagmar North training area, near the demilitarized zone (DMZ), in the Republic of Korea (ROK) in 2015.

Recommended Content:

Health Readiness | Armed Forces Health Surveillance Branch | Epidemiology and Analysis | Medical Surveillance Monthly Report | Public Health
<< < 1 2 3 4 5  ... > >> 
Showing results 1 - 15 Page 1 of 37

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

Some documents are presented in Portable Document Format (PDF). A PDF reader is required for viewing:: Download a PDF Reader or learn more about PDFs.