No Longer Left out in the Cold: MOU Improves FDA and DoD Cooperation

Courtesy Photo | Courtesy photo  

FORT BELVOIR, VIRGINIA, UNITED STATES

06.04.2019

Courtesy Story

Defense Threat Reduction Agency's Chemical and Biological Technologies Department

An old military adage says that amateurs talk tactics while professionals study logistics. For deployed warfighters, perhaps one of the most important logistical items are medical supplies, such as blood products and medicine. But there are numerous challenges to providing medical supplies at the right place and at the right time.

Blood products and some medicines require freezers or refrigeration, and depending on where warfighters are deployed, keeping supplies at the right temperature so that they are effective may not be possible. Even if a freezer is available, some frozen lifesavers — such as plasma — must be thawed before they can be transfused into an injured warfighter.

Additionally, new, effective medicines that fight disease or exposure to chemical, biological or radioactive materials are being developed but are not readily available to warfighters because of lengthy clinical trial and approval processes. However, a new memorandum of understanding (MOU) between the Food and Drug Administration (FDA) and the Department of Defense (DoD) will get some lifesaving therapeutics to the battlefield more quickly and easily.

Although the FDA and DoD have worked together since 1964, the conditions of their cooperation have changed periodically to better care for the warfighter’s health. For example, in December 2018, President Trump signed Public Law No. 115-92 (P.L. 115-92) to amend the Federal Food, Drug and Cosmetic Act. This amendment authorized additional emergency uses for medical products to reduce deaths and other harm caused by chemical, biological, radiological or nuclear (CBRN) agents or agents that may cause, or are otherwise associated with, an imminently life-threatening risk to U.S. service members.

The MOU, directed by the U.S. Congress, provided the framework for increased collaboration between the two agencies for medical product development and assessment. The National Defense Authorization Act for fiscal year 2018 also addressed the need for this collaboration.

The MOU, signed by Tom McCaffery, principal deputy assistant secretary of defense for Health Affairs, and Scott Gottlieb, M.D., commissioner of the FDA, directly enables collaboration between the FDA and DoD stakeholders — including the Joint Science and Technology Office of the Defense Threat Reduction Agency — to prioritize medical products for military emergencies. The results are lifesaving.

One initial success was the fast-track review and approval of freeze-dried plasma for emergency use. Having the right amount of plasma in the body ensures normal blood pressure and good health. Plasma carries many nutrients, including the chemical that clots blood so that a person doesn’t bleed to death from a cut. Excessive bleeding due to trauma, however, depletes plasma, requiring a plasma transfusion to restore the body to good health.

Currently, FDA-approved plasma products intended for transfusion are stored frozen and need to be thawed before use. This significantly limits the use of this medical supply in remote areas without freezers and other support equipment where service members are often deployed. However, freeze-dried plasma products can be at room temperature and, when needed, reconstituted to administer quickly. Because of the MOU, freeze-dried plasma is approved and ready for use wherever required.

This agreement has also resulted in FDA approvals of two other medical supplies. First, the FDA approved the use of tafenoquine, a drug that not only prevents malaria in travelers but also “kills the dormant liver stage of the P. vivax parasite responsible for relapses of malaria,” write Tan and Hwang in their September 2018 article (“Tafenoquine receives regulatory approval in USA for prophylaxis of malaria and radical cure of Plasmodium vivax”) published in the Journal of Travel Medicine. Second, FDA approved the use of the atropine autoinjector to treat poisoning resulting from exposure to a chemical nerve agent. Both approvals allow for better warfighter protections.

It has been the DoD’s long-standing policy to provide service members with the best possible health care along with safe and effective medical products to address CBRN warfare, endemic diseases and battlefield traumas. The newly signed MOU provides a forum for a mutual exchange of opinions, ideas and innovations between the FDA and DoD. It has already significantly benefitted medical product development, including projects happening within Defense Threat Reduction Agency’s Chemical and Biological Technologies Department.

POC: Lt. Col. Jerome L Vinluan; [e-mail]

• Date Taken: 06.04.2019
• Date Posted: 06.04.2019 15:19
• Story ID: 325353
• Location: FORT BELVOIR, VIRGINIA, US