DearColleague.us

Letter

Mark DeSaulnier

From the office of:

Mark DeSaulnier

Sending Office: Honorable Mark DeSaulnier
Sent By:
Ethan.VanNess@mail.house.gov

        Request for Signature(s)

Deadline: March 12th COB

Dear Colleague:

Please join me in sending the below letter to the Department of Defense Appropriations Subcommittee urging a $5 million increase in funding for the Industrial Base Analysis and Sustainment (IBAS) program for freeze dried plasma products for
trauma treatment.

While blood transfusions can be a life-saving measure for wounded service members, all too often those who are deployed in austere environments do not have access to the blood products they need. The first thirty minutes after injury are a critical
time during which a patient must receive blood products to prevent massive hemorrhage. Conventional liquid blood products, however, are difficult to transport and properly store within many forward austere environments in which U.S. Armed Forces currently
operate.

Luckily, efforts are already underway for an alternative – freeze-dried pathogen-inactivated plasma and its derivatives that will have pathways for FDA-approval. These products offer greater longevity and no requirement for cold storage making them more
portable and effective in far-forward military situations. These products can save lives by allowing wounded warriors timely life-saving transfusions sooner.

While the U.S. Armed Forces medical services currently purchases a limited quantity of these products from the French Armed Forces, we must develop these products in the United States to ensure proper quantity, quality, and timely delivery to
our Armed Forces.

Please join me in helping our forward-deployed service members get the medical treatment they need by joining this letter. The deadline to join is
Thursday, March 12, 2020. If you have any questions, please contact Ethan Van Ness in my office at
ethan.vanness@mail.house.gov or at (5-2095). To sign on, please fill out the form

here
.

 

Sincerely,

 

Mark DeSaulnier

Member of Congress

Letter Text

 

Dear Chairman Visclosky and Ranking Member Calvert:

As you begin work on the Fiscal Year 2021 Department of Defense Appropriations bill, we respectfully request you increase the President’s Budget Request for the Research, Development, Test, and Evaluation – Defense-wide budget line for the Industrial Base
Analysis and Sustainment (IBAS) program (PE 0607210D8Z) Line 203 by $5 million for Freeze Dried Blood Plasma Products Manufacturing Technology.

The IBAS program provides the Department of Defense with unique capabilities that improve force readiness. IBAS investments focus on identifying and closing gaps in defense-related manufacturing capabilities addressing critical operational issues. For example,
a top priority for the Army’s Combat Casualty Care Research Program is to optimize survival and recovery from combat-related injury by advancing and improving damage control resuscitation of patients with traumatic hemorrhage; forward surgical and intensive
critical care; casualty transport; and care for traumatic brain injury (TBI) and other neurological trauma.  

To accomplish these goals, the Army needs to transition to FDA-approved pathogen-inactivated blood products including: platelets, plasma, red blood cells, and whole blood for transfusion support of U.S. servicemembers during combat. Specifically, the military
needs simplified, rapidly reconstituted pathogen inactivated freeze-dried plasma-derived products for use in far forward austere environments and during pre-hospital medical evacuation. 

The “Golden Hour” – in reality, the golden fifteen minutes – is the critical time during which a bleeding patient must be resuscitated. Timely administration of blood products is critical for effective treatment of and survival from massive hemorrhage, yet
current conventional liquid blood products require cold-chain supply logistics that are not feasible for transport to and within far forward austere combat environments and thus cannot be administered within minutes of traumatic injury, when treatment is most
effective. Freeze-dried medical products with greater longevity, universal use regardless of blood type, and no requirement for cold storage, would increase the opportunity for those operating in these areas to receive life-saving transfusions sooner.

Manufacture of these medical products requires pathogen inactivated technology to reduce the risk of transfusion-transmitted infections by inactivating a broad range of blood-borne pathogens such as viruses, bacteria, parasites, and leukocytes that may be
present in donated blood and enables the production of these novel freeze-dried blood products for early treatment of trauma. Pathogen-inactivated freeze-dried plasma and plasma-derived products would provide for early replacement of critical clotting factors
that are depleted rapidly in the massively bleeding patient to stop bleeding, promote wound healing, and maintain blood vessel integrity. 

To optimize transfusion therapy on the battlefield, development must be done to enable production of pathogen-inactivated freeze-dried plasma products, all of which can be used for immediate treatment of wounded servicemembers at the point of injury. To
ensure an adequate supply, these products must be produced in the U.S. with FDA licensure. The U.S. military currently purchases limited amounts of pathogen reduced freeze-dried plasma from the Armed Forces Blood Transfusion Center of France. For Fiscal Year
2021, $5 million in funds are needed to invest in the advanced manufacturing process development and scale up in order to meet federal regulatory requirements.

We respectfully request the Committee consider including an additional $5 million in the Department of Defense Appropriations Act for Fiscal Year 2021 for the Industrial Base Analysis and Sustainment Support (PE 0607210D8Z) Line 203 to be competitively awarded
for Freeze Dried Plasma Products for Trauma Treatment.

 

Related Legislative Issues

Selected legislative information:Appropriations, Armed Services, HealthCare

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