October 29, 2018
“Plasma is a critical blood component for the treatment of traumatic injuries that result in extensive bleeding,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Currently, the approved plasma products intended for transfusion are stored frozen and need to be thawed before being transfused. This significantly limits use in remote areas without freezers and other support equipment, including places where our military may be deployed. Dried plasma products do not need to be stored frozen and can be reconstituted and administered quickly. By developing guidance on this topic, we hope to expedite the development and approval of safe and effective dried plasma products.”
Today the U.S. Food and Drug Administration issued a draft guidance titled, “Considerations for the Development of Dried Plasma Products Intended for Transfusion.” Once finalized, this guidance will provide recommendations to assist manufacturers in the development of dried plasma products, including recommendations regarding starting materials for the preparation of dried plasma products, manufacturing and product quality, product characterization studies, packaging and reconstitution, clinical studies and devices for manufacturing dried plasma.
The benefits of dried plasma products were recognized long ago, and dried plasma products were used by the U.S. during World War II. The interest in dried plasma has been renewed because of improvements in infectious disease mitigation, including improved testing methods and pathogen reduction technologies.
Today’s draft guidance builds on recent steps the FDA has taken to advance the development and availability of medical products to help save the lives of American military personnel, through work with the U.S. Department of Defense. In July 2018, the FDA granted an emergency use authorization for a specific freeze-dried plasma product for use by U.S. military personnel for treatment of hemorrhage or coagulopathy in an emergency involving agents of military combat (e.g., firearms, projectiles and explosive devices) when plasma is not available for use or when the use of plasma is not practical.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.