FDA

FDA and Pentagon forge breakthrough designation agreement

Following the Pentagon’s criticism of the FDA sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products.

The framework for the program was established, via H.R.4374, after DoD sought to create its own review pathway whereby it could approve medical products outside of FDA’s purview.

FDA and DoD outlined their new approach to collaborating in an initial work plan, which includes treating “all priority DoD development programs as if they had received breakthrough designation” and providing “extensive manufacturing and clinical advice for prioritized products,” as well as issuing guidance to facilitate the availability of products needed by DoD.

Current high-priority DoD product programs include freeze-dried plasma, cold-stored platelets and cryopreserved platelets, so the initial phase of the program will be conducted by FDA’s Center for Biologics Evaluation and Research and Health Affairs.

CBER senior leaders will complete a review of all products determined by mutual agreement to be a top priority to DoD by 30 June 2018.

Tom McCaffery

CBER will hold formal meetings with DoD at least semiannually to review the Pentagon’s product development pipeline, and the agencies will meet at least quarterly to have a detailed discussion of the DoD’s highest-priority programs. FDA and DoD will also hold at least one workshop this year to discuss aspects of the scientific and clinical development of products for military persons and to inform the guidance.

“This partnership reflects the invaluable collaboration between Health Affairs and the FDA to equip U.S. warfighters with the best possible military medical support as we work to achieve a safer, more secure world,” said Tom McCaffery, acting assistant secretary of defense for Health Affairs. “Expeditious access to life-saving medical products for U.S. troops on the battlefield is part and parcel to ensuring our shared priority of operational readiness.”


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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