Health Care

FDA and Pentagon Forge Breakthrough Designation Agreement

FDA and Pentagon Forge Breakthrough Designation Agreement”

The FDA and Department of Defense (DoD) announced a joint initiative to speed development of drugs and devices intended for use by American military personnel.

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.

The initial phase of the program will be conducted by FDA's Center for Biologics Evaluation and Research (CBER) and Health Affairs, which will meet on a regular basis.

The steps announced Tuesday include quarterly meetings between Pentagon health leadership and CBER leadership to discuss Pentagon priorities; treating the Pentagon's priority programs as if they've received "breakthrough therapy" designation, which is a program created to expedite development and review of medical products for serious conditions; FDA-hosted workshops with the Pentagon to develop guidance on facilitating the development of products; and formal FDA-Pentagon meetings at least two times a year to review the Pentagon's product development pipeline.

"The FDA is fully committed to working closely with our federal partners in the DoD to expedite availability of medical products essential to the health of our military service members, particularly those products used to treat injuries in battlefield settings", FDA Commissioner Dr. Scott Gottlieb said in prepared remarks.

The FDA said it expects to have a licensed product available by the end of the year.

FDA and DoD outlined their new approach to collaborate 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. "The Dept. of Defense looks forward to working with the FDA on this important program to ensure delivery of critical battlefield medicine to our service members downrange".

Using this law, FDA will work closely with Health Affairs to better understand deployed personnel's medical needs, give priority attention to and accelerate its review of priority DoD medical products, provide ongoing technical advice to Health Affairs to help in the rapid development and production of medical products for use by the military, and look closely at products now being developed and opportunities to expedite their availability.

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