Department of Defense: FDA is Too Slow!

United States Army ranger medic treating the wounds of injured fellow ranger.

The Department of Defense has expressed concerns about delays at FDA. In a Politico article on December 13, 2017, titled, “How to Reboot the FDA,” the Department of Defense (DOD), with the help of some Members of Congress tried an end-run around the the FDA and sought authority to approve its own medical products.  The DOD argued that it has the “best sense for what military personnel need, and service members face a very different set of health risks than other Americans, particularly on the battlefield.”

The article cited that the Pentagon wanted to equip more soldiers with freeze-dried plasma, a product that can help clot blood and prevent injured troops from bleeding to death.”  The challenge was that approvals were still needed from FDA; and FDA has denied the annual Defense Department request for freeze-dried plasma to troops in the field for 10 years.

According to the article, “the FDA and Pentagon eventually reached a compromise, with the health agency retaining sole approval power but agreeing to expedite more of the military’s requests. FDA also signaled that freeze-dried plasma might be ready for approval by this year. But there’s still some unhappiness that the Defense Department lost its chance for an independent approval pathway. After all, it’s hard to argue with the assertion that soldiers wounded on the battlefield face a different set of risks than most civilians.”

DOD appears not ready to give up on this fight and with a substantial “plus-up” coming in their FY 2018 and 2019 budget it could prove helpful to their cause.  The Trump Administration has proposed to decrease FDA’s total direct obligations by $25 million for FY 2019.

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