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Legal & Regulatory Feature

Source: U.S. Defense Department and Spc. P.J. Siquig

FDA and Military Reach Medical Products Agreement

Walter Eisner • Thu, February 1st, 2018

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With some disagreement, Hippocrates is often credited with saying that, "He who desires to practice surgery must go to war."

As such, military needs for medical technology is special and unique. The Pentagon and the FDA haven't always been on the same page when it comes to meeting the military's needs and the FDA's caution.

But that is changing as the Pentagon and FDA announced an agreement in January after Congress gave the FDA marching orders to implement a new framework and tools to "prioritize the efficient development and availability of medical products intended to help save the lives of American military personnel on the battlefield."

The agreement reportedly came about after some member of Congress threatened to strip the agency of authority over medical products developed specifically for military use. The Pentagon had apparently been frustrated over delays in FDA review of freeze-dried plasma and other products intended for battlefield use.

According to the FDA, the agency will take the following steps to enhance collaboration and coordination with the Department of Defense's (DoD) priority development programs.

  1. Better understand the portfolio and developmental priorities of DoD;
  2. Treat all priority DoD development programs as if they had received breakthrough designation;
  3. Undertake review of prior advice to DoD and other sponsors of relevant products;
  4. Provide extensive manufacturing and clinical advice for prioritized products;
  5. Develop and issue guidance to facilitate the availability of products needed by DoD;
  6. Maintain an open line of communication to revisit and refine priorities over time; and
  7. Ensure accountability for FDA commitments to DoD.

The FDA said it understands that the military's priority development programs include those programs operated by the U.S. Army Medical Research and Materiel Command, the Joint Program Executive Office for Chemical and Biological Defense, the Defense Health Agency, and the Defense Advanced Research Projects Agency.

The agreement states that the Pentagon may also direct FDA to include additional defense operating units as appropriate. For the initial purposes of this work plan for CBER (Center for Biologics Evaluation and Research), current top priority military programs include freeze-dried plasma, coldstored platelets, and cryopreserved platelets.

The FDA will have formal semi-annual meetings with the Pentagon to review the military's product development pipeline and will meet at least quarterly to have a detailed discussion of the military's highest priority programs. The current high priority programs include freeze-dried plasma, cold-stored platelets, and cryopreserved platelets.

To read more details about the new relationship, click here.

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