DoD, FDA team up on service member medicine, but it stepping on civilian resources?

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Let’s say you’re a service member in the field and you’re bleeding.

A lot.

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In that moment you might be thinking, “If only the Food and Drug Administration approved blood coagulating technologies faster so I might be able to get my butt out of here alive!”

OK, maybe you’re not thinking about government medical policy during a life-threatening hemorrhage, but the Defense Department and FDA are trying to approve medical treatments for the field faster so you don’t have to do that.

It’s all part of a plan to put medical products DoD wants on a fast track for approval through processes similar to the FDA’s breakthrough designation program.

“The FDA recognizes that military personnel are facing increasingly unique challenges in fulfilling their mission to protect the American people,” Anna Abram, deputy commissioner of policy, planning, legislation and analysis for the FDA, said during a Jan. 16 teleconference with reporters. “We recognize that there are essential and in some cases unmet healthcare needs of those protecting our nation and that we at the FDA need to do our part to better protect them.”

Abram said some pressing areas in medicine needed by troops have not been fully addressed by FDA.

One of those areas the FDA and DoD plan to tackle first is products that deal with excessive bleeding.

“Our top priorities are in combat and casualty care and specifically the products that we are working vigorously with FDA on right now is freeze-dried plasma and two platelet products. One is cold storage platelets and the other is cryopreserved platelets. These products in combat casualty care will enable us to provide trauma care largely in the area of stopping noncompressible hemorrhages,” said Terry Rauch, acting deputy assistant defense secretary for health readiness policy and oversight.

DoD plans to have a licensed product by the end of 2018.

The plasma and platelet products have been on DoD’s radar since 2010, but the products were not approved for use by the FDA.

Think of it like any drug. It order for it to go on markets in the United States, the FDA must do tests on the drug and get proof that it actually works. Then you get that “FDA approved” label and it finally goes to the consumers.

DoD doesn’t want to wait that long and freeze-dried plasma was the last straw. Freeze-dried plasma has been used in Europe since 1991. So U.S. Special Operations Command pushed heavily for its use because it could save lives in the field and the plasma had a long shelf life.

Congress heard SOCOM loud and clear and inserted a provision in the 2018 defense authorization act and the Food, Drug and Cosmetics Act to make drugs more accessible to service members through the FDA.

The changes to the Food, Drug and Cosmetics Act allow the FDA to fast track medical products dealing with biological, radiological, chemical or nuclear attacks at the defense secretary’s request.

DoD and the FDA plan to meet twice a year to plan what priorities DoD wants FDA to focus on for the next six months.

But with the FDA moving so quickly on medicine approval, how can it ensure it is safe?

“FDA has basically standards for product development. These are standards for safety and efficacy. We look to the benefit and risk considerations for any given other product. It’s just that we will expedite our considerations and expedite our work on them as much as we can,” said Peter Marks, director of the Center for Biologics Evaluation and Research at FDA.

Resources and authorities

So what does that mean for civilian drugs? Will they now play second fiddle to DoD requests?

The FDA couldn’t fully answer that question. Their resources are obviously limited, but Marks felt FDA was up to doing both in a timely fashion.

“We really are committed to working with DoD and we’ll assign the necessary resources to ensure that the development and approval of safe and effective medical products is expedited,” Marks said. “Even those DoD already has a significant portfolio, we already have engaged a fair number of individuals working on this portfolio and we are committed to ensuring we have the right number of people working on this program. Will it potentially mean there will mean some shifting of resources? It possibility might. But we are also committed to maintaining our efforts to ensure that non-DoD efforts receive the attention they deserve.”

A provision in the 2018 defense authorization act allows the defense secretary to approve medical products not dealing with biological, chemical, radiological or nuclear attacks with consultation from FDA.