FDA, Politics

The Department of Defense could undermine FDA, giving the green light for experimental products

A defense bill making its way through the Senate would give the Pentagon power to approve new drugs and medical devices in some emergency instances, with clearance to ignore advice from the FDA.

The proposed policy would give the Defense Department unprecedented leeway, thanks to the bill’s vague language. The concept is alarming congressional staff and Health and Human Services officials, according to Politco, who first reported the news.

Specifically, the bill gives the Pentagon authority to OK the use of experimental and unapproved drugs and medical devices for emergency use on military personnel and “individuals associated with deployed members of the armed forces,” the bill states. The idea is emergency use of some products could “reduce deaths and severity of injuries caused by agents of war.”

One way the DoD might flex this new power is to approve the use of products like freeze-dried plasma to treat military personnel who have suffered blood loss on the battlefield. Freeze-dried plasma, unapproved for use in the US, is a stable and long-lasting dry product that could be kept at room temperature. Use of the product, it’s thought, could save lives in the field.

Joe Panetta

Joe Panetta, president and CEO of California’s biotech industry group Biocom, tells me he’s not surprised by the DoD’s move.

“I think the military has historically been given unique privileges in a number of areas outside of what applies to industry and the general public,” Panetta said in an email. “This situation is no different. I know that industry wants a process that ensures safety and efficacy thanks to a standardized and universally accepted regulatory process, i.e. FDA … (But) I empathize with the fact that FDA normally proceeds at a pace that does not fit the military’s situation at times.”

Still, concerns arise from how broad the language is in the bill. For instance, the phrase “agents of war” is not a legal definition. Politico reports that it could open the door for the Pentagon to approve a wide range of products and treatments.

The bill does spell out two requirements the DoD has to meet before signing off on an experimental treatment or device. First, the DoD would create a new committee of health care experts who must recommend the use of an unapproved product. Second, the assistant secretary of defense for health affairs would need to authorize the product’s use after consulting with the FDA.

Panetta said he wasn’t sure what other industry experts might say, but personally he thinks this sort of provision is warranted.

“I think that if there is an imminent need for a therapy or device … then they should be allowed to do this,” he wrote in the email.

But, Panetta has caveats. The DoD should waive all company liability for the product, and they should have a review procedure that adequately evaluates the risk to their personnel, Panetta said. He said an attractive alternative might be to work with the FDA to set up a special expidited review process for these situations.

The FDA actually offered such an alternative to the DoD, but the language wasn’t accepted for the bill, according to Politico.

At an event Tuesday, FDA Commissioner Scott Gottlieb said control over medical device and drug approvals should stay in the hands of the FDA, The Hill reports. Still, he said he supports of an accelerated approval process for products used on the battlefield, and is willing to modify the language the agency proposed for the DoD’s bill.

“I’m fully committed to trying to expedite products for the war fighter, and … if they pass the language that has been put forward — the alternative language — we will commit to very quickly putting in place the implementing guidance to stand up that process,” Gottlieb said at the event.

Check out the full text of the National Defense Authorization Act for Fiscal Year 2018 bill. Jump to Section 732 for more on emergency use of unapproved products.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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