New defense bill would allow Pentagon to do medical experiments with soldiers: [View all]

[DetlefK]

https://www.politico.com/story/2017/11/06/defense-department-health-committee-fda-drugs-military-244604

The Defense Department — and not FDA — would have the power to approve drugs and medical devices under the defense policy bill that's being hammered out by a conference committee, alarming congressional health staff and HHS who say it would undermine medical safety and potentially put soldiers at risk.

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Section 732 of the Senate’s version of the National Defense Authorization Act creates a new regulatory structure that would allow the Pentagon to sign off on unapproved devices and drugs for emergency use on military personnel and others in harm's way.

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But because the report language is so broad — for instance, "agents of war" isn't a legal definition — staff say that it would open the door for the military to approve a wide range of products and treatments. For instance, DoD could plausibly approve a vaccine for soldiers who come down with the flu while deployed, one congressional aide said.

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Rather than base a drug or device approval on years of safety and efficacy evaluations, it "leaves the decision up to a five-man committee," said one individual with knowledge of how the DoD committee would be staffed. The Pentagon also could ignore FDA's advice as necessary.

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But the provision is expected to remain, one individual with knowledge of the deliberations said on Monday afternoon. A Senate aide noted that it has bipartisan support from defense lawmakers.

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HHS has warned Congress that the provision would undermine decades of existing protections and processes. For instance, DoD wouldn't have access to FDA's data, which means a decision could be made based on limited information provided by a drug or device manufacturer. DoD also wouldn't be collecting safety and efficacy data in the same way as FDA.



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