Regulatory Focus™ > News Articles > House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

Posted 10 November 2017 | By Zachary Brennan 

House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected.

According to the committee's conference report on the National Defense Authorization Act for FY 2018, the House will add the Senate amendment to authorize the secretary of defense to approve the emergency use of medical products outside the US, broadening the DoD's ability to approve such products.

"The conferees agree that traditional pathways to the Food and Drug Administration's approval and licensure of critical medical products for combat casualty care are too slow to allow for rapid insertion and use of these products on the battlefield," the report said.

The House conferees pointed to "even higher survival rates from severe combat wounds and injuries suffered by servicemembers" as a reason for adding the provision, though they said they expect FDA will be consulted when evaluating medical products "for combat casualty care and to use this new authority strictly for approval of medical products for battlefield wounds and injuries."

FDA and DoD already work together on emergency use authorizations (EUAs), including on submissions from DoD, according to FDA guidance on the use of such EUAs from January. For instance, in 2014, FDA issued an EUA to authorize the use of DoD's EZ1 Real-time RT-PCR Assay for the detection of Ebola Zaire virus during the outbreak in west Africa.

The decision to add the provision to the House bill followed comments from Gottlieb earlier this week, rare for an agency that often says it will not comment on pending legislation, that keeping such approvals within FDA's purview should be maintained. Former FDA commissioners also have taken issue with the provision.

And the move to take it up in the House committee on Monday might not signal that the shift is final. Sen. Patty Murray (D-WA) told Axios that a deal had been reached with Sen. Lamar Alexander (R-TN) to keep EUA reviews under FDA, but DoD would be able to push FDA to expedite certain product reviews.


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