Defense bill could give Pentagon power to authorize medical devices, drugs over FDA: report

Language in the 2018 defense policy bill could give the Defense Department (DOD) power over the Food and Drug Administration (FDA) to approve drugs and medical devices for soldiers, a potential shake-up that Department of Health and Human Services (HHS) officials are pushing back on, Politico reported on Monday.

The Senate’s version of the National Defense Authorization Act (NDAA) would allow the Pentagon to sign off on unapproved medical devices and drugs for emergency use on military personnel. Such language would allow the Defense Department to sidestep the FDA, which now has sole authority to approve devices and drugs for emergency use.

The Pentagon would be able to approve “emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war,” the language states, according to Politico.

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Officials argue that language — backed by Senate Armed Services Chairman John McCain (R-Ariz.) — is too broad and would allow DOD to approve innumerable drugs, devices and treatments.

Staff on congressional committees with health jurisdiction told Politico they were blindsided by the provision and are trying to remove it.

One Democratic aide told Politico the language, if approved, would be “unprecedented,” and “a massive shift,” as there has never been a process for where an individual agency could approve drugs and devices for its own use outside of the FDA.

But the Senate Armed Services Committee’s conference report defended the proposal, noting the difficulty of accessing freeze-dried plasma for soldiers. A limited number of deployed special forces soldiers have access to freeze-dried plasma — which the Pentagon has said could save lives on the battlefield — but the FDA has yet to give the product full approval.

“Traditional pathways to [FDA] approval and licensure of critical medical products, like freeze dried plasma, for battlefield use are too slow to allow for rapid insertion and use of these products on the battlefield,” the report reads, according to Politico.

“The committee believes this provision could lead to even higher survival rates from severe battlefield wounds suffered by servicemembers.”

The conference language includes several safeguards for such a major shift, but congressional aides and HHS staff argue that they don’t measure up to current safety practices and would undermine decades of existing protections and processes.

House and Senate lawmakers are currently in conference to work out the final version of the NDAA, expected as early as this week.