Under a new defense policy bill, the Pentagon also could ignore FDA’s advice as necessary. | Getty Images Lawmakers defend 'unprecedented' Pentagon health panel, which could undermine FDA FDA currently has sole authority to authorize drugs and devices for emergency use.

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.

But the lawmakers backing the bill, including House Armed Services Chairman Mac Thornberry (R-Texas), say the measure is necessary and even overdue.


“The FDA has denied freeze-dried plasma to troops in the field for 10 years,” House Armed Services spokesperson Claude Chafin said, referencing a still-unapproved medical product that the Pentagon says is necessary to save the lives of military personnel. “The chairman has perfect moral clarity on this provision, and there is no doubt in his mind that it is the right thing to do for the troops.”

FDA officials counter that creating a new pathway to approve drugs is both risky and — in the specific case cited by Thornberry — not needed. “FDA has been working closely with DoD to bring freeze-dried plasma to our troops and anticipates that these products will be fully approved for safe and effective use for our armed forces as early as 2018," an FDA official told POLITICO.

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. The bill is in conference committee with final language expected as early as this week.

FDA currently has sole authority to authorize drugs and devices for emergency use.

"It's unprecedented," said one Democratic aide who works on medical safety issues. "We've never had a process for where an individual agency could [approve] drugs and devices ... for its own use" and outside of the FDA. "It's a massive shift."

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The language states that DoD would be able to approve "emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war." For instance, DoD could approve the use of freeze-dried plasma, which the department has repeatedly said can save the lives of military personnel who have suffered blood loss on the battlefield. While a small number of elite soldiers currently are deployed with access to freeze-dried plasma, the product is still awaiting full FDA approval, which hadn't been expected until 2020.

"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," according to the Senate Armed Services Committee's conference report, defending its recommendation of the provision. "The committee believes this provision could lead to even higher survival rates from severe battlefield wounds suffered by servicemembers."

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.

The conference language would create two safeguards. First, a new DoD committee of health care experts, appointed by the Defense secretary, would need to recommend emergency use of an unapproved drug or device. Second, the assistant secretary of Defense for health affairs would need to authorize the drug's or device's use after consulting with FDA.

But congressional aides and HHS staff say those standards don't measure up to current safety practices. 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.

Staff on congressional committees with health jurisdiction say they were blindsided by the language, backed by Senate Armed Services Chairman John McCain (R-Ariz.), and have fought to remove it. 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.

Congressional staff involved in crafting the NDAA also defended the process of preparing the conference report. Three House Energy and Commerce Committee members — Chairman Greg Walden (R-Ore.), ranking member Frank Pallone (D-N.J.) and Texas Republican Joe Barton — were appointed to help negotiate Section 732, among other provisions in the bill that affect their jurisdictions.

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.

FDA offered an alternative proposal, which would have expedited drug and device reviews and approval upon a DoD request, but the language wasn’t accepted.

FDA would not comment on the agency's reported concerns with the bill. "The FDA does not generally comment on pending or potential legislation," spokesperson Jen Rodriguez said.

Connor O'Brien contributed to this report.

