Department of Defense looks to shift medical authority from FDA
The US Department of Defense may gain the power to approve drugs and medical devices under a proposed bill. Critics have said that Section 732 of the Senate’s version of the National Defense Authorization Act could "undermine" medical safety and potentially increase the risk for soldiers, but the bill's backers have said that the move is necessary and long overdue. The FDA said that introducing a new method of approving drugs could be "risky", since it empowers the Pentagon to authorise the use unapproved drugs and devices on military personnel.

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.”

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.

