GOP chairmen seek hold on giving defense new FDA powers

Three GOP chairmen are asking for a delay in moving the defense policy bill’s conference report over concerns the measure would let military personnel receive devices and drugs that haven’t won Food and Drug Administration (FDA) approval. 

At issue is a provision in the Senate’s National Defense Authorization Act that would let the Pentagon sign off on unapproved medical products for emergency use on the battlefield. Currently, the FDA is responsible for such approvals, and its commissioner, Scott Gottlieb, believes that shouldn’t change.

{mosads}Two chairmen who oversee the FDA in their respective chambers — Sen. Lamar Alexander (R-Tenn.) and Rep. Greg Walden (R-Ore.) — along with Senate Intelligence Committee Chairman Richard Burr (R-N.C.) are worried about the provision. 

They say the measure, “though well-intentioned, could jeopardize the FDA’s rigorous and science-based process to ensure the availability of safe treatments and therapies, which may ultimately create more harm than good for those who have risked their lives to defend our nation.”

The trio is seeking a delay in moving the conference report through the House and Senate in an effort to reach a compromise. In a statement, they said they’re working to find a solution that would expedite treatment to soldiers without, in their view, foregoing safety — and that the White House is also concerned and “supports our efforts to find a workable solution.”

The emergency use authority is in the final conference report, senior House and Senate Armed Services committees staffers said at a background briefing Wednesday morning. Lawmakers are expected to sign the report in the coming days.

Some lawmakers have argued that FDA approval takes too long, saying freeze-dried plasma for soldiers has been difficult to obtain but is crucial to saving lives on the battlefield.

Asked if they included any of the substitute language, a Senate committee staffer said: “The Senate provision is more or less I think the final conference report. We’ve obviously throughout the entire process — because this was a provision in the Senate bill from the very beginning — have heard concerns along the way, something that was discussed in the conference, but the conference report ends up more or less where the Senate provision was originally.”

Alternative language aims to improve communication between the FDA and the Department of Defense and to bolster the FDA’s emergency use authority, according to text obtained by The Hill.  

In a letter Monday to Senate Armed Services Committee Chairman John McCain (R-Ariz.), Alexander and Burr asked for the provision to be replaced with the “bipartisan solution drafted by the Chairs and Ranking Members of the authorizing committees of jurisdiction over the FDA.”

“Traditional pathways to the Food and Drug Administration’s 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 Senate committee report released in July states. “The committee believes this provision could lead to even higher survival rates from severe battlefield wounds suffered by servicemembers.”

The agency should retain control over device and drug approvals, the FDA’s chief said this week, adding he’s supportive of ways to accelerate approval.

“I’m fully committed to trying to expedite products for the war fighter,” Gottlieb said Tuesday at an event put on by The Hill.

Rebecca Kheel contributed.