There is a big resistance in Congress over Pentagon’s plan to approve drugs and medical products without Food and Drug Administration’s involvement. Pentagon is facing the resistance before the finalization of a defense policy bill and Senate HELP Chairman Lamar Alexander and Senator Richard Burr said that they will not support the annual bill if negotiators keep a provision that shifts some decision-making from the FDA to the Defense Department, Politico reports.
Previously, there were plenty of warnings that the plan of Pentagon puts soldiers at risk and undermines FDA’s role.
“We share your goal of ensuring military service members have access to safe life-saving medical products during battlefield emergencies or combat settings. The language currently in the bill does not meet that test, and if it remains unchanged we will not be able to support the 2018 National Defense Authorization Act,” Alexander and Burr wrote to John McCain, Senate Armed Services Chairman. McCain supports the provision.
There were some other lawmakers who also said that they were concerned, but they haven’t threatened to oppose the bill.
The defense bill passed the Senate in September by an 89-8 vote and has been in a House-Senate conference committee. Pentagon has been focused on the availability of freeze-dried plasma, saying that it could save lives, but the FDA has to approve it. The plan of the DoD says that a committee appointed by the department would have the power to approve drugs and products for board use by the military.
“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,” FDA official told Politico.
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