The Senate on Thursday passed by unanimous consent a bill to speed up Food and Drug Administration (FDA) approval of medical devices and drugs to be used on the battlefield.
The bill is meant to address a controversial provision of the annual defense policy bill passed by the House on Tuesday that would allow the Pentagon to sign off on unapproved devices and drugs.
{mosads}The Senate passing the bill on medical approvals means it will soon be able to take up the National Defense Authorization Act (NDAA). Despite passing that measure on Tuesday, the House wouldn’t officially send over the defense bill until the Senate approves the separate medical bill.
The Pentagon and its advocates in Congress have been frustrated by the FDA’s slow approval of certain treatments they say could save lives on the battlefield. In particular, there has been a decadelong impasse between the Pentagon and the FDA over freeze-dried plasma, which the military says will help it save troops from bleeding out since it does not need refrigeration.
Because of that frustration, this year’s NDAA would have allowed the Pentagon to approve the use of freeze-dried plasma and other medical products to be used on the battlefield.
But the FDA and its advocates in Congress argued the language in the NDAA could open troops up to more danger because the approval process was not as rigorous as the FDA’s. They also argued the language was too broad and could allow the Pentagon to approve a range of treatments not directly related to battle.
The provision went largely unnoticed until a Politico report days before House and Senate negotiators finished work on the bill.
The bill passed Thursday, the result of a weekend compromise between the Pentagon and the FDA, expands the situations for which the FDA has authority to approve the emergency use of unapproved medical treatments and seeks to expedite the approval process.