The US Congress has approved a bill to establish a fast track for US Food and Drug Administration (FDA) approval of medical devices and therapeutics that could be useful on the battlefield.
The US House on November 15 unanimously passed the bill (HR 4374), which repeals a provision of the 2018 National Defense Authorization Act (NDAA) that some legislators and the FDA had found objectionable. The Senate followed suit on November 16.
The NDAA would have allowed the secretary of the Department of Defense (DoD) to authorize emergency use of unapproved products or would have allowed available products to be used for indications for which they had not been approved. The FDA’s role would only be that of consultant. Currently, only the FDA has the authority to allow such emergency use. Such uses have been limited to therapies or devices that involved response to chemical, radiologic, biological, or nuclear attacks or an influenza pandemic.
When the proposal in the NDAA was publicized, many objected to what was seen as a bypassing of the FDA’s long-standing authority. Other critics expressed concern about exposing military personnel to harm from unapproved medical devices or therapies.
The new legislation requires the defense secretary to request an expedited review from the FDA of any products it believes have potential for battlefield use.
“Our brave men and women in uniform deserve the best care possible, especially timely treatments while they put their lives on the line,” said House Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess, MD (R-TX) in a statement. “HR 4374 addresses a provision that could usurp FDA’s vital authority and long-standing process in reviewing and delivering cutting edge medicines and devices,” they added.
The new legislation had been requested by Walden as well as Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) and Senate Select Intelligence Committee Chairman Richard Burr (R-NC). They did not register their objections to the NDAA provision until it had been approved by a joint House-Senate conference committee. They proposed a compromise that would give the FDA the ultimate authority.
The DoD had requested that the emergency use authorization provision be added to the NDAA bill, but after the compromise proposal, it said it would support the new bill.
“The Department of Defense appreciates the work done by the Senate and House Armed Services Committees in their annual defense policy bill to highlight the need for certain lifesaving medical treatments with military applications to receive expedited review and approval,” Commander Gary Ross of the Secretary of Defense’s press operations told Medscape Medical News.
The DoD “also looks forward to continuing its partnership with the FDA to ensure that this expedited approval process is done in a rigorous and safe manner,” he said.
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