Proposed congressional legislation would grant a special U.S. Department of Defense (DOD) five-member panel authority to approve certain drugs and devices for emergency use when members of the armed forces confront “agents of war” – for which there is no legal definition. Current law gives the U.S. Food and Drug Administration (FDA) sole authority to approve drugs and devices.
A 2003 law already allows the DOD to ask the FDA to approve medical products for emergency use if military forces are attacked with biological, chemical, radiological, or nuclear agents. The lawmakers behind the new proposal want drugs and devices approved for more common battlefield situations. An example often cited is freeze-dried plasma, which is still pending FDA approval.
Critics of the proposal argue that the special panel could not match the resources and expertise to assess medical products for safety and effectiveness that the FDA already has at its disposal. To this point, five former FDA commissioners wrote a letter to the leaders of the House and Senate Armed Services Committees, noting, “These five external advisors are not likely to have the requisite knowledge about the chemistry, manufacturing, and controls that are part of every FDA review, nor will they have access to the raw data that are part of every new product application to the FDA.”
The special panel could green-light products based on limited evidence, effectively turning military personnel into clinical trial participants. “The best course of action is for the agencies to work better together, not cut [the] FDA out of the picture,” said Patti Zettler, a former FDA associate chief counsel.
Source: STAT News, November 13, 2017.