Congress currently is considering a 2018 Department of Defense (DOD) budget bill that would give DOD the power to approve drugs and medical devices for use among military personnel, even if the products have not yet been approved by FDA.
Proposed policy details
According to Politico, section 732 of the National Defense Authorization Act (HR 2810) would create a new regulatory structure to allow DOD to approve drugs and medical devices that have not been approved by FDA for "emergency uses … to reduce deaths and severity of injuries caused by agents of war."
A congressional conference committee is working on the bill and is expected to release final language for the measure this week, Politico reports. According to Politico, language from the conference bill would require the DOD secretary to appoint a committee of health care experts to determine whether emergency use of unapproved drugs or medical devices is necessary. In addition, the language would require the assistant secretary of defense for health affairs to consult with FDA before authorizing an unapproved drug's or device's use.
Stakeholders have offered mixed feedback on the proposal.
The bill's supporters say the provision is needed. House Armed Services Committee spokesperson Claude Chafin said FDA for 10 years has "denied" approval for using freeze-dried plasma among individuals who have lost large amounts of blood on the battlefield, even though DOD argues that using freeze-dried plasma would help save such individuals' lives.
According to Politico, a limited number of deployed servicemembers have access to freeze-dried plasma, but FDA is not expected to approve the product until 2020. A Senate Armed Services Committee conference report stated, "Traditional pathways to (FDA) 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 report continued, "The committee believes this provision could lead to even higher survival rates from severe battlefield wounds suffered by servicemembers."
An FDA official said the agency "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 and HHS officials have expressed concerns about giving DOD the authority to approve its own drugs and medical devices. Particularly, HHS officials have said the provision would undermine longstanding processes and protections.
FDA Commissioner Scott Gottlieb on Tuesday said retaining FDA's power to approve drugs and medical devices is "important because [the agency] provide[s] a level of oversight that helps ensure the safety of products" and "helps follow-up to make sure that if there are adverse events we're monitoring them." Instead, Gottlieb said he supports a proposal that would allow FDA to accelerate drug and device approvals the DOD requests for use in the battlefield.
In addition, some stakeholders have said the proposal's broad language could allow DOD to approve an expansive swath of drugs and medical devices for use among military personnel because "agents of war" is not defined. For instance, a congressional aide said under the provision, DOD potentially could approve an unregulated influenza vaccine for military personnel who contract the flu while deployed.
According to Politico, a Democratic aide called the proposal "unprecedented," adding, "We've never had a process for where an individual agency could [approve] drugs and devices ... for its own use."
On Tuesday, Sens. Lamar Alexander (R-Tenn.) and Richard Burr (R-N.C.) said they would vote against the defense bill if it contains language allowing DOD to approve drugs and medical devices, Politico's "Pulse" reports. The senators in a letter sent to Senate Armed Services Committee Chair John McCain (R-Ariz.) wrote, "We share your goal of ensuring military service members have access to safe life-saving medical products during battlefield emergencies or combat settings," but added, "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" (Diamond, Politico, 11/6; Mitchell, The Hill, 11/6; Roubein, The Hill, 11/7; Diamond, "Pulse," Politico, 11/8).
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