This seems … problematic.
The Defense Department — and not FDA — would have the power to approve drugs and medical devices under the defense policy bill that’s being hammered out by a conference committee, alarming congressional health staff and HHS who say it would undermine medical safety and potentially put soldiers at risk.
The ostensible need for this is that the military, being in the profession of shooting people and blowing things up, may judge that deploying a new drug or device for battlefield health care may do more good than waiting for full FDA approval to ensure those drugs or devices aren’t themselves dangerous. The counterargument is, well, also that.
And the broad language of the military exemption has some worried that it gives blanket permission to the armed forces to treat wounded soldiers like lab rats, and worry about the consequences later:
“It’s unprecedented,” said one Democratic aide who works on medical safety issues. “We’ve never had a process for where an individual agency could [approve] drugs and devices … for its own use” and outside of the FDA. “It’s a massive shift.” […]
HHS has warned Congress that the provision would undermine decades of existing protections and processes. For instance, DoD wouldn’t have access to FDA’s data, which means a decision could be made based on limited information provided by a drug or device manufacturer. DoD also wouldn’t be collecting safety and efficacy data in the same way as FDA.
Whether or not you believe it’s a good idea to grant the Department of Defense broad leeway to test new drugs on their own soldiers without FDA involvement probably depends primarily on whether you believe the Department of Defense would ever abuse such authority. It also may depend on your awareness of history: the United States military has a rich legacy of medical experimentation on their own troops and on civilians, a legacy that these more recent laws and regulations have sought to curtail.
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