Motivated by concern for the health of American troops, members of Congress have proposed solving a hypothetical military problem with a real medical mistake. Their provision to allow the military to approve use of drugs and devices, bypassing the pros at the Food and Drug Administration, would open a loophole in federal drug-approval laws that practically invites unintended consequences. It could even backfire, by turning the service members it’s meant to protect into unwilling test subjects for unapproved products.
The provision, tucked into a massive defense bill, is designed to address a worry that the Pentagon might not be able to get quick access to needed drugs or medical devices. Supporters cite an example: freeze-dried plasma, which is used to treat battlefield injuries. It’s easily portable, making it possible to bring into combat conditions. The Pentagon currently gets its plasma from a French company, but would prefer to buy domestically. The French company also provides the plasma in glass bottles, while the military would rather buy it in lighter blood bags. An American manufacturer that meets the Pentagon’s criteria has been slow to win FDA approval.
Lawmakers would let the Pentagon simply skip that process, empowering the secretary of defense to authorize use of unapproved medical products in an emergency. The provision goes well beyond an existing law, from 2003, that allows the Pentagon to request that the FDA fast-track approval of treatments for chemical, biological, radiological, or nuclear attacks.
But the Pentagon isn’t equipped to make such determinations, and letting the military clear products for use could mean that service members get drugs and devices that don’t meet standards. As much as the wait for the freeze-dried plasma approval might bother the military, the purpose of that process is to ensure that injured soldiers get the best care. The idea also seems to assume real obstinance on the FDA’s part. In the event of a genuine emergency — if the French firm went out of business, for instance — the agency would face pressure to authorize a replacement as quickly as possible. Hopefully, it would.
Could unwarranted delays hypothetically still happen? Perhaps. But in evaluating this legislation, hypothetical scenarios cut both ways. If Congress creates this loophole, it’s reasonable to expect drug makers to want to use it, and to lobby the Pentagon to approve drugs of unproven safety or effectiveness. As one former Air Force officer put it to STAT News, the Globe’s sister news organization, “How do we want to perceive our troops — as lions or guinea pigs?” It would take an exceptional crisis to justify bypassing the FDA’s expertise, and the Pentagon and its Congressional allies just haven’t demonstrated the need.