DEFENSE/FDA: “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 staff and Health and Human Services officials who say it would undermine medical safety and potentially put soldiers at risk.
Section 732 of the Senate’s version of the National Defense Authorization Act creates a new regulatory structure that would allow the Pentagon to sign off on unapproved devices and drugs for emergency use on military personnel and others in harm’s way. The bill is in conference committee with final language expected as early as this week.
FDA currently has sole authority to authorize drugs and devices for emergency use…
The language states that the Defense Department would be able to approve ’emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war.’ For instance, the Defense Department could approve the use of freeze-dried plasma, which the department has repeatedly said can save the lives of military personnel who have suffered blood loss on the battlefield. While a small number of elite soldiers currently are deployed with access to freeze-dried plasma, the product is still awaiting full FDA approval, which isn’t expected until 2020.”
-Dan Diamond, “‘Unprecedented’ Pentagon health committee could undermine FDA,” Politico, Nov. 6, 2017 01:09pm