The Senate gave final congressional approval to a bill designed to resolve a dispute involving the FDA and the Department of Defense, preserving the FDA’s authority over authorizing innovative medical devices for soldiers while streamlining the authorization process.
The measure, H.R. 4374, sponsored by Rep. Greg Walden (R-Ore.), was drafted because of a defense authorization bill working its way through Congress that contains a provision that would give the DoD authority to administer unapproved drugs and devices to soldiers.
FDA Commissioner Scott Gottlieb objected to the provision as a threat to the established process for approvals, with its attendant safeguards.
The Walden bill was drafted to address those concerns while providing for the faster approvals that the DoD wants. Congress adopted a rule requiring passage of the Walden legislation before final voting on the defense authorization bill.