Despite Concerns About Provisions On Use Of New Drugs, Defense Bill Moves Toward Vote
Politico Pro reports the bill is moving along and lawmakers will continue talks on addressing concerns from some members of health committees that the bill would allow the military to use drugs and products that haven't been approved by the Food and Drug Administration.
Politico Pro:
NDAA Moves Forward As Lawmakers Discuss Separate Fix For Drug Approval Provision
Must-pass defense policy legislation will move forward unchanged despite protests from health committees over a provision that would shift some approvals for drugs and medical products from the FDA to the Pentagon. Instead of delaying a vote on the National Defense Authorization Act, H.R. 2810, to make changes, the House Armed Services and Energy and Commerce committees will continue talks on a potential fix, an Armed Services aide told POLITICO. (O'Brien, 11/8)
The Hill:
GOP Chairmen Seek Hold On Giving Defense New FDA Powers
Three GOP chairmen are asking for a delay in moving the defense policy bill’s conference report over concerns the measure would let military personnel receive devices and drugs that haven’t won Food and Drug Administration (FDA) approval. At issue is a provision in the Senate’s National Defense Authorization Act that would let the Pentagon sign off on unapproved medical products for emergency use on the battlefield. Currently, the FDA is responsible for such approvals, and its commissioner, Scott Gottlieb, believes that shouldn’t change. (Roubein, 11/8)
In other FDA news --
Politico Pro:
FDA Moves To Prevent Brand-Name Drugmakers From Slowing Competition
FDA today released guidance to help make it easier for makers of brand-name drugs and generics to collaborate on mandated safety programs known as REMS — a move that should make it harder for brand drug companies to use REMS to prevent competition. (Karlin-Smith, 11/8)
