FDA “Limited Use” Approval Pathway Gains Traction in Congress
This article was originally published in The Pink Sheet Daily
Sens. Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, signal Congressional revival of the Limited Population Antibacterial Development Program, offering antibiotics as the guinea pig for a potentially broader “limited-use” pathway.
You may also be interested in...
The maker of some of the most well-known anti-infectives is now exiting the segment and will focus instead on prophylactic vaccines where it may face some surprises in combating deadly infections.
Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain
Rep. Phil Gingrey, lead sponsor of the Generating Antibiotic Incentives Now Act, says industry still has questions about the proposed approval pathway for antibiotics treating life-threatening diseases, further clouding its prospects.
The agency would like to have a “special medical use” category for drugs, such as antibiotics for bacteria resistant to current therapies, that could be approved based on small trials and whose labeling says they should not be prescribed off-label.