Antibiotic Exclusivity’s Latest Push: Distressing Resistance Data From The VA
This article was originally published in The Pink Sheet Daily
A Pew-funded study found growing use of “last-stand” antibiotics in VA hospitals as resistant pathogens spread. Researchers say the pending GAIN Act will help address some of the economics of convincing drug makers to invest in development of new antibiotics, but other financial – as well as regulatory and scientific challenges – will remain.
You may also be interested in...
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.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.