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.

FDA believes a proposed approval mechanism that would limit the populations eligible to receive a drug could work well with the antibiotic development incentives already included in user fee legislation and may end being better at attracting new sponsors.

The backing was another lift for the Limited Population Antibacterial Drug mechanism proposed by the Infectious Diseases Society of America, but several members of Congress still have questions about the system, leaving

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