Legislation to stimulate antibiotic development is heating up on Capitol Hill, and IDSA members can help during this critical time by contacting their members of Congress. IDSA continues to strongly advocate for the creation of a new antibiotic approval pathway to spur new antibiotic research and development (R&D) as part of the Food and Drug Administration Prescription Drug User Fee Act (PDUFA) reauthorization legislation.
The Society’s proposed Limited Population Antibacterial Drug (LPAD) pathway would provide an important new approval option for companies interested in developing drugs for serious resistant infections with few or no existing treatment options. Fourteen drug companies and 23 health and medical groups have come out in support of the proposal (see IDSA press release).
IDSA also recommends that PDUFA:
- designate a lead federal agency to explore opportunities for public private collaborations to spur antibiotic R&D
- direct the National Institute of Allergy and Infectious Disease to explore the feasibility of establishing a clinical specimen repository to ease diagnostics R&D
View the latest Antibiotic Resistance Policy Newsletter to see what IDSA is saying to members of Congress on this critical issue, and take action today.
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