Bolstering Biodefense with Advanced Antibiotics: BARDA’s Strategic Move
As the threat of antibiotic-resistant infections intensifies, the U.S. Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), has issued a pivotal solicitation under Project BioShield (PBS). The opportunity, RFP #75A50125R00005, calls for proposals to support the late-stage development and procurement of a broad-spectrum antibiotic capable of treating hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI) caused by drug-resistant bacteria or biothreat agents.
This solicitation is rooted in national security and public health strategy. It directly supports priorities outlined in the 2014 National Strategy and Action Plan to Combat Antibiotic-Resistant Bacteria and aligns with preparedness goals of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) by addressing critical capability gaps in our Strategic National Stockpile (SNS).
Solicitation Goals and Program Overview
BARDA is seeking antibiotics that either:
- Have received U.S. Food and Drug Administration (FDA) approval within the past 15 years, or
- Have completed an end-of-Phase 2 meeting with the FDA with a favorable Phase 3 development plan for BSI or HABP/VABP.
Products must be broad-spectrum, targeting two or more drug-resistant pathogens identified as “Urgent” or “Serious” threats in the CDC’s 2019 Antibiotic Resistance Threats report. Generic antibiotics are not eligible.
Offerors may propose products for biothreat indications, including Yersinia pestis, Francisella tularensis, and Burkholderia pseudomallei, if the development plan (including for post-exposure prophylaxis, if feasible) has been reviewed by the FDA. Procurement is contingent on milestone achievements, including FDA approval for a commercial or emergency indication, with delivery to the SNS or maintenance via Vendor Managed Inventory (VMI).
The contract structure includes:
- A Base Period to support regulatory development and post-marketing commitments
- Multiple Option Periods for additional late-stage development activities, onshoring manufacturing, shelf-life extension, post-marketing studies, and staged procurement of up to 10,000 treatment courses
- Support for secure manufacturing and supply chain plans
Proposal Timeline and Due Dates
Key submission milestones for interested Offerors include:
- Initial Questions Due: July 29, 2025, by 12:00 PM ET
- Supplemental Questions Due: August 8, 2025, by 12:00 PM ET
- Full Proposal Submission Deadline: August 25, 2025, by 12:00 PM ET
- All submissions must be electronic and conform to the requirements of Sections L and M of the solicitation.
Contract Scope, Award Details, and Funding Structure
BARDA anticipates at least one award using a hybrid contract model that includes both Cost-Plus-Fixed-Fee (CPFF) and Firm-Fixed-Price (FFP) components. The contract may span up to 10 years, including Base and Option Periods.
Offerors must demonstrate:
- Capability for late-stage development for commercial and/or biothreat indications
- Commitment to U.S.-based manufacturing or a plan for onshoring
- Robust security and inventory management systems to ensure product readiness
- Proven regulatory interactions with FDA and the ability to meet Emergency Use Authorization (EUA) or full NDA/sNDA pathways
Procurements under the contract will be milestone-based and aligned with availability of federal funds and programmatic priorities.
Advancing National Health Security
This solicitation represents a critical step in fortifying the nation’s biodefense infrastructure against emerging antimicrobial-resistant infections and intentional biothreats. The work funded under this contract will directly improve the nation’s ability to respond to public health emergencies where secondary bacterial infections pose a severe risk.
For developers of qualified antibiotics with strong regulatory foundations, this BARDA RFP is a unique opportunity to accelerate commercialization and national deployment. If your company has considered applying for federal funding, your federal funding journey starts here. EverGlade Consulting is a national firm that helps organizations win and manage federal awards. We offer services ranging from Pursuit, Proposal and Post-Award support to comply with federal regulations at agencies including BARDA, ARPA-H, NIH, DTRA, JPEO, DOD, DIU, DOE, and DARPA.
