Strengthening the U.S. Pharmaceutical Supply Chain: ASPR’s Essential Medicines RFI
The U.S. Department of Health and Human Services (HHS), through its Administration for Strategic Preparedness and Response (ASPR), recently issued a Request for Information (RFI) to industry partners regarding domestic manufacturing capabilities for essential medicines. This effort is led by ASPR’s Center for Industrial Base Management and Supply Chain (IBMSC) as part of the ReShoreRx initiative, which seeks to expand and sustain U.S.-based pharmaceutical production capacity to ensure readiness for current and future public health emergencies.
Solicitation Overview
The RFI is a market research effort to understand the current landscape of the Public Health Industrial Base (PHIB). Specifically, ASPR is requesting data on the production and supply of:
- Precursors and key starting materials (KSMs)
- Intermediates
- Active pharmaceutical ingredients (APIs)
- Finished dosage forms (FDFs)
The RFI highlights a list of more than 80 essential medicines, including acetaminophen, insulin, fentanyl, penicillin, vancomycin, and morphine, that are critical to U.S. health security. Respondents are encouraged to detail current production capacity, regulatory approvals, scalability, and supply chain resiliency.
Specific Goals of the RFI
ASPR is seeking information to:
- Identify existing and potential domestic manufacturing sites and their population-scale capacity.
- Assess vulnerabilities, including reliance on foreign-sourced inputs, long lead times, or single-source equipment.
- Understand the flexibility of facilities to pivot across multiple essential medicines.
- Evaluate formulation, packaging, and cold-chain logistics capabilities.
- Gather industry perspectives on regulatory challenges and opportunities for innovation, such as advanced manufacturing techniques or new partnerships.
Responses will also inform ASPR’s planning around investments needed to expand or modernize facilities, improve domestic sourcing, and strengthen long-term resilience of the U.S. supply chain.
Key Dates
Interested respondents should note the following deadlines:
- September 10, 2025 – 5:00 PM ET: Last day to submit clarification questions to the contracting officer.
- September 16, 2025 – 5:00 PM ET: Final RFI submissions due via email to ASPR.
Funding Information
Because this is an RFI, no awards or funding are associated with this announcement. Instead, responses will guide future solicitations or investments under ASPR’s ReShoreRx initiative. Any resulting programs will likely be structured as competitive solicitations at a later date.
Conclusion
By seeking industry feedback, ASPR is working to reduce vulnerabilities in the U.S. essential medicines supply chain and ensure that the nation can respond effectively to future health crises. Strengthening the domestic Public Health Industrial Base will not only mitigate risks of shortages but also improve access to critical therapies that sustain patient care.
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