Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve

8/13/2025

Executive Orders

View Original

Action Summary

Purpose: Enhance U.S. pharmaceutical supply chain resilience by restoring and expanding domestic API production and stockpiling through a Strategic Active Pharmaceutical Ingredients Reserve (SAPIR).
Background:
- Builds on previous efforts (Executive Order 13944, 2020) to secure domestic production of essential medicines, medical countermeasures, and critical inputs.
- Highlights shortfalls during the Biden Administration where billions were spent yet domestic procurement and SAPIR stockpiling lagged.
Section 2 – Filling SAPIR with APIs:
- Critical Drugs List: ASPR to develop a list of approximately 26 drugs essential for national health and security within 30 days, including funding allocations, coordinated with scientific experts and key advisors.
- Repository Readiness: Within 120 days, ASPR must ready the existing SAPIR repository to begin receiving APIs.
- Stockpile Requirement: Secure a 6‐month supply of the APIs needed for the critical drugs with a preference for domestically manufactured APIs, to be placed in SAPIR within 30 days after the repository’s certification.
Section 3 – Ensuring SAPIR Resilience:
- Within 90 days, ASPR shall update the 2022 list of 86 essential medicines and medical countermeasures, developing a plan to obtain, store, and maintain a 6-month API supply for drugs not already prioritized as critical.
- The plan must also include a cost proposal for opening a second SAPIR repository within 1 year.
Section 4 – General Provisions:
- Clarifies that the order does not impair existing agency or budgetary authorities, nor does it create enforceable private rights.
- Implementation is subject to applicable law and funding appropriations.
- Publication costs are designated to be borne by the Department of Health and Human Services.

Risks & Considerations

The Executive Order aims to enhance the resilience of the American pharmaceutical supply chain by focusing on domestic production of Active Pharmaceutical Ingredients (APIs). This could lead to increased demand for research and expertise in pharmaceutical manufacturing and supply chain management.
There is a risk that the focus on domestic production may lead to increased costs for pharmaceutical companies, which could be passed on to consumers. This may also affect the availability of certain medications if domestic production cannot meet demand.
The order emphasizes the need for a Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), which could require significant investment and coordination among various government agencies and private sector partners.
Vanderbilt University may need to consider how these changes in the pharmaceutical supply chain could impact its research programs, particularly those related to drug development and public health.

Impacted Programs

Vanderbilt University Medical Center (VUMC) may see increased opportunities for collaboration with government agencies and pharmaceutical companies to enhance domestic API production and supply chain resilience.
Vanderbilt’s School of Medicine could play a crucial role in researching and developing new methods for efficient API production and storage, potentially leading to new funding opportunities and partnerships.
The Office of Research might need to adjust its strategies to align with the new focus on domestic pharmaceutical production, potentially affecting grant applications and research priorities.
Vanderbilt’s partnerships with pharmaceutical companies and government agencies may need to be reevaluated to ensure alignment with the new policies and priorities outlined in the Executive Order.

Financial Impact

The reallocation of federal funds towards domestic API production could impact the funding landscape for pharmaceutical research, potentially leading to new opportunities for Vanderbilt to secure research grants and contracts.
Vanderbilt University might experience changes in its funding opportunities, particularly if federal discretionary grants prioritize pharmaceutical supply chain resilience. This could necessitate adjustments in grant application strategies and partnerships.
There may be increased opportunities for Vanderbilt to secure funding for research and development in pharmaceutical manufacturing and supply chain management, particularly through collaborations with the Department of Health and Human Services and other federal agencies.
As domestic API production becomes more prevalent, there could be a shift in the focus of pharmaceutical research and development, potentially affecting the university’s research priorities and funding strategies.

Relevance Score: 4 (The order presents a need for potential major changes or transformations of programs.)

Key Actions

Vanderbilt University Medical Center (VUMC) should explore partnerships with domestic pharmaceutical manufacturers to ensure a stable supply of Active Pharmaceutical Ingredients (APIs) for critical medicines. This could enhance VUMC’s ability to respond to public health emergencies and align with national priorities for pharmaceutical supply chain resilience.
The Office of Federal Relations should monitor developments related to the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) and engage with policymakers to advocate for funding and support for research initiatives that align with the goals of increasing domestic API production.
Vanderbilt’s School of Medicine could consider developing research programs focused on the synthesis and production of APIs, potentially positioning itself as a leader in pharmaceutical innovation and contributing to national efforts to reduce dependency on foreign API sources.
The Department of Health Policy should conduct research on the implications of the executive order for healthcare delivery and pharmaceutical access, providing insights that can inform policy decisions and public discourse on pharmaceutical supply chain resilience.

Opportunities

The executive order presents an opportunity for Vanderbilt’s School of Engineering to collaborate on projects aimed at improving the efficiency and sustainability of domestic API production processes, potentially leading to innovations that benefit the broader pharmaceutical industry.
By engaging in public-private partnerships, Vanderbilt can leverage its expertise in healthcare and pharmaceutical research to contribute to the development of a robust domestic pharmaceutical supply chain, enhancing its reputation as a leader in health security and innovation.
The focus on domestic API production offers an opportunity for Vanderbilt’s Owen Graduate School of Management to develop case studies and business models that explore the economic and strategic implications of reshoring pharmaceutical manufacturing, providing valuable insights for industry leaders and policymakers.

Relevance Score: 4 (The order presents the potential for major process changes required for Vanderbilt’s programs due to impacts on pharmaceutical supply chain resilience and opportunities for research and partnerships.)

Average Relevance Score: 3.8

Timeline for Implementation

Within 30 days of the order’s date (August 13, 2025): The ASPR must develop a list of approximately 26 critical drugs and an accounting of available funds.
Within 90 days of the order’s date: The ASPR is to update the 2022 list of essential medicines and medical countermeasures, with a plan to obtain and maintain a 6-month supply of APIs.
Within 120 days of the order’s date: In coordination with other agencies, the ASPR must ready the existing SAPIR repository to begin receiving and maintaining APIs.
No later than 30 days after repository certification: The delivery of a 6-month supply of APIs for the critical drugs must be completed.
Within 1 year of the order’s date: A proposal, including a cost estimate, is required for opening a second SAPIR repository.

The shortest timeline identified is “within 30 days”, making it the most immediate directive that sets the urgency level.

Relevance Score: 4

Impacted Government Organizations

Department of Health and Human Services (HHS): Oversees the Office of the Assistant Secretary for Preparedness and Response (ASPR), which is primarily responsible for implementing the SAPIR-related actions.
Office of the Assistant Secretary for Preparedness and Response (ASPR): Tasked with developing the critical drugs list, preparing the SAPIR repository, and coordinating measures to fill and maintain the supply of APIs for essential medicines.
Office of Management and Budget (OMB): Required to provide assistance in repurposing funds and to receive reports regarding the funding and operational status of the SAPIR initiative.
Office of the Assistant to the President for Economic Policy (APEP) and the Assistant to the President and Homeland Security Advisor (APHSA): These offices provide consultation on economic and homeland security priorities related to the SAPIR operations.

Relevance Score: 2 (A moderate number of key agencies and advisory offices are directly impacted by the order.)

Responsible Officials

Assistant Secretary for Preparedness and Response (ASPR) – Charged with developing the list of critical drugs, readying the SAPIR repository, and obtaining the necessary 6‑month API supply.
Director of the Office of Management and Budget (OMB) – Responsible for receiving the accounting of existing funds, facilitating the repurposing of available funds, and coordinating with ASPR and other agencies.
Assistant to the President for Economic Policy (APEP) – Consulted in developing the list of critical drugs and involved in the overall strategy.
Assistant to the President and Homeland Security Advisor (APHSA) – Consulted on the list and included as a recipient of updates regarding SAPIR resilience and planning.

Relevance Score: 5 (The directives involve high-level officials including key White House advisors and senior agency directors, which impacts strategic national security and public health.)