Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve
This executive order directs the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Preparedness and Response (ASPR), to fill and harden a Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). Its immediate goal is to identify roughly 26 especially critical drugs, secure and store a six-month supply of the active pharmaceutical ingredients (APIs) needed to make them, and prepare the SAPIR repository to receive those APIs. The order also requires updating an existing list of 86 essential medicines and producing a plan to secure six-month API supplies for those drugs (and to open a second SAPIR repository), with a preference for domestically manufactured APIs where possible. The intended impact is to reduce U.S. reliance on foreign API supply chains, encourage domestic API production through government purchasing, and increase resilience against supply disruptions that could threaten patient access to essential medicines. Implementation is subject to available funds and legal authorities; the order calls for coordination with OMB and other White House advisors and does not create enforceable private rights.
Key Points
- 1Immediate identification and funding check: Within 30 days, ASPR must propose a list of about 26 "critical drugs" and report what funds are available, consistent with law, to prepare and open the SAPIR repository and to obtain/maintain six months of APIs for those drugs. This accounting goes to the Director of OMB.
- 2Repository readiness and stocking timeline: Within 120 days (subject to available funds), ASPR must ready the existing SAPIR repository to receive and maintain APIs. After certification that the repository is ready, ASPR must place a six-month API supply for the critical drugs into SAPIR within 30 days.
- 3Preference for domestic APIs: The order directs a preference, when possible, for obtaining domestically manufactured APIs to fill the reserve, aiming to boost U.S. production and reduce dependence on foreign suppliers.
- 4Broader essential medicines plan and second repository: Within 90 days, ASPR must update the 2022 list of 86 essential medicines and provide a plan to obtain, store, and maintain six-month API supplies for those drugs not already covered by the 26 critical drugs. That plan must include a proposal and cost estimate for opening a second SAPIR repository within one year.
- 5Limits and implementation conditions: The order states it will be implemented consistent with applicable law and subject to available appropriations, does not alter statutory authorities of agencies or OMB functions, and does not create private legal rights. Publication costs are assigned to HHS.