Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve
1. Purpose
Executive Order 14336 aims to enhance the resilience of the American pharmaceutical supply chain by establishing the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) and promoting domestic production of essential medicines for national health security.
2. Key Actions And Directives
- Develop Critical Drug List: The ASPR must create a list of approximately 26 critical drugs within 30 days.
- Maintain API Supply: Ensure a 6-month supply of APIs for critical drugs is maintained in the SAPIR.
- Prepare SAPIR Repository: The existing repository must be ready to receive APIs within 120 days, contingent on fund availability.
- Enhance Domestic Production: Encourage procurement and storage of APIs from domestic manufacturers.
- Open Second SAPIR Repository: Develop a proposal for a second SAPIR repository within one year.
3. Important Points
- Current Domestic API Shortage: Only 10% of APIs used in the U.S. are produced domestically, highlighting the need for increased domestic manufacturing.
- Biden Administration's Challenges: The administration's attempts to bolster domestic production of essential medicines have not yielded the expected results, leaving the SAPIR underutilized.
- Legal and Operational Compliance: The Executive Order will be implemented in accordance with existing laws and appropriations, asserting that it does not establish enforceable rights.
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