The Executive Order aims to bolster the resilience of the United States’s pharmaceutical supply chain by stockpiling Active Pharmaceutical Ingredients (“APIs”) for critical medicines in the Strategic Active Pharmaceutical Ingredients Reserve (“SAPIR”) and encouraging the domestic production and procurement of such APIs.
The EO includes several directives and deadlines.
- Section 2(a): Within 30 days of the EO, the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) within the Department of Health and Human Services must create a list “of approximately 26 drugs that are especially critical to the health and security interests of the Nation (the critical drugs).” The ASPR must also create an accounting of funds available to finance and maintain the SAPIR repository with a 6-month supply of APIs for critical drugs referenced in Section 2(c). The list and accounting must be provided to the Director of the Office of Management and Budget (“OMB”), who will assist with repurposing available funds.
- Section 2(b): Within 120 days of the EO, and subject to the availability of funds identified in Section 2(a), the ASPR must prepare the existing SAPIR repository to begin receiving and maintaining APIs.
- Section 2(c): Subject to the availability of funds identified in Section 2(a), the ASPR must secure a 6-month supply of APIs needed to make critical drugs, prioritizing APIs manufactured domestically. APIs must be placed within the SAPIR repository within 30 days after the repository is certified to receive and maintain APIs.
- Section 3(a): Within 90 days of the EO, the ASPR must update its 2022 list of 86 essential medicines and medical countermeasures and provide it to the Assistant to the President and Homeland Security Advisor (“APHSA”), the Assistant to the President for Economic Policy (“APEP”), and OMB. The update should include a plan to obtain APIs for drugs on the updated essential medicines list from domestic manufacturers, where possible, and to store and maintain a 6-month supply of those APIs.
- Section 3(b): The plan in Section 3(a) must also include a proposal to open a second SAPIR site within one year of the EO.
