ASPR Partners with Commerce Department to Ensure Availability and Security of Active Pharmaceutical Ingredient Supply Chain
The U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), in partnership with the U.S. Department of Commerce’s Bureau of Industry and Security (BIS), will conduct a comprehensive assessment of the U.S. active pharmaceutical ingredient (API) industrial base to increase understanding of the state of the U.S. pharmaceutical supply chain network.
“The United States needs resilient, diverse, and secure supply chains to help ensure economic prosperity and national security,” said Administrator and Assistant Secretary for Preparedness and Response Dawn O’Connell. “We are committed to doing what we can do ensure the U.S. API supply chain is secure and resilient, so essential medicines are available in emergencies such as pandemics. APIs must be manufactured domestically and readily available to make medicines, especially during emergencies."
The API supply chain assessment supports ASPR IBMSC’s long-term goal of developing and commercializing infrastructure that will be accessible to a broad community of users for producing critical drug substances and drug products.
This unique study, funded by ASPR's Center for Industrial Base Management and Supply Chain, allows the U.S. Government to better understand how the domestic supply chain changed during COVID. This information will inform future IBMSC investments, pending future Congressional funding. Specifically, BIS will conduct a survey of more than 200 companies, including manufacturers, distributors, suppliers, and customers. The results will allow the federal government to develop strategies and inform funding decisions that ensure the availability and security of the API supply chain. The assessment also will raise awareness of current limited domestic manufacturing capabilities and other potential issues.
“This assessment is the latest step taken by IBMSC to support industry in improving the U.S.-based manufacturing and securing the U.S. public health supply chain,” said Arlene Joyner, ASPR deputy assistant secretary for IBMSC. “IBMSC was able to use limited remaining funds to conduct this assessment. While IBMSC was pleased to receive $10 million from Congress for FY24, the current House bill for FY25 does not fund ASPR’s domestic manufacturing work. This study is critical to better understand how COVID shifted the landscape of domestic manufacturing during COVID and better inform IBMSC investments moving forward. We will continue to work with Congress to support funding ASPR’s domestic manufacturing investments.”
Since 2019, ASPR’s IBMSC has partnered with industry, providing expertise and more than $325 million to develop domestic production capabilities for API. As a result, domestic pharmaceutical manufacturers are establishing continuous manufacturing capabilities using technology that requires only a small footprint to make sterile injectables and solid dose form drugs deemed to be in short supply.
In support of the assessment, BIS will survey U.S. API manufacturers, distributors, suppliers, and customers using the BIS’s survey collection authority under section 705 of the Defense Production Act of 1950, as amended. BIS will distribute (or administer) the API Industrial Base Survey to industry in winter 2024.
In April 2024, HHS released a white paper recognizing the importance of domestic manufacturing in promoting market resilience and supplier diversification, among other policies to address shortages and supply chain vulnerabilities in the United States. In the white paper, HHS expressed its commitment to explore ways to support and reward domestic manufacturing capabilities. This assessment represents another step to further HHS’ actions to prevent shortages and mitigate supply chain vulnerabilities in the United States.
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