Create Public Health Industrial Base and Supply Chain Management Program: HHS is consolidating IBx and DPA-related activities into a new program office in 2022 to align resources and strategic intent to build domestic manufacturing capacity. This new IBx office will work with industry to identify levers to support domestic manufacturing. Subsequent efforts will focus on industrial base partnerships, emphasizing a sustainable and diverse manufacturing portfolio to mitigate a future public health emergency.
Establish DPA Title III9 Program to build domestic industrial resources: HHS’s DPA Title III Program will launch in Summer 2022 as part of broader Departmental efforts to strengthen the public health supply chain and to enhance industrial base capabilities. Dedicated to ensuring the timely availability of essential domestic industrial resources to support national defense, homeland security, and emergency preparedness requirements, the DPA Title III Program will target investments to sustain critical production, commercialize research and development investments, and scale emergency technologies to enhance or expand domestic PHIB capabilities.
The program will work in partnership with key internal and external stakeholders—including HHS offices, interagency partners, and industry—to identify areas where critical industrial capacity is lagging or non-existent. It will help reduce the Nation’s reliance on foreign supply chains, ensure the integrity of materials supplied to the American people, and enhance national defense. The program is one of the key investment tools for HHS and the U.S Government to prepare for and respond to future public health and other threats to the national defense.10
Identify Mechanisms for Sustainable Funding: HHS is building sustainable funding streams for IBx and supply chain activities. For example, the Critical Supply Chain Resilience Program (CSCRP) at DOC provides HHS with additional financing mechanisms to promote resilience for designated critical products in the face of supply chain risks. The DPA Title III Program will establish the necessary authorities and mechanisms to allow the CSCRP to be used for PHIB management. This funding will support extended long-term contracts, on-hand inventory, vendor-managed inventory, and ensure sufficient manufacturing capacity such that the U.S. Government could trigger procurement or production of critical supplies at the start of a public health emergency.
Build Visibility: HHS is building and improving end-to-end visibility of the supply chain, including through the Supply Chain Control Tower (SCCT)11 and the FDA’s Resilient Supply Chain and Shortages Prevention Program, administered by the Center for Devices and Radiological Health.12 Enhancing supply chain surveillance and monitoring will enable earlier identification of concerns, issues, and challenges and help bring this information to leadership and relevant agencies sooner than might have been possible before. HHS is developing conceptual frameworks to support informational needs, recruiting staff with supply chain and data analytic skillsets, and employing technical integration of existing data platforms and designs for future growth.
Currently, the SCCT has eight distributors who voluntarily provide limited data about the supply of five PPE categories, 30+ pharmaceuticals, and other medical products on a near-daily basis. The SCCT receives data from distributors who represent 80 to 85 percent of the volume for the commodities it is tracking, and the total number of distributors varies by commodity. HHS Protect ingests and normalizes the data to create reports and dashboards that provide unprecedented visibility into commercial supply chains. The SCCT has also integrated supply status from around 5,000 hospitals and 15,800 long-term care facilities. The SCCT works closely with federal partners to share information, develop capabilities, and support decision making.13 HHS will share industry insights with the Office of Management and Budget’s Made in America Office and work with procurement category managers to promote domestic sourcing in Federal procurement pursuant to Executive Order 14005 (Ensuring the Future Is Made in All of America by All of America’s Workers, issued January 25, 2021).
Advance Manufacturing Technologies to Build Domestic Manufacturing Capacity: HHS recently launched efforts to enable, engage, and enhance domestic supplies of and improved access to critical drug substances and drug products, which would be subject to future review and approval. It has done this by developing and commercializing advanced manufacturing technologies to reduce overall production costs to ensure price competitiveness with foreign industry while maintaining appropriate quality standards consistent with current good manufacturing practice (cGMP). These advances include development and deployment of 1) platform technologies that enable on-demand, continuous practice (cGMP)-compliant production of pharmaceuticals, and 2) a platform technology that enables distributed on-demand production of cGMP-compliant intravenous saline solution and other supportive care fluids. Continuing innovation, development, and commercial deployment of these platforms, including through coordination with the Made in America Office and the Manufacturing Extension Partnership, will enable distributed domestic drug substance and drug product manufacture. At the same time, these platforms will help strengthen supply chain resilience, grow the bioeconomy, and deploy increasingly renewable and sustainable pharmaceutical resources capable of immediately responding to surges in demand caused by public health emergencies.
Ensure Safe Waste Management Strategies: HHS is investing in research and development efforts to deliver safe and effective long-term waste management strategies to protect human health and the environment. HHS will work in partnership with other federal agencies to design and execute this work.