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Strengthening the Supply Chain & Industrial Base

Public Health Supply Chain and Industrial Base 
One-Year Report​

HHS performs a vital role in the public health supply chain and industrial base. It does this in part by leveraging its convening power to bring stakeholders together to monitor and improve public health supply chains. HHS agencies and offices work, often in collaboration with other departments, such as the Departments of Defense (DoD), Commerce (DOC), and Labor (DOL), to address cross-cutting supply chain challenges and to strengthen the public health supply chain to ensure the United States has the resources it needs to prepare for and respond to public health emergencies. HHS accomplishes these responsibilities by contributing to the advanced development of critical MCMs; acquiring, stockpiling, and distributing needed public health supplies; implementing regulatory standards; and partnering and communicating with industry and other stakeholders to enhance supply chain visibility and to develop solutions to supply chain challenges.

In addition, HHS, ensures medical products are safe for the American public to use. The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) tests and approves respirators to ensure they meet regulatory standards and conducts studies on other PPE types to inform implementation guidance and performance specifications for voluntary consensus standards.ix The Food and Drug Administration (FDA) ensures medical devices, drugs, and biological products, including vaccines, are safe and effective before they are approved for use by the public. FDA’s shortage prevention programs and generic review processes help ensure that essential medical products are available and accessible to the people who need them. FDA advances public health by helping to speed innovations that make public health products more effective, safer, and affordable, by bringing efficiencies to the drug development and review process and promoting robust competition for established drugs, and by providing accurate, science-based information to the public.

Current Actions to Build Public Health Supply Chain Resilience

Themes within the National Strategy for a Resilient Public Health Supply Chain include

  • manufacturing and industrial base expansion (IBx) investments;
  • stockpiling, allocation, and coordination;
  • innovation;
  • trade policy and Buy American;
  • regulations, policy, and standards;
  • workforce development;
  • global partnerships and standards;
  • governance;
  • external stakeholder engagement and coordination.

HHS’s role in the public health supply chain has grown and is increasing as part of the COVID-19 response. Efforts under EOs 14017 and 14001 (A Sustainable Public Health Supply Chain, issued January 21, 2021) have already galvanized a large part of the interagency to fully implement HHS and national strategies. For example, HHS is expanding the PHIB and developing innovative solutions to address critical deficiencies in the public health supply chain by working across the U.S. Government and with academia and the private sector.x Since the COVID-19 pandemic began, HHS and DoD have collaborated on more than $4B of investments to increase domestic production of MCMs to provide a reliable supply chain of medical products and to reduce risk to industry partners by connecting their products with actual customers in the government and the private sector. Stability is essential if the Nation is to count on the private sector to invest in innovations, new facilities, and an expanded workforce. These improvements in domestic manufacturing must occur across the entire supply chain; the companies involved want to know there will be enough demand now and in the future to sustain these expansions.

HHS is implementing recommendations outlined in the National Strategy to address critical gaps in the public health supply chain. Each recommendation is tied to specific interagency actions to mitigate root causes and bolster domestic manufacturing resilience. Recommendations that affect the entire public health supply chain—including PPE and DME, testing and diagnostics, and pharmaceuticals and vaccines—and related activities are outlined below.

9.DPA Title III​ is dedicated to ensuring the timely availability of essential domestic industrial resources to support national defense and homeland security requirements, accessed January 24, 2022.

10. For the purposes of the DPA, the definition of national defense includes military and energy production, military or critical infrastructure assistance to any foreign nation, homeland security, space, stockpiling, emergency preparedness activities under The Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C 5195 et seq.), and critical infrastructure protection and restoration, accessed February 16, 2022.

11. The Office of the Assistant Secretary for Preparedness and Response runs the SCCT.

12.FDA’s Resilient Supply Chain and Shortages Prevention Program will enhance Center for Devices and Radiological Health’s capacity to enable rapid intervention to prevent and mitigate supply chain interruptions, accessed February 16, 2022.

13. The SCCT does not control the number of participating hospitals and long-term care facilities. It is based on the number reporting through teletracking and the CDC’s National Healthcare Safety Network.