Strategic Goal 3

National Health Security Strategy (NHSS) 2023-2026

Strategic Goal 3:
Ensure a resilient and sustainable public health industrial base and supply chain that can rapidly develop and deploy safe medical countermeasures

The COVID-19 pandemic exposed vulnerabilities in the nation’s ability to provide public health supplies critical to mitigating the spread of SARS-CoV-2 and reduce morbidity and mortality. Many of these supply chain challenges are not unique to the COVID-19 pandemic. Offshore manufacturing and just-in-time supply chain practices can disrupt the U.S. public health supply chain in the event of extreme weather, shifting geopolitical forces, global competition for resources – especially in times of high demand – and other factors, including concerns related to ethical production. These challenges illustrate the need to build more sustainable domestic manufacturing capacities that are resilient to shifting demand, can be adapted for new and emerging health security threats, and can meet the health needs of the whole population, especially during public health emergencies and disasters.

3.1 Expand domestic manufacturing capacity, supply chain diversity, and international partnerships with neighbors and allies to fortify a resilient and flexible public health supply chain

The public health supply chain is a vital component of U.S. national health security and preparedness and response efforts. However, the United States has inadequate domestic manufacturing capacity to meet U.S. demand for all needed public health supplies, especially during public health emergencies and disasters. In addition, the United States is dependent on foreign sourcing and offshore manufacturing for some critical public health supplies. In some cases, critical supplies are sourced from or manufactured in one location. Given that the public health supply chain is driven by the private sector, incentivization and coordination can help expand domestic manufacturing capacity.

A diversified supply chain with built in redundancies along with increased domestic manufacturing capacity, diversified distribution outlets, and a skilled supply chain workforce^[g] will lead to a more flexible and scalable public health supply chain that is able to meet increased demand during large-scale emergencies. Implementing regulatory policies requiring greater supplier diversity, incentives—such as production subsidies and tax incentives—and continued investment in innovation to mitigate vulnerabilities of single-sourced materials is vital to having a nimble supply chain structure. Rapidly produced and accurate standards for quality assurance can increase domestic manufacturing to ensure products not only meet demand but are of sufficient quality to meet the purpose. For example, fast production of standards for diagnostic tests could speed production of at home-testing kits to reduce the strain on the health care system while providing the quality control needed to prevent costly false positives/negatives or wasting supplies in high demand due to product failures.

3.2 Strengthen partnerships with MCM suppliers, manufacturers, and distributors to monitor supply chain vulnerabilities and address shortages during an emergency

The public health supply chain is a multifaceted, dynamic, and interdependent system that produces and delivers critical public health supplies, including PPE, diagnostics, and other medical devices; as well as pharmaceuticals – therapeutics, biologics, and vaccines. To identify vulnerabilities, anticipate challenges, and prevent or mitigate disruptions, the U.S. Government should strengthen its industry partnerships to gain more insight and visibility into this complex system.

Robust, streamlined, and real-time information and data sharing between the U.S. Government and industry enables increased visibility into the public health supply chain. This can lead to better coordination between the public and private sectors when challenges occur. Greater visibility can also inform where additional capacity and capability investments may be needed, stockpiling requirements – including distribution needs during public health emergencies and disasters – and effective strategies to build resilience. The U.S. Government can leverage existing stakeholder engagement mechanisms across the interagency to strengthen its industry partnerships. There is also opportunity to expand the programs and tools developed during the COVID-19 pandemic to increase communication with industry and transparency into all components of the public health supply chain.

3.3 Promote innovation across the MCM development pipeline to accelerate the production and equitable deployment of agile, safe, and accessible MCMs

Newly emerging threats without existing diagnostics and treatments will require rapid MCM research and development pipelines. MCM development for unknown threats is a challenge in the United States and globally. MCM preparedness involves rapid development of standards and clinical research response to ensure that the candidate vaccines, therapeutics, and diagnostics are both safe and effective for all populations, including at-risk individuals. This requires standing global and domestic clinical research capacities in the form of integrated networks capable of rapidly pivoting to regulatory-level clinical trials. Sustained public and private funding for basic, translational, and clinical research to develop innovative technology is crucial to building MCM pipelines that are commercially viable and can be easily adapted to combat and mitigate an emerging infectious disease or unknown threat.

Stronger partnerships between research institutions, government, academia, private industry, and community-based philanthropies, along with innovative, adaptable, and scalable MCM development technologies, can facilitate rapid development of new MCMs to combat emerging threats. Promoting the development of innovative technologies and streamlining manufacturing processes can create more agile MCM pipelines that can scale up production quickly. Investing in MCMs that have other commercial applications can enable manufacturers to quickly repurpose existing products and pivot research and development to combat a new or emerging threat. In addition, producing safe and effective MCMs while improving regulatory capacity will further advance and modernize the MCM development process.

AMR is one of the major threats to the health care, veterinary, and agriculture sectors, and remains a concern as antibiotics are overprescribed and misused globally, fueling the evolution of resistant pathogens. Fewer new antibiotics are getting to market due to a lack of financial incentives, new economic models to incentivize antibiotic development and product approval are required. Many infectious diseases are becoming more difficult and expensive to treat as antibiotics become less effective.

Adopting strong antibiotic stewardship strategies and increasing the development of new treatment courses can combat the threat of drug-resistant organisms. Health care, public health, and private industry delivering collaborative communication and education on responsible antibiotic use can improve infection prevention and control. Increased research and development of new antibiotics, novel combination therapies, and new rapid diagnostics to detect AMR bacteria in clinical settings are vital to addressing the AMR threat. These strategies will require collaboration with the private industry to ensure a sustainable antibiotic market and sufficient quality of and access to treatments for everyone in need.

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^g The public health supply chain workforce includes manufacturing, stockpiling, and distribution workforces, as well others vital to the end-to-end public health supply chain.

The National Health Security Strategy
2023-2026