One of the many hard lessons learned from Covid-19 has been that a robust and resilient domestic public health industrial base is essential to the health and security of the United States.
Early in 2020, as the pandemic emerged in the U.S., hospital executives; nursing home directors; clinicians; federal, state, and local officials; and so many others scrambled to get shipments of masks, gowns, and other personal protection supplies from around the world. Companies racing to develop diagnostic tests, therapeutics, and vaccines competed against each other for raw materials and supplies necessary for manufacturing.
The U.S. has come a long way since then, in part due to improvements in American production capacity and capability. Yet both remain far short of what the country needs for pharmaceuticals and medical supplies.
Take the drug manufacturing supply chain as an example. It generally starts with suppliers of raw materials such as the solvents, reagents, and other chemicals used to manufacture intermediate chemical compounds, key starting materials, and active pharmaceutical ingredients that become vaccines or therapeutics. As of March 2021, 73% of the FDA-registered facilities that manufacture raw materials into active pharmaceutical ingredients were outside the U.S. And that percentage does not reflect that many of those facilities are themselves dependent on intermediate compounds imported from other countries. The vast majority of other essential public health supplies, such as N95 respirators, are also manufactured overseas.
Disruptions in the supply chain for health care supplies and pharmaceutical ingredients during this pandemic have put Americans’ lives — and livelihoods — at risk. That’s true, too, for the needles, syringes, and vials needed to administer vaccines and therapeutics.
In response to the heightened understanding of supply-chain vulnerabilities that became apparent during the early days of the pandemic, the U.S. Department of Health and Human Services stepped up efforts to immediately expand the supply chain, while also focusing on longer-range strategic expansion, innovation, and resilience.
Boosting U.S. production requires a blend of targeted investments, financial incentives, and research and development to create new manufacturing technologies, greater supply-chain transparency and management, and better data collection.
To be ready and able to respond to the next pandemic or other public health emergency and to protect the economy, industrial capacity and capabilities must be expanded, used, and sustained. Such readiness requires unified, long-term investments that boost production and that rely on commitments from both the public and private sectors to use these domestically made products. These factors will drive manufacturing innovation and novel business practices to reduce price points and make domestic manufacturing feasible again.
The announcement by the Biden-Harris administration in late July that the federal government will use its purchasing power to create steady demand for essential pandemic-response products made in America is another immediate step that supports the expansion of domestic manufacturing. It comes on top of a more than $1 billion investment by the White House and Congress to expand American production capacity for critical pandemic-response needs across the drug manufacturing and health care supply chains.
Since the pandemic began, the Department of Health and Human Services and the Department of Defense have collaborated on more $4 billion of investments to increase domestic production of personal protective equipment, vaccines, diagnostics, pharmaceuticals, and the spectrum of supplies needed to make and administer vaccines. This kind of strategic sourcing not only provides a reliable supply chain of pandemic supplies but also reduces the risk for industry partners by connecting their products with actual customers in the government and the private sector. That 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.
To promote innovation and expansion, including novel ways to get essential drugs or other supplies to places where they are needed in an emergency, HHS created a program office for innovation and industrial base expansion. This office, known as IBx, is overseen by HHS’s Assistant Secretary for Preparedness and Response, who coordinates the federal government’s public health and medical response to emergencies.
IBx works across government, academia, and the private sector to identify and support innovations that proactively expand the medical supply chain and prepare for the next public health emergency. Its scope includes promoting a culture of quality so companies develop and maintain the ability to consistently provide products that meet regulatory requirements and the public’s need.
IBx has taken steps to expand and secure domestic manufacturing sources through investments in novel platforms that make it possible to make ingredients for small-molecule and biologic drugs as well as complete drug products in completely new ways that are less dependent on foreign suppliers. Experts within the Office of the Assistant Secretary for Preparedness and Response also are working closely with the FDA and key stakeholders in the existing domestic supply chain to gather accurate, timely data on supplies and projected shortages of essential medicines, key starting materials, and active pharmaceutical ingredients.
While IBx supports expansion of the broader industrial base and innovative processes, another arm of the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority (BARDA), focuses on specific, critical components. For example, BARDA has been working with companies to expand the industrial supply chain in order to manufacture hundreds of millions of doses of Covid-19 vaccines in just months. These components include the raw materials to make vaccines as well as single-use consumables such as sterile packaging, tubing, connectors, assemblies, needles, syringes, and vials. It also entailed expanding factories to fill those vials with vaccine doses — all done with American ingenuity and American workers.
This effort across multiple government offices, which includes private-sector experts, will lead to new ways to deliver life-saving therapeutics, vaccines, and other interventions, as well as new and better ways to prevent and respond to health emergencies of any kind. From the development of portable technology that creates sterile saline from tap water to capabilities that can make essential medicines on demand, investments made today not only help save lives and end the pandemic but also protect the U.S. from future public health emergencies.
Even as the pandemic response continues in the U.S. and across the globe, the U.S. has a unique opportunity to apply lessons from the Covid-19 pandemic to create a sustainable public health supply chain. If funded appropriately, implemented rapidly, and used consistently, expanded domestic manufacturing will improve the nation’s health security at the same time as it fosters innovation, efficiency, and resilience for the private sector.
Gary Disbrow is the director of the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Ian Watson is the director of the Office of Strategy, Policy, Planning, and Requirements, which is part of the same HHS office.