Following a three-month review of vulnerabilities in the US supply chain for products important to national security, the Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients. The initiative calls for the Department of Health and Human Services (HHS) to establish a public-private consortium for advanced pharmaceutical production to strengthen domestic competitiveness and supply chain resilience in this area.1
A detailed report presents strategies for preventing supply chain disruptions in several key industrial sectors. The broader aim is to ensure ready access for U.S. manufacturers to semiconductor chips, rare earth elements and large capacity batteries for electric vehicles, as well as pharmaceutical ingredients.2 Such gains will bolster America’s economic and national security and address transitory supply chain challenges. Continued US dependence on key pharmaceutical products and active pharmaceutical ingredients (APIs) from overseas has been driven by pressures to lower costs, the report acknowledges, a situation that leaves the medical supply chain vulnerable and warrants new approaches to support domestic production.
FDA acting commissioner Janet Woodcock applauded the announcement, noting that the COVID-19 pandemic revealed “just how vulnerable the supply chain is” and that it is “essential for the national and health security and economic prosperity of the United States.”3 The report recommends actions long backed by Woodcock and other FDA officials, including a boost in local pharmaceutical production, R&D to advance innovative manufacturing technologies, robust quality management maturity to support reliable drug manufacturing, and leveraging data to improve supply chain resilience.
To start, the HHS consortium will select 50-100 critical drugs from the “essential medicines” list established by FDA, as part of an earlier federal initiative.4,5 The aim is to advance the development of novel platform technologies for domestic production of active pharmaceutical ingredients (APIs), particularly those for widely used generic drugs. The initiative will be able to tap $60 million provided by the American Rescue Plan to spearhead investments in advanced manufacturing technologies, such as systems with on-demand manufacturing capabilities, to increase production of key pharmaceuticals and ingredients.
FDA anticipates playing a prominent role in advancing these and other supply chain resiliency initiatives and is working with other HHS agencies to develop a further plan for designing and building the long-term capability for US manufacture of supplies to combat future pandemics and biological threats.6 And to increase transparency of product sources throughout the pharmaceutical supply chain, HHS will seek legislative authority in two areas:the ability to track API sourcing and production by facility, and a requirement that all pharmaceuticals sold in the US identify the sources of APIs and finished dosage forms on labeling.
The supply chain security report acknowledges that the shift of drug manufacturing overseas, particularly for generic drug APIs, has reduced US costs by trillions of dollars in the past decade, but has left the American health care system vulnerable to shortages of essential medicines. Change is needed, as the COVID-19 pandemic has highlighted the critical importance of a resilient US healthcare manufacturing sector and of the nation’s ability to rapidly develop and strengthen production of vital vaccines and medical products.