In response to the escalating rates of drug shortages in the United States, the Active Pharmaceutical Ingredient Innovation Center (APIIC) is urging the immediate establishment of a public supply-chain entity. This call to action is outlined in a comprehensive whitepaper titled ” A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in Five Years” Comprising a consortium of biotechnology industry leaders, policymakers, and academics, APIIC underscores the pressing need for collaborative efforts to safeguard the nation’s health security.
Drawing insights from leading manufacturers, patient advocates, and other public health stakeholders, the report emphasizes the imperative to counteract factors such as price erosion, industry consolidation, and offshore manufacturing dynamics. A key revelation in the report is that a significant portion of the nation’s top 100 generic drugs—83%, to be precise—lacks a U.S.-based source for the small-molecule active pharmaceutical ingredients (APIs) crucial for today’s medications. Additionally, 90% of frequently prescribed antivirals and antibiotics depend on APIs manufactured offshore, as indicated by researchers at the Olin Business School at Washington University.
APIIC’s recommendations are far-reaching, urging pharmaceutical manufacturers and policymakers to address these vulnerabilities through the adoption of advanced biomanufacturing technologies and the implementation of public incentive programs. The overarching goal is to revitalize dormant capacity within U.S. manufacturing facilities. The report explores critical aspects, including the current state of the workforce, technology adoption, and capacity in U.S. biomanufacturing.
Furthermore, the report delves into approaches for defining and prioritizing essential small-molecule selections for API production, considering factors such as geography and materials availability. It also explores the barriers and opportunities associated with mitigating health risks by diversifying the U.S. manufacturing base through the reshoring of API production.
Dennis Hall, Vice President of Advanced Manufacturing Technologies at U.S. Pharmacopeia (USP), emphasizes the historical significance of collaborative efforts, stating, “For more than 200 years, U.S. Pharmacopeia has brought healthcare professionals, scientists, and regulators together to ensure quality and trust in our drugs.” The APIIC report aligns with the Biden Administration’s ambitious goal to reshore 25% of small-molecule APIs within five years.
The report’s development involved a 15-member working group of subject matter experts from various sectors, including U.S. Pharmacopeia, Pfizer, Thermo Fisher Scientific, Angels for Change, Duke-Margolis Center for Health Policy, and other industry leaders. This collaborative effort, facilitated at a plenary event in November 2023 at the API Innovation Center in St. Louis, serves as a testament to the industry’s commitment to solving the complex issue of drug supply chain surety.
As the APIIC report aligns with calls from theWhite House Office of Science and Technology, the National Economic Council (NEC) Director, and the National Security Advisor (NSA) for a new approach to ensure reliable access to essential medications, it marks a crucial step toward achieving a resilient and secure drug supply chain in the United States.
About APIIC
The API Innovation Center (APIIC) is a 501(c)(3) non-profit public benefit organization headquartered in St. Louis, Missouri, dedicated to delivering a market-competitive commercial supply of U.S.-made Active Pharmaceutical Ingredients (APIs) to address national health security. By fostering collaboration among a network of companies, academic and research institutions, and startups, APIIC stewards innovations in advanced manufacturing and enables solutions for drug supply chain fragility. The Center also works to create a diverse talent pipeline by partnering with local educational and apprenticeship programs that target underrepresented communities. APIIC is supported by the State of Missouri through a grant awarded by the Department of Economic Development and the Missouri Technology Corporation. To learn more about APIIC, visit: www.apicenter.org.