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USP: mapping shows upstream concentration of APIs/KSMs; calls for benchmarks and advanced manufacturing support
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Summary
United States Pharmacopeia told the House subcommittee its medicine‑supply mapping shows geographic concentration of key starting materials and APIs, and recommended a data‑driven approach that includes resiliency benchmarks, expanded supply‑chain visibility and support for advanced manufacturing technologies.
The United States Pharmacopeia (USP) told the House Energy and Commerce Subcommittee that its medicine supply map now covers roughly 94% of U.S. drug products and ingredients and shows a high degree of geographic concentration for key starting materials (KSMs) and active pharmaceutical ingredients (APIs).
USP CEO Ronald J. Piervincenzi testified that the map identifies more than 100 vulnerable medicines that are both at high risk for disruption and hard to substitute therapeutically. Using that evidence, USP urged a set of targeted interventions: continuous identification of vulnerable medicines, investment in advanced manufacturing and alternative synthetic pathways for APIs, resiliency benchmarks for purchasers, and greater use of supply‑chain visibility tools.
Why it matters: USP framed the problem as an upstream vulnerability — many APIs and starting materials are produced in a small number of locations — and said that once the source is mapped it becomes possible to develop alternative synthesis routes or invest in domestic/nearshore production at reasonable cost.
Selected testimony excerpts and recommendations: - "Over 80% of key ingredients and raw materials used in U.S. medicines are manufactured abroad today," Piervincenzi said, and he noted that China’s filings for APIs rose rapidly in recent years. - USP recommended establishing a resiliency benchmark that purchasers (public and private) could use so that contracts and stockpiles value supply reliability and consistency, not just the lowest price. - USP urged Congress to fund and support advanced manufacturing and to invest in KSM and API production as parts of a multi‑year strategy to reduce upstream vulnerability.
Ending: USP told the committee the mapping work makes precise where investments are needed and that targeted investments in chemistry and manufacturing can create durable alternatives to current single‑point dependencies.
