Supply Chain Resilience Was in Focus at CPHI Milan

Ahead of CPHI Milan 2026, PharmTech spoke with 2 leaders from the US Pharmacopeia (USP) about drug shortages, procurement, and the digital tools reshaping pharmaceutical supply chains. Across the conversations, one message stood out: manufacturers and buyers should act now rather than wait for policy to force their hand.

Shortages Are Fewer but Lasting Longer

USP’s June 2026 annual drug shortages report found that total shortage events fell 23% in 2025, but shortages are lasting longer, and product discontinuations rose 60% from 2024 to 2025.¹ Michael Levy, senior vice president, Digital & Innovation at USP, said the rise in discontinuations points to fragility upstream that goes beyond manufacturing problems, with natural disasters, geopolitical pressures, and policy changes all playing a role.²

Look Past the Policy Noise

In part 1 of a 3-part interview, USP CEO Ronald T. Piervincenzi urged manufacturers not to be distracted by the steady flow of policy news.³ Companies should avoid overreacting, he said, but should take seriously the global push for more resilient supply chains and pursue solutions proactively. He noted broad support for the idea that buyers should pay for resilience, but said purchasers currently lack the information and systems to do so.³

Piervincenzi observed that resilience has generated more news items than actions taken so far.⁴ He pointed to Europe’s proposed Critical Medicines Act and ongoing friendshoring discussions, but he cautioned that making all of the roughly 2000 medicines on the market everywhere is impossible and prohibitively expensive. Purchasers and industry that take reasonable steps early, he argued, can help steer policy away from overcorrection.⁴

Benchmarks to Reward Reliability

A centerpiece of USP’s strategy is its Drug Supply Chain Resilience Benchmark Initiative. Through the newly launching USP Resiliency Center, the organization has a proof-of-concept benchmarking methodology and plans to develop benchmarks through its open standard-setting process, then work with public and private procurers to build them into purchasing decisions.⁵ The aim is to make resilience worth paying for at the point of purchase rather than adding direct costs for manufacturers. “The clear trend is toward action,” Piervincenzi said.⁵

USP’s Medicine Supply Map, which traces where finished doses, APIs, and key starting materials originate, offers a near-term tool. Because most shortages stem from quality problems or overreliance on a single site or manufacturer, procurers can begin shifting volume toward suppliers with stronger quality records.⁴

One Resilient Supplier Is Not Enough

Piervincenzi described resilience as a collective-action problem.⁵ If a drug is split between a supplier that invests in alternative sourcing and stockpiles and a low-cost competitor that does not, a quality failure at the cheaper supplier still causes a shortage for every purchaser, because the remaining supply must be shared. “It isn't enough to have one medicine supplier be resilient,” he said. He also called for raising emerging regulatory systems toward international standards rather than lowering the bar of stringent regulators, which could broaden sourcing options such as nearshoring to Latin America.⁵

Digital Standards as the Foundation

Levy, previewing his CPHI panel “The Next Phase of Pharma Supply Chains,” argued that quality control labs need machine-readable, science-based digital standards built into lab information systems and regulatory platforms to cut manual handoffs and strengthen data integrity.² He positioned artificial intelligence as decision support, with scientists retaining judgment. “Technology alone is not the solution to digitalization,” Levy said, highlighting USP tools such as MethodConnect and USP-ID.²

References

1. USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. Accessed September 28, 2026. https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk
2. Haigney S, Levy M. CPHI Milan 2026: digital supply chains. PharmTech. September 28, 2026. https://www.pharmtech.com/view/cphi-milan-2026-digital-supply-chains
3. Piervincenzi RT, Cole C, Zubulake Z. CPHI Milan: USP benchmarks reshape procurement incentives. PharmTech. September 25, 2026. https://www.pharmtech.com/view/generic-drug-resilience-usp-benchmarks-reshape-procurement-incentives
4. Piervincenzi RT, Cole C, Zubulake Z. CPHI Milan: how USP will shape procurement decisions. PharmTech. September 28, 2026. https://www.pharmtech.com/view/how-usp-will-shape-procurement-decisions
5. Piervincenzi RT, Cole C, Zubulake Z. Why one reliable supplier isn't enough. PharmTech. Sept. 30, 2026. https://www.pharmtech.com/view/why-one-reliable-supplier-isn-t-enough