CPHI Milan: How USP Will Shape Procurement Decisions

In part 2, of a 3-part interview, Ronald T. Piervincenzi, CEO, US Pharmacopeia (USP), argues that drug supply chain resilience has drawn more headlines than concrete action. Purchasers and manufacturers, he says, should not wait for policymakers to catch up.

Access Part 1 of this interview, in which Piervincenzi explains how benchmarking could reward reliable generic drug suppliers.

"There have been more news items than actions taken so far, and I suppose that's probably typical when you have a topic that's become a hot topic among policymakers," Piervincenzi says. He points to European laws that are making small but real differences on onshoring like the Critical Medicines Act encourages local production and resilient infrastructure. He also cites ongoing friendshoring discussions, where USP serves as an information provider to policymakers, and a growing overlap between resiliency and security. With roughly 2,000 different medicines on the market, making everything in every country is impossible and prohibitively expensive. Delaying more reasonable measures, however, risks policy that goes too far or is less well informed.

"So what we're advocating is for both the purchasers of medicines, as well as industry, to start taking some of those early actions now, and to help to create and lead to creating better policy," he says.

Those early actions start with data. The USP Medicine Supply Map traces where medicines originate. It covers finished dose, active pharmaceutical ingredients (APIs), and, increasingly, key starting materials. According to Piervincenzi, most shortages trace back to familiar drivers: quality issues and overreliance on a single location or manufacturer. USP has also previously flagged geographic concentration, manufacturing complexity, and low prices as vulnerabilities.

"The difference now is we have the map that can show us exactly where that is," Piervincenzi says. Procurers can then shift sourcing toward suppliers with stronger quality track records. He calls these changes relatively near term, although their full effect across the supply will take longer to arrive.

That approach underpins the newly launching USP Resiliency Center. USP has built a proof of concept for a benchmarking methodology and is now moving to implementation. It plans to develop resilience benchmarks through its transparent, open standard-setting process. It will then work with public- and private-sector procurers to build those benchmarks into buying decisions.