Fixing the Structural Weaknesses in the Global Drug Supply Chain

The global medicine supply chain faces mounting strain from chronic generic drug shortages, geopolitical tensions, and heavy reliance on geographically concentrated manufacturing. Quality failures, pricing pressures, and opaque sourcing of key starting materials have exposed structural vulnerabilities that extend beyond routine disruptions to broader national security and public health risks. 

In a two-part series of the Off Script: A Pharma Manufacturing Podcast, we spoke with Ronald T. Piervincenzi, Ph.D., CEO of the U.S. Pharmacopeia, on the root causes of these vulnerabilities and the structural changes needed to address them.

In part one, Piervincenzi explains why generic drug shortages and national security concerns are often conflated, how extreme price erosion is driving manufacturers out of the market, and what USP’s data reveals about supply concentration, including the critical role of key starting materials sourced from countries like China and India. The conversation also dives into USP’s new Resilience Center and the strategic role it will serve in improving supply chain security.

In part two of the discussion, Piervincenzi discusses the economic and structural barriers to rebuilding domestic capacity for APIs and key starting materials, and explains why resilience will require coordinated incentives that reward supply security rather than simply the lowest price. He also explores how advanced manufacturing approaches could help make domestic production more viable by improving efficiency and reducing environmental impact.The conversation also examines how global quality standards can enable trusted international manufacturing networks among allied countries.