Drug Supply Chain Reliability Assessment Programs

Drug shortages, which most frequently affect low-priced generic drugs, often have devastating impacts on U.S. patients. The U.S. market for already-inexpensive generic drugs, which make up a small fraction of U.S. drug spending, often emphasizes achieving the lowest price at a point in time over ensuring reliable drug availability over time. While limiting costs should remain important, low-cost generic drugs do not benefit patients if they are not available. Policymakers and supply chain actors should shift the market for critical generic drugs to focus more on reliable drug availability than it does today.

Supply chain reliability assessment programs can be a key component in achieving this competitive shift. Supply chain assessment programs that objectively evaluate manufacturer supply chains and communicate findings to the market can help to enable improved drug purchasing and contracting decisions in pursuit of a more reliable supply for patients. Using the following eight criteria, Duke-Margolis identified three supply chain assessment programs (HIRC’s Resiliency Badge Program, USP’s Resiliency Benchmark, and FDA’s Quality Management Maturity Program) that may be positioned to support this competitive shift.

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