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Perspective

Substandard Generic Drugs — Threats to Patient Safety and National Security

Authors: Kevin Schulman, M.D. https://orcid.org/0000-0002-8926-5085, and Arthur L. Kellermann, M.D., M.P.H.Author Info & Affiliations
Published March 18, 2026
DOI: 10.1056/NEJMp2518256

Abstract

Some foreign pharmaceutical plants that export generic drugs to the United States have glaring quality problems that can lead to drug shortages. There is a better way to assure the safety of generic drugs.

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Notes

This article was published on March 18, 2026, at NEJM.org.
Disclosure forms provided by the authors are available at NEJM.org.

Supplementary Material

Disclosure Forms (nejmp2518256_disclosures.pdf)

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