An Analysis of a Recent Publication in the New England Journal of Medicine: Substandard Generic Drugs

Cited publication: Schulman K, Kellermann AL. Substandard Generic Drugs: Threats to Patient Safety and National Security. N Engl J Med. Published March 18, 2026. DOI: 10.1056/NEJMp2518256. Copyright 2026 Massachusetts Medical Society.

Generic drugs account for more than 90% of prescriptions filled in the United States. A newly published perspective in the New England Journal of Medicine by Kevin Schulman, M.D. (Stanford) and Arthur L. Kellermann, M.D., M.P.H. (Emory) presents a five-point framework of recommendations directed at the FDA and policymakers. The purpose of this piece is to provide a short comment and highlight three out of the five noted points within this perspective, primarily to emphasize its importance.

Point One is important because it provides a novel perspective on whether or not the FDA should continue to claim and assure equivalent product quality between brand-name and generic drugs. If we are acknowledging that equivalent quality can no longer be assured, there are market inefficiencies that could be resolved, specifically the practice of basing purchasing solely on price under the assumption that quality is the same, rather than evaluating price against quality.

Point Four proposes making drug quality scores public, which would represent an entirely new criterion for this industry. For this to work, it would need to be well designed and robust, from many facets, beyond just who and what is tested.

"If drug-quality information were widely available, patients, health systems, and pharmacies would reward high-quality suppliers with contracts and market share. Structurally, transparency would drive the market toward higher quality more quickly and definitively than episodic FDA plant inspections can do."

Schulman & Kellermann, NEJM, DOI: 10.1056/NEJMp2518256

This quote demonstrates both the opportunities, if executed properly, as well as the industry impact and potential for positive change across multiple landscapes.

Point Five addresses domestic manufacturing capacity, which has been recently noted as critically important. We continue to see this as a foundational solution to systemic supply chain problems.

Read the full perspective: Substandard Generic Drugs: Threats to Patient Safety and National Security (NEJM, March 18, 2026).

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This piece represents the perspective of George Kwiecinski, Co-Founder and CEO of Global Key Solutions.

This piece is published as a case study representing ongoing GKS work in this landscape as of the date of publication.