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Certification Marks for Supporting Generic Drug Quality

Published online by Cambridge University Press:  28 April 2025

Lars Lindgren
Affiliation:
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States
Aaron S. Kesselheim
Affiliation:
Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
S. Sean Tu*
Affiliation:
West Virginia University College of Law, Morgantown, WV
*
Corresponding author: Shine Sean Tu; Email: [email protected]

Abstract

Certification marks are a type of trademark used to show that a product or service meets specific standards or qualities set by an independent organization (not by the manufacturer or seller). Certification marks could enhance the quality perception and oversight of generic drugs. Despite the FDA’s rigorous regulatory framework, skepticism about generic drug quality persists among patients and prescribers, partly due to the FDA’s limited ability to inspect manufacturing facilities. Independent certification marks — similar to USDA Organic or Energy Star labels — could help communicate drug quality information more effectively to consumers, incentivize manufacturers to exceed baseline standards, and bolster trust in generics. Such a system could operate without legislative changes and offer a cost-effective supplement to existing FDA inspections, particularly given the challenges posed by an increasingly globalized drug supply chain and current FDA resource constraints.

Keywords

Type
Columns: Health Policy Portal
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

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Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at [email protected].

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