Drugs

Valisure Sues USP Over Criticism of Drug-Testing Methods

Valisure has sued the United States Pharmacopeia (USP), accusing the standards-setting organization of making false and misleading statements about the laboratory's methods for detecting potentially harmful impurities in medicines.

The lawsuit centers on a 2023 USP white paper titled Unvalidated Methods for Medicine Quality Testing Can Lead to Misleading Results and Unnecessary Concern. The paper criticized Valisure's analytical approaches, arguing that improperly validated or adapted testing methods can generate misleading drug-quality findings.

Valisure alleges that USP's statements were intended to discredit its testing and portray USP's own standards and methods as inherently reliable, according to media reports on the lawsuit. The laboratory also contends that USP has a financial interest in maintaining confidence in its standards because USP develops and publishes pharmaceutical quality standards used throughout the drug industry.

The dispute stems in part from Valisure's high-profile testing of drug impurities, including its 2019 findings of N-nitrosodimethylamine in ranitidine (see earlier story). Valisure's testing prompted an FDA investigation and ultimately contributed to the withdrawal of ranitidine from the U.S. market.

FDA previously criticized Valisure's laboratory practices. In a 12/2022 untitled letter (see story), the agency raised concerns about methodological deficiencies and analytical discrepancies and said Valisure had inappropriately applied USP methods in some testing. USP subsequently cited the episode in its white paper as an example of how changing, adapting or incorrectly applying compendial methods can undermine method validation and produce inaccurate results.

The scientific dispute has continued beyond ranitidine. Valisure has also reported benzene contamination in benzoyl peroxide acne products, prompting a 2024 citizen petition to FDA. FDA's subsequent testing found elevated benzene in six of 95 tested benzoyl peroxide products, leading manufacturers of those products to issue recalls.

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