STAT+: Drug-testing lab that has sparked controversy sues group that develops drug standards over criticism

A laboratory that tussled with regulators over impurities found in some widely used medicines has accused the group U.S. Pharmacopeia of making false and misleading remarks about its methods for uncovering safety problems.

In a lawsuit filed in a U.S. court, Valisure argued that USP, an independent organization that develops standards for medicines, inaccurately claimed it has used “unvalidated methods” for quality testing that can lead to “misleading results” and “unnecessary concern.”

Valisure maintained USP made these remarks in a 2023 white paper as part of an effort to portray its own testing methods as “inherently and universally safe, while suggesting that other testing approaching undermine public confidence” in medicines. Moreover, the lab alleged USP did so to promote trust in a system that “financially benefits” itself.

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