Valisure Sues U.S. Pharmacopeia Over Claims Its Drug-Testing Methods Are 'Unvalidated'
核心洞察
Valisure (搜索) has filed a lawsuit in a U.S. court accusing the U.S. Pharmacopeia (搜索) (USP) of making false and misleading remarks about its drug-testing methods.
The lab alleges USP inaccurately claimed Valisure (搜索) used "unvalidated methods" that can produce "misleading results" and "unnecessary concern" in a 2023 white paper.
Valisure (搜索) contends USP made the statements to portray its own testing methods as inherently safe while undermining public confidence in alternative approaches.
Valisure (搜索), a laboratory that has previously tussled with regulators over impurities found in some widely used medicines, has filed a lawsuit in a U.S. court accusing the U.S. Pharmacopeia (搜索) (USP) of making false and misleading remarks about its methods for uncovering safety problems.
In the lawsuit, Valisure (搜索) argued that USP, an independent organization that develops standards for medicines, inaccurately claimed the lab has used "unvalidated methods" for quality testing that can lead to "misleading results" and "unnecessary concern."
Valisure (搜索) maintained that 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.
The dispute centers on the credibility of independent drug-quality testing and the standards that govern how medicines are evaluated for safety. Valisure (搜索)'s legal action challenges what it characterizes as disparaging statements that could affect confidence in alternative testing approaches used to identify impurities in widely prescribed medications.