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

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.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. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe