STAT+: Drug-testing lab that has sparked controversy sues group that develops drug standards over criticism — SkimNews
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- Valisure filed a lawsuit in U.S. court accusing U.S. Pharmacopeia (USP) of making false and misleading statements about its drug-testing methods, according to court filings.
- Valisure alleges USP inaccurately claimed the lab uses "unvalidated methods" that produce "misleading results" and "unnecessary concern" about medicine safety.
- The contested remarks appeared in a 2023 USP white paper, which Valisure contends portrayed standards-body testing as "inherently and universally safe" while casting competing approaches as threats to public confidence.
- Valisure argues USP issued the criticism to promote trust in a medicine-quality system that "financially benefits" USP itself.
- The lawsuit stems from Valisure's prior run-ins with regulators over impurities the lab detected in widely used medicines — the same testing USP is now attacking as unreliable.
Why it matters: The suit puts a high-profile drug-testing dispute into the courts rather than the regulatory arena, where Valisure and USP have previously clashed. If Valisure prevails, USP's 2023 white paper — a document that shapes how pharmacists, manufacturers, and regulators evaluate independent impurity testing — could be ruled defamatory and misleading, weakening the standards body's authority.
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