Drug-testing lab sues US Pharmacopeia over alleged false statements about testing methods

Valisure, a laboratory known for testing drug impurities, has filed a lawsuit in a U.S. court accusing the United States Pharmacopeia (USP) of making false and misleading statements about its testing methods.

The suit alleges that USP’s 2023 white paper claimed Valisure used "unvalidated methods" that could produce "misleading results" and cause "unnecessary concern" among the public. Valisure says these remarks were intended to portray its own approach as universally safe while casting doubt on other testing practices.

Valisure further contends that USP made the statements to bolster confidence in a standards system that financially benefits the organization. The lawsuit adds to an ongoing dispute between the lab and regulators over the detection of impurities in widely used medicines.