FDA: Wyeth's DTC for ReFacto has unsubstantiated safety claims

A Wyeth Pharmaceuticals direct-to-consumer brochure for ReFacto antihemophilic factor contains unsubstantiated safety claims, according to an FDA notice of violation letter. The brochure, titled “Bob's World,” contained a “Pathogen Safety” sub-section claiming state-of-the-art manufacturing techniques to optimize pathogen safety.

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