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Talk to a SpecialistTalk to a SpecialistCSL Behring violated FDA regulations when its direct-to-consumer television advertisement for HIZENTRA (Immune Globulin Subcutaneous) overstated the drug's effectiveness and minimized safety information, resulting in misbranding under the Federal Food, Drug, and Cosmetic Act. The advertisement created a misleading impression that HIZENTRA was more effective than demonstrated by substantial evidence while downplaying known risks including thrombosis, hypersensitivity reactions, aseptic meningitis syndrome, and renal dysfunction. This violation raised public health concerns by potentially deceiving consumers about the true risk-benefit profile of the biological product.