CSL Behring

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The U.S. Food and Drug Administration (FDA) has reviewed the Direct-to-Consumer broadcast advertisement (DTC TV ad), *Live in Strength: Supermarket* (USA-HIZ-0963), submitted at time of first use by CSL Behring (CSL) for HIZENTRA (Immune Globulin Subcutaneous (Human)) under cover of Form FDA 2253.***1*** FDA has determined that this DTC TV ad overstates the effectiveness and minimizes the information about the safety of HIZENTRA.

Passage 2

The overall impression of this DTC TV ad, including its imagery and the above statements, misleadingly overstates the efficacy of HIZENTRA. HIZENTRA is indicated as replacement therapy for primary humoral immunodeficiency. Yet, in this DTC TV ad, the woman treated with HIZENTRA effectively is protected from all the germs around her, and her statement that her immune system is being restored is particularly concerning. Replacement therapy replaces what is missing or not functioning properly; it is not a cure and does not make one impervious or provide an extra layer of protection or effectiveness beyond that in the infusion, which is derived from normal human plasma.