CSL Behring
2 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
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…
FDA published a close-out letter on May 21, 2026. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The DTC TV ad overstates the effectiveness of HIZENTRA by implying it protects against all germs and that the immune system is being restored, which is not supported by the approved indication.
Supporting FDA text
Source excerpt · automated text-match checkThe 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.
The ad misleadingly suggests HIZENTRA provides complete protection from all germs and restores the immune system, which is not supported by the approved indication.
Supporting FDA text
Source excerpt · automated text-match checkThe 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.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Submit a written response within 15 working days addressing the concerns described in the letter, listing all other promotional communications (with the 2253 submission date) for HIZENTRA that contain representations such as those described, and explaining a plan for discontinuation of such communications or ceasing distribution of HIZENTRA.
- Include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concerns discussed in the letter, to be distributed to the audience(s) that received the promotional communication(s) identified in the opening paragraph, using the same media, duration, and frequency as the original promotional communication(s), and free of promotional claims.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.