CSL Vifor: Ferinject journal supplement breached Code for unqualified use of “safe” (AUTH/3679/8/22)

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Key facts

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Case number	AUTH/3679/8/22
Parties	Complainant v CSL Vifor
Product	Ferinject (ferric carboxymaltose)
Material	Promotional supplement/article in The British Journal of Cardiology (“Intravenous iron therapies and their differences”)
Applicable Code year	2019
Complaint received	04 August 2022
Case completed	04 September 2023
Appeal	No appeal
Breach clauses	Clause 7.9
No breach clauses	Clauses 3.2, 7.2, 7.3, 7.4, 9.1
Sanctions	Undertaking received; additional sanctions not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous complainant challenged claims in a Ferinject (ferric carboxymaltose) promotional supplement published on the British Journal of Cardiology website (article: “Intravenous iron therapies and their differences”).
The complainant alleged the article: (1) did not state primary endpoints and relied on post hoc/meta-analysis data (inadequate evidence), (2) invited inappropriate comparisons across studies via a table of ongoing trials, (3) used the word “safe” in key messages, and (4) promoted Ferinject outside its licence.
CSL Vifor argued the supplement comprised five articles intended to be read together and was certified as a single piece; it also argued “safe” referred to IV irons as a class and was qualified by safety/tolerability discussion in the article/supplement.
The Panel disagreed that readers must view the whole supplement: each online article had its own webpage and therefore needed to stand alone for Code compliance.
The Panel found that the key message “Intravenous iron is a safe and effective treatment” in a Ferinject promotional article amounted to a “Ferinject is safe” claim, and the surrounding safety discussion did not qualify the use of “safe” in the key messages.

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Breach of Clause 7.9 (2019 Code): use of the word “safe” without qualification.
No breach of Clause 7.2: claims not established to be misleading (including primary endpoint allegation and narrow meta-analysis allegation).
No breach of Clause 7.4: claims not established to lack substantiation (post hoc and meta-analysis use not prohibited if Code requirements met).
No breach of Clause 7.3: comparison not established to be misleading (table compared study designs; no results presented).
No breach of Clause 3.2: off-licence promotion not established in context (SPC section 5.1 referenced HF/iron deficiency studies; discussion focused on HF patients with iron deficiency).
No breach of Clause 9.1: high standards allegation not established (article included some side effect information; HCPs unlikely to think there were no side effects).

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Breach of Clause 7.9 Use of the word 'safe' without qualification.
No Breach of Clause 7.2 Requirement that claims must not be misleading
No Breach of Clause 7.3 Requirement that a comparison must not be misleading
No Breach of Clause 7.4 Requirement that claims must be capable of substantiation
No Breach of Clause 3.2 Requirement that the promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
No Breach of Clause 9.1 Requirement that high standards must be maintained at all times

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