AUTH/3465/2/21: Complainant v Vifor — Venofer symposium and alleged off-licence promotion (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3465/2/21
Company	Vifor Pharma UK Limited
Complainant	Anonymous, contactable complainant (concerned UK health professional)
Medicine	Venofer (iron sucrose for intravenous administration)
Allegation	Off-licence promotion via use of the PIVOTAL study in a sponsored symposium
Material	Sponsored symposium: “High dose proactive intravenous iron treatment in ESKD – sub-analysis of the PIVOTAL study” (15 minutes; October 2020)
Applicable Code year	2019
Clauses considered	2, 3.2, 9.1
Panel decision	No breach (including no breach of Clause 2)
Complaint received	1 February 2021
Case completed	25 August 2021
Appeal	No appeal

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

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An anonymous, contactable complainant (a concerned UK health professional) alleged Vifor Pharma UK Limited used the PIVOTAL study to promote off-licence use of Venofer (iron sucrose IV).
The complaint related to a Vifor-sponsored 15-minute symposium (October 2020) titled: “High dose proactive intravenous iron treatment in ESKD – sub-analysis of the PIVOTAL study”, hosted on another party’s website.
The complainant argued PIVOTAL’s “proactive” high-dose approach meant patients did not need to have iron deficiency to receive treatment (treatment was withheld only if ferritin was high), so using the study in promotion was likely to encourage off-licence use.
The Authority asked Vifor to consider Clauses 3.2, 9.1 and 2 of the Code.
Vifor responded that the Venofer SPC did not specify exact laboratory cut-offs for iron deficiency and that PIVOTAL’s ferritin/TSAT thresholds were within clinically accepted definitions of (classical and functional) iron deficiency in haemodialysis patients, citing British Society for Standards in Haematology guidance (Thomas et al 2013).

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No breach of the Code was ruled.
The Panel did not consider the complainant had shown Venofer use in PIVOTAL was off-licence; it appeared consistent with the SPC indication and clinically accepted definitions of iron deficiency in haemodialysis patients.
No breach was ruled for Clause 3.2; consequently no breach was ruled for Clauses 9.1 and 2.

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