AUTH/2473/1/12: Vifor Pharma – Ferinject journal ads not UK-certified (Clause 14.1 x3) | PMCPA Case

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Key facts

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Case number	AUTH/2473/1/12
Company	Vifor Pharma Limited
Product	Ferinject (ferric carboxymaltose) solution for injection/infusion
Indication (as stated)	Treatment of iron deficiency when oral iron preparations were ineffective or could not be used
Material	Three journal advertisements (international journals; UK-produced)
Journals	European Journal of Heart Failure (Jan 2012); European Heart Journal (Dec 2011); NDT/Nephrology Dialysis Transplantation (Dec 2011)
Issue	Advertisements not certified in accordance with the UK Code
Applicable Code year	2011
Complaint received	24 January 2012
Case completed	23 March 2012
Breach clauses	Clause 14.1 (x3)
Sanction	Undertaking received
Appeal	No appeal
Notable related point	Panel concerned ads used strapline “Mastering the art of iron therapy” previously ruled in breach (AUTH/2423/7/11); no ruling here as not part of complaint/voluntary admission

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

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Vifor Pharma informed the PMCPA that three advertisements for Ferinject (ferric carboxymaltose) solution for injection/infusion placed by its global colleagues in international journals had not been certified in accordance with the UK Code.
The ads appeared in:
- European Journal of Heart Failure, January 2012 (artwork placed 28 November 2011)
- European Heart Journal, December 2011 (artwork placed 3 November 2011)
- NDT (Nephrology Dialysis Transplantation), December 2011 (artwork placed 11 November 2011)
Vifor stated the journals were produced in the UK for European/international circulation (including UK circulation): editorial offices managed through the UK; typeset in Salisbury; printed in Glasgow.
Vifor trained global teams on the Code in December 2011 and revised processes; the ads were placed before that training.
The PMCPA also noted the ads used the strapline “Mastering the art of iron therapy”, previously ruled in breach in AUTH/2423/7/11, raising concern about a potential breach of an earlier undertaking—however this was not ruled on in this case because it was not part of the complaint/voluntary admission.

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The Panel found the advertisements were within the scope of the Code because the journals were considered produced in the UK (per supplementary information to Clause 1.1 on journals with international distribution).
Breach ruled: the three advertisements had not been certified, so Clause 14.1 was breached in relation to each advertisement (x3).
No ruling was made on any potential breach of undertaking relating to the strapline, but the Panel asked that Vifor be advised of its serious concerns.

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