AUTH/2589/3/13: Pharmacosmos/PMCPA Director v Vifor Pharma UK – Ferinject ad alleged to breach prior undertakings (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2589/3/13
Parties	Pharmacosmos/PMCPA Director v Vifor Pharma UK
Complaint received	25 March 2013
Case completed	24 April 2013
Applicable Code year	2012
Product	Ferinject (ferric carboxymaltose)
Challenged material	Advertisement ref UK/FER/12/0163c in Gastrointestinal Nursing, January 2013
Key claim at issue	“Non dextran carboxymaltose shell”
Other ad bullet points noted	“Effective in increasing haemoglobin when inflammation is present”; “1000mg can be administered in 15 minutes by IV injection and IV infusion”
Issue type	Alleged breach of undertaking
Clauses considered	Clause 2; Clause 25
Decision	No breach (no breach of Clause 25; therefore no breach of Clause 2)
Appeal	No appeal

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

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Pharmacosmos A/S complained about a Vifor Pharma UK advertisement for Ferinject (ferric carboxymaltose) (ref UK/FER/12/0163c) published in Gastrointestinal Nursing, January 2013.
The ad showed a leaping ballerina and three bullet points, including: “Non dextran carboxymaltose shell”.
The complaint alleged the “Non dextran…” claim was a further attempt to imply a safety advantage over Pharmacosmos’ Cosmofer (iron dextran) by suggesting dextran-based products have safety concerns.
The matter was taken up by the PMCPA Director because it was framed as an alleged breach of undertakings given in earlier cases (AUTH/2422/7/11 and AUTH/2442/10/11).
Vifor argued the claim described Ferinject’s physiochemical properties and linked to administration per the Ferinject SPC (Section 4.2), not to safety or hypersensitivity, and therefore was not covered by the prior undertakings.

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No breach of the Code was ruled in relation to the alleged breach of undertaking.
No breach of Clause 25 (breach of undertaking) was found.
Consequently, no breach of Clause 2 was found.

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