AUTH/2423/7/11: Pharmacosmos v Vifor Pharma – Ferinject leavepiece claims ruled misleading | PMCPA Case

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Key facts

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Case	AUTH/2423/7/11
Parties	Pharmacosmos v Vifor Pharma UK Limited
Material	Six-page gatefold leavepiece (ref 0090A/FER/2011), “Benefits of Ferinject in managing iron deficiency anaemia in inflammatory bowel disease (IBD)”
Medicine	Ferinject (ferric carboxymaltose solution for injection/infusion)
Main issues	Strapline implying special merit; clinic-time comparative graphics/claim based on SPC timings with an undisclosed added 15 minutes
Decision	Breach of Clause 7.2 (x2)
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	27 July 2011
Case completed	31 August 2011
Appeal	No appeal
Applicable Code year	2011

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

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Pharmacosmos complained about a six-page gatefold leavepiece for Ferinject (ref 0090A/FER/2011) titled “Benefits of Ferinject in managing iron deficiency anaemia in inflammatory bowel disease (IBD)”.
The leavepiece included the strapline “Mastering the art of iron therapy” placed immediately beneath the product logo (front page and inside flap).
It also included the claim “Ferinject reduces time spent in clinics” above two graphics comparing administration times for Ferinject 1000mg vs Cosmofer (iron dextran) and Monofer (iron isomaltoside).
The graphics presented absolute throughput claims (eg, eight Ferinject patients in 4 hours vs one iron dextran patient; two and a half Ferinject patients in 75 minutes vs one iron isomaltoside patient).
Vifor said it used SPC section 4.2 administration times and added a standardised 15 minutes “set up/tidy up” time for each product to reduce subjectivity, but the graphics/text did not disclose this added time.

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The Panel ruled the strapline was a promotional claim for Ferinject and was misleading because it implied a non-specific special merit compared with other iron therapies.
The Panel ruled the clinic-time graphics/claim were misleading because the depicted absolute differences were not accurate (including reliance on an undisclosed, apparently arbitrary 15-minute addition).
Breach of Clause 7.2 was ruled in relation to both issues (two breaches).

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