AUTH/2830/3/16 Pharmacosmos v Vifor: Ferinject promotion found misleading and disparaging about Monofer safety

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Key facts

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Case number	AUTH/2830/3/16
Parties	Pharmacosmos v Vifor Pharma
Product(s)	Ferinject (ferric carboxymaltose) and Monofer (iron isomaltoside)
Main issue	Alleged pattern of misleading and disparaging comparative safety messaging about Monofer in Ferinject promotion; inaccurate medical information email about Lareb report
Key materials referenced	Intravenous Iron Differentiator tool; SPC Comparator tool; medical update slides referencing Grant et al; medical information email enclosing Lareb report
Breach clauses	Clause 7.2; Clause 8.1
Decision	Breaches ruled by Panel and upheld by Appeal Board; appeal unsuccessful
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	1 April 2016
Case completed	7 December 2016
Applicable Code year	2016

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

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What happened

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Pharmacosmos complained that Vifor’s promotion of Ferinject (ferric carboxymaltose) created a national pattern of misleading and disparaging claims about the safety of Monofer (iron isomaltoside), despite no head-to-head comparative studies.
The complaint relied on a pattern of anecdotal HCP reports plus concern about centrally-driven messaging and training materials.
A key piece of evidence was a medical information email sent to a specialist nurse enclosing the Dutch pharmacovigilance “Lareb” report, stating the report had “not mentioned any specific safety concerns with [Ferinject]”.
The Panel noted that statement was untrue because the Lareb report detailed 7 reports of hypersensitivity/anaphylactic reactions associated with Ferinject.
The Panel reviewed Vifor’s internal/promotional materials, including the Intravenous Iron Differentiator tool (designed to be used proactively in accounts considering switching to Monofer or that had switched) and an SPC Comparator tool used to directly compare Ferinject and Monofer SPC sections.
Briefings included a strident, competitive tone (eg “The Ferinject proposition is strong, be confident, we have the best treatment”) and content that implied lack of confidence in Monofer.
Training/briefing materials referenced competitor-critical sources (eg Grant et al audit abstract and the Lareb report) without adequate context or clear instructions limiting use.
Vifor denied wrongdoing, argued it briefed reps not to discuss competitor products beyond SPCs, and appealed the rulings (including procedural/standing arguments). The Appeal Board rejected the appeal.

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Outcome

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Breach upheld: Clause 8.1 (disparagement).
Breach upheld: Clause 7.2 (misleading information).
Appeal by Vifor was unsuccessful; Panel’s rulings were upheld by the Appeal Board.

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