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PMCPA Case

Pharmacosmos v Vifor: Ferinject promotion found misleading and disparaging towards Monofer (AUTH/2830/3/16)

📅 2016 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/2830/3/16
PartiesPharmacosmos v Vifor Pharma
Product(s)Ferinject (ferric carboxymaltose) and Monofer (iron isomaltoside)
Main issueAlleged national pattern of misleading and disparaging comparative safety messaging about Monofer in Ferinject promotion
Key evidence referencedIntravenous Iron Differentiator tool; SPC Comparator tool; briefing on Grant et al audit; briefing and distribution of Lareb report; misleading MI email statement about Ferinject safety in the Lareb report
Breach clausesClause 7.2; Clause 8.1
DecisionBreach of Clauses 7.2 and 8.1 (upheld on appeal)
SanctionsUndertaking received; Additional sanctions: Not stated
Complaint received1 April 2016
Case completed7 December 2016
Applicable Code year2016

Download the full case report (PDF)

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) showed a pattern of misleading and disparaging claims about competitor product Monofer (iron isomaltoside), particularly on safety.
  • Pharmacosmos said there were no head-to-head comparative safety/efficacy studies between Monofer and Ferinject, yet HCP feedback suggested Vifor reps implied Monofer had more adverse reactions.
  • Pharmacosmos cited six anecdotal examples (UK and Ireland) but stated these were provided to show an overall pattern rather than as individual, specific allegations.
  • A key piece of evidence was a medical information email sent to a specialist nurse enclosing the Dutch pharmacovigilance Lareb report. The email stated the report had not mentioned any specific safety concerns with Ferinject—this was untrue (the report included 7 hypersensitivity/anaphylactic reaction reports for Ferinject).
  • The Panel and Appeal Board focused heavily on Vifor’s internal/promotional materials, including:
    • Intravenous Iron Differentiator tool designed to be used proactively in accounts “threatened” by switching to Monofer or that had switched to Monofer, including slides comparing side-effects/contraindications.
    • SPC Comparator tool used to directly compare Ferinject and Monofer SPC sections in a promotional context, with insufficient guidance on appropriate use.
    • Briefings that highlighted Grant et al (a local audit of 40 Monofer patients) and the Lareb report, without adequate context or clear instructions limiting use.
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Outcome

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  • Breach found: Clause 8.1 (disparagement).
  • Breach found: Clause 7.2 (misleading information).
  • Vifor appealed; the Appeal Board upheld both breaches and the appeal was unsuccessful.
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