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PMCPA Case

AUTH/3224/7/19: Vifor misleading comparative safety claims for Ferinject vs Monofer and misused “medical information” response

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3224/7/19
PartiesPharmacosmos v Vifor
Product(s)Ferinject (ferric carboxymaltose) and Monofer (iron isomaltoside 100mg/ml solution for injection or infusion)
IssueMisleading/inaccurate comparative safety claims (ADRs/hypersensitivity), disparagement, and a medical information response ruled promotional and misleading
Key claim at issue“European health authorities have reported differences in the adverse drug reaction profiles of the available intravenous irons”
Material(s)Medical information email to a nurse; “Ferinject Objection Handler (UK-FCM-1900026) ‘Why Ferinject’”; briefing document (UK-FCM-1900027)
Applicable Code year2019
Breach Clause(s)2; 7.2; 7.3; 8.1; 9.1
Complaint received14 July 2019
Undertaking received10 February 2020
Case completed25 January 2024
Sanctions appliedUndertaking received; Public reprimand; Audit of company’s procedures; Advertisement

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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 Pharma UK promoted Ferinject (ferric carboxymaltose) using misleading and inaccurate comparative safety messaging versus Pharmacosmos’ Monofer (iron isomaltoside 100mg/ml solution for injection or infusion).
  • A nurse emailed Vifor after a promotional meeting asking for “the slide you showed about the reduced ADRs when using ferrinject over Monofer” and for “the slide or the reference from the European drug referencing and WHO demonstrating that there are less ADRs than monofer”.
  • Vifor medical information replied, framing the request as references for the statement: “European health authorities have reported differences in the adverse drug reaction profiles of the available intravenous irons”.
  • The medical information response cited and selectively summarised sources (including EMA materials, Lareb, AEMPS, WHO newsletter, Swissmedic), and the Panel found it misrepresented the EMA position and unfavourably compared Monofer with Ferinject.
  • Vifor initially denied having a slide claiming reduced ADRs vs Monofer and denied suggesting regulators/WHO showed fewer ADRs for Ferinject; only after further requests did Vifor provide the “Ferinject Objection Handler (UK-FCM-1900026) ‘Why Ferinject’” and a briefing document (UK-FCM-1900027). The objection handler was later withdrawn.
  • The objection handler contained multiple slides comparing tolerability/hypersensitivity reactions and included strong superiority messaging (eg, “75% lower risk of severe hypersensitivity reactions with Ferinject vs Monofer (p<0.0001)”).
  • The Panel considered Vifor’s initial approach to the complaint obstructive and uncooperative and reported Vifor to the Appeal Board.
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Outcome

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  • The Panel ruled the comparative claim “European health authorities have reported differences in the adverse drug reaction profiles of the available intravenous irons” was misleading and inaccurate in context (particularly given the EMA’s European-wide stance that data did not allow differentiation between IV irons for hypersensitivity reactions).
  • The objection handler claims comparing Ferinject vs Monofer were ruled misleading; some data was not sufficiently complete to allow readers to form their own opinion; and the material did not reflect EMA’s inability to differentiate IV irons for hypersensitivity reactions.
  • The medical information email could not rely on the Clause 1.2 exemption: it was not in reply to an unsolicited enquiry, did not relate solely to the subject matter of the enquiry, and was not accurate, balanced or fair; it was therefore treated as promotional.
  • The objection handler and the medical information email were ruled to disparage Monofer.
  • Vifor was found to have failed to maintain high standards and to have brought the industry into disrepute (Clause 2), particularly due to misleading/disparaging medical information communications.
  • The Appeal Board described Vifor’s early responses as “obstructive, defensive, aggressive, dissembling and untrue” and imposed further measures including a public reprimand and audits, with multiple follow-up audits/re-audits over subsequent years.
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