AUTH/3159/2/19: Pharmacosmos v Vifor – proactive medical call about Ferinject/Monofer paper ruled disguised promotion and uncertified basis | PMCPA Case

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Key facts

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Case number	AUTH/3159/2/19
Parties	Pharmacosmos UK Ltd v Vifor Pharma UK Limited
Product(s)	Ferinject (ferric carboxymaltose); Monofer (iron isomaltoside 1000)
Main issue	Proactive discussion with HCPs of a Vifor-funded comparative safety publication; whether the interaction was promotional/disguised and whether certification was required
Publication referenced	Ehlken et al (2018)
Applicable Code year	2016
Complaint received	12 February 2019
Case completed	13 December 2019
Breach clauses	Clause 12.1; Clause 14.1
No breach clauses	Clause 2; Clause 7.2; Clause 9.1; Clause 12.1 (for HCP2)
Sanctions	Undertaking received
Appeal	No

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

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Pharmacosmos alleged Vifor medical personnel proactively contacted UK health professionals to discuss Ehlken et al (2018), a Vifor-funded paper comparing severe hypersensitivity reaction reporting rates for Ferinject vs Monofer.
A consultant (HCP1) reported being emailed unsolicited by Vifor HQ and invited to a call framed as discussing a potential future study; the HCP said they were surprised the call focused on Ehlken et al and a hypersensitivity risk difference, with no other studies presented.
Vifor said its Chief Medical Officer (a co-author) contacted three UK clinicians and spoke to two in peer-to-peer scientific discussions to explain rationale, results and limitations; Vifor said it did not send the paper or links.
The Panel assessed (1) whether the interactions were promotional and (2) whether misleading information had been provided, noting limited evidence of exactly what was said.

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Breach found: Clause 12.1 (in relation to HCP1 only – promotional nature of the call was, on balance, disguised).
Breach found: Clause 14.1 (Ehlken et al was the basis of the discussion and should have been certified for such use).
No breach: Clause 7.2 (misleading claims not proven on the balance of probabilities, given lack of detail about what was said).
No breach: Clause 9.1 (high standards) and Clause 2 (disrepute) were not upheld on the narrow allegation and evidence available.

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