AUTH/3159/2/19: Pharmacosmos v Vifor – proactive “peer-to-peer” call ruled disguised promotion and uncertified use of publication | PMCPA Case

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Key facts

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Case	AUTH/3159/2/19
Parties	Pharmacosmos UK Ltd v Vifor Pharma UK Limited
Product / topic	Promotion of Ferinject; comparative safety discussion referencing Monofer
Core issue	Proactive discussions with HCPs about Ehlken et al (2018) and whether the interaction was promotional/disguised and whether certification was required
Publication referenced	Ehlken et al (2018), funded by Vifor; analysis of severe hypersensitivity reaction reporting rates using EudraVigilance and VigiBase (2014–2017)
Complaint received	12 February 2019
Case completed	13 December 2019
Applicable Code year	2016
Breach clauses	Clause 12.1; Clause 14.1
No breach clauses	Clause 2; Clause 7.2; Clause 9.1 (and no breach of Clause 12.1 in relation to HCP2)
Sanction	Undertaking received
Appeal	No

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

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Pharmacosmos complained that Vifor medical personnel proactively contacted UK health professionals to discuss safety data from Ehlken et al (2018) about severe hypersensitivity reactions, comparing Ferinject (ferric carboxymaltose) with Monofer (iron isomaltoside 1000).
The contact was initiated by Vifor (via headquarters). A consultant (HCP1) said they accepted a call believing it was about a potential future study, but were surprised it focused on Ehlken et al and a difference in hypersensitivity risk; no other evidence was presented; no honorarium; no contract.
Vifor said its Chief Medical Officer (a co-author) contacted three UK experts and spoke to two in peer-to-peer scientific discussions to explain the rationale, results and limitations, and answer questions; Vifor said it did not send the paper or links and did not brief teams to disseminate it.
The Panel considered whether the interactions were promotional under the broad definition of promotion (Clause 1.2 referenced by the Panel) and whether the content discussed was misleading.

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Breach found: Clause 12.1 (in relation to HCP1 only) and Clause 14.1.
No breach found: Clauses 2, 7.2 and 9.1 (and no breach of Clause 12.1 in relation to HCP2).
The Panel found that, on the balance of probabilities, the paper was discussed with at least one health professional and that Vifor accepted it discussed the paper with two.
The Panel did not consider Pharmacosmos had proved what was said in sufficient detail to establish that the discussions were misleading (Clause 7.2).

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