AUTH/2497/4/12: Pharmacosmos v Vifor — competitor dosing information (Monofer) (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2497/4/12
Parties	Pharmacosmos A/S v Vifor Pharma UK Limited
Issue	Alleged misleading competitor dosing statements about Monofer total dose infusion (claimed 1,000mg maximum)
Product(s)	Monofer (iron isomaltoside) and Ferinject (iron as ferric carboxymaltose)
Applicable Code year	2011
Clause(s) considered	Clause 15.9
Decision	No breach of the Code
Complaint received	13 April 2012
Case completed	28 June 2012
Appeal	No appeal
Evidence highlighted	Part of an anonymised, undated email quotation; original email not provided; no other evidence provided

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

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Pharmacosmos complained that Vifor representatives were allegedly telling health professionals that Monofer (iron isomaltoside) total dose infusion was subject to a maximum total dose of 1,000mg.
Pharmacosmos said this contradicted its interpretation of the Monofer SPC, which allowed total dose infusion up to 20mg iron/kg body weight (with splitting if the total iron dose exceeded 20mg/kg), and did not explicitly state an upper dose limit for total dose infusion.
Pharmacosmos said inter-company dialogue did not resolve the issue and alleged that Vifor training/briefing material encouraged representatives to breach the Code (Clause 15.9).
Evidence provided by Pharmacosmos was limited to part of an anonymised, undated email quotation from a health professional; the original email was not provided and no other UK activity evidence was submitted.
Vifor denied briefing/training staff to discuss a maximum Monofer dose; stated that materials referring to Monofer dosing were withdrawn (Oct–Dec 2011) and that representatives were instructed to refer queries to the Monofer SPC or Pharmacosmos medical information (email 11 April 2012; reinforced at May 2012 sales conference).

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No breach of the Code was ruled.
The Panel did not consider Pharmacosmos had established, on the balance of probabilities, that Vifor representatives had commented on Monofer dosing as alleged or had been briefed to do so.
No breach of Clause 15.9 was ruled.
The Panel noted Vifor’s lack of clarity in inter-company dialogue about its interpretation of the Monofer SPC was “not helpful” and that in that regard inter-company dialogue had been unsuccessful, but this did not lead to a breach finding.

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