AUTH/2442/10/11: Pharmacosmos v Vifor — breach of undertaking over Ferinject hypersensitivity claim in website press releases | PMCPA Case

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Key facts

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Case number	AUTH/2442/10/11
Parties	Pharmacosmos AS / PMCPA Director v Vifor Pharma UK Limited
Issue	Breach of undertaking by using a Ferinject claim about dextran-induced hypersensitivity reactions in two website press releases
Material	Two press releases on Vifor UK website (SMC approval; MHRA approval)
Key claim(s)	Ferinject “not associated with dextran-induced hypersensitivity reactions” (and “since it is free of dextran and dextran derivatives”)
Undertaking referenced	AUTH/2422/7/11 (dated 30 August 2011)
Complaint received	11 October 2011
Case completed	18 November 2011
Applicable Code year	2011
Breach clauses	2, 9.1 and 25 (x2)
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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Pharmacosmos alleged Vifor Pharma UK breached an undertaking given in AUTH/2422/7/11 (dated 30 August 2011) by continuing to use a claim about Ferinject and hypersensitivity reactions.
Two press releases on the Vifor UK website (available in October 2011) included the claim in an “About Ferinject” boilerplate section.
The press releases related to:
- SMC approval (press release dated/signed off 13 June 2011; posted to website 14 June 2011).
- MHRA approval for a simplified dosing regimen (press release dated 13 July 2011; posted to website 7 September 2011).
The claim used (or materially similar wording) was that Ferinject was “not associated with dextran-induced hypersensitivity reactions” (and in one release, “since it is free of dextran and dextran derivatives”).
Vifor said it had withdrawn 58 promotional items after earlier cases and reviewed materials “in circulation”, but missed the globally prepared press releases. It removed both press releases from the website on 12 October 2011 once alerted.
The case was taken up by the PMCPA Director because the Authority is responsible for ensuring compliance with undertakings.

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Breach of Clause 25 was ruled for each press release (x2): the claims were covered by the earlier undertaking and implied there was no need to be concerned about hypersensitivity reactions with Ferinject, without a counter-balancing statement about Ferinject’s own hypersensitivity risk.
Breach of Clause 9.1: high standards were not maintained.
Breach of Clause 2: failure to comply with an undertaking brought discredit upon and reduced confidence in the pharmaceutical industry.
No appeal.

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