Vifor found in breach over ivironheart.co.uk website promoting IV iron (Ferinject/Venofer) without PI, AE statement or certification

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Key facts

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Case	AUTH/3301/1/20
Parties	Anonymous v Vifor
Product / therapy area	Ferinject (ferric carboxymaltose); IV iron in heart failure/iron deficiency (also references to Venofer)
Material	ivironheart.co.uk website (ref UK-NP-1900153, Sept 2019)
Linked materials	Cardiology awareness campaign sales aid (UK-FCM-1800049) and briefing (UK-FCM-1900051)
Audience	Healthcare professionals
Complaint received	22 January 2020
Case completed	27 July 2020
Applicable Code year	2019
Breach clauses	2; 4.1; 4.6; 4.9; 7.2; 7.3; 9.1; 14.1
No breach clauses	9.1; 12.1
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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What happened

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An anonymous, contactable complainant alleged the ivironheart.co.uk website (ref UK-NP-1900153, Sept 2019) was disguised promotion of Vifor’s Ferinject (ferric carboxymaltose) and that it was not fair and balanced.
The website was aimed at healthcare professionals (HCP gate with “I am a healthcare professional/I am not a healthcare professional”).
The site used promotional-style imagery and messaging (eg “Because performance matters to your patients” and “The role of iron and the impact of IV iron therapy…” alongside the Vifor logo) and presented disadvantages of oral iron while emphasising benefits of IV iron in heart failure.
Vifor initially maintained the site was non-promotional medical education and said it had been certified as non-promotional (1 Oct 2019) and went live 7 Nov 2019; it later deactivated the site (28 Jan 2020) to add more comprehensive information.
Vifor later disclosed a link between the website and a global cardiology awareness campaign sales aid (ref UK-FCM-1800049) and briefing (ref UK-FCM-1900051) that explicitly connected “unbranded” content to driving IV iron use and switching to a Ferinject branded sales aid; the website contained imagery/content identical to the sales aid.
The website did not include Ferinject/Venofer prescribing information (or a clear prominent direction to it) and did not include the required adverse event reporting statement.
The complainant also alleged an employee’s conduct created pressure on signatories; the Panel found no evidence provided to support this allegation.

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Outcome

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The Panel ruled the website was promotional for Vifor’s IV iron products (Vifor marketed Ferinject and Venofer), even without naming them.
Breaches were found for missing prescribing information, missing AE reporting statement, lack of certification for promotional use, incomplete/misleading presentation, failure to maintain high standards, and bringing discredit on the industry.
No breach was found for Clause 12.1 (disguised promotion) because the Panel considered the material was clearly promotional rather than disguised.
No breach was found for Clause 9.1 in relation to the allegation about employee pressure on signatories (insufficient evidence).
No appeal.

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Key facts

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