Vifor Pharma: breach of undertaking over Ferinject vs Monofer safety comparisons and medical information email (AUTH/3199/5/19)

📊

Key facts

⌄

Case	AUTH/3199/5/19
Parties	Pharmacosmos/Director v Vifor
Issue	Alleged breach of undertaking relating to promotion of Ferinject and comparative safety messaging about Monofer
Products	Ferinject (ferric carboxymaltose); Monofer (iron isomaltoside)
Applicable Code year	2019
Breach clauses	Clause 2; Clause 29
Key materials referenced	Medical information email response; Ferinject Objection Handler “Why Ferinject” (UK-FCM-1900026, later withdrawn); briefing document (UK-FCM-1900027)
Complaint received	15 May 2019
Undertaking received	10 February 2020
Completed	25 January 2024
Appeal hearing	No appeal
Sanctions applied	Undertaking received; Audit of company’s procedures; Advertisement; Public reprimand

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

⌄

Pharmacosmos alleged Vifor breached undertakings given in earlier cases (AUTH/2830/3/16 and AUTH/2828/3/16) while promoting Ferinject (ferric carboxymaltose) against Pharmacosmos’ Monofer (iron isomaltoside).
A nurse emailed Vifor after a representative visit, referring to “the slide you showed about the reduced ADRs when using Ferinject over Monofer” and asking for the slide or references from European sources/WHO.
Vifor medical information sent an email response citing multiple sources (including EMA/PRAC minutes, Lareb, AEMPS, WHO newsletter, Swissmedic) which the Panel considered selective and misleading, and not eligible for the Clause 1.2 exemption (not unsolicited; not solely answering the enquiry; not accurate/balanced/fair).
Vifor initially denied having a slide claiming reduced ADRs vs Monofer and denied suggesting regulators/WHO showed fewer ADRs for Ferinject.
Only after a further information request did Vifor provide the “Ferinject Objection Handler” (UK-FCM-1900026, later withdrawn) and briefing document (UK-FCM-1900027), which contained comparative tolerability/hypersensitivity content (including claims such as “75% lower risk of severe hypersensitivity reactions with Ferinject vs Monofer”).
The Panel considered Vifor’s initial response lacked full and frank disclosure and appeared obstructive and uncooperative; the matter was reported to the Appeal Board.

⚖️

⌄

Breach ruled: Clause 29 (breach of undertaking) in relation to the medical information response and the objection handler/briefing document continuing behaviour covered by prior undertakings.
Breach ruled: Clause 2 (bringing discredit upon, and reducing confidence in, the industry), linked to breach of undertaking and inadequate action to prevent recurrence.
Appeal Board imposed additional measures including public reprimands and audits; after multiple audits/re-audits, the Appeal Board ultimately decided (Jan 2024) that no further action was required provided progress continued.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access