Syner-Med: Ferinject promotional materials at British Renal Society meeting found misleading and missing required information (AUTH/2149/8/08)

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Key facts

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Case number	AUTH/2149/8/08
Case reference	AUTH2149708
Complainant	Freelance medical writer
Respondent/company	Syner-Med (Pharmaceutical Products) Limited
Product(s)	Ferinject (ferric carboxymaltose); comparator referenced: CosmoFer (iron (III))
Material/channel	Detail aid, two-page brochure, leavepiece distributed at British Renal Society meeting (May 2008)
Key issue	Misleading dosing presentation and misleading infusion-time comparison; missing signposting to prescribing information; unclear/insufficient dating of promotional material
Dates (received/completed if stated)	Complaint received 24 July 2008; case completed 21 August 2008
Appeal	Not stated
Code year	2008 Code (clauses cited stated as same in 2008 and 2006 Code)
Breaches/clauses	Breaches: Clauses 7.2, 4.8, 4.9. No breach: Clause 4.1 (as considered in the rulings described).
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A freelance medical writer complained about the promotion of Ferinject (ferric carboxymaltose) by Syner-Med (Pharmaceutical Products) Limited at the British Renal Society (BRS) meeting in Glasgow on 13/14 May 2008.
The materials at issue were: a 12-page detail aid “The next generation intravenous iron” (ref F07/01-05-08-039), a two-page brochure “Anaemia Service… Redesigning Provision” (ref F09/07-05-08-045), and a leavepiece “The next generation intravenous iron” (ref F08/06-05-08-044).
Concerns included: (a) dosing information presented as “Up to 1000mg” without sufficiently prominent qualifying information that dosing should not exceed 15mg/kg and that cumulative dose must be calculated individually; (b) a comparative claim “Reduces infusion time … 6 hrs to 15 mins” versus CosmoFer, referenced to the CosmoFer SPC; and (c) prescribing information issues (no reference to where prescribing information could be found, legibility/line length, and dating of material).
Syner-Med acknowledged a technical breach regarding no reference to where prescribing information appeared (Clause 4.8) and said it would be corrected.

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The Panel ruled the detail aid was misleading regarding dosage particulars for Ferinject because key qualifying information was separated from the headline dosing claim and important dosing complexity from the SPC was omitted (breach ruled).
The Panel ruled the claim “Reduces infusion time … 6 hours to 15 minutes” was misleading because it referred only to the maximum time for CosmoFer total dose infusion (breach ruled). This reasoning also applied to similar claims in the brochure and leavepiece (breaches ruled).
The Panel ruled breaches where the detail aid and leavepiece did not include a reference as to where prescribing information could be found (breaches ruled; acknowledged by Syner-Med).
No breach was ruled for omitting a statement to consult the SPC for other side effects because the side effects listed were the complete list from the SPC.
No breach was ruled on legibility/line length of prescribing information (around 150 characters per line) because, although on the limits of acceptability, it was considered legible.
The Panel ruled breaches for failure to include an obvious/understandable date on which the promotional material was drawn up or last revised; embedding the date within a reference code was not considered obvious to the reader (breaches ruled for detail aid, brochure, and leavepiece).

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Clause 7.2: Breach ruled (misleading dosage presentation in the detail aid; misleading comparative infusion-time claim vs CosmoFer; and similar misleading claims in brochure and leavepiece).
Clause 4.8: Breach ruled (no reference as to where prescribing information could be found in the detail aid and leavepiece).
Clause 4.9: Breach ruled (date of preparation/drawn up or last revised not obvious/understandable to the reader for the detail aid, brochure, and leavepiece).
Clause 4.1: No breach ruled (legibility of prescribing information; and no requirement to add a statement to consult the SPC for other side effects given the side effects listed were complete).

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