Pierre Fabre found in breach over ‘under-dosing’ Navelbine Oral letter to oncology pharmacists (AUTH/2727/8/14)

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Key facts

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Case number	AUTH/2727/8/14
Parties	Pharmacist v Pierre Fabre
Product	Navelbine (vinorelbine) Oral
Material	Letter to oncology pharmacists headed “Under-dosing of Navelbine Oral”
Main issue	Letter ruled promotional; missing prescribing information and AE reporting statement; indication not fairly reflected; misleading/unsupported claims; unclear monitoring requirements
Complaint received	16 August 2014
Case completed	30 October 2014
Appeal	No appeal
Applicable Code year	2014
Breach clauses	3.2, 4.1, 4.10, 7.2, 7.4
No breach clauses	4.3, 7.8, 12.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A pharmacist complained about a letter sent by Pierre Fabre to oncology pharmacists about Navelbine (vinorelbine) Oral dosing.
The letter was headed “Under-dosing of Navelbine Oral” and stated the “only recommended dose” of single-agent Navelbine Oral in advanced breast cancer was 80mg/m² weekly (following three doses at 60mg/m²).
The letter encouraged recipients to check local protocols to ensure Navelbine Oral was used at the “appropriate dose” and included a bar chart comparing dose delivered per cycle.
The complainant alleged (among other points): missing prescribing information; the indication was stated only as “Advanced Breast Cancer” (not the full licensed wording); blood test/monitoring requirements were unclear vs the SPC; no adverse event reporting statement; and the efficacy/survival claim lacked relevant evidence and was misleading.
Pierre Fabre argued the letter was a non-promotional safety letter from the medical department, based on market research suggesting under-dosing, and that including prescribing information could make it look promotional.
The Panel found the letter did not meet any exemption and was promotional under the Code’s broad definition.

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Breach found of: Clauses 3.2, 4.1, 4.10, 7.2 and 7.4.
No breach of: Clauses 4.3, 7.8 and 12.1.
The Panel was very concerned about lack of clarity on monitoring requirements and the potential impact on patient safety.
The Panel also recorded concerns about the limited market research and aspects of the graph/dose framing, and requested Pierre Fabre be advised of those concerns.

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