AUTH/1992/4/07: Pharmacist practitioner v Sanofi-Aventis (Lantus/Acomplia) — no breach (representative conduct and alleged off-licence implications) | PMCPA Case

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Key facts

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Case number	AUTH/1992/4/07
Complainant	Pharmacist practitioner at a general practice
Company	Sanofi-Aventis
Products	Lantus (insulin glargine); Acomplia (rimonabant)
Main issues alleged	Misrepresentation of ADA/EASD flowchart positioning; confusion/misstatement of study data; implication of off-licence use and replacement of glitazones; representative knowledge/quality
Clauses considered	3.2, 7.2, 15.2 (Panel reasoning also references 3.1 and Clause 1.2)
Decision	No breach of the Code
Complaint received	23 April 2007
Meeting date	19 April 2007
Case completed	3 August 2007 (HTML page also lists completed 06 September 2007)
Appeal	No appeal
Applicable Code year	2006
Sanctions	None

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

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A pharmacist practitioner complained about a Sanofi-Aventis representative’s conduct during promotion of Lantus (insulin glargine) and Acomplia (rimonabant).
Lantus allegation: the rep briefly showed an ADA/EASD flowchart and allegedly implied basal insulin (eg Lantus) was recommended second line to metformin for all type 2 diabetics; the complainant said the flowchart actually showed three options and attendees were not allowed a close look or left a copy.
Acomplia allegation: the rep allegedly confused RIO-Diabetes and SERENADE data, described the population incorrectly, and left an impression Acomplia could reduce HbA1C / be used as a “third line hypoglycaemic” in place of glitazones (ie implying off-licence use).
The complainant said the rep did not caveat that any such use would be outside the marketing authorisation and that the company could not support it; other HCPs present reportedly had a similar impression.
Sanofi-Aventis said the rep used approved materials, discussed SERENADE (not RIO-Diabetes), and positioned Acomplia within its marketing authorisation (weight loss as primary effect; risk-factor improvements as additional benefits in relevant patients).
The Panel noted accounts differed and the complainant had been absent for part of the meeting, making it difficult to establish exactly what was said.

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No breach of the Code was ruled.
The Panel repeatedly found it was impossible to determine on the balance of probabilities exactly how the guideline/data/discussion had been presented.
The Panel also highlighted that representatives must be extremely cautious when responding to questions about unlicensed use, especially in group promotional settings, and that the safest course is referral to medical information.

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