Sanofi-Aventis: anonymous employee alleged off-label discussions about Plavix and competitor intelligence gathering (AUTH/2043/8/07)

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Key facts

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Case	AUTH/2043/8/07 (also referenced in report as AUTH/2043/9/07)
Complainant	Anonymous employee/representative of Sanofi-Aventis
Company	Sanofi-Aventis
Medicine	Plavix (clopidogrel)
Main allegation	Asked to discuss Plavix off-label indications; asked to gather information about an unlaunched competitor product
Panel focus	Risk that scientific advisor arrangements/documentation could imply promotional activity and proactive use of unlicensed data
Clauses considered	2, 3.1, 3.2, 9.1
Outcome	No breach of the Code
Complaint received	7 September 2007
Case completed	24 September 2007
Appeal	No appeal

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

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An anonymous, non-contactable Sanofi-Aventis employee complained they were being asked (as part of a “small specialist team”) to talk about Plavix (clopidogrel) and unlicensed (off-label) indications.
The complainant also alleged they were asked to gain information about a competitor product that was not yet marketed.
Sanofi-Aventis denied promoting Plavix for unlicensed indications and stated only non-promotional staff (medical information/medical affairs, including scientific advisors) could respond to unsolicited off-label requests on a reactive basis only.
The Panel reviewed documentation about the cardiovascular scientific advisor role and noted wording that could imply proactive use of unlicensed data and close linkage to commercial objectives/sales leads.
The Panel noted it is normal commercial practice to seek information about competitor products, provided it is done in a Code-compliant way (no subterfuge, misrepresentation, disparagement, etc.).

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No breach of the Code was found on the balance of probabilities.
The Panel was “very concerned” about the scientific advisor documentation and the potential for a non-promotional role to drift into promotion, but found insufficient evidence that off-label promotion actually occurred.

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