AUTH/2156/8/08: GlaxoSmithKline v Sanofi Pasteur MSD – Gardasil letter to health professionals

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Key facts

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Case number	AUTH/2156/8/08
Case reference	Letter ref 0608 UK11970
Complainant	GlaxoSmithKline UK Ltd
Respondent/company	Sanofi Pasteur MSD Ltd
Product(s)	Gardasil; Cervarix (context)
Material/channel	Letter to health professionals (sent 18 June)
Key issue	Letter ruled promotional; missing prescribing information and adverse event reporting statement; promotion of an unauthorised indication via CHMP positive opinion/“licence extension”; high standards not maintained
Dates (received/completed if stated)	Complaint received 6 August 2008; Case completed 13 October 2008
Appeal	Not stated
Code year	2006 Code (clauses applied); case considered using 2008 Constitution and Procedure
Breaches/clauses	Clauses 3.2, 4.1, 4.10, 9.1 (breaches ruled)
Sanctions	Not stated

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

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GlaxoSmithKline UK Ltd complained about a letter (ref 0608 UK11970) sent to health professionals on 18 June by Sanofi Pasteur MSD Ltd.
The context was the Department of Health (DoH) awarding the national HPV immunisation programme contract to Cervarix (GSK’s vaccine); Sanofi Pasteur MSD marketed Gardasil and had competed for the contract.
Anonymous health professionals sent GSK copies of the letter, concerned it implied the DoH had chosen the wrong vaccine and could undermine confidence in the national programme.
Sanofi Pasteur MSD said the letter was sent by its medical director to a selected group as part of an ongoing legitimate scientific dialogue and was sent to just over 50 health professionals (majority hospital consultants).
The Panel noted that for some recipients, their only relationship with Sanofi Pasteur MSD was sponsorship to attend a European meeting on gynaecological oncology.
The Panel found the letter included product claims (including indications and describing Gardasil as the “world’s leading HPV vaccine”).
The letter did not include prescribing information or a statement about adverse event reporting.
The letter referred to Gardasil having received a positive CHMP opinion for protection against pre-malignant lesions of the vagina “as a licence extension”.

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The Panel ruled the letter was promotional for Gardasil and could not rely on the Clause 1.2 exemption for factual, accurate, informative announcements.
Because it was promotional, the absence of prescribing information was ruled a breach.
Because it was promotional, the absence of an adverse event reporting statement was ruled a breach.
By referring to a positive CHMP opinion and “licence extension”, the letter was ruled to promote an as-yet unauthorised indication and was inconsistent with the marketing authorisation; a breach was ruled.
The Panel ruled that high standards had not been maintained, noting Sanofi Pasteur MSD’s failure to regard the letter as promotional demonstrated poor knowledge of the Code’s requirements.

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Clause 3.2 – Breach (promotion of an unauthorised indication/inconsistency with the marketing authorisation via reference to positive CHMP opinion and “licence extension”).
Clause 4.1 – Breach (promotional letter lacked prescribing information).
Clause 4.10 – Breach (promotional letter lacked a statement about adverse event reporting).
Clause 9.1 – Breach (high standards not maintained; poor knowledge of Code requirements evidenced by treating promotional material as non-promotional).
Clause 1.2 – Considered in relation to exemption for factual, accurate, informative announcements; Panel ruled the letter could not benefit from the exemption because it included product claims (no separate breach stated).

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