Sanofi: internal email sharing off-licence formulary wording for Suliqua treated as briefing material (AUTH/3481/3/21)

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Key facts

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Case	AUTH/3481/3/21
Complainant	Anonymous, non-contactable complainant (described as a Sanofi employee)
Company	Sanofi
Product	Suliqua (insulin glargine with lixisenatide)
Main issue	Internal email reproduced APC formulary wording inconsistent with SPC, with positive commentary and no off-label qualification; WhatsApp group image showed part of a signed prescription
Applicable Code year	2019
Complaint received	2 March 2021
Case completed	10 November 2021
Appeal	No appeal
Breach clauses	9.1, 15.9
No breach clauses	2, 3.2, 9.1 (in relation to WhatsApp image / alleged lack of licence awareness)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, non-contactable complainant (described as a Sanofi employee) raised concerns about internal communications relating to Suliqua (insulin glargine with lixisenatide).
An internal email circulated a screenshot of a local Area Prescribing Committee (APC) formulary listing for Suliqua and congratulated a manager/team on achieving formulary adoption across a region.
The APC formulary wording for Suliqua did not align with the licensed indication in the Suliqua SPC.
The email was subsequently circulated by senior sales employees to other internal staff.
The complainant also raised concerns about a WhatsApp group (“Suliqua info”) whose group image showed part of a signed Suliqua prescription, alleging it was “ethically questionable”.
Sanofi investigated internally, stated it found no evidence of off-label promotion, and contacted the APC via medical to correct the formulary entry; the APC confirmed amendment on 17 March 2021.

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Breach of Clause 15.9: the internal email was considered briefing material and, by reproducing off-licence formulary wording with positive commentary and no qualification, could have indirectly encouraged promotion inconsistent with the licence.
Breach of Clause 9.1: high standards were not maintained (linked to the email/briefing material issue).
No breach of Clause 3.2: insufficient evidence that representatives actually promoted Suliqua to HCPs in a manner inconsistent with the SPC.
No breach of Clause 9.1 in relation to the WhatsApp image: no identifiable patient data; HCP signature illegible; complainant did not explain why it was ethically questionable.
No breach of Clause 2: circumstances did not warrant the particular censure of Clause 2.

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