Sanofi: complaint about alleged off-licence promotion of Suliqua via APC formulary listing (AUTH/3486/3/21) – No breach | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/3486/3/21
Company	Sanofi
Complainant	Anonymous, non-contactable (self-described health professional)
Product	Suliqua (insulin glargine + lixisenatide) pre-filled pen
Allegation	Off-licence promotion alleged to have led to out-of-licence APC formulary positioning (including use with basal insulin)
Evidence cited	Webpage of a local APC formulary
Applicable Code year	2019
Clauses considered	2, 3.2, 7.2, 9.1, 15.9
Panel decision	No breach of the Code
Complaint received	6 March 2021
Case completed	6 October 2021
Appeal	No appeal
Notable remedial action	Sanofi medical contacted APC about inconsistency; APC confirmed it amended the Suliqua entry

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous, non-contactable complainant (self-described health professional) complained about alleged off-licence promotion of Suliqua (insulin glargine + lixisenatide) by Sanofi.
The complainant pointed to a local Area Prescribing Committee (APC) formulary webpage that described Suliqua as indicated in combination with oral antidiabetic drugs “or basal insulin, or both”.
The complainant alleged this formulary positioning was out of line with the Suliqua SPC and suggested Sanofi representatives “might have/would have been having off-licence discussions/promotion” leading to the listing.
Sanofi stated the APC formulary listing was set independently of Sanofi and that its own formulary support materials were aligned with the licensed indication.
Sanofi investigated (including reviewing available formulary materials, a sample of call records, CRM checks, and interviews with relevant staff) and said it found no evidence of off-licence promotion.
After becoming aware of the inconsistency, Sanofi’s medical department contacted the APC; the APC confirmed it amended the Suliqua entry.

⚖️

⌄

No breach of Clause 3.2.
No breach of Clause 7.2.
No breach of Clause 15.9.
No breach of Clause 9.1.
No breach of Clause 2.
The Panel concluded the complainant had not demonstrated, on the balance of probabilities, that Sanofi employees engaged in off-licence discussions or promotion leading to the off-licence formulary listing.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access