Sanofi breached ABPI Code over unsubstantiated “fewer prescriptions” claim for Toujeo DoubleStar in virtual promo meeting

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Key facts

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Case number	AUTH/3455/1/21
Company	Sanofi
Complainant	Anonymous, non-contactable
Product	Toujeo DoubleStar (insulin glargine 300 units/ml)
Setting	Virtual promotional meeting; promotional speaker slide kit / slide deck
Main issue	Claim that Toujeo DoubleStar offered “fewer prescriptions” (and implied time/cost saving)
Other issue	Alleged inappropriate discussion of PRIME programme as inducement (not upheld)
Material references	Slide deck: MAT-GB-2004667 (V1.0); Briefing: MAT-GB-2004668 (V1.0)
Key dates (material)	Deck approved 13 November 2020; error flagged 25 November 2020; revised deck issued 4 December 2020
Complaint received	20 January 2021
Case completed	19 August 2021
Applicable Code year	2019
Breach clauses	7.2, 7.4, 9.1, 15.9
No breach clauses	2, 9.1, 18.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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What happened

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An anonymous, non-contactable complainant alleged a Sanofi representative, in a virtual promotional meeting for Toujeo (insulin glargine 300 units/ml), claimed Toujeo DoubleStar resulted in “fewer prescriptions”, with an implied time/cost saving.
The complainant said they challenged the statement (arguing it should be “fewer pens, not fewer prescriptions”) but the representative moved on without acknowledging the point.
The complainant also alleged a health professional programme (PRIME – Providing Remote Insulin Management and Education) was discussed inappropriately, implying Toujeo use would lead to invitation to a remote insulin management meeting (i.e., an inducement).
Sanofi stated the “fewer prescriptions” claim had been internally agreed as not substantiable, but was included in the approved slide deck in error (human error). The deck (ref MAT-GB-2004667 (V1.0)) was approved 13 November 2020, the error was flagged 25 November 2020, and a revised deck was issued 4 December 2020.
Sanofi acknowledged the claim remained in use for a period (including six working days between identifying the error and replacing the deck).
On PRIME, Sanofi said it was a promotional educational programme intended for all relevant health professionals regardless of prescribing habits; only one slide in the deck summarised PRIME as an example of support during the pandemic, with no language linking it to prescribing Toujeo.
The case preparation manager decided there was no prima facie case to answer regarding the allegation about referring to the Toujeo Coach patient support programme; that allegation was not considered by the Panel.

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Outcome

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The “fewer prescriptions” claim was ruled misleading and incapable of substantiation.
Sanofi was ruled in breach for the misleading/unsubstantiated claim and for failing to maintain high standards due to the delay in withdrawing/replacing the material.
Sanofi was ruled in breach for insufficiently detailed briefing materials for representatives.
No breach was ruled regarding the PRIME programme being an inducement (no breach of Clause 18.1) and consequently no breach of Clauses 9.1 and 2 in relation to that matter.
No appeal.

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Key facts

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