Napp: Invokana renal outcomes discussion at conference stand; internal CREDENCE training slides ruled to breach

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Key facts

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Case	AUTH/3202/6/19
Parties	Pharmacist v Napp
Product	Invokana (canagliflozin)
Issue	Alleged off-licence promotion (renal/CKD progression) at conference stand; compliance of internal CREDENCE training/briefing materials
Setting	National diabetes society conference (exhibition stand) and internal training day materials
Applicable Code year	2019
Complaint received	5 June 2019
Case completed	10 June 2020
No breach clauses	Clause 2; Clause 3.2; Clause 15.2; (one aspect of) Clause 15.9
Breach clauses	Clause 9.1; Clause 15.9
Appeal	Appeal by respondent; breaches of Clauses 15.9 and 9.1 upheld
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 (a “concerned pharmacist”) alleged that at a national diabetes society conference a Napp representative on the Invokana stand discussed new renal outcome data and suggested Invokana could be “first in therapy” to slow chronic kidney disease (CKD) progression in type 2 diabetes (an off-licence indication per the complainant).
Napp said the representative discussed CANVAS-R renal outcomes in line with the SPC, used a sales aid with a prominent disclaimer (“Improvements in renal outcomes with Invokana are additional benefits and not licensed indications”), and referred any off-licence questions to medical/MSL/medical information.
The Panel noted multiple renal-related materials were available at the stand (including a leavepiece summarising ADA/EASD guidance and a “Practice Nurse – Beyond Glycaemic Control” document referencing CREDENCE), and that a Napp-sponsored symposium on the cardio/renal axis was part of the conference.
Because the complainant was anonymous and could not be contacted, and provided no supporting evidence, the Panel could not determine on the balance of probabilities what was said at the stand.
Separately, the Panel reviewed internal briefing/training materials, including a presentation “CREDENCE Results!” (UK/INV-19124) used at an internal training day, and found issues with how the CREDENCE data were framed and caveated.

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No breach was established for the alleged off-licence promotion at the exhibition stand because the complainant did not discharge the burden of proof.
Breach ruled for internal briefing/training material: the “CREDENCE Results!” presentation was found to advocate a course of action likely to lead to a breach due to missing/insufficient caveats and a concluding slide that appeared promotional.
High standards breach was also ruled in relation to the briefing material.
Napp appealed the breaches of Clauses 15.9 and 9.1; the Appeal Board upheld both breaches.
Clause 2 was considered but not found breached (reserved for particular censure).

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