Mundibiopharma breached ABPI Code over Invokana virtual booth email: incomplete prescribing information, misleading non-significant outcomes claims, and uncertified linked papers

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Key facts

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Case	AUTH/3185/4/19
Company	Mundibiopharma
Complainant	Concerned UK health professional
Product(s)	Invokana (canagliflozin); Vokanamet (canagliflozin and metformin)
Channel	Email promotion and “virtual promotional booth” microsite with downloadable slide decks and linked papers
Event referenced	ISN-WCN 2019 (Melbourne, 12–15 April)
Main issues upheld	Incomplete PI via SPC link (cost exemption not applicable); misleading headline claims implying statistical significance; failure to certify linked reprints; high standards not maintained (including omission of Vokanamet non-proprietary name adjacent to brand name at first appearance)
Clauses breached	4.1, 7.2, 7.3, 9.1, 14.1
Clauses not breached	2; 7.8; 4.1 (in relation to the narrow allegation that there was no Vokanamet PI on the microsite)
Sanction	Undertaking received
Complaint received	26 April 2019
Case completed	27 November 2019
Applicable Code year	2016
Appeal	No appeal

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

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A UK health professional complained about an email promoting an Invokana (canagliflozin) “virtual booth” linked to ISN-WCN 2019, and the associated microsite content (including slide decks and linked papers).
The complainant alleged the email linked to the Invokana summary of product characteristics (SPC) rather than compliant prescribing information (PI).
The microsite mentioned Vokanamet but (at first appearance) did not include the non-proprietary name immediately adjacent to the brand name; the complainant also alleged there was no PI for Vokanamet on the microsite.
The complainant challenged several graphs as visually exaggerating effects due to suppressed y-axes / numbering (slides in CANVAS-related decks).
The complainant alleged two headline claims were misleading because the confidence intervals crossed 1 (non-significant results): slide 22 “Canagliflozin reduced risk of CV death” and slide 23 “Canagliflozin reduced risk of mortality in both the intention-to-treat and left-truncated analyses”.
The complainant alleged linked copies of Perkovic et al (2018) and Neal et al (2017) should have been certified and should have included prescribing information.
Mundibiopharma said the email was sent via a third party to pre-subscribed specialist physicians across multiple European countries including the UK; it argued an SPC link was acceptable and that cost was not provided due to multi-country distribution.

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Breach: Clause 4.1 (email link to SPC did not meet Clause 4.2 requirements; cost exemption did not apply).
Breach: Clause 4.1 (microsite link to Invokana SPC did not meet Clause 4.2 requirements; cost exemption did not apply).
No breach: Clause 4.1 (narrow allegation that there was no Vokanamet PI on the microsite—Panel found PI existed within downloadable slide decks, though not sufficiently obvious to users).
No breach: Clause 7.8 (suppressed zero / scales in challenged graphs did not, on balance of probabilities, mislead; axes were labelled and differences/CI were stated).
Breach: Clauses 7.2 and 7.3 (headline claims on slides 22 and 23 implied statistical significance when results were not statistically significant; CI/footnotes did not negate the immediate impression).
Breach: Clause 14.1 (linked papers/reprints in pillars 2 and 4 were promotional material and required certification).
Breach: Clause 9.1 (high standards not maintained, including omission of Vokanamet non-proprietary name adjacent to brand name at first appearance, and overall breaches).
No breach: Clause 2 (Panel did not consider the circumstances met the threshold for particular censure).

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