AUTH/1834/5/06: Pfizer Consumer Healthcare v Novartis Consumer Health UK Ltd – Nicotinell journal advertisement | PMCPA Case

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Key facts

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Case number	AUTH/1834/5/06
Complainant	Pfizer Consumer Healthcare
Respondent	Novartis Consumer Health UK Ltd
Material	Journal advertisement for Nicotinell (nicotine transdermal patches) (ref Nico001-01/06)
Product / therapy area	Nicotinell nicotine patches / smoking cessation (NRT)
Main issues	Implied afternoon/evening craving control based on PK profile; “up to four times” quit-rate claim; alleged graph exaggeration
Breach findings	Clause 7.2 (x 2) breached; Clause 7.8 not breached
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	4 May 2006 (HTML page lists 03 May 2006)
Case completed	23 June 2006 (HTML page lists 22 June 2006)
Appeal	No appeal
Applicable Code year	2006

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

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Pfizer Consumer Healthcare complained about a journal advertisement for Nicotinell (nicotine transdermal patches) issued by Novartis Consumer Health UK Ltd.
The ad promoted Nicotinell as a 24-hour patch and included claims linking its pharmacokinetic profile to afternoon/evening craving peaks and lapses.
Claims included: “When cravings peak in the afternoon… and the evening… …Nicotinell: a 24-hour patch with a profile to match”, “Recommend a patch to match their craving profile…”, and “Nicotinell’s patch delivers peak plasma concentrations during the afternoon…” alongside a graph adapted from Fant et al.
The ad also claimed: “Combined with an intensive behavioural support programme Nicotinell’s patch can increase quit rates by up to four times compared to unaided levels”.
Pfizer also alleged the Fant et al graph was inaccurately reproduced with exaggerated plasma nicotine values.

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Breach upheld: The ad was misleading by implying Nicotinell’s pharmacokinetic profile produced afternoon/evening plasma nicotine peaks aligned with craving peaks and that this was clinically beneficial, without supporting data.
Breach upheld: The “up to four times” quit-rate claim was misleading because it implied a study comparing Nicotinell + intensive behavioural support vs no aid, which was not the case.
No breach: The Panel did not consider the Fant et al graph was inaccurately reproduced (no breach of Clause 7.8).
No appeal.

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