Pfizer Toviaz journal advertisement: prescribing information missing for promoted tolterodine (Detrusitol)

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Key facts

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Case number	AUTH/2130/6/08
Case reference	Toviaz journal advertisement (ref TOV097b)
Complainant	General practitioner
Respondent/company	Pfizer Limited
Product(s)	Toviaz (fesoterodine fumarate); Detrusitol (tolterodine)
Material/channel	Journal advertisement in GP, 6 June
Key issue	Advertisement promoted tolterodine/Detrusitol but did not include its prescribing information (obligatory information)
Dates (received/completed if stated)	Complaint received 9 June 2008; Case completed 10 July 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breach of Clause 4.1; no breach of Clauses 7.2 and 7.10
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A general practitioner complained about a Pfizer Limited journal advertisement (ref TOV097b) for Toviaz (fesoterodine fumarate) placed in GP, 6 June.
Pfizer also marketed Detrusitol (tolterodine); both products were for symptomatic treatment of overactive bladder syndrome (OAB).
The complainant alleged the ad promoted tolterodine alongside Toviaz (eg, “From Pfizer, the maker of tolterodine…” and “Tolterodine is the market leading therapy in OAB”) but omitted tolterodine prescribing information required by the Code.
The Authority asked Pfizer to respond in relation to Clauses 4.1, 7.2 and 7.10.
Pfizer accepted the tolterodine statement could be considered a promotional claim requiring prescribing information; as it was not provided, Pfizer acknowledged a breach of Clause 4.1.
Pfizer stated it would cease further publication of the advertisement and review similar promotional material; it noted it was not possible to immediately amend/withdraw the ad from two publications due to publication processes.

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The Panel considered that, although tolterodine was only referred to by its non-proprietary name, the advertisement nonetheless promoted Detrusitol and prescribing information should have been provided.
The Panel ruled a breach of Clause 4.1.
The Panel did not consider that the lack of prescribing information for Detrusitol rendered the advertisement misleading; no breach of Clause 7.2 was ruled.
The Panel did not consider that the absence of prescribing information meant the advertisement had not encouraged the rational use of Detrusitol; no breach of Clause 7.10 was ruled.

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