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	General Practitioner v Pfizer
Complainant	General practitioner
Respondent/company	Pfizer Limited
Product(s)	Toviaz (fesoterodine fumarate); Detrusitol (tolterodine)
Material/channel	Journal advertisement in GP (6 June); ad ref TOV097b
Key issue	Advertisement for Toviaz also promoted tolterodine/Detrusitol but omitted required prescribing information for tolterodine
Dates (received/completed if stated)	Complaint received 9 June 2008; Case completed 10 July 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 4.1 (breach); Clauses 7.2 and 7.10 (no breach)
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 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 (via statements including “From Pfizer, the maker of tolterodine…” and “Tolterodine is the market leading therapy in OAB”) but omitted tolterodine prescribing information required by the Code.
Pfizer accepted that “Tolterodine is the market leading therapy in OAB” could be considered a promotional claim for tolterodine and acknowledged that prescribing information had not been provided.
Pfizer stated it would cease further publication of the advertisement and review similar promotional material; it noted it was not possible to immediately amend or withdraw the advertisement from two publications due to publication processes.

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

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