AUTH/2167/9/08: Pfizer breached the Code over Toviaz superiority and “new step” claims (Astellas complaint)

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Key facts

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Case number	AUTH/2167/9/08
Parties	Astellas Pharma v Pfizer
Product(s)	Toviaz (fesoterodine); comparator referenced: Detrusitol (tolterodine)
Channel/material	Journal advertisement (ref TOV162); conference stand materials at BAUS meeting (ref TOV093) discussed
Key claims challenged	“Toviaz 8mg was significantly better than tolterodine ER 4mg…”; “Toviaz is a new step in the treatment of Overactive Bladder”
Complaint received	16 September 2008
Case completed	14 November 2008
Applicable Code year	2008
Breach clauses	7.2 (x2), 7.3 (x2), 7.4 (x2), 7.10 (x2)
Clause 2	Alleged (re delayed withdrawal) – no breach ruled
Sanction	Undertaking received
Appeal	No appeal

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

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Astellas complained about Pfizer’s promotion of Toviaz (fesoterodine). Pfizer also supplied Detrusitol (tolterodine).
Issue 1: After agreeing (17 June) to include Detrusitol prescribing information in Toviaz materials that made claims about tolterodine, Pfizer still had materials on its stand at the BAUS Annual Meeting (23–27 June) without the tolterodine prescribing information (ref TOV093). Astellas alleged this showed delay/cynical disregard and should breach Clause 2.
Issue 2: A journal advertisement (ref TOV162) claimed: “By the end of treatment, Toviaz 8mg was significantly better than tolterodine ER 4mg in improving a number of important endpoints; specifically, severe urgency with UUI per 24 hours, mean volume voided per micturition, continent days per week and UUI episodes per 24 hours*” with footnote “* Analysis of Toviaz 8mg vs tolterodine ER was not part of the original study plan”.
Astellas argued the superiority claim was misleading/cherry-picked and derived from a post hoc analysis (Chapple et al 2008) of a phase 3 study (Chapple et al 2007) that was not powered for between-active comparisons.
Issue 3: The advertisement also stated “Toviaz is a new step in the treatment of Overactive Bladder”, which Astellas said implied novelty/special merit beyond an additional antimuscarinic option.

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Clause 2 allegation (delay/stand materials): No breach ruled. The Panel said Pfizer was not obliged to withdraw until it accepted the Panel’s ruling/returned its undertaking; however, it would have been helpful to remove the materials once Pfizer had acknowledged a breach, and the Panel queried whether Pfizer acted within the spirit of the Code.
Superiority claim vs tolterodine (TOV162): Breaches ruled (the Panel applied the prior rulings from Case AUTH/2150/7/08).
“New step” claim: Breaches ruled because it implied more than “a new antimuscarinic” and could not be substantiated.
No appeal in this case.

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