AUTH/2167/9/08: Astellas v Pfizer — Toviaz promotion, post hoc superiority claim and “new step” messaging | PMCPA Case

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Key facts

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Case	AUTH/2167/9/08
Parties	Astellas Pharma v Pfizer
Product	Toviaz (fesoterodine)
Comparator mentioned	Detrusitol / tolterodine ER 4mg
Promotional items	Conference stand materials (BAUS) and journal advertisement (ref TOV162)
Main issues	Comparative superiority claim based on post hoc analysis; “new step” claim implying novelty/special merit; conference materials lacking competitor PI (context from earlier case)
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 outcome	No breach ruled (Panel queried spirit vs letter regarding removal timing)
Sanctions	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 (PI) in Toviaz materials that made claims about tolterodine, Pfizer materials without Detrusitol PI were still available on Pfizer’s stand at the BAUS Annual Meeting (23–27 June).
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…” with a footnote stating the analysis was not part of the original study plan.
Astellas argued the superiority claim relied on a post hoc analysis, cherry-picked endpoints, and did not fairly reflect the totality of evidence.
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 what could be supported.

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Clause 2: No breach ruled regarding continued availability of materials at BAUS (Panel noted Pfizer acted within the letter of the process, but queried whether it acted within the spirit).
Superiority/comparative claim (TOV162): Breaches ruled for misleading/unsubstantiated and unbalanced comparison and failure to encourage rational use.
“New step” claim: Breaches ruled as the wording implied more than could be substantiated and was misleading.
Sanctions: Undertaking received.
Appeal: No appeal in this case.

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