AUTH/2046/9/07: Takeda v GlaxoSmithKline (Avandia press release on global website) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2046/9/07
Parties	Takeda UK Limited v GlaxoSmithKline
Product	Avandia (rosiglitazone); comparator mentioned: Actos (pioglitazone)
Material	Press release on GSK global corporate website titled “GlaxoSmithKline presents Avandia data to FDA”
Channel	Internet (www.gsk.com; also www.usa.gsk.com); sent to UK financial media
Complaint received	20 August 2007 (site listing) / 20 September 2007 (report text)
Completed	11 January 2008
Applicable Code year	2006
Appeal	No appeal
Decision	No breach (press release found not within scope under Clause 21.2 as it did not specifically refer to UK availability/use)

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

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Takeda complained about a GlaxoSmithKline (GSK) press release posted on 30 July 2007 on GSK’s global corporate website (www.gsk.com) (also on www.usa.gsk.com) titled “GlaxoSmithKline presents Avandia data to FDA”.
The release summarised data presented to a US FDA Advisory Committee about Avandia (rosiglitazone) and cardiovascular ischaemic risk, and included “Important Safety Information” framed around US use, plus UK and US media contact details.
Takeda argued the global site was effectively UK-directed (UK registration, LSE share price on homepage, Google routing, UK careers routing) and the press release itself appeared UK-directed due to London contact numbers.
Takeda alleged multiple clauses were breached (including Clause 2), arguing statements were misleading/not in line with the Avandia SPC, insufficiently referenced, potentially disparaging, and amounted to promotion to patients/public in the UK/Europe.
GSK said it was a corporate/business press release for business/financial journalists, investors and analysts, about a US regulatory event, posted by GSK US; it was not promotional and did not refer to UK availability/use. During inter-company dialogue, GSK added clearer audience labelling on the “Avandia News” route to the release.

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No breach of the Code.
The Panel decided the press release did not come within the scope of the Code under Clause 21.2 because it did not make specific reference to the availability or use of Avandia in the UK.
As the material was outside scope, the other allegations (including Clause 2) were ruled not in breach.
The Panel noted it had no locus to rule on the EFPIA Code.

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