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

📊

Key facts

⌄

Case number	AUTH/2046/9/07
Parties	Takeda UK Limited v GlaxoSmithKline
Product	Avandia (rosiglitazone); comparator referenced by complainant: Actos (pioglitazone)
Material	Press release on GSK global corporate website: “GlaxoSmithKline presents Avandia data to FDA”
Channel	Internet (global corporate website) and issued to UK business/financial media (per Panel findings)
Complaint received	20 September 2007
Completed	11 January 2008
Applicable Code year	2006
Appeal	No appeal
Decision	No breach (press release not within scope of the Code under Clause 21.2)
Key reasoning	Although placed by a UK company/affiliate, the release did not make specific reference to UK availability or use; safety information related to US use and FDA context.

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

Takeda complained about a GlaxoSmithKline (GSK) press release posted on GSK’s global corporate website (www.gsk.com) on 30 July 2007: “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 and FDA context.
Takeda argued the global site was effectively UK-directed (UK registration, LSE share price on homepage, UK career routing, Google results, and London contact numbers on the release), so GSK UK was responsible for US affiliate content.
Takeda alleged multiple Code breaches (including Clause 2) and argued some statements were not aligned with the Avandia SPC; it also referenced the EFPIA Code (not within the Panel’s remit).
During inter-company dialogue, GSK amended the website presentation so the version accessed via “Avandia News” was labelled as intended for “business journalists and analysts/investors”.

⚖️

⌄

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 ruled out of scope, the other allegations (including Clause 2) were consequently ruled not in breach.
The Panel noted it had no locus to rule on the EFPIA Code.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access