AUTH/1997/5/07: GlaxoSmithKline v Takeda — Actos mailing and mention of Competact (No breach on appeal) | PMCPA Case

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Key facts

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Case number	AUTH/1997/5/07
Parties	GlaxoSmithKline UK Limited v Takeda UK Limited
Product(s)	Actos (pioglitazone); Competact (pioglitazone + metformin)
Material	Four-page GP mailing for Actos (ref AC070230) including a type 2 diabetes treatment algorithm
Main allegation	Mention of Competact without stating its contraindication for use with insulin was misleading and inconsistent with the SPC/marketing authorisation
Applicable Code year	2006
Clauses cited	Clauses 3.2 and 7.2
Panel decision	Breaches of Clauses 3.2 and 7.2 (later overturned on appeal for the remaining issue)
Appeal Board decision	No breach of Clauses 3.2 and 7.2
Complaint received	8 May 2007
Case completed	4 October 2007
Published	Code of Practice Review November 2007

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

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GlaxoSmithKline (GSK) complained about a four-page Takeda mailing (ref AC070230) sent to GPs promoting a new indication for Actos (pioglitazone): use in combination with insulin in type 2 diabetes patients with insufficient glycaemic control on insulin where metformin was inappropriate (contraindications or intolerance).
The mailing included a treatment algorithm for type 2 diabetes and referenced Competact (pioglitazone + metformin), also marketed by Takeda.
GSK argued Competact was contraindicated for use in combination with insulin and that the mailer’s unqualified mention of Competact in an insulin-focused promotional context was misleading and inconsistent with Competact’s marketing authorisation/SPC.
There was inter-company dialogue on multiple points; agreement was reached on some issues. The Appeal Board later determined two points should not have proceeded because agreement had been reached (Panel rulings on those points were declared a nullity).
The only substantive issue that proceeded was whether the algorithm’s mention of Competact needed to state the insulin contraindication.

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Final decision (Appeal Board): No breach of Clauses 3.2 and 7.2.
The Appeal Board found the algorithm showed five distinct treatment options in separate vertical columns; insulin first appeared only in the final (rightmost) column, whereas Competact appeared earlier (position three), before insulin was introduced.
The Appeal Board also noted Competact’s components (pioglitazone and metformin) were not contraindicated with insulin, and the omission in this context should not give rise to safety issues.
Process point: the Appeal Board criticised aspects of both companies’ inter-company dialogue (Takeda slow responses; GSK seeking a “written undertaking” and complaining on matters already agreed) and stressed complaints should be clear about the status of inter-company dialogue.

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