AUTH/1997/5/07: GlaxoSmithKline v Takeda — Actos mailing and reference to 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
Material	Four-page mailing for Actos (ref AC070230) including a treatment algorithm and a mention of Competact
Products	Actos (pioglitazone); Competact (pioglitazone + metformin)
Main issue	Whether mentioning Competact in an Actos + insulin-focused mailer without stating Competact’s contraindication with insulin was misleading/inconsistent with the 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 point)
Appeal outcome	No breach of Clauses 3.2 and 7.2; appeal successful
Complaint received	8 May 2007
Case completed	4 October 2007
Notes on procedure	Two Panel rulings on other points were declared a nullity because inter-company agreement had been reached; complaint should have proceeded on one point only

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

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GlaxoSmithKline (GSK) complained about a four-page Takeda mailing to GPs (ref AC070230) promoting a new indication for Actos (pioglitazone): use in combination with insulin in certain type 2 diabetes patients.
The mailing included a treatment algorithm with five vertical columns and included a highlighted mention of Competact (pioglitazone + metformin), another Takeda product.
GSK argued Competact was contraindicated for use in combination with insulin and that, given the mailer’s focus on Actos + insulin, the Competact mention should have been qualified with that contraindication.
There was inter-company dialogue on multiple points; two points were agreed between the companies and should not have proceeded. The only substantive unresolved issue was the Competact contraindication point.
The Panel initially ruled breaches, but Takeda appealed.

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Final decision: No breach of the Code (Appeal Board).
The Appeal Board ruled no breach of Clauses 3.2 and 7.2 regarding the unqualified mention of Competact in the algorithm.
The Appeal Board declared the Panel’s rulings on two other points (where agreement had been reached in inter-company dialogue) a nullity and they no longer stood.

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