AUTH/2570/12/12: GSK v Napp — Flutiform leavepieces found misleading on comparability and cost-effectiveness claims | PMCPA Case

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Key facts

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Case number	AUTH/2570/12/12
Parties	GlaxoSmithKline v Napp Pharmaceuticals Limited
Products	Flutiform (fluticasone propionate/formoterol) vs Seretide Evohaler (fluticasone/salmeterol)
Materials	Two leavepieces (UK/FLUT-11050; UK/FLUT-11023a)
Main issues	Unqualified comparability claim; implied substitutability; claim adjacency implying 12-month comparability; broad cost-effectiveness claims based on acquisition-cost model; “simple dosing schedule” implying difference
Applicable Code year	2012
Complaint received	18 December 2012 (HTML listing) / 19 December 2012 (report narrative)
Case completed	17 July 2013
Breach clauses	7.2 (x8), 7.3 (x8), 7.4 (x6), 9.1
No breach clauses	2, 3.2, 8.1 (and some specific allegations under 7.2/7.3/7.4 were not upheld)
Sanctions	Undertaking received; additional sanctions not stated
Appeal	Appeal by complainant on Clause 2; unsuccessful (no breach of Clause 2 upheld)

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

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GlaxoSmithKline (GSK) complained about two Napp Pharmaceuticals leavepieces promoting Flutiform (fluticasone/formoterol) and comparing it with GSK’s Seretide Evohaler (fluticasone/salmeterol), both for asthma.
Leavepiece 1 (UK/FLUT-11050) was a 4-page A5 leaflet; leavepiece 2 (UK/FLUT-11023a) was a double-sided A4 document focused on cost-effectiveness.
Key disputed messages included: “Comparable clinical efficacy” vs Seretide; “The efficacy and tolerability of Flutiform were sustained for up to 12 months”; “Why should I prescribe flutiform instead of Seretide Evohaler?”; and multiple “cost-effective/cost-effectiveness” claims based on a cost-minimisation analysis (data on file).
GSK argued the materials implied broader comparability/substitutability than supported by the cited evidence (notably a 12-week open-label non-inferiority study in adults on low/medium doses) and that cost-effectiveness claims overstated what was actually analysed (acquisition costs only).
Napp defended the claims as supported by the clinical package and the cited studies, and argued cost-minimisation was appropriate; it also highlighted prominent statements that Flutiform was for maintenance therapy (not acute relief).
The Panel ruled multiple breaches; GSK appealed the ruling of no breach of Clause 2. GSK later sought to withdraw the appeal but could not under the Constitution and Procedure; the Appeal Board upheld no breach of Clause 2.

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Breach rulings: Clauses 7.2, 7.3, 7.4 (multiple) and Clause 9.1.
No breach rulings: Clauses 2, 3.2 and 8.1 (and some specific allegations under Clauses 7.2/7.3/7.4 were not upheld for particular items, as detailed below).
The Appeal Board was concerned about the multiplicity of breaches and potential (theoretical) patient-safety consequences, but upheld the Panel’s no breach of Clause 2 decision.

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