AUTH/3714/11/22: GlaxoSmithKline – Trelegy website claim “A simple choice… easy to use and quick to teach” (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3714/11/22
Company	GlaxoSmithKline UK Limited
Product	Trelegy Ellipta (fluticasone furoate/vilanterol trifenatate/umeclidinium bromide)
Channel/material	HCP promotional website (“Dosing and Device” page); PM-GB-FVU-WCNT-200008 (V4.0)
Claim at issue	“A simple choice. One inhaler, easy to use and quick to teach”
Complainant	Anonymous, contactable health professional
Complaint themes	Misleading/unsubstantiated device usability and teachability; “simple choice” challenged due to patient preference, lactose excipient, and side effects
Applicable Code year	2021
Clauses considered	2, 5.1, 6.1, 6.2
Panel decision	No breach of Clauses 2, 5.1, 6.1, 6.2
Appeal	No appeal
Complaint received	24 November 2022
Case completed	24 October 2023

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

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An anonymous, contactable complainant (a health professional) challenged a headline claim on GlaxoSmithKline UK Limited’s HCP promotional website for Trelegy Ellipta (material code: PM-GB-FVU-WCNT-200008 (V4.0)).
The claim was: “A simple choice. One inhaler, easy to use and quick to teach” (on the “Dosing and Device” page, adjacent to an image of the Ellipta device).
The complainant alleged the claim was misleading and not substantiated, arguing the inhaler required multiple steps; some elderly patients may have dexterity issues opening the cover; some may not hear the “click”; and that teaching would take longer due to steps and re-checking technique.
The complainant also argued “simple choice” was misleading because inhaler choice depends on patient preference; Trelegy contains lactose (relevant to lactose intolerance); and Trelegy has common side effects making choice “complex”.
GSK responded that the claim was supported by van der Palen J et al. (NPJ Prim Care Med 2016; 26:16079), which assessed critical errors, teaching time, and patient ease-of-use/preference for Ellipta vs five comparator devices.
The PMCPA Panel assessed each element of the composite claim separately (“easy to use”, “quick to teach”, “a simple choice”) in the context of the whole webpage and referenced data.

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No breach of the Code.
The Panel ruled the complainant had not established that the statements were misleading or incapable of substantiation within the context of the full claim and webpage.
The Panel noted it had some concerns about the wording “easy to use”, but still ruled no breach based on the complainant’s narrow allegations and the context provided on the page (including critical error data vs comparators).
No appeal.

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Clause 6.1 Requirement that claims/information/comparisons must not be misleading – No breach
Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation – No breach
Clause 5.1 Requirement to maintain high standards at all times – No breach
Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry – No breach

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