GSK webinar registration page held to promote Relvar Ellipta without prescribing information (AUTH/3178/3/19)

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Key facts

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Case	AUTH/3178/3/19
Complainant	Anonymous (concerned UK health professional)
Company	GlaxoSmithKline UK Limited
Material	Webinar registration page on GSK website (Events section)
Product referenced/implicated	Relvar Ellipta (fluticasone furoate/vilanterol trifenatate)
Main issue upheld	Promotional page for Relvar Ellipta omitted prescribing information
Breach clauses	Clause 4.1; Clause 4.4; Clause 9.1
No breach clauses	Clause 2; Clause 3.2; Clause 7.2; Clause 7.4
Complaint received	28 March 2019
Case completed	1 November 2019
Applicable Code	2016
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A UK health professional complained about an “Events” listing on a GlaxoSmithKline (GSK) website focused on fluticasone furoate (an active ingredient in Relvar Ellipta).
The listing was a webinar registration page titled: “Engineered for Effectiveness: a next generation ICS molecule in asthma”, marked “For UK Healthcare Professionals” and “This site contains promotional material”.
The page invited HCPs to explore “a once daily medicine for Asthma patients” and included text stating fluticasone furoate was designed as a “next generation” ICS “developed to improve on the success of our previous inhaled steroids and improve asthma control”, with references including the Relvar Ellipta SPC.
The complainant alleged: (a) no prescribing information (PI) on the front page or where the event was listed; (b) “next generation” was misleading/unsubstantiated; (c) implied superior asthma control without a stated comparator; (d) off-licence promotion of fluticasone furoate monotherapy.
GSK said the page was certified promotional, access was gated to UK HCPs, and the webinar aimed to clarify confusion about potency/dose equivalence; it argued fluticasone furoate monotherapy had no UK marketing authorisation/SPC and therefore no PI existed for it.

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The Panel considered the webinar registration page was positive about fluticasone furoate and therefore promoted Relvar Ellipta.
Breach: Relvar Ellipta prescribing information was not provided on the registration page as required.
No breach: Alleged lack of PI on the website “front page” (insufficient evidence provided to the Panel).
No breach: “Next generation” claim (complainant did not discharge burden of proof that it was misleading or incapable of substantiation on the grounds alleged).
No breach: Comparator not stated (Panel considered it was a comparison with “previous inhaled steroids”, so not a hanging comparison).
No breach: Off-licence promotion allegation under Clause 3.2 (Panel found Clause 3.2 not applicable to fluticasone furoate monotherapy as an inhaled corticosteroid because there was no marketing authorisation/SPC for that monotherapy).
No breach: Clause 2 (Panel did not consider the circumstances warranted this sign of particular censure).

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