GSK voluntary admission: Incruse + Relvar online ads ran with illegible generic names, missing Relvar PI link and (in some cases) no final certification (AUTH/2787/8/15)

📊

Key facts

⌄

Case number	AUTH/2787/8/15
Company	GlaxoSmithKline
Products	Incruse Ellipta (umeclidinium bromide) + Relvar Ellipta (fluticasone furoate/vilanterol trifenatate)
Channel	Online/digital advertisements (including Pulse; also referenced Nursing Times and other online journals)
Main issues	Relvar PI not available via link; non-proprietary names not readily readable; some ads published before final certification
Volume/timeframe	Five items published online; issues from 20 April to 2 July 2015; three of five released before certification
Complaint received	07 August 2015 (voluntary admission treated as a complaint)
Case completed	30 September 2015
Applicable Code year	2015
Breach clauses	4.1, 4.3, 9.1, 14.1, 28.1
No breach clauses	2, 16.1
Sanction	Undertaking received
Appeal	No appeal

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

GlaxoSmithKline (GSK) voluntarily admitted that some UK online advertisements for Incruse Ellipta (umeclidinium bromide) plus Relvar Ellipta (fluticasone furoate/vilanterol trifenatate) did not meet the 2015 ABPI Code requirements.
On 2 July 2015, a senior employee saw a Pulse website banner with a blurry/illegible non-proprietary name and a click-through that provided only Incruse prescribing information.
Two other advertisements had similar issues; review of the ZINC job bags showed that for some items final certification had not occurred because signatories had not seen the final form.
GSK instructed its media agency to remove all Incruse + Relvar online advertisements on 2 July 2015 and initiated an investigation; two further items with similar issues were identified.
Root causes described included: a media plan still referring to “Incruse” rather than “Incruse + Relvar”; a broken URL to a dual-PI PDF leading to replacement PI being requested “for Incruse”; and release errors (misread ZINC code / misinterpreted ZINC notification) resulting in publication before certification.
Across five items published online, GSK stated that all five had some illegibility and incomplete prescribing information from 20 April to 2 July; and three of five were released before certification.

⚖️

⌄

Breach found of: Clause 4.1 (Relvar prescribing information not provided), Clause 4.3 (non-proprietary names not readily readable), Clause 14.1 (published before certification), Clause 28.1 (internet promotion must comply), and Clause 9.1 (high standards not maintained).
No breach of: Clause 2 (particular censure) and Clause 16.1 (training/conversance with the Code) — the Panel accepted that mistakes did not necessarily mean personnel were not trained; no evidence was provided to show lack of training.
The Panel noted that while Clauses 4.2 and 4.4 were referenced by GSK, it was not possible to breach 4.2 or 4.4 in these circumstances; the failure was treated as a breach of Clause 4.1 and the Panel made no ruling on 4.2 and 4.4.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access