GSK case AUTH/2841/4/16: Anoro Ellipta COPD exacerbation claims in HCP presentations found misleading without licence context

📊

Key facts

⌄

Case number	AUTH/2841/4/16
Company	GlaxoSmithKline
Complainant	Anonymous, non contactable
Product	Anoro Ellipta (vilanterol/umeclidinium)
Therapy area	Chronic obstructive pulmonary disease (COPD)
Main issue	Use of COPD exacerbation reduction claims in presentations without clear licensed indication context and without key caveats; alleged off-label promotion
Materials at issue	MIMS webpage (independent); multiple GSK materials; three certified HCP presentations (two found in breach)
Complaint received	22 April 2016 (PDF) / 25 April 2016 (website listing)
Case completed	3 November 2016
Applicable Code year	2015 (website listing); Panel rulings made under 2016 Code (substantive requirements unchanged)
No breach clauses	Clause(s) 2, 3.2, 7.2, 9.1
Breach clauses	Clause(s) 3.2, 7.2 (x2), 9.1
Appeal	Appeal by respondent; breach of Clause 3.2 for two presentations upheld
Sanctions	Undertaking received; additional sanctions not stated

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

📋

⌄

An anonymous complainant alleged off-label promotion of LABA/LAMA inhalers for COPD exacerbation reduction, focusing on GSK’s Anoro Ellipta (vilanterol/umeclidinium).
The complainant highlighted a MIMS webpage claiming “COPD exacerbations were reduced by 50%… compared with placebo” and said there was no warning about off-label use.
GSK stated it did not commission the MIMS article and had no editorial control; MIMS confirmed editorial independence.
The Panel reviewed a range of GSK materials. Most were positioned around Anoro’s licensed indication (maintenance bronchodilator to relieve symptoms) and, where exacerbation data appeared, it was typically accompanied by caveats that studies were not designed to evaluate exacerbations and patients were withdrawn if an exacerbation occurred.
The Panel also reviewed three certified presentations delivered by health professionals on behalf of GSK. Two presentations included exacerbation reduction claims but did not clearly state Anoro’s licensed indication and did not include the key caveat that studies were not designed to evaluate exacerbations.
GSK appealed the breach of Clause 3.2 for the two presentations; the Appeal Board upheld the breach.

⚖️

⌄

MIMS webpage: No breach (outside the scope of the Code as it was wholly independent of GSK).
Most GSK promotional/briefing materials reviewed: No breach of Clauses 3.2, 7.2, 15.9, 9.1 (Panel found exacerbation references were within the context of the licensed indication and appropriately caveated).
Three certified HCP presentations:
- Presentation “COPD – Latest therapies”: No breach of Clause 3.2 overall, but breach of Clause 7.2 for a misleading claim about reduced time to first exacerbation vs tiotropium given studies were not designed to evaluate exacerbations.
- Two other presentations (breathlessness in COPD; and “Management and prevention of exacerbations of COPD”): breach of Clause 3.2 (not consistent with SPC) and breach of Clause 7.2 (misleading) because exacerbation data was presented without clearly stating the licensed indication and without the “not designed to evaluate exacerbations” caveat.
Clause 9.1: Breach (high standards not maintained) in relation to the presentations.
Clause 2: No breach (Panel did not consider the matters brought discredit upon or reduced confidence in the industry).
Appeal: GSK’s appeal against the Clause 3.2 breach for the two presentations was unsuccessful; the breach was upheld.

🔒

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