GSK respiratory promotion: meeting invites missing mandatory info and asthma implication for Trelegy (AUTH/3432/12/20)

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Key facts

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Case	AUTH/3432/12/20
Company	GlaxoSmithKline UK Limited
Therapy area	Respiratory (COPD/asthma)
Products referenced	Trelegy (fluticasone/umeclidinium/vilanterol); Anoro (umeclidinium/vilanterol); Incruse (umeclidinium); Relvar (fluticasone/vilanterol); Seretide (fluticasone/salmeterol); Serevent (salmeterol)
Materials at issue	Two meeting invitations; on-demand webinar; patient “How to use the Ellipta inhaler” leaflet; GSKPro webpages with Trelegy claims
Key upheld issues	Missing non-proprietary names; missing black triangles (where required); missing AE reporting statement on invite; implied Trelegy asthma licensing (off-label implication); lack of certification of final invites; patient leaflet missing AE reporting statement; high standards failures
Key not upheld issues	Webinar mandatory info allegation; Trelegy exacerbation relative vs absolute risk allegation; Trelegy cost-effective allegation (as framed); Relvar black triangle requirement
Applicable Code year	2019
Complaint received	28 November 2020
Case completed	6 September 2021
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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What happened

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An anonymous, contactable complainant challenged several GlaxoSmithKline UK Limited (GSK) respiratory promotional items covering Trelegy, Anoro, Incruse and Relvar (all via Ellipta), and references to Seretide and Serevent in one item.
Invitation: “Inhaler Technique & Devices Workshop” (Oct 2019) listed brand names (Trelegy, Anoro, Relvar, Incruse) but omitted non-proprietary names; omitted inverted black triangles for Trelegy/Anoro/Incruse; and did not include an adverse event reporting statement on the invitation itself (only within linked prescribing information).
The Panel also found the final populated invitation had not been certified prior to issue, despite sharing the same job bag number/date as the certified template (creating the impression it had been approved).
Invitation: “Optimising asthma control in your practice” (July 2019) had Trelegy Ellipta branding on the front cover and an asthma-focused title; although the agenda included a COPD session, the overall impression could lead a busy health professional to assume Trelegy was an asthma option (or licensed for both asthma and COPD).
On-demand webinar complaint about missing non-proprietary names/black triangles at a later slide was not upheld because GSK provided evidence that mandatory information appeared at first mention (Slide 2 early in the webinar).
Patient resource: a non-branded “How to use the Ellipta inhaler” leaflet (multiple languages) on GSKPro lacked an adverse event reporting statement.
Trelegy exacerbation claim (44% reduction) was challenged as relative risk without absolute risk; not upheld because the graph displayed absolute values with similar prominence.
Trelegy “cost-effective” claim was challenged as unsupported; not upheld on the narrow allegation because the complainant did not establish there was no cost-effectiveness analysis (GSK referenced NICE COPD guideline context).

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Outcome

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Breaches upheld for: missing non-proprietary names; missing black triangles (where required); missing adverse event reporting statement on an invitation; lack of certification of final invitations; off-label implication (Trelegy in asthma); patient material missing AE reporting statement; and high standards failures.
No breach findings for: Relvar black triangle requirement (not required at the time); the on-demand webinar allegations; the Trelegy exacerbation (relative vs absolute risk) allegation; and the Trelegy “cost-effective” allegation (as framed).
Clause 2 was found breached for the asthma-control invitation (Trelegy implication), but no breach of Clause 2 for the inhaler-techniques invitation and for the webinar-related allegations.

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Key facts

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