GSK: ‘Open, inhale, close’ device claim ruled misleading in Relvar digital sales aids; oversight concerns in pharmacist referral activity

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Key facts

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Case	AUTH/3056/8/18
Parties	Ex-representative v GlaxoSmithKline UK Limited
Complaint received	31 July 2018
Case completed	11 March 2019
Published	May 2019 Code of Practice Review
Applicable Code year	2016
Products	Relvar Ellipta; Anoro Ellipta; Trelegy Ellipta; (also referenced: Incruse Ellipta)
Main issues	Practice-based pharmacist relationship/referrals and switch-related documents; “Open Inhale Close” messaging in digital sales aids
Breach clauses	3.2; 7.2; 9.1
No breach clauses (listed)	2; 3.2; 7.2; 9.1; 15.9; 18.1; 19.1; 19.2; 23.1
Appeal	No appeal
Sanction	Undertaking received

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

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What happened

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An ex-GSK representative complained about (1) GSK’s relationship with a named practice-based pharmacist and (2) a device-use claim in digital sales aids for Relvar Ellipta, Anoro Ellipta and Trelegy Ellipta.
The pharmacist spoke at three internal GSK meetings (national sales conference March 2017; regional meeting December 2017; respiratory leadership meeting March 2018) under paid consultancy arrangements.
At a regional meeting, the pharmacist circulated hard-copy “medicines optimisation” protocols and template letters describing COPD inhaler switches (including switching Seretide/Spiriva to Relvar/Incruse) and referencing GSK support (eg, placebo devices/leaflets/training for NMS), creating the impression GSK was involved.
GSK representatives referred interested practices/health professionals to the pharmacist and a senior representative maintained a tracker of contacts and outcomes; some representatives asked the pharmacist to share copies of the documents with other practices.
Separately, certain historic Relvar digital sales aids (and Relvar/Incruse combination aids) used claims such as “delivers 24 hours of continuous efficacy in 3 steps: patients simply Open Inhale Close” and “With just 3 steps: patients simply Open Inhale Close”.
The complaint also alleged the same “open, inhale and close” message appeared in Trelegy and Anoro sales aids; Trelegy was found not to include it, and Anoro’s page was assessed in isolation.

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Outcome

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Breach of Clause 9.1 (high standards) in relation to GSK’s lack of action/clarification despite knowing the pharmacist’s switch documents were being shared following referrals from GSK representatives.
Breach of Clauses 3.2 and 7.2 for misleading/inconsistent claims in certain Relvar digital sales aids implying patients could obtain efficacy/benefit in “3 steps: Open Inhale Close”, which the Panel found inconsistent with the Relvar SPC instructions.
No breach of Clauses 23.1 and 18.1 regarding payments to the pharmacist for internal speaking engagements (payments considered consistent with time/fair market value on the evidence provided).
No breach of Clause 19.1 (switch/therapy review programmes) and thus no breach of Clause 18.1 on switch facilitation overall, due to insufficient evidence that GSK’s arrangements amounted to prohibited facilitation of a switch service.
No breach of Clause 15.9 (briefing material) on balance, despite concerns that the pharmacist’s documents could be seen as briefing material and lack of follow-up guidance to representatives.
No breach of Clause 2 (particular censure) despite concerns about arrangements/oversight.
No breach of Clauses 3.2 and 7.2 for Trelegy sales aids (no evidence the claim appeared) and for the current Relvar “Interactive Ellipta” section (tabs labelled Open/Look inside/Inhale/Close with PIL signposting) as alleged.
No breach of Clauses 3.2 and 7.2 for the single Anoro page reviewed (no efficacy/benefit linked to the 3 steps on that page).

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Key facts

What happened

Outcome

Clauses

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