GSK webinar registration implied COPD medicines were licensed for asthma; Clause 2 upheld on appeal (AUTH/3515/5/21)

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Key facts

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Case number	AUTH/3515/5/21
Company	GlaxoSmithKline UK Limited
Complainant	Anonymous, non-contactable health professional
Products referenced	Seretide (fluticasone/salmeterol); Trelegy (fluticasone furoate/vilanterol/umeclidinium); Anoro (vilanterol/umeclidinium); Incruse (umeclidinium); also listed on the page: Nucala, Relvar, Ventolin, Flixotide (context only)
Materials at issue	Webinar registration page (ref PM-GB-MPL-WCNT-210010, April 2021) and Seretide webpage (ref PM-GB-FPS-WCNT-200001 (2.0), October 2020)
Main issue (breach)	Asthma-focused webinar registration page included PI links to COPD-only medicines, implying asthma licensing/use
Clause(s) breached	2; 3.2 (for each of Trelegy/Anoro/Incruse); 9.1
Appeal	GSK appealed Clause 2; Appeal Board upheld breach of Clause 2
Complaint received	21 May 2021
Case completed	16 November 2021
Applicable Code year	2019
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous health professional complained about two items promoting Seretide (fluticasone/salmeterol) by GlaxoSmithKline UK Limited (GSK).
Item A (webinar registration page): An online registration page for a GSK-organised and funded webinar (25 May 2021) titled “Patient Management in Severe Asthma - Evolution & Evidence” included links to prescribing information for multiple GSK respiratory medicines.
The list included Trelegy (fluticasone furoate/vilanterol/umeclidinium), Anoro (vilanterol/umeclidinium) and Incruse (umeclidinium), which are licensed for COPD, not asthma.
The complainant alleged that including these links on an asthma-focused promotional page could lead busy health professionals to think these medicines were licensed for asthma.
The complainant also alleged it was inappropriate for a GSK medical department employee (non-promotional role) to chair a promotional webinar and solicit questions, blurring promotional/non-promotional lines.
Item B (Seretide webpage claim): A headline claim stated: “Seretide Evohaler - a combination ICS/LABA treatment for asthma. Now over £5 cheaper than Fostair at medium dose”. The complainant alleged it implied Seretide was suitable for any asthma patient (including under-4s), creating patient safety risk.

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Webinar registration page (Trelegy/Anoro/Incruse links): Breach
- Breach of Clause 3.2 ruled for each medicine (Trelegy, Anoro, Incruse) because the overall impression was they were licensed for asthma when they were not.
- Breach of Clause 9.1 ruled (high standards not maintained).
- Breach of Clause 2 ruled by the Panel and upheld on appeal (implied suggestion of asthma use was a patient safety matter and reduced confidence in the industry).
Medical department employee chairing webinar: No breach
- No breach of Clause 16.3 (chairing did not make the employee a “representative” requiring the representative exam).
- No breach of Clause 9.1 and no breach of Clause 2 in relation to this allegation.
Seretide webpage claim: No breach
- No breach of Clause 7.2 (not misleading).
- No breach of Clause 3.2 (not inconsistent with SPC).
- No breach of Clause 7.4 (substantiation acceptable).
- No breach of Clause 9.1 and consequently no breach of Clause 2.

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