GSK respiratory webinar pages: missing Relvar prescribing information and undertaking breach; COPD ‘triple therapy’ appeal succeeds (AUTH/3308/2/20)

📅 2020 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3308/2/20
PartiesAnonymous/Director v GlaxoSmithKline
MaterialGSK UK HCP events website webinar registration pages (asthma and COPD)
Applicable Code year2019
Complaint received11 February 2020
Case completed17 September 2020
Products referencedRelvar Ellipta (fluticasone/vilanterol); Trelegy Ellipta (fluticasone/umeclidinium/vilanterol)
Asthma webinar page findingPromotional for Relvar Ellipta; PI and Clause 4.6 statement missing; undertaking not complied with
COPD webinar page findingPanel: promotional for Trelegy and PI required; Appeal Board: not promotional for a specific medicine, so PI not required
External guideline link (BTS/SIGN)No breach of Clause 28.6
SanctionsUndertaking received; Advertisement

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

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What happened

  • A health professional complained about two webinar registration pages on GSK’s UK HCP events website.
  • The complainant alleged an earlier asthma webinar page previously ruled in breach (AUTH/3178/3/19) was still live; GSK said it had been removed in May 2019.
  • A different asthma webinar registration page (“Effectiveness by Design: molecules engineered for efficacy and safety”, ref PM-GB-FFV-BRF-190025) went live 24 October 2019 and remained viewable on 11 February 2020.
  • The asthma page included the subheading “Relvar – asthma control with precision potency” and text about fluticasone furoate “improv[ing] asthma control”, but did not include Relvar Ellipta prescribing information or a clear prominent statement of where it could be found.
  • The Panel found this asthma page had not been reviewed as part of GSK’s undertaking in AUTH/3178/3/19 (to take all possible steps to avoid similar breaches).
  • The complainant also alleged a breach for an external hyperlink to BTS/SIGN asthma guidelines (Clause 28.6).
  • A second webinar registration page (“Treating an exacerbating COPD patient in 2019 – From guidelines to practice”, ref PM-GB-FVU-WCNT-19004) was alleged to be disguised promotion and indirectly promotional for Trelegy due to references to stepping up to “triple therapy”.
  • The Panel initially ruled the COPD page was promotional for Trelegy and required prescribing information; GSK appealed.
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Outcome

  • Asthma webinar page (Relvar): Breaches upheld for missing prescribing information and failure to comply with an undertaking.
  • External link to BTS/SIGN guideline: No breach of Clause 28.6.
  • COPD webinar page (triple therapy): Panel initially ruled breaches, but Appeal Board overturnedno breach of Clauses 4.1, 4.6, 9.1 and 2 for the COPD page.
  • GSK accepted the breach rulings relating to the asthma webinar page.
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