AUTH/3363/6/20: GSK Anoro Ellipta public website page – no breach (reference information and certification upheld)

📅 2020 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3363/6/20
CompanyGlaxoSmithKline
ComplainantConcerned UK health professional
MedicineAnoro Ellipta (umeclidinium and vilanterol inhaler)
Indication referencedMaintenance bronchodilator treatment to relieve symptoms in adults with COPD
ChannelCompany website (public product webpage)
Main allegationsPublic promotion/encouraging requests for treatment; patient-directed language; external-link pop-up disclaimer; certification/expiry concerns
Clauses considered9.1, 14.3, 14.5, 26.2
Applicable Code year2019
Panel decisionNo breach of Clauses 9.1, 14.3, 14.5, 26.2
Complaint received15 June 2020
Case completed18 January 2021
AppealNo appeal
SanctionsNone

Download the full case report (PDF)


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

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What happened

  • A UK health professional complained about a GlaxoSmithKline (GSK) public-facing webpage about Anoro Ellipta (umeclidinium/vilanterol) for COPD.
  • The complainant alleged the page encouraged members of the public to ask clinicians for treatment, including by directing readers to the patient information leaflet (PIL).
  • The complainant objected to patient-directed language (eg, “your breathing difficulties”), suggesting it implied the reader would benefit from treatment.
  • The complainant raised concerns about a pop-up shown when clicking links (SPC/PIL) which, in their view, disclaimed responsibility while directing readers to the documents.
  • The complainant suggested inconsistent detail versus other product links and questioned whether the page had been properly certified for public use.
  • The complainant noted a footer stating the page was last updated in May 2018 (suggesting it might be out of date/expired).
  • GSK stated the page was accessible only after the user self-declared as a non-healthcare professional and that the content was “reference information” drawn from the PIL, with links to the SPC and PIL hosted externally (eMC).
  • GSK stated the Anoro Ellipta webpage was certified in November 2019; the footer related to website structure and had been certified in May 2018 and recertified in June 2020.
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Outcome

  • No breach of the Code was ruled.
  • The Panel ruled no breach of Clause 26.2 (public information about POMs as reference information; not encouraging requests for a specific POM).
  • The Panel ruled no breach of Clauses 14.3 and 14.5 (certification and continued use within two years).
  • The Panel ruled no breach of Clause 9.1 (high standards).
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