AUTH/3363/6/20 - Complainant v GlaxoSmithKline

Alleged promotion of Anoro Ellipta on GlaxoSmithKline website

  • Received
    15 June 2020
  • Case number
  • Applicable Code year
  • Completed
    18 January 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about the promotion of Anoro Ellipta (umeclidinium and vilanterol inhaler) on GlaxoSmithKline’s website. Anoro Ellipta was indicated as a maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD).

The complainant alleged that the information provided on Anoro Ellipta would encourage a member of the public to ask his/her clinician for treatment - readers were referred to the patient information leaflet for more information, which, in the complainant’s view, would be suitable for patients on treatment, but not the general public. The complainant stated that there was a pop-up box where GlaxoSmithKline refused to take responsibility for anything contained there - although in the two sentences beforehand the company advocated that readers refire (sic) the document.

The complainant noted that the language was also aimed at patients ie ‘your breathing difficulties’ and so it implied those who read the information would benefit from treatment.

The complainant stated that all the other links to medication on the first page did not display this level of inappropriate detail, so this raised concerns that it had not been certified for the use for the general public in the first place.

The complainant stated that the page stated that it had last been updated in May 2018 - over 2 years ago.

The detailed response from GlaxoSmithKline is given below.

The Panel noted that Clause 26.2 permitted information about prescription only medicines to be supplied directly or indirectly to the public, but such information must be factual, presented in a balanced way, must not raise unfounded hopes of successful treatment and must not encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. The supplementary information to Clause 26.2 set out the detailed requirements for reference information which was intended to provide a comprehensive library resource for members of the public giving information relating to prescription only medicines which had marketing authorizations. Reference information must represent fairly the current body of evidence relating to a medicine and its benefit/risk profile and could include the PIL and SPC for a medicine.

The Panel noted GlaxoSmithKline’s submission that the webpage in question was a product page aimed at members of the UK public who sought information about Anoro Ellipta; readers could only land on the webpage by self-declaring as a non-healthcare professional. The Panel noted GlaxoSmithKline’s submission that the information provided on Anoro Ellipta was reference information.

The Panel noted that the Anoro Ellipta product webpage stated the active substances within the product and featured the indication beneath a subheading ‘What is Anoro Ellipta used for?’ below a prominent photograph of the product followed by information on COPD. The webpage bore links to the SPC and PIL. The Panel queried whether a prominent picture of the product in material aimed at the public was appropriate.

The Panel, however, considered that the information about Anoro Ellipta on the webpage for the public which was the subject of the complaint was not unacceptable in relation to the requirements of reference information. Nor did the Panel consider it was for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel therefore ruled no breach of the Code.

Suggesting that the public consult the PIL for more information was not necessarily unacceptable. The information was part of the approved regulatory information and was in the public domain for anyone to consult for whatever reason. The reference to ‘your breathing difficulties’ was in the context of patients with COPD and in the Panel’s view was not necessarily unacceptable. Neither was referring readers to the electronic Medicines Compendium (eMC) for up-to-date information and making it clear to readers accessing such information that they were being directed to a site which was not that of GlaxoSmithKline.

The Panel noted GlaxoSmithKline’s submission that the footer on the website referred to by the complainant related to the website structure and not to the information on the page.

The Anoro Ellipta webpage was certified for use in November 2019 and related to the entire webpage, including the footer and was still being used within two years of certification. The Panel further noted GlaxoSmithKline’s submission that GlaxoSmithKline had certified the footer in May 2018, and that it had subsequently been recertified in June 2020. The Panel therefore ruled no breaches of the Code.

The Panel did not consider that GlaxoSmithKline had failed to maintain high standards in this regard and no breach of the Code was ruled.