AUTH/3435/12/20 - Complainant v Alimera

Alleged promotion of lluvien

  • Received
    03 December 2020
  • Case number
    AUTH/3435/12/20
  • Applicable Code year
    2019
  • Completed
    30 June 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional complained about the promotion of lluvien (fluocinolone acetonide) intravitreal implant on Alimera Sciences Limited’s website (iluvien.co.uk).
The complainant stated that the initial page of the website which asked visitors to click on one of two options, ‘For UK Healthcare Professionals’ or ‘For Patients and Public’, mixed up patients on treatment with the general public. The complainant alleged that all of the links were clearly for patients on treatment, not for members of the general public and, as such, the website promoted to the general public.

The complainant further noted that the Iluvien prescribing information was difficult to read, probably due to the format with extremely long lines of text.

The detailed response from Alimera is given below.

The Panel noted that the landing page of the website in question had two clearly labelled sections; one titled ‘For UK healthcare professionals’ and the other titled ‘For patients and public’. The section for health professionals had a hyperlinked box which stated ‘Continue if you are a Healthcare Professional’. The section for patients and public stated ‘Download patient guides’, followed by four hyperlinked boxes to resources which included a patient information leaflet (PIL), a patient education leaflet and two treatment support booklets, one for each of Iluvien’s indications which were stated in the hyperlinked boxes.

The Panel noted that it did not have a copy of the materials in question. Nonetheless, it was clear from the landing page that two of the documents were described as patient treatment support booklets and thus directed at those prescribed the product. The Panel was unsure how readers were directed to the website but noted that it appeared that those who arrived at the website were, from the landing page, able to view both indications for Iluvien, and download the relevant support booklets for each directly from the landing page. In the Panel’s view, these booklets were specifically aimed at patients who had been prescribed Iluvien for each of the relevant indications and were not reference information for the general public as referred to in the Code. The Panel considered that those materials intended for patients for whom the prescribing decision had been made should only have been made available once the relevant target audience had been made clear and there should have been a separate section for the general public. The Panel, noting its comments above, and taking all of the circumstances into account, considered that the descriptions of the support booklets and the availability to download materials which were intended for those for whom the prescribing decision has been made, from what appeared to be an open access landing page, meant that the landing page promoted Iluvien to members of the public. A breach of the Code was ruled as alleged.

The Panel noted that the Iluvien prescribing information was printed in grey font on a white coloured background. In that regard, the Panel considered that the contrast between the colour of the text and the background was not unacceptable and did not appear to render the text illegible. The Panel did not know upon what device the complainant had viewed the material and so in what size the text had appeared. However, the complainant’s allegation about extremely long lines of text was consistent with Alimera’s submission that the line length was 115 characters including spaces. The Panel considered that the line length was excessive and, on balance, would make the prescribing information difficult to read on certain devices. A breach of the Code was ruled.

The Panel considered that Alimera had failed to maintain high standards and a breach of the Code was ruled. It did not consider that the specific circumstances of this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such use.