Alimera website ruled to promote Iluvien to the public via open-access patient support downloads (AUTH/3435/12/20)

📅 2020 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3435/12/20
PartiesComplainant v Alimera Sciences Limited
ProductIluvien (fluocinolone acetonide) intravitreal implant
ChannelCompany website (iluvien.co.uk)
Main issuesPublic access to patient-on-treatment support booklets; prescribing information legibility (excessive line length)
Applicable Code year2019
Complaint received3 December 2020
Case completed30 June 2021
AppealNo appeal
Breach clauses4.1, 9.1, 26.1
No breach clauses2
SanctionsUndertaking received; Additional sanctions: Not stated

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

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What happened

  • A UK health professional complained about Alimera’s Iluvien (fluocinolone acetonide) intravitreal implant website (iluvien.co.uk).
  • The landing page offered two routes: “For UK Healthcare Professionals” and “For Patients and Public”.
  • The “Patients and Public” area included downloadable resources: a patient information leaflet (PIL), a patient education leaflet, and two “patient treatment support booklets” (one per indication) available directly from the landing page.
  • The complainant alleged the page mixed up “patients on treatment” with the general public, effectively promoting a prescription-only medicine (POM) to the public.
  • The complainant also alleged the prescribing information was difficult to read due to extremely long lines of text.
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Outcome

  • Breach upheld: Clause 26.1 (promotion of a POM to the public) due to open access to materials aimed at patients already prescribed Iluvien, without clearly identifying/segregating that audience.
  • Breach upheld: Clause 4.1 (prescribing information not clear/legible) because line length (~115 characters incl. spaces) was excessive and could make it difficult to read on some devices.
  • Breach upheld: Clause 9.1 (failure to maintain high standards).
  • No breach: Clause 2 (Panel did not consider the circumstances warranted particular censure).
  • No appeal.
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