Roche: Ocrevus prescribing information on multi-therapy “Congress & Meetings” hub page (AUTH/3663/6/22) – No breach

📅 2022 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3663/6/22
CompanyRoche Products Ltd
ComplainantAnonymous, contactable complainant (described self as a health professional)
MedicineOcrevus (ocrelizumab)
Material/channelRoche Resources website – “Congress and Meetings” landing page (M-GB-00006380; Date of preparation: March 2022)
Main allegationOff-label promotion / implied unlicensed indications (lung cancer, breast cancer, COVID-19) due to Ocrevus PI link on a multi-therapy congress hub page; plus alleged public advertising
Applicable Code2021
Clauses considered2, 3.2, 5.1, 11.2
Panel decisionNo breach of Clauses 2, 3.2, 5.1, 11.2
AppealNo appeal
Complaint received19 June 2022
Case completed14 June 2023

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

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What happened

  • An anonymous, contactable complainant (self-described health professional) alleged off-label promotion of Ocrevus (ocrelizumab) on Roche Products Ltd’s “Roche Resources” website.
  • The complaint focused on the “Congresses and Meetings” landing page (M-GB-00006380; date of preparation: March 2022), which displayed a prominent link to Ocrevus prescribing information near the top.
  • The landing page also contained tiles referencing multiple therapy areas/conditions including non-small cell lung cancer, small cell lung cancer and breast cancer (alongside neurology content).
  • A meeting tile title referenced COVID-19: “COVID-19 in OCREVUS (ocrelizumab) treated patients – the story so far”. Another tile referenced “Multiple Sclerosis: impact of COVID-19 and vaccination”.
  • The complainant alleged that placing Ocrevus prescribing information on a page mentioning oncology and COVID-19 implied Ocrevus was licensed for those conditions, and raised concerns about overall impression for busy HCPs.
  • The Authority asked Roche to respond under Clauses 2, 3.2 and 5.1 (as cited) and also Clause 11.2.
  • Roche said the site was aimed at HCPs, with an entry choice (“I am a healthcare professional” vs “I am a member of the public”), and that Ocrevus PI was included because Ocrevus and MS were referenced in titles and could be construed as a product claim.
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Outcome

  • No breach of Clause 3.2 (Prescription only medicines must not be advertised to the public).
  • No breach of Clause 11.2 (Requirement not to promote a medicine for an unlicensed indication).
  • No breach of Clause 5.1 (Requirement to maintain high standards).
  • No breach of Clause 2 (Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
  • No appeal.
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