Roche: ‘Generally well tolerated’ claim on Ocrevus HCP landing page ruled not misleading (AUTH/3651/5/22)

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Key facts

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Case number	AUTH/3651/5/22
Company	Roche Products Ltd
Complainant	Anonymous, contactable health professional
Product	Ocrevus (ocrelizumab)
Material/channel	Landing page of the Roche Resources website (Ocrevus website landing page)
Main allegation	Claim “generally well tolerated” was misleading/not balanced given serious adverse events described in the SPC; needed significant qualification
Applicable Code	2021
Clauses cited	2, 5.1, 6.1, 6.2
Panel decision	No breach of Clauses 2, 5.1, 6.1, 6.2
Key rationale	Claim was sufficiently qualified by adjacent, eye-catching list of links to safety/tolerability information within the immediate visual field, plus the qualifier “generally”
Complaint received	30 May 2022
Case completed	23 May 2023
Appeal	No appeal

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

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An anonymous, contactable health professional complained about the Ocrevus (ocrelizumab) landing page on the Roche Resources website.
The landing page included the claim: “Ocrevus was generally well tolerated by RMS and PPMS patients”.
The complainant alleged the safety wording was misleading/not balanced given SPC trial data describing serious (and rare fatal) adverse effects, and said the claim needed significant qualification that was not provided.
The claim sat in a “Safety Profile” section and was followed by “Find out more about” with four prominent links: Ocrevus Safety Profile, Ocrevus ADRs, Ocrevus IRRs, and Ocrevus Warnings and Precautions.
Roche argued the complainant conflated “tolerability” and “safety profile”, and that tolerability can be supported by overall AE/discontinuation rates versus comparators; Roche also noted MHRA pre-vetting had approved inclusion of the phrase (while acknowledging this is not determinative of ABPI compliance).
The Panel assessed the version of the webpage provided by the complainant and noted it did not have access to the linked content.

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No breach of Clause 6.1 (Requirement that claims must not be misleading).
No breach of Clause 6.2 (Requirement that claims must be capable of substantiation).
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).
The Panel’s key reasoning: the claim was sufficiently qualified by the immediately adjacent, eye-catching list of links to ADRs/IRRs/warnings & precautions within the immediate visual field, plus the qualifying word “generally”.

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No Breach of Clause 2 Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 6.1 Requirement that claims must not be misleading
No Breach of Clause 6.2 Requirement that claims must be capable of substantiation

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