AUTH/3903/5/24: Complainant v GSK (Blenrep website safety claim) – No breach

A health professional complained about a safety claim on GSK’s UK HCP promotional website (GSKPro) for Blenrep▼ (belantamab mafodotin). The Panel ruled no breach of the 2021 ABPI Code.

What happened

• An anonymous, contactable complainant (later became non-contactable) challenged a claim on the Blenrep homepage: “BLENREP had a generally well tolerated and manageable safety profile”.
• The complainant alleged the claim was inaccurate/misleading and not properly qualified, citing discontinuations due to eye-related side effects (stated as 5%) and the need to stop treatment for serious infusion-related reactions (IRRs), noting Blenrep’s black triangle status.
• The claim appeared twice on the homepage, each time referenced to the Blenrep summary of product characteristics (SPC), and accompanied by prominent links to safety information (e.g., “VIEW SAFETY DATA”, “EXPLORE BLENREP SAFETY HERE”).
• GSK temporarily took down the relevant webpages to review the materials and internal ways of working, then maintained the claim was accurate and substantiated in context.
• The Panel reviewed the homepage layout and the linked safety page content (DREAMM-2 safety summary; managing eye-related side effects; QoL section).

Outcome

• No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
• No Breach of Clause 5.1 Requirement to maintain high standards at all times
• No Breach of Clause 6.1 Requirement that information/claims/comparisons must not be misleading
• No Breach of Clause 6.2 Requirement that information must be accurate, up-to-date and be capable of substantiation

Clauses

• Clause 2
• Clause 5.1
• Clause 6.1
• Clause 6.2

Sanctions

• None (No breach)

Why this matters

• Broad safety/tolerability claims are high-risk, especially for oncology products with common and potentially serious adverse events and for black triangle/conditionally authorised medicines.
• Even when a claim is ultimately upheld, complaints often focus on whether the claim is sufficiently qualified at the point it is made and whether supporting detail is easy to find and clearly signposted.

Where teams slip up

• Using “generally well tolerated” / “manageable” without clear, proximate context on what “manageable” means (dose delays, modifications, discontinuation) and what the key risks are.
• Relying on a separate safety page but failing to make the link prominent, immediate, and clearly connected to the claim.
• Assuming specialist audiences will “know” key safety issues (the Panel noted extra IRR detail would have been helpful, even though it accepted clinicians would likely be familiar with IRR management).

Control that would have prevented it

• A structured “broad claim checklist” in copy approval: define the claim, specify the substantiation package, and require an on-page qualifier or an immediately adjacent, prominent link to detailed safety (with a signatory check that the claim can stand alone under Clause 6.1 supplementary information).