Roche Products Ltd – Polivy dosing webpage omitted key administration instructions (AUTH/3639/4/22) | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/3639/4/22
Company	Roche Products Ltd
Complainant	Anonymous, contactable; described themselves as a health professional
Medicine	Polivy (polatuzumab vedotin)
Material	Polivy promotional website – dosing page (GB-00004744; date of preparation September 2021)
Main issue	Dosing/administration webpage omitted key SmPC administration instructions (dedicated infusion line/filter/catheter; and inadequate signposting that dose-modification info for infusion-related reactions was on the safety page)
Applicable Code year	2021
Complaint received	25 April 2022
Case completed	24 April 2023
Appeal	No appeal
Breach clauses	Clause 6.1; Clause 5.1; Clause 2
No breach clauses (as ruled in parts)	Clause 6.1; Clause 6.2; Clause 5.1; Clause 2
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous health professional complained about Roche’s Polivy (polatuzumab vedotin) promotional website, specifically the dosing page (GB-00004744; date of preparation September 2021).
The complainant alleged the dosing page omitted important administration instructions from the Polivy SPC needed for patient safety, including: use of a dedicated infusion line with a specific in-line/add-on filter and catheter, and that Polivy must not be given as IV push/bolus.
The complainant also alleged the page did not include SPC guidance that the infusion rate should be slowed or interrupted if an infusion-related reaction occurs.
Roche argued the page included references to IV infusion (90-minute initial infusion; 30-minute subsequent infusions), links to prescribing information and a safety page, and prompts to consult the SPC and hospital guidelines.
The Panel found that, in the context of a dosing/administration page, the overall impression was that it contained all important administration information, when it did not (and it did not clearly signpost where the missing dosing-related information could be found).

⚖️

⌄

Breach of Clause 6.1 (misleading) for omission of important administration instructions about the required infusion line/filter/catheter and for not highlighting on the dosing page that additional important dose-modification information (re infusion-related reactions) was on the safety page.
Breach of Clause 5.1 (high standards) in relation to incomplete information about IV administration of an antineoplastic agent.
Breach of Clause 2 (discredit/reduced confidence) because incomplete administration information on a page intended to guide administration risked prejudicing patient safety.
No breach of Clauses 6.1 and 6.2 regarding the allegation that “IV*” could be misinterpreted as IV bolus/push (Panel considered HCPs unlikely to be misled given surrounding references to IV infusion).
No breach of Clause 6.2 (substantiation) as there was no allegation that information was not capable of substantiation.
No breach of Clauses 5.1 and 2 in relation to the infusion-related reaction dose-modification information being on the safety page (in the particular circumstances, the Panel did not consider this alone established a failure of high standards or discredit).

📖

⌄

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

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access