AstraZeneca breached Clause 8.1 over Forxiga website certification differences between desktop and mobile (AUTH/3661/6/22)

📊

Key facts

⌄

Case number	AUTH/3661/6/22
Complainant	Anonymous health professional (alleged breach of undertaking proceeded in the name of the Director)
Company	AstraZeneca UK Limited
Product	Forxiga (dapagliflozin)
Material / channel	Forxiga website diabetes webpage (desktop vs mobile versions)
Main issue	Whether differences between desktop and mobile meant there were two final forms requiring separate certification
Key difference driving breach	Prominent intended-audience statement shown at the top of the desktop webpage but not at the top of the mobile version
Other difference discussed	Breadcrumb/navigation text present on desktop but not mobile (treated as technical/navigation)
Applicable Code	2021
Breach clauses	Clause 8.1
No breach clauses	Clauses 2, 3.3, 5.1
Sanctions	Undertaking received
Complaint received	17 June 2022
Case completed	2 June 2023
Appeal	No appeal

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, contactable health professional complained about certification of the Forxiga (dapagliflozin) diabetes webpage on www.forxiga.co.uk.
The complainant alleged the desktop and mobile versions differed but shared the same job code/date, so the mobile version was not properly certified.
Key difference cited: a prominent intended-audience statement appeared at the top of the desktop page but was missing at the top of the mobile version (though repeated in the footer).
Another difference cited: the breadcrumb/navigation text “HOME > FORXIGA IN TYPE 2 DIABETES” appeared on desktop but not on mobile.
The complainant also alleged a breach of a prior undertaking following an earlier AstraZeneca case about mobile certification (AUTH/3488/3/21).
AstraZeneca said both desktop and mobile screenshots were included in one approval package (VVPM) and the nominated medical signatory reviewed the site on applicable devices before certification.

⚖️

⌄

Breach ruled for Clause 8.1 because the final form differed between desktop and mobile and should have been certified separately.
No breach ruled for Clauses 2, 3.3 and 5.1.
The Panel considered the breadcrumb difference a technical/navigation issue and not, on balance, substantive content requiring separate certification.
The Panel considered the omission of the prominent intended-audience banner on mobile meant there were two different final forms.
No breach of undertaking was found because, unlike the earlier case, the signatory had reviewed the mobile website for certification (even though Clause 8.1 was still breached here).

📖

⌄

Breach of Clause 8.1 Failure to meet the requirements for certifying material
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.3 Requirement to comply with an undertaking
No Breach of Clause 5.1 Requirement to maintain high standards

🔒

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