AstraZeneca breached ABPI Code over missing PI and weak PI signposting on Tagrisso HCP website pop-up (AUTH/3806/8/23)

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Key facts

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Case number	AUTH/3806/8/23
Company	AstraZeneca
Product	Tagrisso (osimertinib)
Material / channel	UK product website for health professionals (“Tagrisso Connect”), including an entry pop-up with promotional claims
Main issues	Availability of and signposting to prescribing information; case study realism disclaimers; presentation of clinical trial data
Applicable Code year	2021
Complaint received	2 August 2023
Case completed	28 January 2025
Appeal	No appeal
Breach clauses	Clause 5.1; Clause 12.1; Clause 12.6 (x2)
No breach clauses (as recorded)	Clause 2; Clause 5.1 (x4); Clause 6.1 (x5); Clause 6.2 (x3)
Sanctions	Undertaking received

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

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An anonymous (initially contactable) complainant, describing themselves as a current AstraZeneca employee, raised concerns about the UK HCP website “Tagrisso Connect” for Tagrisso (osimertinib).
On entry (after HCP self-declaration), users were shown a large promotional pop-up containing Tagrisso claims and ADAURA efficacy/safety data.
The pop-up did not include prescribing information (PI) and did not include a direct single-click link or a clear statement telling users where PI could be found.
On the home page, PI links were located in the bottom third of the page; for some users this would require scrolling, and there was no clear statement at the top indicating where PI could be found.
Additional allegations were made about: (a) whether case studies were real or made up, and (b) presentation of clinical trial data (p-values, exploratory endpoints, and omission of 5-year OS rates).

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Breach of Clause 12.1 (pop-up was promotional and did not include PI / standalone PI requirement not met).
Breach of Clause 12.6 (x2) (no clear, prominent statement on the pop-up as to where PI could be found; and home page signposting required scrolling with no prominent top-of-page direction).
Breach of Clause 5.1 (failure to maintain high standards) in relation to the absence of PI and PI signposting on the first promotional pop-up.
No breach of Clause 2.
No breach of Clauses 6.1 and 6.2 in relation to the narrow p-value allegation (the material stated “p not provided”), clarity that CNS DFS was exploratory (it was labelled “Pre-specified exploratory analysis”), and omission of OS rates on the pop-up (HR/CI/ARR/p-value were shown; omission of OS rates was not shown to mislead).
No breach findings were also made for additional allegations under Clause 5.1 (x4) and Clause 6.1 (x5) and Clause 6.2 (x3), as recorded in the case summary.
The Panel additionally noted a concern (not a breach finding) that exploratory data appeared more prominently than primary endpoint data, and asked that AstraZeneca be advised of this concern.

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Clause 5.1 Failing to maintain high standards (Breach)
Clause 12.1 Failing to include prescribing information (Breach)
Clause 12.6 (x2) Failing to include a clear, prominent statement as to where prescribing information could be found (Breach)
Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (No Breach)
Clause 5.1 (x4) Requirement to maintain high standards at all times (No Breach)
Clause 6.1 (x5) Requirement that claims/information/comparisons must be accurate, up to date and not misleading (No Breach)
Clause 6.2 (x3) Requirement that claims/information/comparisons must be capable of substantiation (No Breach)

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