Daiichi Sankyo: Lixiana HCP mobile site hid PI and AE reporting behind collapsible menu (AUTH/3630/4/22)

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Key facts

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Case	AUTH/3630/4/22
Complainant	Anonymous ex-employee
Company	Daiichi Sankyo
Material	Promotional Lixiana (edoxaban) HCP website homepage (mobile view); site: https://lixiana-hcp.co.uk/; ref EDX/22/0052; date of preparation March 2022
Main issue	PI and AE reporting statement placed within a collapsible menu bar on mobile; AE statement also referenced on a splash/gateway page
Applicable Code year	2021
Complaint received	11 April 2022
Case completed	15 March 2023
Appeal	No appeal
Breach clauses	5.1, 12.1, 12.4, 12.6, 12.9
No breach clauses	2, 12.1 (clear and legible)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous complainant (ex-employee) challenged the mobile view of Daiichi Sankyo’s promotional Lixiana (edoxaban) HCP website (ref EDX/22/0052, date of preparation March 2022).
The complainant alleged that on an Android phone (Chrome), with and without “Desktop site” enabled, the homepage did not show prescribing information (PI) or an adverse event (AE) reporting statement, nor any visible link to them.
Daiichi Sankyo said PI and the AE reporting statement were available on mobile within a collapsible/expandable menu bar; it also referenced an AE statement on an initial “splash”/gateway page.
The Panel assessed the experience when viewing the site from a mobile phone and focused on whether obligatory information was positioned and signposted for easy access and prominence.

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Breach of Clause 12.1 (positioning for ease of reference) because PI was behind an expandable menu with no signposting.
Breach of Clause 12.4 because reaching PI required two clicks (expand menu, then click PI), not a “direct, single click link”.
Breach of Clause 12.6 because the PI location was not clearly and prominently stated (the PI reference only appeared after expanding the menu).
Breach of Clause 12.9 because the AE reporting statement was not sufficiently prominent; it should appear as an integral part of the promotional website, not hidden in a menu or only on a gateway page.
Breach of Clause 5.1 for failure to maintain high standards given the difficulty accessing obligatory information on mobile.
No breach of Clause 12.1 (clear and legible PI) because the complainant did not establish the PI was unclear/illegible.
No breach of Clause 2; the Panel did not consider the circumstances warranted “particular censure” and did not accept this case as sufficiently similar to prior cited cases to amount to cumulative similar serious breaches.

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Breach of Clause 12.1 Not meeting the requirement for prescribing information to be positioned for ease of reference
Breach of Clause 12.4 Failing to provide prescribing information by way of a clear, and prominent, direct, single click link
Breach of Clause 12.6 Failing to include a clear prominent statement as to where the prescribing information can be found
Breach of Clause 12.9 Failing to include the adverse event reporting statement in a prominent manner
Breach of Clause 5.1 Failing to maintain high standards
No Breach of Clause 12.1 The requirement, amongst other things, for prescribing information to be provided in a clear and legible manner
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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