AUTH/3499/4/21: Daiichi-Sankyo website page promoted Efient and Lixiana to the public and breached a prior undertaking

📊

Key facts

⌄

Case	AUTH/3499/4/21
Company	Daiichi-Sankyo
Complaint received	02 April 2021
Case completed	06 December 2021
Applicable Code year	2019
Medicines	Efient (prasugrel); Lixiana (edoxaban)
Channel	Corporate website page (externally accessible via site search)
Main issues	Promotion of POMs to the public; lack of audience restriction/identification; lack of prescribing information; lack of certification; breach of prior undertaking
Breach clauses	4.1, 9.1, 14.1, 26.1, 26.2, 28.1, 28.3, 29
No breach clauses	2, 26.3
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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 complainant alleged Daiichi-Sankyo promoted prescription-only medicines (Efient/prasugrel and Lixiana/edoxaban) to the public via a corporate website page.
The page included brand and generic names, mechanism of action and indications, and was freely accessible (at least via the website search function).
The complainant also alleged this repeated an earlier issue and breached an undertaking given in Case AUTH/3107/10/18.
Daiichi-Sankyo said the antithrombotic section had been disabled in March 2019, but one subpage was mistakenly enabled due to human and technical error and became externally accessible.
The page was not accessible via normal navigation/footers, but could be found via certain search terms; Daiichi-Sankyo deleted the page after the complaint and stated product-name searches would route to approved pages.
Daiichi-Sankyo stated the page had not been reviewed by a medical signatory and was never intended for external publication.

⚖️

⌄

Breaches were ruled for promotion of POMs to the public and failure to restrict access/identify intended audience on the website.
Breaches were ruled for lack of prescribing information and lack of certification/signatory review.
A breach was ruled for failure to comply with a previous undertaking (AUTH/3107/10/18).
No breach was ruled for Clause 26.3 (patient side-effect reporting statement) because the Panel did not consider it established that the page was intended for patients taking the medicines.
No breach was ruled for Clause 2 (the Panel did not consider the circumstances warranted this particular censure).

🔒

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