AUTH/3634/4/22: Complainant v Daiichi Sankyo — Edoxaban (Lixiana) initiation leavepiece (no breach on narrow availability point) | PMCPA Case

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Key facts

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Case number	AUTH/3634/4/22
Parties	Complainant v Daiichi Sankyo
Medicine / topic	Lixiana (edoxaban) initiation leavepiece
Material	Promotional leavepiece “edoxaban leavepiece” (EDX/22/0161; date of preparation March 2022)
Main allegation	Omission of hepatic function considerations from the body of the leavepiece (focus on renal function only), allegedly making it inaccurate/unbalanced and a safety risk
Applicable Code	2021
Clauses considered	2, 6.1, 6.2, 9.1
Complaint received	15 April 2022
Case completed	3 April 2023
Appeal	No appeal
Panel note	Panel had concerns about omission of hepatic considerations in the body, but ruled no breach because there was no evidence the leavepiece was available to HCPs by the complaint date
Distribution timing (as submitted)	Not used/distributed to HCPs before 15 April 2022; rolled out to field force in May 2022

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

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A cardiac specialist complained about a Daiichi Sankyo promotional leavepiece for UK prescribers on how to initiate Lixiana (edoxaban) (EDX/22/0161; date of preparation March 2022).
The complainant alleged the leavepiece discussed renal function but not hepatic function, despite hepatic warnings/contraindications and liver function testing requirements in the SPC.
The complainant said the omission made the piece inaccurate, unbalanced and a safety risk, and alleged breaches of Clauses 6.1, 6.2, 9.1 and 2.
Daiichi Sankyo said the leavepiece was created with input from a learned society HCP and was intended to support educational “Talking Head” videos, focusing on dosing and renal function.
Daiichi Sankyo said hepatic information was included in the prescribing information on page 2 and the top of page 1 directed readers to the PI and full SPC.
Daiichi Sankyo stated the webpage the complainant accessed was an unlisted staging site (not certified/ready for distribution) and the leavepiece had not been distributed or made available to health professionals before the complaint (complaint to PMCPA: 15 April 2022). It was rolled out to the field force in May 2022.
The Panel noted it was concerned about omission of hepatic considerations from the body of the leavepiece (page 1), given the material’s purpose (advising on appropriate prescribing), but focused on whether the material had been made available to HCPs by the complaint date.

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No breach of Clause 6.1.
No breach of Clause 6.2.
No breach of Clause 9.1.
No breach of Clause 2.
Reason: on a very narrow point, there was no evidence the leavepiece had been made available in any format to health professionals on or before the date of the complaint; and the complainant did not establish that relevant personnel were not trained/conversant with the Code.

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Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation
Clause 9.1 Requirement that all relevant personnel must be fully conversant with the Code
Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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