AUTH/3776/6/23: Complainant v Daiichi Sankyo — patient organisation cholesterol programme (no breach)

📊

Key facts

⌄

Case	AUTH/3776/6/23
Company	Daiichi Sankyo
Complainant	Anonymous, contactable
Subject matter	Guideline document on a patient organisation HCP website section (“Tackling Cholesterol Together”); inclusion of screenshots of Daiichi Sankyo promotional material for Nilemdo and Nustendi
Medicines mentioned	Nustendi (bempedoic acid-ezetimibe); Nilemdo (bempedoic acid)
Material referenced	NICE technology appraisal guidance TA694 guidelines card; company reference BEM/21/0086
Main allegations	Material was promotional; lacked contraindication clarity (simvastatin >40mg); lacked prescribing information; not certified; missing declaration of company involvement
Applicable Code	2021
Clauses considered	2, 5.5, 6.1, 6.2, 8.1, 12.1
Panel decision	No breach of Clauses 2, 5.5, 6.1, 6.2, 8.1 and 12.1
Key reasoning	Daiichi Sankyo did not sponsor the guideline document at issue and was not responsible for third-party inclusion of its promotional screenshots; therefore the document was not promotional material for which Daiichi Sankyo was responsible
Complaint received	08 June 2023
Case completed	27 November 2024
Appeal	No appeal
Sanctions	None 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

📋

⌄

An anonymous, contactable complainant challenged a guideline document (“Interactive Lipid Management Pathway”) hosted in a patient organisation’s HCP-facing “Tackling Cholesterol Together” education programme.
The document included screenshots/images of Daiichi Sankyo promotional material (NICE TA694 guidelines card; company ref BEM/21/0086) for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid-ezetimibe).
The complainant alleged the screenshots did not make clear both products were contraindicated with simvastatin doses >40mg, creating a patient safety risk.
The complainant alleged the guideline was therefore promotional, should have been certified, and should have included prescribing information.
The complainant also alleged Daiichi Sankyo’s involvement/funding was not declared on the guideline document or clearly in the guidelines section.
Daiichi Sankyo said it sponsored e-modules in 2021/2022 at arm’s length (no content input), but did not sponsor or develop the “Interactive Lipid Management Pathway” guideline document; it said it was unaware its promotional card had been reproduced and that the guideline was removed from the patient organisation website after the complaint.

⚖️

⌄

No breach of the ABPI Code (2021) in relation to Clauses 2, 5.5, 6.1, 6.2, 8.1 and 12.1.
The Panel concluded Daiichi Sankyo did not directly or indirectly sponsor the development of the guideline document at issue.
The Panel concluded Daiichi Sankyo was not responsible for the inclusion of screenshots of its promotional material (BEM/21/0086) in the guideline document.
Because Daiichi Sankyo was not responsible for the guideline, the Panel did not consider it promotional material for which Daiichi Sankyo was responsible (so certification and prescribing information requirements did not apply to Daiichi Sankyo in this instance).

🔒

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