A Menarini breached Clause 12.1 after PDF supplement lacked clear upfront company involvement (Ranexa case study)

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Key facts

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Case	AUTH/3321/3/20
Company	A Menarini
Complainant	Concerned UK health professional (self-described)
Medicine	Ranexa (ranolazine)
Channel/material	Guidelines in Practice webpage and downloadable PDF supplement/case study
Main issue	Alleged disguised promotion; PI currency/QT prolongation warning raised
Applicable Code year	2019
Complaint received	10 March 2020
Case completed	2 June 2020
Appeal	No appeal
Breach findings	Clause 12.1 (downloadable PDF only)
No breach findings	Clauses 2, 4.1, 9.1; Clause 12.1 (webpage)
Sanctions	Undertaking received; additional sanctions: Not stated

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

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A UK health professional complained that a supplement hosted on the Guidelines in Practice website and produced by A Menarini was disguised promotion for Ranexa (ranolazine).
The item was titled: “Delivering savings by improving the management of patients with chronic coronary syndrome in the [acute medical unit] setting: a case study” (Ako and Smith 2019).
The complainant said they did not realise it was promotional until noticing a link to prescribing information (PI); they made the same allegation about the downloadable PDF (PI included at the back).
The complainant also raised a patient safety concern: the PI was dated 2017 despite later SPC updates (including wording on QT prolongation), questioning whether the company’s review process was robust.
A Menarini stated the webpage clearly declared it was commissioned by A Menarini and included a prominent PI link; the PDF included a detailed statement of involvement in a footnote on the front page and PI at the back, with signposting.

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Online webpage: Not disguised promotion; no breach of Clause 12.1.
Downloadable PDF: Promotional nature considered disguised because company involvement was not immediately obvious on the printed/standalone material; breach of Clause 12.1.
Prescribing information currency/safety allegation: PI not ruled inadequate regarding QT prolongation warning; no breach of Clause 4.1.
High standards / Clause 2: Panel did not consider high standards were not maintained and did not consider Clause 2 warranted; no breach of Clauses 9.1 and 2.
No appeal.

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