Lundbeck: amended Cipralex letter implied local health board endorsement (AUTH/2021/7/07 & AUTH/2024/7/07)

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Key facts

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Case numbers	AUTH/2021/7/07 and AUTH/2024/7/07
Complainants	Two local health boards
Company	Lundbeck Ltd
Product	Cipralex (escitalopram)
Material	Letter ref 0407/ESC/342/411
Main issue	Letter implied health board endorsement for use in generalised anxiety disorder; misleading and not substantiated
Applicable Code year	2006
Complaint received	10 July 2007 (AUTH/2021/7/07); 20 July 2007 (AUTH/2024/7/07)
Case completed	28 August 2007 (both)
Breach clauses	7.2, 7.4, 9.1
Clause 2	No breach
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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Two local health boards complained about a Lundbeck letter regarding Cipralex (escitalopram) and generalised anxiety disorder (GAD).
The health boards alleged the letter misleadingly suggested they had endorsed Cipralex for GAD, when Cipralex was not recommended in their local formularies for depression and GAD use had not yet been considered by their drug and therapeutics committees.
Lundbeck said a key account executive modified a certified template by removing a critical first paragraph and sent the resulting unapproved copy.
Lundbeck stated the letter was sent to 13 budgetary decision makers (not a blanket GP mailing) and prescribing information was attached.
Lundbeck withdrew the template, retrained staff within a week of the complaint, and initiated disciplinary proceedings for the individual involved.
The Panel noted the representative amended a certified letter and sent it to a number of health professionals, outside company instructions.

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The Panel ruled the letters were misleading about the health boards’ positions and were not capable of substantiation.
Breaches were ruled of Clauses 7.2 and 7.4 (in each case).
The Panel ruled a breach of Clause 9.1 (high standards not maintained).
No breach of Clause 2 was ruled (the Panel did not consider the circumstances warranted particular censure).
The Panel raised a concern that adding detailed local information to a template without separate certification did not appear to meet Clause 14.1 requirements (promotional material certified in final form) and asked that Lundbeck be advised.

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