Lundbeck: Cipralex letter misleadingly summarised PCT formulary decision (AUTH/2245/6/09)

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Key facts

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Case number	AUTH/2245/6/09
Complainant	Primary Care Trust (PCT) prescribing support unit
Company	Lundbeck Ltd
Product	Cipralex (escitalopram)
Material	Letter to a hospital physician (ref 0409/ESC/342/905)
Main issue	Selective/partial reporting of PCT newsletter formulary advice; omission of non-formulary status and “infrequent”/example restrictions
Complaint received	26 June 2009
Case completed	03 August 2009
Applicable Code year	2008
Breach clauses	7.2, 7.4, 9.1
No breach	Clause 2
Appeal	No appeal
Sanctions	Undertaking received

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

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A Primary Care Trust (PCT) prescribing support unit complained about a Lundbeck letter about Cipralex (escitalopram) sent to a hospital physician (ref 0409/ESC/342/905).
The PCT newsletter said escitalopram had not been accepted as a formulary drug, but might be used on infrequent occasions when initiated by specialists (with an example: MDD after trying 3 other antidepressants) or in GAD.
Lundbeck’s letter said Cipralex was recently reviewed for the formulary and that it was recognised there would be occasions when it would be initiated by specialists for MDD or GAD.
The letter did not state that Cipralex had not been accepted for the formulary and omitted the “infrequent” limitation and the example conditions described in the PCT newsletter.
Lundbeck argued the PCT wording was imprecise, that quoting it could risk inappropriate prescribing, and that clinicians could access the PCT advice; it also said a senior clinician in the PCT agreed the letter wording was appropriate.
The Panel emphasised that when reporting third-party views, companies must report them with complete accuracy and cannot delegate Code responsibility to a third party.

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Breach of Clause 7.2: the letter’s summary was not a complete/accurate reflection of the PCT formulary review and was misleading.
Breach of Clause 7.4: the statement about the outcome of the review could not be substantiated.
Breach of Clause 9.1: high standards had not been maintained.
No breach of Clause 2: the Panel did not consider the matter brought discredit upon or reduced confidence in the industry.
No appeal.

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