AUTH/2311/4/10: Anonymous v AstraZeneca – Seroquel meeting alleged off-label promotion (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2311/4/10
Parties	Anonymous v AstraZeneca
Product	Seroquel (quetiapine)
Allegation	Misleading meeting content and promotion outwith marketing authorisation (borderline personality disorder)
Licensed indications stated	Schizophrenia and bipolar disorder
Meeting date (company account)	5 November 2009
Meeting topic (complainant)	“Cognitive treatment of borderline personality disorder (BPD)”
Meeting topic (company systems)	“Schizophrenia case study”; approval document referenced Seroquel and schizophrenia topics
Attendees stated	Six general adult psychiatrists and one doctor on a GP rotation (plus speaker); two AstraZeneca representatives
Key evidence gap	No copies of invitation, agenda, or slides; slides not certified; limited meeting record
Applicable Code year	2008
Clauses considered	2, 3.2, 7.2, 9.1, 12.1, 15.2
Panel decision	No breach of the Code
Complaint received	15 April 2010
Case completed	8 July 2010
Appeal	No appeal

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

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An anonymous complainant alleged an AstraZeneca-sponsored meeting was misleading and promoted Seroquel (quetiapine) outside its marketing authorisation (borderline personality disorder).
Seroquel was licensed for schizophrenia and bipolar disorder.
The complainant said the meeting was billed as “Cognitive treatment of borderline personality disorder (BPD)” and then moved to recommending Seroquel as “medicine of choice” without stating it was unlicensed for BPD.
AstraZeneca said the only sponsored meeting at the venue in Oct/Nov 2009 was on 5 November 2009 and was a schizophrenia case study aligned to the Seroquel SPC; BPD was only discussed in response to an unsolicited audience question.
The speaker allegedly used a separate slide deck on their laptop (unknown to the AstraZeneca representative) to answer the unsolicited question, then returned to the agreed presentation.
AstraZeneca could not provide copies of the invitation, agenda, or slides used at the meeting; the Panel described this as “wholly unacceptable” and “extremely poor practice”.
Three attendee accounts were provided: one recalled schizophrenia (with possible mention of BPD); two recalled the meeting as being about BPD, with no recollection of quetiapine being recommended.

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No breach of the Code was ruled.
The Panel found no evidence, on the balance of probabilities, that Seroquel was promoted for borderline personality disorder.
The Panel found no evidence that delegates were misled about Seroquel.
The Panel found no evidence of disguised promotion.
The Panel found no evidence the representative failed to maintain a high standard of ethical conduct.
Despite the no-breach outcome, the Panel strongly criticised AstraZeneca’s lack of meeting records and lack of certified slides.

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