AstraZeneca voluntary admission: uncertified promotional email for Crestor with misleading claims

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Key facts

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Case number	AUTH/2206/2/09
Case reference	Voluntary admission by AstraZeneca (Crestor email)
Complainant	AstraZeneca (voluntary admission treated as a complaint)
Respondent/company	AstraZeneca
Product(s)	Crestor (rosuvastatin)
Material/channel	Promotional email to a dispensing practice/health professional with two PowerPoint slide attachments
Key issue	Uncertified promotional email lacking prescribing information and containing misleading, exaggerated and unsubstantiated claims (including dosing and comparative tolerability/interactions); unapproved promotional slide attachments
Dates (received/completed if stated)	Complaint received 11 February 2009; case completed 17 March 2009
Appeal	Not stated
Code year	2008
Breaches/clauses	Clauses 3.2, 4.1, 7.2, 7.4, 7.9, 7.10, 9.1, 14.1 (no breach of Clause 2)
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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AstraZeneca voluntarily admitted that a dispensing account manager sent an unapproved promotional email for Crestor (rosuvastatin) to a dispensing practice/health professional in response to an enquiry about discounts (13 November; year not specified in the case text).
The email discussed efficacy and tolerability and included claims about starting dose, likelihood of reaching target, and comparative tolerability/interactions versus simvastatin and atorvastatin.
The email was promotional in nature but had not been certified by registered signatories and did not include prescribing information.
The email attached two PowerPoint slides with graphs comparing Crestor favourably with other statins; one slide included the product logo. The slides had not been approved for promotional use and did not include prescribing information.
An internal colleague identified the issue and escalated it to management and compliance; AstraZeneca sent corrective correspondence to the practice and offered a follow-up meeting, and self-reported to the PMCPA.
AstraZeneca described internal corrective actions including one-to-one retraining for the individual, reminders to the wider team, updates to field guidance, and planned face-to-face retraining for dispensing account managers.

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The Panel ruled that the email could not rely on the unsolicited enquiry exemption because it was promotional and did not relate solely to the subject matter of the enquiry.
Breaches were ruled for lack of prescribing information and lack of certification.
Breaches were ruled for misleading/exaggerated/unsubstantiated claims about dosing, efficacy (“85% to 90%...”), and comparative tolerability/interactions.
The attached slides were ruled promotional and in breach because they were not approved for promotional use and lacked prescribing information.
A breach of high standards was ruled (Clause 9.1). No breach of Clause 2 was ruled.

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Clause 3.2 (misleading claims): Breach ruled (starting dose claim inconsistent with SPC).
Clause 4.1 (prescribing information): Breach ruled (email and slides lacked prescribing information).
Clause 7.2: Breach ruled (in relation to the misleading start dose claim).
Clause 7.4 (substantiation/exaggeration): Breach ruled (start dose, “85% to 90%...”, and tolerability/interactions claims).
Clause 7.9 (comparisons): Breach ruled (comparative tolerability/interactions claim).
Clause 7.10: Breach ruled (start dose, “85% to 90%...”, and tolerability/interactions claims).
Clause 9.1 (high standards): Breach ruled.
Clause 14.1 (certification): Breach ruled (email and slides not certified/approved for promotional use).
Clause 2: No breach ruled.

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