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 by the Director)
Respondent/company	AstraZeneca
Product(s)	Crestor (rosuvastatin)
Material/channel	Email to a dispensing practice/health professional with two PowerPoint slide attachments
Key issue	Uncertified promotional email lacking prescribing information and containing misleading/exaggerated/unsubstantiated dosing, efficacy and comparative tolerability/interaction claims; unapproved promotional slides attached
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 about Crestor (rosuvastatin) to a dispensing practice/health professional in response to a request for clarification about discounts.
The email discussed efficacy and tolerability and included claims such as “The start dose for ALL patients is 10mg …”, “85% to 90% of all patients should get to target on 10mg …”, and comparative tolerability/interaction statements versus simvastatin and atorvastatin.
The email was promotional in nature but had not been certified by registered signatories and did not include prescribing information.
Two PowerPoint slides were attached; they contained graphs favourably comparing Crestor with other statins and one slide featured the product logo. They had not been approved for promotional use and did not contain prescribing information.
The matter was identified internally (no external complaint) and escalated to compliance; AstraZeneca sent corrective correspondence to the practice and self-reported to the PMCPA.

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The Panel ruled that the email could not rely on the exemption for replies to unsolicited enquiries 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 dosing, efficacy and comparative tolerability/interaction claims.
Breaches were ruled in relation to the attached slides being promotional, uncertified and lacking prescribing information.
A breach of high standards (Clause 9.1) was ruled; no breach of Clause 2 was ruled.

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Clause 3.2 (misleading claims) – breached.
Clause 4.1 (prescribing information) – breached.
Clause 7.2 (substantiation) – breached.
Clause 7.4 (balanced, fair, objective; not misleading/exaggerated) – breached.
Clause 7.9 (comparisons) – breached.
Clause 7.10 (claims must be capable of substantiation / not exaggerated) – breached.
Clause 9.1 (high standards) – breached.
Clause 14.1 (certification) – breached.
Clause 2 (bringing discredit to the industry) – not breached.

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