AstraZeneca voluntary admission: uncertified Crestor promotional email with misleading dosing and comparative claims

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Key facts

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Case number	AUTH/2206/2/09
Company	AstraZeneca
Product	Crestor (rosuvastatin)
Material	Unapproved promotional email with two PowerPoint slide attachments
Audience	Dispensing practice (dispensary manager)
Main issues	Misleading dosing claim; exaggerated/unsubstantiated efficacy and comparative tolerability/interaction claims; no prescribing information; uncertified material; unapproved promotional slides; high standards
Complaint type	Voluntary admission (treated as a complaint)
Complaint received	11 February 2009
Case completed	17 March 2009
Applicable Code year	2008
Breach clauses	3.2, 4.1(x2), 7.2, 7.4(x3), 7.9, 7.10(x3), 9.1, 14.1(x2)
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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AstraZeneca voluntarily admitted that a dispensing account manager emailed a dispensing practice about Crestor (rosuvastatin) in response to a query about discounts.
The email went beyond the discount query and included promotional statements about dosing, efficacy and tolerability/comparisons versus other statins.
The email was not approved/certified by registered signatories and did not include prescribing information.
The email claimed: “The start dose for ALL patients is 10mg …” (later qualified with “You can use 5mg…”), plus “85% to 90% of all patients should get to target on 10mg…” and “Crestor is so well tolerated with so many fewer interactions than simva and atorva… (metabolised via the same pathway as prava making it much cleaner)…”.
Two PowerPoint slides were attached; they contained graphs favourably comparing Crestor with other statins and one included the product logo. They were not approved for promotional use and did not contain prescribing information.
The issue was identified internally by another employee; AstraZeneca sent corrective correspondence to the practice, offered follow-up, and self-reported to the PMCPA.

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Breaches were ruled for misleading/exaggerated and unsubstantiated claims, lack of prescribing information, use of uncertified material, and failure to maintain high standards.
No breach of Clause 2 was ruled (Panel did not consider the circumstances warranted particular censure).
No appeal.

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