AstraZeneca: Seroquel XL BMJ ad PI not clear due to indistinct headings (AUTH/2300/2/10)

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Key facts

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Case number	AUTH/2300/2/10
Company	AstraZeneca UK Ltd
Complainant	Ex-employee
Issue	Whether prescribing information in BMJ advertisements was clear and legible
Products	Seroquel XL (quetiapine); Zoladex (goserelin); Crestor (rosuvastatin)
Medium	BMJ advertisements (20 February)
Material IDs	Seroquel XL: CZ001847f-SERO; Zoladex: CZ001970m-ZOLA; Crestor: CZ002029-CRES
Applicable Code year	2008
Clauses considered	Clause 4.1
Breach found	Yes – Clause 4.1 (Seroquel XL ad only)
No breach	Zoladex ad; Crestor ad
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	24 February 2010
Case completed	26 March 2010
Appeal	No appeal

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

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An ex-employee queried whether prescribing information (PI) in three AstraZeneca advertisements in the BMJ (20 February) was “clear and legible” under the Code.
Ads concerned: Seroquel XL (quetiapine) double-page ad (CZ001847f-SERO); Zoladex (goserelin) one-page ad (CZ001970m-ZOLA); Crestor (rosuvastatin) one-page ad (CZ002029-CRES).
The Authority asked AstraZeneca to respond in relation to Clause 4.1.
AstraZeneca argued PI was essential information and had been provided clearly/legibly in all three ads (lower case “x” ~1mm; line lengths 80/92/87 characters; appropriate fonts and colour contrast; spacing and columns).
The Panel assessed each ad separately, referencing supplementary guidance to Clause 4.1 (type size not less than 1mm “x”; lines no more than 100 characters; spacing, type style, contrast, emboldened headings, and starting each section on a new line).

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Seroquel XL ad: Breach ruled. PI was legible but not clear because section headings were not on new lines, not emboldened, and underlining was so faint it was almost non-existent, making sections extremely difficult to locate.
Zoladex ad: No breach. Headings were emboldened and underlined; PI considered clear and legible (though on the limits of acceptability).
Crestor ad: No breach. Headings were emboldened; PI considered clear and legible (though on the limits of acceptability).
No appeal.

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