AstraZeneca breached Code over Symbicort MART messaging and missing PI reference in MIMS ad (AUTH/3678/8/22)

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Key facts

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Case number	AUTH/3678/8/22
Company	AstraZeneca
Complainant	Anonymous, contactable health professional
Product	Symbicort (budesonide, formoterol fumarate dihydrate)
Material type	Printed journal advertisement in MIMS (hard copy)
Where/when	MIMS June 2022; pages 293–294; ad ref GB-35766 (April 2022)
Main issue	Overall impression implied all Symbicort strengths could be used for MART; Symbicort 400/12 is maintenance-only; PI reference missing when PI not visible
Applicable Code	2021
Breach clauses	2, 5.1, 6.1, 6.2, 11.2, 12.7
Complaint received	1 August 2022
Case completed	4 July 2023
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous, contactable health professional complained about a Symbicort (budesonide/formoterol) hard-copy advertisement in the June 2022 edition of MIMS (ref GB-35766, April 2022), appearing on pages 293–294.
Page 293 carried prominent claims: “For your eligible asthma patients, prescribe Maintenance and Reliever therapy in one” and “Think MART. Choose Symbicort”, alongside a large inhaler image that showed no strength.
The complainant alleged the overall impression was that any Symbicort Turbohaler strength could be used for MART (maintenance and reliever therapy), despite not all strengths being licensed for MART.
Prescribing information (PI) appeared overleaf (page 294), but page 293 did not include a reference stating where the PI could be found.
AstraZeneca accepted that PI was not visible from the first page and that there was no reference to where PI could be found (accepting a breach of Clause 12.7), but denied the ad was misleading or inconsistent with the marketing authorisation.
AstraZeneca stated the ad had been certified as a double-page spread (so PI would be visible), but MIMS printed it on consecutive pages with PI overleaf; MIMS acknowledged this happened by mistake.

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Breach found for Clauses 2, 5.1, 6.1, 6.2, 11.2 and 12.7 (2021 Code).
The Panel ruled the ad misleadingly implied Symbicort could be prescribed for MART regardless of strength, and that small-font qualifying text at the bottom was insufficient to correct the impression.
The Panel considered the ad encouraged use of Symbicort 400/12 for MART, despite the SPC stating 400/12 is maintenance-only; this had potential patient safety implications.
No appeal.

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Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 Failing to maintain high standards
Clause 6.1 Making a misleading claim
Clause 6.2 Making an unsubstantiated claim
Clause 11.2 Promotion inconsistent with the SPC
Clause 12.7 Failing to include on the pages of a printed journal advertisement where the prescribing information was not visible, reference to where it could be found

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