AUTH/2053/10/07: GlaxoSmithKline v AstraZeneca – Symbicort SMART leavepiece (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/2053/10/07
Parties	GlaxoSmithKline v AstraZeneca
Product	Symbicort (budesonide/formoterol)
Material	Leavepiece explaining Symbicort SMART therapy (ref SYMB 07 11774)
Main issue	Whether ‘Rx Symbicort 200/6 1 inhalation bd plus as needed*’ was unbalanced/misleading and failed to encourage rational use due to lack of upper-limit qualification
Clauses cited	Clause 7.2; Clause 7.10
Decision	No breach of the Code
Complaint received	1 October 2007
Case completed	20 November 2007
Applicable Code year	2006
Appeal	No appeal
Sanctions	None stated

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

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GlaxoSmithKline (GSK) complained about an AstraZeneca UK leavepiece for Symbicort (budesonide/formoterol) explaining Symbicort SMART (Maintenance And Reliever Therapy in one inhaler).
The leavepiece included the statement: ‘Rx Symbicort 200/6 1 inhalation bd plus as needed*’, presented as facsimile handwriting to mimic a prescription.
The asterisk footnote referred readers to the SPC and stated Symbicort ‘as needed’ was not indicated for prophylactic use prior to exercise.
GSK alleged the statement was unbalanced/misleading because it did not include upper limits for ‘as-needed’ inhalations described in SPC section 4.2 (eg limits per occasion and per day), and therefore did not encourage rational use.
AstraZeneca argued the statement was not a promotional “claim” but essential guidance on how to write a prescription for a novel regimen; the SPC was referenced and MHRA pre-vetting had not raised concerns.

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No breach of the Code was ruled.
The Panel found the statement accurately reflected dosage particulars in the SPC and, given the prescriber audience, was not unbalanced, misleading or exaggerated.
The Panel also found the statement did not fail to encourage rational use.
No appeal.

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