AstraZeneca breached ABPI Code over unqualified inhaler lung-deposition comparisons (Symbicort Turbohaler leavepiece)

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Key facts

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Case	AUTH/2320/5/10
Parties	Anonymous v AstraZeneca
Product	Symbicort Turbohaler (budesonide plus formoterol)
Issue	Unqualified comparative claims about lung deposition vs “a pressurised MDI” and contextual implication that Turbohaler outperforms all pMDIs
Material	Leavepiece “Clinically Effective Inspiratory Flow” (ref CZ001110SYMB)
Applicable Code year	2008
Complaint received	21 May 2010
Case completed	06 August 2010
Panel breaches	7.2 (x2), 7.3 (x2), 7.4 (x2), 9.1
Clause 15.2	No breach
Appeal	By respondent; unsuccessful (Clause 9.1 upheld)
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous, uncontactable complainant alleged an AstraZeneca representative gave incorrect information while promoting Symbicort Turbohaler (budesonide + formoterol) for asthma.
The representative provided a leavepiece titled Clinically Effective Inspiratory Flow (ref CZ001110SYMB).
The leavepiece stated: “Turbohaler is effective at a peak inspiratory flow (PIF) of around 30L/min, delivering 15% of dose to the lung (a pressurised MDI, with good inhalation technique, delivers 10–15%).”
It also stated: “Doubling the PIF to 60L/min increases the lung deposition to about 30%.”
The complainant challenged the implied comparison, noting some MDIs (eg ciclesonide and certain beclometasone MDIs) had substantially higher lung deposition (eg >50%, 36%, 52%).
AstraZeneca argued the “10–15%” figure applied to the majority of commonly used “conventional” pMDIs and that health professionals would interpret it that way, but the leavepiece did not explicitly qualify the comparison.

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The Panel ruled the comparative presentation was misleading and not capable of substantiation: breaches of Clauses 7.2, 7.3 and 7.4 (each ruled twice, for the two claims in context).
The Panel ruled a breach of Clause 9.1 (high standards not maintained).
The Panel ruled no breach of Clause 15.2 regarding the alleged representative statement, because what was said could not be reliably established and the issue was covered by the leavepiece rulings.
On appeal, AstraZeneca accepted the Clause 7 breaches but appealed Clause 9.1; the Appeal Board upheld the breach of Clause 9.1 and the appeal was unsuccessful.

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