Chiesi breached Clause 7.2 over “3 steps per inhalation” claim in Fostair NEXThaler online ad (AUTH/2933/2/17)

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Key facts

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Case	AUTH/2933/2/17
Parties	Health professional consultant to a pharmaceutical company (private complaint; Novartis named) v Chiesi Limited
Product	Fostair (beclomethasone and formoterol), NEXThaler device
Material	Online/digital banner advertisement (ref CHNEX20161340 Dec 16) and related PI on Chiesi respiratory website
Main issue	“Efficacy with only 3 steps per inhalation” claim vs SPC/PIL instructions; allegation of out-of-date PI (pneumonia warning)
Applicable Code year	2016
Complaint received	08 February 2017
Case completed	02 May 2017
Breach clauses	7.2
No breach clauses	2, 4.1, 9.1
Sanction	Undertaking received
Appeal	No appeal

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

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A health professional (consultant to Novartis, complaint made in a private capacity) complained about a Chiesi online banner advertisement for Fostair (beclomethasone/formoterol) NEXThaler (ref CHNEX20161340 Dec 16).
The ad included claims: “Efficacy with only 3 steps per inhalation” and “open – inhale – close”, and invited users to “See the features of the Fostair NEXThaler device”.
The complainant alleged the “3 steps” claim conflicted with the patient information leaflet (PIL) instructions (including breath-hold 5–10 seconds) and that prescribing information (PI) in the ad/website was out-of-date and omitted a pneumonia warning.
Chiesi said PI was current and included the pneumonia warning; it had been prepared in July 2016 ahead of MHRA approval of the SPC variation (5 September 2016) and used once the variation was approved.
Chiesi argued “3 steps” referred to the device operating sequence (open–inhale–close) and was supported by SPC headings and published literature.

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Breach: Clause 7.2 (misleading claim) – the “3 steps per inhalation” claim was inconsistent with the SPC and PIL and therefore misleading.
No breach: Clause 4.1 – prescribing information for the online ad and the website was ruled up-to-date at the time of use.
No breach: Clause 9.1 – Panel did not consider the ad failed to maintain high standards.
No breach: Clause 2 – Panel did not consider the circumstances warranted particular censure.
No appeal.

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