Chiesi: Sponsored respiratory journal on BTS stand seen as promoting Fostair for unlicensed COPD use (AUTH/2379/1/11)

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Key facts

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Case	AUTH/2379/1/11
Parties	Anonymous v Chiesi
Product	Fostair (beclometasone and formoterol) pressurised inhalation solution
Setting	Chiesi exhibition stand at a British Thoracic Society (BTS) meeting
Material	Respiratory disease in practice (Volume 21 Number 1) with a Fostair ad on the outside back cover; cover article on small airways in asthma and COPD
Main issue	Distribution from a promotional stand was found to promote Fostair for an unlicensed indication (COPD) and to be misleading / not promote rational use
Applicable Code	2008
Breach clauses	3.2, 7.2, 7.10
Complaint received	04 January 2011
Case completed	01 April 2011
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, non-contactable complainant saw copies of Respiratory disease in practice on a Chiesi exhibition stand at a British Thoracic Society (BTS) meeting.
The journal appeared sponsored by Chiesi (described as an independent title supported by an unrestricted educational grant) and carried a Fostair advertisement on the outside back cover.
The front cover article was titled “The small airways: an important target in asthma and COPD treatment” and the issue also contained COPD-related content.
The complainant, after looking for COPD data and finding a webpage about seeking registration of Fostair for COPD, was surprised to learn Fostair was only licensed for asthma and questioned whether this was made clear enough.
Chiesi argued the journal was independent, the sponsor had no editorial control, the articles did not endorse treatment choices, and Fostair was not named (only generic ingredients were mentioned). Chiesi also noted the ad included prescribing information stating the asthma indication.
The Panel considered that because the journal was distributed from a Chiesi promotional stand, it was being used for a promotional purpose and therefore its content was covered by the Code.

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The Panel ruled that distributing the journal from the promotional stand in effect promoted Fostair for an unlicensed indication (COPD).
The Panel also considered the Fostair ad’s “extrafine particles reaching the small airways” claim linked to the COPD article’s discussion of particle size, reinforcing the unlicensed COPD promotion impression.
Breach found of Clauses 3.2, 7.2 and 7.10 (2008 Code).
No appeal.

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