AUTH/2435/8/11: Chiesi ruled in breach for promoting Fostair in COPD at an international symposium and for breaching an undertaking

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Key facts

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Case number	AUTH/2435/8/11
Parties	GlaxoSmithKline / PMCPA Director v Chiesi
Product	Fostair (beclometasone and formoterol)
Therapy area	Respiratory (asthma/COPD)
Main issue	Promotion of an unlicensed indication (COPD) and breach of undertaking
Setting	Chiesi-sponsored symposium at ATS Conference (May 2011); sponsored journal (Respiratory Disease in Practice, Spring 2011)
UK licence status described	Licensed in the UK for regular treatment of asthma; not licensed for COPD at the time
Key problematic claim (example)	Summary slide: “Translates to clinical benefits in asthma and COPD”
Applicable Code year	2011
Complaint received	30 August 2011
Undertaking received	9 November 2011
Appeal hearing	No appeal (Panel report to Appeal Board)
Completed	10 January 2013
Breaches	Clause(s) 1.8, 2, 3.2, 9.1 (x2) and 25 (x2)
No breach	Clause(s) 2 and 9.1 (pattern-of-behaviour allegation)
Sanctions applied	Undertaking received; Advertisement; Public reprimand; Audit of company’s procedures; Re-audit

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

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What happened

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GlaxoSmithKline complained that Chiesi promoted Fostair (beclometasone/formoterol) for COPD before UK marketing authorisation; in the UK it was licensed for asthma only.
The alleged promotion occurred at a Chiesi-sponsored symposium at the American Thoracic Society (ATS) meeting (May 2011), attended by many European/UK delegates (non‑US delegates only).
UK affiliate staff attended ATS, told UK health professionals about the symposium and provided the symposium flyer; they had been instructed to do so by Chiesi corporate.
A UK health professional’s presentation included an outline item “BDP/F extrafine inhaler in COPD” and slides discussing COPD parameters; the summary slide stated Fostair “Reaches small airways”, “Treats small airways” and “Translates to clinical benefits in asthma and COPD”.
The symposium materials did not state that Fostair was licensed only for asthma in the UK, creating a risk that UK attendees would assume it was licensed for COPD.
GSK also raised concerns about the Spring 2011 edition of Respiratory Disease in Practice sponsored by Chiesi, which included discussion of Fostair clinical trials in COPD.
The complaint included an alleged breach of an undertaking given in Case AUTH/2379/1/11 (which required use of the journal in question and any similar material to cease forthwith).
The Panel was concerned it had to request information multiple times; initial responses were incomplete/contradictory about inviting UK health professionals and about Chiesi’s involvement with the journal (including that Chiesi suggested the author).

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Outcome

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ATS symposium: Breach of Clause 3.2 (promotion not in accordance with marketing authorisation), breach of Clause 9.1 (high standards), no breach of Clause 2 for this element, breach of Clause 25 (breach of undertaking), and breach of Clause 1.8 (failure to comply with applicable codes/laws/regulations).
Spring 2011 journal sponsorship: Breach of Clause 25 (breach of undertaking), breach of Clause 9.1 (high standards), and breach of Clause 2 (brought discredit upon and reduced confidence in the industry).
Pattern-of-behaviour allegation (Clauses 2 and 9.1): No further breach ruled; the Panel considered existing Clause 2 rulings (including in this case) adequately covered the concern.
The Panel reported Chiesi to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure to consider whether further sanctions were warranted, due to failures in providing full and frank disclosure at the outset.

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