Teva educational meeting on Qvar ruled promotional; omission of paediatric licence limitation found misleading (AUTH/2037/8/07)

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Key facts

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Case number	AUTH/2037/8/07
Complainant	Pharmaceutical adviser at a PCT
Company	Teva UK Limited
Product	Qvar (CFC-free beclometasone (BDP) inhaler)
Activity	Teva-sponsored educational meeting; presentation by Teva medical director
Main issue	Omission of statement that Qvar was not licensed for children under 12 (misleading in context)
Applicable Code year	2006
Complaint received	17 August 2007
Case completed	30 October 2007
Appeal	No appeal
Breach clauses	Clause 7.2
Sanctions	Undertaking received; additional sanctions: Not stated

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

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A pharmaceutical adviser at a Primary Care Trust (PCT) complained about statements made by Teva’s medical director at a Teva-organised educational meeting (“How to Improve Asthma in General Practice”).
Teva marketed Qvar (a CFC-free beclometasone (BDP) inhaler). The context was withdrawal/phase-out of CFC-containing BDP inhalers (eg, Becotide/Becloforte) and market confusion following launch of another CFC-free BDP inhaler (Clenil Modulite).
The complainant alleged the speaker implied there was a requirement to switch to CFC-free BDP and “no choice” but to switch to Qvar or Clenil, without acknowledging generic CFC-BDP availability.
The complainant also alleged the presentation failed to mention that Qvar was not licensed for children under 12, despite encouraging therapeutic switching.
In Q&A, the complainant said he was left with the impression that a paediatric licence would be granted “imminently”; Teva said the medical director referred to a growth study with results expected in the second half of 2008 and that regulatory timing could not be shared.
The Authority asked Teva to respond in relation to Clauses 3.2, 7.2, 7.4, 9.5 and 2.

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The Panel ruled the medical director’s presentation was promotional (it promoted Qvar and concluded with Qvar prescribing information).
No breach of Clauses 7.2 and 7.4 in relation to encouraging planning for CFC phase-out / future lack of CFC-BDP availability.
Breach of Clause 7.2 because the presentation omitted that Qvar was not licensed for use in children under 12; the omission was misleading in context.
No breach of Clause 3.2 regarding the Q&A about potential paediatric licensing; the response was treated as an answer to an unsolicited enquiry and there was insufficient evidence it was inaccurate/misleading/promotional.
No breach of Clause 9.1 (high standards) and no breach of Clause 2 (particular censure not warranted).
No appeal.

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