Anonymous v Pfizer and Novartis (AUTH/2928/1/17 & AUTH/2929/1/17): Ultibro promotion, PV concerns and breach of undertaking

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Key facts

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Case number	AUTH/2928/1/17 and AUTH/2929/1/17
Parties	Anonymous v Pfizer and Novartis
Complaint received	04 January 2017
Case completed	06 July 2017
Applicable Code year	2016
Therapy/area	COPD
Products referenced	Ultibro Breezhaler; Seebri Breezhaler
Key materials at issue	Representative GOLD 2017 briefing (ref UK/ULT/160673); “FLAME Business Card – eprint URL link” (ref UK/ULTSBR/16-0286)
Main issue upheld	Exacerbation outcomes presented without sufficient licensed-indication context; unclear representative briefing; breach of undertaking
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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An anonymous, non-contactable complainant (a pharmacovigilance consultant) raised concerns following earlier Ultibro/Seebri cases (AUTH/2840/4/16 and AUTH/2847/5/16).
The complaint focused on pharmacovigilance implications and alleged off-label promotion of Ultibro Breezhaler (indacaterol/glycopyrronium) for exacerbation risk reduction in COPD.
The complainant alleged Pfizer and Novartis failed to clarify what constituted off-label use and failed to train staff to recognise/report off-label use for PV purposes.
The complainant cited promotional activity at ERS (3–7 Sept 2016) and alleged BTS (7–9 Dec 2016) activity, plus use of GOLD 2017 recommendations to position Ultibro as a new standard of care “with or without a history of exacerbations”.
The Panel assessed UK Code issues only (not broader EU PV law/regulatory guideline compliance), and reviewed specific materials and briefings including a GOLD 2017 representative briefing (dated 18 Nov 2016) and a “FLAME Business Card – eprint URL link” (ref UK/ULTSBR/16-0286).

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Breach found: Clause 15.9 (representative briefing about GOLD 2017 not sufficiently clear that exacerbation reduction must be presented as a benefit of maintenance therapy, not a primary reason to prescribe).
Breach found: Clauses 3.2, 7.2, 9.1, 29 and 2 in relation to material ref UK/ULTSBR/16-0286 (“FLAME Business Card – eprint URL link”).
No breach rulings for multiple other allegations/materials, including: ERS meeting activity (not covered by the earlier undertaking timing and treated as already ruled upon in prior cases), alleged PV system/training failures (Clauses 16.2, 25.1, 15.6), and alleged BTS December 2016 use of a specific advertisement (not proven on balance of probabilities).
No appeal.

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