Novartis & Pfizer: COPD inhaler materials implied exacerbation reduction as a reason to prescribe (Ultibro/Seebri)

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Key facts

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Case number	AUTH/2840/4/16 and AUTH/2847/5/16
Parties	Anonymous, non contactable v Novartis and Pfizer
Products	Ultibro Breezhaler; Seebri Breezhaler
Therapy area	Chronic obstructive pulmonary disease (COPD)
Main issue	Whether exacerbation reduction claims implied off-label promotion / a primary reason to prescribe, rather than a benefit within maintenance symptom-relief therapy
Complaint received	25 April 2016
Case completed	16 September 2016
Applicable Code year	2016
Appeal	No appeal
No breach clauses	2
Breach clauses	3.2; 7.2; 9.1; 15.9
Sanctions	Undertaking received

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

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An anonymous, non-contactable complainant alleged that COPD inhalers licensed to relieve symptoms were being promoted as if indicated to reduce exacerbations.
Products: Ultibro Breezhaler (indacaterol/glycopyrronium) and Seebri Breezhaler (glycopyrronium), co-marketed by Novartis Pharmaceuticals UK Ltd and Pfizer Limited.
The complainant cited: (1) an Ultibro journal advertisement claiming it could significantly reduce moderate/severe exacerbations; (2) a Seebri leavepiece claiming a 31% reduction in risk of first moderate/severe exacerbation.
The Authority asked the companies to respond to Clauses 2, 3.2, 7.2, 9.1 and 15.9 (rulings made under the 2016 Code).
The Panel accepted that exacerbation data appeared in SPC section 5.1 for both products, but stressed that any exacerbation references must be clearly framed as a benefit of maintenance therapy to relieve symptoms—not as the primary reason to prescribe.
Some materials were found to cross that line by implying the products could be prescribed per se to reduce exacerbations and/or by failing to keep the licensed indication sufficiently prominent throughout longer materials.

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No breach was ruled for the Ultibro journal advertisement (UK/ULT/16-0028b (1)) in context.
No breach was ruled for the Ultibro “Wealth of data” leavepiece (UK/ULT/15-0270a) and, on balance, the Ultibro interactive sales aid (UK/ULT/15-0268b).
Breach was ruled for the Ultibro leavepiece “What is the right treatment choice for your patients?” (UK/ULT/15-0025) for implying exacerbation reduction as a primary reason to prescribe.
Breach was ruled for the Ultibro speaker slide deck “Evolving science; Dual bronchodilation” (UK/ULT/16-0025) due to the overall impression after a long deck and an ambiguous concluding claim of “superior efficacy”.
No breach was ruled for the Ultibro training course presentation (UK/ULT/15-0474) under Clause 15.9 (though the Panel said it would have benefitted from more explicit indication framing).
No breach was ruled for the Seebri leavepiece at issue (SBR0003) because exacerbation data was presented within the context of symptom-relief maintenance therapy.
Breach was ruled for two internal Seebri training presentations (SBR0023 and UK/SBR/15-0215a) for suggesting Seebri could be prescribed to reduce exacerbations per se.
Breach was ruled for the Seebri sales aid (UK/SBR/15-0354a) and Seebri speaker slides (UK/SBR/16-0012) for implying exacerbation reduction was a primary reason to prescribe and for lack of indication context.
No breach of Clause 2 was ruled.

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