AUTH/2191/12/08: Roche misleading comparative and “cost-effective” claims in Bondronat hospital detail aid (Novartis complaint)

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Key facts

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Case number	AUTH/2191/12/08
Parties	Novartis Pharmaceuticals UK Ltd v Roche Products Limited
Material	Bondronat (ibandronic acid) hospital detail aid (P116402), titled “Time for a change?”
Competitor product mentioned	Zometa (zoledronic acid) (Novartis)
Complaint received	12 December 2008
Case completed	4 March 2009
Applicable Code year	2008
Appeal	No appeal
Breach clauses	7.2 (x6), 7.3 (x5), 7.4, 7.8 (x2), 7.10 and 8.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Main issues upheld	Misleading/ambiguous “innovative” claim; misleading renal safety wording; misleading implied comparisons from hospital time audit; misleading cost/resource claims from very small interim analysis and extrapolations; misleading use of ASCO guideline bullets on summary page

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

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Novartis complained about a Roche hospital detail aid for Bondronat (ibandronic acid) (P116402; prepared March 2007; considered under the 2008 Code).
The detail aid was titled “Time for a change?” and promoted oral and IV Bondronat, including a “Now with 15 minute infusion” message.
Key disputed elements included:
- Brand/logo claim: “Innovative, multi-targeted bone protection” used across the aid and on the front cover.
- Renal safety claim on page 10: “No evidence for any treatment-related deterioration in renal function was seen for any patient…” (von Moos et al 2006).
- Hospital time/resource content using a clinical audit (Barrett-Lee et al 2006) showing total time on unit for IV pamidronate and IV zoledronic acid.
- Resource/cost claims based on a very small interim pharmacoeconomic analysis (Wardley et al 2004; n=9) and extrapolations (eg, “Bondronat – a cost effective choice”, “16 hours time saved per patient per year…”).
- Use of ASCO 2003 guideline bullets on a summary page in a way that implied the guideline had reviewed Bondronat data.
One tolerability comparison page (oral Bondronat vs IV zoledronic acid; Body et al 2005) was challenged, but the Panel did not rule it misleading/disparaging on the points alleged (while noting concerns about robustness of the unequivocal tolerability claim due to lack of p-values).

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Breach rulings were made for multiple claims and comparisons in the detail aid (see Clauses below).
No appeal.
Sanction recorded: undertaking received.
The Panel also requested the parties be advised of additional concerns (eg, missing entry criteria/renal function limitations for the 15-minute infusion study; and robustness of the “better tolerability profile” claim due to lack of statistical significance reporting), even where not ruled as breaches on the specific allegations.

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