Roche and GlaxoSmithKline v Sanofi-Aventis and Procter & Gamble (Actonel exhibition panel): no breach

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Key facts

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Case number	AUTH/2079/1/08 and AUTH/2080/1/08
Case reference	Actonel exhibition panel (ref ACT3664)
Complainant	Roche Products Limited; GlaxoSmithKline UK Ltd
Respondent/company	Sanofi-Aventis; Procter & Gamble Pharmaceuticals UK Ltd (Alliance for Better Bone Health, ABBH)
Product(s)	Actonel (risedronate) 5mg daily; Actonel 35mg weekly (context); Bonviva (ibandronate) referenced in discussion
Material/channel	Exhibition panel at scientific congresses (British Society of Geriatrics; National Osteoporosis Society)
Key issue	Alleged inconsistency with SPC GI warnings and alleged use of out-of-licence safety data / implied bridging between doses
Dates (received/completed if stated)	Complaint received 17 January 2008; Case completed 29 February 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Alleged: 3.2, 7.2, 7.9, 7.10; Ruling: no breach of the Code (no breach of 3.2, 7.9, 7.10; 7.2 ruling not stated)
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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Roche Products Limited and GlaxoSmithKline UK Ltd complained about an Actonel (risedronate) exhibition panel (ref ACT3664) used by Sanofi-Aventis and Procter & Gamble Pharmaceuticals UK Ltd (Alliance for Better Bone Health, ABBH).
The panel was displayed at the British Society of Geriatrics meeting in Harrogate (21–23 November 2007) and related materials were also shown at the National Osteoporosis Society meeting in Edinburgh (26–28 November 2007).
The complaint focused on tolerability/safety claims and presentation of gastrointestinal (GI) warnings, including use of Taggart et al (2002), a pooled analysis of nine studies using Actonel 5mg daily.
Complainants alleged the panel’s claims were inconsistent with the Actonel SPC and used data outside the product licence (including that 1.7% of Taggart et al participants were men or premenopausal women, not licensed for Actonel 5mg).
Complainants also argued the SPC class warning about oesophagitis/oesophageal ulcerations was not sufficiently prominent (described as a small “footnote”) relative to high-level claims.
ABBH responded that the panel clearly related to Actonel 5mg, included text taken directly from SPC section 4.4 adjacent to the chart, and did not encourage prescribing outside the licence; it also stated the panels were certified only for the congresses and were no longer in use.

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The Panel examined exhibition panel ACT3664 and ruled no breach of the Code.
The Panel did not consider the panel promoted Actonel 5mg in unlicensed patient populations, noting the context (postmenopausal osteoporosis) and that the 1.7% out-of-licence population was disclosed.
The Panel did not accept that the panel stated or implied that 5mg data applied to the 35mg dose; it noted there was no mention of the 35mg dose on the panel.
The Panel considered the panel was not inconsistent with the Actonel 5mg SPC and that side effect information reflected current evidence; it also considered the material did not fail to encourage rational use.
The Panel noted the class warning might have been more prominent, but did not consider its placement misleading in the circumstances.

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