Sanofi-Aventis & Procter & Gamble: osteoporosis nurse audit service linked to Actonel prescribing (AUTH/1902/10/06, AUTH/1903/10/06)

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Key facts

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Case numbers	AUTH/1902/10/06 (Sanofi-Aventis) and AUTH/1903/10/06 (Procter & Gamble)
Parties	Anonymous employee complainant v Sanofi-Aventis and Procter & Gamble (ABBH collaboration; Aventis legacy for Sanofi-Aventis)
Product	Actonel (risedronate)
Activity	Osteoporosis nurse audit programme (2002–2004) and associated TOPCAT service
Complaint received	19 October 2006
Applicable Code year	2003
Key issue	Linking provision of a service (audit) and selection of practices to agreement to prescribe Actonel; inadequate separation of promotional and non-promotional roles
Panel decision	Breach of Clauses 18.1 and 2 (nurse audit and TOPCAT); no breach of Clause 3.1
Appeal outcome	Breach of Clauses 18.1 and 2 upheld for nurse audit; no breach for TOPCAT arrangements due to insufficient evidence; no breach of Clause 3.1
Sanctions / actions	Undertakings; audits of both companies’ procedures (including ABBH policies/procedures); Procter & Gamble re-audit required January 2008; Sanofi-Aventis no further action if recommendations implemented
Undertakings received	Sanofi-Aventis: 23 May 2007; Procter & Gamble: 24 May 2007
Review publication	November 2007 Code of Practice Review

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

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An anonymous complainant (a current Sanofi-Aventis UK employee, using a pseudonym) alleged that ABBH osteoporosis “service to medicine” offerings were implemented in a way that linked service provision to Actonel (risedronate) prescribing.
The services were run by the Alliance for Better Bone Health (ABBH), a collaboration between Procter & Gamble and Aventis (later Sanofi-Aventis).
The main service was an osteoporosis nurse audit programme (2002–2004) delivered by third-party agency nurses; an associated tool (TOPCAT) was also considered.
On appeal, the Appeal Board focused on two documents both companies agreed were used by sales personnel:
- “Actonel GP Call Agenda and Follow Up November 02 to January 03”
- Sales Force Call Agenda (June 2003) (ref A2121)
Those documents set out a sequence where the first “hurdle” was gaining agreement to prescribe Actonel as first choice/first line, before progressing to steps that led towards offering/booking the audit service.
The Appeal Board found the promotional and non-promotional roles were not adequately separated in the materials and layout, and the link between Actonel promotion and the service (including practice selection) was unacceptable.
Allegations about promotion for corticosteroid-induced osteoporosis were considered; Actonel 5mg was licensed throughout and there was no evidence Actonel 35mg was promoted for that unlicensed indication (no breach of Clause 3.1).

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Breach upheld (nurse audit programme): Clause 18.1 and Clause 2 (Appeal Board upheld Panel).
No breach (TOPCAT arrangements): Appeal Board found insufficient evidence on the balance of probabilities; Panel’s ruling on TOPCAT no longer stood.
No breach: Clause 3.1 (no evidence of promotion of Actonel 35mg for corticosteroid-induced osteoporosis).
Both companies were required to undergo audits of their Code-related procedures (including ABBH-related policies/procedures).
After audit: no further action for Sanofi-Aventis (provided recommendations implemented); Procter & Gamble required a re-audit in January 2008 due to concerns about implementation progress and certification arrangements.

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