Sanofi cleared in sales row
pharmafile | September 20, 2012 | News story | Medical Communications, Sales and Marketing | ABPI, CDF, Jevtana, PMCPA, Sanofi
Sanofi has been cleared of any wrongdoing after allegations that it had broken multiple clauses in the ABPI Code of Practice.
An anonymous ex-employee claimed that members of Sanofi’s medical oncology team had been pressurised to proactively generate contacts with key cancer specialists – in effect acting as an extra sales team at certain times.
The clauses which Sanofi was alleged to have breached included the most serious, clause 2 (causing discredit to, and reduction of confidence in, the pharma industry) and clause 9.1 (high standards must be maintained at all times).
If the case against Sanofi had been proven, the company would have contravened three points in clause 15, which deals with the conduct of pharma companies’ representatives.
In addition, since the complainant said he or she was also pushed to promote unlicensed drugs, clause 3.1 (a medicine must not be promoted prior to the grant of the marketing authorisation) would also have been broken.
Under the Code, complainants have the burden of proving their complaint on the balance of probabilities – something that may be more difficult where they are, as in this case, anonymous and non-contactable.
The PMCPA panel judging the complaint found that Sanofi’s scientific advisors were to proactively “engage with external stakeholders in the exchange of ‘within licence’ scientific data in a balanced, non-promotional manner and not in conjunction with any promotional-related person or activity”.
This meant they had a mixed role – both non-promotional and promotional – but the Panel found no evidence to suggest the advisors had proactively informed doctors about medicines that had not been given marketing approval.
Although the complainant had suggested that Sanofi was insisting on the team making too many calls – and investigators were ‘concerned’ that Sanofi had not provided any relevant briefing document regarding the expected contacts per week – the panel felt the manufacturer had not set a call rate that exceeded Code restrictions.
The complainant also alleged that doctors had been asked for support in challenging a NICE decision – but Sanofi countered that the rep in question had contacted a health professional to request support for a Cancer Drugs Fund application for Jevtana (cabazitaxel) within one region.
While the panel was again concerned there were no written instructions on this process, it considered there was no evidence to suggest the rep had failed to maintain high standards.
The PMCPA’s verdict will be published in the November Review.
Adam Hill
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