Pierre Fabre publicly reprimanded after uncertified sales meeting slides and incomplete submission to PMCPA (AUTH/2962/7/17)

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Key facts

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Case number	AUTH/2962/7/17
Complainant	Anonymous sales representative
Company	Pierre Fabre
Medicine	Toviaz (fesoterodine)
Indication (as stated)	Treatment of symptoms of overactive bladder syndrome
Marketing authorisation holder (as stated)	Pfizer Limited
Main issues	Certification of sales meeting/cycle meeting briefing materials; alleged pressure on call rates/holidays; governance of speaker meetings; role of overseas corporate consultant; incomplete submission to PMCPA
Complaint received	31 July 2017
Case completed	5 January 2018
Applicable Code year	2016
Breach clauses	2, 9.1, 14.1, 15.9
No breach clauses	9.1, 14.1, 15.4, 15.9, 16.3
Sanctions	Undertaking received; Advertisement; Public reprimand; No audit required

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

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An anonymous sales representative complained on behalf of a group of reps promoting Toviaz (fesoterodine) about call rates and certification/approval of meetings and materials.
Allegations included pressure to see clinicians more than an average of three times per year, comments discouraging holidays, and that training at a June 2017 sales (cycle) meeting was not certified.
Concerns were also raised that promotional speaker meetings were being run without approval/certification and that an overseas corporate consultant was instructing the sales force and may not have taken the ABPI examination.
Pierre Fabre acknowledged that the agenda and certain slides used at the June 2017 cycle meeting had not been certified.
On appeal, it emerged Pierre Fabre had initially provided an incomplete set of the June cycle meeting slides to the PMCPA; additional slides (including “Calibrage”/calibration-related slides) were later provided.
Pierre Fabre admitted that “Calibrage” involved reps asking HCPs during promotional calls: “What is your opinion about the 4 pharmacological properties of Toviaz that are responsible for 97% of patients being satisfied after 2 years?” and that it had failed to provide written briefing and certify the question.

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Breach found: Clause 14.1 (uncertified representatives’ briefing material).
Breach found: Clause 15.9 (briefing material failed to comply with the Code because it was not certified).
Breach found: Clause 9.1 (high standards not maintained, linked to the above).
Breach found on appeal: Clause 2 (brought discredit upon and reduced confidence in the industry, taking all circumstances into account).
No breach: Clause 15.4 (overcalling not proven on the balance of probabilities; no evidence of overcalling).
No breach: Clause 16.3 (corporate consultant did not meet the definition of a “representative” and therefore did not need to take the ABPI examination).
No breach: Clause 9.1 and Clause 14.1 in relation to the July 2017 speaker meeting arrangements/materials (arrangements did not require certification; materials and contracts had been certified; meetings had been checked).

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