Pierre Fabre voluntary admission: uncertified sales briefing materials and pipeline promotion (AUTH/3012/1/18)

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Key facts

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Case number	AUTH/3012/1/18
Company	Pierre Fabre Limited
Type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Product	Toviaz (fesoterodine)
Indication (as stated)	Treatment of symptoms of overactive bladder syndrome
Marketing authorisation holder	Pfizer Limited
Key activities/materials	April 2017 cycle meeting slide decks and framework/agenda; “Meetings in a box” slides; 2 May 2017 email to reps with attachments; company profile presentation and rep briefing material; reference to global website
Main issues	Failure to certify briefing materials; misleading/unsubstantiated comparative statement; promotion of unlicensed medicines via pipeline/partnership slide; inadequate rep instructions; global website reference
Complaint received	19 January 2018
Voluntary admission received	18 January 2018
Case completed	21 March 2018
Applicable Code year	2016
Breach clauses	2; 3.1; 7.2; 7.4; 9.1; 14.1; 15.9
No breach clauses	4.8
Sanctions	Undertaking received; Advertisement; Public reprimand
Appeal	No appeal

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

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What happened

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Pierre Fabre made a voluntary admission of Code breaches relating to materials for Toviaz (fesoterodine) used at an April 2017 cycle meeting and then emailed to representatives (email dated 2 May 2017), plus attachments.
A slide deck titled “Marketing Focus: Strategy for UK & ROI” was used and circulated without certification; it also lacked a code number and (as submitted) a date of preparation and disclaimer about use/distribution.
One slide (“Decision Tree”) included comparative messaging about mirabegron (Betmiga) including the claim “European warning – CV risk” without balancing information from the Toviaz SPC (caution in patients at risk of QT prolongation).
The cycle meeting framework/agenda/objectives (covering quantity/quality of calls on HCPs) was treated as briefing material but was not certified.
“Toviaz Meetings in a box” slides were presented at the cycle meeting while marked “Draft” and were only certified later (certified 5 May 2017).
The 2 May 2017 email to the sales force (with multiple attachments) was not certified and gave limited guidance on how materials should be used.
An attached company profile presentation intended for use with health professionals included a partnerships slide referencing “Develop and commercialize two novel molecules in oncology”, which the Panel considered would elicit questions about the pipeline and amounted to promotion of unlicensed medicines.
Briefing material for representatives for the company profile presentation referenced a “healthy product pipeline” and did not instruct reps how to respond to pipeline questions; that briefing material was not certified.
Another slide referred audiences to the company’s global website (www.pierre-fabre.com); the voluntary admission implied the website had not been certified for UK Code purposes.
Pierre Fabre stated the issues occurred during a period of dysfunctional management with confusion over accountability; two experienced Code individuals were absent on sick leave and the medical director was not present at the cycle meeting.
Context: Toviaz MAH was Pfizer Limited; Pierre Fabre was responsible for UK marketing/promotion and materials should have been certified by both companies. Pierre Fabre suspended all promotion of Toviaz in the UK in September 2017 and stated it had not recommenced; materials were withdrawn on 21 December 2017.

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Outcome

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Breach found of Clauses 2, 3.1, 7.2, 7.4, 9.1, 14.1, 15.9.
No breach of Clause 4.8 (Panel did not consider it applied to the materials as briefing material; date of preparation would have been helpful but not required for briefing material).
Panel concluded that advertising a medicine prior to marketing authorisation (via pipeline/unlicensed promotion) and failures in certification brought discredit upon/reduced confidence in the industry (Clause 2).
No appeal.

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Key facts

What happened

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