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AUTH/3012/1/18 - Voluntary admission by Pierre Fabre

Case number:AUTH/3012/1/18
Case ref:Voluntary admission by Pierre Fabre
Description:Failure to certify material
No breach:No Breach Clause 4.8
Breach:Breach Clauses 2, 3.1, 7.2, 7.4, 9.1, 14.1, 15.9
Appeal:No appeal
Status:Breach ruled, case report pending
Review:Published in the May Review 2018
Received:19/01/2018
Completed:21/03/2018
Case Summary:

​Pursuant to Case AUTH/2962/7/17, Pierre Fabre voluntarily admitted that it had identified certain breaches of the Code in material related to Toviaz (fesoterodine), a treatment for the symptoms of overactive bladder syndrome. The material at issue included that used at a cycle meeting in April 2017, a Toviaz slide set and an email, with attachments, sent to the representatives after the cycle meeting. 

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Pierre Fabre.

Pierre Fabre noted that a slide deck, ‘Marketing Focus: Strategy for UK & ROI’ presented at the cycle meeting and subsequently emailed to the representatives bore no code number or date of preparation and there was no disclaimer regarding its use or distribution. Pierre Fabre submitted that the slides had not been certified before use and that the information on one slide was unbalanced and misleading and not always capable of substantiation. 

With regard to the framework for the cycle meeting, agenda and objectives, Pierre Fabre again noted the absence of a code number, date of preparation and certification. 

Pierre Fabre submitted that the Toviaz ‘Meetings in a box’ slides used at the cycle meeting had also not been certified and nor had an email sent to the sales force after the cycle meeting. 

Pierre Fabre noted that one of the documents sent with the email was a corporate presentation for use with health professionals. The presentation charted the company’s history and a slide which detailed strategic partnerships in 2015 (some of which existed, inter alia, to further the development of new medicines) referred to possible therapeutic targets and a licensing opportunity. Pierre Fabre submitted that such information might encourage an audience to enquire about medicines in development/ commercial opportunities. Further the sales force briefing material for the presentation referred to the healthy product pipeline which might encourage representatives to pay particular attention to the slide. Pierre Fabre also submitted that another slide of the corporate presentation referred the audience to the company’s global website for further information. Pierre Fabre stated that the website was thus not addressed to a UK audience. Pierre Fabre stated that the briefing material was not certified. 

Pierre Fabre submitted that the breaches above collectively demonstrated a failure to understand, to apply and to comply with certification of materials used to brief representatives, and other breaches. Pierre Fabre stated that the breaches above reflected the errors and confusion of accountability for responsibility for compliance with the Code that occurred during a period of dysfunctional management. 

Pierre Fabre submitted however, that there had been no breach of Clause 2 as there were no risks for patient safety and the breaches had not brought discredit upon, or reduced confidence in, the industry. 

Pierre Fabre apologised unreservedly for the breaches above. The company was fully committed to maintaining high standards and to taking all steps to both remedy the failings identified. Pierre Fabre UK and Europe had learned from these failings and were taking all available steps to prevent recurrence. 

The details response from Pierre Fabre is given below. 

The Panel noted that the marketing focus slide deck used at the cycle meeting did not include a date of preparation or guidance as to how it was to be used by representatives. The email dated 2 May 2017 did not give any instructions about the use of this presentation which the Panel considered was briefing material for representatives as required by the Code. The Panel noted the failure to certify the presentation and ruled a breach of the Code. 

With regard to the date of preparation the Panel noted that the Code referred to promotional material. It was not clear whether the marketing focus presentation was to be shown to health professionals. In the Panel’s view, as the presentation was briefing material it would have been helpful to include a date of preparation but as there was no requirement for it do so. The Panel did not consider Clause 4.8 applied so no breach of that clause was ruled. 

One slide was headed ‘Decision Tree’ with three sub headings including‘Mirabegron is better tolerated than any anticholinergic’ beneath which was the claim ‘European Warning – CV risk’. Pierre Fabre stated that the material failed to balance this with the statement in the Toviaz summary of product characteristics (SPC) that it should be used with caution in patients with risk of QT prolongation. The Panel thus considered that the briefing material was misleading and not capable of substantiation as required; breaches of the Code were ruled. The briefing material advocated a course of action which would be likely to lead to a breach of the Code if the representatives used this statement. 

With regard to the framework for the cycle meeting, agenda and objectives, the Panel considered that this constituted briefing material as it referred to the quantity and quality of calls by representatives on health professionals. The failure to certify such material meant that it did not comply with the relevant requirement of the Code. A breach of the Code was ruled. 

With regard to the date of preparation the Panel noted its comments above regarding briefing material and again ruled no breach of the Code. 

With regard to the Toviaz ‘meetings in a box’ slides, the Panel noted that they were not certified at the time of the April cycle meeting. They were certified on 5 May. The first slide of the presentation in April was marked ‘Draft’. The Panel considered that the slides should have been certified prior to being presented at the cycle meeting. Their use at the cycle meeting would constitute briefing material for the representatives and, as previously, the failure to certify briefing material was ruled in breach of the Code. 

With regard to the email sent after the cycle meeting, which provided certain documents to the representatives, the Panel noted that it was not certified and considered that it should have been as it constituted briefing material. A breach of the Code was ruled. 

The company profile presentation was to be used with health professionals. It gave an overview of the company’s history. One slide referred to partnerships which were to ‘Develop and commercialize two novel molecules in oncology’. The briefing material instructed representatives to use the slides at meetings prior to the presentation of main product slides with the key messages that the company had patient interest at its core and it was steadily growing with a healthy product pipeline. It was for promotional use. 

The Panel was concerned that the presentation included focus on strategic partnerships which referred to developing and commercialising two novel molecules in oncology. 

The Panel considered that the presentation went beyond general comments about Pierre Fabre’s interests in oncology. The slide would elicit questions about the pipeline. The briefing material for representatives gave no instructions about the response to such questions nor did it give much information about how the slides were to be used. The Panel considered that slide at issue promoted unlicensed medicines and a breach of the Code was ruled. This presentation had been certified. 

The Panel noted that the briefing material for the presentation had not been certified as required by the Code. The briefing material and the company profile presentation advocated a course of action that would lead to a breach of the Code and thus the Panel ruled a breach of the Code. 

The Panel noted Pierre Fabre’s submission that another slide from the company profile presentation referred the audience to the global website (www. pierre-fabre.com) which was not addressed to a UK audience. Pierre Fabre cited one clause in this regard but provided no further details or the website content. The voluntary admission implied that the website had not been certified and thus the Panel ruled a breach of the Code. 

The Panel noted its comments and rulings above and considered that Pierre Fabre had failed to maintain high standards. A breach of the Code was ruled. 

The Panel noted its ruling above of a breach of the Code with regard to the promotion of unlicensed medicines, an activity likely to be in breach of Clause 2. The Panel noted that a robust certification procedure underpinned self-regulation. The Panel considered that in advertising a medicine prior to the grant of a marketing authorization and failing to certify material meant that Pierre Fabre had brought discredit upon or reduced confidence in the pharmaceutical industry and a breach of the Code was ruled.