AUTH/2663/11/13: Member of the public v Pierre Fabre — Clinical trial disclosure for Javlor (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2663/11/13
Complainant	Anonymous, contactable member of the public
Company	Pierre Fabre
Product	Javlor (vinflunine)
Issue	Clinical trial results disclosure / transparency assessment allegations
Source prompting complaint	CMRO article “Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe” (published 11 November 2013)
CMRO search window	27 December 2012 to 31 January 2013
Alleged clauses	Clauses 2, 9 and 21 (complainant allegation)
Clauses considered/listed	Clause 2; Clause 9.1; Clause 21.3
Applicable Code year	2012 (procedural); assessment involved 2008 Code for certain timing questions
Key trial discussed	IN104 (Phase I PK in liver impairment); also referenced: IN108, IN303, GE106; plus three BMS-registered trials
Panel initial view (before appeal)	Initially ruled breach of Clause 21.3 and 9.1 (2008 Code) for IN104 based on an assumed first publication in 2013; no breach of Clause 2 as results had been disclosed
Appeal outcome	Appeal successful; Appeal Board found IN104 results first published in 2007 (Paule et al), before required disclosure date (November 2010) → no breach
Final outcome	No breach of the Code
Complaint received	21 November 2013
Case completed	12 June 2014

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

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What happened

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An anonymous, contactable member of the public complained about alleged non-disclosure of clinical trial results, based on a transparency assessment published in Current Medical Research & Opinion (CMRO) on 11 November 2013.
The CMRO study assessed publicly available sources (searched 27 December 2012 to 31 January 2013) for registration and results disclosure for 53 new medicines approved by EMA (2009–2011), with product-level detail available via a linked website.
The complainant alleged companies (including Pierre Fabre) had breached Clauses 2, 9 and 21 of the Code for not disclosing trial results for licensed products.
For Javlor (vinflunine), the CMRO-linked output suggested 7 evaluable studies were not disclosed within the timeframe (72% disclosed in timeframe; 74% disclosed at all by 31 January 2013 for trials completed by end January 2012).
Pierre Fabre responded that: some trials were old and required unarchiving; two trials were not subject to FDAAA 801; three trials were registered by Bristol-Myers Squibb during a collaboration and the database was not transferred; one trial related to a new indication and was commercially sensitive; and one Phase I PK study was not considered of significant medical importance (a report/synopsis existed).
The Panel assessed whether disclosure was required under the applicable Code/joint position, noting Javlor was first approved and commercially available in November 2009 (making the 2008 Code and Joint Position 2005 relevant for trials completed before that date).
The Panel initially found a breach for trial IN104 (Phase I PK in liver impairment) because it appeared to impact the SPC and was thought to have first been published in 2013; Pierre Fabre appealed, stating results were first published in 2007 (Paule et al, ASCO abstract).

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Outcome

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Final decision (Appeal Board): No breach of the Code.
The Appeal Board accepted that trial IN104 results were first published in 2007, which was before the required disclosure date of November 2010, so no breach of Clauses 9.1 and 21.3 of the 2008 Code was ruled.
Other alleged undisclosed studies were found not to require disclosure yet (eg, exploratory or unlicensed indication context) or were outside UK Code scope due to no UK involvement in the disputed BMS-registered trials.

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AUTH/2663/11/13: Member of the public v Pierre Fabre — Clinical trial disclosure for Javlor (No breach)

Key facts

What happened

Outcome

Clauses

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