AUTH/2193/12/08: Anonymous v Merck Serono – Pergoveris targeting emails (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2193/12/08
Parties	Anonymous complainant v Merck Serono Limited
Product	Pergoveris (follitropin alfa and lutropin alfa for injection)
Main issue	Alleged encouragement to promote Pergoveris outwith its licence via internal emails targeting Menopur IVF/ICSI cycles
Communications at issue	Emails to fertility sales team dated 23 May 2008 and (complaint alleged) 26 June 2008; company referenced a 20 June email as possible match
Applicable Code year	2008
Clauses considered	Clause 3.2; Clause 9.1
Panel finding	No breach
Complaint received	16 December 2008
Case completed	27 January 2009
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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An anonymous, non-contactable complainant alleged Merck Serono encouraged representatives to promote Pergoveris (follitropin alfa/lutropin alfa) outside its licence.
The allegation related to two emails to the fertility sales team (complainant cited 23 May 2008 and 26 June 2008) about identifying/targeting clinics using Menopur (hMG) in IVF/ICSI cycles because of belief in luteinizing hormone (LH) benefit.
Merck Serono said the complainant was incorrect that Pergoveris was “indicated to produce monofollicular development”; the SPC indication was stimulation of follicular development in women with severe LH and FSH deficiency (clinical trials defined by endogenous serum LH <1.2 IU/L).
Merck Serono could not locate an email dated 26 June matching the description; it found an email dated 20 June which it thought might be the one referenced.
The Panel compared SPCs and noted key differences: Pergoveris was only indicated for severe LH/FSH deficiency with the objective to develop one follicle; Menopur could be used to induce multiple follicular development in assisted conception techniques.
The complainant did not provide the emails and could not be contacted for more information; Merck Serono had found one email and the other was a different date, so it was not possible to confirm it was the email alleged.
The Panel considered the “26 June” email (as described) was not sufficiently clear about product differences and that not every Menopur patient would be suitable for Pergoveris (which required severe LH/FSH deficiency).

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Outcome

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No breach of the Code was ruled.
The Panel did not find sufficient evidence that Pergoveris had been promoted outside its marketing authorisation.
The Panel did not find that Merck Serono failed to maintain a high standard.

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AUTH/2193/12/08: Anonymous v Merck Serono – Pergoveris targeting emails (No breach)

Key facts

What happened

Outcome

Clauses

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