AUTH/2009/6/07: Anonymous v Flynn Pharma — Promotion of Medikinet (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2009/6/07
Parties	Anonymous complainant v Flynn Pharma Ltd
Product	Medikinet / Medikinet XL (controlled release methylphenidate)
Therapy area	Attention deficit hyperactivity disorder (ADHD)
Main issues alleged	Inappropriate targeting of mailings/invitation; rep call requesting appointment; D&T application form provided by rep; German clinical paper with no English translation
Clauses considered	12.1 and 15.3
Decision	No breach of Clauses 12.1 and 15.3
Panel notes	Mailing to child psychiatrists and paediatricians not unreasonable; no evidence of inducement; German reference “not helpful” and English translation should have been provided if substantiation requested
Complaint received	7 June 2007
Case completed	4 July 2007
Applicable Code year	2006
Appeal	No appeal

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

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An anonymous complainant said they received Flynn Pharma promotional mailings about Medikinet/Medikinet XL (ADHD) despite stating they did not and had never treated ADHD.
The mailing included a reply paid card (RPC); the complainant said it did not state anything about having to grant a representative an appointment.
A representative telephoned requesting an appointment.
A colleague allegedly received a drug and therapeutics (D&T) committee application form from a representative; the complainant believed such forms should not be handed out by representatives.
The colleague was also given a clinical paper in German (Döpfner et al) and told there was no English translation.
The complainant was invited to a meeting and considered this inappropriate given they did not treat ADHD; they asked the company to be more specific with targeting.

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No breach of the Code was ruled.
No breach of Clause 12.1 (targeting/distribution of promotional material) — mailing to child psychiatrists and paediatricians was not unreasonable.
No breach of Clause 15.3 (inducements) — no evidence of inducement/subterfuge or repeated attempts to secure an interview.
Panel expressed a concern that providing only a German reference was “not helpful” and said an English translation should have been provided if substantiation had been requested; Panel asked that Flynn be advised of its concerns.

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