AUTH/2034/8/07: MHRA v Recordati — Tradorec XL leavepiece and prohibited ‘MHRA advice’ reference | PMCPA Case

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Key facts

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Case number	AUTH/2034/8/07
Complainant	Medicines and Healthcare products Regulatory Agency (MHRA)
Company	Recordati Pharmaceuticals Ltd
Product	Tradorec XL (tramadol)
Material	Leavepiece (ref TRA06-0020)
Main issue	Promotional reference to “MHRA advice” on prescribing prolonged release preparations by brand/no generic substitution
Applicable Code year	2006
Breach clauses	Clause 9.5
Complaint received	10 August 2007
Case completed	6 September 2007
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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The MHRA complained about a Tradorec XL (tramadol) leavepiece (ref TRA06-0020) issued by Recordati.
Page three included a boxed heading “MHRA advice:” stating: “Prolonged Release preparations should be prescribed by brand, with no generic substitution”.
The statement was referenced to “Personal Communication. Recordati Pharmaceuticals Ltd”.
Recordati said it had emailed the MHRA Information Centre (via a consultant) for advice on prescribing once-daily tramadol formulations and received replies indicating modified/prolonged release preparations should be prescribed by brand/invented name.
The consultant then asked if the MHRA reply could be shown to NHS workers; the MHRA replied that it could.
The Panel noted the emails to MHRA were sent by a consultant describing himself as an independent pharmaceutical consultant, without stating he was writing on behalf of Recordati, and without mentioning the intention to use the information in promotional material.

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