Recordati: Tradorec XL ‘Dear Dispensary Manager’ letter and MHRA reference

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Key facts

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Case number	AUTH/2082/1/08
Case reference	Tradorec XL ‘Dear Dispensary Manager’ letter (ref TRA06-0017)
Complainant	Director, Medicines and Healthcare products Regulatory Agency (MHRA) and a hospital pharmacy manager
Respondent/company	Recordati Pharmaceuticals Ltd
Product(s)	Tradorec XL (prolonged release tramadol)
Material/channel	‘Dear Dispensary Manager’ letter dated 29 June 2007
Key issue	Promotional letter cited “MHRA advises…” regarding substitution/brand prescribing; accuracy/support for the MHRA statement and permissibility of MHRA references; alleged breach of prior undertaking
Dates (received/completed if stated)	Complaint received 21 January 2008; case completed 3 March 2008; letter dated 29 June 2007; complainant best recollection of receipt 5 July 2007
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 9.1 (breach); Clause 9.5 (breach); Clause 22 (no breach); Clause 2 (no breach)
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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The MHRA passed to the PMCPA a complaint it had received from a hospital pharmacy manager about a ‘Dear Dispensary Manager’ letter for Tradorec XL (prolonged release tramadol) dated 29 June 2007 and sent by Recordati Pharmaceuticals Ltd.
The letter stated that Tradorec XL should be prescribed by brand name and included the claim: “The MHRA advises that as a Prolonged Release product, it should not be substituted with any Sustained Release or Modified Release formulation, whether branded or generic”.
The complainant queried whether the MHRA had made such a product-specific statement and noted that the letter’s references did not include a reference to support the MHRA claim (Recordati said reference 3 was present but positioned incorrectly and later corrected).
Because the complaint involved an alleged breach of an undertaking from an earlier case (AUTH/2034/8/07), the Director took up that aspect to ensure compliance with undertakings.
Recordati said the letter was sent to inform dispensing managers about the Tradorec XL discount scheme and argued the MHRA reference issue had been addressed in the earlier case; it also said it believed the letter was sent before the undertaking date.
The complainant’s best recollection was that she received the letter on 5 July 2007.

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Breach ruled of Clause 9.1 (high standards) in relation to the complainant’s allegation about the MHRA statement; the Panel considered high standards had not been maintained.
Breach ruled of Clause 9.5 (references to the MHRA in promotional material).
No breach ruled of Clause 22 (undertakings) because the letter was dated 29 June 2007 and was thought to have been received on 5 July 2007, before the undertaking provided in September 2007 in Case AUTH/2034/8/07.
As there was no breach of Clause 22, the Panel ruled no breach of Clauses 9.1 and 2 in that context.

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