Genzyme in breach of ABPI Code over Fabry drug

Sanofi unit Genzyme has fallen foul of the Association of the British Pharmaceutical Industry’s Code of Practice over claims that switching patients to its Fabry disease therapy Fabrazyme from Shire’s Replagal would result in major cost savings to the NHS.

The Prescription Medicines Code of Practice Authority (PMCPA), which runs the UK pharmaceutical industry’s self-regulatory ethics code, has issued an interim report, which finds Genzyme guilty of 11 breaches and clears the company of seven. The breaches included Clause 2, “bringing discredit to, and reduction of confidence in, the industry” and Clause 3.2, the promotion of “unauthorised indications”.

The case centres on an allegation made by Shire about material used by Genzyme at a meeting of the Lysosomal Storage Disorders Expert Advisory Group (LSDEAG) last month, attended by health professionals, patient groups and senior NHS managers. The material compared Fabrazyme (agalsidase beta) with Shire’s Replagal (agalsidase alfa) as part of Genzyme’s aim to “clarify the science and the significant cost savings” of switching patients to its treatment.

The companies have been at loggerheads since May last year when Genzyme stated that Shire was responsible for “unfounded and incorrect rumours” that the low maintenance dose of Fabrazyme was “unlicensed” or even “illegal”. Shire “strongly refuted this unfounded allegation particularly as a basis for Genzyme’s solicitation of the LSDEAG meeting and inappropriate actions during it”.

‘Astonished’

After reviewing slides used at the meeting and other documents, and in response to protests from Genzyme, the PMCPA’s appeal board said it was “astonished” Genzyme considered that material provided was non-promotional. It was also “extremely concerned” that the aforementioned material had focused on the cost saving “via a simple switch to a 0.3mg/kg dose of Fabrazyme without including the clear caveats in its summary of product characteristics (SPC) and no mention of important patient safety issues such as adverse events”.

The PMCPA noted that as the LSDEAG was “the advisory group…which in effect could decide on commissioning at a national level”, the “potential gain to Genzyme in promoting a switch to 0.3mg/kg Fabrazyme was significant”.

It has ordered Genzyme to issue “a corrective statement to all attendees at the LSDEAG meeting and all recipients of the pre-circulated material if they differed”. The PMCPA is also demanding an audit of Genzyme’s procedures in relation to the Code and will consider whether further sanctions are necessary.

Fabry disease is a rare inherited disorder (affecting one in 117,000 people) caused by the lack of or faulty enzyme needed to break down fatty substances in cells.

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