AUTH/2285/12/09: Consultant Neurologist v Beacon (Episenta letters) – No breach (Clause 7.2) | PMCPA Case

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Key facts

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Case number	AUTH/2285/12/09
Parties	Consultant Neurologist v Beacon Pharmaceuticals Ltd
Product	Episenta (prolonged release sodium valproate)
Promotional material	Letter and 4-page leaflet (ref 20091021) sent to neurologists and paediatric neurologists
Main issue	Claims that Episenta was bioequivalent to and interchangeable with Epilim/Epilim Chrono and other valproate formulations
Applicable Code year	2008
Clause(s) considered	Clause 7.2
Decision	No breach
Complaint received	08 December 2009
Case completed	08 February 2010
Appeal	No appeal
Panel note/concern	Concern that referencing implied the Epilim SPC specifically referred to Episenta (it did not), and that the Epilim SPC’s “adequate control” qualifier was not reflected in the promotional claim

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

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A consultant neurologist complained about a Beacon mailing promoting Episenta (prolonged release sodium valproate).
The mailing (letter and 4-page leaflet; ref 20091021) was sent to neurologists and paediatric neurologists.
The letter asked whether it would be useful if a sodium valproate product was “bioequivalent to, and thus interchangeable with, Epilim or Epilim Chrono”, and said Episenta “can help achieve these outcomes”.
The leaflet stated: “Episenta is bioequivalent to Epilim Chrono” and “Episenta is interchangeable with other conventional or prolonged release formulations of valproate on an equivalent daily dosage basis”.
The complainant argued modified release formulations were not interchangeable for epilepsy and cited guidance (including SIGN, NICE and other epilepsy guidelines) recommending patients with controlled epilepsy should not change preparations.
The Authority asked Beacon to respond in relation to Clause 7.2.

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No breach of the Code was ruled.
No breach of Clause 7.2 was ruled in relation to the interchangeability/bioequivalence claims.
The Panel nevertheless expressed concerns about how the claim was referenced and framed (see below), and requested Beacon be advised of those concerns.

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