ATTACHMENTS: MISLEADING ADVERTISING OF EXEFOR XL (VENLAFAXINE)

Some 80-pages of documentation were attached to the MHRA response – far too much to scan and post here. However, the covering page is reproduced below, [a] to give some idea of the contents and [b] to assist anyone wanting to obtain copies of these documents from the MHRA for themselves.

These papers indeed explain and justify the seven month delay in resolving this complaint, and might prove a valuable resource for anyone undertaking a detailed study of the regulation of medicines and drug advertising. The manufacturers of Efexor XL, Wyeth, makes the most of the MHRA’s original sin – the Agency pre-vetted this advertisement and approved it - and the company really goes to town. No stone is left unturned to try to justify the company’s position and to challenge the MHRA’s revised interpretation of its advertisement. The energy and resources that Wyeth deploy to mount its self-defense is mighty and relentless. No wonder the regulators are scared stiff at the prospect of legal entanglements – having said which, the MHRA deserves credit on this occasion for hanging in there.

If you want the chapter the verse, here’s what to request from the MHRA:

REPRESENTATIONS TO THE INDEPENDENT REVIEW PANEL ON ADVERTISING BY JOHN WYETH & BROTHER LIMITED¹
IN RELATION TO AN ADVERTISEMENT FOR EFEXOR XL

 

Contents

Section		Page
A	Introduction	2
B	Wyeth's Representations	3
C	Background	5
D	Wyeth's Arguments	7
D1	Wyeth's Arguments - Legislative Interpretation	7
D2	Wyeth's Arguments - General Arguments	9
D3	Wyeth's Arguments - MHRA Reasons	12
E	Further Representations	17
E1	Further Representations - Corrective Statement	17
E2	Further Representations - Unfairness	19
	Schedule	21

1 In this document John Wyeth & Brother Limited will be referred to as "Wyeth"

NOTE: THESE PAPERS WERE FIRST RECEIVED BY SOCIAL AUDIT ON 16 JUNE 2006. FOR REASONS THAT REMAIN UNCLEAR, THE MHRA'S LETTER AND THESE ATTACHMENTS WERE NEVER RECEIVED WHEN FIRST SENT ON 9 DECEMBER 2005.

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