|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 020 7 273 0267|
|Facsimile 020 7 273 0293||.|
|1 February 2001|
Dear Mr Medawar,
I am writing in connection with our correspondence during last year in relation to the promotional activities associated with Cipramil marketed by Lundbeck, I apologise for the long delay in collating the information you sought in your letter of 25 July 2000.
When I wrote to you on 30 October 2000, in relation to Seroxat, I indicated that it would not be possible to provide details of our correspondence with the marketing authorisation holder or the basis upon which our decision was made and the reasons for this. I attach a further copy of this letter for ease of reference, as the arguments presented remain valid in respect of this enquiry.
You also asked for references to any definition of or guidance relating to the meaning of the term "objectivity" within the meaning of regulation 3(A) (2) of the Advertising Regulations on which MCA review(s) relied".
Regulation 3(A)(2) requires that an advertisement encourage the rational use of a product by presenting it objectively and without exaggerating its properties. "Objectively" in this context is taken to mean that the advertisement is factual and not based on opinion. In relation to your complaint our assessor found that the claim made by the advertiser was not substantiated and subsequently amended.
In relation to your request to see the standard operating procedures in relation to advertising control, these are currently under revision. On completion of the review process I will be pleased to forward a copy of these to you.
|MRS J MACDONALD|
|Head, Product Information & Advertising|
|Post Licensing Division|