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Our Ref: HJS/jr

14 October 2002

Mr Charles Medawar
Director, Social Audit Ltd
PO Box 111
London              NW1 8XE

Dear Mr Medawar

Case AUTH/1318/5/02 Safety of Seroxat (paroxetine)

Thank you for your email enclosing Social Audit’s statement about the outcome of the appeal last Thursday and a copy of your letter to the Medicines Control Agency

It is of concern that you have stated Social Audit’s view of the Implication of the rulings before the detailed written reasons for the rulings have been disclosed to either party. Your statement does not make it clear that your position is based on very limited information about the outcome of the appeal. As you will recall, the Authority’s brief statement which was sent to you on 11 October and was as follows:

The ABPI Code of Practice for the Pharmaceutical Industry covers the promotion of medicines for prescribing and the provision of information to the public about such medicines It Is not the purpose of the Code to assess the safety of medicines. This is a matter for the various regulatory authorities. Each product has a summary of product characteristics and patient information leaflets both of which are covered by regulations and the contents are approved by the regulatory authorities. Insofar as these documents are not promotional they are not covered by the Code.

The Code of Practice Appeal Board heard an appeal yesterday with regard to a complaint against GlaxoSmithKline. The materials at Issue were statements in the media about Seroxat made by a spokesperson of GlaxoSmithKline. The Appeal Board ruled breaches of the Code. Detailed reasons for the rulings have not yet been provided to the parties. This will be done in due course and following conclusion of the case a full report will be published In the Code of Practice Review.

I would like to reiterate that the rulings are in relation to statements made by a GlaxoSmithKline employee which appeared In the press and not about the contents of the summary of product characteristics and the patient Information leaflet.

One minor point is that there are six independent members of the Appeal Board plus the chairman giving a total of seven independent members and not six independent members including the Chairman as in your statement.

In accordance with the Constitution and Procedure for the Prescription Medicines Code of Practice Authority you will be provided with full details of the outcome of Case AUTH/I318/5/02 in due course.

Yours sincerely

Heather Simmonds (Mrs)


Director Heather Simmonds 020 7747 1438
Secretary Etta Logan 020 7747 1405
Deputy Secretary Jane Landles 020 7747 1415


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