emealogo2.jpg (2881 bytes) The European Agency for the Evaluation of Medicinal Products
Human Medicines Evaluation Unit
London, 20 July, 1998
EMEA-H-RB-plm-25881-1998
Direct Line +44.171.418.8411
Mr Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG

Dear Mr Medawar,

I refer to your letter dated 14 July 1998 and the note enclosed on "SSRIs, EMEA, and the CPMP".

As most of the note is an expression of personal opinion it would of course be difficult for me to either agree or disagree.

Nevertheless, I would like to take this opportunity to comment on a few of the points you noted:

I would certainly be interested in the "average doctor or patient" and their understanding of texts presented to them. Numerous investigations have certainly contributed to improving the value of such information, but I do not share your uni-directional interpretation that "withdrawal reactions were of minor significance" as this does not reflect the text of the Summary of Product Characteristics (SPC)

Whereas SPC and Patient Information Leaflet (PIL) have to give information about adverse reactions, where possible their frequency and severity, and the marketing authorisation takes into account such a situation, it is certainly not possible or useful to mention the "unknown" or personal opinions as listed in [a] to [J] of your letter dated 14 July 1998.

Yours sincerely
Prof Rolf Bass
Head of Human Medicines Evaluation Unit

 

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