Social Audit Ltd
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Dr June Raine, Director, Post-Licensing Division
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

7 October 2004


Dear Dr Raine,

I hope to reply to your letter dated 30 September within the next few days. In the meantime, I am copying to you the letter I have sent this morning to Professor Sir Alasdair Breckenridge.

On a quick reading of your letter, it seems we made one mistake – wrongly assuming that reports whose source was identified on the spreadsheets as ‘ABPI’ had been sent by the ABPI. Thank you for explaining that this referred to reports on Yellow Cards printed in the ABPI Data Sheet Compendium. We apologise for this mistake, but do not think it is material: if you do think it has any significance in the context of the whole report please advise me. I would like to think we could have avoided this error, if the MHRA had been able to meet us at the appropriate time, as we requested on several occasions.

Perhaps you could also clarify one point I found confusing. Your letter twice emphasises that we were not sent ASPPs but some other data - and that you made this clear to us in correspondence and in discussion with us. I do not think we had any such discussion, but please will you refer us to the specific parts of the letters you mention, in which you believe you made this point clear. Many thanks.

Yours sincerely,
Charles Medawar