Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	our ref: OG 98/18, 23 etc.
	16 June 1998

Dear Mr Medawar,

REQUESTS FOR INFORMATION RELATING TO THE COMMITTEE ON SAFETY OF MEDICINES

I am writing further to my letter of 30 April, your reply of 3 May and Professor Rawlins' response to you of 8 May concerning your various requests for information relating to the Committee on Safety of Medicines. I have summarised these as attached.

Professor Rawlins' reply said that members of CSM had decided not to provide you with the answers to your questions and invited you to raise this with the MCA if you wished to take this further. You said in a telephone conversation with Peter Dunlevy that you wished us so to do. We are considering these requests and I will write to you again as soon as I can.

As Dr Jones is now away until the end of this month, I will reply to your most recent letter of 3 June as soon as I can. We will also let you know as soon as possible the outcome of the review you requested of our decision of 6 February not to disclose information. I regret any inconvenience this may be causing. We will include our replies to the additional requests for information you made in your letter of 11 February.

I have also received your request of 4 June for Agency SOPs which we have linked with your previous request of 19 May, and also a copy of your further letter of 10 June to Professor Rawlins which you also ask to be dealt with under the Code of Practice and your letter of today's date about Dr Munro's review, to all of which I shall reply as soon as I can.

Attachment

Letter of 12 March to Prof. Rawlins

• formal votes in CSM meetings in 1991 and 1997 connected with the licensing of any particular drug;
• instances of members absenting themselves from meetings to avoid possible conflicts of interest;
• personal interests declared in relation to (a) SSRI products discussed since 1987 and (b) to any "relevant product" at the last 5 CSM meetings;

Letter of 10 March to Mr Alder 

• copies of any discussions relating to commercial confidentiality recorded in (extracts of) CSM minutes over the last 5 years;

Letter of 20 March to Mr Whitbread

• copies of all 1998 CSM and sub-committee minutes edited to remove confidential information; and
• details of forthcoming CSM and sub-committee meetings.

 Mr Medawar has also asked in a letter of 14 May to Professor Rawlins for:

• CSM's mandate in relation to Code requests;
• extract of relevant minute of CSM's meeting which discussed the request of 12 March;
• any CSM/MCA consideration within the last 6 months (taken to mean since December 1997) of revisions to data sheet warnings about withdrawal reactions with SSRIs;
• if so, whether or not CSM is satisfied with them as they stand; and
• if not, whether CSM has some substantial revision in mind

and a number of further questions in a letter of 10 June relating to the previous correspondence between him and Professor Rawlins on SSRIs.

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