Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	.
	17 August 1998

Dear Mr Medawar,

PAROXETINE: FURTHER LETTER OF 29 JUNE

1. Thank you for your letter of 29 June, to which I am now replying as promised in my letter of 29 July.

2.  I do not believe the questions you put in paragraphs 2, 3 and 6 constitute valid requests for  information under the Code of Practice.

3.  Our replies to your other questions are set out below.

4.  Reports to the EMEA/CPMP Pharmacovigilance Working Party are treated as confidential by member states and by the EMEA.   I therefore regret that I am unable to meet your request for a copy of this paper under exemption 1(b)    ("information whose disclosure would harm the conduct of international relations or affairs") and exemption 2 ("confidential communications between ... regulatory bodies.") of Part II of the Code. Our reasons are that disclosure would impair the candour and effectiveness of communications between the MCA and other regulators. We have always treated such reports as confidential and we need to preserve the facility for exchanging views on a confidential basis.

5 .   However, I can advise you that the paper contained the following non-confidential information

i) a summary and brief commentary of the issues relating to SSRIs and withdrawal reactions/dependence raised by the publication of 'The Antidepressant Web' and the work of the MCA to review the evidence;

ii) a background section comprising:

• a summary of the findings of the paper by Price et al which investigated spontaneous reports of withdrawal reactions associated with paroxetine;

• a statement highlighting the large number of spontaneous reports of withdrawal reactions associated with venlafaxine;

• a brief discussion of spontaneous reporting of withdrawal reactions and dependence for benzodiazepines compared with that for the SSRIs; and

iii) appendices with your and Price et al's articles.

6.     For the same reasons, I regret I am unable to supply a copy of a second paper which we sent          to the Working Party in April and which it discussed at its May meeting.

7.     Between 16 January 1998 and the end of May, we consulted the following bodies:

Food and Drug Administration, USA

Australian Drug Evaluation Committee

Bureau of Pharmaceutical Assessment, Health Canada

National Toxicology Group, New Zealand

8.     A representative example of the letter we sent is attached.

9.     We consulted the following committees:

Sub-Committee on Pharmacovigilance - 24 February 1998

Committee on Safety of Medicines - 26 March 1998

Pharmacovigilance Working Party - 13 May 1998

10.  We also sent reminder letters or had ongoing correspondence during these dates with various  MA holders and other regulatory authorities which centred on clarification of our initial request. A sample copy of the reminder infofax we sent is attached.

11. Our letters did not invite respondents to submit evidence in confidence, nor did those who         replied, with the exception of one respondent, request confidentiality. However, when we consult bodies such as those listed in para. 7 above it is usually on a confidential basis and on the implicit understanding that we will not divulge individual views. For the reasons set out in Dr Munro's report, I am therefore unable to provide copies of replies we have received to our enquiries nor copies of the further correspondence I refer to in para. 10 above. Our consultations with the committees I refer to in para 9 are confidential and exempt from disclosure under exemption 2 of Part II of the Code ("confidential communications between departments, public bodies and regulatory bodies") Disclosure would harm the frankness and candour of our discussions and we need to preserve the facility for exchanging views on a confidential basis.

12.  If you have any query about this letter, please contact me. If you are unhappy with my decision not to provide certain information, you should write to Dr Jones in the first instance and ask for a review. After that, if you remain unhappy, you may ask a Member of Parliament to make a complaint on your behalf to the Ombudsman (known officially as the Parliamentary Commissioner for Administration) who will decide whether or not to conduct his own enquiry. His address is Millbank Tower, Millbank, London SWIP 4QP.

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