4351SKB

Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0729
Facsimile 0171- 273 0286

Dr Anita Stockwell
Director of UK Regulatory Affairs
SmithKline Beecham plc
Mundells	our ref: OG97/16
WELWYN GARDEN CITY
Herts AL7 1EY	7 November 1997

Dear Dr Stockwell,

PAROXETINE (SEROXAT): REQUEST FOR INFORMATION UNDER THE CODE OF PRACTICE ON ACCESS TO GOVERNMENT INFORMATION

I am writing to advise you of a request we have received for information about paroxetine (Seroxat) under the Code of Practice on Access to Government Information (the Code), a copy of which is attached.

We have been asked to provide the following information, in relation to the design, size and characteristics of the patient base, about the incidence of withdrawal reactions observed in clinical trials of paroxetine (on the basis of data published by the US Food and Drug Administration about the numbers involved in pre-clinical testing, though the MCA has not yet confirmed the existence of such published data):

whether the protocols relating to any of the pre-licensing clinical trials of paroxetine required that patients be withdrawn from the active drug in order to observe possible withdrawal symptoms, and, if so, how many patients completed such trials;

to confirm whether the MCA/CSM (Committee on Safety of Medicines) made any specific requirement of SmithKline Beecham to investigate the incidence and severity of withdrawal reactions, and, if so, what the duration of active drug treatment was, and how many patients completed such trials;

what proportion of patients involved in all pre-licensing clinical trials experienced withdrawal symptoms, in relation to the total numbers who discontinued treatment with paroxetine during the study period, excepting those who withdrew because of problems with side effects or protocol violations;

what proportion of patients involved in properly conducted, placebo-controlled, pre-licensing clinical trials experienced withdrawal symptoms, in relation to the total numbers who discontinued treatment with paroxetine during the study period, excepting those who withdrew because of problems with side effects or protocol violations; and

what proportion of patients involved in pre-licensing clinical trials of more than six weeks' duration experienced withdrawal symptoms, in relation to the total numbers who discontinued treatment with paroxetine during the study period, excepting those who withdrew because of problems with side effects or protocol violations.

Such information may be covered by exemptions 13 and 14 of the Code, which exempts commercially and other types of confidential information from the normal disclosure requirements. However, the general presumption under the Code, is that the MCA will make information available unless there are sound reasons of public interest for not releasing it.

We are therefore considering whether it would be appropriate to disclose the information requested, but your views on the following questions will help us in coming to a decision:

i) whether any such disclosure would harm the company's competitive position, and, if so, in what way. and

ii) whether the company is content for all, or part, of the information requested to be disclosed.

We will then decide what, if any, information to release.

The Code requires public bodies to respond to requests for information within certain deadlines. I would therefore be grateful for your reply as soon as possible. If you need further information about this matter, please do not hesitate to contact me.

Yours sincerely

Peter Dunlevy

Executive Support

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List of MCA/CSM Correspondence