Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7 273 0267
Facsimile 020 7  273 0293	.
	30 October 2000
	Ref: OG 00/20

Dear Mr Medawar,

Thank you for your letter of 18 July concerning Seroxat and the MCA's post marketing advertising activities. I understand that you have since then received a letter from Mrs Thyer outlining the activities of the Advertising Unit in general terms (copy enclosed for ease of reference). I now turn to the points in your recent letter.

Please supply ... any other information facts and analyses that would help explain the basis on which the MCA concluded that the overall balance of evidence is in favour of the headline claim ".

The issues you raise have been discussed with colleagues which included taking account of advice from our legal advisors. I consider that the information you request above should be withheld under Exemption 4(c) of the Code of Practice on Access to Government Information. Exemption 4(c) relates to legal proceedings and exempts "Information relating to legal proceedings or the proceedings of any tribunal, public enquiry or other formal investigation which have been completed or terminated, or relating to investigations which have or might have resulted in proceedings".

In relation to this particular complaint we have discussed disclosure of information with the Marketing Authorisation holder. The company have indicated their willingness to discuss the matter with you directly. The contact details are Mr R M Hull, Senior Regulatory Advisor, SmithKIine Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Herts, AL7 IEY.

As you know if you consider that your request has not been properly handled under the code or that any information has been unreasonably withheld, you may seek an internal review. If you remain dissatisfied, you can ask a Member of Parliament to make a complaint on your behalf to the Parliamentary Commissioner for Administration who may decide to conduct his own investigation.

Yours sincerely

MRS J MACDONALD

Head, Product Information & Advertising

Post Licensing Division

 

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