Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0642
Facsimile 0171- 273 0286 .
3 February 2000

Dear Mr Medawar,

Thank you for your letters of 1 December 1999 and 21 January about the dosage formulations for fluoxetine. My apologies that this reply has been delayed.

May I first remind you that under the Code of Practice on Access to Government Information (the Code), departments are not required to obtain information which they do not possess (paragraph 4 of the Code). This is relevant to your question (and associated queries) as to whether the MCA/CSM were aware of the reasons leading to the FDA's approval to the introduction of the l0mg and 5mg strengths of Prozac. This information is not held by the Agency and I can therefore only suggest that you may wish to approach the FDA direct.

I have found no record that the CSM has been asked, 'or expressed a view, over the need for a lower dose (or lower dose formulation) for fluoxetine. I believe that there was arbitration on a generic fluoxetine before the CPW in 1997 (according to the EMEA website the CPW decision was given on 17 December 1997) but this did not address the matter of a lower dose. Nor is the Agency aware of any current safety issues with fluoxetine which relate specifically to the question of posology. We do not therefore consider that there is a need to formally ask the licence holder, as you suggest, about possible changes to the current dosage formulations of their product. Again, you are, of course, free to do so direct if you wish.

If you consider that I have not considered your requests reasonably under the terms of the Code you may, as you know, ask for an internal review of my decision. 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 Anne Thyer
Executive Support


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List of MCA/CSM Correspondence