|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 0171-273 0100 / 0546|
|Facsimile 0171- 273 0548||KHJ/PD/jl|
|27 May 1998|
|From the Office of the Chief Executive|
Thank you for your letter dated 5 May 1998.
You say that almost exactly the information we have refused is on public record in North America. You will appreciate that different countries have different systems. We currently administer our disclosure policy within the terms of the Code of Practice on Access to Government Information. Equivalent policy in the USA, for example, is governed by various laws including those on freedom of information and privacy. The MCA will, in due course, work within the legal and administrative frameworks to be established under forthcoming freedom of information legislation.
We are well aware that clinical trials have limitations and we exist to regulate medicines in the best interests of the "man on the Clapham omnibus". Most decisions we make require a delicate balance to be achieved. Over-restriction may be just as damaging to patients as inaction.
On the specific point of SSRIs, there is little I can add to our previous correspondence and I suspect that we shall have to agree to differ over the issue of the definition of dependence. It is our view that clinical implications are the critical issue. As a consequence of dependence potential, authorised use of benzodiazepines became subject to major restrictions in the late 1980s. We do not believe however that the clinical consequences of withdrawal symptoms with SSRIs justify such action on present evidence. We nonetheless recognise the need for doctors and patients to have access to adequate information on this issue and are currently reviewing the information that is available. We will decide what steps we can take to develop this further once our review is complete and will let you know the outcome.Yours sincerely,
|Dr K H Jones|
|Director and Chief Executive|
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