Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7273 0763
Facsimile  020 7273 0675	.

Dear Dr Healy,

Thank you for your letter of 28 February. Please accept my apologies for the delay in responding.

Thank you for your explanation of what you mean by 'legal jeopardy'. You ask specifically for our comments on this.

You state that a pharmaceutical company could deny that their drug caused a particular problem based on the way side effects are coded in clinical trials. When establishing the causal relationship between a suspected adverse reaction and a drug, all available evidence should be evaluated, not simply clinical trial data. Many adverse reactions are identified through monitoring of the drug in general clinical practice which are not evident in the clinical trials.

The basis for your argument is that certain adverse reaction terms are not being coded for satisfactorily during clinical trials. The Medical Dictionary for Regulatory Activities (MedDRA) is the internationally accepted medical terminology for use in drug regulation. It was, developed under the auspices of the International Conference on Harmonisation and was based on the MCA's own medical dictionary. I would like to point out that the terms that you specifically mention - suicidal ideation, akathisia, emotional indifference and disinhibition are all coded for in MedDRA.

You mention that side effect data produced by pharmaceutical companies is inadequate. Under European law, pharmaceutical companies are under continuing obligation to provide information relevant to the safety of licensed medicines to regulatory authorities. Both pharmaceutical companies and regulators are responsible for ensuring that appropriate action is taken in response to new evidence and for ensuring that product information reflects the available information on the drug. Indeed it is in the interests of the company to ensure that all adverse effects are labelled.

Yours sincerely

Sarah Wark

Senior Scientific Assessor

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